chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: I developed a mild headache, some chills, fatigue, pain at the injection site and bright redness around the injection site and upward - about 4 inches.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Continuous positive airway pressure, Infantile apnoea, Septic screen
Clinical narrative: Apneic event requiring moderate/vigorous stimulation, CPAP, rule-out sepsis
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Rash
Clinical narrative: Patient broke out in a rash on her face and spiked a fever of 100. She was given 1.25 mL of Banophen. She was monitored for 20 minutes before leaving. Patients father advised to continue giving patient Benadryl as needed and come back if symptoms worsen or do not improve.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Continuous positive airway pressure, Infantile apnoea, Septic screen
Clinical narrative: Apneic event requiring mild stimulation, CPAP, and sepsis rule-out
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effects were reported; The patient received a dose of GARDASIL 9 in January 2019, a second dose in April 2019 and the third dose today (25-JUL-2019); This spontaneous report has been received from a medical assistant concerning to a patient of unknown age and gender.  The patient concurrent condition, medical history, past drug reactions or allergies and concomitant medications were not reported.   On an unspecified day in January 2019, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration and anatomical location were not reported) (lot #: R021633, expiration date: 08-MAY-2021). On an unspecified day in April 2019, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration and anatomical location were not reported) (Lot number 15810279 is an invalid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), and on 25-JUL-2019, the patient received the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) (Inappropriate schedule of product administration), all doses administered for prophylaxis. No adverse effects were reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: grand mal seizure; This case was reported by a consumer via call center representative and described the occurrence of grand mal seizure in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 14th April 2019, the patient received Menveo (intramuscular). On 24th April 2019, 10 days after receiving Menveo, the patient experienced grand mal seizure (serious criteria hospitalization and GSK medically significant). The patient was treated with antiepileptics nos (Seizure Medication). 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 Menveo.  Additional details were provided as follows: The reporter was patient's mother. The patient had no prior history of seizures. Approximately 10 days after receiving dose of Menveo, the patient experienced a grand mal seizure, which required hospitalization.    At the time of reporting, the patient was taking anti seizure medication. The reporter consented to follow up and provided name and phone number for physician.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site rash, Injection site reaction, Injection site warmth, Malaise
Clinical narrative: Patient called to state she was having a reaction around the injection site from the Shingrix vaccine 2nd Dose. Patient received vaccine on 07/23/19.  Contacted the pharmacy 7/25/19 to report that she has developed rash around the injection site, states it is the size of an orange and is warm to the touch. Patient reports "not feeling well" such as tiredness and soreness.  Patient states no fever.  Patient stated she had no adverse reaction to Shingrix vaccine with first dose.  Patient contacted PCP office and they directed her to report issue to pharmacy.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient called to state she was having a reaction around the injection site from the Shingrix vaccine 2nd Dose. Patient received vaccine on 07/23/19.  Contacted the pharmacy 7/25/19 to report that she has developed rash around the injection site, states it is the size of an orange and is warm to the touch. Patient reports "not feeling well" such as tiredness and soreness.  Patient states no fever.  Patient stated she had no adverse reaction to Shingrix vaccine with first dose.  Patient contacted PCP office and they directed her to report issue to pharmacy.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient experienced syncopal episode ~5 minutes after receiving vaccination.  No other reactions or history pertinent to reaction
Age: 12.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Dyspnoea, Erythema, Injection site erythema, Injection site swelling, Throat irritation
Clinical narrative: Redness, swollen at injection sight, redness traveled along neck, trouble breathing, itchy throat
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint swelling, Skin discolouration
Clinical narrative: The morning after I received the injection,  my elbow on my left arm was extremely swollen and painful.  by the end of the day my entire elbow was dark purple/black which spread down to my lower arm.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain,  localized swelling, warmth, and redness at injection site. Fever of 102 degrees for 2 days. Body aches, chills, and loss of appetite for 2 days
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Pain,  localized swelling, warmth, and redness at injection site. Fever of 102 degrees for 2 days. Body aches, chills, and loss of appetite for 2 days
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt reports "I am unable to move my left arm", pain reported as "9.4/10 if 10 is passing out".   Pt reports "I did not feel the shot" when injection placed, "but now it hurts like a (expletive)."  Pt denies swelling, redness or heat at injection site.    Pt denies rash or SOB, swelling in the face, lips or tongue.
Age: 1.25
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expiration date 7-07-2019
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site paraesthesia, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Patient stated that vaccine was administers below the deltoid muscle (~5 inches before shoulder bone). She experienced redness, swelling, and a tingling sensation in the area of administration. About a week later, all these symptoms are subsiding.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Injection site pain
Clinical narrative: PAIN ON SITE OF THE INJECTION THAT BECOME SEVER AND GOT WEAK. DAY 6
Age: 57.0
Sex: M
Vaccine: IPV, MMR, MNQ, RAB
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Patient states he has a rash on his face.  He describes it as slightly raised and slightly warm but not terribly itchy.  He denies difficulty breathing or swallowing and also denies any other symptoms.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Dizziness
Clinical narrative: A few hours after my 2nd Shingrix shot I began to feel lethargic and achey. I went to bed early but slept fitfully with shivers. I felt feverish but did not take my temp. My whole body ached. I had a sore left arm where the vaccination shot was so I could not sleep on my left side, nausea but did not vomit, joint pain in my elbows and lower back and dizziness. Thankfully no diarrhea or stomach ache. The following day, Sunday 7/28/2019 I felt very weak and dizzy with shivers began to feel better in the evening. Today I feel much better...phew!
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Nausea, Pain, Poor quality sleep, Pyrexia
Clinical narrative: A few hours after my 2nd Shingrix shot I began to feel lethargic and achey. I went to bed early but slept fitfully with shivers. I felt feverish but did not take my temp. My whole body ached. I had a sore left arm where the vaccination shot was so I could not sleep on my left side, nausea but did not vomit, joint pain in my elbows and lower back and dizziness. Thankfully no diarrhea or stomach ache. The following day, Sunday 7/28/2019 I felt very weak and dizzy with shivers began to feel better in the evening. Today I feel much better...phew!
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site pain
Clinical narrative: A few hours after my 2nd Shingrix shot I began to feel lethargic and achey. I went to bed early but slept fitfully with shivers. I felt feverish but did not take my temp. My whole body ached. I had a sore left arm where the vaccination shot was so I could not sleep on my left side, nausea but did not vomit, joint pain in my elbows and lower back and dizziness. Thankfully no diarrhea or stomach ache. The following day, Sunday 7/28/2019 I felt very weak and dizzy with shivers began to feel better in the evening. Today I feel much better...phew!
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood culture, Chest X-ray, Chills, Culture urine
Clinical narrative: low grade fever 107; blood pressure 152/94 bpm 98; chills; weakness;  Primary care referred to the ER
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram, Pyrexia
Clinical narrative: low grade fever 107; blood pressure 152/94 bpm 98; chills; weakness;  Primary care referred to the ER
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Extrasystoles
Clinical narrative: PATIENT REPORTED AN EXACERBATION OF HIS RECURRENT PERICARDITIS TRIGGERED BY THE ADMINISTRATION OF HIS FIRST DOSE OF SHINGRIX VACCINE ON 6/24/19.  SYMPTOMS BEGAN 60 HOURS (5 DAYS) FOLLOWING THE VACCINATION AND INCLUDED BURNING CHEST PAIN AND EXTRASYSTOLE.  I (THE PHARMACIST HE SPOKE WITH, NOT THE ADMINISTERING PHARMACIST) ADVISED THE PATIENT AGAINST A SECOND AND FINAL DOSE
Age: 59.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Facial paralysis, Malaise, Pyrexia
Clinical narrative: Pt states he had fevers and chills and very ill for about 2 weeks following the vaccine.  Then he developed severe left BELLS PALSY on 7/19/19, 30 days after the vaccine.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: fever - up to 100.4 - ibuprofen - lasted 8 hours headache - lasted 8 hours nausea - lasted 3 hours joint aches - lasted 8 hours injection site pain (more than minor) - lasted 8 hours
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain in extremity, Urticaria
Clinical narrative: Day of injection, left arm soreness.  Day after injection, sore throat.  Two days after injection, hives on arms and legs, continued to progress to torso
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: pt complained of wide area of redness.  but no pain
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Cough, Dyspnoea exertional, Peripheral swelling, Pyrexia, Swelling face
Clinical narrative: Two days following the vaccine, on 7/24/19, patient developed an urticarial rash, fever, swelling of face, hands and arms.  He had no wheezing or shortness of breath at rest.  His mother brought him to a local ED on 7/26/19 due to progressively worsening symptoms where he was reportedly treated with benedryl and motrin.  I saw him today for followup (7/29/19) and noted persistent left facial swelling and mild swelling of his hands.  At that time he admitted to an itchy feeling in his throat and cough and feeling short of breath with exercise.  I prescribed a course of oral steroids and continued bendryl as needed and arranged for follow up at the time of his visit today.   Patient had ingested no new foods, had no new medications, and no known exposure to toxic substances prior to event.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Throat irritation, Urticaria
Clinical narrative: Two days following the vaccine, on 7/24/19, patient developed an urticarial rash, fever, swelling of face, hands and arms.  He had no wheezing or shortness of breath at rest.  His mother brought him to a local ED on 7/26/19 due to progressively worsening symptoms where he was reportedly treated with benedryl and motrin.  I saw him today for followup (7/29/19) and noted persistent left facial swelling and mild swelling of his hands.  At that time he admitted to an itchy feeling in his throat and cough and feeling short of breath with exercise.  I prescribed a course of oral steroids and continued bendryl as needed and arranged for follow up at the time of his visit today.   Patient had ingested no new foods, had no new medications, and no known exposure to toxic substances prior to event.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Fatigue, Injection site pain, Lymphadenopathy, Malaise
Clinical narrative: Beginning a few hours after the injection and throughout the following day:  pain/soreness at injection site, pain and swelling under my left armpit, malaise, fatigue The second day after the shot, the pain was lessened, but there was still swelling under my armpit.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: Beginning a few hours after the injection and throughout the following day:  pain/soreness at injection site, pain and swelling under my left armpit, malaise, fatigue The second day after the shot, the pain was lessened, but there was still swelling under my armpit.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Behcet's syndrome, Rash, Tongue erythema, Tongue ulceration, Vaccination complication
Clinical narrative: Two days after the flu vaccine a rash started on patients hands bilaterally. And tongue broke out in red raised ulcerations. Later was confirmed by rheumatologist that Behcets disease was triggered by the influenza vaccination.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: prickly pain on left shoulder blade (on back)
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blindness, Deafness, Dizziness, Dysarthria, Heart rate decreased
Clinical narrative: 16 YOM pt accompanied by mother presents for pre-participation sports physical exam to participate Band. All positive findings were discussed; all positive answers in History were discussed. No health concerns today. History WNL. No concerns of abuse or neglect at home or school. No concerns of substance use. Eats well balanced diet. Has not been declined for any sports participation in the past. PE unremarkable. Pt due fot Tdap, meningitis and HPV vaccines per Immtrac report. Per mother's report pt is UTD with Tdap. Pt and parent counseled on HPV and meningitis vaccines by clinician and vaccines administered by clinician assistant. About 1-2 mins after vaccines administration, pt became pale and slightly diaphoretic and reported to feel "dizzy." Pt was still on the exam table with legs fully extended and was instructed to lean his head back on head of the bed. Pt felt nauseated and a vomit bag was given. He tried to vomit but was unable. He never lost consciousness but reported "everything is black and I cant hear anything." This lasted about 10 seconds. He then reported he was feeling better. Pt's mother stated that he had a similar episode when he had blood drawn. Pulse oximeter was placed on right index finger, pt was talkative. Then it was noticed that his heart rate (HR) went down from 101 to 61 and pt became pale and diaphoretic again, he did not lose consciousness this time either but he had slurred speech. This episode lasted also about 10 seconds. He continue to experience this for 2 more episodes that lasted about the same. He never lost consciousness or vomited. Pt then regained color, was no longer diaphoretic and his VS were as follows: 98.1 F (ear), 115/60 BP, 77 bpm, and 97% RA. Pt was A/O x 3 and in no distress at time of discharge. Pt's mother was called about 2 hrs after episode. Per pt's mother pt was at home resting and was feeling better. She reported pt has not had any more episodes since the last one in the clinic.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Hyperhidrosis, Nausea, Pallor
Clinical narrative: 16 YOM pt accompanied by mother presents for pre-participation sports physical exam to participate Band. All positive findings were discussed; all positive answers in History were discussed. No health concerns today. History WNL. No concerns of abuse or neglect at home or school. No concerns of substance use. Eats well balanced diet. Has not been declined for any sports participation in the past. PE unremarkable. Pt due fot Tdap, meningitis and HPV vaccines per Immtrac report. Per mother's report pt is UTD with Tdap. Pt and parent counseled on HPV and meningitis vaccines by clinician and vaccines administered by clinician assistant. About 1-2 mins after vaccines administration, pt became pale and slightly diaphoretic and reported to feel "dizzy." Pt was still on the exam table with legs fully extended and was instructed to lean his head back on head of the bed. Pt felt nauseated and a vomit bag was given. He tried to vomit but was unable. He never lost consciousness but reported "everything is black and I cant hear anything." This lasted about 10 seconds. He then reported he was feeling better. Pt's mother stated that he had a similar episode when he had blood drawn. Pulse oximeter was placed on right index finger, pt was talkative. Then it was noticed that his heart rate (HR) went down from 101 to 61 and pt became pale and diaphoretic again, he did not lose consciousness this time either but he had slurred speech. This episode lasted also about 10 seconds. He continue to experience this for 2 more episodes that lasted about the same. He never lost consciousness or vomited. Pt then regained color, was no longer diaphoretic and his VS were as follows: 98.1 F (ear), 115/60 BP, 77 bpm, and 97% RA. Pt was A/O x 3 and in no distress at time of discharge. Pt's mother was called about 2 hrs after episode. Per pt's mother pt was at home resting and was feeling better. She reported pt has not had any more episodes since the last one in the clinic.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: REDNESS, ITCHING AT INJECTION SITE, RASH COVERING ENTIRE UPPER ARM WARM TO TOUCH
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness at injections site moved over to inside of arm (from middle out outside arm to inner arm).  Was hot ..
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: pt had injection site reaction with swelling and intense pain also extending to below where the vaccine was given. pt also had a rash and itching as well around the injection site as well.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Pt developed hives, as described by the pt,  the day after admin.  It continued for 5 days.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Rash
Clinical narrative: Patient stated she had significant swelling at the injection site, she felt sick and broke out in rash (didn't specify whether it's around injection site or whole body, stated she couldn't remember). Patient said her doctor thinks she might have gotten shingles from the shot and advised her not to get the second dose. WHen asked if patient developed fever after the vaccine, she stated no
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Rash, Tremor
Clinical narrative: Patient developed a small rash on the back after her 1st dose. A few days after she had the second dose, she developed a rash over a large area on her upper body including arms, neck, shoulder. She was agitated and shaking.  The patient went to her doctor 2 days later and was given a steroid shot and prescribed Medrol and Kenalog.  On the same day, we called the manufacturer about the patient's adverse reaction and received the case number 003381136.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Patient came back said that he had fever up to 104. There is a red bump on his shoulder. He took some Benadryl and his MD prescribed Bactrim for him.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Neck pain, Pain
Clinical narrative: Shivering, aching, headache, neck ache
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Diarrhoea, Injection site erythema, Injection site pruritus, Injection site swelling, Vomiting
Clinical narrative: Very large amount of swelling 24 hours after DTap vaccination on left thigh. Redness and swelling wrapped around upper thigh greater than 5 inches in diameter. Swelling increased in size 48 hours after injection. Warmth coming from swelling site and my son was scratching it. 72 hours after vaccinations, my son threw up one time and had diarrhea one time.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Removal of foreign body from nose
Clinical narrative: I went to the hospital on 4-25-19 to have a small piece of metal removed from my nose. It was a fairly quick event, and the doctor recommended I get a tetanus shot.  I said okay, and the nurse came in and gave me the shot. It was placed very high on my arm and Immediately, I knew something was off because it hurt my shoulder so bad. My shoulder hurt very bad for about 3 weeks. I had some limited movement in my arm due to the pain, especially moving it over my head.  After 3 or so weeks, the pain lowered but did not go away. I currently still have a sore shoulder to this day.  I went to my primary care Dr and we talked about the sor shoulder and I will be getting x-rays done to hopefully see what's going on.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chiropractic, Injection site erythema, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Typical reaction 7/23 of redness, swelling, pain, right deltoid muscle which diminished after three days.  7/27 sudden onset of right shoulder pain radiating to right side of neck to base of skull.  Pain continued through Monday.  Minimal relief with ibuprofen, heat, and CBD cream.  Monday sought Chiropractic care which will be ongoing.  Hoping for relief.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Typical reaction 7/23 of redness, swelling, pain, right deltoid muscle which diminished after three days.  7/27 sudden onset of right shoulder pain radiating to right side of neck to base of skull.  Pain continued through Monday.  Minimal relief with ibuprofen, heat, and CBD cream.  Monday sought Chiropractic care which will be ongoing.  Hoping for relief.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: Thrusday - Morning:  Got Shingles Vaccine:  By Evening:  Sever Joint Pain (hands, wrists, hips, shoulder, neck feet, and back) began the around 8pm followed by chills.  I had to put an extra blanket on the bed.  Headache.  Swollen area (about 3 inches across) at injection site on right upper arm  became hot and very tender to touch. Slight nausea.  Inability to sleep.  And TWICE in the middle of that same night  I got up to urinate and started leaking as soon as I stood up (which is NOT normal for me).    Friday Morning:  I had some issues with mild feelings of urinary incontinence but nothing like that first night.  I continued to feel awful with the joint aches (sever enough to make walking a bit difficult), headache, chills, heat and soreness at injection site and some swelling along back of arm into right armpit. Sleeping was still difficult but possible.     Saturday Morning:  Still feeling aches (walking still affected) and chills along with hot and sore injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Insomnia, Nausea
Clinical narrative: Thrusday - Morning:  Got Shingles Vaccine:  By Evening:  Sever Joint Pain (hands, wrists, hips, shoulder, neck feet, and back) began the around 8pm followed by chills.  I had to put an extra blanket on the bed.  Headache.  Swollen area (about 3 inches across) at injection site on right upper arm  became hot and very tender to touch. Slight nausea.  Inability to sleep.  And TWICE in the middle of that same night  I got up to urinate and started leaking as soon as I stood up (which is NOT normal for me).    Friday Morning:  I had some issues with mild feelings of urinary incontinence but nothing like that first night.  I continued to feel awful with the joint aches (sever enough to make walking a bit difficult), headache, chills, heat and soreness at injection site and some swelling along back of arm into right armpit. Sleeping was still difficult but possible.     Saturday Morning:  Still feeling aches (walking still affected) and chills along with hot and sore injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Urinary incontinence
Clinical narrative: Thrusday - Morning:  Got Shingles Vaccine:  By Evening:  Sever Joint Pain (hands, wrists, hips, shoulder, neck feet, and back) began the around 8pm followed by chills.  I had to put an extra blanket on the bed.  Headache.  Swollen area (about 3 inches across) at injection site on right upper arm  became hot and very tender to touch. Slight nausea.  Inability to sleep.  And TWICE in the middle of that same night  I got up to urinate and started leaking as soon as I stood up (which is NOT normal for me).    Friday Morning:  I had some issues with mild feelings of urinary incontinence but nothing like that first night.  I continued to feel awful with the joint aches (sever enough to make walking a bit difficult), headache, chills, heat and soreness at injection site and some swelling along back of arm into right armpit. Sleeping was still difficult but possible.     Saturday Morning:  Still feeling aches (walking still affected) and chills along with hot and sore injection site.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Arthralgia, Dystonia, Full blood count, Metabolic function test, Muscle spasms
Clinical narrative: hand cramping, joint pain, dystonia
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Decreased appetite, Fatigue
Clinical narrative: Pain at injection site Muscle pain Weak/Tired Shivering Upset stomach/No appetite
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: Pain at injection site Muscle pain Weak/Tired Shivering Upset stomach/No appetite
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: MUSCULAR PAIN IN LEFT BICEPT X 5 DAYS PAIN LEVEL 4/10, PAIN ALSO WHEN LIFTING ARM. MILD RASH ON ARM W/PINK INFLAMATION ELBOW TO SHOULDER (ITCHINESS) CALLED PHARMACIST AT PHARMACY SHE RECOMMENDED ICE PACKS AND BENADRYL. I TOOK A BENADRYL ON 7/17 AND 7/19. AND USED ICE PACKS SEVERAL TIMES A DAY FOR 4 DAYS. -ALL SIDE EFFECTS HAVE STOPPED BY 6TH DAY -(7/22) - PAIN & RASH WERE NOT PRESENTED AFTER THE 1ST INJECTION (DOSE).
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: MUSCULAR PAIN IN LEFT BICEPT X 5 DAYS PAIN LEVEL 4/10, PAIN ALSO WHEN LIFTING ARM. MILD RASH ON ARM W/PINK INFLAMATION ELBOW TO SHOULDER (ITCHINESS) CALLED PHARMACIST AT PHARMACY SHE RECOMMENDED ICE PACKS AND BENADRYL. I TOOK A BENADRYL ON 7/17 AND 7/19. AND USED ICE PACKS SEVERAL TIMES A DAY FOR 4 DAYS. -ALL SIDE EFFECTS HAVE STOPPED BY 6TH DAY -(7/22) - PAIN & RASH WERE NOT PRESENTED AFTER THE 1ST INJECTION (DOSE).
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Blister, Herpes zoster, Pain, Peripheral swelling
Clinical narrative: "worst singles of his life!" shingles rashes & blisters all over body, leg swelling, body ache, was bed ridden all of the above are still going on since shot on 6/15/19
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash generalised
Clinical narrative: "worst singles of his life!" shingles rashes & blisters all over body, leg swelling, body ache, was bed ridden all of the above are still going on since shot on 6/15/19
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: "worst singles of his life!" shingles rashes & blisters all over body, leg swelling, body ache, was bed ridden all of the above are still going on since shot on 6/15/19
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: redness 7 cm x 9 cm at site of injection, aching in that arm, warmth to area  Instructed to take Ibuprofen or Tylenol, Benadryl  and apply ice pack
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal X-ray, Blood test normal, Body temperature increased, Diarrhoea, Febrile convulsion
Clinical narrative: 7/20/19 Febrile seizure - seen in ER. Also had vomiting + h/o recent diarrhea. Bloodwork, urine normal. Abd sono with mesenteric adenitis. T 100.3 in ER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Full blood count normal, Lymphadenitis, Metabolic function test normal, Streptococcus test negative, Ultrasound abdomen abnormal
Clinical narrative: 7/20/19 Febrile seizure - seen in ER. Also had vomiting + h/o recent diarrhea. Bloodwork, urine normal. Abd sono with mesenteric adenitis. T 100.3 in ER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urine analysis normal, Vomiting
Clinical narrative: 7/20/19 Febrile seizure - seen in ER. Also had vomiting + h/o recent diarrhea. Bloodwork, urine normal. Abd sono with mesenteric adenitis. T 100.3 in ER.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Mass, Pain in extremity, Vaccination complication
Clinical narrative: Patient called today, July 29, 2019 @ 10AM stating his arm is still sore from the injection administered on April 12, 2019. He states there is a lump and he has been to the doctor a number of times regarding other issues and all MD told him was to take anti-inflammatories and heat therapy.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: broke out all over body hives at home  ~8-9 days for hives to resolve pt states she is ok now 7/28/19.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Amnesia, Electroencephalogram, Headache, Seizure
Clinical narrative: Amnesia; Electroencephalogram; Seizure; Headache; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (agency# 707554).  This spontaneous report refers to a 12 years old female patient. No medical history, current illness, no other medications were reported. Information about prior vaccination was not provided.   On 02-AUG-2017, 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) (batch/lot # M009378, intramuscular in the right arm; dose and frequency unspecified) for prophylaxis at the public health clinic/hospital.   On 03-AUG-2017, the patient's mother reported that the patient developed the symptoms of memory loss, severe headache and seizures twelve hours following the vaccine administration. The patient's mother reported that these symptoms were persisting at the time of the report, one week after they began. The patient had been evaluated at two emergency room and in the Primary Care Physician's (PCP's) office with no identifiable cause of the symptoms. On 03-AUG-2017, electroencephalogram (EEG) was performed (result unspecified). The patient was admitted in the hospital on an unspecified date in August 2017. The outcome of the events was reported as not recovered. The causality was not reported.  The agency considered the events to be serious due to hospitalization.  Follow up information has been received from a health care professional on 15-APR-2019. The patient was not pregnant at the time of vaccination. The patient had no allergies to other medication, food or products. The patient had no other illnesses, chronic or longstanding health conditions at the time of vaccination. The patient's concomitant vaccine included first dose of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL). The patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at 14:10. And it was reported that, the events started on 03-AUG-2017 at 03:00. The patient's duration of hospitalization was reported as 2 days.  As of 26-JUL-2019, all telephone attempts to obtain follow-up information have been unsuccessful.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: CSF test abnormal, Demyelination, Muscular weakness, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: CSF test; demyelination; nuclear magnetic resonance imaging brain abnormal; muscular weakness; This report was identified from a line listing obtained on request by the Company from the FDA under the Act.  Information has been received from FDA (HA # 744122) referring to a 17 year old female patient. There was no reported concurrent condition, concomitant medication and medical history. On 21-FEB-2018 the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N013698; dose and expiration date were not reported) intramuscularly in the left arm for prophylaxis. Other suspect therapy included the third dose of meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO) (lot # 15E301A; dose and expiration date were not reported) intramuscularly in the right arm for prophylaxis. On 25-FEB-2018 (reported as "4 days after vaccination"), the patient presented with acute onset of left arm weakness. It progressed to significant weakness within a week and she was found to have acute central demyelination on magnetic resonance imaging (MRI), which were coded as cerebrospinal fluid (CSF) test, nuclear magnetic resonance imaging brain abnormal and demyelination (all start dates were reported on 02-MAR-2018). On an unknown date in 2018, the patient was hospitalized. The outcome of the events was reported as not recovered/not resolved. The causality was not provided.  The agency considered the events to be serious for the following reason: disability.  Follow up information has been received from a healthcare professional via agency (HA# 744122) referring to the patient on 16-APR-2019. On 21-FEB-2018 08:00 (previously reported as 21-FEB-2018), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient was not pregnant (previously reported as unknown).  Follow up information has been received from on 26-JUL-2019. The phone call was answered by medical assistant, but he was unable to assist. There was no way to accurately identify a patient. Additionally, a request was made for patient's use of the product, co-morbid medical issues and concomitant medications.
Age: 0.33
Sex: M
Vaccine: UNK, UNK, DTAPHEPBIP, HIBV, PNC13
Symptoms: Abnormal behaviour, Crying, Death, Endotracheal intubation, Malaise
Clinical narrative: 03/28/19- Initial Visit  @ Health Centers, Recent discharge from CICU @ Hospital. Dx: Down Syndrome, Gastrostomy tube dependent, Atrioventricular Septal defect (AVSD),Coarctation of aorta, Deep Vein Thrombosis 04/18/19-Follow up visit C/O cough, concern for RSV and sent to Hospital for Further evaluation.  04/29/19- ER Follow up,Discharged from Hospital 04/19/19, Negative RSV, Positive Rhinovirus  04/30/19- Mom arrived at Clinic w/ infant. Infant was gasping and became apneic , CPR administered and paramedics arrived and intubated, continued with CPR and transported infant to clinic.
Age: 0.33
Sex: M
Vaccine: UNK, UNK, DTAPHEPBIP, HIBV, PNC13
Symptoms: Respiratory arrest, Resuscitation
Clinical narrative: 03/28/19- Initial Visit  @ Health Centers, Recent discharge from CICU @ Hospital. Dx: Down Syndrome, Gastrostomy tube dependent, Atrioventricular Septal defect (AVSD),Coarctation of aorta, Deep Vein Thrombosis 04/18/19-Follow up visit C/O cough, concern for RSV and sent to Hospital for Further evaluation.  04/29/19- ER Follow up,Discharged from Hospital 04/19/19, Negative RSV, Positive Rhinovirus  04/30/19- Mom arrived at Clinic w/ infant. Infant was gasping and became apneic , CPR administered and paramedics arrived and intubated, continued with CPR and transported infant to clinic.
Age: 0.33
Sex: M
Vaccine: UNK, UNK, DTAPHEPBIP, HIBV, PNC13
Symptoms: Dyspnoea, Endotracheal intubation, Human rhinovirus test positive, Infantile apnoea, Resuscitation
Clinical narrative: 03/28/19- Initial Visit  @ Health Centers, Recent discharge from CICU @ Hospital. Dx: Down Syndrome, Gastrostomy tube dependent, Atrioventricular Septal defect (AVSD),Coarctation of aorta, Deep Vein Thrombosis 04/18/19-Follow up visit C/O cough, concern for RSV and sent to Hospital for Further evaluation.  04/29/19- ER Follow up,Discharged from Hospital 04/19/19, Negative RSV, Positive Rhinovirus  04/30/19- Mom arrived at Clinic w/ infant. Infant was gasping and became apneic , CPR administered and paramedics arrived and intubated, continued with CPR and transported infant to clinic.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: My hand  turned red,itch and spread  like a band around the injection sight. Not  pregnant
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: My hand  turned red,itch and spread  like a band around the injection sight. Not  pregnant
Sex: U
Vaccine: VARZOS, FLUX
Symptoms: Malaise, Pruritus, Pyrexia, Rash, Rash erythematous
Clinical narrative: fever; malaise; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included hypersensitivity (he did had a hypersensitivity history to medications) and gastrointestinal discomfort (noting mycin containing medications cause some gastroentestinal discomfort).   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 fever and malaise. On an unknown date, the outcome of the fever and malaise were recovered/resolved.   It was unknown if the reporter considered the fever and malaise to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient mentioned that, he received flu shots in the past (manufacturer unknown) which caused fever and malaise but was not more intense. The patient received flu shot pretty much every year and his last dose was on December 2018. The patient also received Shingrix and had some adverse events, refer case US2019130838. The patient did not consent to follow up.
Sex: U
Vaccine: VARZOS, FLUX
Symptoms: Skin reaction
Clinical narrative: fever; malaise; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included hypersensitivity (he did had a hypersensitivity history to medications) and gastrointestinal discomfort (noting mycin containing medications cause some gastroentestinal discomfort).   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 fever and malaise. On an unknown date, the outcome of the fever and malaise were recovered/resolved.   It was unknown if the reporter considered the fever and malaise to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient mentioned that, he received flu shots in the past (manufacturer unknown) which caused fever and malaise but was not more intense. The patient received flu shot pretty much every year and his last dose was on December 2018. The patient also received Shingrix and had some adverse events, refer case US2019130838. The patient did not consent to follow up.
Sex: U
Vaccine: VARZOS, FLUX
Symptoms: Malaise, Pyrexia
Clinical narrative: fever; malaise; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included hypersensitivity (he did had a hypersensitivity history to medications) and gastrointestinal discomfort (noting mycin containing medications cause some gastroentestinal discomfort).   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 fever and malaise. On an unknown date, the outcome of the fever and malaise were recovered/resolved.   It was unknown if the reporter considered the fever and malaise to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient mentioned that, he received flu shots in the past (manufacturer unknown) which caused fever and malaise but was not more intense. The patient received flu shot pretty much every year and his last dose was on December 2018. The patient also received Shingrix and had some adverse events, refer case US2019130838. The patient did not consent to follow up.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Pyrexia, Rash pustular, Secretion discharge
Clinical narrative: High fever started the first day. Then Local blisters/redness at vaccine site.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Pyrexia, Vaccination site vesicles
Clinical narrative: High fever started the first day. Then Local blisters/redness at vaccine site.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Pain, Pain in extremity, Skin warm
Clinical narrative: Max pain of L arm with movement, hot to the touch, rash at injection site with high sensitivity to touch.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Warm, itchy, swollen red lump on deltoid, below injection site.  -  Patient went to urgent care because her primary care doctor's office was closed at the time. She was advised to take Benadryl and apply hydrocortisone to the site of injury. No antibiotics were prescribed.
Age: 0.83
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Abnormal behaviour, Audiogram normal, Balance disorder, Eating disorder, Fall
Clinical narrative: The morning after receiving immunization, patient's verbalizations changed to less verbal sounds, more "mmms" with a closed mouth. He was much more muted and nonverbal beginning Day 1 after receiving PEDIARIX. He clearly spoke 7 words prior to immunization at 10 months. His speech began deteriorating by Day 4: his pronunciation of the words "dog" and "book" which he already spoke clearly deteriorated. Eventually he stopped speaking these words altogether. Over the course of the next 4 weeks, he lost all words that he had previously produced except for one: "ball," but no longer pronounces the word fully. About 4-5 weeks later, he did produce one new word, "mama," which he has retained. Now at 4 months after the immunization, he has not produced any other new words or recovered any of the words that he spoke previously (bird, book, dog, etc.). He gets visibly frustrated not being able to communicate what he wants and says "da" a lot. Sometimes he shapes his lips like he's trying to pronounce a word, but no sound comes out. He does not repeat words after us if we try to prompt him to speak. He has also reverted to mouthing things and picking up tiny objects from the floor and eating them, which he had previously stopped doing at 8 or 9 months. He continues to do this at 14 months.  Patient's walking/gait also deteriorated. He was taking about 6 steps at a time prior to the immunization, but the day afterwards, he tried to take steps but kept rolling his ankles and falling - this never happened before. This progressed to the point where de didn't even try to walk. After about 1 month, he started taking steps but his gait has been different and he trips and falls often, doesn't have the same balance that he did before when he was taking steps. He is very bowlegged and pigeon-toed.  His behavior and personality has also changed. He gets frustrated often and almost seems irritable, throwing a fit if he isn't allowed to do what he wants. He used to be a much happier baby. He also is a much pickier eater now, where he used to eat anything we fed him.
Age: 0.83
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Foot deformity, Frustration tolerance decreased, Gait disturbance, Irritability, Knee deformity
Clinical narrative: The morning after receiving immunization, patient's verbalizations changed to less verbal sounds, more "mmms" with a closed mouth. He was much more muted and nonverbal beginning Day 1 after receiving PEDIARIX. He clearly spoke 7 words prior to immunization at 10 months. His speech began deteriorating by Day 4: his pronunciation of the words "dog" and "book" which he already spoke clearly deteriorated. Eventually he stopped speaking these words altogether. Over the course of the next 4 weeks, he lost all words that he had previously produced except for one: "ball," but no longer pronounces the word fully. About 4-5 weeks later, he did produce one new word, "mama," which he has retained. Now at 4 months after the immunization, he has not produced any other new words or recovered any of the words that he spoke previously (bird, book, dog, etc.). He gets visibly frustrated not being able to communicate what he wants and says "da" a lot. Sometimes he shapes his lips like he's trying to pronounce a word, but no sound comes out. He does not repeat words after us if we try to prompt him to speak. He has also reverted to mouthing things and picking up tiny objects from the floor and eating them, which he had previously stopped doing at 8 or 9 months. He continues to do this at 14 months.  Patient's walking/gait also deteriorated. He was taking about 6 steps at a time prior to the immunization, but the day afterwards, he tried to take steps but kept rolling his ankles and falling - this never happened before. This progressed to the point where de didn't even try to walk. After about 1 month, he started taking steps but his gait has been different and he trips and falls often, doesn't have the same balance that he did before when he was taking steps. He is very bowlegged and pigeon-toed.  His behavior and personality has also changed. He gets frustrated often and almost seems irritable, throwing a fit if he isn't allowed to do what he wants. He used to be a much happier baby. He also is a much pickier eater now, where he used to eat anything we fed him.