chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Insomnia, Somnambulism
Clinical narrative: She did not sleep,/ she did not sleep right; she gets up at night and walks around; She did not get hungry; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INSOMNIA (She did not sleep,/ she did not sleep right), SOMNAMBULISM (she gets up at night and walks around) and DECREASED APPETITE (She did not get hungry) in a female patient of an unknown age 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 INSOMNIA (She did not sleep,/ she did not sleep right), SOMNAMBULISM (she gets up at night and walks around) and DECREASED APPETITE (She did not get hungry). At the time of the report, INSOMNIA (She did not sleep,/ she did not sleep right), SOMNAMBULISM (she gets up at night and walks around) and DECREASED APPETITE (She did not get hungry) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-018002 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-018002:Patient friends sister case
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Paraesthesia oral
Clinical narrative: begin to feel a tingling on his/her tongue and lips; begin to feel a tingling on his/her tongue and lips; allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of the first episode of PARAESTHESIA ORAL (begin to feel a tingling on his/her tongue and lips), the second episode of PARAESTHESIA ORAL (begin to feel a tingling on his/her tongue and lips) and HYPERSENSITIVITY (allergic reaction) in an 8-decade-old female patient 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced the first episode of PARAESTHESIA ORAL (begin to feel a tingling on his/her tongue and lips), the second episode of PARAESTHESIA ORAL (begin to feel a tingling on his/her tongue and lips) and HYPERSENSITIVITY (allergic reaction). At the time of the report, last episode of PARAESTHESIA ORAL (begin to feel a tingling on his/her tongue and lips) and HYPERSENSITIVITY (allergic reaction) was resolving.            Concomitant product use was not provided by the reporter. Patient had a mild allergic reaction about 10-15 minutes after each shot, patient began to feel a tingling on her tongue and lips, which fortunately slowly dissipated over the 30 minutes it was always held for afterwards, usually spreading down to tongue but fortunately not getting any worse. Patient also stated that drinking a lot of water immediately helped it lessen. Enquirer asked if she could take Benadryl before to get the next shot or not. Reporter causality was not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2024: Live significant follow-up received: Reporter details, patient gender and reference ID added. On 09-Dec-2024: Live follow-up received: No New Information received.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Melanocytic naevus
Clinical narrative: broke out with moles on her left arm/she looked under her arm and there was all these black moles. It got real dark from her elbow. It started going from her elbow up down her arm; This spontaneous case was reported by a patient and describes the occurrence of MELANOCYTIC NAEVUS (broke out with moles on her left arm/she looked under her arm and there was all these black moles. It got real dark from her elbow. It started going from her elbow up down her arm) in an 87-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Pneumonia. Previously administered products included for Product used for unknown indication: FLU [INFLUENZA VACCINE] (Right arm) on 09-Oct-2024; for COVID-19 prophylaxis: Moderna covid-19 vaccine. Past adverse reactions to the above products included No adverse effect with FLU [INFLUENZA VACCINE] and Moderna covid-19 vaccine. Concurrent medical conditions included Blood pressure high.    In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In November 2024, the patient experienced MELANOCYTIC NAEVUS (broke out with moles on her left arm/she looked under her arm and there was all these black moles. It got real dark from her elbow. It started going from her elbow up down her arm). The patient was treated with Mometasone furoate for Itching, at a dose of 15 milligram. At the time of the report, MELANOCYTIC NAEVUS (broke out with moles on her left arm/she looked under her arm and there was all these black moles. It got real dark from her elbow. It started going from her elbow up down her arm) was resolving.            Patient took high blood pressure pills. A week after getting the Moderna shot, patient broke out with moles on her left arm, and they won't go away. They started itching first, and then patient got a lot of black moles on her arm. The itchiness was kind of going away, but the black moles were still there. Since then, patient has been using that cortisone cream, the itchiness was kind of going away.   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2024: Live non-significant follow-up received: Reference id added
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Therapeutic response unexpected
Clinical narrative: To my surprise and surprise of my family, for the first time in my life I was found the presence of antibodies associated with the condition described earlier; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "To my surprise and surprise of my family, for the first time in my life I was found the presence of antibodies associated with the condition described earlier". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: The patient reported asking you in connection with some medical observation, which may prove to be important for testing vaccines and immune response mechanisms. From early childhood, practically from 1 year old, I have a disease (not related to Covid-19), in which routine laboratory tests for years showed a lack of antibodies characteristic of this disease, previous treatment and prevention did not bring the expected results in patient case. The patient had never obtained an appropriate level of antibody. After taking the Covid 19 vaccine, the patient again did standard control tests. To surprise patient and surprise of patient's family, for the first-time in-patient life patient was found the presence of antibodies associated with the condition described earlier. The patient not able to clearly state whether there is a direct relationship here, but the situation seems so unusual that it may be worth interest from specialists. The patient wonder if the Covid-19 vaccine could in any way affect patient's immune system, starting a defensive reaction against other pathogens. If this type of effect could help other patients with similar problems, it may be worth analyzing it on your side. The patient ready to share medical information about patient's case, provide the results of the tests and discuss it with the appropriate specialists. The patient was very happy to get involved in further discussion if you recognize that patient's story can be valuable research material. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Few words come out "funny"; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old 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: "diabetes" (unspecified if ongoing); "shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "allergic to penicillin-amoxicillin". The following information was reported: SPEECH DISORDER (non-serious), outcome "unknown", described as "Few words come out "funny"".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400159850 same patient, different vaccine dose/AE;US-PFIZER INC-PV202400149377 same patient, different vaccine dose/AE;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Headache, Lethargy, Nausea
Clinical narrative: Severe body aches-hands, legs, feet, arms; headache; fever; lethargy; loss of appetite; nausea; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Dec2024 at 14:45 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Dermatomyositis" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 05Dec2024 as dose number unknown, single. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Dec2024 at 22:00, outcome "recovered" (07Dec2024), described as "Severe body aches-hands, legs, feet, arms"; PYREXIA (non-serious) with onset 05Dec2024 at 22:00, outcome "recovered" (07Dec2024), described as "fever"; HEADACHE (non-serious) with onset 05Dec2024 at 22:00, outcome "recovered" (07Dec2024); LETHARGY (non-serious) with onset 05Dec2024 at 22:00, outcome "recovered" (07Dec2024); DECREASED APPETITE (non-serious) with onset 05Dec2024 at 22:00, outcome "recovered" (07Dec2024), described as "loss of appetite"; NAUSEA (non-serious) with onset 05Dec2024 at 22:00, outcome "recovered" (07Dec2024). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, headache, pyrexia, lethargy, decreased appetite, nausea. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Severe body aches-hands, legs, feet, arms; headache; fever; lethargy; loss of appetite; nausea; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Dec2024 at 14:45 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Dermatomyositis" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 05Dec2024 as dose number unknown, single. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Dec2024 at 22:00, outcome "recovered" (07Dec2024), described as "Severe body aches-hands, legs, feet, arms"; PYREXIA (non-serious) with onset 05Dec2024 at 22:00, outcome "recovered" (07Dec2024), described as "fever"; HEADACHE (non-serious) with onset 05Dec2024 at 22:00, outcome "recovered" (07Dec2024); LETHARGY (non-serious) with onset 05Dec2024 at 22:00, outcome "recovered" (07Dec2024); DECREASED APPETITE (non-serious) with onset 05Dec2024 at 22:00, outcome "recovered" (07Dec2024), described as "loss of appetite"; NAUSEA (non-serious) with onset 05Dec2024 at 22:00, outcome "recovered" (07Dec2024). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, headache, pyrexia, lethargy, decreased appetite, nausea. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: running a fever; chills; This is a spontaneous report received from an Other HCP, Program ID.  A 65-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Oct2023 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset 2023, outcome "recovered" (2023); PYREXIA (non-serious) with onset 2023, outcome "recovered" (2023), described as "running a fever". Therapeutic measures were taken as a result of pyrexia, chills.  Additional information: The patient reported that she took last year flu and COVID vaccine together and had a reaction. She reported running a fever and chills, took Tylenol, and was okay by the next day.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Palpitations, Pyrexia
Clinical narrative: severe fatigue; palpitations; fever; myalgias; This is a spontaneous report received from an Other HCP. Other Case identifier(s): NOV24-00898.  A female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "severe fatigue"; PALPITATIONS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; MYALGIA (non-serious), outcome "unknown", described as "myalgias". Additional information: Reporter's wife gets severe fatigue, palpitations, fever, myalgias for 3-4 days after mrna vaccine. Reporter was asking if she qualifies for Novavax. The reporter's wife got the mRNA vaccine and think both times it was Pfizer. It did not result in any apparent organ damage but she was in bed for about four days. But hers was at least one standard deviation from the normal and thought they should try a different vaccine.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400319568 same patient, different dose number and event;
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: TE where multiple patients received ROTATEQ after stored improperly.; No Additional AE; This spontaneous report has been received from a health care professional and refers to multiple unidentified patients of unknown age and gender. Information regarding the patients' pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications was not provided.  On unknown dates, the patients were vaccinated with improperly stored doses of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter oral liquid, at a dose of 2 milliliter, as prophylaxis (lot number 2003139 has been verified to be valid, expiration date 30-APR-2025; route of administration was not reported), after a temperature excursion of 53.9 fahrenheit  for 7 hours and 30 minutes (product storage error). It was not reported if the information was recorded by a data logger or not.  No previous excursions were reported and no additional adverse events.   This is a non-valid case due to the lack of patients' identifiers.  Follow up has been received from a health care professional on 09-DEC-2024.   It was confirmed that the vaccine was administered to a 7-months old male patient.   On 29-OCT-2024, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, 2 milliliter, at a dose of 2 milliliter, as prophylaxis (lot number 2003139 has been verified to be valid, expiration date 30-APR-2025; route of administration was not reported).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Customer calling to report temperature excursion.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 12-NOV-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #Y011215, expiration date: 18-DEC-2025, administered for prophylaxis (strength, dose description, route of administration and anatomical site of injection were not provided). The vaccine administered experienced a temperature excursion, of 18.4 Fahrenheit (F) for 360 hours (product storage error).   There were no previous excursions, and no additional adverse event reported (no adverse event).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Monoplegia
Clinical narrative: My left arm was paralyzed for 12 hours; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy - penicillin" (unspecified if ongoing); "Allergy: shellfish" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy". The following information was reported: MONOPLEGIA (medically significant) with onset 2023, outcome "recovered" (2023), described as "My left arm was paralyzed for 12 hours".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400149377 same patient, different vaccine dose/AE;
Sex: M
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: never been so sick in my life than after having a flu shot; Initial information received on 05-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a Patient.  This case involves Adult male patient who was never been so sick in my life than after having a influenza vaccine shot.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for prophylactic vaccination.  On an unknown date the patient was never been so sick in my life than after having a flu shot (illness) (unknown latency).  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 7.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Ipol was administered post excursion with no reported adverse event; Initial information received on 06-Dec-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to US-SA-2024SA362437 (master case)  This case involves a 7 years old female patient to whom IPV (VERO) [IPOL] was administered post excursion with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix); Hepatitis a vaccine (Hepatitis A); Hepatitis b vaccine (Hepatitis b); and Measles vaccine live (Enders-Edmonston), Mumps vaccine live (Jeryl Lynn), Rubella vaccine live (Wistar RA 27/3) (MMRVaxPro) for Immunisation.  On 12-Nov-2024, the patient received 0.5 ml dose of IPV (VERO) Suspension for injection 1x(once) lot W1C741M expiry-17-Nov-2025 via subcutaneous route in the right arm for Prophylactic vaccination (Immunisation) (strength-standard) post excursion with no reported adverse event (poor quality product administered) (latency same day).  Reportedly, report temperature excursion that lasted 24 minutes for PUNCTURED IPOL. Nurse stated the vial was warm but could not provide a specific temperature. Medication was administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA362437:02333312 (master case) US-SA-2024SA362335:02333312 US-SA-2024SA362915: US-SA-2024SA363478: US-SA-2024SA364929: US-SA-2024SA363478:02333312 (Matser case)
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Punctured ipol was administered after excursion with no reported adverse event; Initial information received on 06-Dec-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to US-SA-2024SA364281 (master case).  This case involves 5 years old female patient who was administered punctured IPV (VERO) [IPOL] after excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Infanrix) for Immunisation; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.  On 12-Nov-2024, the patient was administered a standard dose 1 (0.5 ml once) of suspect IPV (VERO) Suspension for injection (lot W1C741M, expiry date- 17-NOV-2025) via subcutaneous route in the right arm for Immunization; after excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Nurse called to report temperature excursion that lasted 24 minutes. Reason: thermometer was not recording during transport. human Error: No. Maximum/Low Temperature reached: unknown, but MDV (multidose vial) was warm.   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.; Sender's Comments:  US-SA-2024SA362335:02333375 US-SA-2024SA364281:02333312 (master case)
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion that lasted 24 minutes for PUNCTURED IPOL, Medication was administered with no reported AE; Initial information received on 06-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case was linked to 2024SA362335.  This case involves, a 5 years old male patient who received punctured IPV (VERO) [IPOL] post temperature excursion that lasted 24 minutes for punctured ipol, medication was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) for Immunisation.  On 12-Nov-2024, the patient received 0.5 ml (1X- once) (Standard) IPV (VERO) (lot W1C741M, expiry date: 17-Nov-2025) (unknown strength) via subcutaneous route in the left arm for prophylactic vaccination post temperature excursion that lasted 24 minutes, medication was administered with no reported adverse event (poor quality product administered) (latency-same day).  Reportedly, Temperature excursion: negative disposition not due to human error, temperature unknown. Nurse called to report temperature excursion that lasted 24 minutes for PUNCTURED IPOL. Nurse states the vial was warm but could not provide a specific temperature. Medication was administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA362335:02333376
Age: 10.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Punctured ipol was administered after excursion with no reported adverse event; Initial information received on 06-Dec-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case was linked to other case US-SA-2024SA364281 (Master case).  This case involves a 10 years old female patient who received punctured IPV (VERO) [IPOL] was administered after excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) for Immunization, hepatitis B vaccine (hepatitis B vaccine) for immunization, measles vaccine, mumps vaccine, rubella vaccine (MMR vaccin) for Immunization and varicella zoster vaccine (varicella VACC.) for Immunization.  On 12-Nov-2024, the patient received punctured 0.5 ml of suspect IPV (VERO) of standard strength with lot W1C741M and expiry date 17-Nov-2025 once via subcutaneous route in the right arm for immunization was administered after excursion with no reported adverse event (poor quality product administered) (Latency same day).  Reportedly,Nurse called to report temperature excursion that lasted 24 minutes. Reason: thermometer was not recording during transport. human Error: No. Maximum/Low Temperature reached: unknown, but MDV (multidose vial) was warm.  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.; Sender's Comments:  US-SA-2024SA362335:02333377 US-SA-2024SA364281:02333312 (Matser case) US-SA-2024SA364281:
Age: 10.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion that lasted 24 minutes with no reported adverse event; poor quality vaccine administer with no adverse event; Initial information received on 06-Dec-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to cases 2024SA364281, 2024SA362437, 2024SA362915, 2024SA363478, 2024SA364929, 2024SA365336.  This case involves a 10 years old female patient received  IPV (VERO) [IPOL] post temperature excursion that lasted 24 minutes with no reported adverse event and poor quality vaccine administer with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX); HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 12-Nov-2024, the patient received 0.5 ml (dose 1) (Standard) IPV (VERO) Suspension for injection (lot W1C741M, expiry date: 17-Nov-2025) via subcutaneous route in the right arm for prophylactic vaccination (immunization) post temperature excursion that lasted 24 minutes with no reported adverse event (product storage error) (unknown latency) and poor quality vaccine administer (poor quality product administered).  Reportedly, Temperature excursion: negative disposition and product used. Nurse called to report temperature excursion that lasted 24 minutes for PUNCTURED IPOL. Nurse states the vial was warm but could not provide a specific temperature. Medication was administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA364281:02333312 US-SA-2024SA362437:02333375 US-SA-2024SA362915:02333376 US-SA-2024SA363478:02333377 US-SA-2024SA364929:02333379 US-SA-2024SA365336:02333381
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administering dose of FLUBLOK to a patient whose age is not approved for in prescribing information with no reported adverse event; Initial information received on 06-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 years old female patient who received dose of  INFLUENZA TRIVALENT RECOMBINANT VACCINE [FLUBLOK TIV]whose age is not approved for in prescribing information with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 05-Dec-2024, the patient received 0.5 ml of suspect INFLUENZA TRIVALENT RECOMBINANT VACCINE, Solution for injection (lot TFAA2429 and expiry 30-Jun-2025) (strength: unknown) whose age is not approved for in prescribing information with no reported adverse event (product administered to patient of inappropriate age) (latency same day) via intramuscular route in the left deltoid for prophylactic vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: elderly using the regular FLUZONE instead of the high dose take the regular dose Fluzone with no adverse event; Initial information received on 06-Dec-2024 regarding an unsolicited valid  non-serious case received from a Patient.  This case involves a 69 years old female patient as elderly using the regular INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] instead of the high dose take the regular dose fluzone with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection via unknown route in unknown administration site for Immunization  (strength, dose, batch and expiry date unknown), elderly using the regular fluzone instead of the high dose take the regular dose fluzone with no adverse event (off label use) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence could not be requested
Age: 66.0
Sex: U
Vaccine: FLUA4
Symptoms: Impaired work ability, Polyneuropathy idiopathic progressive, Quality of life decreased
Clinical narrative: developing a progressive polyneuropathy; This spontaneous case, initially received on 20-Nov-2024, was reported by a health professional and concerns an elderly patient.  Administration of company suspect drug(s): On 14-Jan-2024, the patient received Fluad Quadrivalent for influenza immunization, Dose regimen: .5 ml, Route of administration: Intramuscular, Anatomical site: left deltoid; Lot number: 370267, Expiry date: 19-Apr-2024.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 14-Jan-2024, the patient experienced developing a progressive polyneuropathy (Medically Significant, outcome: Not recovered / Not resolved). Soon after receiving vaccine patient began developing a progressive polyneuropathy. Believed this to be a variant of Guillain-Barre or CIDP. Patient was presently receiving treatment which had not halted the spread of the condition. This was greatly interfering with quality of life and profession.   Fluad Quadrivalent action taken: Not Applicable  Reporter assessment: The reporter assessed the seriousness of the event as non-serious and did not provide causality assessment.; Reporter's Comments: Causality: Related for the event considering plausible temporal relationship (same day of vaccination).
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Pt felt dizzy with numbnes at right arm followed by possible fainting episode
Age: 66.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient did not have an adverse event. documenting that patient receive a vaccine outside the age recommended for age group. she is 66 and vaccine is indicated for 10-25 years old
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Flushing, Migraine, Pain, Pyrexia
Clinical narrative: fever, chills, body aches, and facial flushing (days after), migraine headaches (night after vaccine)
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received to doses 7 months apart. no side effects
Age: 30.0
Sex: M
Vaccine: HPV9
Symptoms: Furuncle, Pyrexia, Rash
Clinical narrative: The patient states that they "syphilis-like" symptoms including rashes on legs/ body, boils on face, and fever. He said the symptoms started "2 weeks ago" when I spoke to him on the Dec. 10, 2024 over the phone.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC20
Symptoms: Wrong product administered
Clinical narrative: Pediarix combo vaccine administered instead of stand-alone vaccine Infanrix.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Full blood count, Nausea, Vertigo, Vomiting
Clinical narrative: Vertigo stated about 16 hours after vaccination. Nausea and vomiting due to vertigo.  Lying down was the only way to keep symptoms manageable.  Vertigo lessened after 4 days.  One week after vaccination still feel some vertigo, but no more nausea and vomiting.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Syncope
Clinical narrative: Patient knew that she had vasovagal syncope, and has happened with shots before. I administered the vaccine, and within a few seconds patient stated that she was not feeling normal. Patient started to have syncope episode. Mom was with patient and said that most episodes last only 30 seconds and she is ok. Episode was lasting a few minutes and mom requested i call ems because it was one of the worst episodes she had seen with her. EMS was called and patient was stabilized in counseling room when they came. She was not transported to the hospital and walked out with mom.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Swelling face
Clinical narrative: Patient received flu vaccine (unsure which one), 48 hours developed mid face swelling. No shortness of breath or tongue swelling
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Throat tightness
Clinical narrative: The patient about 10 minutes  after the shot complained of tightness in the throat. She was asked about it and what she had done and she stated she had a history of asthma and had just taken a couple of puffs of albuterol. I asked if it this was usual and if the albuterol helped. She stated it had not and was worse feeling like her throat was closing  so I got an epi pen 0.3mg and we called 911 and gave epi pen at 3:31pm I took bp at 3:34pm of 128/85 p 83. EMS arrived at 3:38pm when I was ready to give another epi pen- they took over and checked vitals which had elevated and there was still no itching, redness or swelling at injection site. Pt reported breathing better at around 3:42 pm and at that point the ambulance had arrived to transport her to the emergency room.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Allergy to vaccine, Dyspnoea, Throat tightness
Clinical narrative: The patient about 10 minutes  after the shot complained of tightness in the throat. She was asked about it and what she had done and she stated she had a history of asthma and had just taken a couple of puffs of albuterol. I asked if it this was usual and if the albuterol helped. She stated it had not and was worse feeling like her throat was closing  so I got an epi pen 0.3mg and we called 911 and gave epi pen at 3:31pm I took bp at 3:34pm of 128/85 p 83. EMS arrived at 3:38pm when I was ready to give another epi pen- they took over and checked vitals which had elevated and there was still no itching, redness or swelling at injection site. Pt reported breathing better at around 3:42 pm and at that point the ambulance had arrived to transport her to the emergency room.
Age: 53.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Heart rate increased, Laboratory test
Clinical narrative: My heart rate became elevated at 2:00 pm. At that time, it went up to 103, then by 4:00 it went from 106 to 108 and stayed there for two days. I take medication to keep my heart rate lowered. My medication did not lower my heart rate for two days.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Patient and friend had an appointment to get their flu shots. The patient that had the adverse event went first. He received his shot and switched places with his friend who then received their shot. There were about three minutes between the shots and them standing up to leave. When the first patient stood up he went to grab the door handle, then grabbed the arm of the chair he was sitting in, and then passed out. His friend and the technician giving the immunizations were able to guide him to the chair until he regained consciousness. He was unconscious for a minute or two. EMS was called and they came to monitor and make sure he was ok to leave. They walked him out of the store. He denied further treatment and went home.
Age: 69.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site swelling, Limb discomfort
Clinical narrative: Patient called to talk to pharmacist  complaining  redness and swelling at injection site and the arm is uncomfortable. Counseled patient to ice the injection site and take advil or Tylenol to reduce injection site reaction.  Patient received flu and pneumonia vaccine in the same left arm on 12/10/24 administered at pharmacy . Patient stated she will try the advil and ice and monitor her arm for 24 hours . Employee will call and check on her tomorrow to make sure the pain has relieved or not
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Duplicate dose given, original dose was given on 10/12/2023
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy bone marrow, Blood test, Platelet count decreased, Platelet transfusion, Thrombocytopenia
Clinical narrative: October 2023 diagnosed with Thrombocytopenia, low platelet count. Was hospitalized December 2023 for three days and required platelet transfusion. Required twice weekly blood draws for first several months, then once a week blood draws, now once per month blood draws. Also require medication and had a bone marrow biopsy in April 2024.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Magnetic resonance imaging spinal, Neuropathy peripheral, Rheumatoid factor negative
Clinical narrative: Peripheral neuropathy bilateral ascending from feet
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received a second Fluad. First on 8/01/2024, second on 12/08/2024
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received a second Fluad. First on 8/01/2024, second on 12/08/2024
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Alanine aminotransferase, Allergy to chemicals, Alopecia, Amylase
Clinical narrative: Flu-like symptoms started by the first night of the Pfizer COVID booster vaccine - felt very fatigued and had a fever over 101 that night. Intense right upper quadrant pain and pain in right shoulder blade started and I still have this 3 years after the vaccine. Within days and months after vaccine I continued to develop additional symptoms to include: elevated heart rate, heart palpitations and fluttering, buzzing and electric shock sensations throughout body, tingling in hands and feet (right side), tingling right side of face, tingling in spine, right leg pain, right foot pain, right knee and right hip pain, right side lower pelvic pain, hands and feet sweating nonstop, severe fatigue, eye floaters, visual snow, seeing after images, intense head pressure, unexplained rashes, unexplained bruises on legs, new food sensitivities or allergies, new chemical sensitivities, brain fog, weight loss, and significant hair loss.  Made an appointment to see a doctor at clinic after right upper quadrant pain and right shoulder blade pain did not subside. Doctor would not acknowledge any connection between getting the Pfizer COVID booster vaccine and the onset of symptoms I started experiencing. Multiple doctors and specialists at clinic would also not discuss my concerns about the timing of receiving the Pfizer COVID booster vaccine and further symptoms I continued to develop. I have had numerous blood tests and other medical tests over the past 3 years since receiving this vaccine.  Three years after receiving this vaccine I still have ongoing upper right quadrant pain and right side shoulder blade pain, right side joint pain, head pressure that comes and goes, tingling that comes and goes on the right side, and fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Arthralgia, Beta-2 glycoprotein antibody, Blood folate
Clinical narrative: Flu-like symptoms started by the first night of the Pfizer COVID booster vaccine - felt very fatigued and had a fever over 101 that night. Intense right upper quadrant pain and pain in right shoulder blade started and I still have this 3 years after the vaccine. Within days and months after vaccine I continued to develop additional symptoms to include: elevated heart rate, heart palpitations and fluttering, buzzing and electric shock sensations throughout body, tingling in hands and feet (right side), tingling right side of face, tingling in spine, right leg pain, right foot pain, right knee and right hip pain, right side lower pelvic pain, hands and feet sweating nonstop, severe fatigue, eye floaters, visual snow, seeing after images, intense head pressure, unexplained rashes, unexplained bruises on legs, new food sensitivities or allergies, new chemical sensitivities, brain fog, weight loss, and significant hair loss.  Made an appointment to see a doctor at clinic after right upper quadrant pain and right shoulder blade pain did not subside. Doctor would not acknowledge any connection between getting the Pfizer COVID booster vaccine and the onset of symptoms I started experiencing. Multiple doctors and specialists at clinic would also not discuss my concerns about the timing of receiving the Pfizer COVID booster vaccine and further symptoms I continued to develop. I have had numerous blood tests and other medical tests over the past 3 years since receiving this vaccine.  Three years after receiving this vaccine I still have ongoing upper right quadrant pain and right side shoulder blade pain, right side joint pain, head pressure that comes and goes, tingling that comes and goes on the right side, and fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin E, Blood iron, Blood thyroid stimulating hormone, Borrelia test, Borrelia test negative
Clinical narrative: Flu-like symptoms started by the first night of the Pfizer COVID booster vaccine - felt very fatigued and had a fever over 101 that night. Intense right upper quadrant pain and pain in right shoulder blade started and I still have this 3 years after the vaccine. Within days and months after vaccine I continued to develop additional symptoms to include: elevated heart rate, heart palpitations and fluttering, buzzing and electric shock sensations throughout body, tingling in hands and feet (right side), tingling right side of face, tingling in spine, right leg pain, right foot pain, right knee and right hip pain, right side lower pelvic pain, hands and feet sweating nonstop, severe fatigue, eye floaters, visual snow, seeing after images, intense head pressure, unexplained rashes, unexplained bruises on legs, new food sensitivities or allergies, new chemical sensitivities, brain fog, weight loss, and significant hair loss.  Made an appointment to see a doctor at clinic after right upper quadrant pain and right shoulder blade pain did not subside. Doctor would not acknowledge any connection between getting the Pfizer COVID booster vaccine and the onset of symptoms I started experiencing. Multiple doctors and specialists at clinic would also not discuss my concerns about the timing of receiving the Pfizer COVID booster vaccine and further symptoms I continued to develop. I have had numerous blood tests and other medical tests over the past 3 years since receiving this vaccine.  Three years after receiving this vaccine I still have ongoing upper right quadrant pain and right side shoulder blade pain, right side joint pain, head pressure that comes and goes, tingling that comes and goes on the right side, and fatigue.