chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: No additional AE; The first PFS was not noticed to be broken; The first PFS was not noticed to be broken until it was being administered to a patient; This spontaneous report was received from a nurse referring to a 11-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 15-AUG-2024, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml  injection, 0.5 mL (1 dosage form), lot#: 1967338, expiration date was reported as 16-JAN-2026 but upon internal validation indicated as 26-JAN-2026 , administered by nurse (route and anatomical location were not provided). During the administration. the prefilled syringe (PFS) was broken (syringe issue and poor-quality device used). The patient received the full dose of the vaccine and was not exposed to blood from the nurse's injury (captured in MARRS# 2408USA005812). No additional adverse events (AE) were reported (no adverse event).  This is one of two reports received from the same reporter (link # US-009507513-2408USA005812). ; Sender's Comments:  US-009507513-2408USA005812:
Sex: F
Vaccine: HPV4, MMR
Symptoms: Presyncope, Tremor
Clinical narrative: HCP also stated that the patient received a dose of MMR-II on 25OCT2009 and had an egg allergy reaction which consisted of "shaking and a vagal episode,"; HCP also stated that the patient received a dose of MMR-II on 25OCT2009 and had an egg allergy reaction which consisted of "shaking and a vagal episode,"; HCP also stated that the patient received a dose of MMR-II on 25OCT2009 and had an egg allergy reaction which consisted of "shaking and a vagal episode,"; This spontaneous report was received from a physician assistant regarding to a 39-year-old female patient. The patient's current conditions included egg allergy. Her medical history, concomitant therapies or dug reactions were not reported.  On an unspecified dates (also reported as "in the past"), the patient was vaccinated with two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (strength, dose, frequency, route of administration, anatomical injection site, lot number and expiration date were not provided) for prophylaxis, and had not yet received her third dose.  On 25-OCT-2009, the patient was vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) injection (strength, dose, frequency, route of administration, anatomical injection site, lot number and expiration date were not provided) for prophylaxis, and had an egg allergy reaction which consisted of "shaking and a vagal episode," which caused the patient to go to the emergency room (ER) (food allergy, tremor, presyncope). The patient was not admitted to the hospital but was discharged from the ER. It was unknown if patient has received any other doses of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) in the past prior to the reaction. On an unspecified date, the patient recovered from the events.  The causal relationship between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) and the events was not provided.  No additional details were known by reporter. No additional adverse event (AE)/ product quality complaint (PQC).  Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; patient inadvertently administered MMR II on 08/23/2024 which expired on 22-AUG-2024; This spontaneous report was received from a Nurse practitioner and refers to a patient of an unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 23-AUG-2024, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHa, injection, lot #X023322, expiration date: 22-AUG-2024, administered for prophylaxis (strength, dose, and route of administration were not provided). No additional adverse event was reported.   Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Patient received pediatric dose of ENGERIX B instead of HEPLISAV-B; Initial report received on 31-Jul-2024.  A consumer reported that an adult (gender, race, and ethnicity not provided) received a pediatric dose of ENGERIX B instead HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unknown date, the patient received a pediatric dose of ENGERIX B (dose number, lot #, expiration date, NDC #, route, and site not reported) instead of HEPLISAV-B. No symptoms were reported.   The reporter declined to provide further information.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-AUG-2024 This case was reported by the patient via interactive digital media. The patient had recurring shingles that break out on his/her right side about once a month, even though he/she got the vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary scheduled, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Pain in injected arm; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a adult patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero (unknown arm). On an unknown date, an unknown time after receiving Bexsero, the patient experienced pain in arm (Verbatim: Pain in injected arm). The outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 19-AUG-2024 After received a dose of Bexsero (did not know which dose), the patient had pain in injected arm which was not serious. The registered nurse (RN) further reported that they had 3 reports in a row of moderate to severe pain at injection site. The reporter did not know how long or how severe.  The reporter responded by referring to (PI) package insert that showed pain as an expected side effect.
Age: 0.08
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Blistering painful rash on chest under breast and right upper back; Blistering painful rash on chest under breast and right upper back; This non-serious case was reported by a non-health professional via sales rep and described the occurrence of blistery rash in a 2-month-old patient who received Herpes zoster (Shingrix) (batch number 747N3, expiry date 15-JUN-2026) for prophylaxis.   On 22-JUL-2024, the patient received Shingrix (right deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced blistery rash (Verbatim: Blistering painful rash on chest under breast and right upper back) and painful rash (Verbatim: Blistering painful rash on chest under breast and right upper back). The outcome of the blistery rash and painful rash were unknown.   The reporter considered the blistery rash and painful rash to be related to Shingrix.     The company considered the blistery rash and painful rash to be related to Shingrix.   Additional Information: GSK Receipt date: 19-AUG-2024  A reporter reported that the patient had blistering painful rash on chest under breast and right upper back.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: arm was swollen; arm was sore; arm was hot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced swelling arm (Verbatim: arm was swollen), pain in arm (Verbatim: arm was sore) and extremities hot feeling of (Verbatim: arm was hot). The outcome of the swelling arm, pain in arm and extremities hot feeling of were resolved (duration 1 week).   It was unknown if the reporter considered the swelling arm, pain in arm and extremities hot feeling of to be related to Shingles vaccine.     It was unknown if the company considered the swelling arm, pain in arm and extremities hot feeling of to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2024AMR107381   Additional Information: GSK Receipt Date: 22-AUG-2024 This case was reported by the patient via interactive digital media. The patient received a first dose of the Shingles vaccine and after first one his/her arm was swollen, sore and hot for a week but not bad.  The reporter further stated that he/she was thankful to have gotten this vaccine. The stories he/she has heard were horrible. For the tolerance of 2nd dose refer linked case US2024AMR107381, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR107381:same reporter
Age: 10.0
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Decreased appetite
Clinical narrative: Kinrix vaccine administered to 10 years old patient; combination of Pentacel happened with the GSK vaccine ( for diphtheria, tetanus, pertussis and polio vaccine component); This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   Co-suspect products included Pentacel for prophylaxis.   On 19-JUN-2024, the patient received the 1st dose of Kinrix and Pentacel. On 19-JUN-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix vaccine administered to 10 years old patient) and overdose (Verbatim: combination of Pentacel happened with the GSK vaccine ( for diphtheria, tetanus, pertussis and polio vaccine component)). The outcome of the inappropriate age at vaccine administration and overdose 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: 15-AUG-2024 The healthcare professional reported that an 10 year old patient was in there she needed the 5th dose of T-dap and 4th dose of Polio and in a rush Kinrix vaccine was given, which led to  inappropriate age at vaccine administration. The reporter also mentioned that a combination of Pentacel happened with the GSK vaccine (Kinrix), which led to overdose for diphtheria, tetanus, pertussis and polio vaccine component.  The Vaccine Administration Facility was the same as Primary Reporter.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Engerix-B administration of an adult dose to an adolescent; Engerix-B administration of an adult dose to an adolescent; This non-serious case was reported by a consumer via call center representative and described the occurrence of adult product administered to child in a 16-year-old female patient who received HBV (Engerix B adult) (batch number y5x9t, expiry date 04-APR-2025) for prophylaxis.   On 17-JUL-2024, the patient received the 1st dose of Engerix B adult. On 17-JUL-2024, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Engerix-B administration of an adult dose to an adolescent) and overdose (Verbatim: Engerix-B administration of an adult dose to an adolescent). The outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK Receipt Date: 19-AUG-2024 The office manager reported that an 17 year-old patient received Engerix-B adult dose instead of the pediatric dose, which led to adult product administered to child and overdose. The patient was going to receive today (on the reporting day) a second pediatric dose. The second dose had not been administered yet. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Dose Administered/ gave hepatitis B, that was expired on April; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 333M4, expiry date 07-APR-2024) for prophylaxis.   On 20-AUG-2024, the patient received the 1st dose of Engerix B. On 20-AUG-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered/ gave hepatitis B, that was expired on April). The outcome of the expired vaccine used 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: 20-AUG-2024 The healthcare professional called to report that she gave a patient expired vaccine and was not sure of what was next step. She gave hepatitis B (Engerix B), that was expired in April and she just (on the day of reporting) gave it to patient, which led to an expired vaccine used. The healthcare professional (HCP) did not provide patient's initials, date of birth nor gender because she said that she could not provide patient's personal information.
Age: 9.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: Maladministration in an overage patient as recommended in prescribing information; Maladministration in an overage patient as recommended in prescribing information; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old female patient who received DTPa-IPV (Kinrix) (batch number Y49B2, expiry date 17-MAY-2026) for prophylaxis.   On 15-MAY-2024, the patient received Kinrix. On 15-MAY-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Maladministration in an overage patient as recommended in prescribing information). On an unknown date, the patient experienced drug prescribing error (Verbatim: Maladministration in an overage patient as recommended in prescribing information). The outcome of the inappropriate age at vaccine administration and drug prescribing error 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: 20-AUG-2024 The licensed practical nurse called and reported that the patient was administered a Kinrix vaccine by one nurse in the facility as it was overage administration of the vaccine, according to the prescribing information, which led to inappropriate age at vaccine administration and drug prescribing error. The reporter wanted the advise regarding the polio portion of the vaccine, and any recommendations about it.  The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2 doses of Dtap, 1st dose at 4 years 3 months old, 2nd dose at 5 year 3 months old.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 7-year-old female patient who received DTPa (DTPa vaccine) for prophylaxis.   Previously administered products included DTPa vaccine (received 1st dose at 4 years of age).   On an unknown date, the patient received the 2nd dose of DTPa vaccine. On an unknown date, an unknown time after receiving DTPa vaccine, the patient experienced drug dose administration interval too long (Verbatim: 2 doses of Dtap, 1st dose at 4 years 3 months old, 2nd dose at 5 year 3 months old.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 19-AUG-2024 The healthcare professional reported that the patient had received 2 doses of Dtap vaccine with 1st dose at 4 years and 3 months old and 2nd dose at 5 years and 3 months old. The reporter said their clinic stocked Boostrix for Tdap and asked was Boostrix labeled for offuse in younger children down to 7 years old. No other information was provided and no brand names was provided. The patient received 2nd dose of Dtap vaccine, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: second dose of Kinrix was administered to a patient by mistake; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number D947X, expiry date 25-JAN-2025) for prophylaxis.   Concomitant products included Kinrix.   On 20-AUG-2024, the patient received the 2nd dose of Kinrix. On 20-AUG-2024, an unknown time after receiving Kinrix, the patient experienced extra dose administered (Verbatim: second dose of Kinrix was administered to a patient by mistake). The outcome of the extra dose administered 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: 20-AUG-2024 The medical assistant called and reported that the second dose of Kinrix was administered to a patient by mistake, which led to extra dose administered. The 2nd dose was 2 months apart from the 1st dose of Kinrix vaccine. The patient had a total of 6 Dtap and 5 IPV doses received after the unintended Kinrix dose given. The reporter consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial injury
Clinical narrative: DAMAGED THEIR HEART; This spontaneous report was received from a patient of unspecified age and sex via social media. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, 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. On an unspecified date, the patient experienced damaged heart (Dose in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of damaged their heart was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Myocardial injury: The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 0.5
Sex: U
Vaccine: COVID19-2, DTAPIPVHIB, PNC15, RV5
Symptoms: Expired product administered, Irritability, Vaccination site bruising
Clinical narrative: Irritability; Some bruising on the right thigh; Patient was administered with vaccine >12 hours post puncture after receiving rotavirus vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of IRRITABILITY (Irritability), VACCINATION SITE BRUISING (Some bruising on the right thigh) and EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine >12 hours post puncture after receiving rotavirus vaccine) in a 6-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 immunisation.    Co-suspect products included non-company products PENTACEL for Prophylactic vaccination, PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) for Prophylactic vaccination and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.    The patient's past medical history included Cough on 06-May-2023. Concomitant products included VITAMIN D NOS for an unknown indication.   On 09-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form, third dose of PENTACEL (Intramuscular use) 1 dosage form, third dose of PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) (Intramuscular use) 1 dosage form and third dose of ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (Oral use) 1 dosage form. On 09-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine >12 hours post puncture after receiving rotavirus vaccine). On an unknown date, the patient experienced IRRITABILITY (Irritability) and VACCINATION SITE BRUISING (Some bruising on the right thigh). At the time of the report, IRRITABILITY (Irritability) and EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine >12 hours post puncture after receiving rotavirus vaccine) outcome was unknown and VACCINATION SITE BRUISING (Some bruising on the right thigh) had resolved.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: experienced extreme tiredness; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (experienced extreme tiredness) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Atrial fibrillation.   On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (experienced extreme tiredness). At the time of the report, FATIGUE (experienced extreme tiredness) had resolved.            No concomitant medication was reported.  Patient mentioned that she took 5-Doses of Moderna Vaccines before and has no side effects and no fast heart rate but experienced extreme tiredness for 2-3 days and it reduced automatically without taking any medications. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2024: Live follow-up received contains no new information added
Sex: U
Vaccine: TD
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: one dose was administered from the affected product with no reported adverse event; came in with a cloudy substance and white dew, gooey white particle that was in syringe after shaking/ White, gooey, and pinhead sized particle with no reported adverse event; Initial information received on 14-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom one dose was administered from the affected product and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] came in with a cloudy substance and white dew, gooey white particle that was in syringe after shaking/ white, gooey, and pinhead sized particle with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT Suspension for injection lot U8303AA/ U80218A (expiry date- 30-sep-2026/ 31-Mar-2026) via unknown route in unknown administration site for Immunization (strength unknown) no reported adverse event (poor quality product administered) and came in with a cloudy substance and white dew, gooey white particle that was in syringe after shaking/ white, gooey, and pinhead sized particle with no reported adverse event (product contamination) (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: F
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received MENQUADFI twice, with not reported adverse event; Initial information received on 22-Aug-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age female patient who received MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] twice, with not reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection via unknown route in unknown administration site for Immunization (strength, dose, batch number and expiry date unknown)  twice, with not reported adverse event (extra dose administered) (latency same day).  Information on batch number corresponding to the one at time of event occurrence could not be requested   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.  No follow up possible as Caller refused follow-up
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: Nurses administered an act hib dose, but it was mixed using sterile water, not saline with no reported adverse event; Initial information received on 22-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom nurse administered an HIB (PRP/T) VACCINE [ACT-HIB] dose, but it was mixed using sterile water, not saline with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received HIB (PRP/T) VACCINE Powder and solvent for solution for injection via unknown route in unknown administration site  for Immunization (strength, dose, batch number and expiry date unknown) but it was mixed using sterile water, not saline with no reported adverse event (product preparation error) (same day latency).  Information on batch number corresponding to the one at time of event occurrence was requested.   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: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: same experience being a-fib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (same experience being a-fib) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (same experience being a-fib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (same experience being a-fib) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   It was unknown whether the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine or not. No concomitant medication was reported. The dosage text was reported as unknown. Reporter causality was not reported.  No treatment medication was reported.  This case contains information for the 2nd patient out of 3 patients. Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected and serious (medically significant) AESI of ATRIAL FIBRILLATION, after an unspecified dose of SPIKEVAX NOS (SPIKEVAX NOS) vaccine. Since the vaccination date and the event´s onset date was not reported, latency could not be properly assessed. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of SPIKEVAX NOS (SPIKEVAX NOS) vaccine is not affected by this report.   This case was linked to US-MODERNA, INC.-MOD-2024-773040 (E2B Linked Report).; Sender's Comments:  US-MODERNA, INC.-MOD-2024-773040:Patient 2 out of 3
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: extended sleepiness, 12 to 18 hours daily; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 1, single (Lot number: GJ2524) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Fibro" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset 2022, outcome "recovered", described as "extended sleepiness, 12 to 18 hours daily".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400245477 same reporter/patient/drug/event, different dose;
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: administered vaccine subcutaneously to R arm.  5 minutes later area was itching, burning, red hot and swollen.  Patient was given cold pack and 25mg diphenhydramine.  within 5 minutes patient states that area in no longer itching or burning.  Redness and swelling diminished
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Electroencephalogram, Encephalitis autoimmune, Immunoglobulin therapy, Laboratory test, Magnetic resonance imaging
Clinical narrative: Patient with autoimmune encephalitis and explosive onset focal seizures
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Partial seizures
Clinical narrative: Patient with autoimmune encephalitis and explosive onset focal seizures
Age: 13.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: The patient was given an expired immunization
Age: 87.0
Sex: M
Vaccine: RSV
Symptoms: Blood pressure measurement, Electrocardiogram
Clinical narrative: Starting at 6am the following morning, patient was delirious did not turn house alarm off. Patient was asking  for deceased mother. Very confused, weak, pain in legs. Patient caretaker called an ambulance to help him off the bathroom floor. Ambulance personal cleared patient and did not go to the ER. Patient then slept off and on the next 24 hours. Patient started feeling a little better each day. Pain in legs continues by day 5 but is slowly getting better.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Wrong product administered
Clinical narrative: Patient administered DTaP instead of pneumococcal 20. Pneumococcal to be scheduled in 1 week.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna COVID vaccine for patients greater than 12 years old ordered and administered to 11 yo patient.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccine administered; Doctor marked wrong vaccine (menquadfi when it should have been TDAP) on the patient sheet.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received the 2nd dose of Menveo sooner than the due date. Patient had no adverse reaction; patient was monitored for 15 minutes. Patient denied any light headedness, dizziness.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tremor
Clinical narrative: Dizziness immediately after vaccine lasting about 15-20 minutes after vaccination. Shaking in hands shortly after dizziness for about 15-20  minutes after vaccination. Patient waited in vaccination room for 15-20 minutes until feeling better enough to leave and get water.
Age: 81.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain, Pain in extremity, Skin warm, Vaccination site erythema
Clinical narrative: Pt received vaccine at 4 pm and noticed pain around 11pm when she got out of the shower.  Located around 3 inches below the vaccine, a 4 inch red area, that is hot to the touch, and painful. "feels like a sunburn" wraps around the arm. Patient was concerned and went the MD.
Age: 81.0
Sex: F
Vaccine: UNK
Symptoms: Vaccination site pain, Vaccination site warmth, Vascular injury
Clinical narrative: Pt received vaccine at 4 pm and noticed pain around 11pm when she got out of the shower.  Located around 3 inches below the vaccine, a 4 inch red area, that is hot to the touch, and painful. "feels like a sunburn" wraps around the arm. Patient was concerned and went the MD.
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Rash erythematous, Skin exfoliation, Swelling
Clinical narrative: Arm redness and swelling at time of administration. Patient reported icing administration site but did not recall duration of icing and reported not having a barrier between ice pack and the site of administration. Administration site then - per patient - looked like a sun burn and began to peel. When patient presented a month after vaccine, patient's arm had some pinkness and flaking skin. Patient reported no pain at time of presenting.
Age: 60.0
Sex: F
Vaccine: FLUC4, RSV, VARZOS
Symptoms: Photopsia
Clinical narrative: Patient states right after leaving pharmacy after she had received her vaccines she experienced a bright flashing light in her right eye. Symptoms come and go. She has visited the optometrist, and he wants to keep an eye on her because he is worried about possible retina detachment.
Age: 63.0
Sex: M
Vaccine: RSV, TDAP
Symptoms: Dizziness, Palpitations
Clinical narrative: After around 5 minutes after administration, patient becoming faint with a racing heart beat. He had to take a seat. An employee asked if he has was okay, and got him a bottle of water. After about 30 minutes, patient felt normal.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Blood test, Gait disturbance, Joint range of motion decreased, Joint stiffness
Clinical narrative: Two weeks after receiving the vaccine, I started experiencing stiffness in my right knee and difficulty walking, particularly down stairs, and squatting. As the day progressed, I developed stiffness in my left knee and by the evening, both knees were starting to swell. My left ankle was also swollen and my left wrist was experiencing pain. The next morning, a rash started to form on my back and spread to my abdomen and chest. It spread down my arms, buttocks and upper legs. It was most prominent on my trunk and appeared like red clusters of dots and felt mildly itchy. My throat was also feeling sore on the left side. I reached out to my doctor who was not able to see me so I went to a dermatologist who fit me in on short notice. He looked at the rash and diagnosed it as Pityrosporum Folliculitis and prescribed me a medicated shampoo (Ketoconazole 2%), which I've used three times. He also noted the swelling in my joints and wrote an order for a blood test to detect if any autoimmune response was occurring. I had my blood drawn the following day and  the results are pending. I continued to ice, elevate and rest my joints for that day and the next. Three days after the stiffness and pain appeared, they started to subside in my knees. Five days later I appeared to have my range of motion back but there was still some slight swelling in my knees and ankle plus my wrists were still hurting. Over a week later, the rash is all but gone and I feel pretty much back to normal.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Joint swelling, Oropharyngeal pain, Pruritus, Rash, Rash erythematous
Clinical narrative: Two weeks after receiving the vaccine, I started experiencing stiffness in my right knee and difficulty walking, particularly down stairs, and squatting. As the day progressed, I developed stiffness in my left knee and by the evening, both knees were starting to swell. My left ankle was also swollen and my left wrist was experiencing pain. The next morning, a rash started to form on my back and spread to my abdomen and chest. It spread down my arms, buttocks and upper legs. It was most prominent on my trunk and appeared like red clusters of dots and felt mildly itchy. My throat was also feeling sore on the left side. I reached out to my doctor who was not able to see me so I went to a dermatologist who fit me in on short notice. He looked at the rash and diagnosed it as Pityrosporum Folliculitis and prescribed me a medicated shampoo (Ketoconazole 2%), which I've used three times. He also noted the swelling in my joints and wrote an order for a blood test to detect if any autoimmune response was occurring. I had my blood drawn the following day and  the results are pending. I continued to ice, elevate and rest my joints for that day and the next. Three days after the stiffness and pain appeared, they started to subside in my knees. Five days later I appeared to have my range of motion back but there was still some slight swelling in my knees and ankle plus my wrists were still hurting. Over a week later, the rash is all but gone and I feel pretty much back to normal.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Tinea versicolour
Clinical narrative: Two weeks after receiving the vaccine, I started experiencing stiffness in my right knee and difficulty walking, particularly down stairs, and squatting. As the day progressed, I developed stiffness in my left knee and by the evening, both knees were starting to swell. My left ankle was also swollen and my left wrist was experiencing pain. The next morning, a rash started to form on my back and spread to my abdomen and chest. It spread down my arms, buttocks and upper legs. It was most prominent on my trunk and appeared like red clusters of dots and felt mildly itchy. My throat was also feeling sore on the left side. I reached out to my doctor who was not able to see me so I went to a dermatologist who fit me in on short notice. He looked at the rash and diagnosed it as Pityrosporum Folliculitis and prescribed me a medicated shampoo (Ketoconazole 2%), which I've used three times. He also noted the swelling in my joints and wrote an order for a blood test to detect if any autoimmune response was occurring. I had my blood drawn the following day and  the results are pending. I continued to ice, elevate and rest my joints for that day and the next. Three days after the stiffness and pain appeared, they started to subside in my knees. Five days later I appeared to have my range of motion back but there was still some slight swelling in my knees and ankle plus my wrists were still hurting. Over a week later, the rash is all but gone and I feel pretty much back to normal.
Age: 78.0
Sex: F
Vaccine: COVID19-2, FLUA4, PNC20
Symptoms: Dyspepsia, Feeling abnormal, Throat irritation
Clinical narrative: During a vaccine clinic at her nursing home, the patient came back and said she did not feel right.  She felt a burning sensation from her throat to her stomach. She denied any trouble breathing. The nursing staff was present and checked her vitals which were normal. She did request Benadryl and received 25 mg. After about 10 minutes she said she was feeling a lot better.
Age: 80.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had no adverse reaction, but got two Fluad  2024-25 vaccines this year. One on 7-30-24 and one on 8-28-24. Patient is fine with no adverse reactions reported. Doctor office is informed and knows patient is doing well.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness, Nausea, Vomiting
Clinical narrative: Sickness for over a week including nausea and vomiting as well an increases in getting sick over the last several years 2021-2024
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Tinnitus
Clinical narrative: tinnitus Right ear
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Since vaccination, patient has been developing discomfort/pain in left arm, with difficulty "putting on her bra." Patient was subsequently seen by MD and diagnosed with SIRVA (shoulder injury related vaccine administration).  Per report, patient is now in physical therapy, on medication, and applying lidocaine patches for the pain.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Limb discomfort, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Since vaccination, patient has been developing discomfort/pain in left arm, with difficulty "putting on her bra." Patient was subsequently seen by MD and diagnosed with SIRVA (shoulder injury related vaccine administration).  Per report, patient is now in physical therapy, on medication, and applying lidocaine patches for the pain.
Sex: U
Vaccine: VARCEL
Symptoms: Contraindicated product administered
Clinical narrative: one child had presumptive vaccine-associated varicella disease, diagnosed with varicella 2 weeks after receiving VZV immunization; was on three immunosuppressive (IS) medications when vaccinated; Literature report.  This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a child of unknown gender who underwent solid organ transplant and was on three immunosuppressive medications (concomitant therapies), therefore was immunosuppressive.  On an unknown date, after transplant, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) injection, administered for prophylaxis (dose, vaccination scheme, strength, lot #, expiration date, injection site and route of administration were not provided) (contraindicated product administered).  On an unknown date, the patient experienced presumptive vaccine- associated varicella disease 37 months post-transplantation, then a local medical provider diagnosed the patient with varicella 2 weeks after receiving varicella-zoster virus immunization (varicella post vaccine). The patient was managed as an outpatient using oral acyclovir. On an unknown date, the patient recovered from the event with no sequelae from the disease.  The authors considered the event varicella post vaccine to be related to varicella virus vaccine live (oka/merck) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  Lot # is being requested and will be submitted if received.
Age: 0.25
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: no adverse event; HCP called to report TE where a product was administered to a patient.; A 3 month old patient received proquad; This spontaneous report was received from a registered nurse concerning a 3-month-old patient of unkown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 29-JUL-2024, the patient was vaccianted with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #y003143, thymerosal status rHA expiration date: 27-JUL-2025, administered for prophylaxis (strength, and route of administration were not provided) (product storage error and product administered to patient of inappropriate age). No adverse event was reported.   The temperature excursion was from 14 fahrenheit degree to 46 fahrenheit degree during a time frame of 15 hours and 0 minutes, and from 6 fahrenheit degree to 14 fahrenheit degree during a timeframe of 0 hours and 45 minutes. No previous temperature excursions were reported.   {Additional information has been requested. / Additional information is not expected.}