chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Anaemia, Angioedema, Blood cholesterol, Blood cholesterol increased
Clinical narrative: Angioedema; Swelling; Itchiness; Hives; Felt crappy; Cholesterol was a little high; Anemia; allergy to COVID boosters; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 4929271.  A 68-year-old female patient received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic urticaria" (ongoing); "Angioedema" (ongoing); "Upset stomach" (ongoing), notes: Upset stomach from salmon; "Allergic urticaria" (unspecified if ongoing); "Bronchial asthma" (unspecified if ongoing); "Wheezing" (unspecified if ongoing); "Reaction to Veraquad" (unspecified if ongoing). Concomitant medication(s) included: XOLAIR; FEXOFENADINE; CALCIUM; LEVOTHYROXINE; EZETIMIBE. The patient also took other concomitant therapy (Multivitamins). Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: ANGIOEDEMA (medically significant), outcome "not recovered"; SWELLING (non-serious), outcome "unknown"; PRURITUS (non-serious), outcome "unknown", described as "Itchiness"; URTICARIA (non-serious), outcome "unknown", described as "Hives"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt crappy"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "Cholesterol was a little high"; ANAEMIA (non-serious), outcome "unknown", described as "Anemia"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergy to COVID boosters". The patient underwent the following laboratory tests and procedures: Blood cholesterol: Little high, notes: Cholesterol was a little high.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, Swelling, Urticaria
Clinical narrative: Angioedema; Swelling; Itchiness; Hives; Felt crappy; Cholesterol was a little high; Anemia; allergy to COVID boosters; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 4929271.  A 68-year-old female patient received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic urticaria" (ongoing); "Angioedema" (ongoing); "Upset stomach" (ongoing), notes: Upset stomach from salmon; "Allergic urticaria" (unspecified if ongoing); "Bronchial asthma" (unspecified if ongoing); "Wheezing" (unspecified if ongoing); "Reaction to Veraquad" (unspecified if ongoing). Concomitant medication(s) included: XOLAIR; FEXOFENADINE; CALCIUM; LEVOTHYROXINE; EZETIMIBE. The patient also took other concomitant therapy (Multivitamins). Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: ANGIOEDEMA (medically significant), outcome "not recovered"; SWELLING (non-serious), outcome "unknown"; PRURITUS (non-serious), outcome "unknown", described as "Itchiness"; URTICARIA (non-serious), outcome "unknown", described as "Hives"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt crappy"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "Cholesterol was a little high"; ANAEMIA (non-serious), outcome "unknown", described as "Anemia"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergy to COVID boosters". The patient underwent the following laboratory tests and procedures: Blood cholesterol: Little high, notes: Cholesterol was a little high.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 21.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect route of product administration, No adverse event, Product administered at inappropriate site, Wrong product administered
Clinical narrative: IPOL was administered instead of the TB test with no reported adverse event; Initial information was received on 31-May-2024 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 21 years old female patient to whom IPV (VERO) [IPOL] was administered instead of the tb(tuberculin) test with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-May-2024, the patient received a 0.1 ml dose of suspect IPV (VERO) Suspension for injection (lot V1B891M, expiry date: 01-Jun-2024, strength: unknown) via intradermal route in the left arm for Immunisation and ipol was administered instead of the tb test with no reported adverse event (wrong product administered) (Latency: same day).  It was reported "HCP (healthcare professional) stated that one of their nurses noticed that a tuberculin skin test vial expired today (31May2024), so she pulled that vial and put it in their expired medications bin. She then proceeded to pull an IPOL vial, mistaking it for a tuberculin skin test vial, and inadvertently injected a 0.1 mL dose intradermally into the patient's left forearm. No concomitant vaccines were administered, since the patient had come in only to have a tuberculin skin test administered. The only similarity between the products that may have contributed to the error, according to the reporter, is that both products are supplied in multi-dose vials, and the size of the cartons is the same".   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: F
Vaccine: RAB
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: received first dose on time and receive second dose tomorrow on day 3 but will be out of country on day 7 and return by day 14. Caller with question on how to proceed with no reported adverse event; Initial information received on 03-Jun-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age female patient who received first dose on time and receive second dose tomorrow on day 3 but would be out of country on day 7 and return by day 14. caller with question on how to proceed with no reported adverse event after receiving vaccine rabies (HDC) vaccine [Imovax rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Jun-2024, the patient received unknown dose 1 of suspect Powder and solvent for suspension for injection of RABIES (HDC) VACCINE (batch number, expiry date, strength, frequency, anatomical location, route was unknown) as Immunization     On an unknown date in Jun-2024, the patient received her first dose on time and receive second dose tomorrow on day 3 but would be out of country on day 7 and return by day 14. caller with question on how to proceed with no reported adverse event (circumstance or information capable of leading to medication error) (unknown latency).  It was reported "Caller reports the patient is receiving IMOVAX for post exposure. Patient reports some type of bat material landing in her eye. No patient or vaccine data available."  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: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was inadvertently administered an expired dose of Adacel intramuscularly into the left deltoid with no reported adverse event; Initial information received on 06-Jun-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 11-year-old female patient was inadvertently administered an expired dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] intramuscularly into the left deltoid 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 HPV vaccine VLP RL1 4V (YEAST) (Gardasil) for Prophylactic vaccination; and meningococcal vaccine B for Prophylactic vaccination.  On 06-Jun-2024, the patient received an 0.5 ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (strength: unknown) (lot: C6003BA, expiry date: 01-jUn-2024) via intramuscular route in the left deltoid as prophylactic vaccination (immunization) with no reported adverse event (expired 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.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired IPOL with no reported adverse event; Initial information received on 06-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4-year-old female patient who was administered expired IPV (VERO) [IPOL] 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Immunisation.   On 06-Jun-2024, the patient received a 0.5 ml Booster dose of suspect IPV (VERO) Suspension for injection Strength: standard, of lot V1B891M expiry date: 01-jun-2024 Frequency: once via intramuscular route in unknown administration site as immunization which was expired with no reported adverse event (expired product administered) latency on 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.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: expired dose of ipol that was administered with no reported adverse event; using different vaccine instead of prescribed QUADRACEL with no reported adverse event; Initial information received on 07-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient who was administered expired dose of IPV (VERO) [IPOL] with no reported adverse event and used different vaccine instead of prescribed quadracel 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation; and measles vaccine live (ENDERS-EDMONSTON), mumps vaccine live (JERYL LYNN), rubella vaccine live (wistar RA 27/3), varicella zoster vaccine live (OKA/MERCK) (PROQUAD) for Prophylactic vaccination.  On 03-Jun-2024, the patient received an expired 0.5 ml dose (dose 2) of suspect IPV (VERO) Suspension for injection of lot V1B901M and expiry: 02-Jun-2024 via intramuscular route in the right arm for immunization, with no reported adverse event (expired product administered) and used different vaccine instead of prescribed quadracel with no reported adverse event (wrong product administered) (latency: same day).  Reportedly, patient was due for the combination QUADRACEL but since they were out of it, they gave it separately as DAPTACEL and IPOL.  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: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human papilloma virus test positive
Clinical narrative: test positive for HPV; One patient is currently pregnant; This spontaneous report has been received from a physician, via company representative, regarding a female patient of unknown age (two patients were reported, 32-year-old and 33-year old, however, no further information as which one was regarding each occurrence). The patient's pertinent medical history, concurrent conditions, drug allergies or concomitant medications were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (dose, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were  not provided).  On an unknown date, the patient tested positive for human papillomavirus (HPV), and furthermore, the patient was currently pregnant (maternal exposure before pregnancy) and would get a colposcopy procedure after delivery. At the time of reporting, the outcome of the event test positive for HPV was not reported.   The causal relationship between test positive for HPV and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; GARDASIL 9 was administered following a TE; This spontaneous report has been received from a other kind of reporter, regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or concomitant medications were not reported.  On an 04-JUN-2024, the patient was vaccinated with the improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot number 1957405, expiration date: 11-NOV-2025, administered for prophylaxis (dose, vaccination scheme, frequency, route of administration, and anatomical site of injection were not provided).  No additional adverse event. No details regarding the temperature excursion were provided.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: HCP who states her daughter has no titers from the RECOMBIVAX vaccination she received "as an infant".; This spontaneous report was received from Health Professional and refers to a 16-year-old female patient.  The patient's medical history  and concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date (when the patient was an infant), she was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for immunisation (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided). However, the patient had no titers from the hepatitis b vaccine (recombinant) (RECOMBIVAX HB) vaccination (Hepatitis B surface antibody negative). The reported stated she would need to be revaccinated as she needed this to volunteer/work in healthcare. At the time of reporting, the outcome of the event Hepatitis B surface antibody negative was unknown.   The causality assessment between Hepatitis B surface antibody negative and the suspect vaccine was not provided.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from an Other HCP.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Mar2023 as dose 4 (booster), single (Lot number: GL0446) at the age of 38 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3249), on 11Feb2021 as dose 2, single (Lot number: EL3247) and on 25Sep2021 as dose 3(booster), single (Lot number: 30135BA) for covid-19 immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 14Oct2023 as dose 5 (booster), single (Lot number: 5683MF012) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cephalexin, reaction(s): "known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 27May2024 to 31May2024.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect products BNT162B2, BNT162B2 OMI BA.4-5 and BNT162B2 cannot be fully excluded.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: Patient sister reported patient went to hospitalization a couple days after with new onset A-fib
Age: 5.0
Sex: F
Vaccine: DTAP, DTAP, MMR, MMR
Symptoms: Injection site erythema
Clinical narrative: Father reported that she has a redness on left arm, picture taken by family shows localized redness around the anterior aspect of deltoid muscle.  Denies pain, or fever. Father did not bring child to medical office because the redness started to subside with time. Father reported she never had a vaccine reaction before.
Age: 1.08
Sex: M
Vaccine: MMRV, PNC20, VARCEL
Symptoms: Extra dose administered
Clinical narrative: 13 month old patient mistakenly given Proquad and varicella in the same day 6/11/2024. Parents notified of this. No report of signs or symptoms at this time, per father 6/11/24 6:05PM.
Age: 77.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: injection site was swollen and red
Age: 43.0
Sex: F
Vaccine: YF
Symptoms: Abdominal pain, Back pain, Nausea
Clinical narrative: patient called office on 5/21/2024 stating she has had right sided abdominal/back pain since 8p the night of her shot. she also states she has left sided abdominal pain. no loose stools or vomiting but has been nauseated. she has not had any fever, sob, or chest pain. She has not pursed any medical treatment for this. she did call on 5/28/2024 and spoke with clinic receptionist and canceled her appointment for typhoid for that day. she was advised by the receptionist to seek medical care via er, urgent care or family doctor since it has been a week since vaccination. she was advised again on 5/31/2024 to seek medical care by myself RN.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE/No PQC; HCP called to report that a 1 yr old patient was inadvertently administered PROQUAD (instead of MMR II) concomitantly with VARIVAX today 5/30/2024. No adverse effects were reported. Consent to contact is yes. No additional AE/No PQC.; HCP called to report that a 1 yr old patient was inadvertently administered PROQUAD (instead of MMR II) concomitantly with VARIVAX today 5/30/2024. No adverse effects were reported. Consent to contact is yes. No additional AE/No PQC.; This spontaneous report was received from a Medical Assistance referred to a 1-year-old female patient. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported. Concomitant therapies included hepatitis a vaccine, inactivated(VAQTA).     On 30-MAY-2024 (also reported as "today"), the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), (strength, dose, dose number, frequency, scheme, route, anatomical location, lot number, and expiration date were not reported), as prophylaxis. Concomitantly, on the same date, the patient was "inadvertently" vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # x020570, Expiration date 03-FEB-2025, 0.5 milliliter, (strength, dose number, frequency, scheme, route, and anatomical location were not reported), for prophylaxis, instead of a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (Overdose and wrong product administered). No adverse event reported.  Lot number is being requested and will be submitted if received.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Syringe issue, Underdose
Clinical narrative: No additional AE/No PQC; HCP called to report that a 12 month old infant kicked while being administered MMR II today (5/29/2024) and the syringe leaked and the infant did not receive the full dose.; HCP called to report that a 12 month old infant kicked while being administered MMR II today (5/29/2024) and the syringe leaked and the infant did not receive the full dose. HCP also asked about the need for revaccination and the timing of the dose.; This spontaneous report was received from a Register Nurse and refers to a 12-month-old patient of unknown age.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 29-MAY-2024, while the patient was being administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, the patient kicked and the syringe leaked and the infant did not receive the full dose (strength, lot #, expiry date, and route of administration were not provided) administered for prophylaxis (Accidental underdose and Syringe issue). The nurse also asked about the need for revaccination and the timing of the dose. No adverse effects were reported. Patient information and lot and expiration were unavailable at the time of the call. Operator of device was reported as Health professional. No additional adverse event (AE) and no product quality complaint.  Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: FEEL POWERLESS; This spontaneous report received from a J&J managed social media site concerned a patient of unspecified age and sex, reporting self. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose (dose series 1), start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Since one year patient was feeling powerless (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of feel powerless was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Brain fog, Chills, Confusional state, Fatigue
Clinical narrative: Foggy brain, fever, chills ,pain  all over my body. Confusion, tired, extremely nervousness and anxiety. I can?t even sleep.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Nervousness, Pain, Pyrexia
Clinical narrative: Foggy brain, fever, chills ,pain  all over my body. Confusion, tired, extremely nervousness and anxiety. I can?t even sleep.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Caller reported AE on behalf of a patient who received an expired dose of MMR-II on 5/30/2024 (w/ no TEs); This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 30-MAY-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #W034593, expiration date: 10-MAY-2024, 0.5 ml/dose, administered for prophylaxis by health professional (strength, and route of administration were not provided) (expired product administered). There was no temperature excursion (TE). No symptoms were reported (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Asthenia, Bone pain, Dyspnoea, Fatigue
Clinical narrative: I couldn't speak; couldn't get up to get help; I could barely breathe; Muscle pain; bone pain; I get very tired; had me in so much pain/ still achy; still achy and weak; This non-serious case was reported by a consumer and described the occurrence of muscle pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included mastectomy bilateral, surgery (reconstruction surgery), delivery (patient did not need an epidural or any significant pain relief when delivering her daughter) and cancer. Previously administered products included Tylenol, Advil and Shingrix with an associated reaction of myalgia (1st dose received on 24-NOV-2023, reference case US2024068369). Concomitant products included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall), gabapentin, mirtazapine, trazodone and topiramate (Topamax).   On 27-MAY-2024, the patient received the 2nd dose of Shingrix. In MAY-2024, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: had me in so much pain/ still achy) and weakness (Verbatim: still achy and weak). On an unknown date, the patient experienced muscle pain (Verbatim: Muscle pain), bone pain (Verbatim: bone pain), aphasia (Verbatim: I couldn't speak), mobility decreased (Verbatim: couldn't get up to get help), difficulty breathing (Verbatim: I could barely breathe) and tiredness (Verbatim: I get very tired). Rechallenge with Shingrix was positive. The outcome of the muscle pain, bone pain, aphasia, mobility decreased, difficulty breathing and tiredness were not reported and the outcome of the pain and weakness were not resolved.   It was unknown if the reporter considered the muscle pain, bone pain, pain, aphasia, mobility decreased, difficulty breathing, weakness and tiredness to be related to Shingrix.     It was unknown if the company considered the muscle pain, bone pain, pain, aphasia, mobility decreased, difficulty breathing, weakness and tiredness to be related to Shingrix.   Linked case(s) involving the same patient: US2024068369   Additional Information: GSK Receipt Date: 02-JUN-2024 The patient self-reported this case. The patient had extreme muscle and bone pain with both doses of the vaccine,  more than with any cancer treatment or surgery she ever had. The patient reported just as a reference, she did not need anything more than Tylenol, Advil for a few days while recovering from double mastectomy and reconstruction surgeries. The patient did not need an epidural or any significant pain relief when delivering her daughter, but this vaccine had her in so much pain that she could not speak or get up to get help. The patient could barely breathe. After a week, the patient was still achy and weak and she get very tired by the end of the day. The patient reported that she could not tell anyone else to do this. This case had been link to the case US2024068369, reported by the same reporter.; Sender's Comments:  US-GSK-US2024068369:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Pain
Clinical narrative: I couldn't speak; couldn't get up to get help; I could barely breathe; Muscle pain; bone pain; I get very tired; had me in so much pain/ still achy; still achy and weak; This non-serious case was reported by a consumer and described the occurrence of muscle pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included mastectomy bilateral, surgery (reconstruction surgery), delivery (patient did not need an epidural or any significant pain relief when delivering her daughter) and cancer. Previously administered products included Tylenol, Advil and Shingrix with an associated reaction of myalgia (1st dose received on 24-NOV-2023, reference case US2024068369). Concomitant products included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall), gabapentin, mirtazapine, trazodone and topiramate (Topamax).   On 27-MAY-2024, the patient received the 2nd dose of Shingrix. In MAY-2024, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: had me in so much pain/ still achy) and weakness (Verbatim: still achy and weak). On an unknown date, the patient experienced muscle pain (Verbatim: Muscle pain), bone pain (Verbatim: bone pain), aphasia (Verbatim: I couldn't speak), mobility decreased (Verbatim: couldn't get up to get help), difficulty breathing (Verbatim: I could barely breathe) and tiredness (Verbatim: I get very tired). Rechallenge with Shingrix was positive. The outcome of the muscle pain, bone pain, aphasia, mobility decreased, difficulty breathing and tiredness were not reported and the outcome of the pain and weakness were not resolved.   It was unknown if the reporter considered the muscle pain, bone pain, pain, aphasia, mobility decreased, difficulty breathing, weakness and tiredness to be related to Shingrix.     It was unknown if the company considered the muscle pain, bone pain, pain, aphasia, mobility decreased, difficulty breathing, weakness and tiredness to be related to Shingrix.   Linked case(s) involving the same patient: US2024068369   Additional Information: GSK Receipt Date: 02-JUN-2024 The patient self-reported this case. The patient had extreme muscle and bone pain with both doses of the vaccine,  more than with any cancer treatment or surgery she ever had. The patient reported just as a reference, she did not need anything more than Tylenol, Advil for a few days while recovering from double mastectomy and reconstruction surgeries. The patient did not need an epidural or any significant pain relief when delivering her daughter, but this vaccine had her in so much pain that she could not speak or get up to get help. The patient could barely breathe. After a week, the patient was still achy and weak and she get very tired by the end of the day. The patient reported that she could not tell anyone else to do this. This case had been link to the case US2024068369, reported by the same reporter.; Sender's Comments:  US-GSK-US2024068369:same reporter
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: patient had been administered a pediatric dose for the 2nd dose of Engerix-B; patient had been administered a pediatric dose for the 2nd dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 58-year-old male patient who received HBV (Engerix B pediatric) (batch number F5L5E, expiry date 30-JUN-2025) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B).   On 11-JAN-2024, the patient received the 2nd dose of Engerix B pediatric. On 11-JAN-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: patient had been administered a pediatric dose for the 2nd dose of Engerix-B) and adult use of a child product (Verbatim: patient had been administered a pediatric dose for the 2nd dose of Engerix-B). The outcome of the underdose and adult use of a child product were 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: 05-JUN-2024 The pharmacist reported that the patient had been administered a pediatric dose of Engerix B, which led to underdose and adult use of a child product. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX was administered on an unspecified date during a temperature excursion; no adverse event; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).    On an unknown date, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X006982, expiration date: 07-MAR-2025 (strength, dose, route and anatomical location were not provided) for prophylaxis.  On unspecified date, the vaccine of varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered during a temperature excursion. The temperature excursión was in 12°F and the time frame was 1 hour 0 minutes, 0 seconds. There was no previous temperature excursión. No additional adverse event reported.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: His sister was also affected by the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (His sister was also affected by the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (His sister was also affected by the vaccine). At the time of the report, IMMUNISATION REACTION (His sister was also affected by the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported that patient had similar reaction as the reporter. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-760217 (Linked Report).  Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2024: Live follow up received and updated suspect product coding.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-760217:Master Case (Brother case)
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Peripheral swelling, Skin infection, Skin warm, Tenderness
Clinical narrative: LEG SWOLLEN, HOTNESS.  TENDER TO TOUCH: SEE ATTACHED DOCUMENTS. SKIN INFECTION Discussed with pt/family superficial wound infections/skin infections to help with swelling,  warm pack if this helps with discomfort as well motrin or tylenol for fever or discomfort massage the area to increase blood flow to encourage the area to get smaller faster  if it is itchy: hydrocortisone otc bid prn ---If you see any signs of a severe allergic reaction, you should call EMS right away-- *hives in multiple places on your baby's body *swelling in your baby's throat or face *difficulty breathing *elevated heart rate
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Erythematous reaction around site of injection (Right thigh) where Kinrix was given. Cirular reaction about 6-7 cm across.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Pt reports arm soreness and dizziness
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: Pt received the incorrect intended vaccine. Received Menquadfi when Bexsero was intended. Both administered same day. Vaccine history for pt is Bexsero: 4/6/2023 and 6/10/2024. Menactra: 11/12/2021. Menquadfi 4/6/2023 and 6/10/2024. No adverse effects noted from 6/10/2024 administrations.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: No adverse event, Unevaluable event
Clinical narrative: Patient had no adverse reaction to any vaccines given today 6/12/24.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Barium double contrast, Gastrointestinal tube insertion, Haematochezia, Hypophagia, Ileectomy
Clinical narrative: 3 month old male admitted on 05/01 for vomiting, poor PO intake, and lethargy for 2 days. Patient had a bloody BM the morning of 05/01 and an abdominal US was ordered. Abdominal US showed intussusception and was unable to be reduced via air and contrast enema. Patient underwent surgery on 05/01 and a portion of his ileum was resected and sent to pathology for further evaluation. Following surgery, patient had NG tube, was on Tylenol and Morphine for pain, and started on an antibiotic regimen of ampicillin and gentamicin for 3 days.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Infantile vomiting, Intussusception, Lethargy, Pain, Pathology test
Clinical narrative: 3 month old male admitted on 05/01 for vomiting, poor PO intake, and lethargy for 2 days. Patient had a bloody BM the morning of 05/01 and an abdominal US was ordered. Abdominal US showed intussusception and was unable to be reduced via air and contrast enema. Patient underwent surgery on 05/01 and a portion of his ileum was resected and sent to pathology for further evaluation. Following surgery, patient had NG tube, was on Tylenol and Morphine for pain, and started on an antibiotic regimen of ampicillin and gentamicin for 3 days.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Procedural failure, Ultrasound abdomen abnormal
Clinical narrative: 3 month old male admitted on 05/01 for vomiting, poor PO intake, and lethargy for 2 days. Patient had a bloody BM the morning of 05/01 and an abdominal US was ordered. Abdominal US showed intussusception and was unable to be reduced via air and contrast enema. Patient underwent surgery on 05/01 and a portion of his ileum was resected and sent to pathology for further evaluation. Following surgery, patient had NG tube, was on Tylenol and Morphine for pain, and started on an antibiotic regimen of ampicillin and gentamicin for 3 days.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Cold sweat, Erythema, Fatigue, Pruritus, Skin induration
Clinical narrative: Mainly, I had about 4 or 5 different spots that were red and felt like they had a hardness under them. They were really itchy and the biggest one was about the size of a quarter. All on my right arm. I was feeling clammy and tired as well.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pt. requested adult HEP A vaccine and Adult HEP B was given.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Myalgia, Pain in extremity
Clinical narrative: Severe headache, myalgia, rigors with painful red wheal over entire left arm  Saturday evening of injection.  Headache and myalgia persisted over next 48 hours then spontaneously resolved.  Left arm wheal persists 4 days following injection but improving.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Severe headache, myalgia, rigors with painful red wheal over entire left arm  Saturday evening of injection.  Headache and myalgia persisted over next 48 hours then spontaneously resolved.  Left arm wheal persists 4 days following injection but improving.
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Numbness and pain left arm.
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Numbness and pain left arm.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Dry skin, Onychomadesis, Pruritus, Scab
Clinical narrative: hands began peeling and itching.  Scalp had scabs and extreme itching and scaling.  fingernails were peeling at cuticles and all fingernails have since fallen off.  No evidence of fingernails growing back as of today.   Scalp is still itchy and scabby/scaling and hands are still itching and extremely dry
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: hands began peeling and itching.  Scalp had scabs and extreme itching and scaling.  fingernails were peeling at cuticles and all fingernails have since fallen off.  No evidence of fingernails growing back as of today.   Scalp is still itchy and scabby/scaling and hands are still itching and extremely dry
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction was reported, this form has been completed only to report that an extra Hep B  vaccine was given
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: pt was only received the diluent .  Shingrix vaccine powder was not mixed .
Age: 0.33
Sex: M
Vaccine: PNC20, RV5
Symptoms: Diarrhoea, Haematochezia, Pyrexia, Rash, Vomiting
Clinical narrative: Order placed for Dtap/Hib/IPV, PCV, and Rotavirus  Patient given PCV and Rotavirus  Patient also given MMRV  Informed of live vaccine administration at approximately 430-445p  on 6/6/24 Notified mom and began period of observation at approximately 5:09p  Advised mom of what occurred and signs to look out for in the next 2 weeks: fever, rash, diarrhea, vomiting, and blood in stool  Patient sleeping comfortably upon return to the room  Mom able to awaken and given 2.5mL of Infant Tylenol with some spillage by provider  Patient observed until 5:19p  Patient continued to sleep comfortably, well perfused, heart RRR, and lungs CTAB  Reiterated signs to look out for and encouraged calling the office if any questions or concerns  Encouraged to return in 1 month to receive Dtap/Hib/IPV vaccine
Age: 52.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE EVENTS
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction, Dyspnoea, Oxygen saturation decreased, Pruritus, Rash
Clinical narrative: Anaphylactic reaction- vomiting, wheezing, difficulty breathing, decreased O2 saturation, itching and rash. Symptoms began about 10 minutes after vaccine administration. EpiPen administered 16 minutes after vaccines given with improvement in symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting, Wheezing
Clinical narrative: Anaphylactic reaction- vomiting, wheezing, difficulty breathing, decreased O2 saturation, itching and rash. Symptoms began about 10 minutes after vaccine administration. EpiPen administered 16 minutes after vaccines given with improvement in symptoms.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 65mm erythema surrounding the injection site, warm, very tender to touch , seen at clinic 2 days later reported symptoms started that night. Took ibuprofen and diphenhydramine at home with some relief yesterday, tried ice, no treatment on day of visit. Ice offered, refused, gave ibuprofen and diphenhydramine. Marked with surgical marker, advised to rtc if worsening
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site pruritus, Injection site urticaria, Urticaria
Clinical narrative: First symptoms started on: 6/10/2024 left arm was itchy when he got home  yesterday right after the shots. left side was MMRV                                                                                   6/11/24 woke up with  itching Hives on torso, arms, legs, and buttocks, hive spread to neck Benadryl around 10:15AM.    TX  Use OTC Benadryl, call if symptoms persist or worsen. Can try other antihistamines or possibly H2 blockers later prn. F/u for worsening rash, cough, wheeze, fever, worsening sxs or concerns
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: Mother states that patient was given vaccines on 06/05/2024 and patient's arms swelled and had knots in them. Patient with palpable BB sized nodule to left arm
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Periorbital swelling, Pyrexia, Rash, Rash macular
Clinical narrative: 5/28/2024 woke up with 102 degree fever and slight wheeze. went to urgent care. advised was a virus and given sterioids.  the fever subsided after 2 days and steroids where stopped.  6/2/2024 noticed his lymphnodes under his ears were swollen. 6/10/2024 woke up with a spotty pink rash with slightly raised bumps on his check that morning, after his afternoon nap rash had moved to his entire body and became almost solid pink splotches also his eyes were swollen underneath and across his noise and very red. immediately went to urgent care. advised he was having an unknown reaction and to follow up with primary care. given steroids again. 6/11/2024 went to primary care with hospital. was seen by 3 different doctors. was told could be heat rash or poison ivy or possibly strep rash. I told them I thought it was Rubella contracted from his MMR on 4/12/2024. They refused any testing and sent us home.  6/12/2024 woke up with no rash.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Rash papular, Swelling face, Viral infection, Wheezing
Clinical narrative: 5/28/2024 woke up with 102 degree fever and slight wheeze. went to urgent care. advised was a virus and given sterioids.  the fever subsided after 2 days and steroids where stopped.  6/2/2024 noticed his lymphnodes under his ears were swollen. 6/10/2024 woke up with a spotty pink rash with slightly raised bumps on his check that morning, after his afternoon nap rash had moved to his entire body and became almost solid pink splotches also his eyes were swollen underneath and across his noise and very red. immediately went to urgent care. advised he was having an unknown reaction and to follow up with primary care. given steroids again. 6/11/2024 went to primary care with hospital. was seen by 3 different doctors. was told could be heat rash or poison ivy or possibly strep rash. I told them I thought it was Rubella contracted from his MMR on 4/12/2024. They refused any testing and sent us home.  6/12/2024 woke up with no rash.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the site of injection ( anterior aspect of left thigh extending to upper knee