chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: some fatigue; sore arm / all in the left upper armmuscle which remained sore for several days each time; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (some fatigue) and VACCINATION SITE PAIN (sore arm / all in the left upper arm muscle which remained sore for several days each time) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (some fatigue) and VACCINATION SITE PAIN (sore arm / all in the left upper armmuscle which remained sore for several days each time). At the time of the report, FATIGUE (some fatigue) outcome was unknown and VACCINATION SITE PAIN (sore arm / all in the left upper armmuscle which remained sore for several days each time) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medication was reported. Reportedly, patient had no other events other than some fatigue and a sore arm. No treatment information was provided.   This case was linked to MOD-2022-669895, MOD-2022-668051, MOD-2022-662883, MOD-2022-662837 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: some fatigue; sore arm / all in the left upper armmuscle which remained sore for several days each time; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (some fatigue) and VACCINATION SITE PAIN (sore arm / all in the left upper arm muscle which remained sore for several days each time) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (some fatigue) and VACCINATION SITE PAIN (sore arm / all in the left upper armmuscle which remained sore for several days each time). At the time of the report, FATIGUE (some fatigue) outcome was unknown and VACCINATION SITE PAIN (sore arm / all in the left upper armmuscle which remained sore for several days each time) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medication was reported. Reportedly, patient had no other events other than some fatigue and a sore arm. No treatment information was provided.   This case was linked to MOD-2022-669895, MOD-2022-668051, MOD-2022-662883, MOD-2022-662837 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Illness, Influenza like illness, Interchange of vaccine products, Pain
Clinical narrative: SICK; FLU LIKE SYMPTOMS; TERRIBLE ACHES AND PAIN; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a 68 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in good medical shape. The patient was previously treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received non-company suspect vaccine elasomeran (Moderna vaccine) (dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, patient felt sick with terrible aches and pains and flu like symptoms for 24 hours and revaccination with different covid-19 vaccine (dose number in series 2).  The patient received non-company suspect vaccine tozinameran (Pfizer vaccine) (dose number in series 3) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced sick, flu like symptoms, and terrible aches and pain (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable. The patient recovered from sick, flu like symptoms, and terrible aches and pain and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Illness, Influenza like illness, Pain
Clinical narrative: SICK; FLU LIKE SYMPTOMS; TERRIBLE ACHES AND PAIN; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a 68 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in good medical shape. The patient was previously treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received non-company suspect vaccine elasomeran (Moderna vaccine) (dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, patient felt sick with terrible aches and pains and flu like symptoms for 24 hours and revaccination with different covid-19 vaccine (dose number in series 2).  The patient received non-company suspect vaccine tozinameran (Pfizer vaccine) (dose number in series 3) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced sick, flu like symptoms, and terrible aches and pain (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable. The patient recovered from sick, flu like symptoms, and terrible aches and pain and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Blood test, Electrocardiogram, Extrasystoles, Heart rate irregular
Clinical narrative: Diagnosed with irregular heart beat on 02Nov2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 09:15 as dose 4 (booster), single (Lot number: GJ6739) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: INFLUENZA taken for immunisation, on 06Oct2022 as dose number unknown, single; SIMVASTATIN; D3; ASPIRINE. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 02Nov2022, outcome "not recovered", described as "Diagnosed with irregular heart beat on 02Nov2022". The event "diagnosed with irregular heart beat on 02nov2022" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate irregular.  Additional information: The patient had no known allergies. Post vaccination, the patient was tested for COVID. The patient had COVID prior to vaccination.
Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Heart rate irregular
Clinical narrative: Diagnosed with irregular heart beat on 02Nov2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 09:15 as dose 4 (booster), single (Lot number: GJ6739) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: INFLUENZA taken for immunisation, on 06Oct2022 as dose number unknown, single; SIMVASTATIN; D3; ASPIRINE. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 02Nov2022, outcome "not recovered", described as "Diagnosed with irregular heart beat on 02Nov2022". The event "diagnosed with irregular heart beat on 02nov2022" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate irregular.  Additional information: The patient had no known allergies. Post vaccination, the patient was tested for COVID. The patient had COVID prior to vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: muscle pains; Fever; chills; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 11:30 as dose 4 (booster), single (Lot number: GJ3275) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX QUADRIVALENT taken for immunisation, start date: 25Oct2022, stop date: 25Oct2022; RALOXIFENE; LEXAPRO; LEVOTHYROXINE; ATENOLOL; WELL [BUPROPION HYDROCHLORIDE]. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE; lot number: 330308D, anatomical location: right arm, , ), administration date: 29Nov2021, when the patient was 47-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE: 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 05Nov2022 at 03:45, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 05Nov2022 at 03:45, outcome "recovering"; HEADACHE (non-serious) with onset 05Nov2022 at 03:45, outcome "recovering"; MYALGIA (non-serious) with onset 05Nov2022 at 03:45, outcome "recovering", described as "muscle pains". Therapeutic measures were not taken as a result of myalgia, pyrexia, chills, headache.  Additional information: The patient had no known allergies. Patient didn't experience COVID prior vaccination. The patient was not tested for COVID post vaccination. The AEs did not result in physician office visit or emergency room visit.
Age: 1.83
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This report is to document that the pharmacy accidentally administered Patient(age 22 months) a dose of the Pfizer COVID19 bivalent booster (10 mcg/0.2 mL dose) for ages 5+, which was intended for his older sibling. Patient had previously received the 1st (7/2/22) and 2nd (7/25/22) shots of the Pfizer COVID19 three-shot primary series. The pharmacist noticed the error immediately after administering the vaccines, and informed me the pharmacy was not authorized to issue vaccines to a patient of patient's age, and therefore no record of either the COVID-19 or Flu vaccine could be provided. Patient has experienced no noticeable adverse effects in the 5 days since vaccination.
Age: 1.83
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This report is to document that the pharmacy accidentally administered Patient(age 22 months) a dose of the Pfizer COVID19 bivalent booster (10 mcg/0.2 mL dose) for ages 5+, which was intended for his older sibling. Patient had previously received the 1st (7/2/22) and 2nd (7/25/22) shots of the Pfizer COVID19 three-shot primary series. The pharmacist noticed the error immediately after administering the vaccines, and informed me the pharmacy was not authorized to issue vaccines to a patient of patient's age, and therefore no record of either the COVID-19 or Flu vaccine could be provided. Patient has experienced no noticeable adverse effects in the 5 days since vaccination.
Age: 56.0
Sex: M
Vaccine: COVID19-2, UNK, COVID19-2
Symptoms: Computerised tomogram, Culture positive, Exercise tolerance decreased, Feeling abnormal, Gait disturbance
Clinical narrative: Week of Oct. 23-29, 2022, patient started having muscle spasms in his back and was seeing chiropractor for them and went to ER on Wednesday the 26th of October. October 28 one of his legs was tingly and going numb. By 2:30 AM both legs were numb and couldn't walk without assistance. Went to ER and continued to progressively get worse. Flown to another hospital and found a blood clot in his spine as well as an abscess when they operated. Working on being able to walk again with physical Therapy and continuing being in the hospital.
Age: 56.0
Sex: M
Vaccine: COVID19-2, UNK, COVID19-2
Symptoms: Loss of control of legs, Magnetic resonance imaging, Muscle tightness, Poor quality sleep, Sensory loss
Clinical narrative: Week of Oct. 23-29, 2022, patient started having muscle spasms in his back and was seeing chiropractor for them and went to ER on Wednesday the 26th of October. October 28 one of his legs was tingly and going numb. By 2:30 AM both legs were numb and couldn't walk without assistance. Went to ER and continued to progressively get worse. Flown to another hospital and found a blood clot in his spine as well as an abscess when they operated. Working on being able to walk again with physical Therapy and continuing being in the hospital.
Age: 56.0
Sex: M
Vaccine: COVID19-2, UNK, COVID19-2
Symptoms: Spinal cord abscess, Spinal laminectomy, Staphylococcal infection, Surgery
Clinical narrative: Week of Oct. 23-29, 2022, patient started having muscle spasms in his back and was seeing chiropractor for them and went to ER on Wednesday the 26th of October. October 28 one of his legs was tingly and going numb. By 2:30 AM both legs were numb and couldn't walk without assistance. Went to ER and continued to progressively get worse. Flown to another hospital and found a blood clot in his spine as well as an abscess when they operated. Working on being able to walk again with physical Therapy and continuing being in the hospital.
Age: 56.0
Sex: M
Vaccine: COVID19-2, UNK, COVID19-2
Symptoms: Abscess, Chiropractic, Computerised tomogram, Gait inability, Hypoaesthesia
Clinical narrative: Week of Oct. 23-29, 2022, patient started having muscle spasms in his back and was seeing chiropractor for them and went to ER on Wednesday the 26th of October. October 28 one of his legs was tingly and going numb. By 2:30 AM both legs were numb and couldn't walk without assistance. Went to ER and continued to progressively get worse. Flown to another hospital and found a blood clot in his spine as well as an abscess when they operated. Working on being able to walk again with physical Therapy and continuing being in the hospital.
Age: 56.0
Sex: M
Vaccine: COVID19-2, UNK, COVID19-2
Symptoms: Magnetic resonance imaging, Muscle spasms, Paraesthesia, Surgery, Thrombosis
Clinical narrative: Week of Oct. 23-29, 2022, patient started having muscle spasms in his back and was seeing chiropractor for them and went to ER on Wednesday the 26th of October. October 28 one of his legs was tingly and going numb. By 2:30 AM both legs were numb and couldn't walk without assistance. Went to ER and continued to progressively get worse. Flown to another hospital and found a blood clot in his spine as well as an abscess when they operated. Working on being able to walk again with physical Therapy and continuing being in the hospital.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Malaise, Pain
Clinical narrative: usually with all 4 doses I was a little off the next day; with maybe a little bit of achiness; The only symptom that lasted for a couple of weeks was the fatigue associated with COVID; came down with a very, very mild Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (came down with a very, very mild Covid), MALAISE (usually with all 4 doses I was a little off the next day), PAIN (with maybe a little bit of achiness) and FATIGUE (The only symptom that lasted for a couple of weeks was the fatigue associated with COVID) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 011J20A, 024M201 and 026D21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 25-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2022, the patient experienced COVID-19 (came down with a very, very mild Covid). On an unknown date, the patient experienced MALAISE (usually with all 4 doses I was a little off the next day), PAIN (with maybe a little bit of achiness) and FATIGUE (The only symptom that lasted for a couple of weeks was the fatigue associated with COVID). At the time of the report, COVID-19 (came down with a very, very mild Covid), MALAISE (usually with all 4 doses I was a little off the next day), PAIN (with maybe a little bit of achiness) and FATIGUE (The only symptom that lasted for a couple of weeks was the fatigue associated with COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, COVID-19: Positive.         Patient had scheduled 3rd Moderna booster vaccine on 07Nov2022 at the pharmacy. Patient had moderna for all vaccinations and came down with a very, very mild Covid in late August, 2022 which was short lived perhaps partly due to his active lifestyle and partly due to the Moderna COVID-19 vaccine. No Concomitant medication was reported by reporter. No Treatment drug was provided by reporter.   This case was linked to MOD-2022-669831 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Nov-2022: Follow-up received: Event added, Dosage information added and Narrative updated.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: No adverse event.  Reporting Medication Error Pt requested flu vaccine on discharge from hospital. RN asked pt the list of questions prior to receiving the flu vaccine. The pt had no contraindications and notified RN that he would like the flu vaccine prior to discharge as he has not had the flu shot yet this year. Flu shot given at 1232. Pt monitored up until discharge at approx. 1530. No adverse reactions noted. Pt VSS. At approx. 1445 pt told RN that he was mistaken and had already received flu shot this year a month or 2 prior to todays dose. Again, no adverse reactions noted.  MD notified. Pt still discharged at 1530.  Investigation showed Pt received Flucelvax at a Pharmacy on 10/13/22.  In System, there was record of it under section.  Missed by RN and Pharmacist during order verification.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Restless legs syndrome
Clinical narrative: Severe RLS triggered in legs and arms
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: I came to this immediate care clinic on 11/8/2022 to receive the newest COVID booster. I filled out paperwork indicating my age and other information, including dates of previous COVID vaccinations. I also brought my vaccination card. The nurse met me and led to a room. I was vaccinated, she filled out my card with the date and "Pfizer Bivalent Booster," as well as the lot number. Later, I looked at the MyChart portal to see my visit summary. The visit summary says the lot number and that I received the pediatric dose for ages 5-11 years. I am 53 years old. There's no reason that the nurse/assistant should have given me a pediatric dose. I assume this means I am unprotected and that the dose is invalid.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immediate post-injection reaction, Lip swelling, Paraesthesia
Clinical narrative: Patient was offered a different option for COVID booster, however, patient verbally stated that she still wanted to receive Pfizer bivalent booster. Patient was then asked to stay for 30 minutes to be monitored. At 1440, the Pfizer bivalent booster was administered to the left arm.  AT 1505, RN assessed patient. Patient stated that she is starting to experience tingling of her fingers and swelling of her lips. Patient stated she would take benadryl immediately after receiving her previous Pfizer doses. RN administered Epi Injection, USP Auto-Injector 0.3mg (Lot #: 1FM458, exp: MAY 2023) to left outer thigh. Provider was notified of the event and to come down immediately to location.  At 1509, PT stated that she was starting to feel better and denies feeling tingling on fingers and swelling of her lips. Vital sign are as follows: BP = 173/105 SPO2 = 98% in RA Pulse = 63  At 1520, patient is AAO X3. vital signs are as follows: BP = 147/85 SPO2 = 96% in RA Pulse = 66  At 1527, PT appears stable and was transferred to the ER via wheelchair.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 27-SEP2022, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #U012004, expiration date: 15-OCT-2022, administered for prophylaxis (strength and route of administration were not provided) reported also as hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W007371, expiration date: 13-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided). Administered dose of vaccine was stored in a temperature 34.5 F for 1 hour 7 minutes. Previous temperature excursion was 66.7F for 13 hours 52 minutes 0 seconds (product storage error). No additional adverse event was reported (no adverse event).  This is one of several reports received from the same reports. ; Sender's Comments:  US-009507513-2210USA005936:MSD US-009507513-2210USA005917:MSD US-009507513-2210USA005916:MSD US-009507513-2210USA005942:MSD US-009507513-2210USA005929:MSD US-009507513-2210USA005937:MSD US-009507513-2210USA005979:MSD US-009507513-2210USA005994:MSD US-009507513-2210USA005996:MSD US-009507513-2210USA006007:MSD
Age: 39.0
Sex: F
Vaccine: COVID19, HPV9
Symptoms: Exposure during pregnancy, Pain in extremity, Wrong product administered
Clinical narrative: Sore arm; She is pregnant and was accidently administered GARDASIL 9; She was supposed to receive a pfizer covid vaccine booster but the nurse made a mistake and administered GARDASIL 9; This spontaneous, prospective, pregnancy report has been received from a consumer referring to herself, a 39-year-old female. The patient's concurrent conditions, concomitant therapies, previous drug reactions or allergies were not reported.  On 18-OCT-2022, the patient was accidently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, once, administered intramuscularly on the left deltoid, administered as prophylaxis (dose and strength were not provided; lot number 1780878 had been verified to be a valid number: expiration date was reported and estalblished as on  02-DEC-2023) instead of a COVID vaccine booster (wrong product administered). At the time of the vaccination, the patient was 13 weeks and 2 days pregnant (exposure during pregnancy). Additionally, the patient experienced sore arm (pain in extremity).  On an unknown date, the patient was vaccinated with with tozinameran (PFIZER BIONTECH COVID-19 VACCINE).  The outcome of the event pain in extremity was not provided.  The causal relationship between the event pain in extremity and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; Patient was accidently administered an expired dose of PNEUMOVAX 23; This spontaneous report was received from a registered nurse and refers to a 10-year-old female patient. The patient's medical history included leukaemia with bone marrow transplant in approximately March 2021(also reported as approximately 20 months ago). The patient's concurrent conditions and drug reactions or allergies were not reported.  On 24-OCT-2022, accidentally the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), lot # U003306, expiration date 15-OCT-2022,  in the right deltoid for prophylaxis (dose and route were not reported) (expired product administered). The product had no prior temperature excursions. No additional adverse event and no product quality complain were reported.   Concomitant therapies included ketoconazole and colecalciferol (CHOLECALCIFEROL).
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported. No additional information was provided to further clarify these details. No additional AE.; improperly stored vaccines were administered to a patient on 24 OCT 2022.; This spontaneous report was received from a vaccine coordinator, concerning a 4-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previously drug reactions or allergies, and concomitant medications were not provided.  On an unknown date, there was a temperature excursion registered for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ), of 33.6 Fahrenheit degrees (F) for 3 hours, and 46.9 (F) for 1 hour 48 minutes. Additionally, it was reported that there were previous temperature excursions of 34.3 (F) for 0 hours 48 minutes, 34.3 (F) for 1 hour 42 minutes, 34.9 (F) for 1 hour 18 minutes, and 34.3 (F) for 1 hour 18 minutes.  On 24-OCT-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #U034522, expiration date: 22-JUN-2024 (dose, route of administration and anatomical location were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #W011278, expiration date: 01-NOV-2023, given orally (dose was not provided). Both vaccines were administered for prophylaxis (product storage error).  No adverse effects were reported. No additional information was provided.
Age: 0.92
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE details were provided; A medical assistant is calling in to report an AE for a patient who received their first dose of MMR-II and VARIVAX 7 days too early.; This spontaneous report has been received from a medical assistant, referring to a 11-month-old female patient.  The patient's concurrent conditions, medical history, and concomitant medications were not provided.  On 26-OCT-2022 the patient was vaccinated 7 days too early with their first dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R-II) 0.5 milliliter subcutaneously (lot number W009104 has been verified to be a valid lot number, expiry date 04-DEC-2023) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter subcutaneously(lot number W017551 has been verified to be a valid lot number, expiry date 06-JAN-2024) (strength, frequency, and anatomical location were not reported) indicated as prophylaxis (inappropriate schedule of product administration). The reporter states that the patient turns 12 months old on 01-NOV-2022 and that was when she should have received her first doses.  No additional adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA009819:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: he caller reports she started getting her GARDASIL 9 vaccination in 2019, however, she never got the third dose of the vaccination due to being unable to see her provider when COVID-19 emerged.; No further information was provided. No additional AE was reported. No PQC was reported.; This spontaneous report was received from a consumer of unknown age concerning herself. The patient's concomitant therapies, pertinent medical history, and drug reactions/allergies were not reported.  On an unknown date in 2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, lot #, and expiration date were not reported) for prophylaxis. However, she never got the third dose of the vaccination due to being unable to see her provider when Coronavirus Disease 2019 (COVID-19) emerged (inappropriate schedule of product administration). The patient would turn to be 45 years old on 07-FEB-2023, and she was wanting to know if she needed to start the vaccination schedule over again. No further information was provided. No additional adverse event (AE) was reported.
Age: 0.83
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO other issues or concerns noted.; A 10 months old was administered GARDASIL 9; This spontaneous report was received from a nurse via company representative and refers to a 10-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-OCT-2022, the patient was vaccinated with a dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (strength, dosage regimen, anatomical location, route of administration, lot #, and expiry date were not reported) as prophylaxis (Inappropriate age at vaccine administration). No adverse event was reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Inbound call from HCP stating that a improperly store PEDVAX that experienced a supported excursion was administered to a patient. No additional AE details or PQC.          ?    Names of vaccines involved (including lot/exp) PEDVAX HIB U031544 Jun; This spontaneous report has been received from a nurse, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 31-OCT-2022, the patient was vaccinated with improperly storage dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular Injection (lot number: U031544, which was determined to be valid, with an expiration date on 23-JUN-2024) administered as prophylaxis (strength, dose, route of administration, and anatomical site of injection were not reported).   Administered doses were stored at a temperature of 33 degrees Fahrenheit (F) during a time frame of 9 minutes. There was no previous temperature excursion.  No additional adverse events were reported in the patient.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error, Somnolence
Clinical narrative: the patient did fall asleep; A HCP called and reported an AE where a dose of VARIVAX was administered to a patient after it was improperly stored.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drugs reactions/allergies were not reported.  On 29-SEP-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, 0.5 ml (lot number W017551, expiration date reported as 01-JUN-2024) for prophylaxis (strength, and route of administration were not provided) after it was improperly stored (product storage error). The patient did fall asleep shortly after the injection (somnolence). At the time of this event, the outcome of the event somnolence was unknown.   The causality between the event somnolence and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: an expired dose of VAQTA was administered to a patient today.; This spontaneous report was received from a Certified Medical Assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions, or concomitant medications.      On 01-NOV-2022 (reported as "today"), the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe lot # U024378 with an expiration date on 22-OCT-2022, for prophylaxis (dose, route of administration, and anatomical location were not reported). It was specified that product was stored according to it's label prior to being administered.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported; expired vaccine administered; This spontaneous report was received from a physician and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 03-NOV-2022, the patient was vaccinated with an expired vaccine of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter (ml) intramuscular (IM), lot #U026792, expiration date: 28-OCT-2022, administered for prophylaxis (strength was not provided) (expired product administered). No additional adverse event (AE) reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reported vaccine administered after temperature excursion; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. Relevant medical history, drug reactions/allergies and concomitant medication for the patient involved were not reported.  On 04-NOV-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHa, 0.5 ml, subcutaneously, lot number: W004026 (expiration date: 02-AUG-2023) for prophylaxis.   The storage characteristics were the following: - Temperature -11.7C - Time frame 6 hours and 17 minutes - Previous temperature excursion? No  No adverse effects were reported.; Sender's Comments:  US-009507513-2211USA002447:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No other issues or concers noted; Nurse calling to report that a patient was administered expired dose of MMR II on 11/7/2022.  No PQC  AE 0228198 reported MMRII:   LOT:  T034389 EXP: Oct 8, 2022 No other issues or concerns noted. No follow-up.; This spontaneous report was received from  a registered nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-NOV-2022, the patient was vaccinated with an expired dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) subcutaneous injection, unk, lot #T034389, expiration date: 08-OCT-2022, administered for prophylaxis (strength, and route of administration were not provided). No other issues or concerns noted.
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Drug intolerance
Clinical narrative: Not able to tolerate Vivotif; Abdominal pain; A spontaneous report was received from a pharmacist on 26SEP2022. It described a 25-year-old male patient who had "abdominal pain" (PT: Abdominal pain) and was "not able to tolerate Vivotif" (PT: Drug intolerance). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunization. It was reported that the patient took his first dose of Vivotif on 21SEP2022. On 25SEP2022, following the third dose of Vivotif the patient had abdominal pain. Reportedly, the patient was not able to tolerate the vaccine and did not want to continue with the fourth dose of Vivotif. The outcome of the reported events was unknown.  Action taken with Vivotif with respect to the event "not able to tolerate Vivotif" was not applicable and for the event "abdominal pain" it was unknown.  No additional information was reported.  Company comment: It was reported that a patient took Vivotif for immunization, and he had abdominal pain and was not able to tolerate Vivotif (drug intolerance). Considering the case information, the role of Vivotif cannot be ruled out and the causality of abdominal pain and drug intolerance is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient took Vivotif for immunization, and he had abdominal pain and was not able to tolerate Vivotif (drug intolerance). Considering the case information, the role of Vivotif cannot be ruled out and the causality of abdominal pain and drug intolerance is assessed as possible. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: was in the hospital with them & had the shots yrs earlier/ Suspected vaccination failure; was in the hospital for 2 weeks with them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant) and shingles (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-Nov-2022  Reporter's Comment: This case was reported by a patient's cousin via interactive digital media. The reporter stated that getting vaccine dose did not mean that you would not get them. But if you dose did it then it would be not be as bad. The patient was in hospital for 2 weeks with shingles and the patient had the Shingles shoots shots 2 years earlier. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule,and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Ischaemic stroke
Clinical narrative: an ischemic stroke on August 20; This case was reported by a consumer via interactive digital media and described the occurrence of ischemic stroke in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 2nd August 2022, the patient received the 1st dose of Shingles vaccine. On 20th August 2022, 18 days after receiving Shingles vaccine, the patient experienced ischemic stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the ischemic stroke was unknown.   It was unknown if the reporter considered the ischemic stroke to be related to Shingles vaccine.     Additional Information: GSK receipt date: 01-NOV- 2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient received first dose of Shingle vaccine and suffered an ischemic stroke. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Got the shot, four weeks later developed shingles; Developed shingles four weeks after shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 weeks after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 1-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shot and about four weeks later he/she came down with the shingles. The patient advised that stay away from the shots. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Had the 2-shot series several years ago, developed shingles over the weekend/suspected vaccination failure; just developed shingles over the weekend; It is miserable; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In October 2022, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 1-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient was told that not good enough and so he/she had the 2-shot series several years ago and just developed shingles over the weekend and it was miserable. The patient asked that what the hell was happened. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot, then shingles/suspected vaccination failure; Shingles, mild case; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shot and then got shingles but a mild case. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.