chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient experienced redness, swelling, and pain in vaccinated arm.  He has been using a cold compress and OTC pain reliever.  Redness and swelling are improving, but he still has pain one week after receiving vaccine.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 29.0
Sex: M
Vaccine: HPV9
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash, hives, itching. Benadryl IM given. Pt had relief from the Benadryl.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Tdap, Polio, 2 step skin test for TB on 05/25/2025.  These were given at the County Public Health Department.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Swollen tongue, Throat irritation
Clinical narrative: ITCHY/SCRATCHY THROAT, TONGUE SWELLLING/NUMB
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: THe patient received TDAP at another clinic earlier in the day. Then came to this clinic and received another dose
Age: 23.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Rash, Rash erythematous
Clinical narrative: bright red rash on both legs and feet
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Exposure to SARS-CoV-2, Fall, Laboratory test
Clinical narrative: Weakness, falls, exposure to COVID
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, UNK
Symptoms: Cough, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Nasal congestion, cough
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Cough, cold symptoms
Age: 1.42
Sex: M
Vaccine: IPV
Symptoms: Unevaluable event
Clinical narrative: None reported.
Age: 89.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus
Clinical narrative: Patient had some itching and redness on the arm.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chronic lymphocytic leukaemia, Lymphocyte count increased
Clinical narrative: Routine labs showed elevated lymphocyte count in October 2021. Counts remained elevated and was diagnosed with chronic lymphocytic leukemia in April 2024, but has not required any treatment. Patient believes her CLL diagnosis may be related to Covid-19 vaccine.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered high-dose flu vaccine to ineligible client.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Impaired work ability
Clinical narrative: Patient reports "heart flutters" that caused him to "leave his job 6-7 months" after getting the Pfizer COVID19 vaccine because he was not able to "carry copper and metal up the stairs anymore due there heart flutters" He says that these heart flutters were not evaluated by any medical professional
Age: 0.75
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Provider ordered Hepatitis B vaccine. Clinical staff administered Hepatitis A.  No adverse effects reported.
Age: 3.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Extra dose of MMR, Hep A and Vaircella given to patient
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Immediate post-injection reaction, Magnetic resonance imaging, Muscle discomfort
Clinical narrative: On 10/27/2021 i got a COVID booster at facility. The moment i was given the injection it felt very different from other vaccinations i had gotten in the past.  On 11/1/2021 i contacted my PCP to inquire about the pain i was suffering in my right shoulder where i had gotten my last injection. Starting on the day after i got the booster i developed persistent excruciating joint pain in my right shoulder where i had the injection.    I had CONSTANT pain and discomfort in the bicep, shoulder and neck. The pain became so severe i experienced trouble sleeping, and i got nauseous at times. I took Tylenol with no results. i tried medicated pads, but nothing relieved the incessant pain.  On 11/03/2021 i messaged my PCP to let her know i was feeling a little better. That did not last too long.  Eventually i was given meloxicam which helped a bit, but after a while i was taken off of it due to the dangers of side effects.  I was referred to Dr (orthopedics). She determined that i suffer from SIRVA.  Dr then prescribed a cortisone injection which gave me temporary relief. When i asked for another treatment i was told i had to be very careful not to have too many of them or i would suffer side effects.  Dr then advised me to seek some Physical Therapy as an alternative to medications, so i went to PT for a complete regimen of PT for the shoulder. Again, the relief i got was temporary. I have periodically done the PT since, but it does not seem to do much, and at times it actually aggravates the problem.  Dr left facility/practice and i began to see Dr. She agreed with Dr's assessment that i have SIRVA and she performed some tests to see if the previous cortisone injections had resulted in side effects, which they had not, and she allowed me to have another injection prior to going away on a vacation which allowed me to better enjoy my holiday. Dr prescribed diclofenac 75 mg EC tablets which at times work, but not always.  When the cortisone wears off i am back to sleepless nights, chronic shoulder pain that radiates up my neck and down my arm, and into my right hand. i still have numbness in the hand when this occurs.  Currently i am suffering more consistently. i have been taking the diclofenac 75 mg EC tablets once or twice a day, but they do not work well enough. At times when the pain becomes worse i will alternate between Tylenol and Advil as instructed by my doctor.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Myalgia, Nausea, Neck pain, Pain
Clinical narrative: On 10/27/2021 i got a COVID booster at facility. The moment i was given the injection it felt very different from other vaccinations i had gotten in the past.  On 11/1/2021 i contacted my PCP to inquire about the pain i was suffering in my right shoulder where i had gotten my last injection. Starting on the day after i got the booster i developed persistent excruciating joint pain in my right shoulder where i had the injection.    I had CONSTANT pain and discomfort in the bicep, shoulder and neck. The pain became so severe i experienced trouble sleeping, and i got nauseous at times. I took Tylenol with no results. i tried medicated pads, but nothing relieved the incessant pain.  On 11/03/2021 i messaged my PCP to let her know i was feeling a little better. That did not last too long.  Eventually i was given meloxicam which helped a bit, but after a while i was taken off of it due to the dangers of side effects.  I was referred to Dr (orthopedics). She determined that i suffer from SIRVA.  Dr then prescribed a cortisone injection which gave me temporary relief. When i asked for another treatment i was told i had to be very careful not to have too many of them or i would suffer side effects.  Dr then advised me to seek some Physical Therapy as an alternative to medications, so i went to PT for a complete regimen of PT for the shoulder. Again, the relief i got was temporary. I have periodically done the PT since, but it does not seem to do much, and at times it actually aggravates the problem.  Dr left facility/practice and i began to see Dr. She agreed with Dr's assessment that i have SIRVA and she performed some tests to see if the previous cortisone injections had resulted in side effects, which they had not, and she allowed me to have another injection prior to going away on a vacation which allowed me to better enjoy my holiday. Dr prescribed diclofenac 75 mg EC tablets which at times work, but not always.  When the cortisone wears off i am back to sleepless nights, chronic shoulder pain that radiates up my neck and down my arm, and into my right hand. i still have numbness in the hand when this occurs.  Currently i am suffering more consistently. i have been taking the diclofenac 75 mg EC tablets once or twice a day, but they do not work well enough. At times when the pain becomes worse i will alternate between Tylenol and Advil as instructed by my doctor.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Shoulder injury related to vaccine administration, Sleep disorder, Spinal X-ray, X-ray limb
Clinical narrative: On 10/27/2021 i got a COVID booster at facility. The moment i was given the injection it felt very different from other vaccinations i had gotten in the past.  On 11/1/2021 i contacted my PCP to inquire about the pain i was suffering in my right shoulder where i had gotten my last injection. Starting on the day after i got the booster i developed persistent excruciating joint pain in my right shoulder where i had the injection.    I had CONSTANT pain and discomfort in the bicep, shoulder and neck. The pain became so severe i experienced trouble sleeping, and i got nauseous at times. I took Tylenol with no results. i tried medicated pads, but nothing relieved the incessant pain.  On 11/03/2021 i messaged my PCP to let her know i was feeling a little better. That did not last too long.  Eventually i was given meloxicam which helped a bit, but after a while i was taken off of it due to the dangers of side effects.  I was referred to Dr (orthopedics). She determined that i suffer from SIRVA.  Dr then prescribed a cortisone injection which gave me temporary relief. When i asked for another treatment i was told i had to be very careful not to have too many of them or i would suffer side effects.  Dr then advised me to seek some Physical Therapy as an alternative to medications, so i went to PT for a complete regimen of PT for the shoulder. Again, the relief i got was temporary. I have periodically done the PT since, but it does not seem to do much, and at times it actually aggravates the problem.  Dr left facility/practice and i began to see Dr. She agreed with Dr's assessment that i have SIRVA and she performed some tests to see if the previous cortisone injections had resulted in side effects, which they had not, and she allowed me to have another injection prior to going away on a vacation which allowed me to better enjoy my holiday. Dr prescribed diclofenac 75 mg EC tablets which at times work, but not always.  When the cortisone wears off i am back to sleepless nights, chronic shoulder pain that radiates up my neck and down my arm, and into my right hand. i still have numbness in the hand when this occurs.  Currently i am suffering more consistently. i have been taking the diclofenac 75 mg EC tablets once or twice a day, but they do not work well enough. At times when the pain becomes worse i will alternate between Tylenol and Advil as instructed by my doctor.
Age: 43.0
Vaccine: HPV9
Symptoms: Intercepted product prescribing error, No adverse event
Clinical narrative: no additional adverse event; looking for 2nd dose at 51 years of age. Patient is coming later today with prescription from HCP; This spontaneous report was received from a pharmacist and refers to a an adult patient of unknown gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On an unknown date, at the age of 43, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (strength,expiration date, lot #, route and site of administration were not reported) for prophylaxis.  The patient was looking for the second dose at 51 years of age. The patient was about to come later on 25-FEB-2025 with a prescription (product prescribing issue). No additional adverse event was reported.   Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: Guilluan barre syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guilluan barre syndrome) (serious criteria death and GSK medically significant). The patient died in 2024. The reported cause of death was guillain barre syndrome.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     The company considered the guillain barre syndrome to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 25-FEB-2025  The case was received from the patient's husband via interactive digital media. The patient got 2 Shingrix shingles shots and died last summer from Guillain Barre syndrome. The reporter stated that it would of been better off with shingles.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix.; Reported Cause(s) of Death: Guillain Barre syndrome
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: states he did not have the second dose of SHINGRIX administered in the recommended time; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of Shingrix on 23-JUN-2021 four years ago).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: states he did not have the second dose of SHINGRIX administered in the recommended time). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 17-FEB-2025 The patient was vaccinated with Shingrix first dose. The reporter stated he did not have the second dose of Shingrix administered in the recommended time specified in the package insert of two to six months for second dose.  Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: aches and pains; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: aches and pains). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-FEB-2025 The patient's wife wanted to know if the patient can take Tylenol (acetaminophen) after the first dose of Shingrix. The patient had taken the first dose of Shingrix and had aches and pain.
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: my arm is sore; Redness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-FEB-2025, the patient received the 2nd dose of Shingrix. In FEB-2025, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: my arm is sore) and erythema (Verbatim: Redness). The outcome of the pain in arm and erythema were not resolved.   It was unknown if the reporter considered the pain in arm and erythema to be related to Shingrix.     It was unknown if the company considered the pain in arm and erythema to be related to Shingrix.   Additional Information: GSK receipt date: 15-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had received second dose of Shingrix vaccine on Wednesday (12th February 2025) and experienced arm sore and redness was worse on the day of reporting than day before reporting.
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This non-serious case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was resolved (duration 1 month).   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK receipt Date: 19-FEB-2025 The case self reported by patient. The patient had the shingrix vaccine and sore arm was the only symptom got.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-FEB-2025 This case was reported by a patient's neighbour via interactive digital media. The patient still got it after shingles hot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Paraesthesia, Sensitive skin
Clinical narrative: My legs were tingling; My legs were tingling and sensitive; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tingling of extremity in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced tingling of extremity (Verbatim: My legs were tingling) and increased skin sensitivity (Verbatim: My legs were tingling and sensitive). The patient was treated with paracetamol (Tylenol). The outcome of the tingling of extremity and increased skin sensitivity were resolved (duration 48 hrs).   It was unknown if the reporter considered the tingling of extremity and increased skin sensitivity to be related to Shingles vaccine.     It was unknown if the company considered the tingling of extremity and increased skin sensitivity to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that the patient had recived Shigles vaccine and experienced  his/her legs were tingling and sensitive and it was lasted for 48 hours. The reporter mentioned that his/her doctor told him/her to take Tylenol.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was supposed to receive a hepatitis A vaccine, but was inadvertently administered a dose of Kinrix instead; 12 month old female patient received kinrix; The Kinrix made the patient's fourth DTaP; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis.   On 31-JAN-2025, the patient received Kinrix. On an unknown date, the patient did not receive Hepatitis A vaccine. On 31-JAN-2025, immediately after receiving Kinrix and not applicable after receiving Hepatitis A vaccine, the patient experienced wrong vaccine administered (Verbatim: patient was supposed to receive a hepatitis A vaccine, but was inadvertently administered a dose of Kinrix instead), inappropriate age at vaccine administration (Verbatim: 12 month old female patient received kinrix) and inappropriate schedule of vaccine administered (Verbatim: The Kinrix made the patient's fourth DTaP). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-JAN-2025 The reporter reported that a 12 month old female patient had been supposed to receive a hepatitis A vaccine, but was inadvertently administered a dose of Kinrix instead on 31st January 2025, which led to wrong vaccine administered and inappropriate age at vaccine administration.  The Kinrix had made the patient's fourth DTaP and IPV dose, with most recent prior dose in August 2024, which led to inappropriate schedule of vaccine administered. The patient had been due for 15 month old DTaP in April 2025.  The Kinrix dose had been administered from lot number 3RT93  and expiration date 03th April 2026.  The patient had left with plans to come back another day to receive the hepatitis A dose.
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: A twelve year old patient received a first dose of BOOSTRIX on August eight twenty-twenty four and a second dose today; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number CX4HL, expiry date 09-NOV-2026) for prophylaxis.   Previously administered products included Boostrix (received 1st dose on 08-AUG-2024).   On 11-FEB-2025, the patient received the 2nd dose of Boostrix. On 11-FEB-2025, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: A twelve year old patient received a first dose of BOOSTRIX on August eight twenty-twenty four and a second dose today). The outcome of the extra dose administered was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-FEB-2025 The reporter gave a Boostrix vaccine that was not needed. A patient received a first dose of Boostrix and received second dose on the day of reporting which led to extra dose administered. Licensed practice nurse inquired about any advice on this situation. Vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter.
Age: 60.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administer to 60 year old patient"; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 60-year-old male patient who received Men B NVS (Bexsero) (batch number 3L339, expiry date 03-SEP-2027) for prophylaxis.   On 11-FEB-2025, the patient received the 1st dose of Bexsero. On 11-FEB-2025, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: administer to 60 year old patient"). The outcome of the inappropriate age at vaccine administration was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-FEB-2025 The reporter reported that there was a vaccine, the Bexsero vaccine that it was administered at our pharmacy on 11th February 2025, it said that the ages was between 10 to 25 years of age for administration, and the pharmacist that worked that day did not see that and administer to 60 year old patient. The Vaccine Administration Facility was the same as Primary Reporter. The healthcare professional mentioned that this was the 1st Bexsero dose that the patient received which led to inappropriate age at vaccine administration.
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Schedule of Vaccine; This non-serious 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 (received 1st dose of Shingrix vaccine 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 19-FEB-2025 The reporter asked that if a person who dosed their first dose of Shingrix more than 2 years ago, what would be the anticipated percentage of coverage for, so they dosed their first dose more than 2 years ago and want another dose now.  Do they need to restart altogether or do they have 80% coverage, 60% coverage.  If you could please give me a call back, I would greatly appreciate it.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix late third dose; Twinrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 52-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   On 20-FEB-2025, the patient received the 3rd dose of Twinrix. On 19-FEB-2025, the patient received the 2nd dose of Twinrix. On 19-FEB-2025, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). On 20-FEB-2025, the patient experienced drug dose administration interval too short (Verbatim: Twinrix late third dose). The outcome of the drug dose administration interval too short and drug dose administration interval too long were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-FEB-2025 Other HCP reported that she could give a third dose of Twinrix to a patient who received the second dose on 19th February 2025 and the first dose six months ago. Third dose has not been given. Patient received 2nd dose of Twinrix,?later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) Patient received 3rd dose of Twinrix,?earlier than the recommended interval, which led to shortening of vaccinations schedule. (Drug dose administration interval too short)
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; lack of effect; This spontaneous report received from a consumer concerned a female patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown.  The patient's concurrent conditions included: non smoker. The patient was previously treated with janssen covid-19 vaccine for covid-19 prophylaxis. (dose series 1)  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 2, for covid-19 prophylaxis. 0.50 mL. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced covid and lack of effect. (dose series 2). It was reported that the Johnson and Johnson vaccines were of the poorest quality and they did not work. Patient had her second vaccine with Johnson and Johnson 2 years ago before Christmas or 3 years ago in November and in January, she died of COVID. And she was perfectly healthy. She had no problems. She didn't have any diabetes, cancer, or what have you. And she was a nonsmoker, and she died of it. The action taken with janssen covid-19 vaccine was not applicable.  It was unknown if an autopsy was performed.  Reported cause of death was covid.  The patient died of covid on an unspecified date. The outcome of lack of effect was not reported.  This report was associated with a product quality complaint: Product Complaint 90000353174.  Investigation Results: 90000353174:Void:N:Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information..  This report was serious (death and other medically important condition).; Sender's Comments: V0: COVID-19: The events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: NATURE OF THE EVENT . Therefore, these events are considered not related.  Drug ineffective: The event is a special reporting situation and owing to its own nature, it is not possible to attribute this occurrence to the suspect drug. Hence, the causality is considered as not related.; Reported Cause(s) of Death: Covid
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain, Vaccination failure
Clinical narrative: pain and suffering; has the COVID virus for 3 times; Moderna sold a product that doesn't work; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (pain and suffering), COVID-19 (has the COVID virus for 3 times) and VACCINATION FAILURE (Moderna sold a product that doesn't work) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.  No Medical History information was reported.  On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain and suffering), COVID-19 (has the COVID virus for 3 times) and VACCINATION FAILURE (Moderna sold a product that doesn't work). At the time of the report, PAIN (pain and suffering), COVID-19 (has the COVID virus for 3 times) and VACCINATION FAILURE (Moderna sold a product that doesn't work) outcome was unknown.    The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.     No concomitant medication was reported.  The patient had the COVID virus for 3 times since having the Moderna vaccine. She experienced pain and suffering. Moderna sold a product that doesn't work.  Investigation Summary & Conclusion with Root Cause Details: On 19FEB2025, a consumer contacted Moderna regarding concerns about the effectiveness of the Spikevax (COVID-19 Vaccine, mRNA). The caller reported that his wife had contracted COVID-19 three times despite receiving the Moderna vaccine, questioning its efficacy. The individual alleged that the vaccine was not properly tested and claimed that it did not prevent COVID-19 as expected. However, no specific product details, such as batch numbers or administration history, were provided, and the caller declined consent for follow-up. The case was forwarded to the Drug Safety team for adverse event reporting, and the regulatory product disclosure was provided. Given that no batch information or additional details were made available, further investigation into the perceived lack of effectiveness was not feasible. It is important to note that while Spikevax is indicated for the prevention of COVID-19, breakthrough infections can still occur due to various factors, including individual immune response and circulating virus variants.  No treatment medication was reported.  Reporter causality was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2025: Live non-significant information received: reference number added. On 21-Feb-2025: Live significant information received: Closed PQC report received, QC comment and narrative updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Ear pain, Malaise, SARS-CoV-2 test
Clinical narrative: tested positive with Covid (home test) on 12FEB2025; Awful taste in the mouth; still feel unwell; ears hurt; chest hurts; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive with Covid (home test) on 12FEB2025), TASTE DISORDER (Awful taste in the mouth), MALAISE (still feel unwell), EAR PAIN (ears hurt) and CHEST PAIN (chest hurts) in a 68-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Ex-smoker (Smoked for 30 years, quit 15 years ago). Previously administered products included for Product used for unknown indication: Covid-19 vaccine (Dose 7) on 21-Nov-2023, Covid-19 vaccine (Dose 8) on 13-May-2024 and Flu (Always receives a flu shot annually in November.). Past adverse reactions to the above products included No adverse effect with Covid-19 vaccine, Covid-19 vaccine and Flu.    On 23-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 12-Feb-2025, the patient experienced COVID-19 (tested positive with Covid (home test) on 12FEB2025), TASTE DISORDER (Awful taste in the mouth), MALAISE (still feel unwell), EAR PAIN (ears hurt) and CHEST PAIN (chest hurts). At the time of the report, COVID-19 (tested positive with Covid (home test) on 12FEB2025), MALAISE (still feel unwell), EAR PAIN (ears hurt) and CHEST PAIN (chest hurts) was resolving and TASTE DISORDER (Awful taste in the mouth) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2025, SARS-CoV-2 test: (Positive) Covid (home test). On 19-Feb-2025, SARS-CoV-2 test: Negative.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 08-Mar-2021, The patient received first dose of moderna COVID-19 vaccine (Lot: 036A21A). On 05-Apr-2021, The patient received second dose of moderna COVID-19 vaccine (Lot: 025B21A). On 01-Nov-2021, The patient received 1st booster of moderna COVID-19 vaccine (Lot: 004 F21A). On 02-May-2022, The patient received 2nd booster of moderna COVID-19 vaccine (Lot: 002M21A). On 12-Sep-2022, The patient received Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Lot: AS7143C  On 25-Jul-2023, The patient received Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Lot:  AS7645B.  Patient never had a fever but due to an "Awful taste in the mouth", decided to test for Covid. Patient had an appointment with HCP on Monday i.e., 24-FEB-2025. No vaccines were received in the 4 weeks prior to last vaccine. It was unknown if the patient experienced any additional symptoms/events.   No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660956 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660956:Same patient with different moderna product
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: tested positive with Covid (home test) on 12FEB2025; Awful taste in the mouth; still feel unwell; ears hurt; chest hurts; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive with Covid (home test) on 12FEB2025), TASTE DISORDER (Awful taste in the mouth), MALAISE (still feel unwell), EAR PAIN (ears hurt) and CHEST PAIN (chest hurts) in a 68-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Ex-smoker (Smoked for 30 years, quit 15 years ago). Previously administered products included for Product used for unknown indication: Covid-19 vaccine (Dose 7) on 21-Nov-2023, Covid-19 vaccine (Dose 8) on 13-May-2024 and Flu (Always receives a flu shot annually in November.). Past adverse reactions to the above products included No adverse effect with Covid-19 vaccine, Covid-19 vaccine and Flu.    On 23-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 12-Feb-2025, the patient experienced COVID-19 (tested positive with Covid (home test) on 12FEB2025), TASTE DISORDER (Awful taste in the mouth), MALAISE (still feel unwell), EAR PAIN (ears hurt) and CHEST PAIN (chest hurts). At the time of the report, COVID-19 (tested positive with Covid (home test) on 12FEB2025), MALAISE (still feel unwell), EAR PAIN (ears hurt) and CHEST PAIN (chest hurts) was resolving and TASTE DISORDER (Awful taste in the mouth) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2025, SARS-CoV-2 test: (Positive) Covid (home test). On 19-Feb-2025, SARS-CoV-2 test: Negative.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 08-Mar-2021, The patient received first dose of moderna COVID-19 vaccine (Lot: 036A21A). On 05-Apr-2021, The patient received second dose of moderna COVID-19 vaccine (Lot: 025B21A). On 01-Nov-2021, The patient received 1st booster of moderna COVID-19 vaccine (Lot: 004 F21A). On 02-May-2022, The patient received 2nd booster of moderna COVID-19 vaccine (Lot: 002M21A). On 12-Sep-2022, The patient received Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Lot: AS7143C  On 25-Jul-2023, The patient received Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Lot:  AS7645B.  Patient never had a fever but due to an "Awful taste in the mouth", decided to test for Covid. Patient had an appointment with HCP on Monday i.e., 24-FEB-2025. No vaccines were received in the 4 weeks prior to last vaccine. It was unknown if the patient experienced any additional symptoms/events.   No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660956 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660956:Same patient with different moderna product
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This spontaneous case was reported by a pharmacist and describes the occurrence of SEIZURE (seizure) in a 68-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Falling (history of falling), Major depressive disorder, Metabolic encephalopathy and Unspecified protein-calorie malnutrition. Concurrent medical conditions included Dementia (unspecified dementia), Adult failure to thrive, Bradycardia, Schizophrenia, Epilepsy, Anemia, Hyperlipidemia, Essential hypertension and Generalized osteoarthritis.    In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In December 2024, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter considered SEIZURE (seizure) to be related.    Patient had no known allergies. All the historical condition was as of 16-May-2024 according to the resident's face sheet. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Concomitant product use was not provided by the reporter.  It was reported that patient was in a skilled nursing facility at the time of vaccination.  There were no lab data or results were available.  Treatment information was not provided.  It was reported that seizure was risk from COVID vaccines.; Reporter's Comments: The medical history of Metabolic encephalopathy, concurrent medical conditions dementia,  Schizophrenia and Epilepsy are confounders for the event. In view of the long non-suggestive onset latency the causality of the event was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes virus infection, Herpes virus test, Respiratory disorder
Clinical narrative: Moderna vaccine caused herpes, and respiratory issues / he now has both; Moderna vaccine caused herpes, and respiratory issues / he now has both; This spontaneous case was reported by a patient and describes the occurrence of HERPES VIRUS INFECTION (Moderna vaccine caused herpes, and respiratory issues / he now has both) and RESPIRATORY DISORDER (Moderna vaccine caused herpes, and respiratory issues / he now has both) in a 60-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HERPES VIRUS INFECTION (Moderna vaccine caused herpes, and respiratory issues / he now has both) and RESPIRATORY DISORDER (Moderna vaccine caused herpes, and respiratory issues / he now has both). At the time of the report, HERPES VIRUS INFECTION (Moderna vaccine caused herpes, and respiratory issues / he now has both) and RESPIRATORY DISORDER (Moderna vaccine caused herpes, and respiratory issues / he now has both) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Herpes virus test: Positive.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medication was reported. Patient had read reports suggesting that the moderna vaccine was linked to herpes and respiratory issues, and he now experiences both conditions. He discovered that moderna planned to release a herpes cure in June 2025, raised questions about accessibility and affordability for average workers, especially since he had limited financial resources. He was inactive sexually for over 20 years, he underwent a physical in 2019 that included herpes testing, which returned negative results. However, after receiving the moderna vaccine and boosters during the covid pandemic, he tested positive for herpes in a 2024 physical, a result he found shocking. Despite retesting twice with the same positive outcome, he felt devastated. Now in his 60s and eager to started dating, he was hesitant to pursue relationships due to the fear of unintentionally transmitting the virus, even with protection. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: lost all sense of recognition as to me were we live anything that was familiar to him; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Feb2025 as dose 1, 30 ug 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: MEMORY IMPAIRMENT (non-serious) with onset 24Feb2025, outcome "unknown", described as "lost all sense of recognition as to me were we live anything that was familiar to him". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500043877 same reporter/event, different patient;
Age: 82.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Hypoaesthesia, Laboratory test
Clinical narrative: much like Guillain Barre Syndrome; Numbness in my extremities/Numbness in my feet and hands; This is a spontaneous report received from a Consumer or other non HCP.  An 82-year-old male patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 18Feb2025 as dose 1, single (Batch/Lot number: unknown) at the age of 82 years intramuscular (left shoulder) for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HYPOAESTHESIA (hospitalization) with onset 21Feb2025 at 06:30, outcome "unknown", described as "Numbness in my extremities/Numbness in my feet and hands"; GUILLAIN-BARRE SYNDROME (hospitalization, medically significant) with onset 21Feb2025 at 06:30, outcome "unknown", described as "much like Guillain Barre Syndrome". The patient was hospitalized for guillain-barre syndrome, hypoaesthesia (start date: 22Feb2025). The patient underwent the following laboratory tests and procedures: Lab work: Unknown results.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 82.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Hypoaesthesia
Clinical narrative: much like Guillain Barre Syndrome; Numbness in my extremities/Numbness in my feet and hands; This is a spontaneous report received from a Consumer or other non HCP.  An 82-year-old male patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 18Feb2025 as dose 1, single (Batch/Lot number: unknown) at the age of 82 years intramuscular (left shoulder) for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HYPOAESTHESIA (hospitalization) with onset 21Feb2025 at 06:30, outcome "unknown", described as "Numbness in my extremities/Numbness in my feet and hands"; GUILLAIN-BARRE SYNDROME (hospitalization, medically significant) with onset 21Feb2025 at 06:30, outcome "unknown", described as "much like Guillain Barre Syndrome". The patient was hospitalized for guillain-barre syndrome, hypoaesthesia (start date: 22Feb2025). The patient underwent the following laboratory tests and procedures: Lab work: Unknown results.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.