chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19-2, COVID19-2, FLUA4, FLUA4, PPV, PPV
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Diagnosed: Cellulitis on R arm per Dr at Urgent Care Treatment: antibiotic (pills) Symptoms: Right arm sore, pain, swelling, redness, hot to the touch, itchiness, fever (101 degree), chills, body aches - Redness on right arm started happening 6-8 hours after vaccination  - Redness on right arm started spreading on day 2 after vaccination  - Symptoms started 6 hours after injections   Outcomes: went to Urgent  care on 12/17/22 at around 9:00 Pm.   Progress: currently on day 3 of antibiotic. Symptoms persists of mild pain and itchiness on R arm for now. Redness and swelling on R arm has reduced. No fever, chills, or body aches.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Extra dose administered
Clinical narrative: Mother declined the HPV vaccine on 10/12/2022, therefore Dr. did not place an order. MA proceeded to administer the vaccine even though there was no written order. MA failed to document the given vaccine although it was administered incorrectly. Patient came for a second visit 10/26/22 now accompanied by father. Father was unaware of the situation and was offered the HPV vaccine, to which he consented. Patient received an invalid second dose not within the vaccine schedule. Mother has been informed. As advised my Dr., there is no harm to patient, patient received an additional dose.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient's monovalent COVID 19 vaccine was not diluted correctly. I spoke with patient's mother to inform her of this. I educated her regarding possible side effects of the vaccine and the possibility of restarting the series. Mother reported that patient was acting normally and was not experiencing any side effects. Mother felt reassured and stated she will keep her appointment in December for COVID dose.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: the Vial was opened a day before but no Date or time was placed on the Vial. not sure if patient would need an additional vaccine.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Vaccine was given vaccine, as soon as needle was ejected from arm, patient fainted. He was unconscious for about 30 seconds and then became conscious. Provider came over to assess patient and determined he was fine. Patient sat for 10 minutes to continue monitoring. Pt stated he felt fine, and mom took him home. She was instructed to call our office if any other reactions occurred at home.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient's monovalent COVID 19 vaccine was not diluted correctly. I spoke with patient's mother to inform her of this. I educated her regarding possible side effects of the vaccine and the possibility of restarting the series. Mother reported that patient was acting normally and was not experiencing any side effects. Mother felt reassured and stated she will keep her appointment in December for COVID dose.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient's monovalent COVID 19 vaccine was not diluted correctly. I spoke with patient's mother to inform her of this. I educated her regarding possible side effects of the vaccine and the possibility of restarting the series. Mother reported that patient was acting normally and was not experiencing any side effects. Mother felt reassured and stated she will keep her appointment in December for COVID dose.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling at injection location site, redness and hardness from shoulder to elbow
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Please be advised, vaccine was not administered at our facility. I know that this patient received Dtap/IPV combination vaccine, but I am unsure if it was Kinrix or Quadracel. This patient experienced a large local reaction consistent of redness and swelling. Seen at Urgent Care on 10/3, where it was determined that no cellulitis component was present to the reaction, and continued monitoring was recommended.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Myocarditis
Clinical narrative: there have only been 3 of us (Further clarifications unknown) that this is happened to/already reported this to Safety and then she gave all the information about myocardia and not been able to walk.; there have only been 3 of us (Further clarifications unknown) that this is happened to/already reported this to Safety and then she gave all the information about myocardia and not been able to walk.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), GAIT INABILITY (non-serious), outcome "unknown" and all described as "there have only been 3 of us (Further clarifications unknown) that this is happened to/already reported this to Safety and then she gave all the information about myocardia and not been able to walk.". Additional information: Reporter mentioned that she already reported this to Safety and then she gave all the information about myocardia and not been able to walk. She wanted compensation for the medial part that haven't been paid and an appointment. She did give this to an attorney. She did state that there have only been 3 of them (further clarifications unknown) that this happened to and reporter did not understand why they do not want to meet with her or why Pfizer does not meet with her. Reporter stated that she filed the adverse event about a year and a half ago because the day after she got the shot, she went to the hospital.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201387564 same reporter/ product/ event; different patient;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Myocarditis
Clinical narrative: myocardia; not been able to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "myocardia"; GAIT INABILITY (non-serious), outcome "unknown", described as "not been able to walk". Reporter mentioned that she already reported this to Safety and then she gave all the information about myocardia and not been able to walk. She wanted compensation for the medial part that haven't been paid and an appointment. She did give this to an attorney. She did state that there have only been 3 of them (further clarifications unknown) that this happened to and reporter did not understand why they do not want to meet with her or why Pfizer does not meet with her. Reporter stated that she filed the adverse event about a year and a half ago because the day after she got the shot, she went to the hospital.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201387552 same reporter/ product/ event; different patient;
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: she has pain in her left arm, upper shoulder, lack of mobility, numbness after typing, pain in neck and left shoulder blade when sitting for too long, which started 11/14 same day she was given the vaccine; Pt case number
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Pain
Clinical narrative: she has pain in her left arm, upper shoulder, lack of mobility, numbness after typing, pain in neck and left shoulder blade when sitting for too long, which started 11/14 same day she was given the vaccine; Pt case number
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Arthralgia, Hypoaesthesia, Magnetic resonance imaging, Mobility decreased, Musculoskeletal pain
Clinical narrative: she has pain in her left arm, upper shoulder, lack of mobility, numbness after typing, pain in neck and left shoulder blade when sitting for too long, which started 11/14 same day she was given the vaccine; Pt case number
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Neck pain, Pain in extremity
Clinical narrative: she has pain in her left arm, upper shoulder, lack of mobility, numbness after typing, pain in neck and left shoulder blade when sitting for too long, which started 11/14 same day she was given the vaccine; Pt case number
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: she has pain in her left arm, upper shoulder, lack of mobility, numbness after typing, pain in neck and left shoulder blade when sitting for too long, which started 11/14 same day she was given the vaccine; Pt case number
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Joint range of motion decreased, Loss of personal independence in daily activities, Muscle tightness, Neck pain, Pain
Clinical narrative: she has pain in her left arm, upper shoulder, lack of mobility, numbness after typing, pain in neck and left shoulder blade when sitting for too long, which started 11/14 same day she was given the vaccine; Pt case number
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, Haemoptysis, Hallucination, Illness
Clinical narrative: sinus infection; covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) and SINUSITIS (sinus infection) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (covid 19). On an unknown date, the patient experienced SINUSITIS (sinus infection). At the time of the report, COVID-19 (covid 19) and SINUSITIS (sinus infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Any other vaccines in the 4 weeks prior to COVID-19 vaccine with unknown information. The patient had call about Moderna shot. She did not get because she had a sinus infection and she got COVID about a month ago. She still has not had booster shock and she was scared to death.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: sinus infection; covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) and SINUSITIS (sinus infection) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (covid 19). On an unknown date, the patient experienced SINUSITIS (sinus infection). At the time of the report, COVID-19 (covid 19) and SINUSITIS (sinus infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Any other vaccines in the 4 weeks prior to COVID-19 vaccine with unknown information. The patient had call about Moderna shot. She did not get because she had a sinus infection and she got COVID about a month ago. She still has not had booster shock and she was scared to death.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Sinusitis
Clinical narrative: sinus infection; covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) and SINUSITIS (sinus infection) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (covid 19). On an unknown date, the patient experienced SINUSITIS (sinus infection). At the time of the report, COVID-19 (covid 19) and SINUSITIS (sinus infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Any other vaccines in the 4 weeks prior to COVID-19 vaccine with unknown information. The patient had call about Moderna shot. She did not get because she had a sinus infection and she got COVID about a month ago. She still has not had booster shock and she was scared to death.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, 1st dose 06Mar2021, Lot EN6199, expiration unknown, injected in left arm, They both had arm soreness after each injection), administration date: 06Mar2021, for Covid-19 Immunization, reaction(s): "they both had arm soreness after each injection"; BNT162b2 (DOSE 2, 2nd dose 27Mar2021, Lot EP6955, expiration unknown, injected in left arm. , They both had arm soreness after each injection), administration date: 27Mar2021, for Covid-19 Immunization, reaction(s): "they both had arm soreness after each injection"; BNT162b2 (DOSE 3,, 3rd dose 20Oct2021, Lot 301558A, expiration unknown, injected in left arm., after 3rd dose, they had soreness of arm that went away after 3-4 days), administration date: 20Oct2021, for Covid-19 Immunization, reaction(s): "soreness of arm". The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "soreness of arm".  Additional information: Reporter mentioned both he and his wife had series of Pfizer COVID vaccine injections 5 injections total. Both of them, after 3rd dose, they had soreness of arm that went away after 3-4 days. He said they both had arm soreness after each injection, not just the 3rd dose. Each time they had injection they had soreness of arm. All injections for wife on same arm, left arm, with exception to 5th, which was on right arm. All soreness started the evening of the injection, and really noticed it the next day. Eventually in a couple or 3 days, the soreness was gone. They did not want Moderna, so all of them were Pfizer. Both of them received their vaccines on the same dates, times, locations, with the exact same lot numbers for all. Both have the same primary care provider. Time: 1st two were at 11:00, before noon, 3rd was done around 13:00, 4th one that had issue with unknown time and 5th one was done at 17:00. Vaccine was not administered at Facility.  Medical History Relevant to Adverse Events (AEs): none. No medical treatment required. He wanted to find out what Pfizer had to say first and then may make an appointment to see the doctor. He then asked what they should do about it.; Sender's Comments: Linked Report(s) : PFIZER INC-PV202200128273 same reporter/patient/drug/AE, different dose;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, 1st dose 06Mar2021, Lot EN6199, expiration unknown, injected in left arm, They both had arm soreness after each injection), administration date: 06Mar2021, for Covid-19 Immunization, reaction(s): "they both had arm soreness after each injection"; BNT162b2 (DOSE 2, 2nd dose 27Mar2021, Lot EP6955, expiration unknown, injected in left arm. , They both had arm soreness after each injection), administration date: 27Mar2021, for Covid-19 Immunization, reaction(s): "they both had arm soreness after each injection"; BNT162b2 (DOSE 3,, 3rd dose 20Oct2021, Lot 301558A, expiration unknown, injected in left arm., after 3rd dose, they had soreness of arm that went away after 3-4 days), administration date: 20Oct2021, for Covid-19 Immunization, reaction(s): "soreness of arm". The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "soreness of arm".  Additional information: Reporter mentioned both he and his wife had series of Pfizer COVID vaccine injections 5 injections total. Both of them, after 3rd dose, they had soreness of arm that went away after 3-4 days. He said they both had arm soreness after each injection, not just the 3rd dose. Each time they had injection they had soreness of arm. All injections for wife on same arm, left arm, with exception to 5th, which was on right arm. All soreness started the evening of the injection, and really noticed it the next day. Eventually in a couple or 3 days, the soreness was gone. They did not want Moderna, so all of them were Pfizer. Both of them received their vaccines on the same dates, times, locations, with the exact same lot numbers for all. Both have the same primary care provider. Time: 1st two were at 11:00, before noon, 3rd was done around 13:00, 4th one that had issue with unknown time and 5th one was done at 17:00. Vaccine was not administered at Facility.  Medical History Relevant to Adverse Events (AEs): none. No medical treatment required. He wanted to find out what Pfizer had to say first and then may make an appointment to see the doctor. He then asked what they should do about it.; Sender's Comments: Linked Report(s) : PFIZER INC-PV202200128273 same reporter/patient/drug/AE, different dose;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness of arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Dec2022 at 17:00 as dose 5 (booster), single (Lot number: GJ3275), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6199, Time: 1st two were at 11:00, before noon), administration date: 06Mar2021, for Covid-19 Immunization, reaction(s): "Soreness of right arm after each injection 1-4"; BNT162b2 (DOSE 2, SINGLE; Lot number: EP6955, Time: 1st two were at 11:00, before noon), administration date: 27Mar2021, for Covid-19 Immunization, reaction(s): "Soreness of right arm after each injection 1-4"; BNT162b2 (Dose 3(Booster), Lot 301558A, 3rd was done around 13:00), administration date: 20Oct2021, for Covid-19 Immunization, reaction(s): "after the 3rd dose, both of them experiences soreness/Soreness of right arm after each injection 1-4/both had arm soreness after each injection, not just the 3rd dose"; BNT162b2 (Dose 4(Booster), Lot FJ4989, 4th one that had issue with unknown time and), administration date: 14Apr2022, for Covid-19 Immunization, reaction(s): "soreness of arm", "soreness of arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "recovered" (2022), described as "soreness of arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Did mention both had series of Pfizer COVID vaccine injections 5 injections total. Both of them, after 3rd dose, they had soreness of arm that went away after 3 to 4 days. He said they both had arm soreness after each injection, not just the 3rd dose. Each time they had injection they had soreness of arm. All soreness started the evening of the injection, and really noticed it the next day. Eventually in a couple or 3 days, the soreness was gone. They did not want Moderna, so all of them were Pfizer. Both of them received their vaccines on the same dates, times, locations, with the exact same lot numbers for all. Family Medical History Relevant to Adverse Events (AEs): none.; Sender's Comments: Linked Report(s) : PFIZER INC-PV202200128272 same reporter/patient/drug/AE, different dose;
Sex: M
Vaccine: HPV9
Symptoms: COVID-19, Infection, SARS-CoV-2 test negative
Clinical narrative: covid; he has had "a lot" of infections; This spontaneous report has been received from a male patient of unknown age concerning himself. His concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date in 2022, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered as prophylaxis (dosage frequency, route of administration, lot number and expiration date were not reported).   The patient wanted to know if HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was made of live or dead virus before getting the second dose because, since an unknown date in 2022, he has had "a lot" of infections (Infection) and coronavirus disease (COVID) recently (COVID-19). On an unknown date in December 2022 (also reported as now), the patient reported he was COVID negative.   Outcome of the event COVID-19 was reported as resolving, outcome of the event infection was not provided.   Causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the events COVID-19 and infection was not reported. The reporter refused to provide additional information or clarifying statements.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs were reported; Nurse called to report that a pediatric dose of RECOMBIVAX was given to an adult on 12/16/2022; Nurse called to report that a pediatric dose of RECOMBIVAX was given to an adult on 12/16/2022; This spontaneous report was received from a Registered Nurse concerning to an adult patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 16-DEC-2022, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) pre-filled syringe, 0.5 milliliter once, lot #W022795, expiration date: 19-MAY-2025, (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (product administered to patient of inappropriate age) (incorrect dose administered).  No additional adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details; patient was inadvertently administered a dose of GARDASIL 9 after it's expiry; This spontaneous report has been received from a pharmacy technician concerning a patient of unknown age and gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 19-DEC-2022, the patient was vaccinated inadvertently with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered as prophylaxis, lot number T025367 with expiration date 18-NOV-2022 (dosage regimen and route of administration were not provided) (Expired product administered). There were no additional adverse events (No adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AE details were provided and no additional AE's were reported; the patient was administered PNEUMOVAX 23 after its labeled expiry date; This spontaneous report was received from a pharmacy thechnician and refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concurrent conditions, drug reaction or allergies, and concomitant therapies were reported.  On 19-DEC-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, lot #U003306, expiration date: 15-OCT-2022, administered intramuscularly (anatomical location was not provided) for prophylaxis, after its labeled expiry date (Expired product administered). No additional adverse event (AE) details were provided and no additional AE's were reported (No adverse event).
Age: 0.5
Sex: F
Vaccine: PPV, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 6-month-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 05-DEC-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892790, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7205AA, expiration date: 23-OCT-2024, administered intramuscularly for prophylaxis (strength and dose were not provided); and pneumococcal vaccine conj (PCV 13) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (strength, dose, formulation, and indication were not provided) (product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007837: US-009507513-2212USA007838:
Age: 0.17
Sex: M
Vaccine: PPV, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 9 weeks old (also reported as 10 weeks) male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 06-DEC-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892790, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7205AA, expiration date: 23-OCT-2024, administered intramuscularly for prophylaxis (strength and dose were not provided); and pneumococcal vaccine conj (PCV 13) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (strength, dose, formulation, and indication were not provided) (product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007838: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007837:
Age: 0.33
Sex: F
Vaccine: PPV, RV5, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No additional AEs; temperature excursion; Inappropriate age at vaccine administration; This spontaneous report was received from a registered nurse and refers to a 19 weeks old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 06-DEC-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892790, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7205AA, expiration date: 23-OCT-2024, administered intramuscularly for prophylaxis (strength and dose were not provided); and pneumococcal vaccine conj (PCV 13) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (strength, dose, formulation, and indication were not provided) (product storage error, product administered to patient of inappropriate age).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA007828:Same Reporter US-009507513-2212USA007829:Same Reporter US-009507513-2212USA007830:Same Reporter US-009507513-2212USA007831:Same Reporter US-009507513-2212USA007838:Same Reporter US-009507513-2212USA007833:Same Reporter US-009507513-2212USA007834:Same Reporter US-009507513-2212USA007835:Same Reporter US-009507513-2212USA007836:Same Reporter US-009507513-2212USA007837:Same Reporter
Age: 0.5
Sex: M
Vaccine: PPV, RV5, UNK
Symptoms: Product storage error
Clinical narrative: No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 6-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 05-DEC-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892790, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7205AA, expiration date: 23-OCT-2024, administered intramuscularly for prophylaxis (strength and dose were not provided); and pneumococcal vaccine conj (PCV 13) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (strength, dose, formulation, and indication were not provided) (product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007837: US-009507513-2212USA007838:
Age: 0.5
Sex: F
Vaccine: PPV, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 6-month-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 06-DEC-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892790, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7205AA, expiration date: 23-OCT-2024, administered intramuscularly for prophylaxis (strength and dose were not provided); and pneumococcal vaccine conj (PCV 13) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (strength, dose, formulation, and indication were not provided) (product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007837: US-009507513-2212USA007838:
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Decreased appetite, Ear pain, Headache, Influenza A virus test positive
Clinical narrative: EARS HURTING; COUGH; HEADACHE; CONGESTION; TESTED POSITIVE FOR INFLUENZA TYPE A; A LITTLE LETHARGIC; FEVER; DECREASED APPETITE; A solicited report has been received from a health professional via Other. The report concerns a female patient (age 4 years, height 111 cm, weight 19 kg).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number PH3533) (expiration date 27-NOV-2022) once/single administration, via nasal route, on 08-NOV-2022.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On 10-NOV-2022, the patient experienced fever (preferred term: Pyrexia), decreased appetite (preferred term: Decreased appetite) and a little lethargic (preferred term: Lethargy). On 14-NOV-2022, the patient experienced tested positive for influenza type a (preferred term: Influenza A virus test positive). On an unknown date, the patient experienced ears hurting (preferred term: Ear pain). On an unknown date, the patient experienced cough (preferred term: Cough). On an unknown date, the patient experienced headache (preferred term: Headache). On an unknown date, the patient experienced congestion (preferred term: Nasal congestion).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v).     The patient recovered from the event(s) of fever, decreased appetite, ears hurting, cough, a little lethargic, headache and congestion on an unspecified date. The outcome of the event(s) of tested positive for influenza type a was unknown.     The events were considered non-serious.     The company physician did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following event(s): ears hurting, tested positive for influenza type a, a little lethargic, fever, headache, cough, congestion and decreased appetite.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Lethargy, Nasal congestion, Pyrexia
Clinical narrative: EARS HURTING; COUGH; HEADACHE; CONGESTION; TESTED POSITIVE FOR INFLUENZA TYPE A; A LITTLE LETHARGIC; FEVER; DECREASED APPETITE; A solicited report has been received from a health professional via Other. The report concerns a female patient (age 4 years, height 111 cm, weight 19 kg).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number PH3533) (expiration date 27-NOV-2022) once/single administration, via nasal route, on 08-NOV-2022.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On 10-NOV-2022, the patient experienced fever (preferred term: Pyrexia), decreased appetite (preferred term: Decreased appetite) and a little lethargic (preferred term: Lethargy). On 14-NOV-2022, the patient experienced tested positive for influenza type a (preferred term: Influenza A virus test positive). On an unknown date, the patient experienced ears hurting (preferred term: Ear pain). On an unknown date, the patient experienced cough (preferred term: Cough). On an unknown date, the patient experienced headache (preferred term: Headache). On an unknown date, the patient experienced congestion (preferred term: Nasal congestion).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v).     The patient recovered from the event(s) of fever, decreased appetite, ears hurting, cough, a little lethargic, headache and congestion on an unspecified date. The outcome of the event(s) of tested positive for influenza type a was unknown.     The events were considered non-serious.     The company physician did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following event(s): ears hurting, tested positive for influenza type a, a little lethargic, fever, headache, cough, congestion and decreased appetite.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Dose of Heplisav-B Received; Initial Report Received on 15-NOV-2022  This is a spontaneous report received from a registered nurse in the regarding a 32-year-old female (race and ethnicity not provided) who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 15-NOV-2022, dose 1 of HEPLISAV B (Lot #935845, expiration date 06-NOV-2022, NDC #435528-003-01), route and site not specified, was administered for hepatitis B immunisation.   The HEPLISAV-B dose was 9 days past the expiration date.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Administered Heplisav-B  While 5 Months Pregnant; Initial Report Received on 18-NOV-2022  This is a spontaneous report, received from a consumer regarding a female patient, aged 31 years, who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 06-OCT-2022, dose 1 of HEPLISAV B (Lot # unknown, expiration date unknown, NDC # unknown), route not specified, was administered in the left arm for hepatitis B immunisation.   The patient was administered the HEPLISAV B vaccine when she was 5 months pregnant. No adverse reactions were reported.  Action taken with HEPLISAV B was not reported.  The outcome of the adverse event was not reported.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Surgery, Vaccination failure
Clinical narrative: Suspected vaccination failure/Both Shingrex in 2018. Shingles 5 times since; have had shingles 5 times since then/Got them after a surgery or during rehabbing; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 61-year-old 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 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant and other) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The patient had received both the injections of Shingrix  in 2018 and have had the shingles 5 times since then. The patient got them after a surgery or during rehabbing after surgery. The patient asked that he/she should get another vaccine and booster or any other advice. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This case was reported by a nurse via patient support programs and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 7VA99, expiry date unknown) for prophylaxis.   On 13th December 2022, the patient received Havrix. On 13th December 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 13-Dec-2022 and 16-Dec-2022 Reporter's comment: The patient was not experiencing any symptoms, but the reporter wanted to see if the patient should come in to the office to be seen/treated. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Doses 18 months apart; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st shot on an unknown date ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 13-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had two shingrix shots were 18 months apart. The patient asked that he/she was still protected. Additional supportive information: The patient received the 2nd shot of shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema
Clinical narrative: Arm is red below the shot; Stomach issues; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th December 2022, the patient received Shingles vaccine. On 13th December 2022, 1 days after receiving Shingles vaccine, the patient experienced erythema of extremities. In December 2022, the patient experienced stomach discomfort. On an unknown date, the outcome of the erythema of extremities was not recovered/not resolved and the outcome of the stomach discomfort was unknown.   It was unknown if the reporter considered the erythema of extremities and stomach discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-DEC-2022 Reporter's comments: The case was reported via interactive digital media. The reporter was patient's wife. The reporter reported that the patient got the shot yesterday and the day of reporting his arm was red below the shot he had some stomach issues that night. The reporter said should be concerned. Additional supportive information:  Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: fever; body aches; tiredness; This case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever, general body pain and tiredness. On an unknown date, the outcome of the fever, general body pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the fever, general body pain and tiredness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 13-DEC-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The reporter wanted to know how long do the side effects of fever, body aches and tiredness last.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR189657   Additional Information: GSK Receipt Date: 19-DEC-2022 Reporter's Comment: The patient self-reported this case and she was worked in administration for the program. The patient reported that she received Shingrix vaccine. The patient stated that after Shingrix vaccine she experienced sore arm. The reporter did not consent to follow up. Additional supportive information: For the tolerance of the 2nd dose, refer linked case US2022AMR189657 reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR189657:Same reporter