chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: seizure; This case was reported by a consumer via call center representative and described the occurrence of grand mal seizure in a 12-year-old female patient who received DTPa (Reduced antigen) (dTpa vaccine) (batch number U6213AA ?, expiry date 12th March 2021) for prophylaxis.   On 25th April 2019, the patient received dTpa vaccine (intramuscular). On 25th April 2019, 5 min after receiving dTpa vaccine, the patient experienced grand mal seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the grand mal seizure was unknown.   It was unknown if the reporter considered the grand mal seizure to be related to dTpa vaccine.  Additional details were provided as follows: The reporter was the mother of the patient. The patient received the dose of Diphtheria, Tetanus and Pertussis (Tdap) vaccine and about 5 minutes after the dose, the patient experienced a grand mal seizure and was taken to emergency room (EM) by ambulance. The brand name or manufacturer of the vaccine was unable to idenfify bt the reporter. The reporter did not consent to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This case was reported by a physician via call center representative and described the occurrence of anaphylaxis in a female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   Concurrent medical conditions included allergic to horses (horse derived products).   On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown.   It was unknown if the reporter considered the anaphylaxis to be related to dTpa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine outside the country, but declined to state which country. A long time age before the reporting, the patient had a anaphylactic reaction to an unknown Diphtheria, Tetanus and Pertussis (Tdap) vaccine. The agent filing Boostrix, as unable to confirm product. The healthcare professional (HCP) was considering administering Boostrix to the patient on 26th April 2019 due to an injury she sustained. After hearing the information on product of animal origin, the HCP indicated that he would not vaccinate the patient.
Age: 10.0
Sex: M
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: her son was given Ipol vaccines,his second and third doses were 2 weeks apart; her son was given Ipol vaccines,his second and third doses were 2 weeks apart; Initial information received on 22-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional by phone.  This case was cross-referenced with case 2019SA113641 (same reporter).  This case involves a 10 years old male patient who was vaccinated with a second and third doses of IPV (VERO) [IPOL] (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 03-Oct-2018 and 25-Oct-2018.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   It was a case of actual medication error due to extra dose administered and inappropriate schedule of vaccine administration.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Age: 1.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: pentacel not mixed right pentacel  (green top vial ) was mixed with sterile diluent and not the liquid Hib (blue top vial)  patients mom was notified.  there wasn't any adverse events
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Red and swelling at injection site (5" diameter). Severe Flu like symptoms: headache, aches, chills, fever, weakness, sweating. Tylenol helps after first night. First time was 2 days, booster did the same thing but still feeling bad on day 3.  He feels it's starting to get better today.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Red and swelling at injection site (5" diameter). Severe Flu like symptoms: headache, aches, chills, fever, weakness, sweating. Tylenol helps after first night. First time was 2 days, booster did the same thing but still feeling bad on day 3.  He feels it's starting to get better today.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: c/o right arm pain at rest and movement
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia, Tremor
Clinical narrative: 6pm fatigue.  9pm increased fatigue, chills, shaking, high fever.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site papule, Injection site swelling
Clinical narrative: PT PRESENTED TO THE OFFICE THE DAY AFTER THE VACCINE WAS GIVEN. PT HAD A RED AND TENDER LEFT THIGH WITH PAPULES EXTENDING DOWN THE LEFT LEG. TREATED WITH PREDNISOLONE, HYDROXYZINE AND TRIAMCINOLONE CREAM. FOLLOWED UP IN 1 DAY.  PT HAD SWELLING AND ENDURATION WITH PAPULES, ERYTHEMA AND WARMTH TO THE AREA IS SLIGHTLY WORSE. PT IS TO FOLLOW UP IN 3 DAYS
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site warmth
Clinical narrative: PT PRESENTED TO THE OFFICE THE DAY AFTER THE VACCINE WAS GIVEN. PT HAD A RED AND TENDER LEFT THIGH WITH PAPULES EXTENDING DOWN THE LEFT LEG. TREATED WITH PREDNISOLONE, HYDROXYZINE AND TRIAMCINOLONE CREAM. FOLLOWED UP IN 1 DAY.  PT HAD SWELLING AND ENDURATION WITH PAPULES, ERYTHEMA AND WARMTH TO THE AREA IS SLIGHTLY WORSE. PT IS TO FOLLOW UP IN 3 DAYS
Age: 15.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Pyrexia, Urticaria
Clinical narrative: Fever, stomachache, followed by hives which he still has 1 month later
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Moderate pain and redness near injection site, chills, fatigue, joint pain, headache, chills
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Moderate pain and redness near injection site, chills, fatigue, joint pain, headache, chills
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Arm very sore, could not lift by 5:00 PM of same day/Also headachy and very achy same day also through the evening and the next day....very much like flu symptoms............first shot symptoms lasted almost 2 weeks....so far the second shot symptoms are the same to the second day.  I am reporting it today...
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Child developed a large area of pink/redness over the upper arm.  This was also warm to the touch.  Dr. advised family to ice the area, and if necessary they could apply Hydrocortisone cream over the area.  They did not contact the office again, so we assume resolution to symptoms.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Suspected vaccination failure; influenza; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received flu vaccine and the flu vaccine did not work properly. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for infuenza, time to onset for event and laboratory confirmation for influenza were not provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blood pressure increased, Incomplete course of vaccination
Clinical narrative: Incomplete course of vaccinatiion; increased blood pressure; joint pain; This case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis. Concomitant products included medication unknown (Blood Pressure Medication).   On 1st September 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 1st September 2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced increased blood pressure. On an unknown date, the patient experienced joint pain and incomplete course of vaccination. On an unknown date, the outcome of the increased blood pressure and joint pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the increased blood pressure and joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix, the patient experienced increase in blood pressure which lasted for approximately 48 hours. The patient's blood pressure was increased from 115 by 70 to 190 systolic. Few days after vaccination, the patient also experienced joint pain, which lasted for approximately  1 month. The patient put ice on her joints to help with the pain. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 37.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: inappropriate schedule of vaccine; inappropriate age at vaccine administration; arm pain/hand pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 38-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ms.   In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In July 2018, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the first week of July 2018. The patient experienced pain on whole arm/hand for about 3 days. The patient's age at the time of vaccination was less than the recommended vaccination age, that led to inappropriate age at vaccine administration. The patient could not get a hold of the vaccine for the 2nd dose and expected to receive it on the date of reporting, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: Shooting right arm pain; Right axillary pain; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABX657AA, expiry date 30th April 2019) for prophylaxis.   Concomitant products included Men ACWY-CRM NVS (Menveo).   On 22nd April 2019, the patient received the 1st dose of Bexsero. On 23rd April 2019, 1 days after receiving Bexsero and Menveo and not applicable after receiving Menveo, the patient experienced pain in arm and axillary pain. On an unknown date, the outcome of the pain in arm and axillary pain were unknown.   It was unknown if the reporter considered the pain in arm and axillary pain to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero in the right arm and Menveo in the left arm. The patient experienced shooting arm pain and axillary pain in right arm, the day following a Bexsero injection. On 22nd April 2019, the patient also received Menveo 30 minutes apart from Bexsero. Menveo was in left arm and experienced no event.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Hot flush, Injection site mass
Clinical narrative: Lump at injection site; Tiredness; Weakness; Hot spell; This case was reported by a consumer via call center representative and described the occurrence of injection site lump in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune deficiency syndrome and raynaud's disease.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 1 day after receiving Shingrix, the patient experienced injection site lump, tiredness, weakness and hot flashes. On an unknown date, the outcome of the injection site lump, tiredness, weakness and hot flashes were not recovered/not resolved.   It was unknown if the reporter considered the injection site lump, tiredness, weakness and hot flashes to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. About 3 weeks prior to the report, the patient received Shinrix and next morning post vaccination, the patient had tiredness, hot spells, weakness and lump at the injection site. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Cough, Dyspnoea, Gastric disorder, Vomiting
Clinical narrative: Vommiting; Stomach distress; Coughing; Trouble breathing; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a male patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B at an unknown dose. On an unknown date, unknown after receiving Engerix B, the patient experienced vomiting, gastric disorder, cough and difficulty breathing. On an unknown date, the outcome of the vomiting, gastric disorder, cough and difficulty breathing were unknown.   It was unknown if the reporter considered the vomiting, gastric disorder, cough and difficulty breathing to be related to Engerix B.  Additional details were provided as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The batch number and expiry date were not reported. The patient experienced vomiting, stomach distress, coughing, and trouble breathing. Due to technical error, no consumer details or address, patient demographics, or additional information were reported. The reporter did not consent to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Gait disturbance, Influenza like illness
Clinical narrative: Flu Like Symptoms; Chills; injection site cold; Difficulty walking; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 24th April 2019, 2 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, chills, feeling cold and walking difficulty. On an unknown date, the outcome of the influenza-like symptoms, chills, feeling cold and walking difficulty were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, chills, feeling cold and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm. About 2 to 3 hours post vaccination the patient experienced flu like symptoms, chills, cold to touch and difficulty walking. At the time of reporting, the patient was feeling better than day of vaccination. The reporter did not give consent to follow up. No further details were provided.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash macular, Rash papular
Clinical narrative: Blotchy rash; Raised rash; Pain at injection site.; This case was reported by a consumer via call center representative and described the occurrence of blotchy rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix. On 24th April 2019, 2 days after receiving Shingrix, the patient experienced blotchy rash, raised rash and injection site pain. On an unknown date, the outcome of the blotchy rash, raised rash and injection site pain were unknown.   It was unknown if the reporter considered the blotchy rash, raised rash and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient called to report that she received Shingrix, and 2 days later experienced blotchy raised rash, and pain at injection site. The patient did not have lot number or expiration date.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: SHE HAS AND OUTBREAK OF SHINGLES ON HER SCALP.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Peripheral swelling, Pyrexia
Clinical narrative: large left upper arm swelling induration erythema and fever localized from upper deltoid to lateral epicondyles on the lateral upper arm
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Herpes virus infection, Oral herpes
Clinical narrative: Child had outbreak of herpes to face and lips starting two days after vaccine. to lower chin and upper right lip
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Headache, Muscle twitching, Pain in extremity
Clinical narrative: Pain in arms and legs. Muscle twitching in arms and legs. Headache Tylenol helped. Seen back in the clinic the next day. PE was WNL.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Gastrointestinal disorder, Nausea, Vomiting
Clinical narrative: Gastrointestinal symptoms, nausea, vomiting, diarrhea, fatigue.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Headache, Nausea, Rash
Clinical narrative: rash on lower leg for first day.  Headache, decrease appetite and nausea for second day.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Pt had some redness and swelling to injection site and small lump under skin. Pt was given Prevnar and Pentacel in same leg. Unsure which vaccine caused reaction.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: ADMINISTERED THE SHOT TO PT ON 05/01/2019 AT 2.29 PM THEN PT CAME BACK NEXT MORNING TELLING ME HER ARM IS SWELLED AND SORE AND YESTERDAY IT WAS RED AND ITCHING THEN CALLED MD AND REPORTED THE CASE TO DR AND TOLD ME PT TO TAKE IBUPROFEN EVERY 6HOURS AND USE ICE PACK ON THE AFFECTED ARE THEN CALLED PT ON 05/03/2019 AND PT SAID IT GOTTEN BETTER NOW JUST LITTLE SORE
Sex: M
Vaccine: DTAPIPV, FLU4, PNC13
Symptoms: Diarrhoea, Insomnia, Irritability, Pyrexia, Screaming
Clinical narrative: Irritability, fever, screaming, insomnia, and diarrhea.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Body temperature decreased, Chills, Fatigue, Headache
Clinical narrative: WAS VACCINATED AT ABOUT 2 PM-BY 6 THE INJECTION SITE WAS SORE-BY 10 PM STARTED TO HAVE HEADACHE-WENT TO BED AND WAS AWAKENDED AT LEAST 20 X IN THE NIGHT WITH CHILLS & INCREASING INJECTION SITE PAIN-BY 5 AM I FELT LIKE I HAD THE FLU-ACHY, UPSET STOMACH, HEADACHE, MUSLE ACHES, CHILLS, LOW TEMP, EXHAUSTED, INCREASED INJECTION SITE PAIN TO POINT THAT I CANNOT GET ARM ABOVE MY BACK TO RAISE IT HIGHER THAN AN INCH
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site pain, Myalgia
Clinical narrative: WAS VACCINATED AT ABOUT 2 PM-BY 6 THE INJECTION SITE WAS SORE-BY 10 PM STARTED TO HAVE HEADACHE-WENT TO BED AND WAS AWAKENDED AT LEAST 20 X IN THE NIGHT WITH CHILLS & INCREASING INJECTION SITE PAIN-BY 5 AM I FELT LIKE I HAD THE FLU-ACHY, UPSET STOMACH, HEADACHE, MUSLE ACHES, CHILLS, LOW TEMP, EXHAUSTED, INCREASED INJECTION SITE PAIN TO POINT THAT I CANNOT GET ARM ABOVE MY BACK TO RAISE IT HIGHER THAN AN INCH
Age: 1.83
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site infection
Clinical narrative: Pt developed a localized infection to injection site and was started on antibiotics.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site discolouration, Injection site erythema, Injection site mass
Clinical narrative: Pt developed a lump to injection site that was red and discolored.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Measles post vaccine, Pyrexia, Rash
Clinical narrative: Pt developed measles rash following vaccination along with fever and decreased appetite.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: current outbreak that is painful lower torso; This case was reported by a physician via call center representative and described the occurrence of painful rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in April 2018).   In June 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced painful rash. On an unknown date, the outcome of the painful rash was unknown.   It was unknown if the reporter considered the painful rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a current outbreak and that was a painful lower torso. The physician inquired if there was any information on how to proceed with the patient. The representative had gathered all the patient information which the physician could provide.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Headache, Influenza like illness, Injection site swelling
Clinical narrative: Large Swollen area on  arm adjacent to injection site, Headache, flu like symptoms, diahreah
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site reaction, Lymphadenopathy, Pyrexia
Clinical narrative: Pt developed red area to injection site, fever, and swollen lymph node to groin area.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Audiogram normal, Deafness neurosensory, Hypoaesthesia, Nuclear magnetic resonance imaging brain normal, Tinnitus
Clinical narrative: Sudden sensorineural hearing loss in left ear, facial numbness, tinnitus starting 4/27/19. Patient seen in our office 4/29/19 with confirmatory audiogram showing severe left hearing loss, loss of discrimination. Started on Valtrex, prednisone 60mg daily, and lipoflavinoid supplements. Subsequent audiiogram 5/3/19 showed no improvement.  MRI of brain and internal auditory canal show no lesions.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Vitreous floaters
Clinical narrative: PATIENT REPORTED 2 DAYS AFTER RECEIVING SHINGRIX VACCINE "FLOATERS" IN HIS EYE. THIS HAD NEVER HAPPENED TO HIM BEFORE. HE DID VISIT HIS EYE DOCTOR WHO SAID THIS IS SOMETIMES AN OCCURRENCE IN AGING, HOWEVER, FELT IT WAS REPORTABLE DUE TO HAVING JUST RECEIVED THE SHINGRIX VACCINE.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Fatigue, Headache, Loss of personal independence in daily activities, Muscle spasms
Clinical narrative: Headache, myalgias, abdominal pain, n/v, fatigue, leg cramps. Unable to perform ADL?s. One day so far.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: Headache, myalgias, abdominal pain, n/v, fatigue, leg cramps. Unable to perform ADL?s. One day so far.
Age: 1.5
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: Hepatitis A dose administered by provider expired on 03/16/2019.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Dizzy, fever 101.9, stomach queazy, headache, arm very sore, red and raised at injection site, fatigued. Called Dr, told to take tylenol.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Dizzy, fever 101.9, stomach queazy, headache, arm very sore, red and raised at injection site, fatigued. Called Dr, told to take tylenol.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Anxiety, Confusional state, Electrocardiogram normal, Heart rate decreased, Laboratory test normal
Clinical narrative: Seizure 15-20 seconds of immunization administration, Pt confused, became oriented within 30 sec. 2nd seizure started 2 min after the first, lasting approx 30 sec.  Pt had decreased pulse, and b/p, skin color pale, pt expressed anxiety.  Ambulance called, vitals stable 20 min after 1st seizure. Pt calm and stable at time of transfer to ER at 3:35 pm. Ambulance arrived 1 hr after calling due to poor road conditions.  ER provider diagnosis was syncope.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pallor, Seizure, Syncope, X-ray normal
Clinical narrative: Seizure 15-20 seconds of immunization administration, Pt confused, became oriented within 30 sec. 2nd seizure started 2 min after the first, lasting approx 30 sec.  Pt had decreased pulse, and b/p, skin color pale, pt expressed anxiety.  Ambulance called, vitals stable 20 min after 1st seizure. Pt calm and stable at time of transfer to ER at 3:35 pm. Ambulance arrived 1 hr after calling due to poor road conditions.  ER provider diagnosis was syncope.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Dizziness, Erythema, Injection site vesicles, Nausea
Clinical narrative: redness of entire upper arm, 2cm blister at site of injection, dizziness, tactile fevers, nausea, diarrhea
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: redness of entire upper arm, 2cm blister at site of injection, dizziness, tactile fevers, nausea, diarrhea
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, X-ray
Clinical narrative: c/o severe pain 10/10 shortly after vaccine
Age: 20.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Pruritus, Rash papular, Swelling face
Clinical narrative: 3 hours following vaccinations, patient developed a fine papular rash to face with mild itching, the rash resolved but he experienced facial swelling  which progressed overnight and was notable the next am. No throat, tongue or lip swelling was noted, no other rashes. He was treated with benadryl and antihistamines but facial swelling worsened and he was treated 24 hours later with a course of oral prednisone with resolution of symptoms.
Sex: M
Vaccine: MMR, UNK
Symptoms: Mumps
Clinical narrative: patient developed mumps two weeks after receiving M-M-R II; This spontaneous report was received from a nurse prescriber, referring to an adult male patient of whose age was not specified. The patient's pertinent medical history, drug reactions, allergies, concomitant medications and concurrent conditions were not disclosed.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) injection, as prophylaxis (administered dose, dose number, route and anatomical location of vaccination were not reported; reported lot number R000552 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date reported as 08-JAN-2020); which was prepared with Merck sterile diluent (lot number and expiration date were not provided).  The reporter stated that, two weeks after receiving the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), the patient developed mumps. The outcome of mumps , as well as the reporter's causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administration and mumps occurrence, was not reported.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: First dose on 07/25/2016, the patient will receive the second dose on 4/30/2019; No adverse effect; This spontaneous report was received from a medical assistant concerning a female patient of unknown age. There was no information about the patient's medical history, concurrent conditions or concomitant medications.  On 28-JUL-2016, 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) lot # M005714 with expiration date of 03-OCT-2017, for prophylaxis (dose, route of administration and anatomical location were not reported). It was reported that the patient would receive the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) on 30-APR-2019. No adverse effect was reported.    Lot No. M005714 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date reported as 03-OCT-201, but upon internal validation established as 03-OCT-2017.
Sex: F
Vaccine: MENB
Symptoms: Circumstance or information capable of leading to medication error, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; Circumstance or information capable of leading to a medication error; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 68-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA32AA, expiry date 20th May 2021) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced inappropriate age at vaccine administration and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the inappropriate age at vaccine administration and circumstance or information capable of leading to medication error were unknown.  Additional details were provided as follows: The patient was immunocompromised, would be receiving Soliris. The age at vaccination was not applicable for this case. At the age of 68 years, the patient was recommended to receive Bexsero from her physician, which led to off label use and if received would led to inappropriate age at vaccine administration (circumstance or information capable of leading to medication error). Till the time of reporting, Bexsero had not been administered to the patient. The batch number and expiry date provided were for the vaccine that would potentially be used. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Incorrect route of product administration, Skin warm, Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 51-year-old female patient who received SHINGRIX (batch number 7447A, expiry date 25th April 2020) for prophylaxis. On 17th April 2019, the patient received SHINGRIX (subcutaneous) .5 ml. In April 2019, less than a day after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), skin warm, redness, swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the cellulitis, skin warm, redness and swelling were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the cellulitis, skin warm, redness and swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on the lateral posterior left arm via subcutaneously, which led to intramuscular formulation administered by other route. The patient was reacted to the dose. The patient called the next day to report their reaction and then was seen at the time of reporting and was being treated for cellulitis.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: tired; achy body; headache; shivering; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number T4952, expiry date 18th June 2021) for prophylaxis.   On 17th January 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th January 2019, less than a day after receiving Shingrix, the patient experienced tiredness, general body pain, headache and shivering. On 17th January 2019, the outcome of the tiredness, general body pain, headache and shivering were recovered/resolved.   It was unknown if the reporter considered the tiredness, general body pain, headache and shivering to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient felt really tired, ached all over, had a headache and shivering after receiving the Shingrix vaccine.  The symptoms resolved after a few hours. The patient did not consent to follow up.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Headache, Peripheral swelling
Clinical narrative: headache; dizziness; swelling on entire arm; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date unknown), via an unspecified route of administration in the right arm on 17Apr2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On the same day, 17Apr2019, the patient experienced headache, dizziness and swelling on entire arm. The patient's mother took him to the emergency room on 17Apr2019. No action was taken at the ER. The patient returned to the doctor the next day. He was feeling better and the symptoms had decreased. The outcome of the events was recovering.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: Fever, shooting pain, cold-like symptoms, and redness and warmth around injection site starting about 4 hours after injection.
Age: 23.0
Sex: F
Vaccine: JEV1, TDAP
Symptoms: Eye pruritus, Lacrimation increased, Nasal congestion, Oral pruritus, Paraesthesia oral
Clinical narrative: Symptoms started around 11:30 am while pt was sitting in class. Started with itchy/watery eyes, increase in nasal congestion, then started having itching  on face, neck, and arms as well as itching in her mouth. Pt presented to health center at 1235 pm to be evaluated. Stated symptoms were still present, but also started having tingling in lower lip and tongue.
Age: 23.0
Sex: F
Vaccine: JEV1, TDAP
Symptoms: Pruritus
Clinical narrative: Symptoms started around 11:30 am while pt was sitting in class. Started with itchy/watery eyes, increase in nasal congestion, then started having itching  on face, neck, and arms as well as itching in her mouth. Pt presented to health center at 1235 pm to be evaluated. Stated symptoms were still present, but also started having tingling in lower lip and tongue.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Abscess, Haematoma, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patient developed a hot, red swollen area on here posterior lateral Right thigh 4 days after she received vaccines in that leg.  Of note clearly she only got 2 vaccines - but 3 were documented to have been on that side.  She was seen in the ER and diagnosed with an abscess, tx with clindamycin.   clinically improved.   however did have persistent nodule palpated there even after completion
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Nodule, Ultrasound scan abnormal
Clinical narrative: patient developed a hot, red swollen area on here posterior lateral Right thigh 4 days after she received vaccines in that leg.  Of note clearly she only got 2 vaccines - but 3 were documented to have been on that side.  She was seen in the ER and diagnosed with an abscess, tx with clindamycin.   clinically improved.   however did have persistent nodule palpated there even after completion
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Rheumatoid arthritis
Clinical narrative: 2 days after injection, patient reported RA flare in injection arm. She happened to see her RA doctor that day who increased her dose of prednisone from 1 mg to 5 mg. Now, 7 days post-injection, the patient is reporting worsening RA flare in both arms.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and pain of around injection site, started the day of vaccination. No treatment.
Age: 7.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Neuroma
Clinical narrative: chronic stomach issue, chronic neuromas
Age: 0.75
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Asthma, Bronchial hyperreactivity, Condition aggravated
Clinical narrative: Asthma--xopenex, buedsonide, orapred, flovent, we had 4 doses of pneumo vaccine--exacerbation of RAD after each shot.
Sex: M
Vaccine: MMRV
Symptoms: Exposure via eye contact, No adverse event
Clinical narrative: Had PROQUAD squirted in to his eye while the nurse was attempting to administered the PROQUAD to different seperate person; No adverse affects; This spontaneous report was received from a nurse regarding a male patient of unknown age. The patient's concomitant therapies included sterile diluent. The patient's pertinent medical history, drug reaction and drug allergies were unknown. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) Lot# T7E48 and expiry date: 20-JUN-2020 (strength, dose, route not reported) for prophylaxis. On an unknown date, the patient had exposed with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) in to his eye while the nurse was attempting to administer the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) to a separate person because they jerked while receiving vaccine (accidental exposure to product). No adverse affects reported (no adverse event).  This case is one of the several reports from the same reporter.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 50-year-old patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis and SHINGRIX for prophylaxis. The patient's past medical history included shingles (had chronic and over 160 times). Previously administered products included ZOSTAVAX (received 5 years before the time of reporting). In January 2018, the patient received the 1st dose of SHINGRIX. In June 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, the patient received the 3rd dose of SHINGRIX. In December 2018, not applicable after receiving SHINGRIX and SHINGRIX and unknown after receiving SHINGRIX, the patient experienced extra dose administered. 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, shingles and extra dose administered were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX, SHINGRIX and SHINGRIX. Additional details were provided as follows: In past December 2018, the patient received 3rd of SHINGRIX, which led to extra dose administered. The patient was in desperate situation. The patient was hoping the LIVE vaccine would help again. The patient needed the ZOSTAVAX. The call center representative wanted to know, the patient that were already shingles suffered before taking the SHINGRIX vaccine, was there any current data on how successful the vaccine had been. It was reported that, who were immunocompromised, had a history of previous HZ (shingles) were vaccinated against varicella or HZ and the patients whose survival was not expected to be at least 4 years or with conditions that might interfere with study evaluations. The SHINGRIX could only help prevent Shingles, it could not treat Shingles if the patient currently had Shingles. The case was considered as suspected vaccination failure as the laboratory confirmation and time to onset were not provided at the time of vaccination.
Sex: M
Vaccine: MEN
Symptoms: Deafness, Feeling abnormal, Meningococcal infection, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), hearing loss (serious criteria GSK medically significant and life threatening) and meningococcal infection (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure, hearing loss and meningococcal infection were unknown. It was unknown if the reporter considered the vaccination failure, hearing loss and meningococcal infection to be related to Meningococcal B vaccine. Additional details were provided as follows: It was reported that the patient caught a different strand and he almost died, thak god he did not but unfortunately he had lost his hearing and felt bad. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pruritus, Swelling
Clinical narrative: Swelling; Itching; Hot fever in her arm; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 69-year-old female 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 swelling, pruritus and feeling hot. On an unknown date, the outcome of the swelling was recovered/resolved and the outcome of the pruritus and feeling hot were unknown.   It was unknown if the reporter considered the swelling, pruritus and feeling hot to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles vaccine and experienced swelling, itching and hot fever in her arm. The patient experienced same event when she received Shingles vaccine (refer case US2019074965) The reporter consented for follow up. This case has been linked to case US2019074965, reported by the same reporter for the same patient.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Pain
Clinical narrative: twinge; This case was reported by a pharmacist via call center representative and described the occurrence of pain localised in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 7X743, expiry date 22nd May 2021) for prophylaxis.   On 11th December 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain localised. On an unknown date, the outcome of the pain localised was recovered/resolved.   It was unknown if the reporter considered the pain localised to be related to Shingrix.  Additional details were provided as follows:  The patient reported after the 1st dose of Shingrix in the left deltoid, he had a twinge in the nerve area, but did not think about it. For tolerance to the 2nd dose of Shingrix, refer case US2019073417.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: lower back pain; This case was reported by a consumer via call center representative and described the occurrence of low back pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 16th April 2019, less than a day after receiving Shingrix, the patient experienced low back pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the low back pain was recovered/resolved.   It was unknown if the reporter considered the low back pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in the left arm at 11am and by dinner the patient had developed excruciating lower back pain.  The patient stated that the pain was located in the center of his lower back.  The patient took Tylenol to help with the pain.  The patient stated that 2 days after the pain started, it started to decrease and by the weekend, the pain was gone completely.  The patient did not consent to follow-up.