chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Echocardiogram, Electroencephalogram, Pseudostroke
Clinical narrative: Stroke mimic; This serious case was reported by a consumer via call center representative and described the occurrence of stroke mimic 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, 1 month after receiving Shingrix, the patient experienced stroke mimic (Verbatim: Stroke mimic) (serious criteria hospitalization and GSK medically significant). The outcome of the stroke mimic was unknown.   It was unknown if the reporter considered the stroke mimic to be related to Shingrix.     The company considered the stroke mimic to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 14-MAR-2025 The case was reported by patient's daughter. Patient had a severe episode which led him to the ER (emergency room) and resulted in his admission to the hospital. They ran all their tests to check for a stroke since it resembled a stroke or TIA (transient ischemic attack). They performed EEG (electroencephalogram) and an echocardiogram.  Reporter mentioned to the staff that he had the shingles vaccine, but none of them followed up on that.  Reporter's father was not inclined to follow up on that. She had read in the package insert about the syncope warning and had asked, what was the time frame (number of days) in which syncope had been recorded after shingrix so that he could acknowledge that perhaps it was related, because if he went and received the second shot, he might have had a worse reaction, which was hard to imagine. Patient stayed in the hospital for about 24 hours.; Sender's Comments: Pseudostroke is an unlisted event which is considered unrelated to GSK drug Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: feeling like she had the flu with aches; Pain injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain injection site) and influenza-like symptoms (Verbatim: feeling like she had the flu with aches). The outcome of the injection site pain was resolved (duration 2 months) and the outcome of the influenza-like symptoms was resolved.   It was unknown if the reporter considered the injection site pain and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the injection site pain and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAR-2025 The patient self-reported this case. The patient had received 1st dose of Shingrix vaccine in 2022 and in 2022 due to feeling like she had the flu with aches and pains and pain at the injection site, she did not went back for the second vaccine within the recommended schedule time.  The patient stated that she did not remember much about the things she experienced with the first dose.   She did remember that the injection site pain lasted for about 2 months before it resolved.  The patient did not remember what medications she was taking during the 1st dose in 2022.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Neck pain
Clinical narrative: Neck pain; lower back pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of neck pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose on unknown date). Concurrent medical conditions included chemotherapy, diabetes, seizure, memory deficit, stomach pain and cholesterol. Concomitant products included brigatinib (Alunbrig), vitamin d, insulin lispro (Humalog), insulin glargine (Lantus), levetiracetam, memantine hydrochloride (Memantine), aluminium hydroxide gel, dried, magnesium carbonate (Pepcid) and rosuvastatin calcium (Rosuvastatin).   On 03-MAR-2025, the patient received the 2nd dose of Shingrix. On 04-MAR-2025, 1 days after receiving Shingrix, the patient experienced neck pain (Verbatim: Neck pain) and low back pain (Verbatim: lower back pain). The outcome of the neck pain and low back pain were not resolved.   It was unknown if the reporter considered the neck pain and low back pain to be related to Shingrix.     It was unknown if the company considered the neck pain and low back pain to be related to Shingrix.   Additional Information: GSK receipt date: 11-MAR-2025 Patient reported neck and lower back pain after receiving the second dose of Shingrix.
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: swelling at the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling at the injection site). The outcome of the injection site swelling was unknown.   The reporter considered the injection site swelling to be related to Shingrix.     The company considered the injection site swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAR-2025 The reporter states within the past 3 months she has administered Shingrix to two patients that had swelling at the injection site.  The reporter could not provide the initials, date of birth, gender or lot number for the two individuals.  No further information was obtained/provided by health care professional. This was 2 of the 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2025029066:Same reporter/ different patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient had the first dose in 2019).   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: never got the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 12-MAR-2025 Patient reported that she had her first dose of Shingrix in 2019 but never got the second dose.  Asked if she need to start over, or just have the second dose. Also stated that unfortunately healthcare providers were also unclear of the protocol in this situation and asked about boosters. Till the time of reporting the patient did not receive the second dose of Shingrix, which lead to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: internal between 1st dose and 2nd dose was too long; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (recived 1st dose over a year ago).   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 drug dose administration interval too long (Verbatim: internal between 1st dose and 2nd dose was too long). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK receipt date: 12-MAR-2025 This case was reported by a patient via interactive digital media. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.  The patient had a question should he/she get another one 2-6 months from the latest dose.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; several people who also got shingles not long after the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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: several people who also got shingles not long after the vaccine). 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: 14-MAR-2025 This case was reported by a patient via interactive digital media. The reporter known several people who also got shingles not long after the vaccine (unspecified time period). 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. This case was linked with case US2025AMR031998 reported by the same reporter, for different patient.; 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  Shingles vaccine. US-GSK-US2025AMR031998:same reporter different patient
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: shingrix missed second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose on unknown date).   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: shingrix missed second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 16-MAR-2025 Patient stated that he/she missed second dose. Asked if they need to take another two doses. Till the time of reporting patient did not receive 2nd dose of vaccine which led to incomplete course of vaccination.
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered
Clinical narrative: Partial dose with leakage; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 86-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 255t2, expiry date 05-DEC-2025) for prophylaxis.   On 10-MAR-2025, the patient received the 1st dose of Arexvy. On 10-MAR-2025, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: Partial dose with leakage). The outcome of the incomplete dose administered was not applicable.   Additional Information: GSK Receipt Date: 10-MAR-2025 A pharmacist called in to request data about the need to readminister a dose of Arexvy after the patient was receiving a dose and recoiled, causing leakage of the vaccine, which led incomplete dose administered.  The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: intramuscular administration of Priorix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 64-year-old male patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   On 10-MAR-2025, the patient received Priorix (intramuscular). On 10-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: intramuscular administration of Priorix). The outcome of the subcutaneous injection formulation administered by other route 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-MAR-2025 The reporter reported that the intramuscular administration of Priorix to patient , which led to subcutaneous injection formulation administered by other route. This was 1 of 3 linked cases , reported by the same reporter.; Sender's Comments:  US-GSK-US2025029884:Same reporter/Different patient US-GSK-US2025029889:Same reporter/Different patient
Age: 67.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: patient that received it was born in 1957; administration via intramuscular; 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 67-year-old female patient who received MMR (Priorix) (batch number 7HG2A, expiry date 01-JAN-2026) for prophylaxis.   On 10-MAR-2025, the patient received Priorix. On 10-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient that received it was born in 1957) and subcutaneous injection formulation administered by other route (Verbatim: administration via intramuscular). The outcome of the inappropriate age at vaccine administration and subcutaneous injection formulation administered by other route 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: 11-MAR-2025 Pharmacist wanted to know if the administration via intramuscular of Priorix in a patient was correct or not, but also mention that the patient that received it was born in X. Patient received the vaccine via intramuscular route at the age of 67 years, which led to subcutaneous injection formulation administered by other route and inappropriate age at vaccination.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered expired vaccine of Havrix 720; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received HAV (Havrix 720) (batch number 2YS34, expiry date 02-MAR-2025) for prophylaxis.   On 11-MAR-2025, the patient received Havrix 720. On 11-MAR-2025, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: administered expired vaccine of Havrix 720). The outcome of the expired vaccine used 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-MAR-2025 The registered pharmacist reported that they had a nurse who administer a dose of Havrix 720 unit to a patient on the day of reporting that was expired which led to, expired vaccine used. The vaccine administration facility was the same as primary reporter.
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: stated that the Covid 19 vaccine "Screwed up my whole body"; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced stated that the covid 19 vaccine "screwed up my whole body". (dose series 1).  The patient had multiple complaints surrounding the covid-19 vaccine. The action taken with janssen covid-19 vaccine was not applicable.  The outcome of stated that the covid 19 vaccine "screwed up my whole body" was not reported.  This report was associated with a product quality complaint: Product Complaint 90000357534.  This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID a month later; got COVID a month later; This is a spontaneous report received from a Physician from medical information team.  A female patient received BNT162b2 (BNT162B2), in Dec2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, latency 1 month after the suspect product(s) administration, outcome "unknown" and all described as "got COVID a month later". Clinical course: the patient took the COVID vaccine BioNTech from Pfizer in Dec2021 and then got COVID infection in Jan2022. So, the patient got COVID the next month. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-202500061109 Same patient, Different vaccine dose number and event;
Age: 19.0
Sex: M
Vaccine: HPV9, MENB, TDAP, TYP, YF
Symptoms: Eye irritation, Myalgia, Rash
Clinical narrative: HAD RINGWORM LOOKING SORE START ABOUT 10-14 DAYS AFTER VACCINATION ON LEFT CHEST BETWEEN ARMPIT AND NIPPLE AREA, SPREADING TO RASH THAT CONTINUES TO WORSEN. TRIED TAKING ZYRTEC FOR 2 DAYS BUT DIDN'T NOTICE ANY DIFFERENCE. COMPLAINING OF MUSCLE ACHES BUT GOES TO THE GYM 6 DAYS A WEEK. STATED RASH DOES NOT ITCH. HAS NOT HAD FEVER. ABOUT 7-10 DAYS AGO EXPERIENCED EYE IRRITATION. GIVEN DROPS FOR EYE BY MOM.
Age: 1.0
Sex: M
Vaccine: MMR, PNC20, RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient experienced NO adverse event other than that he inadvertently received RV5 which he was not due for. The error was noted while the pt./parents were still in the exam room. They were informed of the erro and told not to not expect any adverse symptoms outside what would normally be seen wth this vaccine. Parents were also instructed to report any adverse symtoms and that this nurse would follow-up with them on 03/19/25. I phoned on 03/19/25. I spoke with the child's mother. She informed me the pt. experienced NO adverse effects, stating he was "fine". I instructed her again to notify our agency if there were any adverse symptoms.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Joint swelling
Clinical narrative: The patient came to pick up her prescription on 3/20 and said that the RSV vaccination that she received on 3/1 caused swelling in her left wrist that began on 3/3. It lasted about 2 weeks. I asked if the site of injection was ever red or swollen and she stated that it was not. The issue is now resolved, she just wanted us to know what had occurred.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Dizziness, Nausea, Syncope, Vomiting
Clinical narrative: Tdap, brand unknown (guessed). A few minutes after receiving the vaccine patient complained of stomach paid and said he might throw up. I told him to use the garbage can. He got up, vomited in the garbage can, said he was dizzy and then fainted. After that he started to feel better and then vomited a 2nd time about 20 minutes later.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Computerised tomogram, Gait inability, Hemiparesis, Magnetic resonance imaging
Clinical narrative: Per my Patient - patient became unbalanced and was having/ could not walk and and became weak on her left side- after multiple test it turned out that patient had a stroke the next day after vaccine- per patient- pt. was seen and contacted their PCP.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given 10 days beyond use date
Age: 54.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Patient presented picking up other medications and showed us her arm. Below the site of injection it seemed red and tender. The back side of the arm looked slightly bruised.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Fever, chills, headache, severe fatigue, dizziness, severe pain in and weakness in my right arm and shoulder, unable to lift my right arm or lift any objects, diarrhea, nausea, and vomiting, at injection site: redness, discoloration, hot to touch, swelling, pain, rash, and itching.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Fever, chills, headache, severe fatigue, dizziness, severe pain in and weakness in my right arm and shoulder, unable to lift my right arm or lift any objects, diarrhea, nausea, and vomiting, at injection site: redness, discoloration, hot to touch, swelling, pain, rash, and itching.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Muscular weakness, Nausea
Clinical narrative: Fever, chills, headache, severe fatigue, dizziness, severe pain in and weakness in my right arm and shoulder, unable to lift my right arm or lift any objects, diarrhea, nausea, and vomiting, at injection site: redness, discoloration, hot to touch, swelling, pain, rash, and itching.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Fever, chills, headache, severe fatigue, dizziness, severe pain in and weakness in my right arm and shoulder, unable to lift my right arm or lift any objects, diarrhea, nausea, and vomiting, at injection site: redness, discoloration, hot to touch, swelling, pain, rash, and itching.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Pt noticed a red, inflamed rash approximately the size of a quarter below (unsure of distance from injection site) the button bandage from the shot, covering the injection site on the right arm. Patient noticed rash approx. two days after administration. Patient believes she may have had same reaction on first dose in series but cannot remember due to time between doses (approx 6 months). Patient just reported at date of incident report, unsure of follow up require at the moment but ADR does not seem to be life threatening but was advised if it doesn't improve in 1 to 2 days she should make an appointment with a physician.
Age: 61.0
Sex: M
Vaccine: HEP, PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Heplisav Vaccine: no issues, Prevnar vaccine: patient has already received one dose on 10/13/2023. We were unaware, which is why he received one outside of dosing interval/recommendation on 03/19/25. Patient did not have any adverse events with this second dose of Prevnar.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Dysphagia, Headache, Laboratory test, Motor neurone disease
Clinical narrative: First symptom was difficulty with speach, few weeks later, tongue thickness feeling, and some difficulty with swallowing pills.  (Dysarthria and dysphagia diagnosed) Following month jaw pain and left temple pain.  Outcome after seeing primary doctor, ENT, Rheumatology, and finally Nuerolgist- diagnosed with Bulbar Onset Motor Nueron Disease.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Tongue disorder
Clinical narrative: First symptom was difficulty with speach, few weeks later, tongue thickness feeling, and some difficulty with swallowing pills.  (Dysarthria and dysphagia diagnosed) Following month jaw pain and left temple pain.  Outcome after seeing primary doctor, ENT, Rheumatology, and finally Nuerolgist- diagnosed with Bulbar Onset Motor Nueron Disease.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Chest pain, Dizziness, Pain in extremity, Throat irritation
Clinical narrative: Per patient verbalized that he felt pain in arm, and was feeling dizzy, and throat and chest hurt. Mom expressed concern because of the pallor on his face. Treatment was to provide cooling packs, lay down knees bent, monitor vitals. Some throat swelling was noted but no obstruction. Vitals were within normal ranges. Monitored until symptoms improved. Symptoms resolved on their own. No medication was given.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received extra dose of Prevnar 20. Patient had already received prevnar20 back in 12/06/2022 but was not registered. Patient reports no adverse effects at this time.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pruritus, Nausea, Pain in extremity, Wheezing
Clinical narrative: Itching around injection site approximately 10 minutes after injection. Aching of upper arm, which I consider a normal response developed within a half hour. Fatigue, nausea and mild wheezing developed around 90 minutes later.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Joint swelling, Lymphadenopathy, Pruritus, Skin warm
Clinical narrative: Approximately 7 days after receiving vaccine patient experienced symptoms in left shoulder : red skin, swelling / feeling hot to the touch. Patient also had swollen lymph nodes under left arm. Once redness resolved the skin was itchy. Symptoms resolved on its own after approximately 3 days. Patient did not seek medical attention, and did not take any medication to treat the reaction.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no reverse reaction - given adult dose instead of pediatric dose
Age: 50.0
Sex: F
Vaccine: COVID19, FLU3, HEP, MMR, PNC21, COVID19, FLU3, MMR, PNC20, VARZOS
Symptoms: Arthralgia, Laboratory test, Loss of personal independence in daily activities, Product administered at inappropriate site, X-ray
Clinical narrative: Within less than 12 hours I was in unbearable pain in both of my shoulders. My right side hurt, but my left side was pain like I?ve never felt. I could not move my arms away from my sides,, or lift them up away from my body. My shoulders were swollen and warm, I thought maybe I was going septic. I lost strength in my arms and left hand. I couldn?t even pick up my son, the pain was debilitating.
Age: 50.0
Sex: F
Vaccine: COVID19, FLU3, HEP, MMR, PNC21, COVID19, FLU3, MMR, PNC20, VARZOS
Symptoms: Arthralgia, Asthenia, Joint swelling, Mobility decreased, Skin warm
Clinical narrative: Within less than 12 hours I was in unbearable pain in both of my shoulders. My right side hurt, but my left side was pain like I?ve never felt. I could not move my arms away from my sides,, or lift them up away from my body. My shoulders were swollen and warm, I thought maybe I was going septic. I lost strength in my arms and left hand. I couldn?t even pick up my son, the pain was debilitating.
Age: 6.0
Sex: F
Vaccine: COVID19, IPV, MMRV, UNK
Symptoms: Product storage error
Clinical narrative: No adverse event; Product storage error; Information has been received from Business Partner/CRO on .  This spontaneous report was received from a/an Nurse and refers to a(n) 6-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Ipol (Polio vaccine inact 3v (Vero)), Moderna COVID-19 vaccine (Elasomeran) .  On 09-Jan-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y013583, expiration date: 03-Feb-2026), dose number 2, administered by Subcutaneous route in Left Arm. On 09-Jan-2022, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), administered by Subcutaneous route (indication, expiration date, and lot # were not reported). The patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), for the treatment of prophylaxis.  On 09-Jan-2025, the patient experienced Product storage error. On an unknown date, the patient experienced No adverse event.   At the reporting time, the outcome of Product storage error and No adverse event was unknown.   The action taken with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live and sterile diluent was reported as not applicable.   The causal relationship between the event of No adverse event and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live was unknown/not reported/not provided.  The causal relationship between the event of Product storage error and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live was unknown/not reported/not provided.  The causal relationship between the event of Product storage error and sterile diluent was unknown/not reported/not provided.  The causal relationship between the event of No adverse event and sterile diluent was unknown/not reported/not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 11/14/2018 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 6.0
Sex: F
Vaccine: COVID19, IPV, MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Product storage error; Information has been received from Business Partner/CRO on .  This spontaneous report was received from a/an Nurse and refers to a(n) 6-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Ipol (Polio vaccine inact 3v (Vero)), Moderna COVID-19 vaccine (Elasomeran) .  On 09-Jan-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y013583, expiration date: 03-Feb-2026), dose number 2, administered by Subcutaneous route in Left Arm. On 09-Jan-2022, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), administered by Subcutaneous route (indication, expiration date, and lot # were not reported). The patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), for the treatment of prophylaxis.  On 09-Jan-2025, the patient experienced Product storage error. On an unknown date, the patient experienced No adverse event.   At the reporting time, the outcome of Product storage error and No adverse event was unknown.   The action taken with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live and sterile diluent was reported as not applicable.   The causal relationship between the event of No adverse event and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live was unknown/not reported/not provided.  The causal relationship between the event of Product storage error and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live was unknown/not reported/not provided.  The causal relationship between the event of Product storage error and sterile diluent was unknown/not reported/not provided.  The causal relationship between the event of No adverse event and sterile diluent was unknown/not reported/not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 11/14/2018 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 57.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: She reported having a warm circle that kept expanding starting a few days after the vaccine.  She went to her primary care doctor to get a steroid shot which seemed to have help her with her symptoms.
Age: 57.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Skin warm
Clinical narrative: She reported having a warm circle that kept expanding starting a few days after the vaccine.  She went to her primary care doctor to get a steroid shot which seemed to have help her with her symptoms.
Age: 4.0
Vaccine: MMRV
Symptoms: Device leakage, No adverse event
Clinical narrative: No additional adverse events were reported; The vaccine began leaking out  between the syringe and the luer lock; the needle was in the patient's arm; This spontaneous report was received from a Registered Nurse (RN) and refers to a 4-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 21-FEB-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y015356, expiration date: 10-MAR-2026) for prophylaxis (dose, route and site of administration were not reported) using a sterile diluent (BAXTER Sterile Diluent), (lot #2031275, expiration date: 15-Dec-2026).   The RN said the syringe contained reconstituted Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and was being administered to patient and the needle was in the patient's arm (poor quality device used), but then the vaccine began leaking out between the syringe and the luer lock (device leakage). The RN said she believed that when the needle was attached to prefilled syringes of sterile diluent (BAXTER Sterile Diluent ) that it created a suction and made it where the luer lock loosens. No additional adverse events were reported (no adverse event).; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02757689-02757684 , CLIC number : , ESTAR number : , IRMS number : 500UW00000UKnBWYA1|10032025120014|1860 , Central date : 2025-03-10 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2258717 , MNSC case number : 02757689 , MNSC interaction number : 02757684 , Integration log UniqueID : 500UW00000UKnBWYA1|10032025120014|1860 , Service cloud CaseID : 500UW00000UKnBWYA1
Sex: F
Vaccine: IPV, MMR
Symptoms: Attention deficit hyperactivity disorder, Cerebral disorder, Discomfort, Fatigue, Feeling abnormal
Clinical narrative: She then developed narcolepsy/blacked out; Felt differently afterward; Her brain has been messed up ever/She always feels brain damage; she slept harder after being vaccinated,; her life has been messed up; she's always still tired; ADHD; This spontaneous report was received from a 40-year-old female patient, concerning herself. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On unknown day (reported as when she was 3 and a half years old), the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-RII) (strength, dose, route of administration, anatomical location, lot #, and expiry date were not provided) which was diluted with sterile diluent (expiration date and lot # were not reported) as prophylaxis and an with an unspecified polio vaccine (indication, dose, route of administration, anatomical location, expiration date, and lot # were not reported).  On an unspecified day, the patient reported that her life has been messed up since she received her childhood vaccinations (quality of life decreased). She blacked out and felt differently afterward (feeling abnormal). In addition, she said her brain has been messed up ever since (cerebral disorder) and always felt brain damaged. She stated she has never been the same (she was normal before these vaccines and at the time of the report she was a totally different person). She then developed narcolepsy and ADHD (attention deficit hyperactivity disorder) as a result of a vaccine. Consumer stated she needs ADHD medicine for her brain and to not develop hypoglycemia and she was afraid she would be hypoglycemic if she stopped taking it. She could not function without the ADHD medication. Consumer was concerned that she didn't need these medications when she was a child and blamed vaccinations for her needing them at the time of report. Moreover, the patient informe that she slept harder (sleep disorder) after being vaccinated, but she was always still tired (fatigue). She felt like something was beating her down and felt like a city was weighing or a heavy building was sitting on her. She also felt like kept getting hit by a mac truck. She experienced a "dragging effect" like gravity was pulling was her down. "She could not get that gravity feel off of her".  At the reporting time, the outcome of all the events was not provided.   The reporter considered the events of narcolepsy, cerebral disorder, and ADHD to be related to the suspect vaccines/therapy. While the causal relationship between the remained events and the suspect vaccines/therapy was not provided.   Upon internal review, the event of narcolepsy was determined to be medically significant.
Sex: F
Vaccine: IPV, MMR
Symptoms: Loss of consciousness, Narcolepsy, Pain, Quality of life decreased, Sleep disorder
Clinical narrative: She then developed narcolepsy/blacked out; Felt differently afterward; Her brain has been messed up ever/She always feels brain damage; she slept harder after being vaccinated,; her life has been messed up; she's always still tired; ADHD; This spontaneous report was received from a 40-year-old female patient, concerning herself. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On unknown day (reported as when she was 3 and a half years old), the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-RII) (strength, dose, route of administration, anatomical location, lot #, and expiry date were not provided) which was diluted with sterile diluent (expiration date and lot # were not reported) as prophylaxis and an with an unspecified polio vaccine (indication, dose, route of administration, anatomical location, expiration date, and lot # were not reported).  On an unspecified day, the patient reported that her life has been messed up since she received her childhood vaccinations (quality of life decreased). She blacked out and felt differently afterward (feeling abnormal). In addition, she said her brain has been messed up ever since (cerebral disorder) and always felt brain damaged. She stated she has never been the same (she was normal before these vaccines and at the time of the report she was a totally different person). She then developed narcolepsy and ADHD (attention deficit hyperactivity disorder) as a result of a vaccine. Consumer stated she needs ADHD medicine for her brain and to not develop hypoglycemia and she was afraid she would be hypoglycemic if she stopped taking it. She could not function without the ADHD medication. Consumer was concerned that she didn't need these medications when she was a child and blamed vaccinations for her needing them at the time of report. Moreover, the patient informe that she slept harder (sleep disorder) after being vaccinated, but she was always still tired (fatigue). She felt like something was beating her down and felt like a city was weighing or a heavy building was sitting on her. She also felt like kept getting hit by a mac truck. She experienced a "dragging effect" like gravity was pulling was her down. "She could not get that gravity feel off of her".  At the reporting time, the outcome of all the events was not provided.   The reporter considered the events of narcolepsy, cerebral disorder, and ADHD to be related to the suspect vaccines/therapy. While the causal relationship between the remained events and the suspect vaccines/therapy was not provided.   Upon internal review, the event of narcolepsy was determined to be medically significant.
Age: 34.0
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported; Customer called to report expired GARDASIL 9 administered to a patient post product expiration.  Expiration date was 29JAN2025.  Product was administered on 14MAR2025. No TE occurred.  No symptoms reported.  Caller consented to correspondence.  See r; This spontaneous report was received from a nurse, concerning to a 34-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and  concomitant therapies were not reported.   On 14-Mar-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant, at a dose of 0.5 mL, administered as prophylaxis (route of administration was not provided; lot #W026152 has been verified to be valid for this vaccine, expiration date reported and confirmed as 29-Jan-2025); which was an expired vaccine (Expired product administered). No additional adverse event was reported (No adverse event).
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: administration of ACTHIB with the wrong diluent with no reported ae; Initial information received on 17-Mar-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to US-SA-2025SA079766.  This case involves a 15 months old female patient who had administration of HIB (PRP/T) vaccine [ACT-HIB] with the wrong diluent with no reported AE (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza vaccine (Flu) for Immunisation; and  (Pneumococcal vaccines) for Immunisation.  On 13-Mar-2025, the patient received a 0.5ml dose 4 of suspect HIB (PRP/T) vaccine (lot UK093AB) Powder and solvent for solution for injection standard strength, frequency-once (expiry date-30-Sep-2025) via intramuscular route in the right vastus lateralis for immunization and with the wrong diluent with no reported ae (product preparation error) (latency-same day).  Reportedly-Nurse called to get information about reconstituting ACTHIB with a different diluent (sterile water), which was administered to 2 patients.  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA079766:
Vaccine: VARZOS
Symptoms: Neuralgia, Rash
Clinical narrative: Rash following administration of Shingrix; nerve pain following administration of Shingrix; This serious case was reported by a physician via sales rep and described the occurrence of rash in a elderly 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 rash (Verbatim: Rash following administration of Shingrix) (serious criteria other: serious as per reporter) and nerve pain (Verbatim: nerve pain following administration of Shingrix) (serious criteria other: serious as per reporter). The outcome of the rash and nerve pain were unknown.   The reporter considered the rash and nerve pain to be related to Shingrix.     The company considered the rash and nerve pain to be unrelated to Shingrix.   Additional Information: GKS receipt date: 13-MAR-2025 The reporter reported that the patient recived Shingrix vaccine the dose number was unknown but, after vaccination patient experienced rash and nerve pain. The expiry date of Shingles vaccine was unknown. The provider sent the patient to several specialist (dermatologist and neurologist) to identify the cause. Their only conclusion was that it was probably Shingrix vaccine. The reporter asked if this was a known side effect. She said she had 2 events but only shared information for one patient.; Sender's Comments: Rash is a listed event which, due to the following criteria (insufficient information regarding medical history, concurrent conditions, concomitant medications, completion of primary vaccination schedule, time to onset) is considered unrelated to GSK vaccine Shingrix. Neuralgia is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 57.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: was given Priorix intramuscularly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 57-year-old male patient who received MMR (Priorix) for prophylaxis.   On 10-MAR-2025, the patient received Priorix (intramuscular). On 10-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: was given Priorix intramuscularly). The outcome of the subcutaneous injection formulation administered by other route 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-MAR-2025 The pharmacy manager stated a patient was given Priorix intramuscularly yesterday (day before reporting), which led to subcutaneous injection formulation administered by other route. No further details were provided.