chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 60-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). The patient had Covid maybe 3 or 4 years ago from time of the report. Patient got it pretty soon after it all hit. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient had Covid 3 or 4 years ago and the patient recovered very quickly but this one, this version of Covid was not fun, it was awful. The patient stated that he had 3 total injections, the Covid injection, the original one and 2 boosters (as reported), all Pfizer.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 65-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (PRIMARY IMMUNIZATION SERIES COMPLETED), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN, BOOSTER, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 77.0
Vaccine: COVID19
Symptoms: COVID-19, Cataract, Drug ineffective
Clinical narrative: Cataracts; COVID-19; COVID-19; This is a spontaneous report received from a consumer, Program ID.  A 77-year-old patient received BNT162b2 Omicron (KP.2) (COMIRNATY (2024-2025 FORMULA)), in Aug2024 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for COVID-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Sep2024, outcome "unknown" and all described as "COVID-19"; CATARACT (medically significant), outcome "unknown", described as "Cataracts". The event "covid-19" required physician office visit. The patient was trying to get some nirmatrelvir/ ritonavir (PAXLOVID) as the patient was just diagnosed with COVID-19 for the second time and the patient was trying to get the pills so the patient could take them to get rid of this thing. The patient went to urgent care that morning (23Sep2024). The patient commented that this is miserable. It's the second time and the patient just had a Pfizer booster shot a month ago (Aug2024). And the patient got this thing (COVID-19) the other day (21Sep2024), but didn't know how. The patient also has cataracts. That's the next thing the patient was taking care of as the patient was becoming old.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: they gave patient their dose of menquadfi and when pressing they thought that the expiration date was 30 mar2025 but it was 04mar2025 with no reported adverse event; Initial information received on 13-Mar-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 16 year old female patient who received Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] and when pressing they thought that the expiration date was 30-Mar-2025 but it was 04 Mar-2025 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 13-Mar-2025, the patient received a 0.5ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection standard strength, frequency-once, (lot U7594AA) (expiry date-04-Mar-2025) via intramuscular route in the left deltoid for Immunization and when pressing they thought that the expiration date was 30-Mar-2025 but it was 04 Mar-2025 with no reported adverse event (expired product administered).  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: 0.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: administered the act-hib component of pentacel with a sterile water diluent from mmr instead of the dtap-ipv liquid component with no reported adverse event; Initial information received on 13-Mar-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 5 months old female patient who was administered with act-hib component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with a sterile water diluent from MMR (measles mumps rubella) instead of the Dtap-IPV liquid component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) and Rotavirus vaccine live oral 1v (Rotarix) for Immunisation.  On 11-Feb-2025, the patient received 0.5mL (dose 2) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) vaccine (lot 1973310, expiry date 07-Sep-2026, strength standard and formulation unknown) via intramuscular route in the right thigh for Immunisation and administered with act-hib component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with a sterile water diluent from MMR (measles mumps rubella) instead of the Dtap-IPV liquid component with no reported adverse event (product preparation error).  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: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: possible administration of YF-VAX that was incorrectly reconstituted with sterile water instead of the saline diluent that it comes with, with no reported adverse event; Initial information received on 13-Mar-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was administered with yellow fever vaccine - [YF-Vax] which was incorrectly reconstituted with sterile water instead of the saline diluent that comes with vaccine, 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 in Mar-2025, the patient received an unknown dose of suspect Yellow Fever Vaccine - Solution for injection, Unknown strength and lot UK133AB with expiry date 31-Oct-2025 via unknown route in unknown administration site for Immunization, which was possibly incorrectly reconstituted with sterile water instead of the saline diluent that comes with vaccine, with no reported adverse event (product preparation issue) (latency same days).  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.
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on his wrists 10 days after taking Flucelvax; Allergic reaction 10 days after taking Flucelvax; Sore; This spontaneous case from United States, initially received on 07-Mar-2025, was reported by a non health professional and concerns an child male patient.  Medical History: No. Patient's mom mentioned that he never had a adverse reaction or allergic reaction to a vaccine before.  Concomitant medications reported as no.  Administration of company suspect drug: On 25-Feb-2025, the patient received Flucelvax (TIV) for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine, Dose regimen: 0.5 ml, Route of administration: Unknown, Lot number: No batch number available and would be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 07-Mar-2025, the patient experienced hives on his wrists 10 days after taking Flucelvax (outcome: not recovered / not resolved), allergic reaction 10 days after taking Flucelvax (outcome: not recovered / not resolved), sore (outcome: not recovered / not resolved).  Consumer inquired that her son had an allergic reaction 10 days after taking Flucelvax, he started to sore, presented some hives on his wrists. But he never had an allergic reaction specially related to the skin. She wants to know if we ever had any report such as hers, any adverse reaction report related to skin.  Flucelvax (TIV) action taken: Not Applicable  Treatment measures associated with event: Patient's mom reported that she took him to a doctor and his on medication for the allergy reaction.  Reporter assessment: The reporter considered events hives on his wrists 10 days after taking Flucelvax, allergic reaction 10 days after taking Flucelvax and sore and causality was not reported.; Reporter's Comments: The causality of events were related to the administration of the product Flucelvax (TIV)
Vaccine: UNK
Symptoms: Pneumococcal infection, Vaccination failure
Clinical narrative: the limited protection of PPSV23 against mucosal disease could have made the patient susceptible to the development of IPD; This literature marketed report as received from the authors of a published literature article, and refers to a 66-year-old patient of unknown gender. The patient had a history of tobacco smoking, chronic obstructive pulmonary disease, and poorly controlled diabetes. On an unknown date in 2019 (reported as 3 years prior), the patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). It was reported, the patient had presence of multiple comorbidities and the limited protection of PPSV23 against mucosal disease could have made the patient development of invasive pneumococcal disease (IPD) (Vaccination failure). The event vaccination failure was considered to be related to pneumococcal Vaccine, Polyvalent (23-valent).
Age: 0.5
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: liquid portion of Menveo was administered; liquid portion of Menveo was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 6-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVBO44A, expiry date 31-JUL-2025) for prophylaxis.   Concurrent medical conditions included sickle cell disease.   On 07-MAR-2025, the patient received Menveo. On 07-MAR-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: liquid portion of Menveo was administered) and inappropriate dose of vaccine administered (Verbatim: liquid portion of Menveo was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 11-MAR-2025 The nurse called to report that a patient received only the liquid portion of Menveo vaccine, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient was getting this vaccine because they have a high-risk medical condition. The vaccine administration facility was the same as primary reporter.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain, Pain in extremity, Vomiting
Clinical narrative: developed sore arm, body aches, fatigue and nausea and vomtting, morning after vaccine
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Injected limb mobility decreased
Clinical narrative: pain and limited ROM in the vaccinated upper arm, that has lasted 1 month after vaccination, though is starting to resolve (reduced pain, full ROM in the last few days)
Age: 77.0
Sex: M
Vaccine: PNC21, RSV, VARZOS
Symptoms: Breast discomfort, Breast swelling, Ultrasound scan
Clinical narrative: On day 12 after receiving the vaccine, the patient's right breast became swollen and uncomfortable.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: The patient called 3/18/25 reported she has been experiencing tingling and numbness in her legs and face since she received the vaccination. She has been treated in the past for the symptoms thinking they were caused by something else .  She asked about other symptoms of the RSV vaccination can cause and said she is experiencing them . She still presently is experiencing the tingling and numbness.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Confusional state, Contusion, Erythema, Swelling face
Clinical narrative: She received the vaccine 3/7 and felt fine went to bed and woke up the next day 4 pm with a swollen face and bruising and some confusion
Age: 72.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Limb discomfort, Tremor
Clinical narrative: By 10:30 pm, I experienced an uncontrollable, heavy, and severe shaking of my both arms, it lasted for a minute.  By 2 o'clock in the morning, it happened again.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: About 10 days after the "booster shot," I developed diarrhea.  At first, I had to go to the toilet 4 times a day. Within three days, I needed to go about 10 times to the toilet!  Many times, I was not able to reach the toilet in time.  I contacted my Doctor's office and purchased Diarrhea Medication, but nothing could stop the diarrhea!  It was a life-changing experience.  I stayed in Bed because my toilet was close by.  Even then, I could not make it to the toilet in time!  The diarrhea lasted about ONE YEAR and a HALF!
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Product administered at inappropriate site
Clinical narrative: Prescriber called pharmacy to report incorrect vaccination administration site for patient, adverse site reaction, and to requesting follow up training for vaccine administrator.  Reported injection site looked like it was over the radial nerve of the arm, halfway down arm, vs on deltoid.  Said does not look infection but site is erythematous.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Axillary pain, Computerised tomogram head, Computerised tomogram thorax, Electrocardiogram
Clinical narrative: Diagnosed as Brachial Neuritis/ Neuralgic Amyotrophy.  Symptoms: severe pain in left armpit, left shoulder blade, left arm, left wrist, weakness of left arm, left hand and fingers, numbness in fingers 4 and 5. Symptoms lasting for 2months (2 flares 5 weeks apart), then decreasing in severity to mild weakness and low grade pain over 2 more months. Treatment was tapered prednisone during the 2 flares (from 60mg/day to 0.5mg/day); gabapentin 900mg/day, tapered to 300mg/day across 4 months; tylenol 2g/day during the first 2 months; ibuprofen, vitamin B12, occupational therapy, physical therapy. Mild weakness in left hand and fingers persist after 4 months.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Hypoaesthesia, Magnetic resonance imaging head, Muscular weakness, Musculoskeletal pain
Clinical narrative: Diagnosed as Brachial Neuritis/ Neuralgic Amyotrophy.  Symptoms: severe pain in left armpit, left shoulder blade, left arm, left wrist, weakness of left arm, left hand and fingers, numbness in fingers 4 and 5. Symptoms lasting for 2months (2 flares 5 weeks apart), then decreasing in severity to mild weakness and low grade pain over 2 more months. Treatment was tapered prednisone during the 2 flares (from 60mg/day to 0.5mg/day); gabapentin 900mg/day, tapered to 300mg/day across 4 months; tylenol 2g/day during the first 2 months; ibuprofen, vitamin B12, occupational therapy, physical therapy. Mild weakness in left hand and fingers persist after 4 months.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgic amyotrophy, Pain in extremity, Radiculitis brachial, Scan with contrast, Ultrasound scan
Clinical narrative: Diagnosed as Brachial Neuritis/ Neuralgic Amyotrophy.  Symptoms: severe pain in left armpit, left shoulder blade, left arm, left wrist, weakness of left arm, left hand and fingers, numbness in fingers 4 and 5. Symptoms lasting for 2months (2 flares 5 weeks apart), then decreasing in severity to mild weakness and low grade pain over 2 more months. Treatment was tapered prednisone during the 2 flares (from 60mg/day to 0.5mg/day); gabapentin 900mg/day, tapered to 300mg/day across 4 months; tylenol 2g/day during the first 2 months; ibuprofen, vitamin B12, occupational therapy, physical therapy. Mild weakness in left hand and fingers persist after 4 months.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Computerised tomogram normal, Dysphemia, Electroencephalogram normal, Laboratory test normal
Clinical narrative: Symptoms started 11/2021 with a stutter. Within a week and a half he was having involuntary muscle contractions of the left arm, his neck and head. April2024 he started having seizure like episodes and periods of paralysis.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Muscle contractions involuntary, Paralysis, Seizure like phenomena
Clinical narrative: Symptoms started 11/2021 with a stutter. Within a week and a half he was having involuntary muscle contractions of the left arm, his neck and head. April2024 he started having seizure like episodes and periods of paralysis.
Age: 4.0
Sex: M
Vaccine: MMR, MMR, VARCEL, VARCEL, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: pain in his left upper arm; Vaccination site redness; Vaccination site bruising; This spontaneous report was received from the patient's father and refers to a 4-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 28-Feb-2025, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), dose number 1, (route of administration, dose, lot # and expiration date were not reported) and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), dose number 1, (dose, route of administration, lot # and expiration date were not reported) both for routine vaccination.  On 06-Mar-2025, the patient experienced pain if his left upper arm and did not want his mother to touch the area and she noticed there was a reddened area like a giant rosette in the middle with an extra red ring around the edges that measured about the size of a silver dollar (vaccination site redness, vaccination site bruising and vaccination site pain). His mother gave him Tylenol for the pain, and he went to bed.  At the reporting time, the patient was recovering from the events.   The causal relationship between the events and the vaccines was not provided,; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02766106-02766101 , CLIC number : , ESTAR number : , IRMS number : 500UW00000VUGFFYA5|07032025230011|7667 , Central date : 2025-03-09 , Classification : DMC, Attachment description : NSC Call , Safety case number : , MNSC case number : 02766106 , MNSC interaction number : 02766101 , Integration log UniqueID : 500UW00000VUGFFYA5|07032025230011|7667 , Service cloud CaseID : 500UW00000VUGFFYA5
Age: 4.0
Sex: M
Vaccine: MMR, MMR, VARCEL, VARCEL, MMR, VARCEL
Symptoms: Injection site erythema, Vaccination site bruising, Vaccination site pain
Clinical narrative: pain in his left upper arm; Vaccination site redness; Vaccination site bruising; This spontaneous report was received from the patient's father and refers to a 4-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 28-Feb-2025, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), dose number 1, (route of administration, dose, lot # and expiration date were not reported) and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), dose number 1, (dose, route of administration, lot # and expiration date were not reported) both for routine vaccination.  On 06-Mar-2025, the patient experienced pain if his left upper arm and did not want his mother to touch the area and she noticed there was a reddened area like a giant rosette in the middle with an extra red ring around the edges that measured about the size of a silver dollar (vaccination site redness, vaccination site bruising and vaccination site pain). His mother gave him Tylenol for the pain, and he went to bed.  At the reporting time, the patient was recovering from the events.   The causal relationship between the events and the vaccines was not provided,; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02766106-02766101 , CLIC number : , ESTAR number : , IRMS number : 500UW00000VUGFFYA5|07032025230011|7667 , Central date : 2025-03-09 , Classification : DMC, Attachment description : NSC Call , Safety case number : , MNSC case number : 02766106 , MNSC interaction number : 02766101 , Integration log UniqueID : 500UW00000VUGFFYA5|07032025230011|7667 , Service cloud CaseID : 500UW00000VUGFFYA5
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Nurse called to return a call from someone from Merck asking more information about a patient's AE with GARDASIL 9.  She did not have a case number.  During the call, the call was dropped.  Call back attempted and left a message with a receptionist; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), Injection for prophylaxis (exact dose, dose number, route and site of administration, lot # and expiration date were not reported).  On unknown date the patient experienced unspecified adverse event (reported as "nurse called to return a call from someone, asking more information about a patient's AE"). The outcome of adverse event was unknown. The causality between adverse event and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19, FLU3, PNC20, RSV, COVID19, FLU3, PNC20, RSV
Symptoms: Dysgraphia, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Patient reported to Dr. on 3/19/2025, that she has continued numbness and weakness in right arm since onset several weeks after these injections.
Age: 76.0
Sex: F
Vaccine: COVID19, FLU3, PNC20, RSV, COVID19, FLU3, PNC20, RSV
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Patient reported to Dr. on 3/19/2025, that she has continued numbness and weakness in right arm since onset several weeks after these injections.
Sex: F
Vaccine: PNC21
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: had some swelling at the injection site immediately after the injection.; had redness and swelling of the arm and it had "migrated down the arm towards the elbow"; had redness and swelling of the arm and it had "migrated down the arm towards the elbow"; arm was slightly warm to the touch; This spontaneous report was received from a pharmacist via Company representative concerning to a female patient of unspecified age.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.   On approximately 17-FEB-2025 (reported as "approximately 2 weeks ago"), the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection pre-filled syringe, 1 dosage form (dosage regimen, lot #, route of administration and expiration date were not reported) administered in an unspecified arm as prophylaxis.   On the same date, immediately after the injection, the patient had some swelling at the injection site (vaccination site swelling). Pharmacist reported the patient then came back a week later and since an unspecified date in February 2005, she still had redness (vaccination site erythema) and swelling of the arm, and it had "migrated down the arm towards the elbow" (extensive swelling of vaccinated limb). Pharmacist stated arm was slightly warm to the touch (vaccination site warmth), but she did not think it was an infection, so she gave the patient some diphenhydramine (BENADRYL), and told her to ice the swelling and keep an eye on it.   At the reporting time, the outcome of the events was not known, as pharmacist had reached out to the patient a couple of times since, but had not been able to get a hold of them to check in. No additional information was available.   The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.  Lot # is being requested and will be submitted if received.
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Expired vaccine used; This spontaneous report has been received from a consumer regarding a 28-year-old patient of unknown gender. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On 04-MAR-2025, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis, 0.5 milliliters, lot number W026152 which has been verified to be valid, expiration date reported and validated as 21-JAN-2025. (strength, dose, scheme, route of administration, anatomical site not reported) (expired vaccine used). No temperature excursion occurred. No symptoms reported.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I now get shingles 4 or more times a year.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I now get shingles 4 or more times a year.). 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 and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2025 This case was reported by a patient via interactive digital media. The patient received Shingles vaccine and now get shingles four or more times a year.  The reporter said that have a blessed weekend. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case is linked with US2025AMR032002, reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR032002:same reporter different patient
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, COVID-19, Depression, Inflammation, Migraine
Clinical narrative: nerve issue; migraine; inflammation in head and down in leg and tail bone and; got covid after 6 month of vaccination; arthritis changes from sever to mild; muscle cramps; muscle tight; muscle weak in joint; depression got bad; This spontaneous report received from a patient concerned a male patient in their 50's. The patient's height and weight were not reported. Age at time of vaccination 52 year old.  The patient's past medical history included: iv user, and concurrent conditions included: heart murmur and depression, and other pre-existing medical conditions included: weight; 230 (units unspecified).  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose and frequency not reported, administered on Jun-2021, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced nerve issue, migraine, inflammation in head and down in leg and tail bone and, got covid after 6 month of vaccination, arthritis changes from sever to mild, muscle cramps, muscle tight, muscle weak in joint, and depression got bad. (Dose Series -1) Treatment medications included: prednisone for weird feels that something is their in my system.  Patient had a rare reaction from covid vaccine, headache and rare achy pain, continuous headache, flashed light , migraine, inflammation in head and down in leg and tail bone, got covid after 6 month of vaccination. Consumer stated that his immune system was strong and did not need vaccine. Consumer said his reaction was headache which never went away, it was horrible for 2 days and better after 2 days but never went away, nerve issue. Consumer said he is 230 weight now and in diet, do exercises, arthritis changes from sever to mild, inflammatory nerve condition in tail bone, coccyx block his legs, muscle cramps, muscle tight, muscle weak in joint. Consumer said that he had a heart murmur and former IV user, had depression and due to headache depression got bad. Consumer stated patient have weird feels that something is their in my system, and tried prednisone and it feels better for short period of time. The action taken with janssen covid-19 vaccine was not applicable.  The outcome of nerve issue, inflammation in head and down in leg and tail bone and, got covid after 6 month of vaccination, muscle cramps, muscle tight, muscle weak in joint and depression got bad was not reported. The patient had not recovered from migraine. The patient was recovering from arthritis changes from sever to mild.  This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle tightness, Muscular weakness, Nervous system disorder
Clinical narrative: nerve issue; migraine; inflammation in head and down in leg and tail bone and; got covid after 6 month of vaccination; arthritis changes from sever to mild; muscle cramps; muscle tight; muscle weak in joint; depression got bad; This spontaneous report received from a patient concerned a male patient in their 50's. The patient's height and weight were not reported. Age at time of vaccination 52 year old.  The patient's past medical history included: iv user, and concurrent conditions included: heart murmur and depression, and other pre-existing medical conditions included: weight; 230 (units unspecified).  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose and frequency not reported, administered on Jun-2021, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced nerve issue, migraine, inflammation in head and down in leg and tail bone and, got covid after 6 month of vaccination, arthritis changes from sever to mild, muscle cramps, muscle tight, muscle weak in joint, and depression got bad. (Dose Series -1) Treatment medications included: prednisone for weird feels that something is their in my system.  Patient had a rare reaction from covid vaccine, headache and rare achy pain, continuous headache, flashed light , migraine, inflammation in head and down in leg and tail bone, got covid after 6 month of vaccination. Consumer stated that his immune system was strong and did not need vaccine. Consumer said his reaction was headache which never went away, it was horrible for 2 days and better after 2 days but never went away, nerve issue. Consumer said he is 230 weight now and in diet, do exercises, arthritis changes from sever to mild, inflammatory nerve condition in tail bone, coccyx block his legs, muscle cramps, muscle tight, muscle weak in joint. Consumer said that he had a heart murmur and former IV user, had depression and due to headache depression got bad. Consumer stated patient have weird feels that something is their in my system, and tried prednisone and it feels better for short period of time. The action taken with janssen covid-19 vaccine was not applicable.  The outcome of nerve issue, inflammation in head and down in leg and tail bone and, got covid after 6 month of vaccination, muscle cramps, muscle tight, muscle weak in joint and depression got bad was not reported. The patient had not recovered from migraine. The patient was recovering from arthritis changes from sever to mild.  This report was non-serious.
Vaccine: RSV
Symptoms: Expired product administered
Clinical narrative: The product expired on 24 FEB 2025 and was administered on 7 MAR 2025; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received RSVPreF3 adjuvanted (Arexvy) (expiry date 24-FEB-2025) for prophylaxis.   On 07-MAR-2025, the patient received Arexvy. On 07-MAR-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: The product expired on 24 FEB 2025 and was administered on 7 MAR 2025). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 10-MAR-2025 The reporter was physician who stated that a patient accidentally received an expired dose of Arexvy. The product expired on 24th February 2025 and was administered on 07th  March 2025 which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Injection site swelling, Malaise, Rash, Urticaria
Clinical narrative: Swelling at injection site; extreme hives; rash; malaise; This serious case was reported by a pharmacist via sales rep and described the occurrence of injection site swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Swelling at injection site) (serious criteria other: Serious as per reporter), hives (Verbatim: extreme hives) (serious criteria other: Serious as per reporter), rash (Verbatim: rash) (serious criteria other: Serious as per reporter) and malaise (Verbatim: malaise) (serious criteria other: Serious as per reporter). The outcome of the injection site swelling, hives, rash and malaise were unknown.   The reporter considered the injection site swelling, hives, rash and malaise to be related to Shingrix.     The company considered the injection site swelling, hives, rash and malaise to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 13-MAR-2025  The pharmacist reported that one of their employees of the pharmacy (patient) was around 55 years old who experienced an extreme reaction to the first dose of vaccine.  The patient missed multiple days of work and had to go to urgent care.; Sender's Comments: Injection site swelling, Urticaria, Rash and Malaise are listed events which, due to the following criteria (insufficient information on medical history, concurrent conditions, concomitant medications and time to onset) are considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site induration, Injection site swelling
Clinical narrative: severe localized reaction of the injection site that had a large area of swelling that hardened; severe localized reaction of the injection site that had a large area of swelling that hardened; impacted the pigmentation of that area of the patient's arm; adult approximately 45 years of age received Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site swelling in a adult male 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 injection site swelling (Verbatim: severe localized reaction of the injection site that had a large area of swelling that hardened), injection site induration (Verbatim: severe localized reaction of the injection site that had a large area of swelling that hardened), injection site pigmentation changes (Verbatim: impacted the pigmentation of that area of the patient's arm) and inappropriate age at vaccine administration (Verbatim: adult approximately 45 years of age received Shingrix). The outcome of the injection site swelling, injection site induration and injection site pigmentation changes were resolved and the outcome of the inappropriate age at vaccine administration was not applicable.   It was unknown if the reporter considered the injection site swelling, injection site induration and injection site pigmentation changes to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site induration and injection site pigmentation changes to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-MAR-2025 An adult approximately 45 years of age patient had been vaccinated with Shingrix dose 1 which led to inappropriate age at vaccine administration. The patient indicated that he had a severe localized reaction of the injection site that had a large area of swelling that hardened and the swelling was so significant if impacted the pigmentation of that area of the patient's arm. It was unknown if this was dose 1 or dose 2 of Shingrix. If it was dose 1 then it was unknown if patient returned for dose 2. The patient had now recovered.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; TE for VARIVAX that occurred on 02/24/2025 and the vaccine was also  inadvertently administered on 02/26/2025; This spontaneous report was received from a health professional and refers to a 16-year-old male patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 24-FEB-2025, a temperature excursion (TE) for Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) occurred (-11.4C for 1 hour 0 minutes 0 seconds). On 26-Feb-2025, the patient was inadvertently vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) 0.5mL / once (lot #Y013350, expiration date: 02-Aug-2026), administered for prophylaxis. The vaccine was reconstituted with sterile diluent, solution for injection (product storage error). The patient did not experience any adverse issues or side effects related to the administration of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (no adverse event). No prior excursions were noted. No product quality complaint (PQC) was noted.; Reporter's Comments:
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Immunoglobulin therapy, Therapy non-responder
Clinical narrative: His response to pneumococcal polysaccharide vaccine was minimal; This literature marketed report has been received from the authors of a published literature article, and refers to a male patient of unknown age with recurrent sinus infections, pneumonia throughout childhood with chronic diarrhea, positive tissue transglutaminase IgA, and endoscopy with small bowel enteropathy leading to a diagnosis of celiac disease. Owing to recurrent infections, immunodeficiency evaluation at age 15 years revealed mildly low IgG level with normal IgA and elevated IgM levels. The patient had a pathogenic mutation in PIK3CD.  On an unknown date, the patient was vaccinated with an unspecified pneumococcal vaccine (dose, route of administration, lot # and expiration date were not provided), for prophylaxis.  His response to the suspect vaccine was minimal. The outcome of the event was not provided. He was started on immunoglobulin replacement leading to decreased infections.  The authors of the article considered minimal response to the vaccine as related to pneumococcal vaccine.  This is one of 3 reports derived from the same literature article (linked GSD #2266119 and 2266118).
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse event; Consumer called to report they received their first dose of GARDASIL 9 on 06/20/2017 and their second dose was administered 03/27/2019.; This spontaneous report was received from a physician and refers to a 16-year-old female patient.   The patient's medical history, current conditions and concomitant medications was not reported.   On 20-JUN-2017 patient was vaccinated with first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (lot # and expiration date were not reported) and the second dose on 27-MAR-2019 (inappropriate schedule of product administration).   No additional adverse event.   Lot number is being requested and will be submitted if received.
Sex: M
Vaccine: MMRV, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Side effects or symptoms reported.; HCP called to report PROQUAD and PEDVAX HIB were mixed and administered to one patient.; This spontaneous report was received from a registered nurse and refers to 19-months-old male patient   The patient's medical history, current conditions and concomitant therapies were not reported.   On 13-MAR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD), (lot #Y009982 who had been verified to be a valid lot number, expiration date reported and validated as 24-NOV-2025); and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #Y005457 who had been verified to be a valid lot number, expiration date reported and validated as 06-NOV-2026) (exact doses, anatomical routes of administration, lot number and expiration date were not reported), both vaccines administered for prophylaxis. It was reported that the vaccines were mixed and administered to patient (product preparation issue).  No additional adverse events.
Sex: F
Vaccine: HPV9
Symptoms: Papilloma viral infection
Clinical narrative: HPV infection; This spontaneous report was received from a Physician and refers to an Adult female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, at age 10 or 11, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (dose, route of administration, anatomical location, lot # and  expiration date were not reported).  On an unknown date, the patient experienced HPV infection.   At the reporting time, the outcome of HPV infection was unknown.   The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable.   The causal relationship between the event of HPV infection and Human Papillomavirus 9-valent Vaccine, Recombinant was unknown/not reported/not provided. This is one of two reports received from the same reporter (case # 2262454).;
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; HCP calling to report that patient received post expiry dose of VARIVAX. No Previous TE; This spontaneous report was received from a nurse (Licensed Practical Nurse [L.P.N.]) and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 17-Mar-2025, the patient was vaccinated with an expired dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) single dose (lot #X006981 that was verified to be valid lot # with provided end established expiration date: 07-Mar-2025) administered for prophylaxis (exact dose, dose number, anatomical location and route of administration were not provided); reconstituted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (expiration date, and lot # were not reported) (Expired product administered). No previous temperature excursion (TE) was reported. No additional adverse event (AE) was reported (no adverse event).