chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Today it is very warm and red; Today it is very warm and red; It is painful but not above and beyond; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-MAY-2025, the patient received Shingrix. In MAY-2025, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: It is painful but not above and beyond). On 18-MAY-2025, the patient experienced injection site erythema (Verbatim: Today it is very warm and red) and injection site warmth (Verbatim: Today it is very warm and red). The outcome of the injection site erythema, injection site pain and injection site warmth were not reported.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site warmth to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site pain and injection site warmth to be related to Shingrix.   Additional Information: GSK receipt date: 18-MAY-2025  The case was reported by the patient via (Shingrix GSK Chatbot) interactive digital media. The patient had a vaccine of Shingrix early afternoon one day prior to the reporting day on Saturday.  On the day of reporting, it was very warm and red and about 3 x 3 in diameter.  It was painful but not above and beyond.  The patient asked that he/she should take Benadryl or put a cold compress on the area. After taking Shingrix how he/she calm the redness and pain.
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: my arm still hurts; made me ill; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: my arm still hurts) and illness (Verbatim: made me ill). The outcome of the pain in arm was not resolved and the outcome of the illness was not reported.   It was unknown if the reporter considered the pain in arm and illness to be related to Shingrix.     It was unknown if the company considered the pain in arm and illness to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-MAY-2025 This case was reported by a patient via interactive digital media. The patient received the Shingrix vaccine and his/her arm still hurts and this made him/her ill.
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site, Skin irritation
Clinical narrative: she got an irritation near her shoulder; injected very high on the shoulder above the area where shots are usually given; This non-serious case was reported by a nurse via sales rep and described the occurrence of skin irritation 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 skin irritation (Verbatim: she got an irritation near her shoulder) and vaccine administered at inappropriate site (Verbatim: injected very high on the shoulder above the area where shots are usually given). The outcome of the skin irritation was resolved and the outcome of the vaccine administered at inappropriate site was not applicable.   It was unknown if the reporter considered the skin irritation to be related to Shingrix.     It was unknown if the company considered the skin irritation to be related to Shingrix.   Additional Information: GSK Receipt Date :20-MAY-2025 Patient has had 1 dose of Shingrix.  She reported the lady who did the injection injected very high on the shoulder (above the area where shots are usually given) which led to vaccine administered at inappropriate site and that she got an irritation near her shoulder that looked like cellulitis. The site has healed and she planed to get dose 2, but not to allow that same lady to administer dose.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 20-MAY-2025 This case was reported by a patient's friend via interactive digital media. The reporter reported that he/she had a friend who had shingles despite having received both vaccines. The reporter had a shingles (it was awful) and then was vaccinated. The reporter had a questioned was it unusual to have had them after being vaccinated. That caused him/her some concern he/she did not wanted to go through that again. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2).
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: A patient has been given Priorix diluent at a local GP; patient has been given Priorix diluent; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) (batch number A69CF724) and (batch number A69CE762A) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: A patient has been given Priorix diluent at a local GP) and inappropriate dose of vaccine administered (Verbatim: patient has been given Priorix diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-MAY-2025 The reporter reported that a patient had been given Priorix diluent at a local General Practitioner. They need to identify which patients received it, they have 18 vaccinations and 17 of them have batch numbers recorded as A69CF724 and one is recorded as A69CE762A.  Could this be the number off the diluent. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hepatitis A vaccine was given couple months too soon to a patient about an year ago; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of drug dose administration interval too short in a patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Hepatitis A vaccine was given couple months too soon to a patient about an year ago). The outcome of the drug dose administration interval too short 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: 20-MAY-2025 The reporter called to state that the Hepatitis A vaccine was given couple months too soon to a patient about a year ago which led to drug dose administration interval too short. Upon clarification, the reporter stated that the product was Havrix and not VAQTA. The reporter stated that she would call the corresponding manufacturer.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; shingles for the 3rd time; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles for the 3rd time). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving.   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: 21-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she was hopefully just getting over shingles for the third time he/she had been vaccinated. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria ((insufficient information provided about primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine.  .
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Possible wrong schedule; Possible wrong schedule; This non-serious case was reported by a consumer via sales rep and described the occurrence of inappropriate schedule of drug administration in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate schedule of drug administration (Verbatim: Possible wrong schedule) and incomplete course of vaccination (Verbatim: Possible wrong schedule). The outcome of the inappropriate schedule of drug administration and incomplete course of vaccination 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: 16-MAY-2025 The doctor was inquiring on why they don't need to bring back the patients if they gave them Bexsero at the 0-1 month when Bexsero has an accelerated dosing of 0-1-2 and 6 months which led to inappropriate schedule of drug administration and incomplete course of vaccination. She understood that the 0 1-2 6 is for specific patients however were those patients she gave 0-1 month protected since we have a 3 dose indication. The dosing schedule was confusing her. The Vaccine Administration Facility is the same as Primary Reporter No more information shared.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 40-year-old female patient who received HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 20-MAY-2019 with batch number-95KG9 and expiry date 29-OCT-2020).   On 22-APR-2025, the patient received the 2nd dose of Twinrix. On 22-APR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). The outcome of the drug dose administration interval too long 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: 20-MAY-2025 The patient received 2nd dose at longer interval than recomeded which led lengthening of vaccination schedule. Registered pharmacist wanted to know if he should restart the series or how much time to wait before giving a third dose of Twinrix after his patient received the first dose. The reporter consented to follow up.
Sex: F
Vaccine: DTAP
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete scheme dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received DTPa (Infanrix) for prophylaxis.   Previously administered products included Infanrix (received 1st dose of vaccine on an unknown date), Infanrix (received 2nd dose of vaccine on an unknown date) and Infanrix (received 3rd dose of vaccine on 23rd June 2023).   On an unknown date, the patient did not receive the 4th dose of Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced incomplete course of vaccination (Verbatim: Incomplete scheme dose). The outcome of the incomplete course of vaccination 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: 20-MAY-2025 On 20th May 2025, an physician requested information regarding a 7 year old patient and the possibility of administering a Boostrix booster dose for the DTaP vaccine scheme.  The physician stated that the patient was from another country and had received only three doses of DTaP. Since the patient had not completed the full DTaP vaccination schedule, local authorities required a Boostrix booster dose.  The physician reported that the DTaP vaccines the patient had received were Infanrix, with the last dose administered on 23rd June 2023. During the call, the healthcare professional noted that the patient had received the three doses as an infant but did not provide specific dates, only mentioning that the last dose was given on 23rd June 2023.  The MD consented to follow up. Till the time of reporting, the patient did not receive 4th dose of Infanrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: RV1
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Schedule of Vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a female patient who received Rota (Rotarix liquid formulation) for prophylaxis.   Previously administered products included Rotarix (Patient receive 1st dose of Rotarix on 27th December 2024 with batch number 32PF3 expiry 15 May 2027).   On an unknown date, the patient did not receive the 2nd dose of Rotarix liquid formulation. On an unknown date, an unknown time after receiving Rotarix liquid formulation, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the inappropriate schedule of vaccine administered was not applicable.   Additional Information: GSK receipt date: 21-MAY-2025 HCP reported about late dose of Rotarix. Patient received 1st dose on December 27, 2024 at 2 months of age and is back to received 2nd dose at 7 months of age. Also asked what was the recommendation beyond the 24 weeks for 2nd dose? It was unknown at time of reporting if patient would be receiving 2nd dose on the day of reporting. Till the time of reporting patient did not receive 2nd dose of vaccination which led to incomplete course of vaccination.
Age: 7.0
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix + possible use before recommended age; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix + possible use before recommended age). The outcome of the inappropriate age at vaccine administration was not applicable.   Additional Information: GSK receipt date: 22-MAY-2025 Doctor called to ask information about approved age of Boostrix being to patients older than 10 years of age. They did not have a specific case at the moment of call but mentioned sometime in her facility they receive 7-year-old patients that need to catch-up on the Dtap vaccine schedule which led to inappropriate age at vaccine administration, and wanted to review information to make clinical decision.
Vaccine: COVID19
Symptoms: Peripheral swelling, Pharyngeal swelling, Pruritus, Swelling
Clinical narrative: severe itching; swelling of body; swelling of body hands feet; swelling of body hands feet and throat; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (severe itching), SWELLING (swelling of body), PERIPHERAL SWELLING (swelling of body hands feet) and PHARYNGEAL SWELLING (swelling of body hands feet and throat) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer Vaccine. Past adverse reactions to the above products included No adverse effect with Pfizer Vaccine. Concurrent medical conditions included Iodine allergy (severe) and Fish allergy (fish oil and all fish).    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (severe itching), SWELLING (swelling of body), PERIPHERAL SWELLING (swelling of body hands feet) and PHARYNGEAL SWELLING (swelling of body hands feet and throat). At the time of the report, PRURITUS (severe itching), SWELLING (swelling of body), PERIPHERAL SWELLING (swelling of body hands feet) and PHARYNGEAL SWELLING (swelling of body hands feet and throat) was resolving.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported.  The patient received the Covid -19 vaccine of Moderna in September and experienced severe itching, swelling in body, hands, feet, and throat. Patient still have some attacks, but they were less frequent and patient was afraid. The patient usually took Pfizer vaccine and never experienced a reaction.   No treatment medications were reported.
Age: 35.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient got administered expired Tenivac vaccine with no reported adverse event; Initial information received on 22-May-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case involves a 35 years old male patient who got administered expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-May-2025, the patient got administered expired 0.5 ml dose 2 of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Strength- standard) Suspension for injection lot U7745AA and expiry date- 20-May-2025 via intramuscular route in the deltoid nos (not specified) for Immunization with no reported adverse event (expired product administered) (latency- same day).  Action taken- 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.
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: inappropriate use due to possible administration of vaccine post excursion with no reported adverse event; Initial information received on 23-May-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age and gender patient who was administered with Diphtheria-2/Tetanus/5 AC pertussis vaccine [Adacel] vaccine post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 AC pertussis vaccine Suspension for injection (lot 4CA04C1 and expiry date-31-Oct-2026) (strength-unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) post excursion with no reported adverse event (poor quality product administered) (latency-same day).  Reportedly- The patient received vaccine that was stored at -0.  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.
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: inappropriate use due to administration of vaccine post excursion as stored at -0 with no reported adverse event; Initial information received on 23-May-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who had inappropriate use due to administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] post excursion as stored at -0 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (lot UK114A and expiry date 30-Sep-2025) via unknown route in unknown administration site for immunization that had inappropriate use post excursion as stored at -0 with no reported adverse event (poor quality product administered) (Latency: same day).  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.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Oligohydramnios, Preterm premature rupture of membranes, Ultrasound antenatal screen abnormal
Clinical narrative: I was 13 weeks pregnant and received this vaccination. I started bleeding vaginally the next day. Over the next several days, bleeding increased each day from what looked like spotting to full period type of bleeding. Initial ultrasound could not find what was wrong. Bleeding continued as full period for several weeks until later ultrasound revealed oligohydramnios and PPROM requiring D&C procedure at 18 weeks (miscarriage/pregnancy loss due to no viability).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine dilation and curettage, Vaginal haemorrhage
Clinical narrative: I was 13 weeks pregnant and received this vaccination. I started bleeding vaginally the next day. Over the next several days, bleeding increased each day from what looked like spotting to full period type of bleeding. Initial ultrasound could not find what was wrong. Bleeding continued as full period for several weeks until later ultrasound revealed oligohydramnios and PPROM requiring D&C procedure at 18 weeks (miscarriage/pregnancy loss due to no viability).
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Gait disturbance, Hallucination, Headache
Clinical narrative: Bilateral weakness that required assistance to walk headache fever. Soreness at site. Hallucination times 1   Fatigue.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Bilateral weakness that required assistance to walk headache fever. Soreness at site. Hallucination times 1   Fatigue.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Patient was seen in ER on 2/26/21 for an anaphylactic (acute allergic) reaction to the Moderna COVID Vacine. Patient was given 2 epipens, steroids, benadryl for  symptoms as well as some medications for nausea and stomach irritation. Patient's breathing and symptoms improved with these medications. Patient was sent home with prescriptions for epi-pens  Patient went on to successfully receive 3 Pfizer doses following this.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Eczema, Exposure during pregnancy, Rash, Tinea infection
Clinical narrative: I was approximately 4 months pregnant and the OBGYN recommended the tdap vaccine. I stated I already had the tdap vaccine 5 years prior and she recommended it further so I got the shot.  Approximately 2 weeks later I got a ringworm eczema rash on my hand. When it didn't respond to ringworm treatment I went to my general doctor and he diagnosed me with eczema. I have never had eczema prior. I've lived with consistent eczema flares ever since. I have present day annual checkups that document my eczema and I have a standing prescription medication for.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Echocardiogram, Electrocardiogram, Immediate post-injection reaction, Magnetic resonance imaging heart
Clinical narrative: Got very sick immediately and never recovered. Ended up in hospital in Feb/22 with pericardial effusion. Developed chronic pericarditis leading to pericardectomy on 9/14/22.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pericardial effusion, Pericardial excision, Pericarditis
Clinical narrative: Got very sick immediately and never recovered. Ended up in hospital in Feb/22 with pericardial effusion. Developed chronic pericarditis leading to pericardectomy on 9/14/22.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Shoulder injury related to vaccine administration
Clinical narrative: Patient experienced pain in shoulder approximately 2 days after receiving vaccine.  When symptoms did not improve he sought medical care.  His orthopedist believes his shoulder pain may be a result of his vaccine administration. Possible SIRVA, shoulder injury related to vaccine administration, is suspected.
Age: 35.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Priorix was given intramuscularly, instead of subcutaneously. No adverse effects have been reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation decreased
Clinical narrative: Within 4 days eyes became very dry difficult to produce tears
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site warmth, Lymphadenopathy
Clinical narrative: Huge red mark on left shoulder, Swollen lymph node right side breast area, Fatigue, Site was red and hot to the touch
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Cardiac failure, Cardiomegaly, Catheterisation cardiac normal
Clinical narrative: Developed chest pain 7 days after 2nd shot followed by shortness of breath. Dentist visit determined that I had irregular and rapid heartbeat during visit. Followed up with family MD who recommended Cardiology and Nephrology follow up. Was determined to have enlarged heart with Heart Failure. Also determined that I had Kidney damage with Stage 3 failure.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chronic kidney disease, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: Developed chest pain 7 days after 2nd shot followed by shortness of breath. Dentist visit determined that I had irregular and rapid heartbeat during visit. Followed up with family MD who recommended Cardiology and Nephrology follow up. Was determined to have enlarged heart with Heart Failure. Also determined that I had Kidney damage with Stage 3 failure.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electrocardiogram ambulatory abnormal, Full blood count, Heart rate increased, Heart rate irregular
Clinical narrative: Developed chest pain 7 days after 2nd shot followed by shortness of breath. Dentist visit determined that I had irregular and rapid heartbeat during visit. Followed up with family MD who recommended Cardiology and Nephrology follow up. Was determined to have enlarged heart with Heart Failure. Also determined that I had Kidney damage with Stage 3 failure.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test abnormal, Urine analysis, Ventricular extrasystoles, Ventricular tachycardia
Clinical narrative: Developed chest pain 7 days after 2nd shot followed by shortness of breath. Dentist visit determined that I had irregular and rapid heartbeat during visit. Followed up with family MD who recommended Cardiology and Nephrology follow up. Was determined to have enlarged heart with Heart Failure. Also determined that I had Kidney damage with Stage 3 failure.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache, Influenza virus test negative, Nausea
Clinical narrative: FEVER, HEADACHE, NAUSEA, CHILLS, FATIGUE
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: FEVER, HEADACHE, NAUSEA, CHILLS, FATIGUE
Age: 68.0
Sex: M
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: Patient reported to the pharmacy with a mild rash on right lower arm 2 hours after receiving vaccine.  He had no other symptoms.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Pain at time of injection; soreness and itching for 7 days at injection site; redness and raised welts at injection site started 5 days after injection and lasted 2 additional days
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQC.; HCP reported that improperly stored GARDASIL 9 was administered. No symptoms. Precautionary AE as temperature excursion was within the temperature excursion guidelines in the prescribing information for GARDASIL 9.; This spontaneous report has been received from a physician assistant (reported as medical assistant) (R.T), regarding a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported.  On 23-May-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9) injection, 0.5 mL, administered as prophylaxis (Lot No. Y012508 has been verified to be a valid lot number for [human papillomavirus 9-valent vaccine, recombinant injection], expiration date  reported and upon internal validation established as 01-Jan-2027) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency was not provided) (product storage error), after a temperature excursion of 35.04 degree Fahrenheit (F) during a time frame of 2 hours and 14 minutes. No previous temperature excursion was reported.  No additional information or adverse events or PQC were provided (no adverse event).
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: possible incomplete dose administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in unspecified number of patients who received Men B NVS (Bexsero) (batch number 77KA5, expiry date 30-NOV-2027) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete dose administered (Verbatim: possible incomplete dose administration). The outcome of the incomplete dose administered was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-MAY-2025 The Vaccine Administration Facility is the same as Primary Reporter A registered nurse asked if she could give a lot number of Bexsero to avoid receiving it in a future order given that she had issues trying to expel the air bubble, like losing a significant amount of the vaccine fluid. The reporter mentioned that, approximately 10 patients receive it after trying to expel the bubble between April and May 2025 which led to incomplete dose administered.  The adverse event details were taken but she had no data of exactly which patients received it.
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received vaccine that was stored at -0, with no reported adverse event; Initial information received on 23-May-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age and  gender patient who was administered with meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi]  that was stored at -0 temperature with no reported adverse event.  On an unknown date, the patient received an unknown dose of suspect meningococcal a-c-y-w135 (t conj) vaccine, Solution for injection, lot U8124AA,expiry date:30-Sep-2027, strength not reported via unknown route in unknown administration site for immunization post excursion with temperature -0, with no reported adverse event (poor quality product administered).  Reportedly, product was administered post-excursion.  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.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Amnesia, Fall, Tearfulness
Clinical narrative: After 2nd vaccine, patient was falling down from standing position.  Patient was place on the chair.  Patient is alert, doesn't remember what happened with tears.  Provided tissue and water.  Vital sign is with in normal limit.  Instructed patient to remain in waiting are for 15 minutes.
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse side effects were reported. No additional information available; Indicate at which point in the process the medication error occurred: Dispensing; HCP calling to report an MMR II vaccine was administered to a patient today 5/12/2025 and expired 5/8/2025; This spontaneous report was received from a nurse and refers to a 67-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 12-MAY-2025, the patient was vaccinated with an expired dose of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), injection, lot #X013192; which has been verified to be valid for measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live, expiration date reported and upon internal validation establish as 08-MAY-2025 administered for prophylaxis (strength, exact quantity volume, route and anatomical site of administration were not provided) (Expired product administered). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), expiration date reported as 10-NOV-2025) (lot # was not reported) No adverse side effects were reported. No additional information available (No adverse event).  Follow-up information has been received from a nurse on 19-MAY-2025. The vaccine was administered intramuscularly (IM) in right deltoid (RD) by a registered nurse, at a clinic. The nurse did not realize the vaccine was expired. After vaccination, the nurse immediately spoke with state VCF program coordinator who advised to call the manufacturer. The manufacturer stated that vaccination still counted as a dose and there was no recommendation to re-vaccinate. The nurse was re-educated where expiration dates can be found on box and vaccine to ensure this would not happen again. The clinic had a safety feature on their computer to notify when vaccine expires and placed vaccine expiration dates on the outside of each box. It was reported that the medication error occurred at dispensing (Product dispensing error) and administration.
Vaccine: MEN
Symptoms: Platelet count decreased, Platelet transfusion
Clinical narrative: (plates tanked to zero after the Meningitis B shot).; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of platelet count decreased in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   The patient's past medical history included post herpetic neuralgia and hemoglobin decreased. Previously administered products included Soliris.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, an unknown time after receiving Meningococcal B vaccine, the patient experienced platelet count decreased (Verbatim: (plates tanked to zero after the Meningitis B shot).). The outcome of the platelet count decreased was not reported.   It was unknown if the reporter considered the platelet count decreased to be related to Meningococcal B vaccine.     It was unknown if the company considered the platelet count decreased to be related to Meningococcal B vaccine.   Additional Information: GSK Receipt ate:21-MAY-2025 The reporter was a patient with PNH.  The reporter had hemoglobin counts of less than 5 a few times and dozens of blood transfusions, tried Soliris and Ultamiris, was injured by the vaccine required to take those treatments (plates tanked to zero after the Meningitis B shot). The patient then received platelet.
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Product prescribing error
Clinical narrative: Stem cell transplant after Shingrix series; Extra series prescribed; This serious case was reported by a pharmacist via call center representative and described the occurrence of stem cell transplant in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix and the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced stem cell transplant (Verbatim: Stem cell transplant after Shingrix series) (serious criteria clinically significant/intervention required) and drug schedule prescribing error (Verbatim: Extra series prescribed). The outcome of the stem cell transplant was unknown and the outcome of the drug schedule prescribing error was not applicable.   It was unknown if the reporter considered the stem cell transplant to be related to Shingrix.     The company considered the stem cell transplant to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 20-MAY-2025 The pharmacist explained that an adult patient had received two doses of Shingrix in 2019 (specific dates were unknown).  Since the patient had undergone a stem cell transplant, their healthcare provider had recommended administering another series of Shingrix, which led to Drug schedule prescribing error.; Sender's Comments: Stem cell transplant is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 11.0
Sex: F
Vaccine: COVID19, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swollen itching - hard area underneath injection site  Rt arm - reaction  Swelling, warm & tender to touch started on Friday 5-16-25
Age: 11.0
Sex: F
Vaccine: COVID19, HPV9, MNQ, TDAP
Symptoms: Ultrasound scan normal, X-ray normal
Clinical narrative: Redness, swollen itching - hard area underneath injection site  Rt arm - reaction  Swelling, warm & tender to touch started on Friday 5-16-25
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Immunoglobulin therapy, Insomnia, Lumbar puncture, Magnetic resonance imaging, Meningoencephalitis viral
Clinical narrative: Day after Vaccines, had seizure. IVIG and steroids administered following week. Experience psychosis with insomnia. Viral meningoencephalitis but cause still unknown to date. Months later beginning 2/2025 developed movement disorder and speech impediment.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Movement disorder, Psychotic disorder, Seizure, Sleep study, Speech disorder
Clinical narrative: Day after Vaccines, had seizure. IVIG and steroids administered following week. Experience psychosis with insomnia. Viral meningoencephalitis but cause still unknown to date. Months later beginning 2/2025 developed movement disorder and speech impediment.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received an email notification from patient's father stating that the school reported that the above vaccinations were due. Immunizations given to patient. No side effects were noted after the vaccination. After patient left, I recorded the vaccination information and noticed that these vaccinations were given in a different facility on 2/14/25. My collaborative physician was notified; patient's father was notified. No adverse side effects noted.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eosinophil count increased, Joint swelling, Night sweats, Oedema peripheral, Pain
Clinical narrative: Within two weeks fingers would swell after a couple hours of sleep - would go away in morning.  Progressed to completely swollen at all times.  Fingers turned purple/red.  Bottom of feet and lower legs throbbing/tingling/painful.  Night sweats. Weird colors in lower legs.  Edema  Back of hands purplelish  Eosiphinals were tripled.  After about 4-6 month eosiphinals returned to normal and bumps came up on lower wrist followed by joint swelling in hands and feet
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Rheumatoid arthritis, Skin discolouration
Clinical narrative: Within two weeks fingers would swell after a couple hours of sleep - would go away in morning.  Progressed to completely swollen at all times.  Fingers turned purple/red.  Bottom of feet and lower legs throbbing/tingling/painful.  Night sweats. Weird colors in lower legs.  Edema  Back of hands purplelish  Eosiphinals were tripled.  After about 4-6 month eosiphinals returned to normal and bumps came up on lower wrist followed by joint swelling in hands and feet
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received an email notification from patient's father stating that the school is requiring patient to have the above vaccinations. Patient came to the office with grandparents. Vaccinations given. Patient tolerated well. Patient had no adverse events. Patient left. Documentation completed. Once information was entered, I identified that patient had received the same immunizations on 2/14/25 at another facility. Father, was notified via email and phone conversation.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Patient came in stating her arm is still sore to the tough in that area.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Endocrine pancreatic disorder, Faecal elastase test
Clinical narrative: Exocrine pancreatic insufficiency
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Mobility decreased, Nausea, Pain
Clinical narrative: Patient sent mychart message " I have been ill for 2 days with severe headache, pains and difficulty getting up. I had a fever of over 102 and nausea. It?s the 23rd of May and I?m still sweating through my shirts."
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient sent mychart message " I have been ill for 2 days with severe headache, pains and difficulty getting up. I had a fever of over 102 and nausea. It?s the 23rd of May and I?m still sweating through my shirts."
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Emotional distress, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: I had terrible shoulder and arm pain for over two weeks and still, ongoing. I could not move my arms and experienced difficulty sleeping and mental stress due to the horrible pain.
Age: 66.0
Sex: M
Vaccine: COVID19, PNC20
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PT STATED THAT HE LOST RANGE OF MOTION AND WAS IN A LOT OF PAIN IN HIS RIGHT ARM. HE STATED THAT HE DID NOT SEE THE DOCTOR ABOUT THIS PROBLEM.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: No adverse event reported