chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: female patient received two doses of IMOVAX RABIES  vaccine on 03-Jul-2021 and next 08-Jul-2021, no AE; Initial information received on 20-Jul-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an unknown age female patient who received two doses of suspect RABIES (HDC) VACCINE [IMOVAX RABIES] (Inappropriate schedule of vaccine administered).  Past vaccination included initial encounter with Imovax Rabies was in 2011 with a suspected bat exposure that turned out to be an insect; that on the initial she received the immunoglobin and the Imovax vaccine, also she was given Imovax Rabies three shots; that in 2018, she had an exposure and had to receive two to three Imovax shots and she had a suspected encounter with an animal, that prior to this exposure she had one in 2019 when a bat flew out and left scratches on the arm.  Medical history included Animal scratch on 19-JUL-2021 (flying animal left scratches on her face and on her legs; that she is not sure if she needs another series due to having previous exposure Imovax vaccines; that she has had several rounds of post rabies exposure doses of Imovax).  Medical treatment, concomitant medication and family history were not provided.  On 03-Jul-2021 and 08-Jul-2021, the patient received a 1 ml doses of suspect RABIES (HDC) VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site (Inappropriate schedule of product administration) for post exposure immunization.  It was a case of actual medication error due to inappropriate schedule of vaccine administered.  It was reported that "a consumer that has recently received post exposure doses of Imovax is wanting to know does she have to get the post exposure series again since she was possibly exposed to rabies on 19Jul2021".  At the time of report no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient given Menactra on 7/6, but was not quite 16 years old/came back today and was given another dose with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00690055) and transmitted to Sanofi on 20-Jul-2021.  This case involves an unknown age and unknown gender patient for whom it was reported "patient given menactra on 7/6, but was not quite 16 years old/came back today and was given another dose" (inappropriate schedule of vaccine administered) while receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number and expiry date: not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was case of actual medication error due to inappropriate schedule of vaccine administered (Latency: on the same day).  It was reported that, "Caller printed a certificate expires 14-Sep-2021. Caller has an appointment on 28-sep-2021 to get another injection. It is it ok that she is waiting longer than 8 weeks to give another injection. It is it ok that she is waiting longer than 8 weeks to give another injection".  Details of laboratory data not reported.  At time of reporting, the outcome was unknown for the event patient given menactra on 7/6, but was not quite 16 years old/came back today and was given another dose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: patient received a 5th dose of PENTACEL instead of QUADRACEL/no AE; Initial information received on 22-Jul-2021 regarding an unsolicited valid non-serious received from other health professional via phone via Agency (Reference number- 00693083).  This case involves a 4-years-old (unknown gender) patient who received a fifth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] instead of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (Wrong product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a fifth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE instead of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)( Wrong product administered ) (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  It was of actual medication error due to Wrong vaccine administered (latency: same day).  At the time of reporting, no adverse event reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient got Kinrix and Ipol injections the same day with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional.  This case involves a 5-year-old male patient who had POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID[KINRIX] on same day (Extra dose administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), HEPATITIS A VACCINE and HEPATITIS B VACCINE for prophylactic vaccination.  On 20-Jul-2021, the patient received a 0.5 ml second dose of suspect IPV (VERO) (lot: T1D481M, expiry date: 25-Jul-2022) via intramuscular route in the right arm for prophylactic vaccination.  On 20-Jul-2021, the patient received a dose of suspect KINRIX not produced by Sanofi Pasteur (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Extra dose administered (latency same day).  It was reported "Caller stated she was waiting on recommendations on what to do since IPOL and Kinrix that was administered at the same time. Caller stated she request a call back on her cell phone. She asks how long do you monitor for the potential adverse event (AE)?"   No adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: No adverse event, Product preparation issue
Clinical narrative: questions on PENTACEL If only Dtap and IPV component given without HIB portion, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Agency inbound (reference number-00694792) and transmitted to Sanofi on 23-Jul-2021.  This case involves a six-month-old female patient who had questions on Pentacel if only DTaP and IPV [DIPHTHERIA, TETANUS, ACELLULAR PERTUSSIS, and POLIOMYELITIS VACCINE (INACTIVATED)] component given without HiB (HAEMOPHILUS TYPE B (HIB) VACCINE) portion, no adverse event (product preparation error) while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].   The patient's past vaccination(s) included PENTACEL with Dose 1: at 2 months and Dose :2 at 4 months.  The patient's past medical history, medical treatment(s), and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE on an unknown date for prophylactic vaccination.  On 23-Jul-2021, the patient received a dose 3 (0.5ml) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE without the HIB portion (lot number for Quadracel portion: U6940BA; expiry date: 21-May-2021) via intramuscular route in right vastus lateralis for prophylactic vaccination.  It was case of actual medication error due to product preparation error (latency: same day).  It was reported, "Caller has questions on PENTACEL If only Dtap and IPV component given without HIB portion, will the patient need Pentacel re-administered or only the HIB portion. AE (adverse event) symptoms or no AE - No reaction reported."  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Product preparation issue
Clinical narrative: ACT-HIB was given to a patient without reconstituting with proper diluent and instead it was reconstituted with sterile water/ no adverse event; Initial information received on 26-Jul-2021 regarding an unsolicited valid non-serious case received from a physician and Other Health Care Professional.  This case involves a 6 month-old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] without reconstituting with proper diluent (reconstituted with sterile water) [product preparation error].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for prophylactic vaccination.  On 26-Jul-2021, the patient received third dose 0.5 mL (once) of suspect HIB (PRP/T) VACCINE (lot UJ405AAB and expiry date 08-Oct-2021) via an intramuscular route at the right thigh for prophylactic vaccination.  It was reported that "Physician assistant student reports that he gave ACT-HIB to a patient without reconstituting with proper diluent. States he did not see diluent packaged with ACT-HIB and instead he reconstituted with sterile water".  It was a case of an actual medication error due to wrong solution used in drug reconstitution (latency was on same day).  At the time of report, no adverse event was reported.  Event outcome was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient received a expired dose of TENIVAC which was expired in Jan 2021 with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via medical information (Reference number- 00700714) and transmitted to Sanofi on 28-Jul-2021.  This case involves a 52-year-old female patient received an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] which was expired in Jan-2021 (expired product administered).   Medical history, medical treatment, vaccination, family history and concomitant medications were not provided.  On 16-Jun-2021, the patient received a 0.5 mL total dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [once, lot C5578AA, expiry date: Jan-2021] via an intramuscular route at the left deltoid for prophylactic vaccination (expired product administered). (Latency: on the same day)  It was a case of actual medication error due to expired vaccine use.   It was reported that, "Nurse called to inquire about an expired Tenivac vaccine that was given. When should the patient be re-vaccinated?"  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered an expired dose of ACTHIB with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional.  This case involved 1 year old female patient was administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  On 27-Jul-2021, the patient received fourth 0.5ml dose of suspect HIB (PRP/T) VACCINE (lot: UJ355AA and expiry date: 24-Jul-2021) (Frequency = once) (Strength = standard) via intramuscular route in unknown administration site for prophylactic vaccination (expired product administered)  It was reported that,"Caller wanted to know if that dose could be considered valid if blood work were drawn and analyzed on the patient."  This case was an actual medication error case due to expired vaccine used (latency: same day)   At the time of reporting, no adverse event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Onset of tinnitus that HAS NOT gone away, and sometimes gets extremely unbearable
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone normal, C-reactive protein normal, Colitis microscopic, Colonoscopy abnormal, Diarrhoea
Clinical narrative: She developed severe diarrhea 1-2 weeks after her second Moderna dose. Her symptoms have persisted since 4/2021 (now 8/2021). lab testing normal. She underwent colonoscopy with pathology showing lymphocytic colitis with possible early collagenous colitis
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Laboratory test normal, Pathology test, Red blood cell sedimentation rate normal, Serology normal
Clinical narrative: She developed severe diarrhea 1-2 weeks after her second Moderna dose. Her symptoms have persisted since 4/2021 (now 8/2021). lab testing normal. She underwent colonoscopy with pathology showing lymphocytic colitis with possible early collagenous colitis
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Heart rate irregular, Hypoaesthesia
Clinical narrative: Numbness on arms legs and left side  face with  pain tight cheat  and irregular heart  beat.
Age: 18.0
Sex: U
Vaccine: HPV9, UNK
Symptoms: Expired product administered
Clinical narrative: No additional adverse events reported; an expired dose of GARDASIL 9 was administered; This spontaneous report was received from a healthcare worker referring to an 18 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 09-JUL-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml; lot # R029515, expiration date 08-JUL-2021; strength, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). This dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was found supported by memo with no temperature excursion. No other information given. No additional adverse events were reported (no adverse event). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R029515; expirationdate: 08-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: No additional AEs; The patient received MMR II by the intramuscular route instead of the recommended subcutaneous route; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 19-JUL-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, 0.5 milliliter (lot# S028913 has been verified to be a valid lot number and expiration date was 16-SEP-2021) by the intramuscular route instead of the recommended subcutaneous rout for prophylaxis (incorrect route of product administration). The nurse reported the needle size used was a 25 Gauge, 1 inch length needle. No additional adverse events were reported. The outcome of the event was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster related injuries; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.   On or about 17-DEC-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported), for the long-term prevention of herpes zoster or shingles.         Subsequently, on an unknown date, the patient was treated for shingles and other zoster-related injuries. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; expired dose of GARDASIL 9 was administered; the patient had previously been vaccinated with the GARDASIL 9 series in 2017 and wanted to receive the vaccine series again; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  In 2017, the patient received series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact doses, route of administration, anatomical locations, lot numbers and expiration dates were not provided) for prophylaxis. On 28-JUL-2021, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 time dose, lot # R029900, expiration date 23-JUL-2021 (exact dose, route of administration and anatomical location were not provided), because they wanted to receive the vaccine series again (expired vaccine used, extra dose administered). No adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R029900; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Diarrhoea, Headache
Clinical narrative: headache; fever; body aches; joints aching; chills; sweats; nausea; diarrhea; general stomach discomfort; This case was reported by a consumer and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2021, the patient received Shingrix. In July 2021, 12 hrs after receiving Shingrix, the patient experienced headache, fever, general body pain, joint pain, chills, sweating, nausea, diarrhea and stomach discomfort. On an unknown date, the outcome of the headache, fever, general body pain, joint pain, chills, sweating, nausea, diarrhea and stomach discomfort were recovered/resolved.   It was unknown if the reporter considered the headache, fever, general body pain, joint pain, chills, sweating, nausea, diarrhea and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient wanted to report his or her reaction to the Shingrix vaccine. The patient received the Shingrix vaccine and approximately 12 hours later the patient began to experience headache, fever, body aches, especially joints aching, chills, sweats, nausea, diarrhea, general stomach discomfort.  These was more severe symptoms lasted for about 8 hours, followed by milder stomach discomfort over two days. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Nausea, Pain, Pyrexia
Clinical narrative: headache; fever; body aches; joints aching; chills; sweats; nausea; diarrhea; general stomach discomfort; This case was reported by a consumer and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2021, the patient received Shingrix. In July 2021, 12 hrs after receiving Shingrix, the patient experienced headache, fever, general body pain, joint pain, chills, sweating, nausea, diarrhea and stomach discomfort. On an unknown date, the outcome of the headache, fever, general body pain, joint pain, chills, sweating, nausea, diarrhea and stomach discomfort were recovered/resolved.   It was unknown if the reporter considered the headache, fever, general body pain, joint pain, chills, sweating, nausea, diarrhea and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient wanted to report his or her reaction to the Shingrix vaccine. The patient received the Shingrix vaccine and approximately 12 hours later the patient began to experience headache, fever, body aches, especially joints aching, chills, sweats, nausea, diarrhea, general stomach discomfort.  These was more severe symptoms lasted for about 8 hours, followed by milder stomach discomfort over two days. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received the 2 shingles shots BUT I got shingles anyway/Suspected Vaccination failure; got shingles anyway; severe stress can bring them on; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd 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 stress. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the vaccination failure, shingles and stress were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the 2 shingles shots but got shingles anyway.  Doctor said severe stress could bring them on. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Rash
Clinical narrative: got so sick; terrible rashes; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and rash. The patient was treated with steroids nos (Steroids) and dermatologicals nos (Cream (Nos)). On an unknown date, the outcome of the sickness and rash were unknown.   It was unknown if the reporter considered the sickness and rash to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got so sick after getting the first shot of Shingles vaccine and later got terrible rashes, even a month later the patient had to take steroids and creams. The patient was contemplating not getting the second shot. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shot on Sept / 2020 /missed the second shot; This case was reported by a consumer via SHINGRIX 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 (received 1st dose of Shingrix in September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the patient for herself or himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wanted to ask if he or she could still take the second shot after almost a year. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and got guillain barre syndrome and could not get any vaccines, till the time of reporting. The patient stated he/she could not get Covid vaccine and be protected. The follow-up would not be possible as no contact details were available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pruritus, Rash
Clinical narrative: shingles blister left upper chest; shingles blister left upper chest; itchiness on left side upper chest; rash on back and chest on right side; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (In February 2021), post herpetic neuralgia (In February 2021) and rash (had a rash on back and chest on right side).   On 8th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 9th July 2021, 1 days after receiving Shingrix, the patient experienced shingles, blister, localized itching and rash. On an unknown date, the outcome of the shingles, blister, localized itching and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blister, localized itching and rash to be related to Shingrix.  Additional details were provided as follows: The case was reported bypatient herself.  The patient received the Shingrix vaccine in left arm. The patient stated the next day she had one shingles blister on upper chest left side and had a rash on back and chest on right side.  The patient asked if Shingrix can cause a shingles outbreak? The patient referred to health care professional, Spoke per content.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Depressed mood, Illness, Incomplete course of vaccination
Clinical narrative: sick; rounded down; 2nd dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness, feeling down and incomplete course of vaccination. On an unknown date, the outcome of the sickness, feeling down and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the sickness and feeling down to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose and it was not applicable for 2nd dose. The patient received first dose of Shingrix and was rounded down and sick. Till the time of reporting, the patient did not receive  2nd dose of Shingrix, which led to incomplete course of vaccination. No vaccine information was available since it was administered 4 years ago in unknown facility. The reporter was not sure about the symptoms patient described after receiving the first dose but clarified that was not an "actual" reaction to the vaccine. The reporter did not consented to follow-up.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: might have received the Menveo / reconstituted with sterile water.; might have received the Menveo / 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 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA548A, expiry date 28th February 2022) for prophylaxis.   On 21st July 2021, the patient received Menveo. On 21st July 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient might had received the Menveo vaccine reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter stated might, because she was not sure if it was this patient or another that received the improperly reconstituted vaccine. No further events were reported at the time of reporting. The reporter consented to follow up. This case has been linked with the case US2021163838 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021163838:same reporter
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: might have received the Menveo /reconstituted with sterile water.; might have received the Menveo /reconstituted with sterile water.; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA548A, expiry date 28th February 2022) for prophylaxis.   On 26th July 2021, the patient received Menveo. On 26th July 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient might had received the Menveo vaccine reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter stated might, because she was not sure if it was this patient or another that received the improperly reconstituted vaccine. No further events were reported at the time of reporting. The reporter consented to follow up. This case has been linked with the case US2021163836 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021163836:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received dose 1 / 3 years ago; 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 (received 1st dose on an unknown date 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that, the patient received first dose of Shingrix 3 years ago. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose was given on 03Nov2020 and third dose on 04Dec2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 26-year-old male patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HBV (Engerix B).   On 4th December 2020, the patient received the 3rd dose of Engerix B. On 4th December 2020, unknown after receiving Engerix B, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received an early third dose of Engerix-B.  Second dose was given on 3rd November 2020 and third dose on 4th December 2020 earlier than recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose back in possibly11/2020 / Potential first/second dose / (7/29/2021); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2020).   On 29th July 2021, the patient received the 2nd dose of Shingrix. On 29th July 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 patient was vaccinated with 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The pharmacist had enquired to proceed with Shingrix series. Pharmacist would like information if potentially a third dose was required with series. Pharmacist stated that additional dose had not been administered. The reporter did not consent to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: injection site has pain /left arm injection site has pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DC924, expiry date 26th October 2020) for prophylaxis.   On 14th March 2020, the patient received Boostrix (intramuscular). On 14th March 2020, less than a day after receiving Boostrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced left arm injection site pain. Till the time of reporting, the pain was ongoing and was not resolved. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness
Clinical narrative: feeling / weak; feeling dizzy; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2021 02:00, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2021, 1 days after receiving Shingrix, the patient experienced weakness and dizziness. On an unknown date, the outcome of the weakness and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the weakness and dizziness to be related to Shingrix.  Additional details provided were as follows: The reporter called to report that he received the dose of Shingrix in the right deltoid and next day he started feeling dizzy and weak. The patient was referred to health care professional. As per PI and content severe allergic reactions were less common and included hives, swelling of the face/throat, difficulty breathing, a fast heartbeat, dizziness and weakness. Reporter was encouraged to seek medical attention multiple times. Patient insisted he would wait until to see how he felt before seeking medical attention.  Reporter consented to follow-up.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquid portion; received only the liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA432A, expiry date 31st August 2022) for prophylaxis.   On 13th July 2021, the patient received the 1st dose of Menveo. On 13th July 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse reported that a 11 years and 8 month old patient received only the liquid portion of the Menveo vaccine, which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered. All patients identifiers were reported as well as batch number and expiration date. The reporter consented to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administration of a partial dose / only liquid portion was given; administration of a partial dose / only liquid portion was given; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA14A, expiry date unknown) for prophylaxis.   On 14th July 2021, the patient received the 1st dose of Menveo (unknown). On 14th July 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. It was stated that the patient received the partial dose of Menveo and only liquid portion was given to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up by fax.
Sex: U
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: the vaccine leaked / unknown how much medication was /administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) (batch number 7354R, expiry date 15th November 2022) for prophylaxis.   On 2nd August 2021, the patient received the 1st dose of Shingrix. On 2nd August 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that while injecting the 1st dose of Shingrix into a patient the vaccine leaked out between the syringe and the needle and it was unknown how much medication was actually administered to the patient, which led to incomplete dose administered. The reporter consented to follow up. The Pharmacist was warm transferred to GRC for reporting of potential PQC. No further details provided.