chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: a patient who received the first dose of the Pfizer BioNTech COVID-19 vaccine about 3 months ago and then  developed the COVID-19 infection 2 weeks later; a patient who received the first dose of the Pfizer BioNTech COVID-19 vaccine about 3 months ago and then  developed the COVID-19 infection 2 weeks later; This is a spontaneous report from a contactable other Healthcare professional. This other HCP reported for a female consumer (patient) via medical information team.  A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 vaccine, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient developed the Covid 19 virus about 2 weeks after receiving the first Covid 19 vaccine. The patient received About 2 weeks after receiving the first Covid 19 vaccine she developed the Covid 19 virus and she missed her second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. About 2 weeks after receiving the first Covid 19 vaccine she developed the Covid 19 virus. The patient wanted to know the information regarding repeating the first dose or is it ok to receive the second dose. The outcome of the events were unknown.  Follow-up: This is a spontaneous report from a Pfizer sponsored program. A contactable other HCP reported for a female consumer (patient).   Information on Lot/Batch information has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, Covid-19 Positive and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: has a full blown Covid-19 infection. It has been 6 months past after getting her second shot of the vaccine on 07Jan2021; has a full blown Covid-19 infection. It has been 6 months past after getting her second shot of the vaccine on 07Jan2021; This is a spontaneous report from a contactable physician (Patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, batch/lot number and Expiration date was not reported), via an unspecified route of administration, on 07Jan2021 as Dose 2,Single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. On an unknown date, (also reported as: It has been 6 months past after getting her second shot of the vaccine), she had experienced full blown COVID-19 Infection. She mentioned that she had reported this to CDC and asked her to report to Pfizer. It was her first time to report. She wanted to know about the possible waning immunity of the vaccine after 6 months. She had read this online if there was more information about this. It was reported that provided information from attached document Antibody Persistence and Duration of Immunity, "Pfizer and BioNTech announced an updated topline analysis up to 6 months following second dose of Landmark COVID-19 Vaccine Study. Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) is effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to 6 months after the second dose." and Table 1: Vaccine Efficacy First COVID-19 Occurrence From 7 Days After Dose 2, by Age Subgroup. The outcome of the event was Unknown.   Information about Lot/Batch number were requested.; Sender's Comments: The events of drug ineffective and covid-19 are assessed as possibly related to the suspect BNT162B2 based on information provided.
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report received from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pericarditis on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This is a spontaneous report from a contactable consumer or other non-health care professional. A 74-years-old patient of an unspecified gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6202), via intramuscular, administered in Arm Right on 24Mar2021 08:00 (at 74 years of age) as single dose for covid-19 immunisation. Vaccination Facility Type was Public health clinic. Patient received first vaccination dose of bnt162b2 (Batch/Lot Number: EN6200) on 03Mar2021 09:00 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 31Mar2021, the patient experienced joint pain. Patient received Pain killer, swelling reduce and Muscle relaxer as treatment for the events. No Prior vaccination (within 4 weeks) administered. No relevant tests done. At the time of report, patient was not recovered from the event.  Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: She had a breakout of herpes; This is a spontaneous report from a non-contactable consumer (patient's husband) via Pfizer-sponsored program Support. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in left arm on 19Jan2021 at 13:00 (at the age of 70-years-old) as dose 1, single for COVID-19 immunisation. Medical history included thyroid cancer from 2009 to an unknown date and herpes. Concomitant medication(s) included levothyroxine sodium (TIROSINT) taken for thyroid cancer from unspecified date of 2009 to ongoing (She takes Tirosint, which was Synthroid. She has not been on this pill but she has been on this hormone for 11 years, since 2009). No additional vaccines were administered on same date of the Pfizer suspect. No other vaccinations were administered within four weeks prior to the first administration date of the suspect vaccine. On 21Jan2021 late afternoon or early morning (2 days after the first shot), the patient had a breakout of herpes. 4 doctors said it was from the shot. She inquired with 4 doctors and they told her that the herpes breakout, which lasted for 6 weeks and needed medical treatment, was probably caused by a reaction from the Pfizer shot. She was scheduled to get the second dose of the Pfizer COVID-19 vaccine 3 weeks after the first dose but missed second dose because of the breakout. She previously had herpes, but she did not had an outbreak in 35 years and that was concerning. The event did not require a visit to emergency room or physician office. Therapeutic measures were taken as a result of the event. The patient mentioned that 2 of her friends got shingles after the second shot and did not want to take it. The one was still dealing with it 11 weeks later. Family medical history relevant to adverse event was none. Relevant tests were none. The outcome of the event was resolved on an unspecified date.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: The caller's wife mentioned that 2 of her friends got Shingles after the second; This report from a Pfizer sponsored program support. A non-contactable consumer. reported that a 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. Medical history included, thyroid cancer from 2009 to an unknown date. The patient's concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration on an unknown date (Batch/Lot number : Not provided) as dose 1, single for covid-19 immunisation. On an unknown date, the caller's wife mentioned that her friends got shingles after the second. It was reported that the caller's wife mentioned that her friends got Shingles after the second shot and didn't want to take it. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC same product/reporter, different patient/event
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer(patient) received via Pfizer sales representative. A 25-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Medical history included tetanus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other medications had gotten the shingles one week after getting the second vaccine, no other medications had taken just gotten a tetanus shot a few weeks before. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot number was not reported), via unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unspecified date the patient experienced shingles. Event took place after use of product. The outcome of event was unknown.  Information about Lot/batch number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Feeling abnormal, Paraesthesia
Clinical narrative: foggy brain; tingling in hands and feet; This is a spontaneous report from a contactable consumer (patient's mother). A 15-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0173), via an unspecified route of administration, administered in arm left on 02Jun2021 (at the age of 15-year-old,) as dose 1, single for covid-19 immunisation from doctor's office/urgent care.  Medical history included asthma. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient experienced foggy brain and tingling in hands and feet two weeks after the first dose (Jun2021). Her pediatrician examined her and took bloodwork with normal results. The tingling lasted one week and then disappeared. She started feeling tingling in her hands and feet again, it being constant starting on the evening of 15Jul2021. This was reported to patient's pediatrician again and the patient was advised to take rest and stay cool. The events were reported as non-serious. The patient did not receive any treatment in response to the events.  The outcome of event foggy brain was not recovered and tingling in hands and feet first episode was recovered in Jun2021, while second episode was not recovered.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Needle issue, Underdose, Wrong technique in product usage process
Clinical narrative: the patient only received about 90% of the dose/no AE; vaccine leaked between the needle and syringe during injection/no AE; Initial information was received on 14-Jul-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 21-year-old female patient for whom it was reported that that the RABIES (HDC) VACCINE [IMOVAX RABIES] leaked between the needle and syringe during injection (wrong technique in product usage process) and the patient only received about 90% of the dose (underdose).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 14-Jul-2021, the patient received a 90% of 1 ml dose of suspect RABIES (HDC) VACCINE (lot 768914, expiry date- 26-Aug-2022) via an unknown route in unknown administration site for unknown indication (underdose).  It was a case of actual medication error due to vaccine underdose (latency same day).  It was also a case of wrong technique in product usage process (latency same day).  Pharmacist reported:" While administering a dose of Imovax Rabies to a patient, the vaccine leaked and the patient only received about 90% of the dose. How should I proceed?"  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 holders 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.  There would be no information available on the lot number for this case.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Anaphylactic shock
Clinical narrative: anaphylactic reaction/anaphylactic shock; The vial has a warning in very tiny print. Why is it not clearly marked on the package; Initial information was received on 15-Jul-2021 regarding an unsolicited valid serious case from a other health professional (Inquiry number: 00684271)..  This case involves a 22-year-old female patient who experienced anaphylactic reaction/anaphylactic shock (anaphylactic reaction) after she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing Latex allergy.  On 12-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number: U6737AA, expiry date: 09-Jul-2022] via an intramuscular route at right deltoid for prophylactic vaccination.  On 12-Jul-2021 the patient developed a serious anaphylactic reaction/anaphylactic shock (anaphylactic reaction) and was transported by ambulance to the ER for treatment on the same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  It was reported that they were not aware at the time that the tip was latex and the patient had a severe latex allergy and also the vial had a warning in very tiny print (Product use complaint).   Reporter states that the incident could have been avoided if the latex content was clearly noted. Reporter also says on other manufacturers boxes, it boldly states the latex content, the patient is a college student who came in to satisfy requirements and she ended up in the hospital. She has no way of paying the hospital and ambulance bill.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the patient was recovered from the event anaphylactic reaction.; Sender's Comments: This case involves a 22-year-old female patient who experienced anaphylactic reaction on the same day after vaccination with ADACEL. The ADACEL vial had a warning in very tiny print (Product use complaint). The time to onset was compatible. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Body temperature increased, Chills, Discomfort, Dizziness
Clinical narrative: Aching body, sore head, temperature, chills jabing feeling in my back, feeling very dizzy and and faint and sick. Irregular heart beats and being aware of my heart feeling uncomfortable
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate irregular, Malaise, Pain
Clinical narrative: Aching body, sore head, temperature, chills jabing feeling in my back, feeling very dizzy and and faint and sick. Irregular heart beats and being aware of my heart feeling uncomfortable
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Headache, Heart rate irregular, Palpitations
Clinical narrative: Irregular heart beat, heart palpitations, headaches, fatigue
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Polymyalgia rheumatica, Post herpetic neuralgia
Clinical narrative: polymyalgia rheumatica; postherpetic neuralgia; shingles; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. In or around July 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles, postherpetic neuralgia and polymyalgia rheumatica. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events shingles, postherpetic neuralgia and polymyalgia rheumatica was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events shingles, postherpetic neuralgia and polymyalgia rheumatica to be disability.   Upon internal review, polymyalgia rheumatica was determined to be medically significant.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Extra dose administered, Myalgia, Nausea
Clinical narrative: mistakenly given a 3rd round of shingrix /received 2 dose series /around 2-3 years ago; She is having reactions/ fever; She is having reactions /chills; She is having reactions/nausea; She is having reactions/vomiting; She is having reactions/muscle / aches; She is having reactions/stomach aches; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose around 2-3 years ago) and Shingrix (received 2nd dose around 2-3 years ago).   On 13th July 2021 12:00, the patient received the 3rd dose of Shingrix. On 13th July 2021, unknown after receiving Shingrix, the patient experienced extra dose administered, fever, chills, nausea, vomiting, muscle pain and stomach pain. On an unknown date, the outcome of the extra dose administered, fever, chills, nausea, vomiting, muscle pain and stomach pain were unknown.   It was unknown if the reporter considered the fever, chills, nausea, vomiting, muscle pain and stomach pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The reporter was the husband of the patient. The reporter reported that the patient went to HCP yesterday (day of reporting) and was received 3rd dose of Shingrix (around 12 noon), which led to extra dose administered. Later that evening (around 10 pm) the patient experienced fever, chills,nausea, vomiting, muscle and stomach aches. The reporter asked would the reactions be more severe with a 3rd shot. No further information reported. The reporter did not consent to follow-up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: mistakenly given a 3rd round of shingrix /received 2 dose series /around 2-3 years ago; She is having reactions/ fever; She is having reactions /chills; She is having reactions/nausea; She is having reactions/vomiting; She is having reactions/muscle / aches; She is having reactions/stomach aches; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose around 2-3 years ago) and Shingrix (received 2nd dose around 2-3 years ago).   On 13th July 2021 12:00, the patient received the 3rd dose of Shingrix. On 13th July 2021, unknown after receiving Shingrix, the patient experienced extra dose administered, fever, chills, nausea, vomiting, muscle pain and stomach pain. On an unknown date, the outcome of the extra dose administered, fever, chills, nausea, vomiting, muscle pain and stomach pain were unknown.   It was unknown if the reporter considered the fever, chills, nausea, vomiting, muscle pain and stomach pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The reporter was the husband of the patient. The reporter reported that the patient went to HCP yesterday (day of reporting) and was received 3rd dose of Shingrix (around 12 noon), which led to extra dose administered. Later that evening (around 10 pm) the patient experienced fever, chills,nausea, vomiting, muscle and stomach aches. The reporter asked would the reactions be more severe with a 3rd shot. No further information reported. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Product supply issue
Clinical narrative: I got a shot 3 years ago, then/ got another 11 months ago, and a third twp days ago.; got a shot 3 years ago, then because of shortages, got another 11 months ago; got a shot 3 years ago, then/ got another 11 months ago, and a third twp days ago.; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first shot on an unknown date 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long, product supply issue and extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long, product supply issue and extra dose administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. This case was reported by patient herself/himself. The patient had got Shingrix shot 3 years ago and then because of shortage got another 11 month ago which led to lengthening of vaccination schedule and product supply issue. The patient had received third dose of Shingrix two days ago after second dose which led to extra dose administered. The patient asked about should he/she get the fourth dose. The reporter not sure about the follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Needle issue, Syringe issue
Clinical narrative: In the process of giving / second dose / had a needle failure /unknown amount was injected /the rest leaked from the syringe; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, In the process of giving a patient their second dose of Shingrix, had a needle failure. An unknown amount was injected while the rest leaked from the syringe, which led to incomplete dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed 2nd Shingrix dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had missed 2nd of Shingrix dose and till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Face injury, Herpes zoster, Scar, Vaccination failure, Visual impairment
Clinical narrative: Suspected vaccination failure; shingles anyway on my face; Still have a scar on my forehead; left eyebrow is strange looking; can't see so well with my left eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, scar, damaged eyebrows and abnormal vision. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the scar, damaged eyebrows and abnormal vision were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, scar, damaged eyebrows and abnormal vision to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for himself/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles on his/her face.  At the time of reporting, the patient still had a scar on his/her forehead, left eyebrow was strange looking and could not see so well with his/her left eye.  The patient was not willing to pay for removing the scar.  The patient stated that he/she was glad that he/she was married and not in the market. 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 for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 patient had reported for himself/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles.  The follow-up would not possible as no contact details were available. 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 for shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late second dose / received the first dose of Shingrix on 11/27/2019 and had not yet received the second dose of Shingrix; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. No further events were reported.  The reporter consented to follow up.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: After / dose 2  / experienced fatigue; After / dose 2  / experienced / muscle aches; After / dose 2  / experienced / pain in joints; This case was reported by a physician via call center representative and described the occurrence of fatigue in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date). Concomitant products included COVID-19 VACCINE MRNA (MRNA 1273) (COVID 19 VACCINE MODERNA) and COVID-19 VACCINE MRNA (MRNA 1273) (COVID 19 VACCINE MODERNA).   On 9th June 2021, the patient received the 2nd dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced fatigue, muscle pain and joint pain. On an unknown date, the outcome of the fatigue was unknown and the outcome of the muscle pain and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, muscle pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and experienced fatigue, muscle aches and pain in joints few days after the vaccination. The patient was still experiencing pain in joints and muscles. The physician wanted to mention that the patient received the Covid Moderna vaccine in between dose 1 and 2 of shingrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late for the second dose of Shingrix / first dose was administrated on 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   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: No patient's identifiers provided. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. No exact vaccination date provided. No lot number and expiration date provided. The reporter did not consent to follow up.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: was administered an extra dose of BOOSTRIX / and/ extra dose of MENVEO /received both vaccines one year earlier; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA518A, expiry date 30th April 2022) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 9335X, expiry date 29th January 2023) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Menveo (already received a doses, 1 year earlier of reporting date) and Boostrix (already received a doses, 1 year earlier of reporting date).   On 7th July 2021, the patient received Menveo (intramuscular) .5 ml, Boostrix (intramuscular) .5 ml and Boostrix Pre-Filled Syringe Device. On 7th July 2021, unknown after receiving Menveo, Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was recovered/resolved.   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 reported as follows: On 7th July 2021 the patient was administered with an extra dose of Boostrix 0.5ML and an extra dose of Menveo 0.5ML.  The patient had received both vaccines one year earlier. The HCP ( healthcare professional ) contacted the patient (parent of patient) and the patient had no symptoms. The reporter consented to follow up. This case has been linked with US2021152833,US2021152840 and US2021152845 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152833:same reporter US-GLAXOSMITHKLINE-US2021152840:same reporter US-GLAXOSMITHKLINE-US2021152845:same reporter
Age: 11.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: KINRIX 1 DS/0.5ML was  administered to a patient at inappropriate age; This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th June 2021, the patient received Kinrix (intramuscular) .5 ml and Kinrix Pre-Filled Syringe Device. On 28th June 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 reported as follows: The 11 years old patient was administered with 0.5 ml of Kinrix dose which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary reporter. The reporter consented to follow up. This case has been linked with US2021152836,US2021152845 and US2021152833 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152836:same reporter US-GLAXOSMITHKLINE-US2021152845:same reporter US-GLAXOSMITHKLINE-US2021152833:same reporter
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: 1st dose/10 days ago/his arm is still "extremely sore"/pain almost reaches the elbow.; the pain almost reaches the elbow; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th July 2021, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm and pain in elbow. On an unknown date, the outcome of the pain in arm and pain in elbow were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and pain in elbow to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The patient received the dose of Shingrix 10 days ago in left arm and experienced extremely sore arm which had almost reached the elbow. No further information was available. Lot and expiration date were unknown. Patient provided consent to consent to follow up with healthcare professional even though he got vaccinated at a pharmacy.
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: adult dose was administered to a pediatric female patient; adult dose was administered to a pediatric female patient; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 15-day-old female patient who received HBV (Engerix B adult) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th July 2021, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 15th July 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were 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 nurse reported that an adult dose of Engerix B was administered to a pediatric patient, which led to overdose and adult product administered to child. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of shingrix january 3rd, 2021/ has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd January 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: vaccinated on  4-21-18 / the second dose is not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 21st April 2018, batch number 54KZ4).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021152864 and US2021152861, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152864:Same reporter US-GLAXOSMITHKLINE-US2021152861:Same reporter
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient given one pediatric dose of Havrix; adult patient given one pediatric dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 21-year-old male patient who received HAV (Havrix pediatric) (batch number 3HR79, expiry date unknown) for prophylaxis.   On 13th July 2021, the patient received Havrix pediatric. On 13th July 2021, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The nurse reported that, adult patient given one pediatric dose of Havrix, which led to adult use of child product and underdoes. The reporter consent to follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: DISCOMFORT; ACHY HERE AND THERE; FEVER; SWOLLEN ARM AT THE AREA OF VACCINATION; REDNESS AT THE SITE OF THE INJECTION; HEADACHE HERE AND THERE; This spontaneous report received from a parent concerned a 30 year old male. The patient's height, and weight were not reported. The patient's past medical history included stroke, and covid-19, and concurrent conditions included immunocompromised, and low immunoglobulin g (igg). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. Concomitant medications included immunoglobulin human normal for low igg. On FEB-2021, Laboratory data included COVID-19 virus test positive (NR: not provided) Positive. On 06-JUL-2021, the subject experienced discomfort. On 06-JUL-2021, the subject experienced achy here and there. On 06-JUL-2021, the subject experienced fever. On 06-JUL-2021, the subject experienced swollen arm at the area of vaccination. On 06-JUL-2021, the subject experienced redness at the site of the injection. On 06-JUL-2021, the subject experienced headache here and there. On 14-JUL-2021, treatment medications included paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, swollen arm at the area of vaccination, discomfort, redness at the site of the injection, headache here and there, and achy here and there. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: DISCOMFORT; ACHY HERE AND THERE; FEVER; SWOLLEN ARM AT THE AREA OF VACCINATION; REDNESS AT THE SITE OF THE INJECTION; HEADACHE HERE AND THERE; This spontaneous report received from a parent concerned a 30 year old male. The patient's height, and weight were not reported. The patient's past medical history included stroke, and covid-19, and concurrent conditions included immunocompromised, and low immunoglobulin g (igg). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. Concomitant medications included immunoglobulin human normal for low igg. On FEB-2021, Laboratory data included COVID-19 virus test positive (NR: not provided) Positive. On 06-JUL-2021, the subject experienced discomfort. On 06-JUL-2021, the subject experienced achy here and there. On 06-JUL-2021, the subject experienced fever. On 06-JUL-2021, the subject experienced swollen arm at the area of vaccination. On 06-JUL-2021, the subject experienced redness at the site of the injection. On 06-JUL-2021, the subject experienced headache here and there. On 14-JUL-2021, treatment medications included paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, swollen arm at the area of vaccination, discomfort, redness at the site of the injection, headache here and there, and achy here and there. This report was non-serious.