chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired IPOL administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional (Nurse practitioner).  This case involves a five-year-old male patient who received expired dose of vaccine IPV (VERO) [IPOL] (expired product administered).   The patient had a history of vaccination with DTAP and Hep B vaccine.  Medical history, medical treatment and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE, VARICELLA ZOSTER VACCINE [MMRV].  On 22-Jul-2021, the patient received a 0.5 mL first dose of suspect IPV (VERO) [oral solution, lot R1D973M, expiry date: 17-Jul-2021, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test-0.5 mL, strength: standard except for Fluzone HD-standard] via an intramuscular route at the left arm for prophylactic vaccination (expired product administered, latency: on the same day).  It was a case of actual medication error due to expired vaccine used.  It was reported that, 'Caller is looking for information on next steps. As per NP this should have been the 4th dose with this being the patient's initial visit to this practice and there was a language barrier had all dtap and hep b but missing Ipol'  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: 15.0
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was administered a 2 days expired vaccine/ no AE; Initial information was received on 22-Jul-2021 regarding an unsolicited valid non-serious case received from an Other healthcare professional (Reference number- 00694350) and transmitted to Sanofi on 23-Jul-2021.  This case involves a 15-year-old patient (unknown gender) and it was reported that he/ she administered a 2 days expired IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect IPV (VERO) [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  It was reported that, "I was just calling about your IPV vaccine for children and um this vaccine was administered to a 15 year old and it was 2 days expired. I was just wondering what the next action plans. Product used: Used".  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  There will be no information available on the batch number for this case.  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 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.
Sex: F
Vaccine: UNK
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: patient was inadvertently administered intramuscularly only the liquid (DTaP-IPV) component of the Pentacel vaccine, and not the lyophilized (Hib) component of the vaccine withno adverse event; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Medical Information (MI) (Reference number- 00694606) and transmitted to Sanofi on 23-Jul-2021.  This case involves a 2-month-old female patient who was "inadvertently administered intramuscularly only the liquid (dtap-ipv) component of the pentacel vaccine and not the lyophilized (hib) component of the vaccine" (product preparation issue) while receiving DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)].  The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 22-Jul-2021, the patient received a dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [lot UJ434ABA and expiry date: 08-Mar-2022] via an unknown route at an intramuscularly for prophylactic vaccination.  It was a case of actual medication error due to product preparation issue (Latency: on the same day).  It was reported that, "pharmacist did not have information on where on the body the vaccine was administered".   At time of reporting, the outcome was unknown for the event.  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.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: 7 m onth old male patient received expired dose o f PENTACEL vaccine, no AE; Initial information received on 23-Jul-2021 regarding an unsolicited non-valid non-serious case from a other health professional via physician(Reference number- 00694713).  This case involves a 7 month old male patient who was vaccinated with the expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination.  On 24-Jun-2021, the patient received a 0.5 ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ342AAA and expiry date: 22-Jun-2021) (Frequency: once) via an  intramuscular route in the left vastus lateralis (expired product administered) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  At the time of reporting, no adverse event was reported.   It was reported that "patient Information patient age lees than one year enter as 2 month, 4month, etc. Many pediatric vaccines need month for age. Dose 0.25 mL to 2 mL for vaccines or 0.1 mL for TB (Tuberculosis) skin test-0.5ML, Strength standard for Fluzone HD-STANDARD. Pregnancy-not applicable, Last menstrual period, due date, AE (adverse event) symptoms or no AE, If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food drug administration) requirement".  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: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: 4 month old male patient received expired dose of Pentacel was given with no reported adverse event; Initial information received on 23-Jul-2021 regarding an unsolicited non-valid non-serious case from a other health professional via physician (Reference number- 00694718).  This case involves a four month old male patient who was vaccinated with the expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation.  On 06-Jul-2021, the patient received a 0.5 ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ342AAA and expiry date: 22-Jun-2021) (Frequency: once) via an  intramuscular route in the right thigh (expired product administered) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported that "Patient Information patient age less than year enter as 2-month 4month etc. Many pediatric vaccines need month for age. Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB (Tuberculosis) skin test-0.5ML, strength: standard except for Fluzone HD-STANDARD , Pregnancy-not applicable, last menstrual period, due date, AE (adverse event) symptoms or no AE, vaccine presentation. If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food drug administration) requirement".  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: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was given expired ACTHIB, with no reported adverse event; Initial information was received on 26-Jul-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves a 15-month-old female patient who was given expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product used).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination.  On 26-Jul-2021, the patient received fourth dose of suspect HIB (PRP/T) VACCINE (lot UJ328AF and which was expired on 29-Jun-2021) via intramuscular route at an unknown administration site for prophylactic vaccination (expired product used).  It was reported that, "caller reports patient was given expired ACTHIB; caller would like instruction on how to proceed."  It was a case of an actual medication error due to expired vaccine used (same day).  At 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.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: ANAPHYLACTIC REACTION; This spontaneous report received from a consumer concerned (1400) multiple patients of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient's experienced anaphylactic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210745140.; Sender's Comments: V0: 20210757746-Covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: No additional AE reported; The consumer was supposed to receive MMR-II in the right leg; however, PROQUAD was inadvertently administered instead; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 13-JUL-2021, the patient was vaccinated once with 0.5 milliliter (ml) of varicella virus vaccine live (oka/merck) (VARIVAX) in the left leg (lot number and expiration date was unknown). The consumer was supposed to receive measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) in the right leg, however, a dose of 0.5ml of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number T027294 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA), expiration date reported as 08-FEB-2023, but upon internal validation established as 08-FEB-2022) was inadvertently administered instead (wrong product administered). No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has been 3 years since my first Shingrix vaccine; 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 (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: This case was reported by patient himself/herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient enquired that should he/she start over the vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got them AFTER a shot/can be rash- free´/was the kind I suffered; This case was reported by a consumer and described the occurrence of shingles 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 shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. Patient reported that the shots was not 100 percent effective. They also can be rash free and that was the kind patient had suffered. No further details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shot was more painful took it twice and still feeling it; 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 the 1st dose of 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 recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the 1st Shingles shot and that was painful. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR160980:same patient, same reporter, same suspect, differnet dose (2nd)
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shot was more painful took it twice and still feeling it; 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.   Previously administered products included Shingles vaccine with an associated reaction of pain (1st dose received on an unknown and experienced more painful, refer case US2021AMR160938).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the 2nd Shingles shot and that was more painful and still feeling it and never event wanted to take again. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR160938:same patient, same reporter, same suspect, differnet dose (1st)
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose/ on October 6, 2020. I never got the 2nd shot.; This case was reported by a consumer via 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 vaccine (1st dose received on 6th October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient. 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 vaccine, which led to incomplete course of vaccination. The patient inquired that if it was ok to still get the 2nd shot. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I know 6 people that got the shot and then got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not reported. The reporter reported that, he/she knew the patient who received Shingles vaccine and then got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of singles were not provided.    This was 1 of 6 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR161279:Same reporter. Pt 3/6 US-GLAXOSMITHKLINE-US2021AMR161280:Same reporter. Pt 4/6 US-GLAXOSMITHKLINE-US2021AMR161282:Same reporter. Pt 6/6 US-GLAXOSMITHKLINE-US2021AMR161281:Same reporter. Pt 5/6 US-GLAXOSMITHKLINE-US2021AMR161267:Same reporter. Pt 1/6
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I know 6 people that got the shot and then got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not reported. The reporter reported that, he/she knew the patient who received Shingles vaccine and then got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of singles were not provided.    This was 1 of 6 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR161278:Same reporter. Pt 2/6 US-GLAXOSMITHKLINE-US2021AMR161267:Same reporter. Pt. 1/6 US-GLAXOSMITHKLINE-US2021AMR161280:Same reporter. Pt 4/6 US-GLAXOSMITHKLINE-US2021AMR161281:Same reporter. Pt 5/6 US-GLAXOSMITHKLINE-US2021AMR161282:Same reporter. Pt 6/6
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I know 6 people that got the shot and then got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not reported. The reporter reported that, he/she knew the patient who received Shingles vaccine and then got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of singles were not provided.    This was 1 of 6 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR161278:Same reporter. Pt 2/6 US-GLAXOSMITHKLINE-US2021AMR161279:Same reporter. Pt 3/6 US-GLAXOSMITHKLINE-US2021AMR161281:Same reporter. Pt 5/6 US-GLAXOSMITHKLINE-US2021AMR161282:Same reporter. Pt 6/6 US-GLAXOSMITHKLINE-US2021AMR161267:Same reporter. Pt 1/6
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I know 6 people that got the shot and then got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not reported. The reporter reported that, he/she knew the patient who received Shingles vaccine and then got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of singles were not provided.    This was 1 of 6 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR161278:Same reporter. Pt 2/6 US-GLAXOSMITHKLINE-US2021AMR161279:Same reporter. Pt 3/6 US-GLAXOSMITHKLINE-US2021AMR161280:Same reporter. Pt 4/6 US-GLAXOSMITHKLINE-US2021AMR161282:Same reporter. Pt 6/6 US-GLAXOSMITHKLINE-US2021AMR161267:Same reporter. Pt 1/6
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I know 6 people that got the shot and then got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not reported. The reporter reported that, he/she knew the patient who received Shingles vaccine and then got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of singles were not provided.    This was 1 of 6 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR161278:Same reporter. Pt 2/6 US-GLAXOSMITHKLINE-US2021AMR161279:Same reporter. Pt 3/6 US-GLAXOSMITHKLINE-US2021AMR161280:Same reporter. Pt 4/6 US-GLAXOSMITHKLINE-US2021AMR161281:Same reporter. Pt 5/6 US-GLAXOSMITHKLINE-US2021AMR161267:Same reporter. Pt 1/6
Age: 24.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Unable to move her arm / cannot move both arms; And is having pain / arm-ache; This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 24-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7SY34, expiry date 13th January 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) (batch number ABXA04AA, expiry date 28th February 2022) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th July 2021, the patient received the 1st dose of Boostrix (intramuscular), Boostrix Pre-Filled Syringe Device, the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. In July 2021, 6 days after receiving Boostrix, Boostrix Pre-Filled Syringe Device, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injected limb mobility decreased and pain in arm. The patient was treated with antiinflammatory/antirheumatic products (Anti-Inflammatory). On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Boostrix, Boostrix Pre-Filled Syringe Device, Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received the first dose of Boostrix and Bexsero on the same day. The patient experienced arm-ache, was having pain and was not able to move both arms. Pharmacist wanted to know if this was likely to happen after 6 days of receiving the vaccine because it was the first time that a patient came up with this symptoms after receiving these vaccines. Pharmacist stated that both vaccines were administered in the shoulder muscle of each arm.  These symptoms were still present and were not resolved. The patient had seen her physician and was prescribed anti-inflammatory medication.   The father thought that the vaccine was not administered correctly.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021156450:Same reporter. FU1 - deleted.
Age: 67.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: was vaccinated / (22/07/2021) with the second dose / first dose was administered on 12/29/2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 29th December 2020).   On 22nd July 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 22nd July 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The Health care professional reported that, the patient received the first dose of Twinrix on 29th December 2020 and the second dose on 22nd Jul 2021, which led to lengthening of vaccination schedule. They had skipped the 1 month dose and received dose at 0 and 6 months instead of 0-1-6 month schedule.  The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: could not get the second shot within 6 months due to Covid-19 vaccination; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date intramuscularly in the left deltoid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: This case was reported by the patient himself. The age  at vaccination was not applicable for this report. The patient reported that he could not get the second shot within 6 months due to Covid-19 vaccination, which led to social problem. The medical disclaimer was given. The reporter was referred to Health care professional. Consented to follow up.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: exposed at room temperature for 906  hours; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 73-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2372H, expiry date unknown) for prophylaxis.   On 9th July 2021, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: Pharmacist reported that the patient was administered Boostrix which was exposed at room temperature for 906 hours, which led to incorrect storage of drug. No information about expiration date was available. The reporter consented to follow up by fax. This case was linked with US2021159295, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021159295:Same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: headache; sore arm; muscle pain; stomach upset; tiredness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd July 2021, 1 days after receiving Shingrix, the patient experienced headache, pain in arm, muscle pain, upset stomach and tiredness. On an unknown date, the outcome of the headache, pain in arm, muscle pain, upset stomach and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the headache, pain in arm, muscle pain, upset stomach and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient had received dose of Shingrix shot yesterday and now she had experienced headache, sore arm, muscle pain, stomach upset, tiredness. The reporter did not consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia, Rash pruritic
Clinical narrative: Itchy rash; tiredness; Fever; Chills; Body aches; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced itchy rash, tiredness, fever, chills and general body pain. On an unknown date, the outcome of the itchy rash, tiredness, fever, chills and general body pain were unknown.   It was unknown if the reporter considered the itchy rash, tiredness, fever, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The Patient received 1st dose of Shingrix and experienced itchy rash, tiredness, fever, chills and body aches. The patient wanted to know if the second shot was necessary. The caller declined to provide his address or answers any questions related to his adverse event. The caller ended the call abruptly before any questions could be asked.  No Healthcare professional information was provided. The reporter did not consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hyperhidrosis
Clinical narrative: He began sweating / resolved about 4 hours later; Husband is feeling very fatigued / has not yet resolved; This case was reported by a consumer via call center representative and described the occurrence of sweating in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 20th July 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 25th July 2021, 5 days after receiving Shingrix, the patient experienced sweating and fatigue. On 25th July 2021, the outcome of the sweating was recovered/resolved. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the sweating and fatigue to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient's wife. The reporter reported that the patient received  dose of Shingrix vaccine in the right arm and he began sweating for about 4 hours and he was feeling very fatigued on 25th July 2021. The fatigue had not yet resolved. The reporter did not consent to follow up. The reporter does not gave permission to contact HCP.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 11-JUL-2021, the patients experienced suspected covid-19 infection. The reporter stated that 10 days in & her parents still getting their asses kicked hard by Covid and experienced excruciating bone & body pain, cough, extreme fatigue, zero appetite, nausea, insane headaches. On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187633; Sender's Comments: V0: 20210749603-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Influenza, Limb discomfort, Pneumonia
Clinical narrative: HEAVY FEELING ON HIS BOTH ARMS; CONFIRMED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 (TEST UNSPECIFIED); This spontaneous report received from a consumer concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart valve replacement last year, and concurrent conditions included allergic reaction to anesthesia, non-alcohol user, and non-smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, 1 total administered to left arm (deltoid) on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-JUL-2021 (last Sunday) patient started to develop dry cough towards the end of the day. On 19-JUL-2021 (Monday) patient started to experience weakness, heavy feeling on his both arms, fever with a temperature between 99-100 degree Fahrenheit, achiness all over the body, chills, headache and nausea. Patient decided to visit to the hospital. Patient undergone a series of blood test, flu test, pneumonia and Covid-19 test. On 23-JUL-2021, patient clinically tested positive of COVID-19 [Suspected covid-19 (test unspecified) and confirmed clinical vaccination failure]. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid 19 (test unspecified), and heavy feeling on his both arms, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187127.; Sender's Comments: V0: 20210753055:Covid-19 Vaccine Ad26.Cov2.S: Confirmed Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: HEAVY FEELING ON HIS BOTH ARMS; CONFIRMED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 (TEST UNSPECIFIED); This spontaneous report received from a consumer concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart valve replacement last year, and concurrent conditions included allergic reaction to anesthesia, non-alcohol user, and non-smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, 1 total administered to left arm (deltoid) on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-JUL-2021 (last Sunday) patient started to develop dry cough towards the end of the day. On 19-JUL-2021 (Monday) patient started to experience weakness, heavy feeling on his both arms, fever with a temperature between 99-100 degree Fahrenheit, achiness all over the body, chills, headache and nausea. Patient decided to visit to the hospital. Patient undergone a series of blood test, flu test, pneumonia and Covid-19 test. On 23-JUL-2021, patient clinically tested positive of COVID-19 [Suspected covid-19 (test unspecified) and confirmed clinical vaccination failure]. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid 19 (test unspecified), and heavy feeling on his both arms, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187127.; Sender's Comments: V0: 20210753055:Covid-19 Vaccine Ad26.Cov2.S: Confirmed Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Eye pain, Fatigue, Feeling abnormal, Memory impairment
Clinical narrative: COULD NOT THINK; BRAIN FOG; CAN'T FOCUS; FORGETTING WORDS; AFFECTING BEHIND EYES; BRAIN FATIGUE; VERY TIRED AND PHYSICAL FATIGUE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient had no prior health issues and patient did not take any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, 1 total administered in left arm on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-JUL-2021, the patient experienced brain fog, forgetting words, affecting behind eyes, brain fatigue, very tired and physical fatigue and patient couldn't focus.  Patient was ok for few days. Symptoms started three days later of vaccination and it is progressing worse and worse. Patient stated that Friday was really bad and Saturday was horrible. On Saturday 17-JUL-2021 patient came home and slept for five hours because she could not think. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, very tired and physical fatigue, can't focus, forgetting words, affecting behind eyes, and brain fatigue, and the outcome of could not think was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210755714-Covid-19 vaccine ad26.cov2.s-Could not think . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Mental fatigue, Mental impairment
Clinical narrative: COULD NOT THINK; BRAIN FOG; CAN'T FOCUS; FORGETTING WORDS; AFFECTING BEHIND EYES; BRAIN FATIGUE; VERY TIRED AND PHYSICAL FATIGUE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient had no prior health issues and patient did not take any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, 1 total administered in left arm on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-JUL-2021, the patient experienced brain fog, forgetting words, affecting behind eyes, brain fatigue, very tired and physical fatigue and patient couldn't focus.  Patient was ok for few days. Symptoms started three days later of vaccination and it is progressing worse and worse. Patient stated that Friday was really bad and Saturday was horrible. On Saturday 17-JUL-2021 patient came home and slept for five hours because she could not think. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, very tired and physical fatigue, can't focus, forgetting words, affecting behind eyes, and brain fatigue, and the outcome of could not think was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210755714-Covid-19 vaccine ad26.cov2.s-Could not think . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).