chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Epilepsy, Investigation, Palpitations, Seizure
Clinical narrative: seizures; epilepsy; heart palpitations; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 22-year-old female patient received BNT162b2 (BNT162B2), on 12Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 22 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (Dose 1, single), administration date: 2021, for COVID-19 immunization. The following information was reported: EPILEPSY (hospitalization, medically significant) with onset Feb2022, outcome "unknown"; PALPITATIONS (hospitalization, medically significant) with onset Feb2022, outcome "unknown", described as "heart palpitations"; SEIZURE (hospitalization, medically significant) with onset Feb2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "seizures". Reporter stated that her daughter received her first dose of the Pfizer Covid-19 vaccine at the end of 2021 and second dose in Dec2021. In Feb2022 (started 2 months after receiving the second dose of the Pfizer Covid-19 vaccine), her daughter started experiencing heart palpitations, seizures, and epilepsy. The patient has these seizures at least two to three times a week that sometimes it really got to where she has hospitalized for like a week. She has been intubated probably 20 times. This did not start until after she got that second Pfizer shot for the COVID. She has been tested for epilepsy, she had all kind of tests running on her and then to several different specialists and all the test always come back negative, everything comes back fine/normal. Testing was performed and several EEDS, "ton of them were done,"were performed, however they are "not detecting brain magnetism through the EED." Reporter was asking if there is some time of testing that can be performed to see if the vaccine is causing her daughter's epilepsy and if there is anything they can do to control her daughter's seizures. Patient takes Lacosamide (twice a day) and Briviact (Brivaracetam) 20 mg (as reported), both for Epilepsy.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: patients are hard to get back for their second dose; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 1st dose of vaccine on an unknown date).   On an unknown date, the patients did not receive the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: patients are hard to get back for their second dose). The outcome of the incomplete course of vaccination was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-JUN-2025 The field representative reported the question from a pediatrician who wanted to know what the efficacy after just one dose was of Bexsero. She was asking this because multiple patients were hard to get back for their second dose and she was just curious about what efficacy would give just one dose. This AE (adverse event) was filed as potential since the reporter stated that the pediatrician said that it was hard to get back the patients to complete their schedules. So, more than one patient could be involved. Till the time of reporting, the patient did not receive 2nd dose of Bexsero, which led to an incomplete course of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Blood calcium, Blood calcium increased, Blood disorder, Blood test
Clinical narrative: had very high levels, very big lymph nodes, all over body; did not have right balance in blood; he had little higher calcium than he should; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 79-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fall" (unspecified if ongoing), notes: They did all sorts tests; "cholesterol" (ongoing); "blood pressure" (ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol (ongoing); LOSARTAN taken for blood pressure measurement (ongoing). The following information was reported: LYMPHADENOPATHY (medically significant), outcome "unknown", described as "had very high levels, very big lymph nodes, all over body"; BLOOD DISORDER (non-serious), outcome "unknown", described as "did not have right balance in blood"; BLOOD CALCIUM INCREASED (non-serious), outcome "unknown", described as "he had little higher calcium than he should". The events "had very high levels, very big lymph nodes, all over body" and "he had little higher calcium than he should" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: Unknown results; Blood calcium: little higher; Blood test: Unknown results; Body height: 6, notes: feet. When he was in air force; test: Unknown results, notes: did all sorts tests; Positron emission tomogram: Unknown results, notes: twice for lymph nodes. They are not cancerous; Unknown results, notes: year later, they had reduced in size but, still there. Therapeutic measures were taken as a result of blood calcium increased.  Clinical course: For the last couple of years, 2 or 3 years, doctors sent him on wild goose chase. One doctor said he did not have right balance in blood, and particular vitamin. They maybe considered cancer, he did not have cancer. Brought him to pulmonologist, found out, he had enlarged lymph nodes. Had PET scan, twice for lymph nodes. They are not cancerous, they have no idea why he has them. Patient does not smoke, never smoked in life, does not drink, maybe a little wine with dinner. Used to drink twice a week, now, not much at all. No treatment was received for the adverse event/incident. Hair loss, enlarged lymph nodes, caught Covid. Patient was not allergic to any previous vaccination, medications, food or other products. Only started to come down with sinus issue that was minor. There are no any other diagnos; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500113368 same patient and drug, different dose and event;
Sex: M
Vaccine: COVID19
Symptoms: Body height, Investigation, Lymphadenopathy, Positron emission tomogram
Clinical narrative: had very high levels, very big lymph nodes, all over body; did not have right balance in blood; he had little higher calcium than he should; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 79-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fall" (unspecified if ongoing), notes: They did all sorts tests; "cholesterol" (ongoing); "blood pressure" (ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol (ongoing); LOSARTAN taken for blood pressure measurement (ongoing). The following information was reported: LYMPHADENOPATHY (medically significant), outcome "unknown", described as "had very high levels, very big lymph nodes, all over body"; BLOOD DISORDER (non-serious), outcome "unknown", described as "did not have right balance in blood"; BLOOD CALCIUM INCREASED (non-serious), outcome "unknown", described as "he had little higher calcium than he should". The events "had very high levels, very big lymph nodes, all over body" and "he had little higher calcium than he should" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: Unknown results; Blood calcium: little higher; Blood test: Unknown results; Body height: 6, notes: feet. When he was in air force; test: Unknown results, notes: did all sorts tests; Positron emission tomogram: Unknown results, notes: twice for lymph nodes. They are not cancerous; Unknown results, notes: year later, they had reduced in size but, still there. Therapeutic measures were taken as a result of blood calcium increased.  Clinical course: For the last couple of years, 2 or 3 years, doctors sent him on wild goose chase. One doctor said he did not have right balance in blood, and particular vitamin. They maybe considered cancer, he did not have cancer. Brought him to pulmonologist, found out, he had enlarged lymph nodes. Had PET scan, twice for lymph nodes. They are not cancerous, they have no idea why he has them. Patient does not smoke, never smoked in life, does not drink, maybe a little wine with dinner. Used to drink twice a week, now, not much at all. No treatment was received for the adverse event/incident. Hair loss, enlarged lymph nodes, caught Covid. Patient was not allergic to any previous vaccination, medications, food or other products. Only started to come down with sinus issue that was minor. There are no any other diagnos; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500113368 same patient and drug, different dose and event;
Age: 61.0
Sex: M
Vaccine: RSV
Symptoms: Dyspnoea, Gait inability
Clinical narrative: difficulty breathing/more trouble breathing; could not walk; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 11Jun2024 at 15:00 as dose 1, single (Lot number: HMO168) at the age of 61 years for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DOVATO. The following information was reported: GAIT INABILITY (life threatening) with onset 14Jun2024 at 07:00, outcome "recovering", described as "could not walk"; DYSPNOEA (life threatening) with onset 14Jun2024 at 07:00, outcome "recovering", described as "difficulty breathing/more trouble breathing". The events "difficulty breathing/more trouble breathing" and "could not walk" required emergency room visit. Therapeutic measures were not taken as a result of dyspnoea, gait inability.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Nausea
Clinical narrative: Nausea and headache since day of immunization. Headache described as "needle being poked into her eye". New onset numbness in left arm last night or this morning (6/5). Seems to be resolving as of 6pm this evening. Has not sought treatment for any of the above complaints.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Injection site discharge
Clinical narrative: Family notified office about 1.5 hours after visit that a yellow, mostly clear fluid with some areas of congealed consistency, leaked out of the injection site of the right thigh after they got home. It streamed down to his knee, an estimated .5mL of fluid. Pt was dancing at the baby gate when the fluid came out. It did not bother him. He is happy and acting normally. This was the site of the MMR injection. The MMR vaccine is yellow fluid
Age: 52.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Pruritus, Rash erythematous, Rash papular, Skin warm, Swelling
Clinical narrative: Reports red raised bumps, itching, swelling and warm to the touch. No fever.  Symptoms started 3 days after the vaccines were administered.  Pt was prescribed ibuprofen and triamcinolone cream by physician.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose normal, Crying, Immediate post-injection reaction, Malaise
Clinical narrative: PATIENT FELT WEAK 5-7 MINUTES AFTER ADMINISTRATION. SHE WAS SITTING DOWN AT THE MOMENT AS PER  PHARMACIST ADVISED ORIGINALLY . SHE COMPLAINED RIGHT AFTER VACCINE THAT SHE FELT NERVOUS.  THEN AFTER 7 MINUTES APPROXIMATELY SHE SAID SHE DOES  NOT FEEL GOOD . PHARMACIST CAME OVER, PATIENT LOOKED  PALE, CLOSED HER EYES. HER BLOOD PRESSURE WAS CHECKED AND IT WAS 80/50. SHE WAS GIVEN WATER, SALTY FOOD, COLD CLOTH ON THE CHEST AND FOREHEAD. IN A FEW MINUTES SHE START COMPLAINING ABOUT TINGLING ON HANDS, SPOTTY REDNESS AROUND EYE AREAMAY BE FROM CRYING. WE CALLED EMT. BY THE TIME EMT ARRIVED PATIENT WAS FEELING BETTER, HER BLOOD PRESURE AND BLOOD SUGAR WERE OK. VITALS CAME BACK TO NORMAL. SHE WAS ADVISED TO SIT FOR A WHILE AND THEN CAN GO HOME. NO COMPLAINTS AFTER THIS. PATIENT LEFT AROUND 6:30PM.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Ocular hyperaemia, Pallor, Paraesthesia
Clinical narrative: PATIENT FELT WEAK 5-7 MINUTES AFTER ADMINISTRATION. SHE WAS SITTING DOWN AT THE MOMENT AS PER  PHARMACIST ADVISED ORIGINALLY . SHE COMPLAINED RIGHT AFTER VACCINE THAT SHE FELT NERVOUS.  THEN AFTER 7 MINUTES APPROXIMATELY SHE SAID SHE DOES  NOT FEEL GOOD . PHARMACIST CAME OVER, PATIENT LOOKED  PALE, CLOSED HER EYES. HER BLOOD PRESSURE WAS CHECKED AND IT WAS 80/50. SHE WAS GIVEN WATER, SALTY FOOD, COLD CLOTH ON THE CHEST AND FOREHEAD. IN A FEW MINUTES SHE START COMPLAINING ABOUT TINGLING ON HANDS, SPOTTY REDNESS AROUND EYE AREAMAY BE FROM CRYING. WE CALLED EMT. BY THE TIME EMT ARRIVED PATIENT WAS FEELING BETTER, HER BLOOD PRESURE AND BLOOD SUGAR WERE OK. VITALS CAME BACK TO NORMAL. SHE WAS ADVISED TO SIT FOR A WHILE AND THEN CAN GO HOME. NO COMPLAINTS AFTER THIS. PATIENT LEFT AROUND 6:30PM.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Irritability
Clinical narrative: Pfizer Covid vaccine with beyond use date of 5/29/25 was given on 6/4/25. Patient's mother reports patient fussier than usual today (6/5/25) after receiving the Covid vaccine, Hepatitis A vaccine, and DTaP vaccines on 6/4/25.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP, UNK
Symptoms: Chest X-ray, Chest pain, Chills, Cough, Electrocardiogram
Clinical narrative: Symptoms 1st 24hrs: Cold chills, fever, tight throat.  Symptoms within 36hrs: Chest pain, painful to swallow, throat worsen, dry cough-no constipation (no signs of it being a common cold). Symptoms after a week continue as hard dry cough, chest pain, fever is gone, cold chills and fever come and go.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP, UNK
Symptoms: Laboratory test, Odynophagia, Pyrexia, Throat tightness
Clinical narrative: Symptoms 1st 24hrs: Cold chills, fever, tight throat.  Symptoms within 36hrs: Chest pain, painful to swallow, throat worsen, dry cough-no constipation (no signs of it being a common cold). Symptoms after a week continue as hard dry cough, chest pain, fever is gone, cold chills and fever come and go.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Contusion, Immune thrombocytopenia, Petechiae, Platelet count decreased
Clinical narrative: Two weeks after vaccinations, child started getting bruising all over his legs along with body wide petechia.
Age: 56.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: This is not  an adverse event issue.  pharmacist forgot to mix the antigen powder with the provided prefilled syringe with sterile water.  pt was only injected with the sterile water ONLY.   no side effects were reported.  pt was called to come back to revaccinate
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Patient came to office with rash on L arm that extended underneath the arm as well. The area where vaccine was given was red, swollen and warm to the touch. Dr. recommended that the patient not have any more HPV vaccinations.
Age: 36.0
Sex: F
Vaccine: VARZOS
Symptoms: Amenorrhoea, General physical health deterioration, Laboratory test, Malaise, Menopause
Clinical narrative: that since receiving the ZOSTAVAX, she has had ovarian failure; her HCP prescribed her to GABAPENTIN for the nerve damage/she "will probably have nerve damage for the rest of her life; she has had menopause/her menstruation cycle has stopped; she was deemed as "permanently disabled; in 2014 she got "very, very sick; she received the vaccine at age 38, which she did not know that she shouldn't have received the vaccine until age 50; Indication: shingles; overall health has been on the decline/she is "49 years old" but feels like she is "89; This spontaneous report was received from a Consumer regarding herself, a 36-year-old female patient.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.   On 30-APR-2012, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX), administered by Subcutaneous route for shingles (dose, formulation, anatomical site of injection, lot number and expiration date were not reported) (Product use in unapproved indication), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number and expiration date were not reported). She stated she was vaccinated at age 38, which she did not know she should not have received the vaccine until age 50 (Product administered to patient of inappropriate age).   On an unknown date in 2012 (reported as ever since receiving Zoster Vaccine Live [ZOSTAVAX]), the patient´s health has been on the decline (General physical health deterioration). Since the vaccination, she has had ovarian failure, her menstruation cycle has stopped, and she has had menopause (Menopause). On an unknown date in 2014, the patient got ¨very very sick¨ (Malaise), and then, on an unknown date in 2016, she was deemed as permanently disabled (Disability). Also, on an unknown date, the patient´s doctor informed her that she will probably have nerve damage (Nerve injury) for the rest of her life, for which she was prescribed Gabapentin, but no other doctor has provided her anything for the recovery of her health decline. The patient also stated she is currently 49 years old but feels like she is 89 years old. It was reported that some lab work was done (unspecified, results not provided) on an unspecific date, and that the patient sought medical attention due to the events. No further information reported by the patient.   At the reporting time, the patient had not recovered from the events of Disability, Ovarian failure, Malaise, Nerve injury, General physical health deterioration and Menopause.  The reporter considered the event of General physical health deterioration to be related to the suspect vaccine and sterile diluent. The causal relationship between Zoster Vaccine Live (ZOSTAVAX) and sterile diluent regarding the events of Disability, Ovarian failure, Malaise, Nerve injury, and Menopause was not reported.   The event of Disability was considered to be a disabling/incapacitating event.
Age: 36.0
Sex: F
Vaccine: VARZOS
Symptoms: Nerve injury, Ovarian failure, Product administered to patient of inappropriate age
Clinical narrative: that since receiving the ZOSTAVAX, she has had ovarian failure; her HCP prescribed her to GABAPENTIN for the nerve damage/she "will probably have nerve damage for the rest of her life; she has had menopause/her menstruation cycle has stopped; she was deemed as "permanently disabled; in 2014 she got "very, very sick; she received the vaccine at age 38, which she did not know that she shouldn't have received the vaccine until age 50; Indication: shingles; overall health has been on the decline/she is "49 years old" but feels like she is "89; This spontaneous report was received from a Consumer regarding herself, a 36-year-old female patient.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.   On 30-APR-2012, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX), administered by Subcutaneous route for shingles (dose, formulation, anatomical site of injection, lot number and expiration date were not reported) (Product use in unapproved indication), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number and expiration date were not reported). She stated she was vaccinated at age 38, which she did not know she should not have received the vaccine until age 50 (Product administered to patient of inappropriate age).   On an unknown date in 2012 (reported as ever since receiving Zoster Vaccine Live [ZOSTAVAX]), the patient´s health has been on the decline (General physical health deterioration). Since the vaccination, she has had ovarian failure, her menstruation cycle has stopped, and she has had menopause (Menopause). On an unknown date in 2014, the patient got ¨very very sick¨ (Malaise), and then, on an unknown date in 2016, she was deemed as permanently disabled (Disability). Also, on an unknown date, the patient´s doctor informed her that she will probably have nerve damage (Nerve injury) for the rest of her life, for which she was prescribed Gabapentin, but no other doctor has provided her anything for the recovery of her health decline. The patient also stated she is currently 49 years old but feels like she is 89 years old. It was reported that some lab work was done (unspecified, results not provided) on an unspecific date, and that the patient sought medical attention due to the events. No further information reported by the patient.   At the reporting time, the patient had not recovered from the events of Disability, Ovarian failure, Malaise, Nerve injury, General physical health deterioration and Menopause.  The reporter considered the event of General physical health deterioration to be related to the suspect vaccine and sterile diluent. The causal relationship between Zoster Vaccine Live (ZOSTAVAX) and sterile diluent regarding the events of Disability, Ovarian failure, Malaise, Nerve injury, and Menopause was not reported.   The event of Disability was considered to be a disabling/incapacitating event.
Vaccine: MMR, MMR, VARCEL, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; HCP called and reported a patient who received their first dose of MMR-II and VARIVAX on 08AUG2024 and was inadvertently given a second dose of MMR-II and VARIVAX on 15MAY2025. No additional information was known by reporter. No additional AE/PQC.; This spontaneous report was received from a medical assistant and refers to a 24-month-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 08-Aug-2024, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (indication, expiration date, and lot # were not reported) diluted with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported) for prophylaxis. On 15-May-2025, the patient received inadvertently the second dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (indication, expiration date, and lot # were not reported) diluted with sterile diluent (MERCK STERILE DILUENT) (indication, expiration date, and lot # were not reported) (Inappropriate schedule of product administration). No additional adverse event was reported.
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: HCP called to state that the patient has missed their window to receive a second dose of GARDASIL 9 series according to the outlined schedule in the prescribing information.; No additional AE; This spontaneous report was received from a pharmacist referring to a 25-year-old patient, gender was not provided.  Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided. On an unknown date, reported as 1 or 2 years ago, the patient received the first dose of Human Papillomavieus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) injection 0,5 ml, administered for prophylaxis (route of administration, anatomical location, lot number and expiration date was not reported), the reporter mentioned that the patient not received their second dose. (Inappropriate schedule of product administration). There was not adverse event reported.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Administration of the liquid portion only; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 3273H, expiry date 31-MAR-2027) for prophylaxis.   On 22-MAY-2025, the patient received the 1st dose of Shingrix. On 22-MAY-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administration of the liquid portion only). The outcome of the inappropriate preparation of medication was not applicable.   Additional Information: GSK Receipt Date: 30-MAY-2025 A nurse administered the Shingrix vaccine incorrectly. She drew up the adjuvant and she administer it without mixing it into the antigen component which led to inappropriate preparation of medication. And when she realized what she did, she attempted to correct the error on her own and she mix the antigen component with sterile saline, then drew that and administer that into a separate limb. A nurse reported that this happened on 22 May 2025 and the patient received both injections on the same day (on different limb). This was the 1st Shingrix dose. The Vaccine Administration Facility is the same as Primary Reporter. Consented to follow up.; Reporter's Comments: Wrong tech used in reconstitution Inappropriate preparation of medication
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: pentacel liquid component was administered, however, not with the ActHIB lyophilized powder with no reported adverse event; first dose of PENTACEL was administered at 3 months instead of 2 months with no reported AE; Initial information received on 03-Jun-2025  regarding an unsolicited valid non-serious case received from a other health professional with a live follow-up together (CSD: 03-Jun-2025).  This case involves a 3 months old male patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] liquid component was administered, however, not with the ACT-HIB lyophilized powder instead at the age of 2 months 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 for Immunization.  On 12-May-2025, the patient received 0.5 ml of dose 1 of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection with strength- standard (expiry date- 31-Oct-2025 and lot UK167AA) once via intramuscular route in the right thigh for Immunization and liquid component was administered, however, not with the ACTHIB lyophilized powder (single component of a two-component product administered) at the age of 3 months instead of 2 months with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).   Reportedly, reporter asked if the liquid was a valid dose and what diluent could be used.   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: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: two-day old patient was administered ADACEL last month, with no reported adverse event; Initial information received on 04-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 days old male patient who was administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] last month, 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 May 2025, the 2 days old patient last month received a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (strength: standard and frequency: once) (lot number and expiry date not reported) via intramuscular route in unknown administration site for immunization with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence  Reportedly, They wanted to know what the possible adverse events are and what the monitoring requirements would be. Treatment: Patient was monitored for reactions.  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: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACTHIB was prepared with 0.7 ml SW as diluent with no reported adverse event; Initial information received on 04-Jun-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a patient with unknown age and gender who was administered with HIB (PRP/T) Vaccine [ACT-HIB] which was prepared with 0.7 ml SW as diluent with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot number, expiry date and strength not reported) for Immunisation and it was prepared with 0.7 ml SW as diluent with no reported adverse event (single component of a two-component product administered).  Information on the batch number was requested corresponding to the one at time of event occurrence.   Reportedly, they asked for appropriate follow up and any potential side effect.  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: 57.0
Vaccine: TD
Symptoms: Off label use, Skin laceration
Clinical narrative: tenivac prescribed with off label diagnosis laceration without foreign body of other part of head, initial encounter (with no reported ae); Initial information received on 29-May-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 57 years old and unknown gender patient to whom diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] prescribed with off label diagnosis laceration without foreign body of other part of head, initial encounter with no reported ae (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult; Suspension for injection (lot number, strength and expiry date not reported) via intramuscular route in unknown administration site for Laceration without foreign body of other part of head, initial encounter (Skin laceration) with no reported ae (off label use) (unknown latency).  There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 0.58
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no other AE; the MMR-II vaccine to a 7 month old patient; This spontaneous report was received from a health business professional (HBP) and refers to a 7-month-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 19-MAY-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), administered for prophylaxis (strength, dose, route, lot #, and expiration date were not reported) (Product administered to patient of inappropriate age). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported).  It was reported that the patient would be travelling outside of the country next week, so the patient was back in the office on 04-JUN-2025 to receive Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) and Pneumococcal vaccine conj 7v (CRM197) (PREVNAR). The reporter did not provide which "PREVNAR" that the patient would be receiving and did not provide any further information or patient information. No other adverse event was reported.  Lot# is being requested and will be submitted if received.
Sex: F
Vaccine: PNC21, PPV
Symptoms: Antibody test negative
Clinical narrative: she's (physician) not seeing the antibodies she is looking for; This spontaneous report was received from a pharmacist on 04-Jun-2025 and refers to a female patient of unknown age.   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 (a long time ago), the patient may be vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), (lot # and expiration date were not reported) as prophylaxis (it was stated that the reporter was uncertain as the patient may have never received it). In April 2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # and expiration date were not reported) as prophylaxis. The physician wanted the patient to receive Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) because the physician not seeing the antibodies she was looking for (Antibody test negative). The reporter inquired about dosing interval between the two vaccines. At the reporting time, the outcome of the event was unknown.   The action taken with the vaccines was not applicable.   The causal relationship between the event and both of the vaccines not provided.   Batch/lot number is being requested and will be submitted if received.
Vaccine: PPV, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: HCP called as she was looking over documentation and realized that the patient may have received 2 doses of PNEUMOVAX 23 about 6 months apart (please see below). The HCP was unable to confirm if this was a simple documentation error or if the patient; No additional AE/No PQC.; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.   The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 02-Sep-2021, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), lot #T016159 which has been verified to be valid, expiration date: 28-Feb-2022, administered at a dose of 0.5 milliters, for prophylaxis (route of administration and anatomical site of injection were not reported). On 02-Mar-2022, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), lot # T034630 which has been verified to be valid, expiration date: 22-Jun-2022, administered at a dose of 0.5 milliters, for prophylaxis (route of administration and anatomical site of injection not reported). The reporter was looking over documentation and realized that the patient may have received 2 doses of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) about 6 months apart (Extra dose administered). The reporter was unable to confirm if this was a simple documentation error or if the patient actually received two doses. The reason behind the second dose in question was unknown.   No additional information and no additional adverse event were reported at the time (no adverse event).
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: After my previous dose last December, I had a fever of 101°F, which has been a consistent reaction for me after Moderna vaccines in the past; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (After my previous dose last December, I had a fever of 101°F, which has been a consistent reaction for me after Moderna vaccines in the past) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PYREXIA (After my previous dose last December, I had a fever of 101°F, which has been a consistent reaction for me after Moderna vaccines in the past). At the time of the report, PYREXIA (After my previous dose last December, I had a fever of 101°F, which has been a consistent reaction for me after Moderna vaccines in the past) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101degree Farenheit.   The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   No concomitant medications were reported.  It was reported that patient received last dose of Moderna vaccine on last December and she experienced fever of 101-degree Fahrenheit, which had been a consistent reaction for the patient after Moderna vaccines in the past.  It was reported that patient recently received Spikevax 2024-2025 PFS vaccine and patient doesn't experience any fever at all.  Patient was just wondering since the "DIS" date was quite a while ago (Aug-2024), could that affect the vaccine's effectiveness.  It was unknown if the patient experienced any additional symptoms or events.  No treatment medications were reported.   This case was linked to MOD-2025-787102 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2025: Live follow-up received contains non-significant information and reference number added.
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: After my previous dose last December, I had a fever of 101°F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (After my previous dose last December, I had a fever of 101°F) in a  patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PYREXIA (After my previous dose last December, I had a fever of 101°F). At the time of the report, PYREXIA (After my previous dose last December, I had a fever of 101°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: I had a fever of 101°F.         Concomitant medication use information was not provided by reporter.  It was reported that, in Dec-2024 patient received vaccine and experienced fever of 101-degree Fahrenheit, which was consistent reaction after Moderna vaccines in the past.   Patient recently received another dose of Spikevax 2024-2025 PFS vaccine (lot 3043333) and did not experience any fever at all at this time. Patient was just wondering since the "DIS" date was quite a while ago (Aug-2024), could that affect the vaccine's effectiveness.  Treatment medication use information was not provided by reporter.   This case was linked to MOD-2025-787103 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2025: Live follow-up received which contains non-significant information, reference number added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: B-cell lymphoma
Clinical narrative: Low grade B cell non-Hodgkin's lymphoma; This spontaneous case was reported by a consumer and describes the occurrence of B-CELL LYMPHOMA (Low grade B cell non-Hodgkin's lymphoma) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A20A, 027A21A, 058E21A and 065K21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Gaucher's disease, Hypertension and Obesity.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On 11-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On 15-Jul-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced B-CELL LYMPHOMA (Low grade B cell non-Hodgkin's lymphoma) (seriousness criterion medically significant). At the time of the report, B-CELL LYMPHOMA (Low grade B cell non-Hodgkin's lymphoma) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported. Moderna COVID-19 Vaccine Dose 5 with lot AU3918E taken on 7-Nov-2023 and Dose 6 lot number 3042388 taken on 08-Oct-2024. The patient was diagnosed with low grade B cell non-Hodgkin's lymphoma in Jul-2023 after receiving the Moderna COVID-19 vaccine. She also had an incurable, lysosomal storage disorder genetic (Gaucher's) disease in which she had a Medi port that she took treatment, and an enzyme replacement therapy every other week to stay alive. She also had hypertension and was obese, all which was confirmed to be pre-existing prior to receiving the COVID-19 vaccines.; Reporter's Comments: Due to lack of biological plausibility (and long latency), the causality of the events was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Drug ineffective, Influenza A virus test, Influenza B virus test
Clinical narrative: covid; covid; This is a spontaneous report received from a Physician from medical information team, Program ID.  An 80-year-old female 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "recovering" and all described as "covid". The event "covid" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (2025) Unknown results; Influenza A virus test: (2025) Unknown results; Influenza B virus test: (2025) Unknown results; Respiratory syncytial virus test: (2025) Unknown results; SARS-CoV-2 test: (2025) Positive, notes: 3rd or 4th day tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was the first time both reporter (husband) and his wife (the patient) had COVID since the beginning of the year. 3rd or 4th day, tested positive. They were put on Paxlovid and symptoms went absolutely away progressively. 5 days when they were on it, nasal drainage was much less, and it was putrid and coughing started to clear quite a bit. After 5th day, it was like a  reticence of the disease and it was worse that they have ever had and next 2 or 3 days it was progressively worse and worse and worse. At time of report, week after that, and they seem to be doing well.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with COMIRNATY (2024-2025 FORMULA can not be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: Respiratory syncytial virus test, SARS-CoV-2 test
Clinical narrative: covid; covid; This is a spontaneous report received from a Physician from medical information team, Program ID.  An 80-year-old female 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "recovering" and all described as "covid". The event "covid" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (2025) Unknown results; Influenza A virus test: (2025) Unknown results; Influenza B virus test: (2025) Unknown results; Respiratory syncytial virus test: (2025) Unknown results; SARS-CoV-2 test: (2025) Positive, notes: 3rd or 4th day tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was the first time both reporter (husband) and his wife (the patient) had COVID since the beginning of the year. 3rd or 4th day, tested positive. They were put on Paxlovid and symptoms went absolutely away progressively. 5 days when they were on it, nasal drainage was much less, and it was putrid and coughing started to clear quite a bit. After 5th day, it was like a  reticence of the disease and it was worse that they have ever had and next 2 or 3 days it was progressively worse and worse and worse. At time of report, week after that, and they seem to be doing well.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with COMIRNATY (2024-2025 FORMULA can not be fully excluded.