chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: difficulty sleeping; pain/discomfort from back of the elbow to shoulder and up to neck on left side.; pain in arm; pain from shoulder to elbow; discomfort from elbow to shoulder and neck; injection far back on arm; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2022, the patient received the 1st dose of Shingrix. On 14th February 2022, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 15th February 2022, the patient experienced shoulder pain, neck discomfort, neck pain and pain in arm. On an unknown date, the patient experienced difficulty sleeping. On an unknown date, the outcome of the shoulder pain and neck discomfort were not recovered/not resolved and the outcome of the difficulty sleeping, neck pain, pain in arm and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the shoulder pain, neck discomfort, difficulty sleeping, neck pain and pain in arm to be related to Shingrix.  Additional details reported were as follows: The age at vaccination was unknown. The registered pharmacist gave Shingrix injection on the back of the left arm, which led to vaccine administered at inappropriate site.  The patient never received an injection that far back on arm before. Next day after vaccination, the patient had pain or discomfort from back of the elbow to shoulder and up to neck on left side.  The patient reached out to registered pharmacist the day after he gave her vaccine, to report pain in arm and was told to use ice. After a week of no relief, the patient called her pain management healthcare professional.  Less than a month after receiving Shingrix, the patient experienced difficulty in sleeping. He gave her 2 pain shots, patient felt better but still had some discomfort. The patient was referred to healthcare professional.   Consent to follow up was given.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: ongoing tinnitus/ringing in her ears/ringing is very loud, very bad; mental health issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Lot number: EN6201) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Lot: no: EL9269), administration date: 10Feb2021, when the patient was 57 years old, for covid-19 Immunisation, reaction(s): "ringing in her ears/ongoing tinnitus". The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "ongoing tinnitus/ringing in her ears/ringing is very loud, very bad"; MENTAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "mental health issues".  Additional information: She was 57 when she had both doses. She is currently 58. Patient has been experiencing ringing in her ears since her first dose and states the ringing is very loud, very bad, and causing mental health issues for her now. Patient asking if Pfizer has further information about similar reports of tinnitus and recommendations for how to treat it.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mental disorder, Tinnitus
Clinical narrative: ongoing tinnitus/ringing in her ears/ringing is very loud, very bad; mental health issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Lot number: EN6201) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Lot: no: EL9269), administration date: 10Feb2021, when the patient was 57 years old, for covid-19 Immunisation, reaction(s): "ringing in her ears/ongoing tinnitus". The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "ongoing tinnitus/ringing in her ears/ringing is very loud, very bad"; MENTAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "mental health issues".  Additional information: She was 57 when she had both doses. She is currently 58. Patient has been experiencing ringing in her ears since her first dose and states the ringing is very loud, very bad, and causing mental health issues for her now. Patient asking if Pfizer has further information about similar reports of tinnitus and recommendations for how to treat it.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Severe Uterine cramping; heavy menses x5 months; no menses x4 months; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2020 (Lot number: EK5730) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; TIROSINT; JUNEL; VITAMIN D NOS. The following information was reported: UTERINE SPASM (medically significant) with onset 14Jan2021, outcome "recovered", described as "Severe Uterine cramping"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 14Jan2021, outcome "recovered", described as "heavy menses x5 months"; AMENORRHOEA (non-serious) with onset 14Jan2021, outcome "recovered", described as "no menses x4 months". The events "severe uterine cramping", "heavy menses x5 months" and "no menses x4 months" were evaluated at the physician office visit. Therapeutic measures were taken as a result of uterine spasm, heavy menstrual bleeding, amenorrhoea.  Clinical information: The patient was treated with Ibuprofen and referral to surgeon for Hysterectomy. No other vaccine in four weeks. No COVID prior vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event uterine spasm cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Heavy menstrual bleeding, Uterine spasm
Clinical narrative: Severe Uterine cramping; heavy menses x5 months; no menses x4 months; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2020 (Lot number: EK5730) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; TIROSINT; JUNEL; VITAMIN D NOS. The following information was reported: UTERINE SPASM (medically significant) with onset 14Jan2021, outcome "recovered", described as "Severe Uterine cramping"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 14Jan2021, outcome "recovered", described as "heavy menses x5 months"; AMENORRHOEA (non-serious) with onset 14Jan2021, outcome "recovered", described as "no menses x4 months". The events "severe uterine cramping", "heavy menses x5 months" and "no menses x4 months" were evaluated at the physician office visit. Therapeutic measures were taken as a result of uterine spasm, heavy menstrual bleeding, amenorrhoea.  Clinical information: The patient was treated with Ibuprofen and referral to surgeon for Hysterectomy. No other vaccine in four weeks. No COVID prior vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event uterine spasm cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Grip strength decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: Left arm pain/ shooting pain in left arm; Joint and muscle pain at shoulder, elbow and wrist/ intense pain periodically between elbow and wrist; Joint and muscle pain at shoulder, elbow and wrist; Unable to grip with left hand; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2022 (Lot number: FJG369) at the age of 39 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing), notes: IBS; "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. Concomitant medications included: TOLTERODINE XR and VISTARIL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: ER8732; Anatomical site: Left arm), administration date: 10Apr2021, when the patient was 38 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: ER8729; Anatomical site: Left arm), administration date: 01May2021, when the patient was 38 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Feb2022, outcome "recovering", described as "Left arm pain/ shooting pain in left arm"; ARTHRALGIA (non-serious) with onset 18Feb2022, outcome "recovering", described as "Joint and muscle pain at shoulder, elbow and wrist/ intense pain periodically between elbow and wrist"; MYALGIA (non-serious) with onset 18Feb2022, outcome "recovering", described as "Joint and muscle pain at shoulder, elbow and wrist"; GRIP STRENGTH DECREASED (non-serious) with onset 18Feb2022, outcome "recovering", described as "Unable to grip with left hand". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, myalgia and grip strength decreased.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Grip strength decreased, Myalgia, Pain in extremity
Clinical narrative: Left arm pain/ shooting pain in left arm; Joint and muscle pain at shoulder, elbow and wrist/ intense pain periodically between elbow and wrist; Joint and muscle pain at shoulder, elbow and wrist; Unable to grip with left hand; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2022 (Lot number: FJG369) at the age of 39 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing), notes: IBS; "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. Concomitant medications included: TOLTERODINE XR and VISTARIL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: ER8732; Anatomical site: Left arm), administration date: 10Apr2021, when the patient was 38 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: ER8729; Anatomical site: Left arm), administration date: 01May2021, when the patient was 38 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Feb2022, outcome "recovering", described as "Left arm pain/ shooting pain in left arm"; ARTHRALGIA (non-serious) with onset 18Feb2022, outcome "recovering", described as "Joint and muscle pain at shoulder, elbow and wrist/ intense pain periodically between elbow and wrist"; MYALGIA (non-serious) with onset 18Feb2022, outcome "recovering", described as "Joint and muscle pain at shoulder, elbow and wrist"; GRIP STRENGTH DECREASED (non-serious) with onset 18Feb2022, outcome "recovering", described as "Unable to grip with left hand". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, myalgia and grip strength decreased.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: CSF protein increased, Demyelinating polyneuropathy, Electromyogram abnormal, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Pt presented to ER  2/17/22 with c/o tingling. and strange sensations for 3 days  bilat legs and right arm;   seen and d/c   Called with increased sx  in legs sent back to ER.  Eventually admitted and dx with AIDP  acute inflammatory demyelinating polyneuropathy/  Guillain Barre.    Treated with IVIG,  then to Rehab.  Discharged March 10, 2022
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Inflammation, Laboratory test, Lumbar puncture, Paraesthesia, Sensory disturbance
Clinical narrative: Pt presented to ER  2/17/22 with c/o tingling. and strange sensations for 3 days  bilat legs and right arm;   seen and d/c   Called with increased sx  in legs sent back to ER.  Eventually admitted and dx with AIDP  acute inflammatory demyelinating polyneuropathy/  Guillain Barre.    Treated with IVIG,  then to Rehab.  Discharged March 10, 2022
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Angiocardiogram, Blood test, Chest X-ray, Dyspnoea
Clinical narrative: shortness of breath for a few weeks and slight heart pain and then moderate heart pain and went to hospital. I have myopericarditis (1.3cm inflammation to inside of my heart)  Test included blood tests, echo, CTCA, MRI, Chest xrays among others and am on colchicine
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Laboratory test, Magnetic resonance imaging, Myopericarditis
Clinical narrative: shortness of breath for a few weeks and slight heart pain and then moderate heart pain and went to hospital. I have myopericarditis (1.3cm inflammation to inside of my heart)  Test included blood tests, echo, CTCA, MRI, Chest xrays among others and am on colchicine
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Aspiration, Fall, Generalised tonic-clonic seizure, Headache, Pneumonia aspiration
Clinical narrative: Severe Headaches, Grand Mall Seizure, vomited, fell into vomit, inhaled vomit, ended up with pneumonia due to aspiration
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe Headaches, Grand Mall Seizure, vomited, fell into vomit, inhaled vomit, ended up with pneumonia due to aspiration
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Influenza virus test negative, SARS-CoV-2 test negative, Urticaria
Clinical narrative: All over recurring hives. They come and go and are still continuing today. I have gone to the hospital twice and had blood work and other tests and no other reason for the hives can be found.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Immediate post-injection reaction, Migraine, Nipple pain, Pyrexia
Clinical narrative: Hives on face, head, neck, chest immediately after vaccine. Took Benadryl with no relief. Prescribed prednisone and steroid cream . Helped but hives returned after prednisone ran out.  Prescribed extra dose of zrytec- no relief after 2 weeks. Consistent use of steroid and albuterol inhalers starting day after- use 3-5 time daily, still after 2 weeks. Menstrual like cramping starting 1 week after- continues after week 2. I had a hysterectomy 10 years ago and haven?t had cramping since then. Sore, very sensitive nipples starting 1 week after.  Migraine like headache and fever of 102 after week 1 lasting 2 days.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on face, head, neck, chest immediately after vaccine. Took Benadryl with no relief. Prescribed prednisone and steroid cream . Helped but hives returned after prednisone ran out.  Prescribed extra dose of zrytec- no relief after 2 weeks. Consistent use of steroid and albuterol inhalers starting day after- use 3-5 time daily, still after 2 weeks. Menstrual like cramping starting 1 week after- continues after week 2. I had a hysterectomy 10 years ago and haven?t had cramping since then. Sore, very sensitive nipples starting 1 week after.  Migraine like headache and fever of 102 after week 1 lasting 2 days.
Age: 26.0
Sex: M
Vaccine: FLU4, HEPA, HPV9
Symptoms: Syncope
Clinical narrative: Syncope; Information has been received from the US Food and Drug Administration (FDA) on 05-FEB-22.  This solicited report was received from a health care professional regarding a 26-year-old male patient.  The patient did not have any allergies to medications, food or other products. The patient did not have any other illnesses at the time of the vaccination and up to one month prior, or any chronic or long-standing health conditions. The patient was not taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at the time of the vaccination.   On 23-JAN-2020 10:43:00, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly on the right arm for prophylaxis (lot number reported as R0209, strength,dose and expiry date were not provided). Lot # R0209 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Lot # R0209 does not match any company product as confirmed by Lot Verification Team.  On the same day, the patient was also vaccinated with hepatitis a vaccine inact (HAVRIX) dose 1 administered intramuscularly  on the left arm(lot # reported as E22NT, strength, dose, formulation, expiry date, and indication were not provided), and with influenza vaccine inact split 4v (FLULAVAL QUADRIVALENT) dose 1 administered intramuscularly on the right arm (lot # reported as 55GY9,strength, dose, formulation, expiry date, and indication were not provided). The patient was vaccinated at a public health clinic.  On 23-JAN-2020 10:45:00, the patient experienced syncope. The event lasted only 1 minute. The patient's treatment included  juice, snack, ice pack and rest. The patient recovered with treatment withing 10 minutes. No medical tests or laboratory results were performed.   The action taken with the suspect vaccines and the causality assessment were not provided.  Follow-up information has been received from the healthcare professional on 18-FEB-2022.  The reporter stated that they were not able to identify the patient and they could not provide any further information.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: A patient received improperly stored vaccine; No additional AEs were reported; This spontaneous report was received from a medical assistant regarding a 1-year-old patient of unspecified gender. Information regarding medical history, concurrent conditions and concomitant medications was not reported.   On 07-DEC-2021, the patient received an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (lot number U024221 and expiration date 04-AUG-2023; both verified as valid (expiration date was reported as 04-OCT-2023)) (no more vaccination details provided). The vaccine had a temperature excursion of 39.5 Fahrenheit (F) for a time frame of 10 hours; there was no previous temperature excursion. No additional adverse events (AEs) were reported, no further information was provided.
Sex: U
Vaccine: HPV9, MENB, TDAP
Symptoms: No adverse event, Product use issue
Clinical narrative: no adverse event; Vaccine administered on the same day as Trumenba; This spontaneous report was received from a doctor's office representative refers to a 11 year old patient of unknown gender. No information regarding the patient's concurrent conditions, concomitant medications and medical history was provided.  On 09-FEB-2022 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1775809, expiration date 18-AUG-2023, intramuscular in the left deltoid (strength and dose not reported) for prophylaxis. Other suspect vaccines administered on the same day included meningococcal vaccine b rfhbpa/fhbpb (TRUMENBA) lot # CN8296, expiration date ??-AUG-2022, intramuscular in the right deltoid (strength and dose not reported) (product use for unapproved combination) for prophylaxis and diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL) lot # U7184AA, expiration date 09-SEP-2023, intramuscular in the right deltoid (strength, dose and indication not reported). No additional adverse events reported. No product quality complaints reported.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine on 28-JAN-2022; This spontaneous report was received from a Medical Assistant and refers to a 4-year-old female patient. The patient's medical history included frequent chronic ear infections. The patient's concurrent conditions were not reported. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX).   On 28-JAN-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot #U002532, expiration date: 24-JUL-2022, administered subcutaneously (anatomical location: right thigh) for prophylaxis (strength was not provided).   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in temperature - 12.3 degree Celsius for 1 hour (product storage error). Previous temperature excursion were reported as follows: -13.3 degree Celsius for 30 minutes; -11.1 degree Celsius for 1 hours 15 minutes; -8.9 Cdegree Celsius for 1 hour 30 minutes; -14.4 degree Celsius for 6 hours. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: did not get the 3rd dose of GARDASIL 9 on an unspecified date at 6 months; no additional AE reported; This spontaneous report was received from Pharmacist and refers to a 25-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (reported as 0 months), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unspecified date (reported as on 2 months), she received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The patient did not get the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on an unspecified date at 6 months. No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: A dose of VARIV AX was given after its expiration date; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not provided.  On 14-FEB-2022, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration, anatomical location and lot # were unknown) for prophylaxis. It was stated, that the vaccine expired on 23-JAN-2022 (expired product administered). The vaccine had not undergone temperature excursions. No additional information was provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Patient was administered VAQTA after temperature excursion on Dec 30, 2021; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 30-DEC-2021, the patient was vaccinated with improperly stored hepatitis aAvaccine, inactivated (VAQTA) prefilled syringe, lot # 1792241, expiration date 01-OCT-2022 (route of administration and anatomical location were not reported) for prophylaxis (Product storage error). Temperature 35.9 Fahrenheit degrees for 20 minutes. There was no previous temperature excursions. No additional adverse event was reported (No adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2202USA006998: US-009507513-2202USA007571: US-009507513-2202USA007118: US-009507513-2202USA007032: US-009507513-2202USA007028:
Age: 1.25
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE reported; inadvertently administered a GARDASIL 9; administered a GARDASIL 9 to a 15th month old; This spontaneous report was received from a certified medical assistant and patient's father referring to a 15-month-old male patient. The patient's current conditions, medical history, concomitant medications and drug reactions were not reported.   On 23-FEB-2022, the patient was inadvertently vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot # S033308, expiration date 08-APR-2022, route of administration not provided) 0.5ml for prophylaxis instead of influenza vaccine (reported as flu shot)(wrong product administered, product administered to patient of inappropriate age). After vaccination, he came back home with his father and had fallen asleep. No additional adverse events reported (no adverse event). The father inquired if he could sue the medical office for giving his son the wrong vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored dose of V ARlV AX was administered to the patient on 15 FEB 2022; This spontaneous report has been received from a medical assistant referring to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.   On 15-FEB-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliters (ml) (route of administration, anatomical site of vaccination and vaccine scheme were not reported; lot number U008181 has been verified to be valid, expiration date reported and established as 08-FEB-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of 9 degrees Fahrenheit (F) during a time frame of 293 hours and 14 minutes (product storage error). There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA008282: US-009507513-2202USA008270: US-009507513-2202USA007865:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; dose of MMR-11 expired on 11/20/2021 and was administered on 2/23/2022.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 23-FEB-2022 , the patient was vaccinated with measles(+)mumps and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA (recombinant Human albumin))(M-M-R II), dose of 0.5 milliliter, lot # S037497, expiration date 20-NOV-2021 (dose number and exact route of administration was not reported) for prophylaxis (Expired product administered). It was reported that the product had no temperature excursions through date of administration. No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: an improperly stored dose of VARIVAX; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-FEB-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # U010400, expiration date: 01-APR-2023, dose: 0,5 ml (route of administration, dose number were not reported) for prophylaxis (product storage error). Administered dose of vaccine experienced the temperature excursion of 9 degrees Fahrenheit (F) for 293 hours and 14 minutes. There were no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA007938: US-009507513-2202USA008282: US-009507513-2202USA007865:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse event's were reported; Administration of an expired dose of MMR Il; This spontaneous report as received from an office manager referring to a patient of unknown age and gender. The patient's current condition, pertinent medical history and drug reactions or allergies were not reported.     On 02-FEB-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # S037497 and expiration date reported as 20-NOV-2021), 0.5 ml one time reconstituted with 0.5 ml sterile diluent one time (lot # T010321 and expiration date reported as 25-OCT-2022) for prophylaxis (expired product administered). measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) has not undergone a temperature excursion. No other adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; Expired dose PROQUAD administered; This spontaneous report as received from a physician referring to a patient of unknown age and gender. The patient's current condition, pertinent medical history, concomitant medications and drug reactions or allergies were not reported.   On 24-FEB-2022, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (lot # T029102 and expiration date 23-FEB-2022) (dose, dose number, route of administration, anatomical location were not reported) for prophylaxis (expired product administered). No temperature excursions during the storage of this measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD). No additional AE reported. No Product quality complaint. No Additional information provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; Patient received PROQUAD after the expiry; This spontaneous report as received from a physician referring to a patient of unknown age and gender. The patient's current condition, pertinent medical history, concomitant medications and drug reactions or allergies were not reported.   On 22-FEB-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), one dosage form (expiration date: 20-FEB-2022, lot, route of administration, anatomical location were not reported) for prophylaxis after the expiry (expired product administered). No additional Adverse event reported. No Product quality complaint. No Additional information provided.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; HCP accidently administered expired GARDASIL 9 to patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.    On 28-FEB-2022 the patient was vaccinated with an expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (once, lot # S022599, expiration date 25-FEB-2022; dose and route were not reported) for prophylaxis by a HCP accidently (expired product administered). Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) had not experienced any temperature excursions. No additional event reported.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: fever; sores; This spontaneous report has been received from a lawyer (reporter), via a Fact Sheet from a case in litigation (MARRS # 2108USA004395), concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, lot #, expiration date and anatomical location were not reported) for prophylaxis. On an unspecified date, the patient experienced fever (values and units were not reported) and sores.     The outcome of fever and sores was unknown and the causality assessment between the aforementioned events and the vaccination with Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown) was considered as related.  This is one of the several reports received from the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness unilateral, Deafness unilateral, Demyelinating polyneuropathy, Eye disorder
Clinical narrative: loss of hearing in left ear; loss of sight in left eye; loss of left eye; demyelinating polyneuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), patient suffered a demyelinating polyneuropathy, loss of hearing in left ear, loss of sight in left eye and ultimately the loss of left eye. As a result of these symptoms, patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  All events were considered to be disabling by the reporter.  Upon internal review, demyelinating polyneuropathy, loss of hearing in left ear, loss of sight in left eye and ultimately the loss of left eye were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 02-MAR-2022. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around January 2015 the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered shingles (herpes zoster). As a direct and proximate result of using Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of the event herpes zoster was considered as not recovered. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: HCP reports no further AE's.; an expired dose of GARDASIL 9/Dose was administered today (03Mar2022) and expired on 25Feb2022; This spontaneous report was received from a medical assistant and refers to a male patient with an age reported as 13 (units not provided). The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not provided.   On 03-MAR-2022, the patient was vaccinated with one time dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (mL) (vaccination scheme frequency, route of administration and anatomical site of application were not provided; lot number S022599 that was verified for syringe formulation with an expiration date reported and established as 25-FEB-2022) (expired product administered) for prophylaxis.  It was stated that the vaccine had not experienced temperatures excursions. No further adverse events (AE's) were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccines experienced temperature excursion and were administered after the excursion; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-OCT-2021, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # U017140, expiring on 28-NOV-2022 was improperly stored and experienced a temperature excursion of 6°F up to 14°F for 4 hours and of 14°F up to 26°F for 4 hours and 45 minutes (product storage error).   On an unspecified date after the excursion, the patient was vaccinated with the improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), for prophylaxis (dose, route and site of administration  were not reported).   The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test positive, Bacterial infection, Bacterial test positive, Cellulitis, Disseminated varicella zoster virus infection
Clinical narrative: Despite previous varicella vaccination, our patient developed disseminated infection consistent with chickenpox; Despite previous varicella vaccination, our patient developed disseminated infection consistent with chickenpox; This literature marketed report as received from the authors of a published literature article, titled as stated above, refers to a 9-year-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On an unknown date, the patient was fully vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for prophylaxis.   On an unknown date, she was transferred from an outside hospital for worsening cellulitis of her right upper extremity. Two weeks prior to admission she was treated with 10 days of oral clindamycin for cellulitis of her face, chest, and right arm with clinical improvement. Four days after resolution of the cellulitis she developed a new pruritic papule on her right arm. Her sister had several similar lesions which resolved within 48 hours. The patient developed progressive erythema of her right antecubital fossa with evolution to a large, serum crusted plaque. Pruritic vesicles developed on her face, abdomen, and legs. She was transferred to the author's hospital for worsening cellulitis and was started on intravenous vancomycin while wound cultures were pending. Though she experienced moderate improvement in the right arm plaque after several days of vancomycin, she developed progressive vesicles, facial swelling, eye pain, and severe pruritus. Varicella infection was confirmed by direct fluorescence antibody testing. The bacterial culture grew methicillin sensitive Staphylococcus aureus. She was discharged home with oral acyclovir and cephalexin. Despite previous varicella vaccination, the patient developed disseminated infection consistent with chickenpox, which was complicated by a superimposed bacterial infection.  The outcome of the events was not reported. The author considered the events to be related to varicella virus vaccine live (oka/merck) (manufacturer unknown).  Upon internal review, the event of disseminated infection consistent with chickenpox was determined to be medically significant.   A copy of the published article is attached as further documentation of the patient's experience.  Literature report:
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Eye pain, Pruritus, Staphylococcus test positive, Superinfection
Clinical narrative: Despite previous varicella vaccination, our patient developed disseminated infection consistent with chickenpox; Despite previous varicella vaccination, our patient developed disseminated infection consistent with chickenpox; This literature marketed report as received from the authors of a published literature article, titled as stated above, refers to a 9-year-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On an unknown date, the patient was fully vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for prophylaxis.   On an unknown date, she was transferred from an outside hospital for worsening cellulitis of her right upper extremity. Two weeks prior to admission she was treated with 10 days of oral clindamycin for cellulitis of her face, chest, and right arm with clinical improvement. Four days after resolution of the cellulitis she developed a new pruritic papule on her right arm. Her sister had several similar lesions which resolved within 48 hours. The patient developed progressive erythema of her right antecubital fossa with evolution to a large, serum crusted plaque. Pruritic vesicles developed on her face, abdomen, and legs. She was transferred to the author's hospital for worsening cellulitis and was started on intravenous vancomycin while wound cultures were pending. Though she experienced moderate improvement in the right arm plaque after several days of vancomycin, she developed progressive vesicles, facial swelling, eye pain, and severe pruritus. Varicella infection was confirmed by direct fluorescence antibody testing. The bacterial culture grew methicillin sensitive Staphylococcus aureus. She was discharged home with oral acyclovir and cephalexin. Despite previous varicella vaccination, the patient developed disseminated infection consistent with chickenpox, which was complicated by a superimposed bacterial infection.  The outcome of the events was not reported. The author considered the events to be related to varicella virus vaccine live (oka/merck) (manufacturer unknown).  Upon internal review, the event of disseminated infection consistent with chickenpox was determined to be medically significant.   A copy of the published article is attached as further documentation of the patient's experience.  Literature report: