chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidentally got the Shingrix vaccine instead of varicella; accidentally got the Shingrix vaccine / I'm 24 years old.; This case was reported by a consumer via (Shingrix  interactive digital media and described the occurrence of wrong vaccine administered in a 24-year-old 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 wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient self-reported this case. The age at the vaccination was not reported.  However could be 23 years or 24 years old at the time of vaccination. The patient accidentally got the Shingrix vaccine instead of varicella, which led to wrong vaccine administered and inappropriate age at vaccine administration.  The patient was contacting the company to see what were the side effects and what had to be done.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: received Shingrix first dose with a final volumen of 0.45ml.; first dose with a final volumen of 0.45ml.; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis. This case was associated with a product complaint.   On 22nd September 2021, the patient received the 1st dose of Shingrix. On 22nd September 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered and pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered and pharmaceutical product complaint were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, the patient received shingrix first dose with a final volumen of 0.45ml, which led to incomplete dose administered and pharmaceutical product complaint. The nurse manager needs time to collect patients details. The reporter consented to follow up. This case was linked with case US2021201392, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201392:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had this vaccine, got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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 reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient had this so called vaccine, got shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got a shingles shot n got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a month 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 reported as follows: The age at vaccination was not reported. The reporter knew a women who got a shingles shot and got shingles within 1 month. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm still hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 3 weeks after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the first shingle shot 3 weeks ago and still arm hurt. The patient could go back to get second one in 3 months when he/she off.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, between 1 and 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle a week and a half after Shingles vaccination. The patient was informed that vaccine might had not been effective yet.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: got very sick from both vaccines; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and felt very sick. The above event didn't last long (24) hours and so far no shingles. The patient stated that it had been a year since he/she got it. For 2nd dose refer case US2021AMR202715, reported by the same reporter. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202715:same reporter same patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Vaccination failure
Clinical narrative: had the vaccine and got the shingles/suspected vaccination failure; got the shingles; sick; 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), shingles and sickness. On an unknown date, the outcome of the vaccination failure, shingles and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to 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 the vaccine and got the shingles, the patient was sick a long time. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Vaccination failure
Clinical narrative: suspected vaccination failure/received the vaccination for prevention/ shingles; shingles; nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve damage. On an unknown date, the outcome of the vaccination failure, shingles and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and nerve damage to be related to Shingles vaccine.  Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingles vaccine for prevention and a few months later experienced Shingles. The patient also experienced permanent nerve damage. The patient stated that she/he would not wish shingles on his/her worst enemy. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: ended up in the hospital with the flu for a week; Suspected vaccination failure / got the flu shot and ended up in the hospital with the flu; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received dose on an unknown date and experienced shingles, refer case US2021AMR202752).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Flu shot and ended up in the hospital with the flu for a week.  The patient stated that this was why the patient would not get the Covid vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202752:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot still got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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 patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: got them a month after vaccinated/ suspected vaccination failure; got them; had ugly rash; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient friend. The age at vaccination was not reported. The patient received Shingles vaccine and got them a month after vaccinated also had ugly rash two weeks are vaccinated. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and  laboratory confirmation for shingles were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurts like crazy; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got a Shingles vaccine shot and stated it hurts like crazy. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the second shot of Shingrix; This case was reported by a consumer 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 (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked, did need to start over or took them both.
Sex: U
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This case was reported by a consumer via interactive digital media and described the occurrence of stroke in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2020, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was unknown.   It was unknown if the reporter considered the stroke to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got a stroke by taking vaccine shingles. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine then got the shingles/suspected vaccination failure; shingles; This case was reported by a consumer 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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the vaccine then got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dyspnoea, Hypotension, Rash papular
Clinical narrative: Heavy chest; Hypotension; Trouble breathing; Raised rash; This case was reported by a consumer via call center representative and described the occurrence of chest heaviness in a adult female 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, immediately after receiving Shingrix, the patient experienced chest heaviness, raised rash, hypotension and difficulty breathing. The patient was treated with epinephrine (Epi Pen). On an unknown date, the outcome of the chest heaviness, raised rash, hypotension and difficulty breathing were recovered/resolved.   The reporter considered the chest heaviness, raised rash, hypotension and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received the shingrix shot about 2 years ago and was advised not to take the second shot (underdose) due to adverse reactions. The patient stated that minutes after receiving the vaccine, she experienced a heavy chest, hypotension, raised rash (which lasted for 24 hrs), and trouble breathing.  She eventually took an epi-pen and began to feel better.  All her symptoms had resolved at the time of reporting.  The patient did not consent to follow-up and no health care professional was provided.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Hypertonia, Muscular weakness, Musculoskeletal stiffness, Pain, Peripheral swelling
Clinical narrative: leg weakness; Fever; Stiffness; Soreness; arm was hot to the touch; arm swelled up; hypertonia; This case was reported by a other health professional via call center representative and described the occurrence of lower extremities weakness of in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA70BA, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th September 2020, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than a year after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced lower extremities weakness of, fever, stiffness, pain, skin warm, large arm swelling and hypertonia. The patient was treated with non-drug therapy (Physical Therapy). On an unknown date, the outcome of the lower extremities weakness of, fever, stiffness, pain, skin warm, large arm swelling and hypertonia were recovered/resolved.   It was unknown if the reporter considered the lower extremities weakness of, fever, stiffness, pain, skin warm, large arm swelling and hypertonia to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by an office manager reported for her daughter. The patient received bexsero vaccine and had bad reaction. The patient's  arm swelled up and was hot to the touch, she had soreness, stiffness, fever, and leg weakness. The reporter stated that, the patient was diagnosed with hypertonia and received physical therapy. The events resolved after about 2.5 months. The reporter consented to follow up. The reporter works at the doctor's office and her daughter was the patient experiencing the adverse events. The reporter did not have the expiration date of the Bexsero. The reporter has consented to follow-up via email.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Skin warm
Clinical narrative: leg weakness; Fever; Stiffness; Soreness; arm was hot to the touch; arm swelled up; hypertonia; This case was reported by a other health professional via call center representative and described the occurrence of lower extremities weakness of in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA70BA, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th September 2020, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than a year after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced lower extremities weakness of, fever, stiffness, pain, skin warm, large arm swelling and hypertonia. The patient was treated with non-drug therapy (Physical Therapy). On an unknown date, the outcome of the lower extremities weakness of, fever, stiffness, pain, skin warm, large arm swelling and hypertonia were recovered/resolved.   It was unknown if the reporter considered the lower extremities weakness of, fever, stiffness, pain, skin warm, large arm swelling and hypertonia to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by an office manager reported for her daughter. The patient received bexsero vaccine and had bad reaction. The patient's  arm swelled up and was hot to the touch, she had soreness, stiffness, fever, and leg weakness. The reporter stated that, the patient was diagnosed with hypertonia and received physical therapy. The events resolved after about 2.5 months. The reporter consented to follow up. The reporter works at the doctor's office and her daughter was the patient experiencing the adverse events. The reporter did not have the expiration date of the Bexsero. The reporter has consented to follow-up via email.
Age: 0.75
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given a 9 month old the Havrix; 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 9-month-old patient who received HAV (Havrix 720) (batch number 2jd3y, expiry date 4th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st September 2021, the patient received Havrix 720 (intramuscular) and Havrix Pre-Filled Syringe Device. On 21st September 2021, unknown after receiving Havrix 720 and Havrix 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 reported as follows: This case was reported by the medical assistant. The medical assistant calling from pediatric office about having given a 9 month old patient, the Havrix vaccine, which led to Inappropriate age at vaccine administration. The reporter did not consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Gastrointestinal disorder, Headache, Immediate post-injection reaction
Clinical narrative: Headache; Malaise; Fatigue; Gastrointestinal symptoms; Shivering; Fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2021, the patient received the 1st dose of Shingrix. On 15th September 2021, immediately after receiving Shingrix, the patient experienced headache, malaise, fatigue, gastrointestinal symptom nos, shivering and fever. On an unknown date, the outcome of the headache, malaise, fatigue, gastrointestinal symptom nos, shivering and fever were unknown.   It was unknown if the reporter considered the headache, malaise, fatigue, gastrointestinal symptom nos, shivering and fever to be related to Shingrix.  Additional details were reported as follows: This case reported by the father in law of patient. The age at vaccination was not reported. The reporter stated that, the patient received Shingrix vaccine last Wednesday and immediately began experiencing all listed side effects , including headache, malaise, fever, shivering, fatigue, and gastrointestinal symptoms. The reporter did not provide details regarding whether symptoms have resolved. The reporter did not consent to follow-up. The reporter declined to provide demographics for son in law/patient.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Headache; Malaise; Fatigue; Gastrointestinal symptoms; Shivering; Fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2021, the patient received the 1st dose of Shingrix. On 15th September 2021, immediately after receiving Shingrix, the patient experienced headache, malaise, fatigue, gastrointestinal symptom nos, shivering and fever. On an unknown date, the outcome of the headache, malaise, fatigue, gastrointestinal symptom nos, shivering and fever were unknown.   It was unknown if the reporter considered the headache, malaise, fatigue, gastrointestinal symptom nos, shivering and fever to be related to Shingrix.  Additional details were reported as follows: This case reported by the father in law of patient. The age at vaccination was not reported. The reporter stated that, the patient received Shingrix vaccine last Wednesday and immediately began experiencing all listed side effects , including headache, malaise, fever, shivering, fatigue, and gastrointestinal symptoms. The reporter did not provide details regarding whether symptoms have resolved. The reporter did not consent to follow-up. The reporter declined to provide demographics for son in law/patient.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose one month apart from first; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 9-year-old male patient who received HAV (Havrix) (batch number YR532, expiry date 9th September 2022) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 28th August 2021, the patient received the 2nd dose of Havrix. On 28th August 2021, unknown after receiving Havrix, 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: Nurse Practitioner reported that the patient had received a Havrix second dose one month apart from first dose, which led to shortening of the vaccine schedule. The reporter consented to follow up via email.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chest pain, Electrocardiogram
Clinical narrative: Chest pain; Elevated Blood Pressure; This case was reported by a other health professional via call center representative and described the occurrence of chest pain in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19. Concurrent medical conditions included atrial fibrillation.   On 13th August 2021 10:00, the patient received the 1st dose of Shingrix. On 13th August 2021, less than a day after receiving Shingrix, the patient experienced chest pain (serious criteria hospitalization). On an unknown date, the patient experienced increased blood pressure. On an unknown date, the outcome of the chest pain was recovered/resolved and the outcome of the increased blood pressure was unknown.   It was unknown if the reporter considered the chest pain and increased blood pressure to be related to Shingrix.  Additional details provided were as follows: The patient self-reported this case. The patient stated that she had a terrible/bad reaction from her first dose of Shingrix and asked if she should get 2nd shot. The patient received 1st dose and experienced chest pain at that mid night. She was sent to the emergency room and was hospitalized. Less than 2 months after vaccination, the patient also experienced elevation in the blood pressure and had electrocardiogram (EKGs) performed during this time. Provided Medical Information number for customer to provide to health care professional. The patient did not have further information regarding lot and expiration of the Shingrix. The reporter consented to follow-up.
Age: 59.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Pediatric dose administered to adult; Pediatric dose administered to adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 59-year-old female patient who received HAV (Havrix) (batch number B23EA, expiry date 15th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were reported as follows: The age at vaccination was not reported. Medical assistant reported that a 59 year old patient received a pediatric dose of HAVRIX, which led to adult use of a child product and underdose.  No adverse events were reported at the time of the call. No further details were provided at the time of the call. The reporter consented to follow up. Consented to follow-up by email.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: received Shingrix first dose with a final volumen of 0.45ml.; first dose with a final volumen of 0.45ml.; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis. This case was associated with a product complaint.   On 23rd September 2021, the patient received the 1st dose of Shingrix .45 ml. On 23rd September 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered and pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered and pharmaceutical product complaint were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, the patient received shingrix first dose with a final volumen of 0.45ml, which led to incomplete dose administered and pharmaceutical product complaint. The nurse manager needs time to collect patients details. The reporter consented to follow up. This case has been linked with case US2021AMR202069, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202069:same reporter
Age: 49.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 49-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date August 2021) for prophylaxis.   On 23rd September 2021, the patient received the 1st dose of Menveo. On 23rd September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: It was reported that the patient had received an expired dose of Menveo, which led to expired vaccine administered. The reporter consented to follow up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose was administered; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number P7N2H, expiry date 30th January 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2019) and Shingrix (received 2nd dose in April 2020).   On 23rd September 2021, the patient received the 3rd dose of Shingrix. On 23rd September 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter stated that, 3rd dose of Shingrix vaccine was administered to patient, which led to extra dose administered. No additional details provided by caller. The reporter did not consent to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: third dose of Shingrix administered; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On 23rd September 2021, the patient received the 3rd dose of Shingrix. On 23rd September 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The pharmacy intern reported that, the patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st September 2018, batch number G933B).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that, the patient did not return for second dose within dosing window. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist did not have expiration date information. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; MISCARRIED; This spontaneous pregnancy report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: clotting. The patient was gravida 1, para 0. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine exposure during pregnancy. Reporter stated that, the report showed that the fetus stopped developing at five weeks. On an unspecified date in JUL-2021, the patient miscarried at ten weeks and the pregnancy resulted in a spontaneous abortion. The date of the patient's last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy on JUL-2021, and the outcome of miscarried was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210941603-COVID-19 VACCINE AD26.COV2.S-miscarried. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s) 20210941603-COVID-19 VACCINE AD26.COV2.S-vaccine exposure during pregnancy . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE SYNDROME; This spontaneous report received from a patient concerned a 43-year-old male of unspecified race. The patient's weight was 147 pounds, and height was 67 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: unknown) dose was not reported, 01 total, administered on 09-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. In APR-2021, 3 weeks post vaccination, the patient started experiencing symptoms like muscle pain all over the body, his feet felt like he had walked for miles, the bottom of his feet and fingers felt numb, he felt tingling and numbness that was getting worse, his legs started to feel numb; and arms and hands also started to feel the same. He tried to remember what he ate and what he did and may be what was causing the symptoms, he was finding it hard to do his job. On 23-JUL-2021, the patient visited the emergency room and was diagnosed with Guillain Barre syndrome was hospitalized for 5 days and discharged on 28-Jul-2021. Patient was administered unspecified treatment medication and did not remember what it was. The patient's symptoms were not resolved and he also reported that he felt worse when he laid down and was unable to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from guillain barre syndrome.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210943950-COVID-19 VACCINE AD26.COV2.S- Guillain barre syndrome. This event is labeled per RSI and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Off label use, Product storage error
Clinical narrative: UNPUNCTURED VACCINE STORED AT 35 F AND LATER ADMINISTERED TO PATIENTS; RECEIVED EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced received expired vaccine. On SEP-2021, the patient experienced off label use. On an unspecified date, the patient experienced unpunctured vaccine stored at 35 f and later administered to subjects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unpunctured vaccine stored at 35 f and later administered to patients, received expired vaccine and off label use was not reported. This report was non-serious.   This report was associated with product quality complaint: 90000194295.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Headache, Malaise, Nasal congestion
Clinical narrative: REAL COUGH; CONGESTION/NASAL CONGESTION; FEELING ACHY, BODY ACHES; COULD NOT THINK RIGHT NOW; FEELING ILL; NAUSEA; HEADACHE; FEVER; THREW UP; FEELING FOG,FEELING ALL CLOUDY; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient (reporting on herself) concerned a 50 year old white female. The patient's weight was 200 pounds and height was 68 inches. The patient's concurrent conditions included: alcohol user (every once and a while) and non-smoker. The patient had no known allergies and had no history of drug abuse or illicit drug use. The patient was not pregnant at time of reporting. The patient mentioned that she had no other known medical conditions. The patient also stated that she had covid twice once on Aug-2020 (pre-vaccination).The patient stated that she was told by her doctors that she had covid-19 on AUG-2020 but she had not tested positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported,1 total administered on 31-MAR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that on JUL-2021, the patient became symptomatic and tested positive for covid-19 and she experienced symptoms as nausea, body aches, headaches, congestion, nasal congestion but she did not had fever and real cough and stated that she threw up (coded as suspected covid-19 infection, suspected clinical vaccination failure).The patient also stated that the symptoms from her infection with covid-19 in JUL-2021 was resolved in early AUG-2021 and she was feeling ill again at the time reporting. On 21-SEP-2021, the patient experienced achy and suspected that she had covid-19 and was awaiting for the test results that she performed on 21-SEP-2021. Later patient experienced foggy feeling and mentioned that this 'COVID business' makes all cloudy. She also stated that she could not think at the time of reporting. The patient recovered from suspected covid-19 infection on AUG-2021, had not recovered from feeling fog,feeling all cloudy, nausea, feeling achy, body aches, headaches, congestion/nasal congestion, feeling ill, fever, real cough, threw up, and could not think right now, and the outcome of suspected clinical vaccination failure was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Other Medically Important Condition). This report was associated with product complaint (PQC): 90000194338.; Sender's Comments: V0: 20210944635-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS