chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Psoriasis, Rheumatoid arthritis, SARS-CoV-2 test
Clinical narrative: rheumatoid arthritis and psoriasis flare ups; rheumatoid arthritis and psoriasis flare ups; tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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. Past drug history included: Xeljanz for rheumatoid arthritis; Xeljanz for psoriasis, notes: severe. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Aug2024, outcome "unknown" and all described as "tested positive for Covid"; RHEUMATOID ARTHRITIS (medically significant), PSORIASIS (non-serious), outcome "unknown" and all described as "rheumatoid arthritis and psoriasis flare ups". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Aug2024) Positive.  clinical information: Patient was on Xeljanz. She mentioned that every time she needs to get vaccinated, in this case the Covid-19 vaccine from Pfizer, she will be instructed by her HCP to stop taking Xeljanz and go on cold turkey. She will then have a flare up of her rheumatoid arthritis, severe psoriasis, "and it just goes angry." She wants to know if the reaction is related to her going cold turkey on Xeljanz. No further information found on abruptly stopping Xeljanz, causing rheumatoid arthritis and psoriasis flare ups. Condition may or may not be related to abrupt discontinuation of Xeljanz. She wants to know if the reaction is related to the Pfizer Covid-19 vaccine. No information on the vaccine causing rheumatoid arthritis and psoriasis flare ups. Condition may or may not be related to to the Covid-19 vaccine. She wants to know if her doctor did the right thing of making her stop Xeljanz every time she will get vaccinated. People who take XELJANZ/XELJANZ XR/XELJANZ Oral Solution should not receive live vaccines. People taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution can receive non-live vaccines. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to COMIRNATY. Patient was on Xeljanz. She tested positive for Covid yesterday. She had a prescription for Paxlovid. However, her doctors did not give her instructions on what to do with her Xeljanz medication. She was calling to see if she should stop or continue taking Xeljanz if she will be on Paxlovid. Explained that the flare up could be related to the Covid infection while on Xeljanz.
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Limb mass
Clinical narrative: developed a large red lump circular in arm; This is a spontaneous report received from an Other HCP from a sales representative.  A female patient (unknown if pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MASS (non-serious), outcome "unknown", described as "developed a large red lump circular in arm". Therapeutic measures were taken as a result of vaccination site mass.  Additional information: Patient received any other vaccines on the same date as the reported vaccine(s) was unknown. Patient received any other vaccines within four weeks PRIOR to the reported vaccine(s) was unknown. The patient was taking any other medications within two weeks of the event starting was unknown. Treatment received for the adverse event was mentioned as seen by provider. Reported Event: Shot given about a week ago and recently developed a large red lump circular in arm.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Caller first had Covid when everybody had Covid, was sometime during Christmas.; Caller first had Covid when everybody had Covid, was sometime during Christmas.; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID:.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: MEN6201), on 09Mar2021 as dose 2, single (Lot number: ENU199) and on 15Oct2021 as dose 3 (booster), single (Lot number: 30125BA) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Had one kidney", start date: 2017 (unspecified if ongoing), notes: had tumor on it so had to have kidney removed, tumor was cancerous; "tumor was cancerous", start date: 2017 (unspecified if ongoing), notes: had tumor on it so had to have kidney removed, tumor was cancerous. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Caller first had Covid when everybody had Covid, was sometime during Christmas.". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid. Clinical course: Had COVID shots, had Covid: Clarified caller received multiple doses of the Pfizer COVID vaccine. Unknown how many doses total caller had of the Pfizer COVID vaccine because caller was told they were no longer writing down the information on the PRIVACY vaccination card. Caller thought probably had some doses of Pfizer COVID vaccine. Caller first had Covid when everybody had Covid, was sometime during Christmas. Caller has information for some of the doses, but then was told they weren't writing down the information on vaccination card anymore and some handwritten information caller cannot read on PRIVACY vaccination card. Caller has one kidney, sees kidney doctor, had tumor on it so had to have kidney removed, tumor was cancerous, sent to try to save but because was so large could not save the kidney. Date: Was probably been maybe 7 years ago.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400233993 same patient/product, different dose/event;US-PFIZER INC-202400234019 same reporter, different patient/event;
Sex: M
Vaccine: COVID19
Symptoms: Necrobiosis lipoidica diabeticorum
Clinical narrative: weird spots on legs/spots are dark and look like bruises/diagnosed with necrobiosis lipoidica; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NECROBIOSIS LIPOIDICA DIABETICORUM (non-serious) with onset Jun2021, 6 months after the suspect product(s) administration, outcome "not recovered", described as "weird spots on legs/spots are dark and look like bruises/diagnosed with necrobiosis lipoidica". The events "weird spots on legs/spots are dark and look like bruises/diagnosed with necrobiosis lipoidica" required physician office visit. It was unknown if therapeutic measures were taken as a result of necrobiosis lipoidica diabeticorum. Additional information: It was unknown if the patient receives any other vaccines within 4 weeks prior to the vaccine. Patient noticed weird spots on legs approximately 6 months after first series of the COVID-19 vaccine. Spots are dark and look like bruises. Spots are located on lower extremities mostly on calves although some occasional spots are seen on elbows as well. Patient visited a dermatologist and was diagnosed with necrobiosis lipoidica. Patient was otherwise healthy with no episodes of dark spots on legs prior to receiving the vaccine. It was unknown if the patient is taking any other medications within 2 weeks of the event start.    The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost taste and smell; lost taste and smell; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2020 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), administration date: 2020, for COVID-19 immunization. The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 2020, latency 1 week after the suspect product(s) administration, outcome "not recovered" and all described as "lost taste and smell".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Malaise; pain in injection arm; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: MALAISE (non-serious), outcome "recovered"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "pain in injection arm". It was unknown if therapeutic measures were taken as a result of malaise, vaccination site pain.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient (not pregnant) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 09Aug2024 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) in upper arm for immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Aug2024 at 15:00, outcome "not recovered", described as "Injection site pain". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccines on the same date nor within 4 weeks prior to Prevnar 20.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: asthma; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: ASTHMA (non-serious), outcome "unknown".  Additional information: Caller mentioned that she had her covid 19 vaccine today and she is having some asthma. Caller is asking if taking Ventolin inhaler will lower the effectiveness of the vaccine in anyway. Created manual AE form because had her covid-19 vaccine today and she is having asthma. Caller is asking if she can take Ventolin inhaler, possible drug  interaction.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: When I did get COVID I would never have known. but I would never have suspected I was sick.; When I did get COVID I would never have known. but I would never have suspected I was sick.; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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), outcome "unknown" and all described as "When I did get COVID I would never have known. but I would never have suspected I was sick.".  Clinical course: The reporter stated that "I remained Covid free until Jan2024. When I did get Covid I would never have known. I quarantined, but I would never have suspected I was sick"  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: Patient received vaccinations at 2:50 PM of TDAP, MCG, and HPV. After vaccination, patient became pale and was light headed. Patient's provider came to assist and brought her back to patient room. Patient did not lose consciousness.  Patient was alert.  Patient is continuing care with provider.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: C-reactive protein, Full blood count, Headache, Metabolic function test, Musculoskeletal stiffness
Clinical narrative: initially began with neck soreness/stiffness, headache, low grade fevers (100 F), then progressing to hives and urticaria
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Neck pain, Red blood cell sedimentation rate, Urticaria
Clinical narrative: initially began with neck soreness/stiffness, headache, low grade fevers (100 F), then progressing to hives and urticaria
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Cold sweat, Dizziness, Presyncope, Tinnitus
Clinical narrative: Patient had received the MenQuadfi vaccine, patient was standing to side watching twin sister have her vaccination and started to faint but did not faint completely or lose consciousness. Patient stated he felt dizzy and clammy and had ringing in his ears. This all resolved in a few minutes after sitting in a chair. Patient was observed for 30 minutes and patient had no further symptoms and all other symptoms had completely resolved. Patient was given an unopened cold bottle of water and sat in front of a fan (patient wanted cold air) during the 30 minute observation period. Patient stated he had the first dose of this vaccine series when he was younger and had no issue. (I checked the system and this first dose was not reported, however it may have been given before reporting was mandatory).
Age: 8.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Pruritus, Rash, Tuberculin test
Clinical narrative: Received IM Polio and Varicella this AM. Returned with Father a few hours later complaining of itching and rash. No report of difficult  breathing or wheezing. States itching is limited to chest and back. No itching to legs, arms or face. No previous allergic reactions. No other medications recently other than had a PPD test this AM also for TB testing. On exam noted very small granular rash to upper back and chest. No wheezing noted. Lung sounds clear throughout. Speaking in full sentences, no generalized rash noted. Recommended OTC loratidine and calamine lotion. Discussed concerning symptoms that would require an ER visit or calling 911 such as difficulty breathing, wheezing swelling of lips/tongue throat. Voiced undstanding.
Age: 67.0
Sex: F
Vaccine: RSV, FLU4, RSV
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis
Age: 67.0
Sex: F
Vaccine: RSV, FLU4, RSV
Symptoms: Chills, Hypopnoea, Throat tightness, Tremor
Clinical narrative: anaphylaxis
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: patient reports consistent pain in right arm muscle since injection 3/13/23. states that the pain limits the use of his arm.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Myalgia, Panic attack, Rash pruritic
Clinical narrative: Itchy rash, extreme fatigue, achy muscles, weakness, panic. Symptoms began the night after getting vaccine. Improved somewhat the next day.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Patient immediately had her vasal-vagal reaction right after receiving vaccine and passed out.  Myself and her acquaintance helped support her so she would not get hurt and I immediately administered smelling salts.  Patient regained consciousness quickly but felt very woozy and weak.  We laid her down with her legs elevated and monitored her blood pressure.  After about 10 minutes patient was feeling better and we moved her to sitting upright in a chair.  Observed for another 15-20 minutes in chair to be sure nothing else occurred before letting her go.  She confirmed this was her normal reaction that she has to most vaccines.  Her blood pressure had returned to her normal before she left.  I did a follow-up phone call 8/13/2024 and patient was doing well.
Age: 8.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Pediatrix which is approved for children 6 and under.  Patient was 8 years old at time of vaccination.  CDC recommends in this scenario vaccine is treated as a TDAP instead of DTAP and no other vaccines are needed.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Anxiety, Crying, Dyspnoea, Lethargy, Pallor
Clinical narrative: Pt was seen in office for routine vaccinations RN called into room by 2 Medical Assistants due to pt having a "possible reaction" to the vaccines he received - Patient received Kinrix (DTap/IPV) and MMR vaccines.   -Upon entrance into the room, RN observed patient alert but anxious, spitting into trash bin. Pt was crying, but did not have labored breathing at that time. -Dr. and RN provided patient reassurance and assessed for signs of reaction -Patient then went into respiratory distress-audible wheezing, gasping, increased work of breathing present  SP02 83% RA: RN delegated to MA to bring nasal cannula for oxygen tank Pt placed on 4L: 95% ON 4L Pt tachycardiac, HR 140s-150s  Pt developing hives on thighs and back, swelling in throat  RN administered Epinephrine 0.15 mg to patient (1 dose) Site: R thigh Lot 3FE405 EXP Nov 2024 After EpiPen Jr. administered: Pt's hives reduced Pt stable on 4L 02.  Pt appears lethargic but easily arousable, lips pale HR - 114 to 120's, BP stable and O2 sat 94%   Front desk placed call to 911 When EMS arrived, they assessed patient, and transported patient to hospital.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Pharyngeal swelling, Respiratory distress, Tachycardia, Urticaria, Wheezing
Clinical narrative: Pt was seen in office for routine vaccinations RN called into room by 2 Medical Assistants due to pt having a "possible reaction" to the vaccines he received - Patient received Kinrix (DTap/IPV) and MMR vaccines.   -Upon entrance into the room, RN observed patient alert but anxious, spitting into trash bin. Pt was crying, but did not have labored breathing at that time. -Dr. and RN provided patient reassurance and assessed for signs of reaction -Patient then went into respiratory distress-audible wheezing, gasping, increased work of breathing present  SP02 83% RA: RN delegated to MA to bring nasal cannula for oxygen tank Pt placed on 4L: 95% ON 4L Pt tachycardiac, HR 140s-150s  Pt developing hives on thighs and back, swelling in throat  RN administered Epinephrine 0.15 mg to patient (1 dose) Site: R thigh Lot 3FE405 EXP Nov 2024 After EpiPen Jr. administered: Pt's hives reduced Pt stable on 4L 02.  Pt appears lethargic but easily arousable, lips pale HR - 114 to 120's, BP stable and O2 sat 94%   Front desk placed call to 911 When EMS arrived, they assessed patient, and transported patient to hospital.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects, but vaccine was given 3 days after BUD day.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Redness, inflammation, and itching on the injection site started 3 days after vaccination.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Fall, Head injury, Nausea, Skin abrasion
Clinical narrative: After leaving our vaccine clinic pt was walking with his Father suddenly he fell to the ground.  He hit his head on the concrete, small abrasion to the let temporal area and to both knees. Father states he felt nausea no vomiting. He was cool and clammy O2 Sats 97 to 100% HR92 to 95. Patient was alert and oriented. EMS called per protocol, paramedics took patient to ER .
Age: 12.0
Sex: F
Vaccine: HIBV, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given Haemophilus B PedvaxHIB in error.  Staff realized and then administered the Meningococcal conjugate vaccination. Patient was evaluated by provider (who is also the patient's mom). No symptoms noted.  Provider was spoken to at 6:30 pm and still no symptoms noted.  Patient was being seen in the clinic at the time of administration.
Age: 27.0
Sex: F
Vaccine: COVID19-2, HEP, MMR, TDAP, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a dose of boostrix and covid-19 after they just received a dose of each on 6/27/24. No adverse event reported by patient but vaccines were given outside of the recommended dosing interval
Sex: M
Vaccine: MENB
Symptoms: Diarrhoea, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Fever the next day. Swelling 1 cm at injection site. Diarrhea. Itchy skin around mouth which mother thinks due to avocado.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Discomfort, Injection site pain
Clinical narrative: Besides the normal soreness at the injection site, my hip joints hurt.  I've never had any issues with any of my joints.  I'm healthy, not overweight, eat well, and I am on no medications.  They are just so sore and I can not seem to get comfortable, even while sitting down.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Mild, Additional Details: vaers asked for patient medical record to fax or email--but fax been busy, so i am reporting on vaers
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Foetal distress syndrome, Intensive care, Maternal exposure before pregnancy, Meconium in amniotic fluid
Clinical narrative: Stress on the baby during birth; Long labor; Defecate within womb; C-section; Vaccination in 2009 then pregnancy on an unspecified date after vaccination; This retrospective pregnancy report has been received from a lawyer on 17-MAY-2024 referring an approximately 20-year-old female patient regarding a case in litigation (same patient related case 2306USA007593 and child case 2405USA008164). The patient's medical history included use of cannabis for 9 years as needed for pain and diet. The patient's concurrent conditions and concomitant medications were not reported.  On 14-JUL-2009, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), with lot number 0653X, applied in left deltoid (dose and route of administration were not reported).  On an unspecified date in August 2019, the patient became pregnant with unknown last menstrual (LMP) date and unknown estimated delivery date (EDD). Due to the presence or the scar tissues from her cervical cancer surgeries, her birth became very difficult and she was obligated to have a C-section. Many complications occurred as a result or this as she and her child Ianded in the neonatal intensive care unit (NICU) from the long labor (long labour). The stress on the baby during birth (foetal distress) caused him to defecate within the womb (meconium in amniotic fluid) in which he inhaled and affected his breathing.  At the reporting time, the outcome of the reported events was unknown. The patient considered the events to be related to vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as claimed that vaccine affected her gynecological health in this way.  Follow-up information information has been received on 08-AUG-2024 from via medical records (MR). On 14-JUL-2009, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) with expiration date: 25-FEB-2011, administered intramuscularly.  Upon internal review, the events caesarean section, foetal distress and meconium in amniotic fluid were determined to be medically significant.  This is one of several reports captured from the same source.; Sender's Comments:  US-009507513-2306USA007593:
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Post procedural complication, Pregnancy, Prolonged labour
Clinical narrative: Stress on the baby during birth; Long labor; Defecate within womb; C-section; Vaccination in 2009 then pregnancy on an unspecified date after vaccination; This retrospective pregnancy report has been received from a lawyer on 17-MAY-2024 referring an approximately 20-year-old female patient regarding a case in litigation (same patient related case 2306USA007593 and child case 2405USA008164). The patient's medical history included use of cannabis for 9 years as needed for pain and diet. The patient's concurrent conditions and concomitant medications were not reported.  On 14-JUL-2009, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), with lot number 0653X, applied in left deltoid (dose and route of administration were not reported).  On an unspecified date in August 2019, the patient became pregnant with unknown last menstrual (LMP) date and unknown estimated delivery date (EDD). Due to the presence or the scar tissues from her cervical cancer surgeries, her birth became very difficult and she was obligated to have a C-section. Many complications occurred as a result or this as she and her child Ianded in the neonatal intensive care unit (NICU) from the long labor (long labour). The stress on the baby during birth (foetal distress) caused him to defecate within the womb (meconium in amniotic fluid) in which he inhaled and affected his breathing.  At the reporting time, the outcome of the reported events was unknown. The patient considered the events to be related to vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as claimed that vaccine affected her gynecological health in this way.  Follow-up information information has been received on 08-AUG-2024 from via medical records (MR). On 14-JUL-2009, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) with expiration date: 25-FEB-2011, administered intramuscularly.  Upon internal review, the events caesarean section, foetal distress and meconium in amniotic fluid were determined to be medically significant.  This is one of several reports captured from the same source.; Sender's Comments:  US-009507513-2306USA007593:
Age: 1.08
Sex: M
Vaccine: VARCEL, MMR
Symptoms: Immunodeficiency, Laboratory test abnormal, Rash, Skin ulcer, Streptococcal bacteraemia
Clinical narrative: Patient received his 12 month MMR vaccine on 2/2/24 and roughly a month later he and his twin developed skin manifestations of disseminated varicella infection with confirmation by PCR.  Genetic testing revealed a diagnosis of NIK deficiency, a rare life-threatening immunodeficiency.    Patient was admitted on 3/9/24 to hospital for disseminated varicella infection with concern for superimposed infection with purulent lesions. He was transferred to another hospital on 4/1 for ongoing treatment of disseminated varicella and expedited work up of immunocompromised state. He was intubated on 5/17 given decline in respiratory status presumably due to varicella pneumonitis. With his brother also having measles pneumonitis based on autopsy and given PCR testing that was positive for measles, this was considered a likely as well.
Age: 1.08
Sex: M
Vaccine: VARCEL, MMR
Symptoms: Varicella
Clinical narrative: Patient received his 12 month MMR vaccine on 2/2/24 and roughly a month later he and his twin developed skin manifestations of disseminated varicella infection with confirmation by PCR.  Genetic testing revealed a diagnosis of NIK deficiency, a rare life-threatening immunodeficiency.    Patient was admitted on 3/9/24 to hospital for disseminated varicella infection with concern for superimposed infection with purulent lesions. He was transferred to another hospital on 4/1 for ongoing treatment of disseminated varicella and expedited work up of immunocompromised state. He was intubated on 5/17 given decline in respiratory status presumably due to varicella pneumonitis. With his brother also having measles pneumonitis based on autopsy and given PCR testing that was positive for measles, this was considered a likely as well.
Age: 1.08
Sex: M
Vaccine: VARCEL, MMR
Symptoms: Disseminated varicella, Endotracheal intubation, Gene mutation identification test positive, Immunodeficiency, Morbillivirus test positive
Clinical narrative: Patient received his 12 month MMR vaccine on 2/2/24 and roughly a month later he and his twin developed skin manifestations of disseminated varicella infection with confirmation by PCR.  Genetic testing revealed a diagnosis of NIK deficiency, a rare life-threatening immunodeficiency.    Patient was admitted on 3/9/24 to hospital for disseminated varicella infection with concern for superimposed infection with purulent lesions. He was transferred to another hospital on 4/1 for ongoing treatment of disseminated varicella and expedited work up of immunocompromised state. He was intubated on 5/17 given decline in respiratory status presumably due to varicella pneumonitis. With his brother also having measles pneumonitis based on autopsy and given PCR testing that was positive for measles, this was considered a likely as well.
Age: 1.08
Sex: M
Vaccine: VARCEL, MMR
Symptoms: Pneumonitis, Polymerase chain reaction positive, Respiratory depression, Skin lesion, Varicella virus test positive
Clinical narrative: Patient received his 12 month MMR vaccine on 2/2/24 and roughly a month later he and his twin developed skin manifestations of disseminated varicella infection with confirmation by PCR.  Genetic testing revealed a diagnosis of NIK deficiency, a rare life-threatening immunodeficiency.    Patient was admitted on 3/9/24 to hospital for disseminated varicella infection with concern for superimposed infection with purulent lesions. He was transferred to another hospital on 4/1 for ongoing treatment of disseminated varicella and expedited work up of immunocompromised state. He was intubated on 5/17 given decline in respiratory status presumably due to varicella pneumonitis. With his brother also having measles pneumonitis based on autopsy and given PCR testing that was positive for measles, this was considered a likely as well.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, UNK
Symptoms: Laboratory test abnormal, Mobility decreased, Peripheral swelling, Pyomyositis, Skin ulcer
Clinical narrative: Patient received his 12 month MMR vaccine on 2/2/24 and roughly a month later he and his twin developed skin manifestations of disseminated varicella infection with confirmation by PCR.  Subsequent testing also revealed positive measles PCR.  Genetic testing revealed a diagnosis of NIK deficiency, a rare life-threatening immunodeficiency.    He developed progressive mixed hypercapnic and hypoxic respiratory failure requiting intubation on 4/26. He ultimately escalated to ECMO on 5/1. He remained on ECMO until time of death when care with was withdrawn on 5/24.  Autopsy revealed 1. Viral pneumonia, extensive and severe, with features of active measles infection 2. Viral hepatitis, with features of active measles infection  3. Viral adrenalitis, with features of active measles infection 4. Innumerable round cutaneous lesions suggestive of VZV infection, at various stages of healing/scarring
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, UNK
Symptoms: Streptococcal bacteraemia, Varicella, Varicella virus test positive
Clinical narrative: Patient received his 12 month MMR vaccine on 2/2/24 and roughly a month later he and his twin developed skin manifestations of disseminated varicella infection with confirmation by PCR.  Subsequent testing also revealed positive measles PCR.  Genetic testing revealed a diagnosis of NIK deficiency, a rare life-threatening immunodeficiency.    He developed progressive mixed hypercapnic and hypoxic respiratory failure requiting intubation on 4/26. He ultimately escalated to ECMO on 5/1. He remained on ECMO until time of death when care with was withdrawn on 5/24.  Autopsy revealed 1. Viral pneumonia, extensive and severe, with features of active measles infection 2. Viral hepatitis, with features of active measles infection  3. Viral adrenalitis, with features of active measles infection 4. Innumerable round cutaneous lesions suggestive of VZV infection, at various stages of healing/scarring
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, UNK
Symptoms: Adrenalitis, Autopsy, Cytogenetic analysis abnormal, Death, Disseminated varicella zoster virus infection
Clinical narrative: Patient received his 12 month MMR vaccine on 2/2/24 and roughly a month later he and his twin developed skin manifestations of disseminated varicella infection with confirmation by PCR.  Subsequent testing also revealed positive measles PCR.  Genetic testing revealed a diagnosis of NIK deficiency, a rare life-threatening immunodeficiency.    He developed progressive mixed hypercapnic and hypoxic respiratory failure requiting intubation on 4/26. He ultimately escalated to ECMO on 5/1. He remained on ECMO until time of death when care with was withdrawn on 5/24.  Autopsy revealed 1. Viral pneumonia, extensive and severe, with features of active measles infection 2. Viral hepatitis, with features of active measles infection  3. Viral adrenalitis, with features of active measles infection 4. Innumerable round cutaneous lesions suggestive of VZV infection, at various stages of healing/scarring
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, UNK
Symptoms: Endotracheal intubation, Gene mutation, Hepatitis viral, Immunodeficiency, Lung assist device therapy
Clinical narrative: Patient received his 12 month MMR vaccine on 2/2/24 and roughly a month later he and his twin developed skin manifestations of disseminated varicella infection with confirmation by PCR.  Subsequent testing also revealed positive measles PCR.  Genetic testing revealed a diagnosis of NIK deficiency, a rare life-threatening immunodeficiency.    He developed progressive mixed hypercapnic and hypoxic respiratory failure requiting intubation on 4/26. He ultimately escalated to ECMO on 5/1. He remained on ECMO until time of death when care with was withdrawn on 5/24.  Autopsy revealed 1. Viral pneumonia, extensive and severe, with features of active measles infection 2. Viral hepatitis, with features of active measles infection  3. Viral adrenalitis, with features of active measles infection 4. Innumerable round cutaneous lesions suggestive of VZV infection, at various stages of healing/scarring
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, UNK
Symptoms: Morbillivirus test positive, Pneumonia measles, Pneumonia viral, Respiratory failure, Scar
Clinical narrative: Patient received his 12 month MMR vaccine on 2/2/24 and roughly a month later he and his twin developed skin manifestations of disseminated varicella infection with confirmation by PCR.  Subsequent testing also revealed positive measles PCR.  Genetic testing revealed a diagnosis of NIK deficiency, a rare life-threatening immunodeficiency.    He developed progressive mixed hypercapnic and hypoxic respiratory failure requiting intubation on 4/26. He ultimately escalated to ECMO on 5/1. He remained on ECMO until time of death when care with was withdrawn on 5/24.  Autopsy revealed 1. Viral pneumonia, extensive and severe, with features of active measles infection 2. Viral hepatitis, with features of active measles infection  3. Viral adrenalitis, with features of active measles infection 4. Innumerable round cutaneous lesions suggestive of VZV infection, at various stages of healing/scarring
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, UNK
Symptoms: Skin lesion, Varicella virus test positive
Clinical narrative: Patient received his 12 month MMR vaccine on 2/2/24 and roughly a month later he and his twin developed skin manifestations of disseminated varicella infection with confirmation by PCR.  Subsequent testing also revealed positive measles PCR.  Genetic testing revealed a diagnosis of NIK deficiency, a rare life-threatening immunodeficiency.    He developed progressive mixed hypercapnic and hypoxic respiratory failure requiting intubation on 4/26. He ultimately escalated to ECMO on 5/1. He remained on ECMO until time of death when care with was withdrawn on 5/24.  Autopsy revealed 1. Viral pneumonia, extensive and severe, with features of active measles infection 2. Viral hepatitis, with features of active measles infection  3. Viral adrenalitis, with features of active measles infection 4. Innumerable round cutaneous lesions suggestive of VZV infection, at various stages of healing/scarring
Age: 0.17
Sex: U
Vaccine: HPV9, HPV9, HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AEs were reported; Physician reported that a 2 month old infant received a dose of GARDASIL 9 due to a human error; This spontaneous report was received from Physician and refers to a 2-month-old patient (gender not provided).  The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were not reported.  On 08-AUG-2024, the patient was vaccinated  with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #x020725, expiration date: 16-APR-2026, administered for prophylaxis (strength, and route of administration were not provided) due to a human error. No additional adverse event was reported. .
Age: 0.17
Sex: U
Vaccine: HPV9, HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs were reported; Physician reported that a 2 month old infant received a dose of GARDASIL 9 due to a human error; This spontaneous report was received from Physician and refers to a 2-month-old patient (gender not provided).  The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were not reported.  On 08-AUG-2024, the patient was vaccinated  with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #x020725, expiration date: 16-APR-2026, administered for prophylaxis (strength, and route of administration were not provided) due to a human error. No additional adverse event was reported. .
Age: 1.0
Sex: M
Vaccine: MMR, PNC20, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Improper storage of product in use; no adverse event; This spontaneous report was received from Medical Assistant and refers to an 1-year-old male patient. The patient was born with birth weight of 6.6 lb 5 oz; no more information about the patient's medical history, or concurrent conditions were reported. The patient's concomitant therapies were reported as "none". The patient on an unknown dates, was vaccinated with one dose of Pneumococcal Vaccine (13V) and two doses of Pneumococcal Vaccine (20V).  On 21-MAY-2024, the patient was vaccinated with an improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #W035041, expiration date: 24-MAY-2024, albumin status of recombinant human albumin (rHA), it was his first dose, administered for prophylaxis in his right tight (strength, frequency, scheme, and route of administration were not provided); varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X018954, expiration date: 13-JUL-2025, it was his first dose, administered for prophylaxis in his right tight (strength, frequency, scheme, and route of administration were not provided); and  pneumococcal vaccine conj 20v (crm197) (PREVNAR 20), unk, expiration date: 31-JAN-2025, administered for prophylaxis in his left tight, lot #HA2258, expiration date: 31-JAN-2025, (strength, formulation, frequency, scheme, and route of administration were not provided) (Improper storage of product in use). The vaccines were administered according to the instruction leaflet by a healthcare professional trained operator, in a Private doctor's office/hospital and purchased with public funds.  It was reported that a Digital Data Logger was involved in the sixteen different temperature excursions which underwent the vaccines. No adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No side effects reported; HBP calling to report VARIVAX and PROQUAD were inadvertently administered on the same day. No side effects reported. No additional information/clarification. No additional AE/no PQC.; This spontaneous report was received from an office manager and to a 1 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. Concomitant medications included sterile diluent (manufacturer unknown).     On 10-JUL-2024, the patient was inadvertently vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL (lot # X026789, expiration date: 14-NOV-2025); and with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL (lot # X026409, expiration date: 07-MAY-2025, albumin status established as rHA) (dose number, route of administration, anatomical location not provided) as prophylaxis (inappropriate schedule of product administration). No side effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse side effects were reported.; HCP called for TE for ROTATEQ . Products were administered 6/26/2024; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 14-JUN-2024, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1989398, expiration date: 25-NOV-2024 underwent a temperature excursion (TE) at a temperature of 51 degrees Fahrenheit (F) for time frame of 446 hours. On 26-JUN-2024, the patient was vaccinated with improperly stored vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1989398, expiration date reported and confirmed as 25-NOV-2024, administered orally for prophylaxis (strength and exact dose were not provided) (Product storage error). The healthcare professional did not have patient information at the time of the call. In addition, no adverse side effects were reported (no adverse event).   This is one of several reports that were received from the same reporter.; Sender's Comments:  US-009507513-2407USA010431: US-009507513-2407USA015892: US-009507513-2407USA015881: US-009507513-2407USA010455: US-009507513-2407USA015998: US-009507513-2407USA015997: US-009507513-2407USA016011: US-009507513-2408USA000111: US-009507513-2408USA002567: US-009507513-2407USA016011:
Age: 1.0
Sex: U
Vaccine: HEP, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; HCP calling to find out the side effects for a 12-month-old patient who received extra dose of Hepatitis B in the form of RECOMBIVAX HB.; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 05-OCT-2023, 11-DEC-2023, and 14-FEB-2024, the patient was vaccinated with the first, second, and third dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) completing the vaccine series. However, inadvertently on 08-AUG-2024, the patient received hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, vial formulation, lot #X002469, expiration date: 22-MAY-2025, administered for prophylaxis (strength, and route of administration were not provided) (Extra dose administered). No additional adverse event was reported.
Sex: F
Vaccine: DTAP
Symptoms: No adverse event
Clinical narrative: advised that she would be needing a 2nd dose of Daptace due to being malnourished with no reported adverse event; Initial information received on 02-Aug-2024 regarding an unsolicited valid  non-serious case received from a patient.  This case involves an unknown age female patient who was advised that she would be needing a 2nd dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] due to being malnourished with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Malnutrition.   On an unknown date, patient was advised that she would be needing a 2nd dose of  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection via unknown route in unknown administration site for Immunization (strength, dose, batch number and expiry date unknown) due to being malnourished with no reported adverse event (off label use) (latency same day).  Information on batch number corresponding to the one at time of event occurrence could not be requested
Sex: U
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired IMOVAX RABIES vaccine, with no reported adverse event; Initial information received on 07-Aug-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves an unknown age and unknown gender patient who was administered an expired rabies (HDC) vaccine [Imovax Rabies], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 03-Aug-2024, the patient received an unknown (total) dose of suspect rabies (HDC) vaccine, Powder and solvent for suspension for injection (strength: unknown) (lot: 151256, expiry date: 20-Jan-2024) via unknown route in an unknown administration site as prophylactic vaccination (immunization) and administered an expired imovax rabies vaccine, with no reported adverse event (expired product administered).  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.