chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Following day my arm was hurting to the point where it is difficult to move. Until present, my arm is still in pain that comes and goes.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blood lactic acid, C-reactive protein, Electrocardiogram, Full blood count, Liver function test normal
Clinical narrative: At 1815 patients activity decreased. Nausea and vomiting times 1. Patient laid on the ground and said I'm going to die. Patient went limp, pale and became non responsive. He was lethargic for 20 seconds then walking to car he went limp for 10 seconds then would not speak or follow commands.  Taken to the  ED for evaluation and treatment. Mother states  patients aunt was believed to have had seizure activity in response to Pertussis vaccine.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Metabolic function test, Nausea, Vomiting
Clinical narrative: At 1815 patients activity decreased. Nausea and vomiting times 1. Patient laid on the ground and said I'm going to die. Patient went limp, pale and became non responsive. He was lethargic for 20 seconds then walking to car he went limp for 10 seconds then would not speak or follow commands.  Taken to the  ED for evaluation and treatment. Mother states  patients aunt was believed to have had seizure activity in response to Pertussis vaccine.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: patient had arm pain and swelling, went to ED on 06/14 got diagnosis of left arm cellulitis, treatment of Bactrim and cephalexin. on 06/19 patient followed up with pcp to inform us and discus what happened to patient after vaccine was administered on 06/12.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Detoxification, Echocardiogram, Electrocardiogram, Immunisation reaction, Laboratory test
Clinical narrative: PFIZER #1 3/15/21 PFIZER #2 4/12/21 DEVELOPED VACCINE MYOPERICARDITIS AND POTS BY JULY 2021 HAD THREE ER VISITS AND WAS ULTIMATELY TREATED SUCCESSFULLY BASE SPIKE DETOXIFICATION. Clinical Approach to Post-acute Sequelae After COVID-19 Infection and Vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myopericarditis
Clinical narrative: PFIZER #1 3/15/21 PFIZER #2 4/12/21 DEVELOPED VACCINE MYOPERICARDITIS AND POTS BY JULY 2021 HAD THREE ER VISITS AND WAS ULTIMATELY TREATED SUCCESSFULLY BASE SPIKE DETOXIFICATION. Clinical Approach to Post-acute Sequelae After COVID-19 Infection and Vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Endoscopy, Tinnitus
Clinical narrative: Tinnitus in both ears, sudden onset
Sex: M
Vaccine: HEP, HEP
Symptoms: Death, Life support, Pulse absent, Resuscitation, Unresponsive to stimuli
Clinical narrative: (note for above info - only lot number documented by clinic - not brand or manufacturer)  Patient received Hep B vaccine at well child visit on 6/13 at approximately 1100.  Patient was in good health.  Patient last fed by parents at 0100 on 6/14.  Burped and laid in crib.  Parents found baby unresponsive and pulseless at 0700 on 6/14.   Patient brought to Emergency Center.  CPR/PALS began.  No pulse.  Patient pronounced dead approximately 0815.
Sex: M
Vaccine: HEP, HEP
Symptoms: Cardiac arrest, Death, Pulse absent, Resuscitation, Skin discolouration
Clinical narrative: (note for above info - only lot number documented by clinic - not brand or manufacturer)  Patient received Hep B vaccine at well child visit on 6/13 at approximately 1100.  Patient was in good health.  Patient last fed by parents at 0100 on 6/14.  Burped and laid in crib.  Parents found baby unresponsive and pulseless at 0700 on 6/14.   Patient brought to Emergency Center.  CPR/PALS began.  No pulse.  Patient pronounced dead approximately 0815.
Sex: M
Vaccine: HEP, HEP
Symptoms: Unresponsive to stimuli
Clinical narrative: (note for above info - only lot number documented by clinic - not brand or manufacturer)  Patient received Hep B vaccine at well child visit on 6/13 at approximately 1100.  Patient was in good health.  Patient last fed by parents at 0100 on 6/14.  Burped and laid in crib.  Parents found baby unresponsive and pulseless at 0700 on 6/14.   Patient brought to Emergency Center.  CPR/PALS began.  No pulse.  Patient pronounced dead approximately 0815.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute coronary syndrome, Angiocardiogram, Arteriosclerosis, Coronary arterial stent insertion, Detoxification
Clinical narrative: MODERNA #1 10/2/2021 MODERNA #2 10/30/2021, SUFFERED VACCINE INDUCED PROGRESSIVE ASCVD WITH ACUTE CORONARY SYNDROME WITH STENTING OF DIAGONAL BRANCH, NO MYOCARDIAL INFARCTION.  TREATED WITH ASPIRIN, BRILINTA, ATORVASTATIN, EZETIBIMBE, ISOSORBIDE,  PATIENT THEN DEVELOPED VACCINE SUBCLINICAL MYOPERICARDITIS REQUIRING TREATMENT WITH COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Immunisation reaction, Laboratory test, Myopericarditis
Clinical narrative: MODERNA #1 10/2/2021 MODERNA #2 10/30/2021, SUFFERED VACCINE INDUCED PROGRESSIVE ASCVD WITH ACUTE CORONARY SYNDROME WITH STENTING OF DIAGONAL BRANCH, NO MYOCARDIAL INFARCTION.  TREATED WITH ASPIRIN, BRILINTA, ATORVASTATIN, EZETIBIMBE, ISOSORBIDE,  PATIENT THEN DEVELOPED VACCINE SUBCLINICAL MYOPERICARDITIS REQUIRING TREATMENT WITH COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 74.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Injected limb mobility decreased, Injection site pain, Magnetic resonance imaging, Product administered at inappropriate site, Tendon disorder
Clinical narrative: Patient originally said that the Covid shot was administered in his left forearm . He later claimed that it was his left bicep, not deltoid. He said that the area was extremely painful and he lost some ability to move the arm.  He discussed the situation with his orthopedic doctor who told him that the shot caused a tendon rip and that it could not be repaired.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: patient given expired Hep B vaccine
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Fatigue, Injection site pain, Loss of consciousness, Muscle rigidity, Tonic convulsion
Clinical narrative: Unremarkable visit but patient returned to clinic and was evaluated following an episode described by parent when she took him to the car.  He had 4 year vaccinations and had left the office.  He was talking and behaving normally, told mom that his legs were hurting.  As they were getting into the car, mom observed that he had a tonic convulsive movement of the body stiffening suddenly for several seconds and then a brief LOC.  She brought him back into the office around 1544 and he appeared awake, followed commands and generally alert.  He was quiet and at times did appear tired and leaning into mother.  I asked him to take a few sips of apple juice.  He had a normal blood pressure and oximetry was 100%.  He had no
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient missed their "birth dose" vaccine of Hep B for unknown reason (delivered at hospital), was later administered at follow up visit. First Hep B vaccine administered 4 days late. No noted reactions/harm.
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Computerised tomogram, Haemoptysis, Pulmonary embolism, X-ray
Clinical narrative: Blood clots in  the lungs, need to take blood thinners for the rest of my life.PNUCN20 (Prevnar 20)
Age: 80.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Patient shows the left arm where the Prevnar 20 vaccine was given is still bright red, looks inflammed and swollen, itchy and pain only when she moves her arm. Started the morning after the shot was given. Denies shortness of breath, difficulty breathing, or any other symptoms. The other arm that received Boostrix has no symptom.
Age: 15.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Dizziness, Dyspnoea, Hyperhidrosis, Hypersensitivity
Clinical narrative: pt presents with an allergic reaction last night after taking a typhoid pill. Pt had a stomach ache and was nauseous, dizzy, sweating and had shortness of breath. Pt reports that his throat felt tight. Mom gave him benadryl and that improved the symptoms. No diarrhea, vomiting or hives. Pt states that he feels better today and is eating and drinking as normal.
Age: 15.0
Sex: M
Vaccine: TYP
Symptoms: Nausea, Throat tightness
Clinical narrative: pt presents with an allergic reaction last night after taking a typhoid pill. Pt had a stomach ache and was nauseous, dizzy, sweating and had shortness of breath. Pt reports that his throat felt tight. Mom gave him benadryl and that improved the symptoms. No diarrhea, vomiting or hives. Pt states that he feels better today and is eating and drinking as normal.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: NONE, the vaccine was given 2 days past expiration date, moderna was contacted and stated the patient would be protected
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Vaccine administered at 1343 on 6/18/24. Patient called RN triage at 2056 same date to report he developed hives in left shoulder and chest that were itchy. Pt advised to treat with OTC oral antihistamine and topical hydrocortisone cream at that time. Patient called the clinic at 12:31 PM 6/19/24 to report hives were spreading and were now on his abdomen, back, shoulders, legs. PCP prescribed prednisone 40 mg daily x5 days and Benadryl 25 MG 2-3 times per day.  Patient was advised Monitor for symptoms any lip swelling or tongue swelling or any respiratory difficulty.  If noticing any advised to call 911 immediately or go to the nearest ER.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: L shoulder pain and stiffness
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Hypertonia, Musculoskeletal stiffness, Nausea, Pallor, Vomiting
Clinical narrative: The nurse administered the Meningococcal (MenQuadfi) vaccine first and then the HPV vaccine in the patient's left deltoid while the patient was sitting on the exam table. After receiving the HPV vaccine, the patient slumped over, became limp and rigid, and then turned pale. The patient vomited at around 11:20 am and again at 11:45 am. Several sets of vital signs were taken at different times:  - 10:59 am: 127/71 mmHg (blood pressure), 97% (oxygen saturation), and 78 bpm (heart rate)          - 11:13 am: 102/61 mmHg (blood pressure), 99% (oxygen saturation), and 72 bpm (heart rate) - 11:26 am: 88/59 mmHg (blood pressure), 98% (oxygen saturation), and 69 bpm (heart rate) The patient was administered 4 mg of Zofran at 11:20 am and then again at 11:50 am to alleviate nausea. Following the incident, the patient was monitored for one hour.  The patient did not have any other complaints and left the office unassisted.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Atrial fibrillation, Cardiac monitoring abnormal, Heart rate increased, Heart rate irregular
Clinical narrative: Cardiac atrial fibrillation.  One day after covid vaccination my heart rate accelerated and became irregular.  Over the course of date of injection to March 30th 2023 (surgery) I dealt with atrial fibrillation that progressively beame worse.  As someone that lives a very active lifestyle and extremely cognize of health including working out up to 6x per week I struggled with debilitating Afib that progressed to have onset conditions last up to 3 days per occurence.  Post surgery results have been very successful (Zero occurences) and surgery confirmed no underlyinh issues (normal heart, no valve issues, no plague).
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Surgery
Clinical narrative: Cardiac atrial fibrillation.  One day after covid vaccination my heart rate accelerated and became irregular.  Over the course of date of injection to March 30th 2023 (surgery) I dealt with atrial fibrillation that progressively beame worse.  As someone that lives a very active lifestyle and extremely cognize of health including working out up to 6x per week I struggled with debilitating Afib that progressed to have onset conditions last up to 3 days per occurence.  Post surgery results have been very successful (Zero occurences) and surgery confirmed no underlyinh issues (normal heart, no valve issues, no plague).
Age: 50.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Abdominal pain upper, Lethargy
Clinical narrative: lethargy, stomach ache that began about 12 hours after vaccination and continued for three days
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reaction, vaccine given within 28 days of another live vaccine
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no Adverse event, pt was given an extra vaccine of Tdap had one in feb of 2024 already. Our MD was contacted to clear pt to leave, PT felt fine and went home.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Partial seizures
Clinical narrative: FOCAL SEIZURE
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Gave the vaccine 9 days early, no adverse effects.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient was given MenB and Menquadfi vaccines. Directly after administration of 2nd injection (Menquadfi) patient states "I'm gonna pass out", patient was gently laid back onto the exam table. She did lose consciousness for approx. 5 seconds. Provider was called to the exam room. Cold compresses placed on patient's forehead and back of her neck. Vitals were as follows-- BP 122/86 HR 56 O2 99%. Patient was monitored closely and stayed in laying position for another 5 minutes after she was feeling much better. Patient was then placed in sitting position for additional 10 minutes. Provider went into the room to check on patient. Vitals were as follows following the reaction. BP 116/68 HR 60 O2 100%. Patient noted she was feeling much better and was able to leave the office
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle tightness, Pain in extremity
Clinical narrative: Patient says they have experienced the shoulder muscle tightening  up to the neck area and pain going down to the fingers in that arm. Patient said they had taken ibuprofen and tizanidine, which they had previously been prescribed, but the pain persisted
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Nerve conduction studies, Pain, Pain in extremity, Paraesthesia
Clinical narrative: I had sever pain that radiated down my arm, hand and fingers.  I couldn't lay down I had to sleep in a reclined position because of the pain.  Later I have tingling and numbness and on occasion pain that radiates down my arm.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: I had sever pain that radiated down my arm, hand and fingers.  I couldn't lay down I had to sleep in a reclined position because of the pain.  Later I have tingling and numbness and on occasion pain that radiates down my arm.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: the spot of vaccine became swollen, and is STILL swollen and hard, occasional pain
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: There was no adverse event.  The patient received the vaccine after the Use by date of 4/9/2024.  No concerns following the vaccine.  This report is solely for informational purposes
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Food allergy, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Peeling skin on left arm and red bumpy itchy rash on right arm
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called to report a TE with MMR II.  See TE case 02614675.  MMR II was administered on 4/16/2024 after being improperly stored.  No adverse effects were reported. Consent to contact is yes. No additional AE/No PQC.; This spontaneous report was received from a medical assistant, referring to a 33-year-old male patient.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. The illness at the time of vaccination was reported as none.  On 16-APR-2024, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) subcutaneous injection, lot #X012616, expiration date: 02-MAY-2025, 0.5 milliliter, administered subcutaneously for prophylaxis by health professional (strength was not provided) (product storage error). It was reported that the number of previous doses was 1. The vaccine was exposed to a temperature excursion (TE) on an unknown date. It was reported that the temperature excursion occurred as a result of a reading from a Digital Data Logger. The action taken with the suspect vaccine was reported as the vaccine removed from freezer.  No adverse effects were reported (no adverse event).
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medical assistant reports no other symptoms or side effects; Medical Assistant reports that a single dose of PNEUMOVAX 23 was administered on 5/29/2024 to a 10 weeks old infant. Medical Assistant reports no other symptoms or side effects. Medical assistant gives permission to contact. Medical Assistant has no; This spontaneous report as received from a medical assistant referring to a 10-week-old patient of unknown gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 29-MAY-2024, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine(PNEUMOVAX23) lot number W027449, expiration date 25-SEP-2024, 0.5 milliliter (route of administration not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Poor quality device used, Product quality issue, Syringe issue
Clinical narrative: No additional AE/PQC reported; Product quality compaint; The FBE states that the part the needle connects to keeps coming off and mentions the " luer lock port"/ The FBE was unable to confirm what part exactly is coming off of the syringe and exactly what location the syringe is leaking from; The FBE was unable to confirm if the any patients missed any doses or if the product was still administrated to patients; This spontaneous report has been received from a nurse regarding a patient of unknown gender and age. The patient's medical history, previous drug reactions or allergies, concurrent conditions, and concomitant medications were not provided.   On 11-JUN-2024, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin [rHA]) (M-M-R II) injection, 0.5mL/series (strength, frequency, route of administration, vaccination scheme, and vaccination site administration were not provided; lot number X019101, which has been validated, expiration date reported and validated as 16-JUL-2025) as a prophylaxis. This was reconstituted with merck sterile diluent injection (strength, dose, frequency, route of administration, vaccination scheme, and vaccination site administration were not provided; lot number 1946079, which has been validated, expiration date reported and validated as 03-DEC-2025) as a prophylaxis. The reporter noticed that after administration the product was leaking at the hub of the syringe due to the luer lock came off of the merck sterile diluent injection prefilled syringe at the hub (syringe issue, poor quality device used, and product quality issue). However, it was reported that the reporter was unable to confirm what part exactly was coming off of the syringe and exactly what location the syringe was leaking from. No symptomatic adverse events were reported. No injuries were reported. There was no missed any doses. No product replacement was requested at this time. The product could not be obtained as it was discarded, and no pictures were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles with a rash and on two subsequent occasions without a rash; got shingles with a rash; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got shingles with a rash and on two subsequent occasions without a rash) and rash (Verbatim: got shingles with a rash). The outcome of the vaccination failure was unknown and the outcome of the shingles and rash were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine and Shingles vaccine.   The company considered the vaccination failure and rash to be related to Shingles vaccine and Shingles vaccine. The company considered the shingles to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 12-JUN-2024 This case was reported by a patient via interactive digital media. The patient had both shingles vaccines, got shingles with a rash and on two subsequent occasions without a rash. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case has been linked with cases US2024AMR074176 and US2024AMR074179, reported by same reporter.; Sender's Comments: Vaccination failure and Rash are listed events which are considered related to GSK vaccine Shingles dose I  and Shingles dose II.  Herpes zoster is unlisted events which is considered unrelated to GSK vaccine Shingles dose I  and Shingles dose II. US-GSK-US2024AMR074176:same reporter, patient No.1 US-GSK-US2024AMR074179:same reporter, patient No.2
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles with a rash/ Spoke with 2 other women who had the same; rash; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got shingles with a rash/ Spoke with 2 other women who had the same) and rash (Verbatim: rash). The outcome of the vaccination failure was unknown and the outcome of the shingles and rash were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine and Shingles vaccine.   The company considered the vaccination failure to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and rash to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 12-JUN-2024 This case was reported via (social media) interactive digital media. The patient had both shingles vaccines, got shingles with a rash. The reporter spoke with 2 other women who had the same. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case has been linked with cases US2024AMR074168 and US2024AMR074179, reported by same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingles vaccine 1 and Shingles vaccine 2. US-GSK-US2024AMR074168:same reporter, different patient US-GSK-US2024AMR074179:same reporter, patient no. 2
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles with a rash/ Spoke with 2 other women who had the same; rash; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got shingles with a rash/ Spoke with 2 other women who had the same) and rash (Verbatim: rash). The outcome of the vaccination failure was unknown and the outcome of the shingles and rash were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine and Shingles vaccine.   The company considered the vaccination failure to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and rash to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 12-JUN-2024 This case was reported by the consumer via (social media) interactive digital media. The reporter spoke with 2 other women who had the same. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case has been linked with cases US2024AMR074168 and US2024AMR074176, reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingles vaccine 1 and Shingles vaccine 2. US-GSK-US2024AMR074176:same reporter, patient No.1 US-GSK-US2024AMR074168:same reporter, different patient US-GSK-US2024AMR074176:same reporter, patient no. 2
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles; still painful; Topical creme prescribed by doctor for rash; This serious case was reported by a consumer and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles), pain (Verbatim: still painful) and rash (Verbatim: Topical creme prescribed by doctor for rash). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved and the outcome of the rash was not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, pain and rash to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2024 The patient self-reported this case for herself. The patient had been vaccinated against shingles but still got shingles.  The patient reported that, it was a milder case but still painful. Topical cream was prescribed by physician for rash after 2nd dose of vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: being improperly stored out of temperature guidelines/being improperly stored out of temperature guidelines; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number td2fd, expiry date 31-MAY-2026) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: being improperly stored out of temperature guidelines/being improperly stored out of temperature guidelines). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 13-JUN-2024 The healthcare professional called and reported Boostrix had been administered to a patient after being improperly stored out of temperature guidelines, which led to incorrect storage of drug. The reporter stated that there was no any symptoms reported, no further information reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Pain, Pain in extremity
Clinical narrative: Redness around the injection site; pain in arm; Sore to lift; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site erythema in a adult female 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 injection site erythema (Verbatim: Redness around the injection site), pain in arm (Verbatim: pain in arm) and mobility decreased (Verbatim: Sore to lift). The outcome of the injection site erythema and mobility decreased were not reported and the outcome of the pain in arm was resolved.   It was unknown if the reporter considered the injection site erythema, pain in arm and mobility decreased to be related to Shingrix.     It was unknown if the company considered the injection site erythema, pain in arm and mobility decreased to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR074470   Additional Information: GSK receipt date: 13-JUN-2024 This case was reported by patient itself. The patient reports significant pain in arm. She said it was very sore for a few days. The patient had redness around the injection site. The patient was still able to attend work, but she said the arm was very sore to lift. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2024AMR074470:Same patient
Sex: U
Vaccine: VARZOS
Symptoms: Wrong technique in device usage process
Clinical narrative: shaked vigorious/Vaccine shaken vigorously; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong technique in product usage process 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 wrong technique in product usage process (Verbatim: shaked vigorious/Vaccine shaken vigorously). The outcome of the wrong technique in product usage process was unknown.   Additional Information: GSK Receipt date: 11-JUN-2024 A reporter reported that he/she had a staff member shake shingrix vigorously which led to Wrong technique in product usage process.  The reporter was wondering if they need to redo the shot or if it was ok to give and what should happen next.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Shingrix administered less that 0.5 mL; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-JUN-2024, the patient received Shingrix. On 10-JUN-2024, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Shingrix administered less that 0.5 mL). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 11-JUN-2024 The reporter stated, some of the liquid of the Shingrix vaccine leaked out the needle and was administered to a patient. It was administered less that 0.5 mL, which led to incomplete dose administered. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Question about the 3rd dose (if the patient should received it or not); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 1st November 2023, with batch number 797F9, expiry date as-30th December 2025) and Twinrix (2nd dose received on 4th December 2023, with batch number 797F9, expiry date as-30th December 2025). Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Recombivax).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Question about the 3rd dose (if the patient should received it or not)). The outcome of the incomplete course of vaccination 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 Information: GSK Receipt Date: 11-JUN-2024 The reporter called and asked how a patient should finish their Twinrix series. They had administered the 2 doses of Twinrix and then they went to their doctor, and the doctor gave them Recombivax (a Merck vaccine) to finish the Hepatitis-B part of the series and at the time of reporting came back to receive an additional Hepatitis-A vaccination. The reporter did not know if they should receive it. The batches number on the report were from the Twinrix vaccine, both doses were from the same lot with same expiration date. The vaccine administration facility was the same as primary reporter. Till the time of reporting the patient did not receive the 3rd dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix adminstered after below temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 73-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TD2FD, expiry date 31-MAY-2026) for prophylaxis.   On 11-JUN-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix adminstered after below temperature excursion). The outcome of the incorrect storage of drug 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 Information: GSK Receipt Date: 11-JUN-2024 A reporter reported to have a temperature excursion of several vaccines. She state that the vaccines were between 34.4 to 34.6 degree Fahrenheit, from  07:41 p.m. to 08:41 p.m. of 10th June 2024. At 11th June 2024 they administered a Boostrix vaccine to a patient. Of this temperature excursion, the reporter reported to administrated 2 doses of Boostrix to 2 different patients and 1 dose of Shingrix. This patient received one of the Boostrix vaccines which led to incorrect storage of drug. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024072703:Same reporter,Different patient US-GSK-US2024072705:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix - Admin. after Below temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number YA493, expiry date 13-APR-2026) for prophylaxis.   On 11-JUN-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Shingrix - Admin. after Below temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 11-JUN-2024 The reporter reported to had a temperature excursion of several vaccines (Shingrix, Boostrix, Menveo 1 vial, Bexsero, Arexvy, Infanrix, Pediarix, Kinrix, Havrix, Twinrix and Hiberix), she said that the vaccines were between 34.4 to 34.6 degree F, from 07:41 pm to 08:41 pm on 10-Jun-2024, which led incorrect storage of drug. The Shingrix vaccine administrated to a patient. This case was linked with US2024072703 and US2024072700 for the same reporter.; Sender's Comments:  US-GSK-US2024072703:Same reporter US-GSK-US2024072700:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; received 2 doses of Shingrix and developed shingles; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: received 2 doses of Shingrix and developed shingles). 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 Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 13-JUN-2024 The registered pharmacist stated she had a patient who was undergoing chemotherapy and received 2 doses of Shingrix vaccine and developed shingles. The name of the chemotherapy not known and reason for chemotherapy not known. The registered pharmacist had no details on patient or product. This case was considered as suspected vaccination failure since the details regarding 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 vaccine Shingrix (dose 1) and Shingrix (dose 2).
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration of liquid only; Administration of liquid only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA989A, expiry date 31-DEC-2024) for prophylaxis.   On 11-JUN-2024, the patient received Menveo. On 11-JUN-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Administration of liquid only) and inappropriate dose of vaccine administered (Verbatim: Administration of liquid only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-JUN-2024 Pharmacist reported that somebody in the pharmacist administered Menveo, liquid portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product storage error
Clinical narrative: product storage error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) (batch number 4723S, expiry date 14-JUN-2026) for prophylaxis.   On 13-JUN-2024, the patient did not receive Shingrix. On 13-JUN-2024, an unknown time after receiving Shingrix, the patient experienced intercepted product storage error (Verbatim: product storage error). The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2024 It was reported that Shingrix was delivered day before reporting and accidentally put in the freezer (by a new employee) for about 24 hours. Freezer has been as low as minus 4.9 Fahrenheit. No mention of administration as caller stated she caught it which led to intercepted product storage error.
Age: 0.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: an expired dose of Hiberix was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-month-old female patient who received Hib (Hiberix) (batch number H43J7, expiry date 13-JUN-2024) for prophylaxis.   On 14-JUN-2024, the patient received Hiberix. On 14-JUN-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: an expired dose of Hiberix was administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2024 A nurse reported that an expired dose of Hiberix was administered on day reporting and asked if the dose was considered valid or not which  led to expired used.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Accidental underdose, Device connection issue, Syringe issue
Clinical narrative: accidentally received a less than recommended dose after the needle unscrewed; needle unscrewed from the syringe and leaked out; needle unscrewed from the syringe and leaked out; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 35-year-old female patient who received HBV (Engerix B) (batch number X527B, expiry date 17-MAR-2025) for prophylaxis.   On 14-JUN-2024, the patient received the 3rd dose of Engerix B. On 14-JUN-2024, an unknown time after receiving Engerix B, the patient experienced accidental underdose (Verbatim: accidentally received a less than recommended dose after the needle unscrewed), syringe leak (Verbatim: needle unscrewed from the syringe and leaked out) and syringe connection issue (Verbatim: needle unscrewed from the syringe and leaked out). The outcome of the accidental underdose, syringe leak and syringe connection issue 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 Information: GSK Receipt Date: 14-JUN-2024 A pharmacist contacted GlaxoSmithKline to reported that a patient accidentally received a less than recommended dose after the needle unscrewed from the syringe and leaked out which led to accidental underdose, syringe leak and syringe connection issue.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Myocardial infarction
Clinical narrative: heart attack; brain bleed; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) and CEREBRAL HAEMORRHAGE (brain bleed) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria death and medically significant) and CEREBRAL HAEMORRHAGE (brain bleed) (seriousness criteria death and medically significant). The reported cause of death was Heart attack and brain bleed. It is unknown if an autopsy was performed.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.  Company Comment: This spontaneous case concerns a male patient of an unknown age with no reported medical history who experienced the serious (Fatal and medically significant) unexpected AESIs of Myocardial infarction and Cerebral haemorrhage. The events occurred on an unknown date after a dose of SPIKEVAX 2023-2024 vaccine (dose number, onset dates and dates for vaccination were not provided, hence latency could not be determined). The outcome of the events was reported as fatal; the reported cause of death was "heart attack and brain bleed". It is unknown if autopsy was performed. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-769582 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2024: Follow Up accepted - No new information was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-769582:same reporter, Different patient; Reported Cause(s) of Death: Heart attack; Brain Bleed