chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus, Vaccination complication, Vertigo, Vision blurred
Clinical narrative: Vertigo, dizzy, blurred vision, ringing ears
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Pain, Respiration abnormal
Clinical narrative: Chest Pain, Body Aches, Rapid Breathing, Headaches
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Tiredness. Severe (barely lasted through my work day and was very unproductive) Headache. Mild. On and off throughout the day. Muscle pain. Severe throughout the day.  Chills. Mild. A few times a day. Fever. Up to 102°F  I was taking 400mg Ibuprofen as directed on the bottle throughout the day.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Daughters has missed her period main event the COVID shot. She is very regular so this is not a normal reaction/event. Will wait a few more weeks and if it still has not come we will make a doctors appointment.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Disturbance in attention, Feeling abnormal, Impaired driving ability
Clinical narrative: Symptom that gave me in an unknown event for the first time of a dazed, confused head and difficulty concentrating and I was driving When it gave me this time after about 4 hours of the vaccine. He had not given me again since the first time September 5, 2020.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypoaesthesia, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: 5/22 9pm 10 out of 10 pain headache at back left side behind ear, like a threaded plug was being screwed into my skull. Never felt pain like that before. Could think, brought me to tears.   5/23 brain fog continued. 2pm Burned myself cooking because I wasn't myself.   5/24 5am screwball headache returned (10 out of 10 pain) Could not work. Called off sick.  5/25 brain fog all-day. 9am slight headache (same area).  6/3 4pm left arm pain (injection site arm). Feels like arm numb. Intense pain (7/10). 10pm Took 3  baby aspirin. 1030pm arm pain still intense (7/10), no relief yet.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment, Pain in extremity, Tearfulness, Thermal burn
Clinical narrative: 5/22 9pm 10 out of 10 pain headache at back left side behind ear, like a threaded plug was being screwed into my skull. Never felt pain like that before. Could think, brought me to tears.   5/23 brain fog continued. 2pm Burned myself cooking because I wasn't myself.   5/24 5am screwball headache returned (10 out of 10 pain) Could not work. Called off sick.  5/25 brain fog all-day. 9am slight headache (same area).  6/3 4pm left arm pain (injection site arm). Feels like arm numb. Intense pain (7/10). 10pm Took 3  baby aspirin. 1030pm arm pain still intense (7/10), no relief yet.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Pain
Clinical narrative: Events: fever, chills,, achy all over, headache, tired, loss of appetite Treatment: rested and drank liquids Time: lasted from 11:00 pm Saturday (06/29/2021)  until 1:00 pm Tuesday (06/01/2021)
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Events: fever, chills,, achy all over, headache, tired, loss of appetite Treatment: rested and drank liquids Time: lasted from 11:00 pm Saturday (06/29/2021)  until 1:00 pm Tuesday (06/01/2021)
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Erythema, Inflammation, Pruritus, Skin exfoliation
Clinical narrative: Redness all over the body, including flaky scalp and skin, inflammation, cracked skin on hands and feet, itchy body.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Skin texture abnormal
Clinical narrative: Redness all over the body, including flaky scalp and skin, inflammation, cracked skin on hands and feet, itchy body.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Injection site reaction, Skin exfoliation, Syringe issue
Clinical narrative: The pharmacist injected my left arm with Moderna. The rubber in the syringe failed and a substantial, but unknown quantity, of the vaccine squirted out. Some of it dripped down my left arm. Because it was unclear how much made it into my shoulder and it could have been less than 50%, I got a full second shot in my right shoulder. The day after my vaccinations, I noticed scaly skin in a quarter-sized diameter around the injection site on my left shoulder. I did not experience scaly skin any where else, including with my right shoulder . Two months later, the skin around the left shoulder injection site is still scaly despite me applying lotion. It does not itch, hurt, or otherwise bother me, but because I heard we may get Covid patches I thought I'd report this in the event it's helpful.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Injection site warmth, Rash, Rash erythematous
Clinical narrative: strong rash (aching red area at the injection site, sometimes very warm) Arm pain throughout the area, numbness in the hand
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound scan
Clinical narrative: DVT of lower extremity
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation delayed, Pruritus
Clinical narrative: Days 3-5 post vaccine extremely itchy, on stomach  Day 7-9  post vaccine very late period 10 days late, with spotting when it should have started. During period heavy bleeding for longer than normal. 3 negative pregnancy tests days when my period should have come.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache
Clinical narrative: Headaches for 3-4 days following and chest tightness for 3-4 days following
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient did not return to complete the series. The patient was now 24 year old.; No additional AE reported; This spontaneous report was received from a pharmacist, referring to a 24 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On an unknown date, the 14 year old patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). The patient did not return to complete the series. The patient was now 24 year old. No additional AE reported.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: very itchy rash on her legs and back, a very diffuse reaction; This spontaneous report as received from a other health professional referring to a female patient of currently 55 years old. The patient's medical history, concomitant medications, drug allergies, or reactions at the time of the reported event were not reported.      On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, frequency, strength, route of administration, lot number, indication and expiry date were not reported).         On an unknown date, the patient experienced a very itchy rash on her legs and back, a very diffuse reaction. The outcome of rash pruritic was unknown.   The reporter considered rash pruritic to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; Caller stated that the PROQUAD that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 27-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number T035393, expiration date 14-APR-2022) as prophylaxis, that underwent a temperature excursion (product storage error). No additional adverse effects (AE's).  The vaccine underwent a temperature excursion between minus 58 degrees Fahrenheit (F) to 5F (15.2F) for 2 hours, 15 minutes and 0 seconds, as recorded by a data logger. There was no previous temperature excursion.
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: She denied further adverse event; patient was administered GARDASIL 9 that expired; This spontaneous report as received from a nurse health professional refers to a female patient of unknown age. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 28-MAY-2021 the patient was vaccinated with  an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter, lot # R025155, expired dose: 23-MAY-2021 for prophylaxis  (dose, and route of administration was unknown).   The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) had not had any temperature excursions. She was verbally provided the supported disclaimer. No additional adverse events reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R025155; expirationdate: 23-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; A dose of an expired M-M-R II was administered; This spontaneous report was received from a nurse referring to an 18-month-old patient. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 28-MAY-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S014429 with an expiration date on 09-MAY-2021) at a dose of 0.5 milliliters (ml) for prophylaxis  (strength, anatomical location,  and route of administration were not reported).         On 28-MAY-2021, the patient was administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (expired product administered).    No additional adverse events were reported.  No temperature excursions were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE occurred; The patient received a dose of MMRII that was expired; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medication were not reported.  On 28-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number s015427, had been verified to be a valid number; expiration date 20-MAY-2021). No other adverse events occurred.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Confusional state, Diplopia, Disorientation
Clinical narrative: Hallucination; Back pain; Burning sensation; Confusional state; Diplopia; Disorientation; Hypoaesthesia; Vomiting; This case was received via  FDA VAERS (Reference number:) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of HALLUCINATION (Hallucination) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HALLUCINATION (Hallucination) (seriousness criterion medically significant), BACK PAIN (Back pain), BURNING SENSATION (Burning sensation), CONFUSIONAL STATE (Confusional state), DIPLOPIA (Diplopia), DISORIENTATION (Disorientation), HYPOAESTHESIA (Hypoaesthesia) and VOMITING (Vomiting). At the time of the report, HALLUCINATION (Hallucination), BACK PAIN (Back pain), BURNING SENSATION (Burning sensation), CONFUSIONAL STATE (Confusional state), DIPLOPIA (Diplopia), DISORIENTATION (Disorientation), HYPOAESTHESIA (Hypoaesthesia) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment drug information was not given.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Hypoaesthesia, Vomiting
Clinical narrative: Hallucination; Back pain; Burning sensation; Confusional state; Diplopia; Disorientation; Hypoaesthesia; Vomiting; This case was received via  FDA VAERS (Reference number:) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of HALLUCINATION (Hallucination) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HALLUCINATION (Hallucination) (seriousness criterion medically significant), BACK PAIN (Back pain), BURNING SENSATION (Burning sensation), CONFUSIONAL STATE (Confusional state), DIPLOPIA (Diplopia), DISORIENTATION (Disorientation), HYPOAESTHESIA (Hypoaesthesia) and VOMITING (Vomiting). At the time of the report, HALLUCINATION (Hallucination), BACK PAIN (Back pain), BURNING SENSATION (Burning sensation), CONFUSIONAL STATE (Confusional state), DIPLOPIA (Diplopia), DISORIENTATION (Disorientation), HYPOAESTHESIA (Hypoaesthesia) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment drug information was not given.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Loss of consciousness; Seizure; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) and SEIZURE (Seizure) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant) and SEIZURE (Seizure) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness) and SEIZURE (Seizure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient lost consciousness seconds after vaccine. This was followed by seizure activity for 20 seconds. Blood pressure and heart rate were measured by emergency medical service, however results were not provided.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Very limited information regarding these events has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash erythematous, Vaccination failure
Clinical narrative: I had both shingles shots & still got them. It was a very mild case/Suspected vaccination failure; Still got them. It was a very mild case / Dr. Said it was probably from stress; Felt like I had a sunburn on my back; Itched; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, sunburn-like rash and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, sunburn-like rash and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, sunburn-like rash and pruritus to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had both the Shingles shots and still got the shingles, it was a very mild case. It felt like the patient had the sunburn on his/her back and itched. The physician said that it was probably from the stress and that was last year during Covid. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature decreased, Injection site erythema, Injection site pain, Malaise
Clinical narrative: Soreness; redness; Low temp; didn't feel too good; This case was reported by a consumer via media and described the occurrence of injection site 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, less than a year after receiving Shingles vaccine, the patient experienced injection site pain, injection site erythema, body temperature decreased and feeling unwell. On an unknown date, the outcome of the injection site pain, injection site erythema, body temperature decreased and feeling unwell were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, body temperature decreased and feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient received 1st dose of Shingles vaccine and experienced injection site pain, injection site redness, low temperature and did not felt too good.  The reporter stated that small price to pay instead of getting shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shingles vaccine still got the Shingles/ suspected vaccination failure; got the Shingles , was milder; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Shingles vaccine and still got the shingles, was milder. The patient's doctor said that it helps to have vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: The injection site is very itchy; This case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2021, the patient received the 2nd dose of Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was not recovered/not resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient had 2nd shingles vaccine this past week from the time of reporting. The patient stated that the injection site was very itchy. The patient asked what was suggested for relief.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had 2 shots for shingles and got them anyway/ suspected vaccination failure; I had 2 shots for shingles and got them anyway; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) 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 and Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient had 2 shots for shingles and got them anyway. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had vaccine and am now suffering through them/ Suspected Vaccination failure; I had vaccine and am now suffering through them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient had shingles vaccine and was now suffering through shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: Due to the pandemic/ did not get his second dose/first dose/ January/2020; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (received 1st dose on 20th January 2020 and also experienced achy, refer case US2021117069).   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.  The additional details were provided as follow: The case was reported by the patient itself. Till the time of reporting, the patient did not receive 2nd dose of Shingrix due pandemic. The patient inquired if he needs to get his 2nd dose of Shingrix or needed to start over. No consent given to follow up with his healthcare professional. The reporter did not consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral, Immediate post-injection reaction, Magnetic resonance imaging abnormal, Tinnitus
Clinical narrative: This case was reported by a lawyer and described the occurrence of hearing loss unilateral in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On 19th October 2020, the patient received Shingrix (unknown). On an unknown date, immediately after receiving Shingrix, the patient experienced hearing loss unilateral (serious criteria GSK medically significant) and tinnitus. On an unknown date, the outcome of the hearing loss unilateral and tinnitus were not recovered/not resolved. It was unknown if the reporter considered the hearing loss unilateral and tinnitus to be related to Shingrix. The patient received her first Shingrix vaccine on 19/10/2020. Shortly after the vaccination she noticed a constant hissing in her left ear. Date of injury 04/12/2020.She went to ENT and was assessed with hearing loss and tinnitus after an MRI was performed. She continues to suffer from the constant ringing in her left ear.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose, Exposure via skin contact, Product preparation issue, Syringe issue
Clinical narrative: Shingrix Vial / final volume was 0.4 ml / Pharmacist requesting credit for low fill vial; Administered the / vaccine / does not know how much the patient actually received; Vaccine leaked from the syringe and on to the patient; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 7Y359, expiry date 15th November 2022) for prophylaxis. This case was associated with a product complaint.   On 28th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .4 ml. On 28th May 2021, unknown after receiving Shingrix, the patient experienced accidental underdose, accidental exposure while administering drug and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, accidental exposure while administering drug and exposure via skin contact were unknown.  Additional details were provided as follows: The reporter reconstituted the Shingrix vial and the final volume was 0.4 ml. The reporter advised the patient that the vial was not 0.5 ml and she did not have another vial on hand. The patient requested to administer the vaccine even though the fill was low. The reporter administered the Shingrix vaccine in the left arm and did not know how much the patient actually received due to the faulty syringe, but it was less than 0.4 ml, which led to accidental underdose. The reporter states she drew up the dose with a faulty syringes, the vaccine leaked from the syringe and on to the patient, which led to accidental exposure while administering drug and exposure via skin contact. Reporter contacted GSK to see if patient needed to be revaccinated and to report the low fill of the vial.  The reporter was unable to return the vial as she has thrown the vial and syringe away. The reporter was requesting credit for low fill vial. The reporter consented to follow up.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 3 year old was given 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 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number PP9L5, expiry date 16th October 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On an unknown date, 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 3 years patient received Kinrix in right arm, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix on 1/4/2020 / not received a second dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 4th January 2020, batch number-L9F99, expiration date-10th May 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details was reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the patient had only provided year of birth. The reporter did not consented to follow up. The case is linked with US2021117065, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021117065:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: late second dose/ the first dose was given on Jan2020; expiration date was/ 23May2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 23rd May 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose of Shingrix on unknown date in January 2020.).   On 1st June 2021, the patient received the 2nd dose of Shingrix. On 1st June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long and expired vaccine used. On an unknown date, the outcome of the drug dose administration interval too long and expired vaccine used were unknown.  Additional details were provided as follows: The age at vaccination not reported.  The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lenghtening of vaccination schedule. The patient received 2nd dose, which was also expired on 23rd May 2021. The reporter did not had specific date. The reporter consented to follow up.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: patient received Menveo subcutaneously.; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 19-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 31st May 2021, the patient received Menveo (subcutaneous). On 31st May 2021, unknown after receiving Menveo, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were reported as follows: The patient received Menveo subcutaneously which led to intramuscular formulation administration by other route. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received dose one of Shingrix in February of 2020 but has not yet received dose two.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received in February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter could not provide lot number and expiration date for dose one.  No exact date of administration of 1st dose was provided, only February of 2020. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: consumer only received the "diluent" portion of the Shingrix vaccine #1; consumer only received the "diluent" portion of the Shingrix vaccine #1; This case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The case was reported by the patient's friend, as the patient was not available. The age at vaccination was not reported. The patient received only diluent portion of the Shingrix vaccine, which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered. The physician's office notified and rescheduled the patient to return in 4 weeks for the complete Shingrix vaccine. The reporter did not want to give any other information. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix two years ago / only received the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received 2 years prior to the reporting 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 reported as follows: The age at vaccination was not applicable for this report. Till the time of report, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. No further information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had the first dose / on 8/25/2020 and did not go back for the second dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 25th August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The patient did not go back for the 2nd dose. The reporter did not consent to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: it was not IM nor Subcutaneous / was given at shoulder level in the interior part of the arm, not in the muscle; site of administration was "near the epiphyseal line of the arm" / Almost given near the bone where the humerus meets the clavicle, a little lower; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number K3YC7, expiry date 7th November 2022) for prophylaxis.   On 28th May 2021, the patient received the 1st dose of Shingrix. On 28th May 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. On an unknown date, the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown.  Additional details were provided as follows: The patient was given 1st dose of Shingrix, not intramuscular nor subcutaneous and the site of administration was near the epiphyseal line of the arm which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site. The reporter stated that, it was given at shoulder level in the interior part of the arm, not in the muscle and almost given near the bone where the humerus meets the clavicle, a little lower. The reporter consented to follow up by email.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: reported on June 1st 2021 today / patient received a 2nd dose /first dose was received on April 25th 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) (batch number K3YC7, expiry date 7th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 1st June 2021, the patient received the 2nd dose of Shingrix. On 1st June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix on 25th April 2021 and on the day of reporting received a 2nd dose of Shingrix earlier than then recommended schedule, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was given to a child that was under the approved age; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female 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 1st June 2021, the patient received Kinrix (intramuscular) .5 ml and Kinrix Pre-Filled Syringe Device. On 1st June 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 reporter mentioned that a vaccine was given to a child that was under the approved age for the Kinrix vaccine. The patient with age 2 years, 1 month and 7 days old received Kinrix vaccine, which led to inappropriate age at vaccine administration. No other adverse events were reported for the patient. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient / 48 year old / mistakenly received the first dose of Shingrix; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 48-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 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 reported. The healthcare professional reported that the patient was a 48 year old male and mistakenly received Shingrix, which led to inappropriate age at vaccine administration.  The date of the incident was unknown.   The reporter consented to follow up.
Age: 0.08
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Patient was injected with the vaccine instead of being given oral; This case was reported by a other health professional via call center representative and described the occurrence of wrong route of administration in a 6-week-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 27th April 2021, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 27th April 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of 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 health care professional called to report the administration of the Rotarix vaccine that was injected instead of being given oral, which led to wrong route of administration. The reporter did not consent nor deny follow up.  No further events were reported. The reporter did not consent nor deny follow up. No further events were reported.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient received the power portion / reconstituted with sterile water; Patient received the power portion / reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA392A, expiry date 12th January 2027) for prophylaxis.   Previously administered products included Menveo (1st dose received on an unknown date).   On 1st June 2021, the patient received the 2nd dose of Menveo. On 1st June 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was medical assistance. The reporter stated that the patient received the power portion of Menveo reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The health care professional did not had lyophilize portions lot number/expiry date. The reported batch number AMXA3928 was not available in sales data sheet, hence updated to AMVA392A. The reporter did not consent to follow-up.