chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix was administered via intramuscular; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 39-year-old male patient who received MMR (Priorix) (batch number 72AB2) for prophylaxis.   On 14-MAY-2025, the patient received Priorix. On 14-MAY-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix was administered via intramuscular). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAY-2025 Nurse reported that Priorix was administered via intramuscular injection to a patient, which led to subcutaneous injection formulation administered by other route.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: she's got muscle aches, headaches, so every, everything hurts; she's got muscle aches, headaches, so every, everything hurts; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYALGIA (she's got muscle aches, headaches, so every, everything hurts) and HEADACHE (she's got muscle aches, headaches, so every, everything hurts) in a 78-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (NOS). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine (NOS).   On 07-May-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MYALGIA (she's got muscle aches, headaches, so every, everything hurts) and HEADACHE (she's got muscle aches, headaches, so every, everything hurts). At the time of the report, MYALGIA (she's got muscle aches, headaches, so every, everything hurts) and HEADACHE (she's got muscle aches, headaches, so every, everything hurts) had not resolved.      No concomitant medications were reported.  The dose was probably a 4th Moderna COVID shot pretty much every 6 or 7 months or so and she never, never had a problem.  The patient took painkillers and fell asleep.  The patient was still experiencing the symptoms. She had no fever.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Inflammation
Clinical narrative: Inflammation; Weakness; Joint pain; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation), ASTHENIA (Weakness), ARTHRALGIA (Joint pain), HEADACHE (Headache) and FATIGUE (Fatigue) in a 60-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 4 microgram. On 17-Jun-2023, the patient experienced INFLAMMATION (Inflammation), ASTHENIA (Weakness), ARTHRALGIA (Joint pain), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, INFLAMMATION (Inflammation), ASTHENIA (Weakness), ARTHRALGIA (Joint pain), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       Concomitant medication was not provided. It was unknown if the patient experienced any additional symptoms or events. Treatment information was not reported.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site swelling, Injection site warmth, Nausea, Pyrexia
Clinical narrative: Injection site swelling; nausea; vomiting; fever; erythema; hot at the injection site; This is a spontaneous report received from a Pharmacist.  A 55-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 29Apr2025 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years for immunisation. The patient's relevant medical history included: "vaccination side effect" (unspecified if ongoing), notes: Has not done well with vaccines in general; similar reaction but not as extreme.; "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 30Apr2025, outcome "unknown", described as "Injection site swelling"; ERYTHEMA (non-serious) with onset 30Apr2025, outcome "unknown"; PYREXIA (non-serious) with onset 30Apr2025, outcome "unknown", described as "fever"; VACCINATION SITE WARMTH (non-serious) with onset 30Apr2025, outcome "unknown", described as "hot at the injection site"; NAUSEA (non-serious) with onset 30Apr2025, outcome "unknown"; VOMITING (non-serious) with onset 30Apr2025, outcome "unknown". It was unknown if therapeutic measures were taken as a result of vaccination site swelling, nausea, vomiting, pyrexia, erythema, vaccination site warmth. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Vomiting
Clinical narrative: Injection site swelling; nausea; vomiting; fever; erythema; hot at the injection site; This is a spontaneous report received from a Pharmacist.  A 55-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 29Apr2025 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years for immunisation. The patient's relevant medical history included: "vaccination side effect" (unspecified if ongoing), notes: Has not done well with vaccines in general; similar reaction but not as extreme.; "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 30Apr2025, outcome "unknown", described as "Injection site swelling"; ERYTHEMA (non-serious) with onset 30Apr2025, outcome "unknown"; PYREXIA (non-serious) with onset 30Apr2025, outcome "unknown", described as "fever"; VACCINATION SITE WARMTH (non-serious) with onset 30Apr2025, outcome "unknown", described as "hot at the injection site"; NAUSEA (non-serious) with onset 30Apr2025, outcome "unknown"; VOMITING (non-serious) with onset 30Apr2025, outcome "unknown". It was unknown if therapeutic measures were taken as a result of vaccination site swelling, nausea, vomiting, pyrexia, erythema, vaccination site warmth. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Haematocrit, Haematocrit abnormal, Haemoglobin
Clinical narrative: out of range hemoglobin; out of range Hematocrit; out of range MCH/MCHC; heavy bleeding/blood loss; menstrual cycle started a few days later but did not stop; paleness; weakness; high blood pressure; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Apr2025 as dose 1, 0.1 ug/ml single (Batch/Lot number: unknown) at the age of 41 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant) with onset 15Apr2025, outcome "not recovered", described as "heavy bleeding/blood loss"; HYPERTENSION (non-serious) with onset 15Apr2025, outcome "not recovered", described as "high blood pressure"; MENSTRUATION ABNORMAL (medically significant) with onset 15Apr2025, outcome "not recovered", described as "menstrual cycle started a few days later but did not stop"; PALLOR (non-serious) with onset 15Apr2025, outcome "not recovered", described as "paleness"; ASTHENIA (non-serious) with onset 15Apr2025, outcome "not recovered", described as "weakness"; HAEMATOCRIT ABNORMAL (non-serious) with onset 29Apr2025, outcome "not recovered", described as "out of range Hematocrit"; MEAN CELL HAEMOGLOBIN CONCENTRATION ABNORMAL (non-serious) with onset 29Apr2025, outcome "not recovered", described as "out of range MCH/MCHC"; HAEMOGLOBIN ABNORMAL (non-serious) with onset 29Apr2025, outcome "not recovered", described as "out of range hemoglobin". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (29Apr2025) High; Haematocrit: (29Apr2025) out of range; Haemoglobin: (29Apr2025) out of range; Mean cell haemoglobin: (29Apr2025) out of range; Mean cell haemoglobin concentration: (29Apr2025) out of range. Therapeutic measures were taken as a result of heavy menstrual bleeding/menstrual cycle started a few days later but did not stop.  Clinical course: The shot was given on 12Apr2025. The menstrual cycle started a few days later but did not stop. On 28Apr and 30Apr patient went to urgent care and doctor. The doctor gave her progesterone birth control to stop the bleeding. Patient has been taking one a day, but period has not ended. As of 18May2025, period has continued and is heavy bleeding. Patient has many expected symptoms from blood loss paleness, weakness, high blood pressure, out of range hemoglobin, hematoctit, MCH and MCHC on 29Apr. A new test will take place soon. Event treatment included Progesterone birth control pills. Patient had no known allergies.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin abnormal, Heavy menstrual bleeding, Hypertension, Mean cell haemoglobin, Mean cell haemoglobin concentration
Clinical narrative: out of range hemoglobin; out of range Hematocrit; out of range MCH/MCHC; heavy bleeding/blood loss; menstrual cycle started a few days later but did not stop; paleness; weakness; high blood pressure; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Apr2025 as dose 1, 0.1 ug/ml single (Batch/Lot number: unknown) at the age of 41 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant) with onset 15Apr2025, outcome "not recovered", described as "heavy bleeding/blood loss"; HYPERTENSION (non-serious) with onset 15Apr2025, outcome "not recovered", described as "high blood pressure"; MENSTRUATION ABNORMAL (medically significant) with onset 15Apr2025, outcome "not recovered", described as "menstrual cycle started a few days later but did not stop"; PALLOR (non-serious) with onset 15Apr2025, outcome "not recovered", described as "paleness"; ASTHENIA (non-serious) with onset 15Apr2025, outcome "not recovered", described as "weakness"; HAEMATOCRIT ABNORMAL (non-serious) with onset 29Apr2025, outcome "not recovered", described as "out of range Hematocrit"; MEAN CELL HAEMOGLOBIN CONCENTRATION ABNORMAL (non-serious) with onset 29Apr2025, outcome "not recovered", described as "out of range MCH/MCHC"; HAEMOGLOBIN ABNORMAL (non-serious) with onset 29Apr2025, outcome "not recovered", described as "out of range hemoglobin". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (29Apr2025) High; Haematocrit: (29Apr2025) out of range; Haemoglobin: (29Apr2025) out of range; Mean cell haemoglobin: (29Apr2025) out of range; Mean cell haemoglobin concentration: (29Apr2025) out of range. Therapeutic measures were taken as a result of heavy menstrual bleeding/menstrual cycle started a few days later but did not stop.  Clinical course: The shot was given on 12Apr2025. The menstrual cycle started a few days later but did not stop. On 28Apr and 30Apr patient went to urgent care and doctor. The doctor gave her progesterone birth control to stop the bleeding. Patient has been taking one a day, but period has not ended. As of 18May2025, period has continued and is heavy bleeding. Patient has many expected symptoms from blood loss paleness, weakness, high blood pressure, out of range hemoglobin, hematoctit, MCH and MCHC on 29Apr. A new test will take place soon. Event treatment included Progesterone birth control pills. Patient had no known allergies.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell haemoglobin concentration abnormal, Menstrual disorder, Pallor
Clinical narrative: out of range hemoglobin; out of range Hematocrit; out of range MCH/MCHC; heavy bleeding/blood loss; menstrual cycle started a few days later but did not stop; paleness; weakness; high blood pressure; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Apr2025 as dose 1, 0.1 ug/ml single (Batch/Lot number: unknown) at the age of 41 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant) with onset 15Apr2025, outcome "not recovered", described as "heavy bleeding/blood loss"; HYPERTENSION (non-serious) with onset 15Apr2025, outcome "not recovered", described as "high blood pressure"; MENSTRUATION ABNORMAL (medically significant) with onset 15Apr2025, outcome "not recovered", described as "menstrual cycle started a few days later but did not stop"; PALLOR (non-serious) with onset 15Apr2025, outcome "not recovered", described as "paleness"; ASTHENIA (non-serious) with onset 15Apr2025, outcome "not recovered", described as "weakness"; HAEMATOCRIT ABNORMAL (non-serious) with onset 29Apr2025, outcome "not recovered", described as "out of range Hematocrit"; MEAN CELL HAEMOGLOBIN CONCENTRATION ABNORMAL (non-serious) with onset 29Apr2025, outcome "not recovered", described as "out of range MCH/MCHC"; HAEMOGLOBIN ABNORMAL (non-serious) with onset 29Apr2025, outcome "not recovered", described as "out of range hemoglobin". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (29Apr2025) High; Haematocrit: (29Apr2025) out of range; Haemoglobin: (29Apr2025) out of range; Mean cell haemoglobin: (29Apr2025) out of range; Mean cell haemoglobin concentration: (29Apr2025) out of range. Therapeutic measures were taken as a result of heavy menstrual bleeding/menstrual cycle started a few days later but did not stop.  Clinical course: The shot was given on 12Apr2025. The menstrual cycle started a few days later but did not stop. On 28Apr and 30Apr patient went to urgent care and doctor. The doctor gave her progesterone birth control to stop the bleeding. Patient has been taking one a day, but period has not ended. As of 18May2025, period has continued and is heavy bleeding. Patient has many expected symptoms from blood loss paleness, weakness, high blood pressure, out of range hemoglobin, hematoctit, MCH and MCHC on 29Apr. A new test will take place soon. Event treatment included Progesterone birth control pills. Patient had no known allergies.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Having arm pain from the shoulder all down to forearms; some serious pain that had been going on for at least a week; Having arm pain from the shoulder all down to forearms; some serious pain that had been going on for at least a week; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28Apr2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2025, outcome "unknown" and all described as "Having arm pain from the shoulder all down to forearms; some serious pain that had been going on for at least a week". Additional information: the patient was probably going to end up having some test run, thinking it will be at the emergency hospital but not sure.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Attention deficit hyperactivity disorder, Depression
Clinical narrative: anxiety; depression; attention deficit; This is a spontaneous report received from an Other HCP.  A 20-year-old male patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1), administration date: 08Apr2021, for COVID-19 immunization. The following information was reported: ATTENTION DEFICIT HYPERACTIVITY DISORDER (non-serious) with onset 05Apr2024, outcome "unknown", described as "attention deficit"; ANXIETY (non-serious) with onset 02May2024, outcome "unknown"; DEPRESSION (non-serious) with onset 02May2024, outcome "unknown". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500088407 Same Pt/SD, Diff Dose/AE;
Age: 0.33
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: MENVEO INADVERTANTLY DRAWN AND ADMINISTERED INSTEADOF PEDVAXHIB O PATIENT
Age: 32.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, TDAP, TYP, YF
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Client was having conversation when he suddenly put his back and passed out. RN grabbed an ice pack. 911 called. After 10 seconds client jolted awake. Client appeared pale and diaphoresis. Client on awakening was confused about where he was. Client reorientated and moved to vaccine chair where his feet were elevated and put in supine position. Client's BP taken for 99/57 HR 74 at 1346. Client provided with water. ANS was informed about situation. Client BP retaken at 1405 for 100/65. Client stated he felt better and had no sign of diaphoresis. Client had more color to his face as well. Clients in for appointment with his friend who said he will be driving client home. Client's ICV updated. Client was watched for 30 mins post incident.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Brain fog, Fatigue, Injection site reaction, Injection site swelling, Sensitive skin
Clinical narrative: The following day she developed large local swelling at injection site with extreme skin sensitivity. This was followed by severe fatigue and brain fog which have persisted and remain present until today (5/20/2025)
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Diarrhoea, Dyspnoea, Laboratory test normal
Clinical narrative: Shortness of Breath, Diarrhea, Abdominal pain, Bloating      She went to the ER and they ran a bunch of lab work but did not find anything wrong with her. She is still experiencing symptoms.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle swelling
Clinical narrative: Patient stated he had muscle swelling
Age: 0.5
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Infant irritability, Product preparation issue, Pyrexia, Rash
Clinical narrative: Nurse prepared pediatric COVID vaccine and missed that the dose needs to be reconstituted with 1.1 mL of normal saline. Nurse did not see instruction for reconstitution on vial or in electronic medical record. Patient administered undiluted vaccine. Father reports patient was symptomatic with fever, fussiness on the night that the vaccine was give. Temp 102.5 F. The following day after vaccine administration patient had a rash and fever (101 F) which both had resolved with tylenol.
Age: 0.5
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Nurse prepared pediatric COVID vaccine and missed that the dose needs to be reconstituted with 1.1 mL of normal saline. Nurse did not see instruction for reconstitution on vial or in electronic medical record. Patient administered undiluted vaccine. Father reports patient was symptomatic with fever, fussiness on the night that the vaccine was give. Temp 102.5 F. The following day after vaccine administration patient had a rash and fever (101 F) which both had resolved with tylenol.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Client was notified within 30 minutes of vaccination to notify provider of receipt of live vaccination based on immunosuppressive medication that she is taking.  Client states that she will call or message her provider through MyChart
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site infection, Injection site rash
Clinical narrative: The patient developed a rash on May 19th below the right deltoid, partially on the bicep. It was a diffuse red area marked by inflammation and slightly raised margins. It was approximately 2 inches in diameter. It looked like a localized Arthus reaction. Patient showed me the area on the 20th, and said it had slightly improved with time. He took 1 dose of Tylenol only. He reported the condition had improved within 24 hours.
Age: 54.0
Sex: M
Vaccine: TYP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling sensation like pins and needles from shoulder down to fingertips when at rest
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Diarrhoea, Influenza A virus test negative, Influenza B virus test negative, Irritability, Pyrexia
Clinical narrative: Refusal to bear weight and fussiness around 4 hours after immunizations administered.  Fever and diarrhea the following day, 38.3C in office on 5/20/2025 at 1930. .  Treated with NSAID
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Weight bearing difficulty
Clinical narrative: Refusal to bear weight and fussiness around 4 hours after immunizations administered.  Fever and diarrhea the following day, 38.3C in office on 5/20/2025 at 1930. .  Treated with NSAID
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody positive, Blood test normal, Diplopia, Laboratory test normal, VIth nerve paralysis
Clinical narrative: 3 days after receiving the vaccine, I developed diplopia. I was told I had a palsy of my 6th occular nerve on my right side. The double vision is horizontal, and occurs when both eyes are open. If I close either eye, I see single vision.  It has been almost 2 months and I still have the double vision.
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Condition aggravated, Dry eye, Impaired work ability
Clinical narrative: SEVERE DRY eye symptoms started the next day after vaccine.  Debiliating. Unable to work. I have been doing IPL treatments for dry eye and have had no dry eye sumptoms for the past several months until this vaccine.
Age: 1.17
Sex: F
Vaccine: IPV
Symptoms: Aphasia, Autoantibody positive, Cytogenetic analysis abnormal, Decreased eye contact, Electroencephalogram normal
Clinical narrative: 15 minutes after receiving the vaccine, Patient began vomiting. She refused food for several days, was lethargic, and began having facial tics and absence seizures. She stopped speaking and stopped responding to her name. Eye contact was lost.  She went from happy and energetic to disengaged and unresponsive.
Age: 1.17
Sex: F
Vaccine: IPV
Symptoms: Encephalopathy, Food refusal, Lethargy, Petit mal epilepsy, Tic
Clinical narrative: 15 minutes after receiving the vaccine, Patient began vomiting. She refused food for several days, was lethargic, and began having facial tics and absence seizures. She stopped speaking and stopped responding to her name. Eye contact was lost.  She went from happy and energetic to disengaged and unresponsive.
Age: 1.17
Sex: F
Vaccine: IPV
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: 15 minutes after receiving the vaccine, Patient began vomiting. She refused food for several days, was lethargic, and began having facial tics and absence seizures. She stopped speaking and stopped responding to her name. Eye contact was lost.  She went from happy and energetic to disengaged and unresponsive.
Vaccine: DTPPVHBHPB, VARCEL, DTPPVHBHPB, VARCEL
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Caller stated that VARIVAX was reconstituted using a VAXELIS pre-filled syringe rather than the sterile diluent and administered to a 2 month old patient on 02/18/2025; Caller stated that VARIVAX was reconstituted using a VAXELIS pre-filled syringe rather than the sterile diluent and administered to a 2 month old patient on 02/18/2025; No reported signs or symptoms of adverse effects have been reported; This non-serious spontaneous safety report, with reference number 02757161 (Interaction number 02757158), was received by partner on 20-FEB-2025 and forwarded on 21-FEB-2025 from a nurse.  Due to the nature of the event, the causality between the event "Caller stated that VARIVAX was reconstituted using a VAXELIS pre-filled syringe rather than the sterile diluent and administered to a 2-month-old patient on 02/18/2025" and Vaxelis was not applicable.  Further information is expected.  SIGNIFICANT FOLLOW UP INFORMATION was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 23-APR-2025 with the following VAERS Primary ID 2830176. The original narrative from the sender is the following:  No reported signs or symptoms of adverse effects have been reported; VARIVAX was reconstituted using a VAXELIS pre-filled syringe rather than the sterile diluent and administered; This spontaneous report was received from a nurse and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-FEB-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) as prophylaxis, the vaccine was reconstituted using a diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus (VAXELIS) prefilled syringe rather than the sterile diluent (product preparation error) (exact dose, strength, vaccination site, route of administration, lot number and expiration were not reported). No reported signs or symptoms of adverse effects have been reported. Lot number is being requested and will be submitted if received.  No further information is expected.
Vaccine: DTPPVHBHPB, VARCEL, DTPPVHBHPB, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: Caller stated that VARIVAX was reconstituted using a VAXELIS pre-filled syringe rather than the sterile diluent and administered to a 2 month old patient on 02/18/2025; Caller stated that VARIVAX was reconstituted using a VAXELIS pre-filled syringe rather than the sterile diluent and administered to a 2 month old patient on 02/18/2025; No reported signs or symptoms of adverse effects have been reported; This non-serious spontaneous safety report, with reference number 02757161 (Interaction number 02757158), was received by partner on 20-FEB-2025 and forwarded on 21-FEB-2025 from a nurse.  Due to the nature of the event, the causality between the event "Caller stated that VARIVAX was reconstituted using a VAXELIS pre-filled syringe rather than the sterile diluent and administered to a 2-month-old patient on 02/18/2025" and Vaxelis was not applicable.  Further information is expected.  SIGNIFICANT FOLLOW UP INFORMATION was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 23-APR-2025 with the following VAERS Primary ID 2830176. The original narrative from the sender is the following:  No reported signs or symptoms of adverse effects have been reported; VARIVAX was reconstituted using a VAXELIS pre-filled syringe rather than the sterile diluent and administered; This spontaneous report was received from a nurse and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-FEB-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) as prophylaxis, the vaccine was reconstituted using a diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus (VAXELIS) prefilled syringe rather than the sterile diluent (product preparation error) (exact dose, strength, vaccination site, route of administration, lot number and expiration were not reported). No reported signs or symptoms of adverse effects have been reported. Lot number is being requested and will be submitted if received.  No further information is expected.
Age: 61.0
Sex: M
Vaccine: PNC21, PNC21, PNC21
Symptoms: Acute respiratory failure, Blood creatine phosphokinase normal, Endotracheal intubation, Heavy metal test, Hypoaesthesia
Clinical narrative: Muscle pain in hips and legs, numbness in hands and feet, headache. Progressed to severe pain. Progressed to total paralysis and placed on ventilator all on 4/28/2025. He remains in ICU as we speak on a ventilator. Will require LTAC.
Age: 61.0
Sex: M
Vaccine: PNC21, PNC21, PNC21
Symptoms: Immunoglobulin therapy, Intensive care, Pain, Paraesthesia, West Nile virus test
Clinical narrative: Muscle pain in hips and legs, numbness in hands and feet, headache. Progressed to severe pain. Progressed to total paralysis and placed on ventilator all on 4/28/2025. He remains in ICU as we speak on a ventilator. Will require LTAC.
Age: 61.0
Sex: M
Vaccine: PNC21, PNC21, PNC21
Symptoms: Guillain-Barre syndrome, Headache, Hypoaesthesia, Intensive care, Laboratory test
Clinical narrative: Muscle pain in hips and legs, numbness in hands and feet, headache. Progressed to severe pain. Progressed to total paralysis and placed on ventilator all on 4/28/2025. He remains in ICU as we speak on a ventilator. Will require LTAC.
Age: 61.0
Sex: M
Vaccine: PNC21, PNC21, PNC21
Symptoms: Mechanical ventilation, Myalgia, Pain, Paralysis
Clinical narrative: Muscle pain in hips and legs, numbness in hands and feet, headache. Progressed to severe pain. Progressed to total paralysis and placed on ventilator all on 4/28/2025. He remains in ICU as we speak on a ventilator. Will require LTAC.
Age: 1.0
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other information provided. No additional AEs/PQC reported.; vaccines administered after temperature excursions; This spontaneous report was received from an Other health professional and refers to a(n) 1-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Hepatitis A Vaccine, Inactivated (VAQTA)  (manufacturer unknown) Prevenar 20 (Pneumococcal vaccine conj 20v (CRM197)) .  On 15-Apr-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot #Y017511, expiration date: 15-Apr-2026, dose number 1, (strength, dose, and vaccination scheme were not reported), administered by Subcutaneous route in Left Thigh, as Prophylaxis. On an unknown date, the vaccine underwent a temperature excursion of -9.8 Celsius Degrees during a timeframe of 2 h 3 m, with no previous temperature excursions. No adverse event was reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-04-28 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : , Central date : 2025-04-28 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 4.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported; an expired dose of PROQUAD was administered to a 4-year-old male patient on 5/8/2025; This spontaneous report has been received from a Nurse referring to a 4-year-old male patient.   The patient's concurrent conditions, pertinent medical history, previous drug reactions/allergies, and concomitant therapies were not provided.  On 08-MAY-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (+) diluent, with valid lot # X026409 and expiration date: 07-May-2025 (strength, dose, frequency, route of administration, lot #, and expiration date were not provided) as prophylaxis (Expired product administered). No symptoms reported (No adverse event).
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: inappropriate preparation of medication; inappropriate dose of vaccine administered.; This non-serious case was reported by a consumer and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: inappropriate preparation of medication) and inappropriate dose of vaccine administered (Verbatim: inappropriate dose of vaccine administered.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 30-APR-2025 The reporter was the Clinic Administrator and needing some guidance on a situation that they had encountered here.  The situation was that a CMA was getting a Menveo vaccine ready to administer and noticed that it was the last vial of the gray cap but that there were 2 vials of the orange caps left, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. She administered the correct dose with the two correct vials, but he/she was needing to see if there was a recommendation since we are not able to identify the patient that received only the gray top vial of the 4 other doses.  The reporter had a report that identified the 4 patients.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: He states he forgot to get dose 2 within the 2-6 month window; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine in May 2024).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: He states he forgot to get dose 2 within the 2-6 month window). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date : 14-MAY-2025 The reporter stated that he received Shingrix dose 1 in May 2024.  He was scheduled to get dose 2 May 20, 2025.  He stated that he forgot to get dose 2 within the 2-6 month window. Till the time of reporting the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; two vaccine and still get an out break, just not as bad; 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: two vaccine and still get an out break, just not as bad). 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 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: 14-MAY-2025 This case was reported by a patient via interactive digital media. The patient had two vaccine and still get an out break, just not as bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, 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 vaccine Shingles vaccine (Dose 1 & 2).
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9 degree F as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree F as the minimum reached.). The outcome of the incorrect storage of drug 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: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for following product Boostrix, which led to incorrect storage of vaccine. The Vaccine Administration Facility was the same as Primary Reporter. No expiration date given for the vaccines nor date of administration. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061574:Same reporter,Different patient US-GSK-US2025061573:Same reporter,Different patient US-GSK-US2025061572:Same reporter,Different patient US-GSK-US2025061571:Same reporter,Different patient US-GSK-US2025061570:Same reporter,Different patient US-GSK-US2025061569:Same reporter,Different patient US-GSK-US2025061568:Same reporter,Different patient US-GSK-US2025061567:Same reporter,Different patient US-GSK-US2025061565:Same reporter,Different patient US-GSK-US2025061564:Same reporter,Different patient US-GSK-US2025061563:Same reporter,Different patient US-GSK-US2025061562:Same reporter,Different patient US-GSK-US2025061561:Same reporter,Different patient US-GSK-US2025061560:Same reporter,Different patient US-GSK-US2025061559:Same reporter,Different patient US-GSK-US2025061558:Same reporter,Different patient US-GSK-US2025061557:Same reporter,Different patient US-GSK-US2025061556:Same reporter,Different patient US-GSK-US2025061555:Same reporter,Different patient US-GSK-US2025061554:Same reporter,Different patient US-GSK-US2025061553:Same reporter,Different patient US-GSK-US2025061552:Same reporter,Different patient US-GSK-US2025061551:Same reporter,Different patient US-GSK-US2025061550:Same reporter,Different patient US-GSK-US2025061549:Same reporter,Different patient US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061547:Same reporter,Different patient US-GSK-US2025061545:Same reporter,Different patient US-GSK-US2025061538:Same reporter,Different patient US-GSK-US2025061537:Same reporter,Different patient US-GSK-US2025061536:Same reporter,Different patient US-GSK-US2025061534:Same reporter,Different patient
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: PENTACEL was given to patient 14 days after expiration with no reported adverse event; Initial information received on 14-May-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who received diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] 14 days after expiration 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 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, Powder and suspension for suspension for injection,(lot number, expiry date and strength not reported) via unknown route in unknown administrative site for immunization, after 14 days of expiration with no reported adverse event (expired product administered) (latency: same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  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: 6.0
Sex: M
Vaccine: TD
Symptoms: Off label use
Clinical narrative: off-label use as per local labelling due to administration of tenivac to a 6 year old patient with no reported ae; Initial information received on 15-May-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 6 year old male patient who received diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Teniva] with no reported AE (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-May-2025, the 6 years old male patient received an unknown dose (dose 1) of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection standard strength (lot U7920AA) (expiry date-unknown) via unknown route in unknown administration site for Immunization with no reported AE (off label use) (latency-same day).  Reportedly-Nurse reported that the patient was 6 years old when they got their first dose of TENIVAC in the hospital and it was approved by their physician because the patient cannot get a pertussis shot.  Action taken was not applicable.
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Occupational exposure to product
Clinical narrative: the liquid dripped all over her hands with no reported adverse event; the liquid dripped all over her hands with no reported adverse event; Initial information received on 15-May-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender physician and the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] dripped all over her hands with no reported adverse event.   On an unknown date, the suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine Suspension for injection (Unknown strength) with lot UK168AB and expiry date 31-Oct-2025 for Immunization dripped all over physician hands with no reported adverse event (accidental exposure to product) (exposure via skin contact).  Reportedly, Bottle leaked. Replacement requested. HCP (Healthcare professional) stated she had pentacel and that when she went to pull up the liquid to use with a patient, the bottle leaked everywhere. HCP stated that it wasn't from the needle, that it was from the bottle itself and that she was unable to use it. HCP stated she did not notice a crack in the bottle, that the leak was not coming from the needle. HCP stated that, initially, she was unable to determine where the leak was coming from, that she has seen leaks before if a needle wasn't on tight enough. HCP stated she took the needle out and put it back in, but the leaking continued. HCP stated it was then that she noticed the leak was coming from "the soft portion in the center" of the bottle. HCP stated the liquid dripped all over her hands. HCP stated she pulled a second bottle from the same box and it worked fine  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: 0.5
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: reconstituted ACT-HIB with sterile water with no reported adverse event; reconstituted ACT-HIB with sterile water and administered it to a patient; Initial information received on 19-May-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old with unknown gender patient who was administered with reconstituted HIB (PRP/T) Vaccine [ACT-HIB] with sterile water 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 Pediarix, Rotavirus vaccine and Prevnar 20 for Immunisation.  On 14-May-2025, the patient received 0.5mL (dose 3) (frequency once) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK148AA, expiry date 30-Sep-2025, strength standard) via intramuscular route in the right thigh for TB skin test (Immunisation) and reconstituted act-hib with sterile water and administered it to a patient (poor quality product administered), (product preparation error) (latency same day).  Reportedly, reported called to ask if the ACTHIB dose needs to be repeated. They reported that one of their nurses reconstituted ACTHIB with sterile water and administered it to a patient.  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: 0.5
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Infant irritability, Product preparation issue, Pyrexia, Rash
Clinical narrative: RN drew up undiluted pediatric pfizer covid vaccine and it was administered - equivalent of 3 doses.