chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: really felt very ill; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. Other Case identifier(s): MOD-2024-770340 (Moderna Therapeutics), US-OCCC-CINT0014464 (Moderna Therapeutics), US-MODERNATX-MOC20240626000045 (Moderna Therapeutics).  An elderly patient received BNT162b2 (BNT162B2), in Feb2021 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: Bnt162b22 (DOSE 1), administration date: Jan2021, for COVID-19 immunization, reaction(s): "I didn't feel well". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "really felt very ill".  Additional information: The patient first vaccines were Pfizer and did not feel well.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cor pulmonale, Hypertension
Clinical narrative: pulmonary heart disease; hypertension; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 75-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2024 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization completed), for Covid-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER)), for Covid-19 Immunization. The following information was reported: COR PULMONALE (medically significant), outcome "unknown", described as "pulmonary heart disease"; HYPERTENSION (non-serious), outcome "unknown".  Clinical course: Caller stated have taken paxlovid before. Patient has hypertension and pulmonary heart disease took booster shot this year. Caller stated has had every vaccine and booster pfizer has given.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400208004 Same Patient/drug, different dose/AE;
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ipol was not prepared in a sterile hood with no adverse event; Initial information received on 27-Jun-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient and ipv (vero) [Ipol] was not prepared in a sterile hood with no 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 a dose of suspect Suspension for injection of ipv (vero) (dose, batch number, expiry date, frequency, strength, route, administration site was unknown) as prophylactic vaccination and ipol was not prepared in a sterile hood with no adverse event (product preparation error) (unknown latency).  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   It was reported "Caller wanted to know how long the product was good for after first puncture. Caller stated that they do not use a hood but have a AC filter. They use excellent technique but not aseptic. Their airconditioner is excellent but the IPOL was just not prepared in a sterile hood. They do clean the area prior to administering the vaccines."   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: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: vaccine coordinator stated that only the liquid component (dtap-ipv) of pentacel was administered and not the lyophilized component (hib) with no reported adverse event; Initial information received on 27-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient whose vaccine coordinator stated that only the liquid component (dtap-ipv) of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero)] was administered and not the lyophilized component (hib) 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 hepatitis A vaccine for Prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination.  On 20-Jun-2024, the patient's vaccine coordinator stated that only the liquid component (dtap-ipv) of 3rd dose of 0.5 ml dose of suspect Powder and suspension for suspension for injection of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (lot UJ972AA, Expiry date: 10-Nov-2024) via intramuscular route in the right vastus lateralis as immunization was administered and not the lyophilized component (hib) with no reported adverse event (single component of a two-component product administered) (Latency: same day).   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: IPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: overdose of IPOL with no adverse event; Initial information received on 28-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 45 years old male patient who had overdose of IPV (VERO) [IPOL] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jun-2024, the patient received 2.5 ml dose of suspect IPV (VERO), Suspension for injection (lot W1A101M; strength, expiry date not reported) via unknown route in the left arm for Immunization  On 26-Jun-2024 on same day the patient had overdose of ipol with no adverse event (overdose).  The reporter reported that a consumer received IPOL 2.5 mL dose due to thinking the multidose vial was a single-dose vial. The consumer was given the entire vial of IPOL.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.
Age: 0.17
Sex: F
Vaccine: MEN, PNC
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2-month old patient was given with menquadfi instead of prevnar with no reported adverse event; Initial information received on 03-Jul-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 2 months old female patient who was given With Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] instead of Prevnar (Pneumococcal Vaccine CONJ 7V (CRM197)) 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 Rotavirus Vaccine for Immunisation; and Diphtheria Vaccine Toxoid, Hib Vaccine Conj (Tet Tox), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Mrc 5), Tetanus Vaccine Toxoid (Pentacel) for Immunisation.  On 03-Jul-2024, the patient received a  dose of 0.5 ml of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine  (Solution for injection) (expiry date, lot number not reported) via unknown route in the right thigh and PREVNAR not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for all prophylactic vaccination (Immunization). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested.  On 03-JUL-2024 the 2-month old patient was given with Meningococcal A-C-Y-W135 (T Conj) Vaccine instead of Prevnar((Pneumococcal Vaccine CONJ 7V (CRM197)) ) with no reported adverse event (wrong product administered) (latency : same day).  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 and Module of the 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: 1.67
Sex: M
Vaccine: RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reported signs/symptoms reported by parent.
Age: 84.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient presented to the pharmacy ~48 hours following vaccination noting redness, soreness, and tightness of the arm several inches below injection site. Unclear if due to vaccine and advised patient to go to urgent care as symptoms are somewhat concerning of potential DVT. Patient verbalized understanding and stated they would be seen.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity, Vision blurred, Vitreous floaters
Clinical narrative: Patient received the vaccine around 10 AM in his left arm.  He felt well afterwards.  While at work around 3 PM he started to notice worsening pain in his left arm which was then followed by blurring of the vision of the left eye.  His vision change was limited only to his left eye.  He had normal vision when covering his left eye.  States he saw both fuzzy objects and it was harder to read as well as some doubling of letters.  He felt some irritation in the eye during the event.  He also felt lightheaded as though he may lose consciousness during the event.  His symptoms persisted for around 2 hours.  They started improving at that time and were resolved by the time he arrived in the emergency department.  He had a normal neurologic exam and funduscopic exam in the ED.  His visual acuity was normal. No further diagnostics were performed.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 10-year-old patient was given Moderna Spikevax - indicated for 12 year and older.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Single component of a two-component product administered
Clinical narrative: It was discovered that two patients received only the diluent and it wasn't reconstituted with the HIB vaccine. This patient is one of the last five patients to receive HIB when it was discovered. Unknown if patient received the diluent only or the actual HIB vaccine.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Single component of a two-component product administered
Clinical narrative: It was discovered that two patients received diluent only, and it wasn't reconstituted with the HIB vaccine. Patient is one of the last 5 patients to receive this vaccine and unknown if she received the actual vaccine or the diluent
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Single component of a two-component product administered
Clinical narrative: It was discussed that two patients received only the diluent and it wasn't reconstituted with the HIB vaccine. This patient is one of the last five patients to receive HIB when it was discovered. Unknown if patient received the diluent only or the actual HIB vaccine
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, HIBV, RV5
Symptoms: Fatigue, Pyrexia, Vomiting projectile
Clinical narrative: Fever ~ 104 evening of the vaccines with reported increased fatigue. "Projectile vomiting" the following day with fatigue. Parents brought patient to ED and received IV fluids prior to be discharged home.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Muscular weakness
Clinical narrative: Dizziness, weakness in knees
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient age at time of vaccine is 46 yrs old and is not immunocompromised or any other conditions, therefore does not meet the criteria for shingrix given prior to age 50yrs.  However, patient did receive shingrix vaccine.  Patient did not report any adverse reactions. I am reporting the incident based  on the patient not meeting the criteria for this vaccine.
Age: 56.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Diarrhoea, Pain
Clinical narrative: DIARRHEA, WHOLE BODY ACHES
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Asthenia, Decreased appetite, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Fever of 102.4 F, redness and swelling at injection site  about 1.5? in diameter, loss of appetite, loss of energy, headache
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever of 102.4 F, redness and swelling at injection site  about 1.5? in diameter, loss of appetite, loss of energy, headache
Age: 4.0
Sex: F
Vaccine: IPV, PNC20
Symptoms: Erythema, Swelling
Clinical narrative: Patient developed a localized erythema and swelling exceeding 4 inches.  Of note this was her first time receiving PCV 20, which I think is the vaccine of concern.  We are treating her with supportive management using NSAIDs and diphenhydramine
Age: 26.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Tinnitus
Clinical narrative: ringing in left ear
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site rash, Pain, Pyrexia
Clinical narrative: Low-grade fever, body aches, rash at injection site, fatigue, headache
Age: 71.0
Sex: U
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Patient stated that arm was extremely sore from shot. Advised that sore arm was normal.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error, Single component of a two-component product administered
Clinical narrative: It was discovered that two patients received only the diluent and not reconstituted with the actual vaccine. Patient is one of the first patients to last receive when this was discovered. Not sure if received actual vaccine or diluent
Sex: U
Vaccine: HEP, HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Pregnancy; Heplisav-B Administered in Error; Initial report received on 02-May-2024.  A physician in the initially reported to the Pregnancy Registry that she, a 36-year-old pregnant female (race and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while 12 weeks pregnant.  Medical history, allergies, and concomitant medications at the time of vaccination were not reported.   The last menstrual period date, pregnancy history, pregnancy risk factors, and estimated date of delivery were not reported.   On 16-Feb-2024, the patient received dose 1 of a hepatitis b vaccine {HEPLISAV-B (Lot number 943192, expiration date 08 Mar-2026, and NDC number unknown)} intramuscularly in the right deltoid when she was 12 weeks pregnant.   On an unreported date, week 20 of gestation,  the fetus was found to have pyelectasis.  Per the reporter, this can be something that will correct during growth. She has a follow up growth scan scheduled in Jul-2024 at 32 weeks gestation.    On 01-May-2024, 76 days after having been vaccinated with the first dose of a hepatitis B vaccine, HEPLISAV-B, the patient received the second dose of a hepatitis B vaccine {ENGERIX-B (no details provided)} and is scheduled for the third dose in August (date not yet determined).  At the time of reporting, on 02-May-2024, week 23 of gestation no adverse effects from the injection were reported.  No additional information was provided.  Company Comment: The company assessed the events as non-serious. Pyelocaliectasis is listed as an important medical event in EMA, however the company considers the event as non-serious. Pyelectasis is a variation of fetal development, occurs in about 1% of pregnancies and in over 90% of cases, it resolves on its own. With fetal pyelectasis, blockage is mild and results in a slight enlargement in the central area of the kidney. Additional monitoring during pregnancy and after birth is needed.; Sender's Comments: The company assessed the events as non-serious. Pyelocaliectasis is listed as an important medical event in EMA, however the company considers the event as non-serious. Pyelectasis is a variation of fetal development, occurs in about 1% of pregnancies and in over 90% of cases, it resolves on its own. With fetal pyelectasis, blockage is mild and results in a slight enlargement in the central area of the kidney. Additional monitoring during pregnancy and after birth is needed.
Sex: U
Vaccine: HEP, HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Heplisav-B Administered in Error; Initial report received on 02-May-2024.  A physician in the initially reported to the Pregnancy Registry that she, a 36-year-old pregnant female (race and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while 12 weeks pregnant.  Medical history, allergies, and concomitant medications at the time of vaccination were not reported.   The last menstrual period date, pregnancy history, pregnancy risk factors, and estimated date of delivery were not reported.   On 16-Feb-2024, the patient received dose 1 of a hepatitis b vaccine {HEPLISAV-B (Lot number 943192, expiration date 08 Mar-2026, and NDC number unknown)} intramuscularly in the right deltoid when she was 12 weeks pregnant.   On an unreported date, week 20 of gestation,  the fetus was found to have pyelectasis.  Per the reporter, this can be something that will correct during growth. She has a follow up growth scan scheduled in Jul-2024 at 32 weeks gestation.    On 01-May-2024, 76 days after having been vaccinated with the first dose of a hepatitis B vaccine, HEPLISAV-B, the patient received the second dose of a hepatitis B vaccine {ENGERIX-B (no details provided)} and is scheduled for the third dose in August (date not yet determined).  At the time of reporting, on 02-May-2024, week 23 of gestation no adverse effects from the injection were reported.  No additional information was provided.  Company Comment: The company assessed the events as non-serious. Pyelocaliectasis is listed as an important medical event in EMA, however the company considers the event as non-serious. Pyelectasis is a variation of fetal development, occurs in about 1% of pregnancies and in over 90% of cases, it resolves on its own. With fetal pyelectasis, blockage is mild and results in a slight enlargement in the central area of the kidney. Additional monitoring during pregnancy and after birth is needed.; Sender's Comments: The company assessed the events as non-serious. Pyelocaliectasis is listed as an important medical event in EMA, however the company considers the event as non-serious. Pyelectasis is a variation of fetal development, occurs in about 1% of pregnancies and in over 90% of cases, it resolves on its own. With fetal pyelectasis, blockage is mild and results in a slight enlargement in the central area of the kidney. Additional monitoring during pregnancy and after birth is needed.
Age: 83.0
Sex: M
Vaccine: CHIK, CHIK, CHIK
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood creatinine increased, Brain fog
Clinical narrative: Headache, chills, slight fever, muscle aches, joint aches, severe fatigue, brain fog, instable walking  which caused several days of sleeping day & night, followed by 2 trips to the Emergency Room and ultimately admission to the hospital for 2 days. Ultimately it has taken 4 weeks to completely recover. The symptoms lasted from 06/16/2024 until 07/09/2024.
Age: 83.0
Sex: M
Vaccine: CHIK, CHIK, CHIK
Symptoms: C-reactive protein increased, Chills, Dehydration, Encephalopathy, Fall
Clinical narrative: Headache, chills, slight fever, muscle aches, joint aches, severe fatigue, brain fog, instable walking  which caused several days of sleeping day & night, followed by 2 trips to the Emergency Room and ultimately admission to the hospital for 2 days. Ultimately it has taken 4 weeks to completely recover. The symptoms lasted from 06/16/2024 until 07/09/2024.
Age: 83.0
Sex: M
Vaccine: CHIK, CHIK, CHIK
Symptoms: Immunisation reaction, Influenza virus test negative, Liver function test increased, Magnetic resonance imaging, Malaise
Clinical narrative: Headache, chills, slight fever, muscle aches, joint aches, severe fatigue, brain fog, instable walking  which caused several days of sleeping day & night, followed by 2 trips to the Emergency Room and ultimately admission to the hospital for 2 days. Ultimately it has taken 4 weeks to completely recover. The symptoms lasted from 06/16/2024 until 07/09/2024.
Age: 83.0
Sex: M
Vaccine: CHIK, CHIK, CHIK
Symptoms: Muscular weakness, Pain, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Headache, chills, slight fever, muscle aches, joint aches, severe fatigue, brain fog, instable walking  which caused several days of sleeping day & night, followed by 2 trips to the Emergency Room and ultimately admission to the hospital for 2 days. Ultimately it has taken 4 weeks to completely recover. The symptoms lasted from 06/16/2024 until 07/09/2024.
Age: 83.0
Sex: M
Vaccine: CHIK, CHIK, CHIK
Symptoms: Arthralgia, Blood test, Brain fog, Chest X-ray, Chills
Clinical narrative: Headache, chills, slight fever, muscle aches, joint aches, severe fatigue, brain fog, instable walking  which caused several days of sleeping day & night, followed by 2 trips to the Emergency Room and ultimately admission to the hospital for 2 days. Ultimately it has taken 4 weeks to completely recover. The symptoms lasted from 06/16/2024 until 07/09/2024.
Age: 83.0
Sex: M
Vaccine: CHIK, CHIK, CHIK
Symptoms: Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram spine, Fatigue, Gait disturbance
Clinical narrative: Headache, chills, slight fever, muscle aches, joint aches, severe fatigue, brain fog, instable walking  which caused several days of sleeping day & night, followed by 2 trips to the Emergency Room and ultimately admission to the hospital for 2 days. Ultimately it has taken 4 weeks to completely recover. The symptoms lasted from 06/16/2024 until 07/09/2024.
Age: 83.0
Sex: M
Vaccine: CHIK, CHIK, CHIK
Symptoms: Headache, Hypersomnia, Magnetic resonance imaging head, Myalgia, Pyrexia
Clinical narrative: Headache, chills, slight fever, muscle aches, joint aches, severe fatigue, brain fog, instable walking  which caused several days of sleeping day & night, followed by 2 trips to the Emergency Room and ultimately admission to the hospital for 2 days. Ultimately it has taken 4 weeks to completely recover. The symptoms lasted from 06/16/2024 until 07/09/2024.
Age: 83.0
Sex: M
Vaccine: CHIK, CHIK, CHIK
Symptoms: Fatigue, Impaired work ability, Loss of personal independence in daily activities, Malaise, Mobility decreased
Clinical narrative: Headache, chills, slight fever, muscle aches, joint aches, severe fatigue, brain fog, instable walking  which caused several days of sleeping day & night, followed by 2 trips to the Emergency Room and ultimately admission to the hospital for 2 days. Ultimately it has taken 4 weeks to completely recover. The symptoms lasted from 06/16/2024 until 07/09/2024.
Age: 83.0
Sex: M
Vaccine: CHIK, CHIK, CHIK
Symptoms: Myalgia, Pain
Clinical narrative: Headache, chills, slight fever, muscle aches, joint aches, severe fatigue, brain fog, instable walking  which caused several days of sleeping day & night, followed by 2 trips to the Emergency Room and ultimately admission to the hospital for 2 days. Ultimately it has taken 4 weeks to completely recover. The symptoms lasted from 06/16/2024 until 07/09/2024.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; VARIVAX was administered to a patient after experiencing a temperature excursion; This spontaneous report was received from a registered nurse referring to a 15-month-old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 13-MAR-2024, the patient was vaccinated with a dose varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X021930, expiration date: 29-AUG-2025, administered for prophylaxis (strength, and route of administration were not provided) after experiencing a temperature excursion. No symptoms were reported. No additional adverse event reported.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: No injuries occurred due to breakage.; HCP called to report finger flange on 1 VAXNEUVANCE syringe broke upon administering it to patient.  Patient received full dose.  No injuries occurred due to breakage.  Caller unable to provide lot#/expiration but will provide photos. Replacement req; HCP called to report finger flange on 1 VAXNEUVANCE syringe broke upon administering it to patient.  Patient received full dose.  No injuries occurred due to breakage.  Caller unable to provide lot#/expiration but will provide photos. Replacement req; Poor quality product administered; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 25-JUN-2024, the patient was vaccinated with a full dose (reported as quantity: 1) of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, valid lot #Y002963 (batch#0001716939), expiration date reported and confirmed as 04-OCT-2026, administered for prophylaxis (strength, and route of administration were not provided). The syringe tip cap was attached properly prior to use.  On the same day, it was noted that the finger flange (along the ring of where it attaches to the syringe) on the suspect vaccine syringe broke upon administering it to patient (syringe issue/poor quality device used/poor quality product administered). It was also reported that the tip of the syringe or Luer lock adaptor was not loose or broken off of the syringe tip and there was no difficulty attaching the syringe needle. In addition, the cellophane covering the syringe tray and it was completely sealed; the syringe carton was not damage prior use. The syringe was  not broken into 2 pieces or more, there was not crack. No injuries occurred due to breakage (no adverse event).
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: incomplete vaccination records including only a single dose of Twinrix from years prior.; This non-serious case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HAB (Twinrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date receive 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: incomplete vaccination records including only a single dose of Twinrix from years prior.). The outcome of the incomplete course of vaccination was unknown.   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-2024 The reporter participated in community pharmacist.  Many patients at supported present with incomplete vaccination records including only a single dose of Twinrix from years prior. The reporter wanted to complete the three-dose vaccine serious as efficiently as possible for these patients but could not found any resources indicating how long to wait between doses two (2) and three (3) when patients have well exceeded a typical dosing schedule of 0-1-6 months. In short, how long should a patient wait after receiving a second dose of Twinrix before receiving their last dose if they have exceeded their estimated vaccine schedule timeline. Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEP, MMR, UNK, VARZOS
Symptoms: Pain, Product storage error
Clinical narrative: Patient complained of being achy for 3 days after vaccines; This spontaneous report has been received by a nurse via other company regarding a patient of unknown age and gender (race reported as other). The patient's medical history, previous allergies, and concurrent conditions medication were not provided. The patient had not chronic problems. No information of previous coronavirus (covid) vaccine. The patient's concomitant medications included prenatal multivitamin plus DHA.   On 04-JUN-2024, the patient was vaccinated with the first regimen of Hepatitis B Vaccine (Recombinant) (manufacturer unknown) intramuscular injection, dose of 1 dosage form, intramuscularly administrated in deltoid (strength, frequency, vaccination scheme, and expiration date were not provided; lot number PE9G5, which was an invalid number); and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknow) subcutaneous injection, dose of 1 dosage form, subcutaneously administrated in deltoid (strength, frequency, vaccination scheme, lot #, and expiration date were not provided) as prophylaxis. Other suspect therapy included andusomeran (SPIKEVAX 2023-2024 PFS) (Moderna) injection, 0.5 mL, intramuscularly administrated in the deltoid (strength, frequency, vaccination scheme, and expiration date were not provided; lot number 203F23A and expiration date 01-MAY-2024) as COVID-19 prophylaxis. On unspecified date, the patient was vaccinated with the first regimen of Zoster Vaccine Live (manufacturer unknown) formulation as default: subcutaneous injection, dose of 1 dosage form (strength, frequency, route of administration, vaccination scheme, site of vaccination, and expiration date were not provided; lot number X007358, which was an invalid number) as prophylaxis. It was stated that the patient did not receive any vaccine 4 weeks prior to these vaccines, and the vaccines did not undergo any temperature excursions and they was thawed on the same day they were administered.  On 04-JUN-2024, the patient experienced pain and complained of it for 3 days after vaccines. Therefore, on 06-JUN-2024, the event of pain was recovered. No treatment information was reported.   The action taken regarding suspect vaccines with the event was considered as not applicable.  The causal relationship between suspect vaccines with the event was not provided.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Rash erythematous
Clinical narrative: red rash, non raised, no itching from my neck to torso. Some generalized achiness, fatigue.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypertonia, Pallor
Clinical narrative: Within a few minutes after injection my 2 month old turned pale and went limp like he was dead and had lacing on his arms. The nurse had to take him from me and bounce him to get him to come back to.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; HCP called to report TE where patient received the PEDVAX HIB. No symptoms reported. No further information provided. No additional AE/PQC.    PEDVAX HIB LOT: w006595   EXP: 10/10/2024  39.4F FOR 1 HOUR 50 MINUTES 0 SECONDS- CURRENT  NO PRIOR EXCURSI; This spontaneous report was received from a nurse concerning to a 9-week-old female patient. The patient's concurrent conditions, medical history, and concomitant medications were not provided.  On 29-MAY-2024, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) after stored improperly, at a dose of  0.5 milliliter, lot # W006595 with an expiration date of 10-OCT-2024, for prophylaxis (strength, vaccine schedule, route of administration, anatomical site of injection were not reported) (product storage error).  The vaccine had a temperature excursion of 39.4 Fahrenheit for 1 hour, 50 minutes and 0 seconds. No prior excursions. No adverse event.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Nausea, Pain in extremity
Clinical narrative: extremely sore arm, terrible flu like symptoms - chills, fever, nausea, headache, achy legs,
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: extremely sore arm, terrible flu like symptoms - chills, fever, nausea, headache, achy legs,
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: LEFT THIGH SWELLING REDNESS
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Bexsero was given at the wrong site causing pain, redness, and heat. Affected site is currently 4x4 inches and growing
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities
Clinical narrative: I received the pneumovaccine and the shingles vaccine on the same day in the same arm. I have subsequently developed progressive decrease in the range of movement in the left arm and pain with abduction above the horizontal. I can no longer use my left arm to wash my back and I experience shoulder pain when I sleep on my left side. I have no history of injury to my shoulders that would otherwise explain the stiffness and pain in my left arm. Prior to the vaccination, I was reassured that giving both vaccines in the same arm was not unsafe.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: I received the pneumovaccine and the shingles vaccine on the same day in the same arm. I have subsequently developed progressive decrease in the range of movement in the left arm and pain with abduction above the horizontal. I can no longer use my left arm to wash my back and I experience shoulder pain when I sleep on my left side. I have no history of injury to my shoulders that would otherwise explain the stiffness and pain in my left arm. Prior to the vaccination, I was reassured that giving both vaccines in the same arm was not unsafe.
Sex: U
Vaccine: MNQ
Symptoms: Product lot number issue
Clinical narrative: Menveo vaccination administered in clinic to patient. Nursing then noticed lot number printed on MenA Lyophilized vial was AMAA989A but the lot number printed on the removable sticker was AMVA989A
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: I feel flu like symptoms after having 2nd shingles prevention shot.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Gastrointestinal pain
Clinical narrative: Gastrointestinal pain and diarrhea that has not gone away.
Age: 72.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood culture positive, CSF cell count, CSF culture positive, CSF glucose decreased, Cryptococcus test positive
Clinical narrative: Patient was admitted to the Med-Surg/Tele unit of hospital with headache, dizziness, fever, and weight loss following a loading dose 2700 mg of Ultomiris for myasthenia gravis on 04/22/2024 and a 3300 mg maintenance dose on 05/06/2024. The patient received both the MenQuadfi and Bexsero vaccines on 04/04/2024. The patient was evaluated and was diagnosed with meningitis in hospital. A blood culture and CSF sample were taken, both of which grew Cryptococcus neoformans, which was deemed the causative organism for the patient's meningitis. Cryptococcus neoformans/gattii was also identified via Meningitis Encephalitis Panel by PCR. No other risk factors for meningitis were identified.
Age: 72.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Headache, Meningitis, Myasthenia gravis, Polymerase chain reaction positive
Clinical narrative: Patient was admitted to the Med-Surg/Tele unit of hospital with headache, dizziness, fever, and weight loss following a loading dose 2700 mg of Ultomiris for myasthenia gravis on 04/22/2024 and a 3300 mg maintenance dose on 05/06/2024. The patient received both the MenQuadfi and Bexsero vaccines on 04/04/2024. The patient was evaluated and was diagnosed with meningitis in hospital. A blood culture and CSF sample were taken, both of which grew Cryptococcus neoformans, which was deemed the causative organism for the patient's meningitis. Cryptococcus neoformans/gattii was also identified via Meningitis Encephalitis Panel by PCR. No other risk factors for meningitis were identified.
Age: 72.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pyrexia, Weight decreased
Clinical narrative: Patient was admitted to the Med-Surg/Tele unit of hospital with headache, dizziness, fever, and weight loss following a loading dose 2700 mg of Ultomiris for myasthenia gravis on 04/22/2024 and a 3300 mg maintenance dose on 05/06/2024. The patient received both the MenQuadfi and Bexsero vaccines on 04/04/2024. The patient was evaluated and was diagnosed with meningitis in hospital. A blood culture and CSF sample were taken, both of which grew Cryptococcus neoformans, which was deemed the causative organism for the patient's meningitis. Cryptococcus neoformans/gattii was also identified via Meningitis Encephalitis Panel by PCR. No other risk factors for meningitis were identified.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Amnesia, Anger, Chromaturia, Computerised tomogram abnormal
Clinical narrative: Subject presented to ER on 3/29/2024. Subject's son noted since previous hospitalization patient has been experiencing increased confusion at home. Son notes that he has had to stay with his father x 1 week as the patient has been experiencing increased confusion that include: occasional loss of time, difficultly ambulating d/t weakness, bouts of anger and yelling, and hallucinations. Son states that the patient usually ambulates by self but notes he has had to help him ambulate. Son notes he was treated for a UTI while admitted 1 week prior. Son denies any previous AMS hx. Patient states he has been experiencing left upper tooth pain x 1 week. Patient was seen by a dentist a few days ago and was referred to an oral surgeon for f/u April 2nd but notes the pain has become severe. Notes he has been unable to sleep d/t the pain. Patient notes this pain radiates to the left ear and left eye, causing occasional episodes of blurry vision. Patient also he has not experienced a BM x5 days. Patient denies abdominal pain but notes discomfort in his abdomen. Patient also notes decreased urinary output, states when he urinates, he only produces a mild amount of urine, and is very dark. Patient denies fever/chills. Patient received dialysis this morning but did not complete the dialysis treatment due to tooth pain. Patient was given morphine injection 2 mg. On this admission, MRI on (3/29/24) showed no acute pathology but only chronic infarcts. No stigmata of CNS infection or new stroke. Neurology was consulted due to concerns of CNS infection or meningoencephalitis due to previous VZV infection. CT Lumbar puncture on 4/2/24 showed no signs of infectious or inflammatory cause. Most likely a toxic metabolic encephalopathy versus vascular dementia due to medical cormorbidities, hospital acquired delirium, chronic infections, antivirals. Patient's symptom was unlikely secondary to tooth pain. CT Imaging of head and neck (3/13/24) on previous admission was remarkable for tooth infection without signs of abscess. Per patient's family's concern, follow-up with Neurology was set up for possible dementia. A follow-up with Palliative was set up to discuss further care as well. Subject discharged on 4/7/2024 to Rehab facility. Study Principal investigator has assessed the causality as not study related.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head abnormal, Computerised tomogram neck, Confusional state, Constipation, Dialysis
Clinical narrative: Subject presented to ER on 3/29/2024. Subject's son noted since previous hospitalization patient has been experiencing increased confusion at home. Son notes that he has had to stay with his father x 1 week as the patient has been experiencing increased confusion that include: occasional loss of time, difficultly ambulating d/t weakness, bouts of anger and yelling, and hallucinations. Son states that the patient usually ambulates by self but notes he has had to help him ambulate. Son notes he was treated for a UTI while admitted 1 week prior. Son denies any previous AMS hx. Patient states he has been experiencing left upper tooth pain x 1 week. Patient was seen by a dentist a few days ago and was referred to an oral surgeon for f/u April 2nd but notes the pain has become severe. Notes he has been unable to sleep d/t the pain. Patient notes this pain radiates to the left ear and left eye, causing occasional episodes of blurry vision. Patient also he has not experienced a BM x5 days. Patient denies abdominal pain but notes discomfort in his abdomen. Patient also notes decreased urinary output, states when he urinates, he only produces a mild amount of urine, and is very dark. Patient denies fever/chills. Patient received dialysis this morning but did not complete the dialysis treatment due to tooth pain. Patient was given morphine injection 2 mg. On this admission, MRI on (3/29/24) showed no acute pathology but only chronic infarcts. No stigmata of CNS infection or new stroke. Neurology was consulted due to concerns of CNS infection or meningoencephalitis due to previous VZV infection. CT Lumbar puncture on 4/2/24 showed no signs of infectious or inflammatory cause. Most likely a toxic metabolic encephalopathy versus vascular dementia due to medical cormorbidities, hospital acquired delirium, chronic infections, antivirals. Patient's symptom was unlikely secondary to tooth pain. CT Imaging of head and neck (3/13/24) on previous admission was remarkable for tooth infection without signs of abscess. Per patient's family's concern, follow-up with Neurology was set up for possible dementia. A follow-up with Palliative was set up to discuss further care as well. Subject discharged on 4/7/2024 to Rehab facility. Study Principal investigator has assessed the causality as not study related.
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Eye pain, Facial pain, Gait disturbance, Hallucination
Clinical narrative: Subject presented to ER on 3/29/2024. Subject's son noted since previous hospitalization patient has been experiencing increased confusion at home. Son notes that he has had to stay with his father x 1 week as the patient has been experiencing increased confusion that include: occasional loss of time, difficultly ambulating d/t weakness, bouts of anger and yelling, and hallucinations. Son states that the patient usually ambulates by self but notes he has had to help him ambulate. Son notes he was treated for a UTI while admitted 1 week prior. Son denies any previous AMS hx. Patient states he has been experiencing left upper tooth pain x 1 week. Patient was seen by a dentist a few days ago and was referred to an oral surgeon for f/u April 2nd but notes the pain has become severe. Notes he has been unable to sleep d/t the pain. Patient notes this pain radiates to the left ear and left eye, causing occasional episodes of blurry vision. Patient also he has not experienced a BM x5 days. Patient denies abdominal pain but notes discomfort in his abdomen. Patient also notes decreased urinary output, states when he urinates, he only produces a mild amount of urine, and is very dark. Patient denies fever/chills. Patient received dialysis this morning but did not complete the dialysis treatment due to tooth pain. Patient was given morphine injection 2 mg. On this admission, MRI on (3/29/24) showed no acute pathology but only chronic infarcts. No stigmata of CNS infection or new stroke. Neurology was consulted due to concerns of CNS infection or meningoencephalitis due to previous VZV infection. CT Lumbar puncture on 4/2/24 showed no signs of infectious or inflammatory cause. Most likely a toxic metabolic encephalopathy versus vascular dementia due to medical cormorbidities, hospital acquired delirium, chronic infections, antivirals. Patient's symptom was unlikely secondary to tooth pain. CT Imaging of head and neck (3/13/24) on previous admission was remarkable for tooth infection without signs of abscess. Per patient's family's concern, follow-up with Neurology was set up for possible dementia. A follow-up with Palliative was set up to discuss further care as well. Subject discharged on 4/7/2024 to Rehab facility. Study Principal investigator has assessed the causality as not study related.
Sex: M
Vaccine: COVID19
Symptoms: Infarction, Magnetic resonance imaging heart abnormal, Pain, Procedure aborted, Screaming
Clinical narrative: Subject presented to ER on 3/29/2024. Subject's son noted since previous hospitalization patient has been experiencing increased confusion at home. Son notes that he has had to stay with his father x 1 week as the patient has been experiencing increased confusion that include: occasional loss of time, difficultly ambulating d/t weakness, bouts of anger and yelling, and hallucinations. Son states that the patient usually ambulates by self but notes he has had to help him ambulate. Son notes he was treated for a UTI while admitted 1 week prior. Son denies any previous AMS hx. Patient states he has been experiencing left upper tooth pain x 1 week. Patient was seen by a dentist a few days ago and was referred to an oral surgeon for f/u April 2nd but notes the pain has become severe. Notes he has been unable to sleep d/t the pain. Patient notes this pain radiates to the left ear and left eye, causing occasional episodes of blurry vision. Patient also he has not experienced a BM x5 days. Patient denies abdominal pain but notes discomfort in his abdomen. Patient also notes decreased urinary output, states when he urinates, he only produces a mild amount of urine, and is very dark. Patient denies fever/chills. Patient received dialysis this morning but did not complete the dialysis treatment due to tooth pain. Patient was given morphine injection 2 mg. On this admission, MRI on (3/29/24) showed no acute pathology but only chronic infarcts. No stigmata of CNS infection or new stroke. Neurology was consulted due to concerns of CNS infection or meningoencephalitis due to previous VZV infection. CT Lumbar puncture on 4/2/24 showed no signs of infectious or inflammatory cause. Most likely a toxic metabolic encephalopathy versus vascular dementia due to medical cormorbidities, hospital acquired delirium, chronic infections, antivirals. Patient's symptom was unlikely secondary to tooth pain. CT Imaging of head and neck (3/13/24) on previous admission was remarkable for tooth infection without signs of abscess. Per patient's family's concern, follow-up with Neurology was set up for possible dementia. A follow-up with Palliative was set up to discuss further care as well. Subject discharged on 4/7/2024 to Rehab facility. Study Principal investigator has assessed the causality as not study related.