chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pericardial effusion, Presyncope, Syncope
Clinical narrative: - First dose of phzier vaccine, on April 21, 2021 no severe symptoms.  - Second dose of Phizer on May 18, 2021,  gradually felt increasing fatigue, which became severe enough that I was unable to move or work as I normally do.  I was sleeping more than 11 hours per night and napping during the day without feeling rested. I am full time engineer and life-long endurance athlete, my resting HR is 30-40 bpm.  - June 27, I was experiencing weakness and fatigued and collapsed at home.  - June 28, I went to urgent care with shortness of breath and chest pain and weakness, near fainting.  I was brought to the hospital and saw MD who did ultrasound of my heart and found some pericardial effusion. No other issues we found at hospital with blood tests and examinations.  - June 28, I was dismissed from ER and told to return if I have more issue -June 29-July 11 continued to have extreme fatigue, shortness of breath, chest pain near my heart, heart palpitations, ongoing headaches and
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: It has been almost a year, and my arm is still so painful that I am unable to really use it.  This cannot be normal.
Sex: U
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: 7 other people got rheumatoid arthritis; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (7 other people got rheumatoid arthritis) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (7 other people got rheumatoid arthritis) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (7 other people got rheumatoid arthritis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was provided by reporter. No treatment drug was provided by reporter.  On 29-MAR-2022, case MOD-2022-523941 became invalid as the case contains multiple patients and no information about the patient provided with the source document.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Diplopia, Dizziness, Immediate post-injection reaction, Nausea, Vision blurred
Clinical narrative: Within 15min developed double vision and blurry vision; Within 15min developed double vision and blurry vision; patient was immediately nauseated after the vaccines, then became dizzy.; patient was immediately nauseated after the vaccines, then became dizzy.; Information has been received from Food and Drug Administration (FDA) on 04-FEB-2022.  This spontaneous report was received from a consumer and refers to a male patient of unknown age. The patient's current medical condition included attention deficit hyperactivity disorder (ADHD) and allergy to ciprofloxacin hydrochloride (+) dexamethasone (CIPRODEX) ear drops. On 22-NOV-2016, he received influenza vaccine inact split 3v (FLUARIX) and fainted a few hours after while at school and 12 hours after vaccine. Received vaccine as part of a well child visit. He also received annual influenza vaccines prior to that dose. Have not received influenza or any vaccines since 22-NOV-2016 until present round of vaccine. Concomitant therapies included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL).  On 14-JAN-2020 at 15:30, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) first dose, administered intramuscularly into left arm as prophylaxis (strength, lot #, and expiration date were not provided), diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), fourth dose, administered intramuscularly into right arm (strength, formulation, lot #, and expiration date were not provided) and meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) first dose, administered intramuscularly right arm (strength, formulation, lot #, and expiration date were not provided).  On 14-JAN-2020 15:31, (immediately after vaccines) patient experienced nausea, then became dizzy. On the same date at 15:31 (also reported as within 15 min after vaccination) the patient developed double vision and blurry vision. The outcome of nausea and diplopia was not recovered. The outcome of dizziness and vision blurred was also reported as not recovered/not resolved (reported as not resolved after more than 12 hours later).  The relatedness between the events and HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) was unknown.  Follow up information has been received on 25-MAR-2022 via telephone call from a licensed vocational nurse. She stated that the physician searched system in the office and was unable to locate any patients for this case. No further information was available.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; The patient was past her due date for her second dose of GARDASIL 9; This spontaneous report has been received from a pharmacist regarding a 28-year-old Caucasian female patient. The patient did not have illness on day of vaccination; pertinent medical history, concomitant therapies, drug reactions or allergies were not reported.  On 30-NOV-2021, the patient started the 3-dose series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) first dose, (strength, dose, route, and anatomical location were not provided) as prophylaxis.  On 07-MAR-2022, the patient received her second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered into the patient's left deltoid (valid lot # 1775809, expiration date: 18-AUG-2023). The patient was past her due date for her second dose of vaccine (inappropriate schedule of product administration). The patient received any other vaccines in the 4 weeks prior or on the same day. Moreover, no previous adverse events with vaccinations were listed.   The causal relationship between the event and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was unknown.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse events reported; expired dose of PROQUAD was found administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 18-FEB-2015, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live human serum albumin (hsa) (PROQUAD) 0.5 milliliter, lot #J008158, expiration date: 08-JAN-2015 (strength, site and route of administration were not provided) for prophylaxis (Expired product administered). The medical assistant stated they had no record of this in their office, and only on the vaccine record printed and brought in by the patient.  No adverse events were reported (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; PROQUAD was administered after a temperature excursion; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 17-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)) (PROQUAD) (strength and route were not reported; lot # U029147, expiration date: 16-MAR-2023) 0.5 milliliter for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of 9 Fahrenheit (F)for a time frame of 1 hour and 25 minutes. There was no previous temperature excursions. No digital data logger was reported.  No additional adverse event (AE) information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Shingles/rash on the right side of back and chest, headache and burning sensation at the location of rash; Post herpetic neuralgia/burning sensation at the location of rash; Information has been received from a lawyer regarding a case in litigation which referred to a male patient (pt) of unknown age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. In or around 22-MAR-2018, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and for routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), he suffered a rash on the right side of back and chest, headache and burning sensation at the location of the rash and was later diagnosed with shingles (herpes zoster) and post herpetic neuralgia (PHN). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, his symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). In addition, the pt sustained severe and permanent personal injuries. Further, the pt had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), he had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster and postherpetic neuralgia were considered as disabling events by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. In or around November 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event shingles was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event shingles to be disability.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE or PQC reported; patient was administered expired MMR II; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 19-MAR-2022, the patient was administered expired measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) dose of 0.5 mL, lot number: T007233, expiry date: 27-FEB-2022 (strength, frequency, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event (AE) or product quality complaint (PQC) reported (no adverse event). The reporter confirmed the measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) did not have any temperature excursions.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation issue
Clinical narrative: MMRII that had been reconstituted with normal saline instead of the supplied sterile diluent; No additional AE reported; This spontaneous report was received from a pharmacist concerning to a patient of unknown gender and age. The patient's medical history, concomitant medications and drug history were not provided.     On unspecified date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (route of administration, dose, frequency, lot number and expiration date were not reported) for prophylaxis. This vaccine was reconstituted with normal saline instead of the supplied diluent. It was stated that the patient was "doing fine." No additional adverse event reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired dose of PROQUAD was administered; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug allergies were not reported.  On 24-FEB-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) 0,5 ml, lot # T029103 was confirmed to be valid, expiration date 23-FEB-2022 (expired product administered) (route of administration and injection site were not reported) for prophylaxis. No adverse events were reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported; Caller reported expired dose of PROQUAD was administered.; Confirmed with caller vaccine was administered IM; This spontaneous report as received from a physician and an unspecified reporter and refers to a 4-year-old male patient. The patient's concurrent conditions, medical history, or medical history were not provided.       On 26-MAR-2022, the patient was accidentally vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T032150 and expiration date 20-MAR-2022 0.5 milliliter, intramuscularly in the right arm for prophylaxis. No adverse events were reported.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a missed dose AE for GARDASIL. The caller stated that she was given two doses of GARDASIL on an unspecified date when she was 15; No additional AE reported; caller stated that she is now 31 and received a dose of GARDASIL 9 on 03/16/2022; This spontaneous report as received from a a 31-year-old female patient, concerning herself. The patient's concurrent conditions, medical history, or concomitant therapies were not provided.   On an unknown date (reported when she was 15 years old), the patient was vaccinated with two doses  quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (strength, dose, route, lot number, expiration date were not provided) for prophylaxis . At the time of this report, she was now 31 years old and  on 16-MAR-2022, she was vaccinated with a dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot number, expiration date were not provided) for prophylaxis. No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Headache, Influenza like illness
Clinical narrative: severe fatigue; joint pain; headache; stomachache; nausea; felt like oncoming flu symptoms; I got no sleep; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID 19 BOOSTER).   On 19th March 2022, the patient received the 2nd dose of Shingles vaccine. In March 2022, less than a day after receiving Shingles vaccine, the patient experienced sleeplessness. On 20th March 2022, the patient experienced influenza-like symptoms, fatigue, joint pain, headache, stomach pain and nausea. On an unknown date, the outcome of the influenza-like symptoms, sleeplessness, fatigue, joint pain, headache and nausea were recovered/resolved and the outcome of the stomach pain was unknown.   It was unknown if the reporter considered the influenza-like symptoms, sleeplessness, fatigue, joint pain, headache, stomach pain and nausea to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR052525   Additional Information: GSK Receipt Date: 22-MAR-2022 Reporter's Comment:  This case was reported via interactive digital media.  The patient received second shot on Saturday and asked the pharmacist if there were any side effects and he said just injection site pain.  The patient received first shot with Covid booster and was not sure when just the shingles shot.  Though patient's actual side effects were nothing compared to what shingles like but the night of the shot patient got no sleep.  On the morning patient had severe fatigue, joint pain, head or stomachache and slight nausea.  The reporter mostly felt like oncoming flu symptoms and on the reporting day, patient felt absolutely great.  Additional supportive information The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR052525:same report, 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Nausea
Clinical narrative: severe fatigue; joint pain; headache; stomachache; nausea; felt like oncoming flu symptoms; I got no sleep; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID 19 BOOSTER).   On 19th March 2022, the patient received the 2nd dose of Shingles vaccine. In March 2022, less than a day after receiving Shingles vaccine, the patient experienced sleeplessness. On 20th March 2022, the patient experienced influenza-like symptoms, fatigue, joint pain, headache, stomach pain and nausea. On an unknown date, the outcome of the influenza-like symptoms, sleeplessness, fatigue, joint pain, headache and nausea were recovered/resolved and the outcome of the stomach pain was unknown.   It was unknown if the reporter considered the influenza-like symptoms, sleeplessness, fatigue, joint pain, headache, stomach pain and nausea to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR052525   Additional Information: GSK Receipt Date: 22-MAR-2022 Reporter's Comment:  This case was reported via interactive digital media.  The patient received second shot on Saturday and asked the pharmacist if there were any side effects and he said just injection site pain.  The patient received first shot with Covid booster and was not sure when just the shingles shot.  Though patient's actual side effects were nothing compared to what shingles like but the night of the shot patient got no sleep.  On the morning patient had severe fatigue, joint pain, head or stomachache and slight nausea.  The reporter mostly felt like oncoming flu symptoms and on the reporting day, patient felt absolutely great.  Additional supportive information The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR052525:same report, 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: How does the second dose affects me if I get it several years later?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-Mar-2022 Reporter's comment: This case was reported via Shingirx.  The patient was asking how does the side effects of Shingles vaccine if he/she get it after several years later.  Additional Supportive Information: The case was self reported by the patient. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: due to the pandemic, many missed their 2nd dose. Some don't remember if they returned to the facility; This case was reported by a pharmacist and described the occurrence of social problem 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 social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 24-Mar-2022 Reporter Comment: The pharmacist reported that due to the pandemic, many patients missed their second dose for a myriad of reasons. Some patients were over 1 year from when they got the first dose and some did not remember if they returned to the facility they got the first one to complete the series. It was enquired that did these patients who got the 1st Shingrix outside the 2-6 months, even 2-12 months range, need to restart the series.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR054447:same reporter
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult given pediatric dose; adult given pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On 21st March 2022, the patient received Engerix B pediatric. On 21st March 2022, unknown after receiving Engerix B 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.   GSK Receipt Date: 24-MAR-2022 Reporter's Comment:  The registered pharmacist reported that adult patient was given pediatric dose of Engerix B. The health care professional gave fax number as contact address. The reporter consented to follow up. Additional supportive information:  The adult patient received pediatric dose of Engerix B, which led to underdose and adult use of a child product. This case was 1 of 3 cases reported by the same reporter..; Sender's Comments:  US-GLAXOSMITHKLINE-US2022053923:Same reporter US-GLAXOSMITHKLINE-US2022AMR054854:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose DEC 2019, requested 2nd dose; This case was reported by a other health professional via interactive digital media 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 in 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 Information: GSK Receipt Date:24-Mar-2022 Reporter's comment: This case was reported via interactive digital media. The reporter received Shingrix request for 2nd dose and asked would they need to start over. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Had 1st dose on 2019 and 2nd dose last week.; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (received 1st dose in 2019).   In March 2022, the patient received the 2nd dose of Shingles vaccine. In March 2022, unknown after receiving Shingles vaccine, 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 Information: GSK Receipt Date:25th March 2022 Reporter's comment: This case was reported via interactive digital media. The patient had first dose in 2019 and 2nd dose was received in last week. The reporter asked whether he/she need another dose. Additional Supportive Information: The patient received 2nd dose late which led lengthening of vaccination was schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: back pain; This case was reported by a consumer and described the occurrence of back pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced back pain. The patient was treated with steroids nos (Steroid Shot (Nos)). On an unknown date, the outcome of the back pain was unknown.   It was unknown if the reporter considered the back pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Mar-2022 Reporter's comment: The case was self-reported by the patient. The patient enquired how long should he/she wait between steroid shot and second shot of Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: skin rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Mar-2022 Reporter's comment: This case was reported via interactive digital media. The reporter reported was it possible to developed skin rash after taking second dose of Shingles vaccine. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: received Kinrix, exposed to temperatures above recommended; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-IPV (Kinrix) (batch number 237C4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that in october 2021 patient received Kinrix which has been exposed to temperatures above the recommended range. The Kinrix reached 59 f for 80 cumulative hours, which led to incorrect storage of drug. The permission for follow up was not asked.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received 1 additional series; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered 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 extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 23-Mar-2022 Reporter's Comments: Pharmacist submitted a  inquiry so a patient might have received an additional series of the Shingrix vaccine. Additional Supportive Information: The patient might have received an additional series of Shingrix vaccine, which led to extra dose administered. The reporter did not consent to follow up.
Age: 71.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Not received 3rd dose; Patient received 1st dose on 07-feb-2019 and 2nd dose administrated 14-feb-2019.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 71-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 14th February 2019, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 14th February 2019, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too short and incomplete course of vaccination were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24th March 2022 Reporter's Comments: The pharmacist reported that a the patient received a second dose of Twinrix  outside recommended schedule. The first dose  was administrated on 7th February 2019 and the second dose administrated on 14th February 2019. No know side effect reported. The vaccine was administrated on another facility. The reporter consented to follow up.  Additional Supportive Information: The patient received 1st and 2nd dose 7 days apart and it should be 1 month, which led to shortening of vaccination schedule. The patient did not received 3rd dose which led to incomplete course of vaccination
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: 1st dose Trumenba, 2nd dose Bexsero; This case was reported by a physician via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero, Bexsero Pre-Filled Syringe Device and the 1st dose of TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:24-Mar-2022 Reporter's comment: The patient was administrated with two different vaccines for the schedule of Men b. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The patient received first dose of Trumenba and the second dose with Bexsero, which led to interchange of vaccine products.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient got an incomplete dose; 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 an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 24-Mar-2022 Reporter's comment: The patient was administrated with an incomplete dose. No adverse event was reported. The patient's identifiers, vaccination date, LOT number and expiration date was not provided. The reporter consented to follow up.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: some of the  vaccine came out of the syringe; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number D5754, expiry date 18th December 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 11th October 2021, the patient received the 2nd dose of Shingrix. On 11th October 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 24-Mar-2022 Reporter's comment: The patient received 1st dose of Shingrix on 12th August 2021. The patient was being administered the 2nd dose of Shingrix and the needle malfunctioned and some of the vaccine came out of the syringe part, which led to incomplete dose administered. The reporter was unsure how much of the vaccine the patient received. The pharmacist called to inquire and asked for further guidance on vaccination. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash papular
Clinical narrative: developed shingles; rash on his chest; BUMPS ON NECK; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th March 2022, the patient received the 2nd dose of Shingrix (intramuscular). In March 2022, less than a week after receiving Shingrix, the patient experienced shingles, rash and papular rash. On an unknown date, the outcome of the shingles, rash and papular rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash and papular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-Mar-2022 Reporter's Comments: The patient self-reported this case. The reporter declined to give any contact information including patient demographic information. The reporter disconnected the call and agent was unable to obtain additional adverse event information and was offered (package insert) PI or transferred call to after call survey.  Additional Supportive Information: The patient experienced bumps on his head and neck and a rash on his chest (onset of adverse events not known). The reporter would like to know if Shingrix could cause these reactions. The reporter reported that he spoke with his pharmacist and he developed shingles.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose administered in 2019. Second dose not yet received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-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 August 2019, batch number: 3TP42, expiry date: 31st August 2020).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24th March 2022 Reporter's Comments: The pharmacist reported late 2nd dose of Twinrix. The second dose not received per health care professional. The reporter consented to follow up but declined to provide additional contact information other than telephone number. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of twinrix which led to incomplete course of vaccination.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administering only the adjuvant of MENVEO; administering only the adjuvant of MENVEO; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number IMAA687A, expiry date unknown), (batch number AMVI6H7A, expiry date unknown) and (batch number AMVA687A, expiry date 31st January 2022) for prophylaxis.   On 14th March 2022, the patient received Menveo. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On 14th March 2022, 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.   GSK Receipt Date: 24-MAR-2022, 24-MAR-2022 Reporter's Comments: The patient received a partial dose of Menveo as the nurse only administered the liquid CYW-135 component. The reporter consented to follow up. Additional supportive information: The patient received only liquid component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case US2022053912 is identified as duplicate of case US2022053914. All future correspondence would be added in case US2022053912, which stands as case of record for this patient and the case US2022053914 would be deleted. This case has been linked to US2022053914, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022053917:same reporter/patient - FU1 deleted US-GLAXOSMITHKLINE-US2022053914:same reporter
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the diluent of was administered; Only the diluent of was administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2022, the patient received Shingrix. On 2nd March 2022, 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 Information: GSK Receipt Date: 24-Mar-2020 Reporter's Comments:  Only the diluent of of the Shingrix was administered to patient. The reporter did not have the lot number of the diluent. The reporter consented to follow up. Additional supportive information: The patient only received diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on mid section, looks bad; This case was reported by a consumer via call center representative and described the occurrence of rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 5 days after receiving Shingrix, the patient experienced rash. The patient was treated with topical steroid nos (Steroid Cream). On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-March-2022 Reporter's Comments: The patient got the first shingrix vaccine 8 weeks ago and about 5 days post the vaccine she developed a rash on her mid section. The rash had not gone away. She had been using a steroid cream on the rash. She also stated that the rash wasn't itchy or painful, but just looks bad. She had no further information such as lot number or expiration date for the vaccine. Additional Supportive Information: The patient self-reported this case. The reporter did not consent to follow-up.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 20 y/o patient received the pediatric dose; 20 y/o patient received the pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 20-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   On 15th February 2022, the patient received the 1st dose of Engerix B pediatric 10 ug. On 15th February 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose and inappropriate age at vaccine administration were unknown.       Additional Information: GSK Receipt Date: 25th March 2022 Reporter's Comments: Office Manager stated that a 20 year patient received the pediatric dose (10 mcg) of Engerix-B back in February 2022 and was at the office today to get the 2nd dose.  The reporter asked how to proceed since he received the pediatric dose for the first dose. No lot number or expiry available as the first dose was administered at a different facility. The health care professional declined follow up. Additional Supportive Information: The pediatric dose of Engerix-B administered to 20 year patient, which led to inappropriate age at vaccine administration and underdose.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received dose 1 18 months ago; 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 with an associated reaction of no adverse event (received 1st dose on an unknown date 18 months ago).   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 Information: GSK Receipt Date: 25th March 2022 Reporter's Comments: The health care professional reported that patient received dose 1 of Shingrix 18 months ago. No reactions reported. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting patient did not received 2nd dose which led to incomplete course of vaccination. Case kept conservatively valid for incomplete course of vaccination since the details regarding 2nd dose was not provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact
Clinical narrative: Shingrix second underdose; There were a few drops on patient´s arm; There were a few drops on patient´s arm; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number DC434, expiry date 3rd June 2027) for prophylaxis.   On 23rd March 2022, the patient received the 2nd dose of Shingrix. On 23rd March 2022, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.       Additional Information: GSK Receipt Date: 25th March 2022 Reporter's Comments: The pharmacist reported that patient received Shingrix second dose but there were a few drops (probably 5) on patient´s arm. Her doctor indicated a third Shingrix shot. The possible third shot was not given at the time of reporting. The reporter consented to follow up by Fax. Additional Supportive Information: Few drops of vaccine (probably 5) leaked on patient´s arm which led to accidental underdose and exposure via skin contact and inadvertent exposure to vaccine.