chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Client presented at vaccination site on 01/19/22. The client reported she received her Janssen COVID vaccine on 06/01/21 (Lot #: 1808980). Client reported after 15 minutes observation and leaving the vaccine site, she had sore arm on the injection side lasted for two to three hours. Client reported after 30 minutes after the Janssen vaccine at home, she had shortness of breath which lasted two to three hours and went away on its own. At nighttime on 06.01.21, she reported she had headache and fever which woke her up and she took one aspirin pill and both the headache and fever lasted only three hours. Client reported she has history of childhood asthma and bronchitis. Client told she didn?t follow-up with her PCP. Client said she has no chronic illnesses or taking any medications, nor any known allergy. Client is requesting the booster dose of Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the booster dose of Pfizer COVID vaccine. Per the doctor, approval to proceed with the booster dose of Pfizer COVID vaccine was obtained via text message from clinical project coordinator. Client received the booster dose of Pfizer COVID vaccine, LOT#: FL3209 on 01/19/22 at 1618 by LVN. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1648 unassisted and with a steady gait.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Glossodynia, Oral lichen planus, Plicated tongue, Tongue abscess, Tongue discomfort
Clinical narrative: Fissure on tongue, Lesions on the tongue around the fissure which was recently diagnosed as Oral Lichen planus. Horribly burning and sensitive tongue. Topical steroids prescribed but not helping much
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Since 12 December she has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affect her palms and soles, and resolve without post-inflammatory changes. She denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes also associated with stress but not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 2 December, 10 days prior to onset of symptoms. He has used oral antihistamines with some benefit. She denies constitutional symptoms. UCT score today is 30 (3, 4, 3, 4, 4, 4, 4, 4). No history of adverse reactions to prior vaccines.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion, Stress, Urticaria
Clinical narrative: Since 12 December she has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affect her palms and soles, and resolve without post-inflammatory changes. She denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes also associated with stress but not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 2 December, 10 days prior to onset of symptoms. He has used oral antihistamines with some benefit. She denies constitutional symptoms. UCT score today is 30 (3, 4, 3, 4, 4, 4, 4, 4). No history of adverse reactions to prior vaccines.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered >12(US)/24(CA) hours post puncture; administer  over 5000 doses, after the12 hours limit on open vials/administering past the BUD date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer  over 5000 doses, after the12 hours limit on open vials/administering past the BUD date) and PRODUCT STORAGE ERROR (Dose administered >12(US)/24(CA) hours post puncture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer  over 5000 doses, after the12 hours limit on open vials/administering past the BUD date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered >12(US)/24(CA) hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer  over 5000 doses, after the12 hours limit on open vials/administering past the BUD date) and PRODUCT STORAGE ERROR (Dose administered >12(US)/24(CA) hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided. BUD is 01-Nov-2021   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2022: Live significant follow up- Date of administration update
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Tinnitus in both ears 2 weeks after first Booster; Decrease in hearing in both ears  2 weeks after first Booster; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus in both ears 2 weeks after first Booster) and HYPOACUSIS (Decrease in hearing in both ears  2 weeks after first Booster) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J & J Covid 19 Vaccine (1 primary dose) on 05-Mar-2021. Past adverse reactions to the above products included No adverse event with J & J Covid 19 Vaccine.    On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced TINNITUS (Tinnitus in both ears 2 weeks after first Booster) and HYPOACUSIS (Decrease in hearing in both ears  2 weeks after first Booster). At the time of the report, TINNITUS (Tinnitus in both ears 2 weeks after first Booster) and HYPOACUSIS (Decrease in hearing in both ears  2 weeks after first Booster) had not resolved.            No concomitant medication was provided by the reporter.  On 29 Oct 2021 patient received first Moderna booster dose of vaccine. It was reported that about 2 weeks after the first booster, patient started having tinnitus, and decrease in hearing in both ears. These side effects never went away and patient did not call the doctor.  No treatment medication was provided by the reporter.   This case was linked to MOD-2022-550323 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: after my second vaccine I started having severe migraines approximate about 5 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Primary Immunization complete), for Covid-19 Immunization. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "after my second vaccine I started having severe migraines approximate about 5 weeks".  Additional information: Patient was inquiring who could he/she report a concern to with the vaccine, after second vaccine patient started having severe migraines approximate about 5 weeks after the vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Liquid product physical issue
Clinical narrative: the fluid was clear, rather than cloudy.; experienced some pain immediately upon injection that lasted all day.; This spontaneous report has been received from an approximately 35-year-old female patient concerning herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in January 2022 (reported as 2 months ago), the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot #, and expiry date were not provided), for prophylaxis. She noticed the pharmacist vigorously shaking the vial prior to administering.  The patient reported that she experienced some pain immediately upon injection, that lasted all day. She did not seek medical attention. On 28-MAR-2022, the patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot #, and expiry date were not provided), for prophylaxis. It was administered at the pharmacy. The patient stated the pharmacist did not shake the vial and she noticed the fluid was clear, rather than cloudy (Liquid product physical issue). She also mentioned that the pharmacist claimed they had shaken it, but they did not witness this, nor did the appearance of the fluid seem this way. The patient was concerned if this would affect efficacy of the vaccine.  The patient did not experience any pain at all following the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9); however, at the time of reporting, the patient's pain experienced upon injection of the first dose was unknown.  The causal relationship between experienced pain and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE information; Customer calling to report expired vaccine administered. Vaccine did not experience any temperature excursions.; This spontaneous report was received from an unspecified customer and also a reporter from the regulatory agency referring to a 12-months-old male. It was reported that the patient had no (reported as none) illness at the time of vaccination or pre-existing physician-diagnosed allergies, birth defects or medical conditions.   On 01-APR-2022, the patient was vaccinated with dose one (1) (also reported as 1 dose) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) by subcutaneous route on his right vastus lateralis (dosage and vaccination scheme frequency were not reported; lot number T010650 that was verified to be a valid lot number with an expiration date reported and established as 26-MAR-2022) (expired product administered) for prophylaxis. It was stated that the vaccine did not experience any temperature excursion.  The outcome for the expired vaccine used was reported as recovered; however, defaulted to unknown per internal guideline.No additional adverse event was reported (no adverse event).
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: administered GARDASIL 9 while pregnant; The patient was suppose to receive a Tdap vaccination; This spontaneous, prospective pregnancy report was received from a physician and refers a 33-year-old, pregnant female patient. Her pertinent medical history, concomitant medications and drug reactions or allergies were reported as none.  Date of the patient's last menstrual period (LMP) was calculated as 30-SEP-2021. At the time of the report, pregnancy gestation period was 28 weeks. The pregnancy outcome was pending (unknown fetal outcome). Estimated date of delivery (EDD) was calculated as 07-JUL-2022.  On 14-APR-2022, the patient was incorrectly vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection in the arm (dose, route of administration, lot # and expiration date were not reported) for prophylaxis, while she was supposed to receive a diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) vaccination (wrong vaccine administered).
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: No other adverse events reported; one dose was administered on 12Oct2021, the patient's chart for some reason was not updated prior to patient getting extra dose on 14Apr2022 which contributed to the extra dose being administered; This spontaneous report was received from a nurse referring to a 5 year old male patient. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not provided.   On 12-OCT-2021, the patient was administered with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number T035410 and expiration date 14-APR-2022; strength, dose detail and route were not provided) for prophylaxis.   The patient's chart for some reason was not updated prior to patient getting extra dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number U031564 and expiration date 06-APR-2023; strength, dose detail and route were not provided) on 14-APR-2022 which contributed to the extra dose being administered.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; administration of an expired PROQUAD (Lot: T034828; Exp: 11APR2022) to a patient on 21APR2022.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, concomitant medications, pertinent medical history or drug reactions/allergies was not provided.  On 21-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin, rHA) (PROQUAD) lot number: T034828, expiration date: 11-APR-2022 (dose, strength, route of administration and anatomical location was not reported) for prophylaxis (expired product administered). The reporter confirmed measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) had no temperature excursions and had been stored per the recommended storage range until administration. No additional adverse event (AE) was reported (no adverse event). No product quality complaint (PQC) reported.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Injection site pain, Insomnia, Pyrexia, Seizure
Clinical narrative: the patient had a "really strong" seizure [...] the patient had another seizure when the ambulance was on the way and a third seizure when the ambulance finally arrived; his arm hurt at the injection site of the vaccine; developed a fever; he could not sleep during the night after receiving the vaccine; This spontaneous report was received from a patient's mother, referring to a 12-year-old male patient. The patient's medical history, concomitant medications, concurrent conditions, historical drugs and drug allergies were not reported.  On 09-APR-2021, the patient was vaccinated with a first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARASIL 9) (dose, route and site of administration, lot number and expiration date were not reported) for prophylaxis. On 14-MAY-2021, the patient received his second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), lot# 1659422, expiration date not reported but upon internal validation established as 04-SEP-2022 (dose, route and site of administration were not reported) for prophylaxis.  On 14-MAY-2021, after administration of the second dose, the patient's arm was hurting at the injection site of the vaccine and he developed a fever. It was also reported that he could not sleep during the night after receiving the vaccine (insomnia) and the fever did not go down. On 15-MAY-2021, the patient experienced a "really strong" seizure. He had another seizure when the ambulance was on the way and a third one when the ambulance arrived. The patient was taken to the emergency room but was not admitted to the hospital. On an unknown date, the patient recovered from the events.  The relatedness between the events and the suspect vaccine was not reported.  Upon internal review, the event of seizures was determined to be medically significant.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administration of vaccine following temperature excursion; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and previous drugs reactions or allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 11-APR-2022,the patient was vaccinated with a improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter/once (lot number U024221, has been verified to be valid, expiration date: 04-AUG-2023), administered for prophylaxis (route of administration were not provided). Patient did not have any symptoms or adverse effects of receiving vaccine (also reported as no adverse event). The stored temperature was -13.0 degrees Celsius (C) and the time frame was reported as 1 hour. There was no previous temperature excursion. No further information was provided.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC, RV5
Symptoms: Generalised tonic-clonic seizure, Laboratory test normal, Ultrasound head normal
Clinical narrative: Experienced generalized compulsive seizures; This spontaneous report has been received from a vaccine/patient coordinator on behalf of a physician, regarding a 4 months-old (by the time of the event) female patient. The patient's pertinent medical history included ventricular septal defect as current condition, her previous drugs reactions or allergies and concomitant medications were not reported.  On 13-APR-2022, the patient was vaccinated with the second series of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral (lot number 1742434, which was determined to be a valid lot number, expiration date: 16-MAR-2023), and with diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) intramuscular (lot number U7125AA, which was determined to be a valid lot number, expiration date: 15-JUL-2024) and pneumococcal vaccine CONJ 13V (CRM197) (PREVENAR 13) both administered intramuscularly (lot number EX1979, expiration date: 31-DEC-2023) . All suspect vaccines were administered as routine vaccination (doses and anatomical locations were not reported).  On 21-APR-2022, the patient experienced generalized compulsive seizures that lasted for 45 seconds (generalised tonic-clonic seizure). The patient was taken to the emergency room and was under observation for several hours; treatment (unspecified) was given for the  event.. She had a head ultrasound and labs done; the results were normal. The outcome of the event was reported as recovered.  The causal relationship between generalised tonic-clonic seizure and rotavirus vaccine, live, oral, pentavalent (ROTATEQ), diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) and pneumococcal vaccine CONJ 13V (CRM197) (PREVENAR 13) was not reported.  Upon internal review, the event generalised tonic-clonic seizure was determined to be medically significant.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC, RV5
Symptoms: Blood glucose normal, Metabolic function test normal, Seizure, Ultrasound head normal
Clinical narrative: Experienced generalized compulsive seizures; This spontaneous report has been received from a vaccine/patient coordinator on behalf of a physician, regarding a 4 months-old (by the time of the event) female patient. The patient's pertinent medical history included ventricular septal defect as current condition, her previous drugs reactions or allergies and concomitant medications were not reported.  On 13-APR-2022, the patient was vaccinated with the second series of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral (lot number 1742434, which was determined to be a valid lot number, expiration date: 16-MAR-2023), and with diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) intramuscular (lot number U7125AA, which was determined to be a valid lot number, expiration date: 15-JUL-2024) and pneumococcal vaccine CONJ 13V (CRM197) (PREVENAR 13) both administered intramuscularly (lot number EX1979, expiration date: 31-DEC-2023) . All suspect vaccines were administered as routine vaccination (doses and anatomical locations were not reported).  On 21-APR-2022, the patient experienced generalized compulsive seizures that lasted for 45 seconds (generalised tonic-clonic seizure). The patient was taken to the emergency room and was under observation for several hours; treatment (unspecified) was given for the  event.. She had a head ultrasound and labs done; the results were normal. The outcome of the event was reported as recovered.  The causal relationship between generalised tonic-clonic seizure and rotavirus vaccine, live, oral, pentavalent (ROTATEQ), diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) and pneumococcal vaccine CONJ 13V (CRM197) (PREVENAR 13) was not reported.  Upon internal review, the event generalised tonic-clonic seizure was determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; HCP reports patient was accidently administered an expired dose of MMR II on Apr 19, 2022. Product expired on Apr 14, 2022.; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.  On 19-APR-2022, the patient was accidently administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) once (lot #T012808, expiration date: 14-APR-2022) (expired product administered) for prophylaxis (formulation, strength, and route of administration were not provided). The product had no known temperature excursions. No additional adverse event (AE) was reported (no adverse event). No product quality compliant (PQC) reported.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: Pain in her arm; Fatigue; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced pain in arm, fatigue and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, fatigue and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fatigue and influenza-like symptoms to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR068660   Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received her first Shingrix vaccine on the left arm, about 3 months before reporting and had pain in her arm, fatigue and flu like symptoms, these symptoms started about 12 hours after the vaccine and had resolved. The patient did not have any further information about the vaccines (lot number, expiry date) and disconnected prior to getting her date of birth. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR068660:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received 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 upset stomach, tiredness and chills. On an unknown date, the outcome of the upset stomach, tiredness and chills were unknown. It was unknown if the reporter considered the upset stomach, tiredness and chills to be related to Shingrix. Additional Information: GSK Receipt Date: 20-APR-2022. Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced stomach upset, tiredness and chills.  The patient asked how long did the side effects of the booster usually last, Today (day of reporting) was his/her day after shot and felt some effects. The patient also asked was it generally safe to take tylenol, advil, excedrin for these symptoms. The patient didn't have a reaction with the first time so a little surprised this time. The patient did not wish to give all the information. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Myalgia, Pain
Clinical narrative: Pain; Redness; Muscle pain; Shivering; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2022, the patient received the 1st dose of Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced pain, erythema, muscle pain, shivering and tiredness. On an unknown date, the outcome of the pain, erythema, muscle pain, shivering and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the pain, erythema, muscle pain, shivering and tiredness to be related to Shingrix.     Additional Information: GSK receipt date: 20-Apr-2022 Reporter's comment: The patient received a dose of Shingrix two days ago and had pain, redness, muscle pain, shivering and tiredness. The patient just wanted to know how many days he/she could expect the side affects to last. The patient did not provide full name, mailing address, email address, phone number and date of birth. The patient did not consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: needle and hub separate during administration; needle and hub separate during administration; This case was reported by a consumer via interactive digital media and described the occurrence of incorrect dose administered in a 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 incorrect dose administered and incomplete dose administered. On an unknown date, the outcome of the incorrect dose administered and incomplete dose administered were unknown.   Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient reported that during administration of Shingrix vaccine needle and hub were separated. The patient asked for guidance on revaccination. Additional Supportive Information: The patient reported that during administration of Shingrix vaccine needle and hub were separated, which led to incomplete dose administered. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd dose after 2weeks; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that his/her doctor gave him/her GlaxoSmithKline Shingrix vaccine but he/she received 2nd dose after 2weeks. The patient  noticed 2-6 months was the usual. The patient asked was his/her vaccination invalid because his/her doctor did not wait 2-6 months for his/her 2nd dose. Additional supportive information: The patient received 2nd dose of Shingrix vaccine earlier than the recommended interval, which led to shortening of vaccination schedule. The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: my injection site is still swollen like a softball; my injection site is red hot.; my injection site is red hot.; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine on Thursday and his/her injection site was still swollen like a softball and red hot. The patient asked was this normal. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got first shingles shot, have a small patch of 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 23rd March 2022, the patient received the 1st dose of Shingles vaccine. In April 2022, less than 2 months 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 Information: GSK Receipt Date: 24-Apr-2022 Reporter's comments: This case was received from Shingrix GSK chatbot. This case was reported by the patient. On 23rd March the patient received Shingles vaccine and in the reporting week, the patient developed small patch of shingles. The patient asked that should he get 2nd shot now.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shot does hurt after; 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 Information: GSK Receipt Date: 24-Apr-2022 Reporter's comments: This case was received from media page. This case was reported by the patient. The patient received Shingles vaccine and shot hurt after. But from what the patient hear it would be worth it.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had it twice even after the shot/suspected vaccination failure; had it twice even after the shot; so painful; This case was reported by a consumer via interactive digital media and described the occurrence of 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 pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 23-APR-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The reporter stated that, shingles was so painful had it twice even after the shingles shot. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: don't help you still can get shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 Information: GSK receipt date: 23-Apr-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient reported that vaccines did not help still could get shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: still got shingles/ SUSPECTED VACCINATION FAILURE; shingles, light case; This case was reported by a consumer via interactive digital media and described the occurrence of 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, 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 Information: GSK Receipt Date: 24-Apr-2022 Reporter's Comments: This case was reported by the patient's bother/sister via interactive digital media. The reporter stated that one might be safe, but the patient still got shingles after vaccine, doctor said it was a lighter case. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles shot, got shingles again/suspected vaccination failure; shingles again on face; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient got shingles on right shoulder blade).   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 Information: GSK Receipt Date: 22-APR-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient got the Shingles shot and then recently got the shingles again on his/her face.  The patient thankfully got the medicine (unspecified) to help it and they stayed on the milder side. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: have them again/suspected vaccination failure; have them again; pain is excruciating; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 71-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (when was in 40's, got the shot). Previously administered products included Shingels vaccine.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 24-APR-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient got the two shots. In early 60's. Now patient was 71 and had shingles again. The pain was excruciating. Would not bother with any more shots. The patient would not wish the shingles on his/her worst enemy. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: l got vaccinated but still l got it/Suspected vaccination failure; l got vaccinated but still l got it; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of 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 pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-APR-2022 Reporter's comment:  This case was reported by the patient via interactive digital media. The patient got vaccinated but still got it very horrible and painful. The patient had Shingles vaccine 3 years prior to the reporting and asked why he/she was still suffering it right now. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got the shot about 4 or 5 months later I caught shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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, between 4 and 6 months 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 Information: GSK Receipt Date: 24-Apr-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient heard how horrible the shingles was so he/she got the shot, about 4 or 5 months later, the patient caught shingles. The patient stated that it was such a minor case, enough to let him/her know he/she had it but no serious effects. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the vaccine and got shingles./Suspected vaccination failure; I had the vaccine and got shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-APR-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, it was not 100 percent because he/she had the shingles vaccine and got shingles.  It was a very mild case and was gone in 2 weeks. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had vaccine, got shingles next year/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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, 1 year 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 Information: GSK receipt date: 24-Apr-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated just because you get the Shingles vaccine did not mean you could not get shingles. The patient had vaccine and then got shingles next year, not very common for that to happen.  Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got shingrix vaccine in 2019; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient got Shingrix vaccine in 2019 and asked when should he/she get it again. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible, as no contact, details were available.