chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pharyngitis streptococcal, Somnolence
Clinical narrative: a lot coughin flem; sleepy; monday full flown strep throat with flem; coughing; small headaches; sore throat; feeling like the flu/still flu feeling; saturday in bed; very tired/tiredness; This is a spontaneous report received from a contactable consumer (Patient). A female non pregnant patient of an adult age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/Lot Number: EN0178) via an unspecified route of administration, administered in left arm on 10Jun2021 14:00 as single dose for COVID-19 immunization. Medical history included high blood pressure and thyroid hipo. Concomitant medications included Synthroid And Losartan. The patient previously took vitamins NOS, losartan + hydrochlorothiazide and Synthroid. Patient did not receive any other vaccines within 4 weeks. prior to the COVID vaccine. Patient was not diagnosed with covid-19 prior to vaccination, and she was not diagnosed with covid-19 since vaccination. On 11Jun2021 16:00, Friday afternoon the patient experienced very tired/tiredness, on 12Jun2021 on Saturday in bed, on 13Jun2021, on Sunday sore throat, feeling like the flu/still flu feeling, on 14Jun2021, Monday full flown strep throat with flem, coughing, small headaches and on 15Jun2021, sleepy and a lot coughing flem (flu type, tiredness, sleepy, Wednesday a little better, mind you been taking zythromax and congestion medicine. It was not normal, as she had not been sick in over three years. Therapeutic measures were taken as a result of adverse event. The outcome of events was recovering.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray normal, Chills, Cold sweat, Dehydration
Clinical narrative: Chills, cold sweats, dizziness, fatigue, muscle weakness, other dehydration symptoms
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Muscular weakness, SARS-CoV-2 test negative, Urine analysis
Clinical narrative: Chills, cold sweats, dizziness, fatigue, muscle weakness, other dehydration symptoms
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Confusional state, Dysarthria, Heart rate increased, Hyperhidrosis
Clinical narrative: Dose 1: slurring speech, confusion, sweating, rapid heart beat, chest pain   Dose 2: Mydriasis in both eyes, rapid heart beat, oxygen sat lower than my normal, cold hands and feet, under eye swelling
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mydriasis, Oxygen saturation decreased, Periorbital swelling, Peripheral coldness
Clinical narrative: Dose 1: slurring speech, confusion, sweating, rapid heart beat, chest pain   Dose 2: Mydriasis in both eyes, rapid heart beat, oxygen sat lower than my normal, cold hands and feet, under eye swelling
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities
Clinical narrative: Joint pain in left knee, spread to both shoulders and now in both knees and hips.  Started approximately a month after 2nd dose.  Trouble getting in and out of car, getting up after sitting down, Putting on shirt, socks and tying shoes.  Trouble lifting both legs to get into shower.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Metabolic function test
Clinical narrative: Flare of autoimmune hepatitis with AST/ALT 10x prior levels.  Patient had been in remission for 4+ years off medications prior to vaccination.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone increased, Electrocardiogram normal, Full blood count normal, Hypoaesthesia, Pain
Clinical narrative: Lower extremity numbness/tingling and pain
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Lower extremity numbness/tingling and pain
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE; the patient received the first Rotateq dose at 16 weeks of age; This spontaneous report was received from a nurse and refers to a 16-week-old female patient. She had no past medical history and she was not taking any medications. Information concerning drug reactions or allergies was not provided. On 08-MAR-2021, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), 2 milliliter via oral route, lot # 1691300, expiry date: 24-NOV-2021, for prophylaxis (product administered to patient of inappropriate age). On the same day, the patient was vaccinated with hepatitis b vaccine, diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine 13v. At the time of vaccination, the patient had no illness. No additional adverse event was reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed with customer that no other AE occurred; PROQUAD was administered after experiencing a temperature excursion; This spontaneous report was received from a nurse referring to a 4-year-old male. Information about patient's medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 07-MAY-2021, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rha) (PROQUAD), 1 dose, in the left upper arm (LUA), subcutaneously (SQ), Lot No. T005404 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rha) (PROQUAD), expiration date reported as 24-MAR-2022, but upon internal validation established as 12-AUG-2021(strength, dose detail and scheme of vaccination were not provided) for prophylaxis.   On an unknown date, before of the event the measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rha) (PROQUAD) vaccine was exposed to temperature excursion of 37.2 Fahrenheit degree (F), for a time frame of 3 hours, which was detected by the data logger. The reporter stated that the freezer door was inadvertently left open causing the temperature excursion and was noticed after the incident. No previous temperature excursion. No adverse events reported. Data logger was involved.
Age: 38.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AEs; first dose on 25-JUL-2020 and second dose on 06-JUN-2021; This spontaneous report was received from a pharmacist via a company representative referring to a 39 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 25-JUL-2020, the 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 (dose, frequency, route, lot# and expiration date were not reported and on 06-JUN-2021, the patient was vaccinated with the second dose. The reporter confirmed that did not have any additional data to provide. No additional adverse events were reported. The reporter was inquiring about the dosing schedule for the suspect therapy for the patient.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: no additional AE.; administered PROQUAD and V ARlV AX concomitantly in error; PROQUAD was given in error and the patient was supposed to be given MMR II. No MMR II was given.; administered PROQUAD and V ARlV AX concomitantly in error; This spontaneous report was received from a registered nurse and refers to a 1-year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown) (lot # T009586, with expiration date of 26-OCT-2022).  On 16-JUN-2021, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T036565, with expiration date of 26-APR-2022) and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T032319, with expiration date of 22-SEP-2022), both for prophylaxis (routes of administration and anatomical locations were not reported). The vaccines were administered concomitantly in error, the reporter stated that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was given in error and the patient was supposed to be given measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (inappropriate schedule of product administration, accidental overdose, and wrong product administered). No measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was given. No adverse event or product quality complaint were reported, and no additional information was provided.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event; Subcutaneous injection formulation administered by other route; This spontaneous report as received from a pharmacy tech and refers to female patient of unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 21-JUN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # T007231, Expiration date 27-FEB-2022, 1 injection, intramuscularly instead of subcutaneously for prophylaxis.
Sex: U
Vaccine: VARCEL
Symptoms: Booster dose missed, No adverse event
Clinical narrative: Missed dose of Varivax; no adverse events; This spontaneous report as received from a physician refers to a 11 year old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 27-OCT-2009, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route, lot number and expiration date were not reported) for prophylaxis. The patient did not receive the second dose of varicella virus vaccine live (oka/merck) (VARIVAX).
Age: 33.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Per caller patient has had no adverse side effects; Phlebotomist reporting that an expired dose of MMR-11 ( expired 6/17/2021) was accidently administered to a patient on 6/18/2021.; Information has been received from a phlebotomist, referring to a 33 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 18-JUN-2021, the patient was accidentally vaccinated with an expire dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S018594, expiration date on 17-JUN-2021 (administration route and anatomical location were not provided) for prophylaxis. Per caller patient has had no adverse side effects.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Device malfunction, Drug dose omission by device, Seizure
Clinical narrative: Had 2 seizures; her Enbrel misfired and did not inject; her Enbrel misfired and did not inject; This is a spontaneous report from a contactable consumer, based on information received by Pfizer.  This serious spontaneous report was reported on 09/JUN/2021 by a consumer and involves an approximately 66 years old female patient who had two seizures [PT: seizure] and her Enbrel misfired did not inject [PT: accidental exposure to product] while receiving Enbrel with Single Dose Prefilled Autoinjector (lot number: 1125683, expiration date: 30Sep2023). No historical medical condition was reported. The patient's current medical condition included psoriatic arthritis mutilans. The patient's concomitant medications included covid-19 vaccine (batch/lot number unknown). No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, when she took Enbrel before getting covid vaccine she had two seizures and the physician thinks it because she took covid vaccine to close to taking with Enbrel also patient stated that her Enbrel misfired and did not inject. No treatment information was received. The outcome of the events seizure and accidental exposure to product was reported as unknown. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the event seizure. The consumer reported that the event seizure was possibly related to Enbrel. The causal relationship between the event accidental exposure to product and Enbrel was not provided by the consumer. The causal relationship between the events seizure, accidental exposure to product and Single Dose Prefilled Autoinjector was not provided by the consumer. No follow up attempts are possible. No further information is expected.  Manufacturer Comment: This safety report does not necessarily reflect a conclusion that etanercept, and device, caused or contributed to the adverse event reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Amenorrhoea, Ovulation disorder, Pregnancy, Uterine spasm
Clinical narrative: Amenorrhoea; Abortion spontaneous; Ovulation disorder; Pregnancy; Uterine spasm; This case was received via  VAERS on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Abortion spontaneous) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Mar-2021, the patient experienced ABORTION SPONTANEOUS (Abortion spontaneous) (seriousness criterion medically significant), OVULATION DISORDER (Ovulation disorder), PREGNANCY (Pregnancy) and UTERINE SPASM (Uterine spasm). On an unknown date, the patient experienced AMENORRHOEA (Amenorrhoea). At the time of the report, ABORTION SPONTANEOUS (Abortion spontaneous), OVULATION DISORDER (Ovulation disorder), PREGNANCY (Pregnancy), UTERINE SPASM (Uterine spasm) and AMENORRHOEA (Amenorrhoea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the provided. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.; Sender's Comments: This is a case of product exposure during pregnancy which resulted in Abortion spontaneous, for this 29 years old female. Very limited information has been provided at this time.
Sex: U
Vaccine: FLUX
Symptoms: Near death experience
Clinical narrative: Flu shot almost killed me; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   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 near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that, the flu shot almost killed her.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: experienced arthalgia for several weeks.; This case was reported by a physician via sales rep and described the occurrence of arthralgia in a 56-year-old male 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 arthralgia. On an unknown date, the outcome of the arthralgia was recovered/resolved.   It was unknown if the reporter considered the arthralgia to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The physician reported that the patient received Shingrix and experienced arthralgia for several weeks. The reporter consented to follow up. This case was linked with case US2021AMR136260, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR136260:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: didn't get the 2nd shot until almost 10 months later; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The received the 1st dose of shingles vaccination, but didn't get the 2nd shot until almost 10 months later, which led to lengthening of vaccination schedule. The patient also enquired if a third shot was required within the period of 2 to 6 months.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received the 1st dose / on 26Mar2019 and is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received 1st dose of shingrix on 26th March 2019.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. A pharmacist reported the patient was late for the 2nd dose, which lead to incomplete course of vaccination.  No symptoms was reported.  Reporter consented to follow up.   Follow up information received from pharmacist on 22nd June 2021: The batch number of 1st dose of Shingrix was updated (batch number LT7744, expiry date 1 July 2021, intramuscularly). The pharmacy technician tried to called patient on 23rd July 2019 for 2nd Shingrix vaccine to complete the series. The VAERS details were updated. The batch number of 1st dose was not found in sales data sheet.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021044021:Possible same patient
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: placing the Shingrix vaccine in the freezer by error; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) (batch number GL79C, expiry date 13th November 2022) for prophylaxis.   On 16th June 2021, the patient received Shingrix. On 16th June 2021, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix ,which was stored in freezer, which led to incorrect storage of drug. No further events were reported. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: In adverted administration on 6/16/2021 of a third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number K2CJ4, expiry date 11th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unknown date).   On 16th June 2021, the patient received the 3rd dose of Shingrix. On 16th June 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 are as follows: The patient inadvertedly received third dose of Shingrix, which led to extra dose administered. The reporter mentioned that, patient forgot that he had already received second dose of Shingrix and failed to tell the Health care professional. No further events were reported. The reporter consented to follow up.
Sex: U
Vaccine: RV1
Symptoms: Diarrhoea
Clinical narrative: presented diarrhea that lasted for 7 days / after first dose; This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a patient who received Rota (Rotarix lyophilized formulation) (batch number ZY5YH, expiry date 4th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator 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 provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received dose of Rotarix and experienced diarrhea for 7 days. The health care professional was not willing to provide further patient information, nor other detailed until was transferred to 2nd line agent to get an answer if the second dose should be administered. No adverse event details nor follow-up could be requested since health care professional was busy and left the call. Consent for follow-up by safety not requested due to reporter being busy and not being able to complete the call.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021133168:Same reporter
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 16th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: On 16th June 2021, the patient received Pediarix, which was expired on 14th June 2021. No symptoms were reported. The reporter consented to follow up.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Musculoskeletal pain
Clinical narrative: soreness at the injection site; increased pain on his right hip and buttocks / HCP asked what / pain level was prior to / injecting / replied a SIX; increased pain on his right hip and buttocks / About 14 hours after receiving / Vaccine pain moved to / left buttocks / HCP asked what / pain level was prior to / injecting / replied a SIX; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 83-year-old male patient who received Herpes zoster (Shingrix) (batch number EG3A3, expiry date 31st December 2021) for prophylaxis.   Concurrent medical conditions included low back pain. Concomitant products included gabapentin.   On 17th June 2021 14:00, the patient received the 1st dose of Shingrix (intramuscular). On 17th June 2021, 4 hrs after receiving Shingrix, the patient experienced injection site pain, pain in hip and buttock pain. The patient was treated with diclofenac (Diclofenac Patch) and paracetamol (Tylenol Arthritis Strength). On an unknown date, the outcome of the injection site pain, pain in hip and buttock pain were recovering/resolving.   The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the pain in hip and buttock pain to be related to Shingrix.  Additional details provided were as follows: Patient himself is the reporter. Patient received his first Shingrix vaccine,after 4 hours later he experienced soreness at the injection site, increased pain on his right hip and buttocks.About 14 hours after receiving his first Shingrix Vaccine the pain moved to his left buttocks. Patient reported that he is scheduled to receive an epidural late next week for his back pain which was unrelated to the Shingrix vaccine. The patient reported that the Health care professional had asked about what his pain level was prior to her injecting the Shingrix vaccine and he replied a six. Patient reported that his adverse events was better since he used a Diclofenac pain patch and Arthritis strength Tylenol. Patient did not given permission to contact the health care professional. Reporter did not consented to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received the adjuvant only; received the adjuvant only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number XG52X, expiry date 28th November 2021) for prophylaxis.   On 18th June 2021, the patient received the 1st dose of Shingrix. On 18th June 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received only adjuvant during the day and then completed reconstitution of vaccine after that ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered  The reporter consented to follow up.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the only adjuvant only of Shingrix during the day, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient was given complete reconstituted vaccine after that. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received / first dose of Shingrix on Nov 18 2020 / not received the second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th November 2020, batch number XG52X, 28th November 2021).   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 case. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: on Jun 18th 2021, Engerix-B expired dose was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a days-old female patient who received HBV (Engerix B) (batch number CP275, expiry date 13th April 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th June 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 18th June 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: On 18th June 2021, patient received Engerix B, which was expired on 13th April 2021. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose /administered on November 2019 / not sure of receiving the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 95-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 reporter stated that, the patient did not remember receiving the 2nd dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose, Exposure via skin contact, Syringe issue
Clinical narrative: during administration vaccine leaked from the syringe and ran down the patient's arm; vaccine leaked from the syringe and ran down the patient's arm; during administration vaccine leaked from the syringe and ran down the patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 2ZN2D, expiry date 16th September 2022) for prophylaxis.   On 19th June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 19th June 2021, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were provided as follows: Pharmacist reported that the patient had received Shingrix vaccine in the left deltoid. During administration the vaccine leaked from the syringe and ran down the patient's arm, which led to accidental underdose and exposure via skin contact and Inadvertent exposure to vaccine. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: received the second dose / 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 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date 13th November 2022) for prophylaxis.   On 20th June 2021, the patient received the 2nd dose of Shingrix (subcutaneous). On 20th June 2021, unknown after receiving Shingrix, 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 provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received the second dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the 1st dose / in 2019 / is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No symptoms reported. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of Shingrix on 11Sep2019 / 2nd dose on 06Apr2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 9NH54, expiry date 14th October 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th September 2019).   On 6th April 2021, the patient received the 2nd dose of Shingrix. On 6th April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter stated that, the patient received 2nd dose late than the recommended schedule which led to lenghtening of vaccination schedule. No symptoms reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Accidental underdose, Pain, Syringe issue
Clinical narrative: did not receive the full dose for dose two of Shingrix/ some of the medication leaked out.; Soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) (batch number K2CJ4, expiry date 11th November 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th June 2021, the patient received the 2nd dose of Shingrix (intramuscular). In April 2021, the patient received the 1st dose of Shingrix. In April 2021, not applicable after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced pain. In June 2021, the patient experienced accidental underdose. On an unknown date, the outcome of the pain and accidental underdose were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of shingrix in April 2021, exact date was not provided. No lot or expiration date provided and the patient experienced soreness after the administration. The patient did not receive the full dose for 2nd dose of Shingrix because some of the medication leaked out. which led to accidental underdose. The Healthcare professional noted she had a faulty needle because the product leaked out between the needle and the hub. HCP (healthcare professional ) was uncertain how much of the product leaked out and how much of the product was administered. PQC (product quality complaint )ruled out. HCP (healthcare professional ) declined to provide full patient details because she did not have the patients permission. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Nausea
Clinical narrative: Nausea; Malaise; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea, malaise and fatigue. On an unknown date, the outcome of the nausea, malaise and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the nausea, malaise and fatigue to be related to Shingrix.  Additional details were provided as follows The reporter reported for himself. After getting the vaccine the patient began having nausea, malaise and fatigue. The patient would speak with health care professional. No health care professional information was given. The reporter did not consent to follow-up
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix in Oct 2020 and has not received the second dose yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on October 2020, batch number-J3CD5, expiry date-26th March 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pyrexia
Clinical narrative: patient developed shingles/symptoms are still on going; patient developed/fever/symptoms are still on going/the fever has been present for more than a week; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number XH2DF, expiry date unknown) for prophylaxis.   In June 2021, the patient received Shingrix (intramuscular). In June 2021, 1 week after receiving Shingrix, the patient experienced shingles and fever. On an unknown date, the outcome of the shingles and fever were not recovered/not resolved.   It was unknown if the reporter considered the shingles and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The reporter stated that, the dose of Shingrix was received on 9th June 2021 or 10th June 2021. The patient received dose of Shingrix in an unknown arm. The reporter does not know if the vaccine was administered in left or right arm. A week later, after administration, the patient developed shingles and fever. The symptoms were still on going and the reporter mentioned that the fever had been present for more than a week. The reporter was informed about the adverse event on 18th June 2021 around 2:00 pm. The reporter does not know if the patient had given a consent to follow-up with healthcare professional.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Patient received Pediarix 8 days after the expiration date; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: Age at vaccination was not reported. Nurse reported that a patient received Pediarix 8 days after the expiration date, which led to expired vaccine used. No further information reported. The reporter consented to follow up.
Age: 6.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of Engerix-b; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received HBV (Engerix B) (batch number AN3NC, expiry date 3rd June 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st June 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 21st June 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: HCP reported that the patient received an expired dose of Engerix B on 21st June 2021, which was already expired on 3rd June 2021. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Possible administration of the Shingrix vaccine reconstituted with sterile water; Possible administration of the Shingrix vaccine 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 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 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: Age at vaccination was not reported. The reporter reported that the possible administration of the lyophilized portion of the Shingrix vaccine reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter was not sure if the vaccine was administrated or not because they were only missing the powder portion of the vaccine. No further information reported. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of the vaccine two years prior/planning to receive the second dose/The vaccine was not yet administrated; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose two years prior).   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: Age at vaccination was not applicable to this report. Pharmacist reported that the patient received the first dose of the vaccine two years prior and was planning to receive the second dose, which led to incomplete course of vaccination. The vaccine was not yet administrated.  No further information were reported. The reporter did not consent nor decline follow up.