chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: was administered a dose of Menveo on 01Aug2024 that had an expiration date of 31Jul2024.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA944A, expiry date 31-JUL-2024) for prophylaxis.   On 01-AUG-2024, the patient received Menveo. On 01-AUG-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: was administered a dose of Menveo on 01Aug2024 that had an expiration date of 31Jul2024.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-AUG-2024 The patient received expired Menveo, which led expired vaccine used. The product was 2 vial formulation. At the time of reporting, a repeat dose has not been administered.  The reporter consented to follow up.
Age: 5.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Menveo (1 vial) to a 5 year-old patient; 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 5-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number NR394, expiry date 31-JUL-2025) for prophylaxis.   On 05-AUG-2024, the patient received Menveo. On 05-AUG-2024, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Menveo (1 vial) to a 5 year-old patient). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt date: 06-AUG-2024 An HCP reported that the administration of Menveo (1 vial) to a 5 year-old patient which led to Inappropriate age at vaccine administration. The reporter wanted to know about safety data.
Age: 1.0
Sex: F
Vaccine: HEP, RVX
Symptoms: Extra dose administered
Clinical narrative: Inadvertently maladministration of additional dose of Engerix-B vaccine and rotarix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 1-year-old female patient who received HBV (Engerix B) (batch number 39KS9, expiry date 07-SEP-2025) for prophylaxis.   Co-suspect products included Rotavirus vaccine (batch number Y4NG3, expiry date 03-OCT-2025) for prophylaxis.   On an unknown date, the patient received Engerix B and Rotavirus vaccine. On an unknown date, an unknown time after receiving Engerix B and Rotavirus vaccine, the patient experienced accidental overdose (Verbatim: Inadvertently maladministration of additional dose of Engerix-B vaccine and rotarix). The outcome of the accidental overdose 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: 06-AUG-2024 The same patient was given an inadvertently maladministration of additional dose of Engerix-B and Rotarix in the same vaccination date, which led accidental overdose. The pharmacist calls medical information for further information or advice regarding safety or adverse events to advise the patient´s family. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: a day expired and it was given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (expiry date 04-AUG-2024) for prophylaxis.   On 05-AUG-2024, the patient received Shingrix. On 05-AUG-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: a day expired and it was given). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-AUG-2024 In the clinic where it was a day expired and it was given to the patient, which led expired vaccine used. The reporter consented to follow up.
Age: 15.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pharmacy to report TWINRIX dose 2 were given to a 15 year old male patient; pharmacy to report TWINRIX dose 1 were given to a 15 year old male patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old male patient who received HAB (Twinrix adult) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Co-suspect products included HAB (Twinrix adult) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   On 27-NOV-2023, the patient received the 2nd dose of Twinrix adult. On 24-OCT-2023, the patient received the 1st dose of Twinrix adult. On 24-OCT-2023, not applicable after receiving Twinrix adult and an unknown time after receiving Twinrix adult, the patient experienced inappropriate age at vaccine administration (Verbatim: pharmacy to report TWINRIX dose 1 were given to a 15 year old male patient). On 27-NOV-2023, the patient experienced inappropriate age at vaccine administration (Verbatim: pharmacy to report TWINRIX dose 2 were given to a 15 year old male patient). The outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration 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: 06-AUG-2024 A pharmacist reported that Twinrix 2 doses were given to a 15 year old male patient which led to Inappropriate age at vaccine administration.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patients tend to sometimes like to expand timeline (come in late) for their doses of Twinrix/were off schedule in the past; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patients who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (on an unknown date received).   On an unknown date, the patient received Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patients tend to sometimes like to expand timeline (come in late) for their doses of Twinrix/were off schedule in the past). The outcome of the drug dose administration interval too long 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: 06-AUG-2024 A reporter reported that the patients tend to sometimes like to expand timeline (come in late) for their doses of Twinrix.  The reporter stated she had seen people who were off schedule in the past
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: received a 3rd dose of Menveo instead; 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 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number JT347, expiry date 30-SEP-2025) for prophylaxis.   Previously administered products included Menveo (1st dose received on an unknown date) and Menveo (2nd dose received on an unknown date).   On 06-AUG-2024, the patient received the 3rd dose of Menveo. On 06-AUG-2024, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: received a 3rd dose of Menveo instead). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 06-AUG-2024 An office manager called to inform that earlier that day a patient was due for 2nd Bexsero but they received a 3rd dose of Menveo instead which led to extra dose administered.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: a 12 month old patient was administered the adult dose of Havrix, the 1440 by mistake"; a 12 month old patient was administered the adult dose of Havrix, the 1440 by mistake"; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 12-month-old patient who received HAV (Havrix 1440 adult) for prophylaxis.   On an unknown date, the patient received Havrix 1440 adult. On an unknown date, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: a 12 month old patient was administered the adult dose of Havrix, the 1440 by mistake") and accidental overdose (Verbatim: a 12 month old patient was administered the adult dose of Havrix, the 1440 by mistake"). The outcome of the adult product administered to child and accidental 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: 06-AUG-2024 The healthcare professional reported that the 12 month old patient was administered the adult dose of Havrix 1440 vaccine by mistake, which led to adult product administered to child and accidental overdose. The reporter consent to follow-up.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: accidentally administered a first dose of Kinrix on August 7th 2024 to a 15 month old patient; Inappropriate schedule of vaccine administrtion; 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 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   Previously administered products included dtpa-ipv (received 1st dose on 22nd August 2023), dtpa-ipv (received 2nd dose on 24th October 2023) and dtpa-ipv (received 3rd dose 06th February 2024).   On 07-AUG-2024, the patient received the 1st dose of Kinrix. On 07-AUG-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: accidentally administered a first dose of Kinrix on August 7th 2024 to a 15 month old patient) and inappropriate schedule of vaccine administered (Verbatim: Inappropriate schedule of vaccine administrtion). The outcome of the inappropriate age at vaccine administration was unknown and the outcome of the inappropriate schedule of vaccine administered was not reported.   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: 07-AUG-2024 The medical Assistant explained they accidentally administered a first dose of Kinrix to a 15 month old patient, which led to inappropriate age at vaccine administration.  Patient received prior doses of varicella, polio, measles, mumps, and rubella (unknown dates and brands).  Total of Diphtheria-Tetanus-Pertussis and Inactivated Poliovirus Vaccine doses: 4, which led to inappropriate schedule of vaccine administered. Consented to follow up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: vaccine that expired on 04Aug2024, and we administer to  patient today; 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 54-year-old male patient who received Herpes zoster (Shingrix) (batch number 22M3K, expiry date 04-AUG-2024) for prophylaxis.   On 07-AUG-2024, the patient received the 1st dose of Shingrix. On 07-AUG-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: vaccine that expired on 04Aug2024, and we administer to  patient today). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-AUG-2024 The healthcare professional reported that the patient was administered an expired dose of Shingrix vaccine on the reporting day, which led to expired vaccine used.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 07-AUG-2024 A reporter reported to wondering what the recommendation was for someone who had received 1 dose of shingrix grid but was over 6 months ago.  Do they need to restart series or just get 2nd dose asap. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products, Wrong product administered
Clinical narrative: Interchangeability with Trumenba; This non-serious case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis.   Previously administered products included Bexsero (on an unknown date in 2023 received 1st dose).   On an unknown date, the patient received the 2nd dose of Bexsero and Trumenba. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: Interchangeability with Trumenba). The outcome of the interchange of vaccine products 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: 07-AUG-2024 The health care professional (HCP) had a patient receive the wrong Men B booster.  The reporter asked if they have to wait to receive the Bexsero booster.  Trumenba was given to a patient at a local pharmacy, which led to interchangeability of vaccine product. They were in the need of the Bexsero. only the original 2 (Bexsero) in 2023, they were due for a year booster according to ACIP.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered
Clinical narrative: administration of incorrect vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9P329, expiry date 06-MAR-2026) for prophylaxis.   Co-suspect products included Polio vaccine for prophylaxis.   On 06-AUG-2024, the patient received Pediarix and Polio vaccine. On 06-AUG-2024, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: administration of incorrect vaccine). The outcome of the overdose was not reported.   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: 08-AUG-2024 Medical assistant requested potential adverse event data following the administration of incorrect vaccine.  HCP stated that Pediarix and and extra polio (IPV) vaccine IPOO was administered to a patient.  Pediarix was the intended vaccine and was administered on the same day.  The patient received an "extra polio" vaccine, which led to overdose of polio vaccine. Consented to follow up.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Adult patient was given a pediatric Engerix-B dose inadvertently; Adult patient was given a pediatric Engerix-B dose inadvertently; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 45-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   On 31-JUL-2024, the patient received Engerix B pediatric. On 31-JUL-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Adult patient was given a pediatric Engerix-B dose inadvertently) and accidental underdose (Verbatim: Adult patient was given a pediatric Engerix-B dose inadvertently). The outcome of the adult use of a child product and accidental underdose were unknown.   Additional Information: GSK Receipt Date: 08-AUG-2024 The healthcare professional reported that the adult patient was given a dose of Engerix-B pediatric vaccine inadvertently, which led to adult use of a child product and accidental underdose. The Vaccine Administration Facility was the same as Primary Reporter The reporter consent to follow up.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered the first dose of Rotarix to a 6 month old patient on August 7th 2024; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received Rota (Rotarix liquid formulation) (batch number 737J5, expiry date 05-OCT-2025) for prophylaxis.   On 07-AUG-2024, the patient received the 1st dose of Rotarix liquid formulation. On 07-AUG-2024, an unknown time after receiving Rotarix liquid formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: administered the first dose of Rotarix to a 6 month old patient on August 7th 2024). The outcome of the inappropriate age at vaccine administration 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: 08-AUG-2024 The physician stated they administered the first dose of Rotarix liquid presentation to a 6 month old patient, which led to inappropriate age at vaccine administration. The patient did not had any reactions or adverse events so far. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consent to follow up.
Age: 81.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A dose of Kinrix was administered to an 81 years old male patient; 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 81-year-old male patient who received DTPa-IPV (Kinrix) (batch number F5492, expiry date 27-OCT-2024) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: A dose of Kinrix was administered to an 81 years old male patient). The outcome of the inappropriate age at vaccine administration 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: 08-AUG-2024 The other health professional reported that, a dose of Kinrix was administered to an 81 years old male patient which led to inappropriate age at vaccine administration.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: inadvertently administered a dose of expired Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 2BR9G, expiry date 09-JUL-2024) for prophylaxis.   Previously administered products included Zostavax (on an unknown date received).   On 05-AUG-2024, the patient received the 1st dose of Shingrix. On 05-AUG-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: inadvertently administered a dose of expired Shingrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-AUG-2024 The nurse reported she inadvertently administered a dose of Shingrix to a patient that was expired.  The Vaccine Administration Facility was the same as Primary Reporter. Consented to follow up. The case is linked with US2024100357, by same reporter.; Sender's Comments:  US-GSK-US2024100357:Same reporter/Diffrent patient
Age: 0.17
Sex: M
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Hep B vaccine at 02-MAY-2024 and on 11-JUL-2024; This spontaneous report has been received by other company from a manager administrator for practice, regarding a 2-months-old male patient. The patient's medical history included an affectation by maternal use of opiod. The patient's concurrent conditions were not provided. The patient's concomitant medications included meningococcal vaccine b rfhbpa/fhbpb (TRUMENBA) (Pfizer) lot # HJ1517/GP8622 and expiration date 30-JUN-2026; Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot # 2003170 and expiration date 19-SEP-2025; diphtheria vaccine toxoid, (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) lot # UJ985AA and expiration date 14-FEB-2025.  On 02-MAY-2024 (reported as vaccination prior to the first vaccination of suspect vaccine), the patient was vaccinated with first dose (reported as at birth) of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection (strength, dose, frequency, route of administration, vaccination scheme, site of administration, lot number, and expiration date were not provided) as prophylaxis.       On 11-JUL-2024, the patient was vaccinated with the second dose (reported as first set since the Hep B he had when was newborn) with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection, administrated in the left thigh (strength, dose, frequency, route of administration, vaccination scheme, were not provided; lot # X021478, which has been verified to be a valid number, expiration date reported and stablished as 18-MAY-2026) as prophylaxis (inappropriate schedule of product administration).  Lot number of the first dose was unknown. Lot # was being requested and will be submitted if received.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Antiphospholipid syndrome, Musculocutaneous nerve injury, Myocarditis
Clinical narrative: Myocarditis with symptomatic rbbb; activation of Antiphospholipid syndrome; cutaneous nerve injury; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDITIS (Myocarditis with symptomatic rbbb) and ANTIPHOSPHOLIPID SYNDROME (activation of Antiphospholipid syndrome) in a 78-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis with symptomatic rbbb) (seriousness criterion medically significant), ANTIPHOSPHOLIPID SYNDROME (activation of Antiphospholipid syndrome) (seriousness criterion medically significant) and MUSCULOCUTANEOUS NERVE INJURY (cutaneous nerve injury). At the time of the report, MYOCARDITIS (Myocarditis with symptomatic rbbb), ANTIPHOSPHOLIPID SYNDROME (activation of Antiphospholipid syndrome) and MUSCULOCUTANEOUS NERVE INJURY (cutaneous nerve injury) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.  Company comment: This spontaneous case concerns a 78-year-old, female patient with no medical history information reported, who experienced the expected serious (medically significant) event of myocarditis and unexpected serious (medically significant) event of antiphospholipid syndrome and non serious event of musculocutaneous nerve injury (cutaneous nerve injury). The events occurred on an unknown date after a dose of SPIKEVAX NOS. No further information about the events was provided. The benefit-risk relationship of SPIKEVAX NOS is not affected by this report.
Age: 44.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: fdfd; Inappropriate age at vaccine administration; vaccine underdose; This spontaneous case was reported by a non-health professional and describes the occurrence of ILL-DEFINED DISORDER (fdfd), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and UNDERDOSE (vaccine underdose) in a 44-year-old male patient who received mRNA-1345 (mRESVIA) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Aug-2024, the patient received dose of mRNA-1345 (mRESVIA) (Intramuscular use) 22 milliliter. On 07-Aug-2024, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and UNDERDOSE (vaccine underdose). On 08-Aug-2024, the patient experienced ILL-DEFINED DISORDER (fdfd). At the time of the report, ILL-DEFINED DISORDER (fdfd), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and UNDERDOSE (vaccine underdose) outcome was unknown.        The action taken with mRNA-1345 (mRESVIA) (Intramuscular use) was unknown.       No concomitant and treatment medication were reported. It was unknown if the patient experienced any additional symptoms/events.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatomyositis
Clinical narrative: dermatomyositis NXP2 antibody; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DERMATOMYOSITIS (dermatomyositis NXP2 antibody) in a 60-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) 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 20-Nov-2023, the patient experienced DERMATOMYOSITIS (dermatomyositis NXP2 antibody) (seriousness criterion medically significant). At the time of the report, DERMATOMYOSITIS (dermatomyositis NXP2 antibody) had not resolved.        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.   The patient was not breastfeeding at the time of receiving the vaccine. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No other medical conditions, allergies, or risk factors for COVID were reported.  No concomitant medications were reported.  The reporter who was the patient's son was a healthcare professional, confirmed the patient experienced a side effect and was diagnosed with dermatomyositis NXP2 antibody surface antibody after receiving the Moderna COVID vaccine. The patient was first diagnosed on November 20th, 2023, which was not recovered as it was a lifelong disease, there was no cure for that, it was a rare disease. The patient had received 2 or 3 doses of COVID vaccines. The last dose the patient received, within 6-7 months roughly.  No treatment information was provided.  Company Comments: This spontaneous case concerns a 60-year-old female patient with no medical history information reported, who experienced the unexpected serious (medically significant event) dermatomyositis that occurred on unknown date after of SPIKEVAX NOS. As reported the patient had received 2 or 3 doses of COVID vaccines. The last dose the patient received, within 6-7 months roughly. At the time of report dermatomyositis was not resolved. Considering lack of information about patient medical history, information about previous vaccination, concomitant medication and diseases the event is assessed as not related to SPIKEVAX NOS (SPIKEVAX NOS). The benefit-risk relationship of SPIKEVAX NOS (SPIKEVAX NOS) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-772356 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-772356:Invalid case
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: muscle weakness; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) 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 MUSCULAR WEAKNESS (muscle weakness). At the time of the report, MUSCULAR WEAKNESS (muscle weakness) had not resolved.        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.   No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Computerised tomogram, Exostosis, Gait inability, Magnetic resonance imaging
Clinical narrative: He can't walk; bone spurs; they had cut; patient's sciatic nerve is clamped severely to the floor with the two bone spurs. There's a wedge on top and like a hook at the bottom, the wedge is getting bigger and bigger. So the bigger it gets, the more pressure it's putting on his nerve; I had a neuro temper; This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (He can't walk), EXOSTOSIS (bone spurs), WOUND (they had cut), NERVE COMPRESSION (patient's sciatic nerve is clamped severely to the floor with the two bone spurs. There's a wedge on top and like a hook at the bottom, the wedge is getting bigger and bigger. So the bigger it gets, the more pressure it's putting on his nerve) and AGGRESSION (I had a neuro temper) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) 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 GAIT INABILITY (He can't walk), EXOSTOSIS (bone spurs), WOUND (they had cut), NERVE COMPRESSION (patient's sciatic nerve is clamped severely to the floor with the two bone spurs. There's a wedge on top and like a hook at the bottom, the wedge is getting bigger and bigger. So the bigger it gets, the more pressure it's putting on his nerve) and AGGRESSION (I had a neuro temper). At the time of the report, GAIT INABILITY (He can't walk), EXOSTOSIS (bone spurs), WOUND (they had cut), NERVE COMPRESSION (patient's sciatic nerve is clamped severely to the floor with the two bone spurs. There's a wedge on top and like a hook at the bottom, the wedge is getting bigger and bigger. So the bigger it gets, the more pressure it's putting on his nerve) and AGGRESSION (I had a neuro temper) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: It had kept him away from walking. On an unknown date, Magnetic resonance imaging: It had kept him away from walking.     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.   No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2024: Live follow-up received, and follow-up information included no new information.
Sex: M
Vaccine: COVID19
Symptoms: Nerve compression, Wound
Clinical narrative: He can't walk; bone spurs; they had cut; patient's sciatic nerve is clamped severely to the floor with the two bone spurs. There's a wedge on top and like a hook at the bottom, the wedge is getting bigger and bigger. So the bigger it gets, the more pressure it's putting on his nerve; I had a neuro temper; This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (He can't walk), EXOSTOSIS (bone spurs), WOUND (they had cut), NERVE COMPRESSION (patient's sciatic nerve is clamped severely to the floor with the two bone spurs. There's a wedge on top and like a hook at the bottom, the wedge is getting bigger and bigger. So the bigger it gets, the more pressure it's putting on his nerve) and AGGRESSION (I had a neuro temper) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) 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 GAIT INABILITY (He can't walk), EXOSTOSIS (bone spurs), WOUND (they had cut), NERVE COMPRESSION (patient's sciatic nerve is clamped severely to the floor with the two bone spurs. There's a wedge on top and like a hook at the bottom, the wedge is getting bigger and bigger. So the bigger it gets, the more pressure it's putting on his nerve) and AGGRESSION (I had a neuro temper). At the time of the report, GAIT INABILITY (He can't walk), EXOSTOSIS (bone spurs), WOUND (they had cut), NERVE COMPRESSION (patient's sciatic nerve is clamped severely to the floor with the two bone spurs. There's a wedge on top and like a hook at the bottom, the wedge is getting bigger and bigger. So the bigger it gets, the more pressure it's putting on his nerve) and AGGRESSION (I had a neuro temper) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: It had kept him away from walking. On an unknown date, Magnetic resonance imaging: It had kept him away from walking.     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.   No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2024: Live follow-up received, and follow-up information included no new information.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Hypersensitivity, Illness, Skin exfoliation
Clinical narrative: knee disorder; I was really sick; I was really sick and my skin was peeling off; severe allergy; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: " sensitivity to nickel" (unspecified if ongoing); "emulsifier" (unspecified if ongoing), notes: an emulsifier that is used in everywhere, baking, cream, deodorants everything; "Lactose allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARTHROPATHY (medically significant), outcome "unknown", described as "knee disorder"; ILLNESS (non-serious), outcome "unknown", described as "I was really sick"; SKIN EXFOLIATION (non-serious), outcome "unknown", described as "I was really sick and my skin was peeling off"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "severe allergy". The events "knee disorder" and "severe allergy" required physician office visit. Clinical course: Patient reported that she was really sick and my skin was peeling off.  Then last year, she went to an allergist because she was getting a knee operation and they want to see what kind of knee implant to put in and he said, she had sensitivity to nickel and all that and then they said, she had two severe allergy, she had lactose. She wanted to go for Moderna vaccine as Moderna took out this emulsifier. Moderna no longer put that emulsifier in it but she wanted to know if it had Polysorbate 80.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Lyme disease
Clinical narrative: can't get rid of Lyme and its 10 times worse; can't get rid of Lyme and its 10 times worse; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Shingles vaccines (has Lyme disease for 30 years, took shingles vaccines, DOSE 2, SINGLE), for Lyme disease; Shingles vaccines (has Lyme disease for 30 years, took shingles vaccines, DOSE 1, SINGLE), for Lyme disease; Comirnaty (2023-2024 formula) (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: LYME DISEASE (medically significant), CONDITION AGGRAVATED (non-serious), outcome "not recovered" and all described as "can't get rid of Lyme and its 10 times worse". The action taken for BNT162b2 omi xbb.1.5 was unknown.  Clinical course: He has Lyme disease for 30 years, took shingles vaccines and COVID twice, can't get rid of Lyme and its 10 times worse, it's not removing from his body, and he is struggling now.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Incorrect route of product administration
Clinical narrative: diagnosed with all sorts of colitis; Route: subcutaneously; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 63-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose 1, 0.3 ml single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation. The patient's relevant medical history included: "thyroid cancer", start date: 1999, stop date: 2019, notes: 25 years ago; been clean for about five years now; "Sick" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu shot (Dose number unknown), for Immunization. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Oct2023, outcome "unknown", described as "Route: subcutaneously"; COLITIS (medically significant), outcome "unknown", described as "diagnosed with all sorts of colitis". Clinical course: Patient is in the 60-65 age range for work. Patient was recently diagnosed with all sorts of colitis. That is totally under control. There is nothing that is an emergency from that or are concerned from that. There is another vaccine in six months to a year. Patient would definitely want to take that other vaccine.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Rubber sensitivity
Clinical narrative: anaphylactic reaction to latex; anaphylactic reaction to latex; Initial information received on 08-Aug-2024 regarding an unsolicited valid serious case received from a health professional.  This case involves an unknown age and gender patient who experienced anaphylactic reaction to latex, after receiving vaccine Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2006, the patient received unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, (lot number, expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (immunization).  On an unknown date the patient developed anaphylactic reaction to latex (anaphylactic reaction) and (rubber sensitivity) (unknown latency) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine.   No lab data reported.  Action taken : not applicable.  It was not reported if the patient received corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.  Seriousness criteria: Medically significant for the event anaphylactic reaction.; Sender's Comments: Sanofi company comment dated 14-Aug-2024: This case involves an unknown age and gender patient who experienced anaphylactic reaction to latex, after receiving vaccine Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 12.0
Sex: F
Vaccine: MEN
Symptoms: Syncope
Clinical narrative: generalized swelling that started almost immediately after receiving vaccination that got progressively worse during the month after administration, swelling on the back of the neck, arms, legs, chest and back; progressively worse during the month after administration; headaches; having periods of dizziness; fainting which began within the month after receiving the meningococcal vaccination; Initial information received on 12-Aug-2024 regarding an unsolicited valid  serious case received from a consumer/Non-Healthcare Professional.  This case involves a 12 years old female patient who had fainting which began within the month after receiving the meningococcal vaccination, generalized swelling that started almost immediately after receiving vaccination that got progressively worse during the month after administration, swelling on the back of the neck, arms, legs, chest and back, headaches and having periods of dizziness.  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 (TDAP) for Immunisation.  On 26-Jan-2018, the patient received a dose 1 TOTAL of suspect Meningococcal Vaccine produced by unknown manufacturer lot A17013 via unknown route in unknown administration site for Immunization (strength, dose, and expiry date unknown).  On 26-Jan-2018 the patient developed generalized swelling that started almost immediately after receiving vaccination that got progressively worse during the month after administration, swelling on the back of the neck, arms, legs, chest and back (generalised oedema) (latency same day). On an unknown date in 2018 the patient developed fainting which began within the month after receiving the meningococcal vaccination (syncope), headaches (headache), periods of dizziness (dizziness) and progressively worse during the month after administration (condition aggravated) (latency within months).  Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Not Recovered / Not Resolved for all the events  Seriousness criteria-Medically significant for syncope; Sender's Comments: Sanofi Company Comment dated 14-Aug-2024: This case involves a 12 years old female patient who had fainting which began within the month after receiving the meningococcal vaccination, generalized swelling that started almost immediately after receiving vaccination that got progressively worse during the month after administration, swelling on the back of the neck, arms, legs, chest and back, headaches and having periods of dizziness. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Colon cancer, Laboratory test abnormal, Metastases to liver
Clinical narrative: Started to have anemia.  Work up showed colon cancer with mets to liver
Age: 11.0
Sex: F
Vaccine: HPV9, MENB, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction. Wrong meningococcal vaccine was given.
Age: 68.0
Sex: M
Vaccine: CHOL
Symptoms: Intercepted product administration error, Product administered to patient of inappropriate age
Clinical narrative: Dose was not mixed nor administered by pharmacist
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: She received second series of posttransplant immunizations on 8/13/2024. Pneumococcal 20 valent conjugate vaccine (Prevnar 20), CpG-adjuvanted recombinant hepatitis B vaccine (HepB-CpG) (Heplisav-B) and Coronavirus disease 2019 vaccine 2023-2024 were administered in the right deltoid, and inactivated polio vaccine and Haemophilus influenzae type B conjugate vaccine were administered in the left deltoid. She developed pain in the right deltoid area on 8/14/2024.  She applied ice to that area and started taking (what she thought was) ibuprofen every 6 hours (turned out to acetaminophen 500 mg).  Pain has persisted and she is now having shooting pains proximally to right side of her neck and distally to the lower part of the right upper arm.  She noticed reddish discoloration distal to the site of vaccines administration on the lateral aspect of the right upper arm, but no rash or warmth.  No tingling or numbness in the right upper extremity.  No fever or other systemic symptoms.  She is unable to move her right shoulder due to pain, but is moving her neck and right elbow and hand freely. Fortunately she is left-handed.  No history of surgery on the right shoulder or the neck. She played softball on 8/10/2024 and 8/11/2024 and recalls falling twice on gluteal area.  She did not fall on her right shoulder or right upper extremity.   Ibuprofen 400 mg PO TID was started 8/16/24
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Crying, Emotional distress, Eye movement disorder, Hyperhidrosis, Hyporesponsive to stimuli
Clinical narrative: 3-5 minutes after receiving vaccines infant had an event of sweating, pallor including oral pallor and decreased responsiveness. SpO2 98%. self resolved and returned to baseline color w/ in 3-5 min, was active and cooing. then became more upset, crying. had intermittent episodes of staring/ eye deviation between crying. Mild belly breathing