chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Contusion, Erythema, Joint swelling, Swelling
Clinical narrative: Significant swelling in thigh, extending upwards towards hip & also extending below the knee. Accompanied by redness & what almost looks like bruising. No pain present from what I can tell.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient came to immunization clinic to receive a Tdap vaccine for her 28 week pregnancy.  A medication error occurred and the patient received a Pfizer vaccine instead.  she had received her 2 doses previously on May 14, 2021 and June 12, 2021.  The patient was fine for the next 30 minutes without any adverse effects noted.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis, Night sweats
Clinical narrative: Hot flashes throughout the day with excessive sweating , night sweats
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia, Haemorrhoids
Clinical narrative: On July 22, 2021, my daughter had a bloody stool.  This was the day after she recieved her first dose of the COVID-19  Pfizer shot.  The first bloody stool had the most blood.   She had three more bloody stools that were on different days (first one was Thursday7/22/21, then Saturday7/24/21, Monday7/26/21, and the last one was on Tuesday July 27, 20021.  The last three bloody stools had less blood each time.  Her first normal stool with no blood was on Thursday July 29, 2021.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fatigue over a week, then a week following receiving the vaccine had a fever, bad aches, dry cough, headache, and still persisting at day 8
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Fatigue over a week, then a week following receiving the vaccine had a fever, bad aches, dry cough, headache, and still persisting at day 8
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Localised oedema, Lymphoedema, Oedema peripheral, Pain
Clinical narrative: Sore Left arm for 48 hrs and lynphedema in neck an both ankles. Burning pain in left scapula area.  Recovered from all , except buring pain in Left scapula pain.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Left arm for 48 hrs and lynphedema in neck an both ankles. Burning pain in left scapula area.  Recovered from all , except buring pain in Left scapula pain.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Heavy menstrual bleeding
Clinical narrative: Metal taste in mouth for 10 days  Heavy menstrual bleeding outside of normal period cycle for approx 3 days
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: REdness and itching approximately 7 cm diam around injection site. No fluctuance but some warmth
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Epistaxis, Pyrexia
Clinical narrative: Aleve for fever. My husband is experiencing chronic heavy nose bleeds three to five times a week every since the second vaccination that he received on June 9, 2021. Yesterday, August 5, 2021, he was at work when the worst one began to date. His  mask was full of blood, his clothes covered in blood, blood was all of the work floor  at my job from my work station leading to another part of the building. These nose bleeds did not begin until the same day hours after I was administered a second vaccine dose on June, 9, 2021. I have tried to report this to  but the representatives on  the phone are rude and hung up. This health department administered both vaccines that I have received of Pfzier.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Neuritis, Vaccination complication, Vertigo
Clinical narrative: About 2-3 weeks after my second Pfzier vaccine shot, I started to have vertigo.   I was referred to see an ENT (ear/nose/throat doctor), and he said it is nerve inflammation due to the vaccine side effect.  He gave me steroids for two weeks, and it helped.  But I still have some vertigo.  My doctor said it will take time and to give it a few months to recover.    I was perfectly healthy before the Pfzier vaccine.  If I had known that the side effects were this serious with the Pfzier vaccine, I would never have taken the shots.  I really regret the shots now, and I am afraid if my body will ever recover fully.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Antinuclear antibody, Full blood count, Thyroid function test
Clinical narrative: diffuse thining of hair
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Death, Thrombosis
Clinical narrative: Stroke on March 24, 2021.  Widespread blood clots discovered on April 3rd, 2021.  Death on April 5th, 2021.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Hiccups, Injection site pain, Injection site swelling
Clinical narrative: I am experiencing extremely heavy longer periods (cycle menstruation) with violent painful cramps that I have never had prior to the vaccinations. It is atrocious!!! I am using two boxes of 36 or more count due to the vaccines that I never had experience prior to the vaccinations. Also, my right arm was swollen for three weeks after the second dose was adminstered. The site is still sore and wasn't until the vaccinations. I am  having horrendous hiccups almost every day ever since I have been vaccinated and had not been prior to the vaccines.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hiccups, Vaccination site pain, Vaccination site swelling
Clinical narrative: I am experiencing extremely heavy longer periods (cycle menstruation) with violent painful cramps that I have never had prior to the vaccinations. It is atrocious!!! I am using two boxes of 36 or more count due to the vaccines that I never had experience prior to the vaccinations. Also, my right arm was swollen for three weeks after the second dose was adminstered. The site is still sore and wasn't until the vaccinations. I am  having horrendous hiccups almost every day ever since I have been vaccinated and had not been prior to the vaccines.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature increased, Decreased appetite, Diarrhoea, Eye pain
Clinical narrative: severe body aches, massive headache ,eyes hurt, left arm and lymph nodes under arm  sore and painful ,nausea, temperature 101.2, loss of apatite, stomach cramps ,diarrhea, muscle pain in legs ,back hurts .pretty much same aggressive symptom's when I had covid in October . I am still sick day 2 not hungry head hurts ,eyes hurt but feeling a little better .arm and arm pit still hurt
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: severe body aches, massive headache ,eyes hurt, left arm and lymph nodes under arm  sore and painful ,nausea, temperature 101.2, loss of apatite, stomach cramps ,diarrhea, muscle pain in legs ,back hurts .pretty much same aggressive symptom's when I had covid in October . I am still sick day 2 not hungry head hurts ,eyes hurt but feeling a little better .arm and arm pit still hurt
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: severe body aches, massive headache ,eyes hurt, left arm and lymph nodes under arm  sore and painful ,nausea, temperature 101.2, loss of apatite, stomach cramps ,diarrhea, muscle pain in legs ,back hurts .pretty much same aggressive symptom's when I had covid in October . I am still sick day 2 not hungry head hurts ,eyes hurt but feeling a little better .arm and arm pit still hurt
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Started with temperature of 100.4 degrees Fahrenheit at around 0200 on 02Aug21 accompanied by chills, excessive sweating, nausea, lightheadedness, and a headache. Extreme exhaustion set in as well around the same time with my temperature increasing to 101.2 after an hour (0300). The same symptoms continued until 1000 on 02Aug21 when my temperature reached 101.8 degrees. Around 1600 on 02Aug21, I was having a very hard time breathing while sitting down. I also felt very dizzy when not in motion, more chills and excessive sweating, a very intense headache, and a temperature of 102.7 degrees. I slept through the night and my fever had gone down to 100.2 degrees by 0700 on 03Aug21. I developed a dry cough that would often leave me out of breath (similar to bronchitis in asthmatic people). I also had a lingering headache until roughly 1400 on 03Aug21 and no longer had a fever. Lingering cough remains on 06Aug21 with no other symptoms. Throughout the few days of having symptoms, I only took over the counter ibuprofen to help with my headache and my Albuteral inhaler to help with breathing.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Started with temperature of 100.4 degrees Fahrenheit at around 0200 on 02Aug21 accompanied by chills, excessive sweating, nausea, lightheadedness, and a headache. Extreme exhaustion set in as well around the same time with my temperature increasing to 101.2 after an hour (0300). The same symptoms continued until 1000 on 02Aug21 when my temperature reached 101.8 degrees. Around 1600 on 02Aug21, I was having a very hard time breathing while sitting down. I also felt very dizzy when not in motion, more chills and excessive sweating, a very intense headache, and a temperature of 102.7 degrees. I slept through the night and my fever had gone down to 100.2 degrees by 0700 on 03Aug21. I developed a dry cough that would often leave me out of breath (similar to bronchitis in asthmatic people). I also had a lingering headache until roughly 1400 on 03Aug21 and no longer had a fever. Lingering cough remains on 06Aug21 with no other symptoms. Throughout the few days of having symptoms, I only took over the counter ibuprofen to help with my headache and my Albuteral inhaler to help with breathing.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Impaired work ability
Clinical narrative: My second covid 19 vaccine was on 02/11/2021.  In March, my period was exceedingly heavy.  I was changing a pad every 2 hours and it wasn't enough.  I had to leave work because I am a traveling nurse and was unfit to enter patient's houses with this condition.  Prior to the vaccine my menstrual cycle lasted 3-4 days. Since the vaccine, my cycle has lasted nearly 7 days consistently, with much heavier bleeding.  Also my cycle starts very slowly and lingers at the end.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: 5 minutes after receiving the first dose, I started feeling tachycardia; This is a spontaneous report from a contactable consumer. A 53-years-old non-pregnant female patient received the first dose of bnt162b2 (Formulation: Solution for injection), via an unspecified route of administration, administered in arm left on 04Feb2021 08:30 (age at the vaccination: 53-years-old) (Batch/Lot Number: EL9264) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included atopic dermatitis, reflux, allergy: crustaceans, allergy: various foods and allergy: environmental; all from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (PRILOSEC) and cetirizine hydrochloride (ZYRTEC); both taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Feb2021 09:00, it was reported that 5 minutes after receiving the first dose, I started feeling tachycardia. No treatment was received for the adverse event. The outcome of the event was recovered on an unknown date in 2021.  Follow-up attempts completed. No further information expected
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test, Seizure
Clinical narrative: I was hospitalized for seizure episodes.; dose 1, single on 17Mar2021 at 16:30 (Batch/Lot Number: EP6955) and dose 2, single on 17Mar2021; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EP6955) via an unspecified route of administration in arm left on 17Mar2021 at 16:30 as DOSE 1, SINGLE and dose 2 (Lot number: ER8734) via an unspecified route of administration in arm left on 17Mar2021 (at the age of 59-years-old) both for covid-19 immunization. Medical history included HBP (high blood pressure) from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medication included lisinopril taken for an unspecified indication start and stop date were not reported. Patient had not received any other vaccine in four weeks. No covid prior vaccination. Patient was tested covid post vaccination. On 23Jun2021 at 10:00 AM (after receiving the dose of vaccine), the patient suffered dizziness, involuntary eye movements, she could not move her hands and legs. She was hospitalized for seizure episodes for 8 days. The adverse event resulted in Emergency or urgency room/department, Hospitalization, Disability, or permanent damage. Therapeutic measures were taken as a result of the events dizziness, involuntary eye movements, she could not move her hands and legs. On 08Jun2021 (Post vaccination), the patient underwent lab tests and procedures which included Covid-19 test (SARs COV 2, (nasal swab (sample) test) was negative. The outcome of the events was reported as not recovered.  Amendment: This follow up is being submitted to amend previously reported information: Suspect vaccine coding and drug authorization country were updated. Upon follow up on 27Jul2021 it was reported that, caller got disconnected after delivering the greetings. Narrative was added with case closure comment.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EVENT; Incorrect storage PEDV AX HIB was administered to (3) patients on 7/6/2021; This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 06-JUL-2021, the patient was vaccinated with improper storage haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T026961, expiration date 02-APR-2023 (dose, frequency and route were not provided), for prophylaxis. No additional adverse event reported.  Temperature (8.6F) Time frame 45 minutes Previous temperature excursion? N Was call because of a "data logger"? Y; Sender's Comments:  US-009507513-2108USA001447: US-009507513-2108USA001448:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; medical assistant reporting an expired dose of ROT ATEQ was administered; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not provided.  On 07-JUL-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) dose reported as "1 injection" (expired product administered) (strength, vaccination scheme, anatomical and route of administration and formulation were not reported; lot number 1684155 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) ,expiration date upon internal validation established as 25-JUN-2021) for prophylaxis.  No other adverse event was reported.
Age: 1.17
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; a 14 month old who was mistakenly given PNEUMOVAX 23 instead of Prevnar 13; a 14 month old who was mistakenly given PNEUMOVAX 23 instead of Prevnar 13; This spontaneous report was received from an office manager referring to a 14-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 26-JUL-2021, the patient was mistakenly vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml, lot # T035379 with expiration date 31-MAY-2022, for prophylaxis (strength and route of administration were not reported) instead of pneumococcal vaccine conj 13v (crm197)(PREVNAR 13). No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: husband's Zostavax vaccination record with this letter as proof of patient's infection and vaccination with the Zostavax virus through secondary transmission; This spontaneous report was received from a nurse practitioner, referring to a currently 82-year-old patient, via a immunization record from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs# 1801USA001762). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 29-DEC-2006, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported).  On an unknown date, the patient experienced shingles (herpes zoster). It was reported, the patient's wife infection and vaccination with zoster vaccine live (ZOSTAVAX) virus through secondary transmission (captured on Marrs# 1801USA001762).       The outcome of herpes zoster and the causality assessment between zoster vaccine live (ZOSTAVAX) and the aforementioned event was not reported.        This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-1801USA001762: US-009507513-2107USA007312:
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; temperature excursion / temperature: 1.1 C; This spontaneous report was received from a licensed practical nurse and refers to a 2-year-old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 29-JUL-2021, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # T023914, expiration date 31-MAR-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered vaccine was stored in a temperature of 1.1 degree Celsius (C) for 3 hours 9 minutes. No previous temperature excursion was reported. Digital data logger was not involved. No adverse event (AE) was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T023914; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient received an expired VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 19-JUL-2021, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # T014836, expiration date 17-JUL-2021, 0.5 milliliter, once for prophylaxis (anatomical location and route of administration were not reported). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014836; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: received the VARIVAX vaccine while she was one month pregnant; No additional AE information reported; This spontaneous prospective pregnancy report was received from the consumer's mother, a female patient patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided      On an unknown date, when the patient was one month pregnant, was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration, lot number and expiration date were not reported) for prophylaxis (exposure during pregnancy). No adverse events were reported      The patient became pregnant on an unknown date. The LMP and EDD were not reported. The pregnancy outcome was unknown.
Sex: F
Vaccine: VARCEL
Symptoms: Accident, Disability, Seroconversion test negative, Viral titre
Clinical narrative: accident; Caller reports having a titer test for chickenpox done in September 2020 and the results said she had no immunity; This spontaneous report was received from a 63-year-old female consumer reporting on herself. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided      On an unknown date between 1996 and 1997, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration ,lot number and expiration date were not reported) for prophylaxis.         In September 2020, the patient had a titer for chikenpox that showed she had no immunity (seroconversion test negative). Also in the same month patient reported she was in the hospital due to an accident, being in rehabilitation for 3 months.  The outcome of accident and seroconversion test negative was not reported as well as theri causal relationship with varicella virus vaccine live (oka/merck)(VARIVAX).         The patient considered the event of accident as disabling.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No other information provided; Caller reports dose of expired VAQTA administered to a patient; 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 medical history, concurrent conditions or concomitant medication.  On 02-AUG-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA)vial,  dose: 1 milliliter, lot # T033517, expiration date: 11-JUL-2021,  for prophylaxis (route of administration was not reported). No other information provided. No product quality complaint or additional adverse events were reported.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: No additional AE/PQC was reported; her second dose of the vaccine on 02-AUG-2021; This spontaneous report as received from a 38-year-old female patient regarding herself. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  Approximately in 2003, reported as around ages 20-21, the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).    On 02-AUG-2021, the patient was vaccinated with a second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No further information was provided. Pateint  did not report experiencing any symptoms after receiving her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).No product quality complaint or additional adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse events reported; pediatric patient received an extra dose of VAQTA; This spontaneous report was received from a registered nurse and 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 an unknown dates, the patient received two doses of hepatitis A vaccine, inactivated (VAQTA) (dose, route of administration, anatomical location, lot # and expiration date were not reported). On 02-AUG-2021, they received third dose of hepatitis A vaccine, inactivated (VAQTA) 0.5 mL, lot # 2JD3Y(lot # not valid for hepatitis A vaccine, inactivated (VAQTA) and does not match any company product), expiration date reported as 04-DEC-2022 (route of administration and anatomical location were not reported) (extra dose administered). All doses were administered for prophylaxis. There was no additional adverse event reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; lnadvertenly administered expired vaccine; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications or concurrent conditions was provided.  On 02-AUG-2021, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 1 time dose, lot # T018670 was confirmed to be valid, expiration date 11-JUL-2021 (dose, route and site of administration were not reported) for prophylaxis. The vaccine had no temperature excursion. No additional adverse event was reported.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: negative antibody tests; This spontaneous report was received from a consumer referring to herm mother, a female patient of unknown age.      On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (dose, route of administration, frequency, lot/batch # and expiration date were not reported).   The reporter referred that the patient did not make antibodies to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine.   It was also reported that she did not make antibodies to vaccine (linked case # US-009507513-2107USA007803).  It was reported that the patient was vaccinated with PFIZER-BIONTECH COVID-19 VACCINE and finish her scheme of two doses in June 2021 (reported as "this year").  The outcome of antibody test negative was unknown.  No further clarify.   This one of two reports from the same reporter.; Sender's Comments:  US-009507513-2107USA007803:
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported/ No side effects; She reported PROQUAD was administered with VARIVAX; The patient was suppose to receive MMR II but the PROQUAD was inadvertently administered instead.; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.   On 30-JUN-2021, the patient was inadvertently vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # T036562, expiration date 26-APR-2022, 1 injection for prophylaxis (exact dose, anatomical location and route of administration were not reported) (case # 2107USA000507) instead of planned measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). On the same date, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T032316, expiration date 22-SEP-2022) for prophylaxis.    No additional adverse event reported.  Follow up information has been received on 21-JUL-2021, from the vaccine provider and refers to a 12 months old female patient. The patient was vaccinated with a first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), subcutaneously in the right thigh and with a first dose of varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously in the left thigh . Concomitant therapy included first dose of hepatitis A Vaccine, Inactivated (VAQTA), intramuscularly, lot # T037788, expiration date 30-APR-2022, in the left thigh. The vaccines were administered by healthcare professional at private doctor's office/ hospital.   The vaccine provider confirmed that there were no adverse reactions and no vaccines were disposed.  This is one of two reports regarding the same patient. ; Sender's Comments:  US-009507513-2107USA000507:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EVENT; Incorrect storage PEDV AX HIB was administered to (3) patients on 7/6/2021; This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. THe patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 06-JUL-2021, the patient was vaccinated with improper storage haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T026961, expiration date 02-APR-2023 (dose, frequency and route were not provided), for prophylaxis. No additional adverse event reported.  Temperature (8.6F) Time frame 45 minutes Previous temperature excursion? N Was call because of a "data logger"? Y  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2107USA002009: US-009507513-2108USA001448:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EVENT; Incorrect storage PEDV AX HIB was administered to (3) patients on 7/6/2021; This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. THe patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 06-JUL-2021, the patient was vaccinated with improper storage haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T026961, expiration date 02-APR-2023 (dose, frequency and route were not provided), for prophylaxis. No additional adverse event reported.  Temperature (8.6F) Time frame 45 minutes Previous temperature excursion? N Was call because of a "data logger"? Y; Sender's Comments:  US-009507513-2108USA001447: US-009507513-2107USA002009:
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: was on the hospital on April; This case was reported by a consumer via patient support programs and described the occurrence of hospitalization in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In April 2021, unknown after receiving Shingrix, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   The reporter considered the hospitalization to be unrelated to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. This report was submitted via the online direct entry reporting system. Reporter was the patient herself. Patient history was not provided. Batch number and expiry date was not provided. The patient was called for the assistance on Shingrix and she mentioned that she was on the hospital on April. Dates for hospitalization was not provided. Reporter was unable to gather more information. Reporter called the patient and her number did not take unknown numbers. Reporter consented to follow-up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: got both shots / shingles again/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles over all left side of head and face).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got both Shingles shots and got shingles again. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got vaccinated still got them/ suspected vaccination failure; got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that he/she got vaccinated and still got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: have had both shots / still break out chronically/suspected vaccination failure; have had both shots / still break out chronically; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shigles vaccine (received original vaccine years before the date of reporting).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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.   The reporter considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had both shots and the original vaccine years ago and still break out chronically and severely.  It had nothing to do with the vaccine, it's the pervasive nature of the virus. This case was considered as suspected vaccination failure as details regarding primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; gotten shingles 3 times; This case was reported by a consumer via Shingrix interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both the shots. The patient asked for suggestions since he or she experienced shingles 3 times. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Guillain-Barre syndrome
Clinical narrative: nasty (rare) side effect / Guillain-Barre syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient.  The age at vaccination was not reported. The patient got shingles shot 2 years ago and got a nasty (rare) side effect.  The patient experienced Guillen-barre syndrome.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Nerve compression, Paraesthesia, Vaccination failure
Clinical narrative: it was the shot/fellt like I had Shingles on my fore arm/ suspected vaccination failure; had a reaction/fellt like I had Shingles on my fore arm; ulnar nerve entrapment; Numbness/ my pinky and fourth finger that goes up my left forearm to my elbow; tingling/ my pinky and fourth finger that goes up my left forearm to my elbow; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In November 2020, unknown after receiving Shingles vaccine, the patient experienced trapped nerve, numbness in fingers and tingling. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the trapped nerve, numbness in fingers and tingling were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, trapped nerve, numbness in fingers and tingling to be related to Shingles vaccine.  Additional details were reported as follows: The case reported by the patient. The age at vaccination was not reported. The patient might have a reaction, not sure 100 percent if it was the shingles shot, how it was administered or a combination of factor but the patient felt like he/she had shingles on his/her fore arm for weeks. Since then (November 2020), the patient had ulnar nerve entrapment or something similar, numbness and tingling in his/her pinky and fourth finger that goes up his/her left fore arm to elbow. It was better than it was but still an issue. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral, Pain, Vaccination failure
Clinical narrative: had both shingle shots/ it's shingles/suspected vaccination failure; hurtful side effect on my left side, NEUROPATHY; it's shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and Flu vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine and Shingles vaccine and not applicable after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), neuropathy (serious criteria GSK medically significant) and shingles. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure, neuropathy and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, neuropathy and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the neuropathy and shingles to be related to Flu vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had both shingles shots and Flu vaccine this spring and ended up with the hurtful side effects on his/her left side, neuropathy. The patient was told it was shingles that never broke the skin. The patient enter Gabapentin which he/she was still taking. The patient was very worried about getting the Covid 19 and so he/she opted for the single dose brand vaccine. Now with all the variants he/she would had to wait and see how that turns out, never thought had get more vaccines now the when he/she was a child. This case was considered as suspected vaccination failure as details regarding, exact time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; have had shingles for 3 years above the right eye. Awful; Awful; This case was reported by a consumer via interactive digital media (facebook) and described the occurrence of suspected 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), ophthalmic herpes zoster (serious criteria GSK medically significant) and feels awful. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and feels awful were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The case reported by the patient herself/himself. The age at vaccination was not reported. The patient received the shingles shot and patient had shingles above the right eye for 3 years. The reporter stated that it was awful. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; came down with shingles this week; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In August 2021, more than a year 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 details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The patient reported that, he or she took the shingles vaccine 2 years ago and the patient came down with shingles on the week of reporting. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation for shingles was not provided.
Sex: U
Vaccine: FLUX
Symptoms: Allergy to vaccine, Hypersensitivity
Clinical narrative: allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) (batch number FX77G, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient experienced allergic reaction to a GlaxoSmithKline Flu vaccine.