chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; Have gotten / shingles vaccine yet have had it 6 times over the past 4 years; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included 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: Age at vaccination was not reported. The patient reported that the patient received all available shingles vaccine yet have had shingles 6 times over the past 4 years. The case was considered as suspected vaccination failure since the details regarding dose number, time to onset and laboratory confirmation was not given.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a couple of patients past the 6 month time frame for their 2nd dose of Shingrix; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in an unspecified number of patients 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. The patients did not receive the 2nd dose till the time of reporting and were past the 6 month time frame for their 2nd dose which led to incomplete course of vaccination. The reporter declined to provide any patient details, stating that he did not have permission from the patients. This case has been linked with US2021072245, reported by same reporter.; Sender's Comments:  AE-GLAXOSMITHKLINE-US2021072245:Same reporter. 1 patient.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Alcohol use, Arthralgia, Exostosis, Joint swelling, Neck pain
Clinical narrative: Rhumatoid arthritis; Hand/wrist swelling; Mild shoulder pain; Osteophytosis; Neck pain; Polymyalgia Rheumatica; This case was reported by a lawyer and described the occurrence of polymyalgia rheumatica in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for an unknown indication.   The initial information was received on 31 March 2021 via medical record (case is medically confirmed) The patients current condition included Polymyalgia Rheumatica onset date 26 June 2019, Rhumatoid arthritis, Hand/wrist swelling, Mild shoulder pain, Osteophytosis and Neck pain. family medical history includes Mother had Hypertensive disorder and father had heart disease. Additional patient details include Nonsmoker and Alcohol uses around 12 beers per week. The patient was used Shingrix 0.5 ml via Intramuscular route on 27 June 2016. The patient was hospitalized on 11 August for patient had right total knee replacement / total join replacement performed on right femur with Stryker triathlon PA knee system.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Non-tobacco user, Peripheral swelling, Polymyalgia rheumatica, Rheumatoid arthritis
Clinical narrative: Rhumatoid arthritis; Hand/wrist swelling; Mild shoulder pain; Osteophytosis; Neck pain; Polymyalgia Rheumatica; This case was reported by a lawyer and described the occurrence of polymyalgia rheumatica in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for an unknown indication.   The initial information was received on 31 March 2021 via medical record (case is medically confirmed) The patients current condition included Polymyalgia Rheumatica onset date 26 June 2019, Rhumatoid arthritis, Hand/wrist swelling, Mild shoulder pain, Osteophytosis and Neck pain. family medical history includes Mother had Hypertensive disorder and father had heart disease. Additional patient details include Nonsmoker and Alcohol uses around 12 beers per week. The patient was used Shingrix 0.5 ml via Intramuscular route on 27 June 2016. The patient was hospitalized on 11 August for patient had right total knee replacement / total join replacement performed on right femur with Stryker triathlon PA knee system.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Flank pain, Muscular weakness, Musculoskeletal chest pain
Clinical narrative: Polyarticular Joint Pain; Costal margin pain; Knee buckling; Left flank pain; This case was reported by a lawyer and described the occurrence of polyarthralgia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced polyarthralgia (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the polyarthralgia was unknown.   It was unknown if the reporter considered the polyarthralgia to be related to Shingrix.  Additional information: The initial information received on 31 March 2021 through medical records (case is now medically confirmed). The plaintiff was a male patient. His concurrent condition included he was a nonsmoker. His historical condition includes Bursitis and Olecranon bursitis. He had used the Shingrix vaccine 0.5 ml intramuscularly on 12 February 2019 for prophylaxis. He was diagnosed with Costal margin pain on 06 November 2020, left Knee buckling on 13 October 2020, Left Flank Pain on 10 July 2020 and the out come was unknown.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Unknown at this time; This case was reported by a lawyer and described the occurrence of adverse event in a patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 24th December 2020, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced adverse event. The action taken with Shingrix was unknown. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details: The patient ingested Shingrix vial on 24 December 2020. The patient had experienced event as Unknown at this time.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Death, Dementia, Encephalopathy, Parkinson's disease
Clinical narrative: Parkinson's Disease; mild dementia; Encephalopathy; This case was reported by a lawyer and described the occurrence of parkinson's disease in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   The patient's past medical history included parkinson's disease.   On 7th January 2020, the patient received Shingrix (intramuscular) 50 mcg. On 23rd January 2020, more than 2 weeks after receiving Shingrix, the patient experienced encephalopathy (serious criteria GSK medically significant). On an unknown date, the patient experienced parkinson's disease (serious criteria death and GSK medically significant) and dementia (serious criteria GSK medically significant). On an unknown date, the outcome of the parkinson's disease was fatal and the outcome of the encephalopathy and dementia were unknown. The patient died on 18th March 2020. The reported cause of death was parkinson's disease. An autopsy was not performed.   It was unknown if the reporter considered the parkinson's disease, encephalopathy and dementia to be related to Shingrix.  The initial information was received on 31 March 2021 via medical record (case is medically confirmed). As per pharmacy record, the patient ingested Shingrix 50mcg injection administered 0.5 ml in the muscles as directed on 07 January 2020. As per death certificate, patient died on 18 March 2020, the cause of death was Parkinson's Disease. The autopsy was not performed. The manner of death was natural. The patient had parkinsonism by September 2015. Patient has had evidence of parkinsonism and mild dementia. The patient experienced Encephalopathy diagnosed on 23 January 2020. He was hospitalized a day after shingles vaccine at which point he was noted to be encephalopathic. He remains encephalopathic although better than when in hospital.; Reported Cause(s) of Death: Parkinson's Disease
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: 25 year old / pediatric dose of Havrix; 25 year old / pediatric dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 25-year-old female patient who received HAV (Havrix pediatric) (batch number Y4FL4, expiry date 28th January 2022) for prophylaxis.   On 7th December 2020, the patient received the 1st dose of Havrix pediatric .5 ml. On 7th December 2020, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were reported as follows: The nurse practitioner reported that the patient was administered Havrix pediatric dose, which led to unerdose and adult use of a child product. No symptoms reported. The reporter consented to follow up. The reported batch number Y4SL4 for Havrix pediatric did not exist and was updated to Y4FL4 as per the sales database.   Follow up information was provided by nurse on 29th March 2021: The patient demographic details were updated. The VAERS details were updated. The reporter stated that no adverse effects were seen and the wrong vaccination given was discovered during billing process. Then the patient received correct dose of Havrix adult.
Age: 6.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 6 year patient was given Bexsero; as meant for a 16 year old patient in a different room because the rooms got mixed up; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB26AB, expiry date February 2022) 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.   On 3rd March 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd March 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The Bexsero was recommended from aged 10 through 25 years. The physician stated 6 year patient was given Bexsero that was meant for a 16 year old patient in a different room because the rooms got mixed up, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.   Follow up information received by the pharmacist on 31st March 2021: The patient's demographic details were added. The batch number and expiry details were updated. Since 2019, the patient had learning problems and was in program for several years and recently was advised to see an outside and to visit psychologist for further evaluation. The patient received 1 ml Bexsero (intramuscular).  The reporter stated that the vaccine was ordered for 16 years old patient in the office. When medical assistant called the 16 years old patient's name, the 6 year patient who was in the office for another reason waked in the room with his mother. The medical assistant did not verify the name and age of the patient and administered Bexsero to the 6 years old patient. The patient had next appointment 1 week post reporting date and the patient's mother reported that the patient was doing good and had no side effects or complaints.
Age: 30.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 30 year old patient who received a dose of Shingrix / administered shingrix by mistake; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 30-year-old male patient who received Herpes zoster (Shingrix) (batch number E9C7K, expiry date 14th October 2022) and (batch number MM59F, expiry date 14th October 2022) for prophylaxis.   On 3rd March 2021, the patient received Shingrix. On 3rd March 2021, the dose was an unknown dose. On 3rd March 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The 30 year patient received shingrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.   Follow up information received from other health care professional on 29th March 2021: The patient's demographic details were updated. The reporter stated that, the patient received shingrix vaccine by mistake. The patient was feeling fine and no reactions. The VAERS details were updated.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: A patient was administered a third dose of Shingrix today; sore arm after injection; received 1st 12/8/2020, 2nd dose 01/20/2021; 1-2 days of fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of pain in am in a 56 years old, adult patient who received Herpes zoster (Shingrix) (batch number 744AH, expiry date 3rd October 2022) (adjuvant batch number 4JH43, expiry date 13th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st two doses on unknown date).   On 16th March 2021, the patient received the 3rd dose of Shingrix. On 16th March 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 age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.   Follow up information was received from the pharmacist on 30th March 2021: The patient's demographics details were updated. The batch number was updated. The patient received 1st dose of the Shingrix on 8th December 2020 and 2nd dose was received on 20th January 2021 earlier than recommended schedule time, which led to shortening of vaccination schedule. The patient had 3rd dose of 0.5 ml on unknown arm via intramuscular route. The VAERS details were updated. Less than 2 weeks after vaccination, the patient had sore arm after injection and 1 or 2 days of fatigue, but no other adverse events. On an unknown date, the event fatigue was recovered. The reporter considered extra dose administered to be related to the Shingrix. It was unknown if the reporter considered the fatigue and sore arm to be related to the Shingrix.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: left arm pain /  The pain goes down her arm/ includes injection site pain; left arm and left hand go numb; she cannot drip items well and thus she drops items from the left arm / cannot rotate her arm in a circle; the pain goes up her arm to her left shoulders; as a result, she could not drip items well and thus she drops items from the left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date.).   On 10th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, couple of days after receiving Shingrix, the patient experienced pain in arm, numbness of extremities, injected limb mobility decreased, shoulder pain and weakness of arms. The patient was treated with acetylsalicylic acid (Aspirin Oral) and diclofenac (Voltaren). On an unknown date, the outcome of the pain in arm, numbness of extremities, injected limb mobility decreased, shoulder pain and weakness of arms were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, numbness of extremities, injected limb mobility decreased, shoulder pain and weakness of arms to be related to Shingrix.  Additional details were reported as follows: The patient did not know the date of the first dose of Shingrix vaccine and also she did not know the lot number of the vaccine. The patient received second dose of Shingrix vaccine in her left arm. Few days after, the patient she started to have left arm pain which also included injection site pain. The pain went down her arm and also made her left arm and left hand go numb and as a result, she could not drip items well and thus she drops items from the left arm. She could not lift her left arm and also the pain went up her arm to her left shoulders. She could not rotate her arm in a circle. She had tried topical Voltaren and topical Icy Hot which had not helped her with her pain. She did take oral aspirin. The pain was constant. She reported lack of drug effect for Voltaren gel and the call center representative had emailed the Voltaren gel event to the Agency. The patient consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: left arm pain /  The pain goes down her arm/ includes injection site pain; left arm and left hand go numb; she cannot drip items well and thus she drops items from the left arm / cannot rotate her arm in a circle; the pain goes up her arm to her left shoulders; as a result, she could not drip items well and thus she drops items from the left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date.).   On 10th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, couple of days after receiving Shingrix, the patient experienced pain in arm, numbness of extremities, injected limb mobility decreased, shoulder pain and weakness of arms. The patient was treated with acetylsalicylic acid (Aspirin Oral) and diclofenac (Voltaren). On an unknown date, the outcome of the pain in arm, numbness of extremities, injected limb mobility decreased, shoulder pain and weakness of arms were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, numbness of extremities, injected limb mobility decreased, shoulder pain and weakness of arms to be related to Shingrix.  Additional details were reported as follows: The patient did not know the date of the first dose of Shingrix vaccine and also she did not know the lot number of the vaccine. The patient received second dose of Shingrix vaccine in her left arm. Few days after, the patient she started to have left arm pain which also included injection site pain. The pain went down her arm and also made her left arm and left hand go numb and as a result, she could not drip items well and thus she drops items from the left arm. She could not lift her left arm and also the pain went up her arm to her left shoulders. She could not rotate her arm in a circle. She had tried topical Voltaren and topical Icy Hot which had not helped her with her pain. She did take oral aspirin. The pain was constant. She reported lack of drug effect for Voltaren gel and the call center representative had emailed the Voltaren gel event to the Agency. The patient consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Peripheral swelling
Clinical narrative: Had body aches; chills; arm swelling; Got / shot in 11/2019, got 2nd shot yesterday; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   On 23rd March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd March 2021, less than a day after receiving Shingrix, the patient experienced general body pain, chills, swelling arm and drug dose administration interval too long. On an unknown date, the outcome of the general body pain, chills and swelling arm were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.  It was unknown if the reporter considered the general body pain, chills and swelling arm to be related to Shingrix.  Additional details were reported as follows: A day before reporting, the patient received 2nd dose of Shingrix and experienced body aches, chills and arm swelling. The patient received 2nd dose later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: prescription for Shingrix  that was written for a 44 year old patient; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 44-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 Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated they just received the prescription for Shingrix that was written for a 44-year age of patient and physician confirmed the prescription was due to prior Shingles, which led to intercepted drug prescribing error. The health care professional stated, the written prescription for Shingrix however no confirmation if the health care professional administered the vaccine during reporting. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: after receiving the his Shingrix vaccine with us, within 7 days he had the Shingles virus / experienced the Shingles virus; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 51-year-old 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, less than a week after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and within 7 days had the Shingles. The doctor recommended to report it and to find out if the patient allowed to get a second dose of vaccine, as the patient would be coming up due in just a couple months.  The reporter stated that he/she was calling about the same  The patient was treated for the Shingles.  The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Syringe issue, Underdose
Clinical narrative: a drop didn't make it into his arm / possible underdose.; experienced arm pain (in the injected left arm) / isn't the "typical pain that you get" for a day or so / his arm hurt more than normal / is still a little bit there; it is not 100% resolved yet; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid-19 vaccine (received a Covid-19 shot in right arm months earlier from reporting day).   On 23rd March 2021, the patient received the 1st dose of Shingrix (intramuscular). In March 2021, less than a week after receiving Shingrix, the patient experienced pain in arm. On 23rd March 2021, the patient experienced underdose. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the underdose was unknown.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient received Shingrix shot intramuscularly in the left deltoid and told that normally he gets immunizations in right arm but because he have received a Covid-19 shot in right arm months earlier, he decided to receive the Shingrix into his left arm instead.  The patient told that normally when gets a shot the patient did not flinch but with this Shingrix shot the patient did flinch and jump and due to that the pharmacist stated that a drop did not make it into arm, which led to possible underdose. The reporter was concerned about a possible underdose.  The reporter was wondering if the pharmacist might had used a longer needle than normal.  The patient experienced arm pain in the injected left arm after the injection.  The patient stated that it was not typical pain that get for a day or so after a shot, but that his arm hurt more than normal.   The patient was asked whether his arm pain had resolved at time of reporting to which he replied as there was still a little bit there and it was not 100 percent resolved. The reporter did not consent to follow up. The patient did not had a personal fax number and did not had the lot number and expiration date of the injection on the paperwork was given however the patient did provide pharmacy's contact information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR071417:same reporter(deleted)
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: adult dose (20 mcg) of Engerix B was administered to a 19 year old; adult dose (20 mcg) of Engerix B was administered to a 19 year old; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number 5L27A, expiry date 11th February 2022) for prophylaxis.   On 24th February 2021, the patient received Engerix B adult (intramuscular) 20 µg. On 24th February 2021, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional information provided were as follows: The patient who was 19 years old, received 20 mcg of Engerix B adult, which led to overdose and adult product administered to child. The patient was transferred to medical information for further assistance. The health care professional's information was not provided. The reporter did not consented to follow-up.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received Menveo / mixed with saline diluent and not the liquid conjugate component.; received Menveo / mixed with saline diluent and not the liquid conjugate component.; This case was reported by a nurse via sales rep and described the occurrence of inappropriate dose of vaccine administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA439A, expiry date 28th February 2022) for prophylaxis.   On 10th March 2021, the patient received Menveo. On 10th March 2021, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional information was provided as follows: The patient received Menveo on 10th March 2021 which had been mixed incorrectly; it was mixed with saline diluent and not the liquid conjugate component, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The mistake was discovered and patient returned for a complete/correct dose of Menveo on 24th March 2021. The reporter did not consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Nausea, Pain
Clinical narrative: aches; low grade temperature of 100 degrees; tired / feeling tired; nauseous feeling; This case was reported by a consumer via call center representative and described the occurrence of pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 25th March 2021, less than a day after receiving Shingrix, the patient experienced pain, slight temperature, tiredness and nausea. On an unknown date, the outcome of the pain, slight temperature, tiredness and nausea were not recovered/not resolved.   It was unknown if the reporter considered the pain, slight temperature, tiredness and nausea to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received Shingrix and experienced aches, a low grade temperature of 100 degrees Fahrenheit, tired and nauseous feeling.  The patient reported that all these symptoms were ongoing and not resolved. The reporter consented to follow up. The patient declined to give address, email and fax number. The patient was unable to provide a full address, email, or fax number for pharmacy and was also unable to provide a dose, lot number, or expiration date for the shingrix vaccine the patient received.
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient that is under 50 years old received the first dose of Shingirx; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2021, the patient received the 1st dose of Shingrix. On 27th January 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The patient was under 50 years old received the first dose of Shingirx, which led to inappropriate age at vaccine administration. No further information was reported. Reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021054978:same reporter US-GLAXOSMITHKLINE-US2021042056:same reporter US-GLAXOSMITHKLINE-US2021030891:same reporter
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, Product administered to patient of inappropriate age, Underdose
Clinical narrative: 23 year old patient was administered a pediatric dose of Engerix-B; 23 year old patient was administered a pediatric dose of Engerix-B; dose was also expired; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 23-year-old male patient who received HBV (Engerix B pediatric) (batch number YX547, expiry date 24th March 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th March 2021, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 25th March 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose, adult use of a child product and expired vaccine used. On an unknown date, the outcome of the underdose, adult use of a child product and expired vaccine used were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The patient was administered a pediatric dose of Engerix-B (10 mcg), which led to underdose and adult use of a child product. The dose was received on 25th March 2021 and was expired on 24th March 2021, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: first dose of Shingrix on November 2019 / when she was ready for the second dose, "covid struck"; This case was reported by a consumer via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on November 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 age at vaccination was not applicable for this report. The patient wanted to know the time frame for the 2nd dose of Shingrix Vaccine. When the patient was ready for the second dose covid struck and the patient missed the 2nd dose. No further information available. The patient did not consent to follow up. The patient refused to provide email, home address, fax number, date of birth, vaccine rout of administration, expiration date or lot number. The patient refused to provide healthcare providers name, phone number, fax number and address.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Impaired work ability, Malaise
Clinical narrative: felt "Wiped Out"/still did not feel "100% the next day / called out at work; Headache; Chills; Nausea; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced fatigue, headache, chills and nausea. On an unknown date, the outcome of the fatigue, headache, chills and nausea were recovered/resolved.   The reporter considered the fatigue, headache, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received the first Shingrix vaccine in June 2020 in the AM. By 4 AM, the next day she had Nausea, Chills, and a Headache. The reporter stated that these symptoms seemed to be a twenty four hour thing. On the next day, patient felt wiped out. The patient was not feeling 100 percent and was called out at work. The reporter did not consent to follow up. All information was not available.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: felt "Wiped Out"/still did not feel "100% the next day / called out at work; Headache; Chills; Nausea; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced fatigue, headache, chills and nausea. On an unknown date, the outcome of the fatigue, headache, chills and nausea were recovered/resolved.   The reporter considered the fatigue, headache, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received the first Shingrix vaccine in June 2020 in the AM. By 4 AM, the next day she had Nausea, Chills, and a Headache. The reporter stated that these symptoms seemed to be a twenty four hour thing. On the next day, patient felt wiped out. The patient was not feeling 100 percent and was called out at work. The reporter did not consent to follow up. All information was not available.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: pediatric patient received an adult dose of Havrix; pediatric patient received an adult dose of Havrix; received / on March 25th, 2021 / first dose was given on November 2019; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 4-year-old male patient who received HAV (Havrix adult) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received in November 2019).   On 25th March 2021, the patient received the 2nd dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 25th March 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose, adult product administered to child and drug dose administration interval too long. On an unknown date, the outcome of the overdose, adult product administered to child 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 reported as follows: The reporter stated that the pediatric patient received adult Havrix dose, which led to overdose and adult product administered to child. The patient received 2nd dose of Havrix, later than the recommended interval, which led to lengthening of vaccination schedule. No further information was reported. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Influenza like illness, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Flu-like symptoms; felt as if she was "hit by a train"; pain in her arm; difficulty getting out of bed; first dose of Shingrix about a year ago / never received her second dose; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, pain in arm, mobility decreased and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, general body pain, pain in arm, mobility decreased and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient received 1st dose of Shingrix about a year ago from the date of reporting, The patient felt as if she was hit by a train, also experienced pain in her arm, difficulty getting out of bed and she felt flu-like symptoms.  The patient did not remember the arm she received it on since it was almost a year ago.  The patient never received her 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to following up with her physician.  The reporter did not consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Limb discomfort, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: 102 Fahrenheit Fever; Sore arms; Stiff arms; Flu-like symptoms; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fever, pain in arm, limbs stiffness and influenza-like symptoms. On an unknown date, the outcome of the fever, pain in arm, limbs stiffness and influenza-like symptoms were unknown.   It was unknown if the reporter considered the fever, pain in arm, limbs stiffness and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The case was reported by the managing pharmacist and pharmacy technician. After receiving Shingrix, the patient experienced fever, sore and stiff arms and flu like symptoms. The patient's body temperature was recorded as 102-degree Fahrenheit. The reporter did not consent to follow up.
Age: 14.0
Sex: F
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Twinrix has been given to a 14 year old; Twinrix / Instead of havrix and engerix b individually; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-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.   On 29th March 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 29th March 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by the agency without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received Twinrix instead of Havrix and Engerix B individually at 14 years of age, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter asked what side effects should be expected and how to proceed with appropriate vaccination. The reporter consented to follow up.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: was maladministrated with Kinrix  on March 22 2021; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7p5j5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd March 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd March 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 case was reported by manager supervisor. The 15 month old patient received Kinrix, which led to inappropriate age at vaccine administration. No adverse event was reported. The reporter consented to follow up. This case has been linked with US2021072205, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021072205:same reporter
Age: 0.83
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 10 month male patient was maladministrated with Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd March 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd March 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 10 month old patient received Kinrix, which led to inappropriate age at vaccine administration. No adverse event was performed. The reporter consented to follow up. This case has been linked with US2021072204, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021072204:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix on January 6th 2020 /  due to the pandemic situation / the second dose was delayed / administered on December 15th 2020; This case was reported by a nurse via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 6th January 2020).   On 15th December 2020, the patient received the 2nd dose of Shingrix. On 15th February 2020, 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 age at vaccination was not reported. No expiration date or vaccine lot number was provided. The patient received 2nd dose of Shingrix, more than the recommended interval, due to pandemic situation. Nurse was at the same time the patient that received the doses. The reporter consented to follow up.