chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: JEV1
Symptoms: Urticaria
Clinical narrative: Recvd Japanese Encephalitis dose #2 (had dose #1  28 days ago without any problems) at 9:30 am. at 8:00 pm states startd getting hives on the back of her lower leg in the calf area. By midnight the other leg had hives as well  Texted me at 1:30 am asking what to do.I referred to Urgent Care or ER. Denies any other symptoms. No fever, aches or headache. No SOB, difficulty swallowing or other symptoms. Stated injection site was fine. Sent me a pic of hives on legs. Mild, but do confirm it was hives.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Breath sounds abnormal, Chest X-ray normal, Cyanosis, Irritability, Laboratory test normal
Clinical narrative: Brief resolved unexplained event (BRUE) in infant  Healthy 2 m.o. Infant with fever and extreme fussiness following vaccines  yesterday, with brief cyanotic event of unknown origin on same day as vaccinations. Occurred while in  car seat and preceded by unusual-sounding breathing. . Suspect a transient airway event in the car seat, less likely  febrile seizure.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Physical examination normal, Pyrexia, Respiratory disorder, Urine analysis normal
Clinical narrative: Brief resolved unexplained event (BRUE) in infant  Healthy 2 m.o. Infant with fever and extreme fussiness following vaccines  yesterday, with brief cyanotic event of unknown origin on same day as vaccinations. Occurred while in  car seat and preceded by unusual-sounding breathing. . Suspect a transient airway event in the car seat, less likely  febrile seizure.
Age: 41.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Contusion, Headache, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Few hours after receiving vaccines patient developed headache, red itchy rash about the body, bruising to the left thigh and swelling to  face  ( both sides.)  Denied difficulty breathing. Pt did not go to the Emergency Room. She took Benadryl beginning the next day.
Age: 41.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Swelling face
Clinical narrative: Few hours after receiving vaccines patient developed headache, red itchy rash about the body, bruising to the left thigh and swelling to  face  ( both sides.)  Denied difficulty breathing. Pt did not go to the Emergency Room. She took Benadryl beginning the next day.
Age: 1.67
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction, Pyrexia
Clinical narrative: 6/5/19 patient had a fever of 101.4 with swollen, red, warm area on right leg. Grandmother drew circle around area. 6/6/19 area increased in size to about the size of 1/2 dollar bill. Grandmother called pediatrician who in turn referred her to the ER. Evaluated in ER and sent home with instructions for Tylenol and benedryl. When asked what the ER doctor said, the grandmother thinks they told her it was a local reaction to a vaccine that can occur. Called grandmother the next day to check on patient. Left message. no response to phone call.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Body temperature increased, Immediate post-injection reaction, Injection site swelling, Pruritus, Respiratory disorder
Clinical narrative: Immediate 103 temperature, persistent hives continuing for now 7 days. Enormous swelling at the site of injection. Wheezing and respiratory issues. Extreme itchiness.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria, Wheezing
Clinical narrative: Immediate 103 temperature, persistent hives continuing for now 7 days. Enormous swelling at the site of injection. Wheezing and respiratory issues. Extreme itchiness.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chapped lips, Injection site erythema, Injection site swelling, Lip swelling, Local reaction
Clinical narrative: The patient went to the doctor on 7/16/19 due to adverse events from the vaccine.The patient had a local reaction (swelling, redness) at the injection site that just started to go away on 7/16/19. She developed a splotchy rash on her anterior shin and had extreme chapped lips. She had increased sun sensitivity when she was outside and developed swelling of the lips and face. She was given erythromycin 2% gel and prednisone 40 mg for 3 days. As of 7/25, she returned to the doctor because there was no improvement in her symptoms. She was prescribed a taper of prednisone and pimecrolimus 1% cream. She also developed two bumps on her lateral neck.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Photosensitivity reaction, Rash, Rash macular, Swelling face
Clinical narrative: The patient went to the doctor on 7/16/19 due to adverse events from the vaccine.The patient had a local reaction (swelling, redness) at the injection site that just started to go away on 7/16/19. She developed a splotchy rash on her anterior shin and had extreme chapped lips. She had increased sun sensitivity when she was outside and developed swelling of the lips and face. She was given erythromycin 2% gel and prednisone 40 mg for 3 days. As of 7/25, she returned to the doctor because there was no improvement in her symptoms. She was prescribed a taper of prednisone and pimecrolimus 1% cream. She also developed two bumps on her lateral neck.
Sex: F
Vaccine: MMR
Symptoms: Allergy to vaccine
Clinical narrative: allergy; This spontaneous report was received from an anonymized reporter via Pfizer regarding a female patient of unknown age. The patient's relevant medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with Measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, frequency, anatomical location, lot # and expiry date unknown) for prophylaxis. On an unknown date, the patient was allergic to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (allergy to vaccine). The outcome of allergy to vaccine was unknown. The reporter assessed the causality of allergy to vaccine to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II).; Sender's Comments:  US-PFIZER INC-2019047356:
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Headache, Initial insomnia, Malaise
Clinical narrative: feeling woozy; sleeping hard; muscle tenderness; redness; headache; malaise; not sleeping well; This case was reported by a consumer via call center representative and described the occurrence of tenderness muscle in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 12th July 2019, unknown after receiving Shingrix, the patient experienced tenderness muscle, erythema, headache, malaise and poor sleep. On 13th July 2019, the patient experienced trouble falling asleep. On 14th July 2019, the patient experienced woozy. On an unknown date, the outcome of the tenderness muscle, erythema, headache, malaise, poor sleep, trouble falling asleep and woozy were recovering/resolving.   It was unknown if the reporter considered the tenderness muscle, erythema, headache, malaise, poor sleep, trouble falling asleep and woozy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the 1st dose of Shingrix, the patient experienced muscle tenderness, redness, headache, malaise, she was not sleeping well, had sleeping hard and felt oozy. There was a discrepancy in the reported outcomes of the events tenderness muscle, erythema, headache, malaise, poor sleep, trouble falling asleep and woozy. Outcome was mentioned as fatal, it was autoloaded as recovering/resolving. However outcome of all these events is captured as autoloaded. This case has been linked to the case US2019127914, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Poor quality sleep
Clinical narrative: feeling woozy; sleeping hard; muscle tenderness; redness; headache; malaise; not sleeping well; This case was reported by a consumer via call center representative and described the occurrence of tenderness muscle in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 12th July 2019, unknown after receiving Shingrix, the patient experienced tenderness muscle, erythema, headache, malaise and poor sleep. On 13th July 2019, the patient experienced trouble falling asleep. On 14th July 2019, the patient experienced woozy. On an unknown date, the outcome of the tenderness muscle, erythema, headache, malaise, poor sleep, trouble falling asleep and woozy were recovering/resolving.   It was unknown if the reporter considered the tenderness muscle, erythema, headache, malaise, poor sleep, trouble falling asleep and woozy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the 1st dose of Shingrix, the patient experienced muscle tenderness, redness, headache, malaise, she was not sleeping well, had sleeping hard and felt oozy. There was a discrepancy in the reported outcomes of the events tenderness muscle, erythema, headache, malaise, poor sleep, trouble falling asleep and woozy. Outcome was mentioned as fatal, it was autoloaded as recovering/resolving. However outcome of all these events is captured as autoloaded. This case has been linked to the case US2019127914, reported by the same reporter.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Bed rest, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: pain/swelling at the injection site.  Fever and body aches for two days after the injection.  Max temperature was 100.2 F.  No treatment, just bed rest until the symptoms went away.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: rash on trunk and face
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Feeling hot, Flushing, Headache, Hyperhidrosis
Clinical narrative: In less than a minute the patient stated he did not feel well. His face flushed to a deep red color. States he felt hot. Had complaint of back pain and pain down the right leg.  He was sweating.  He had neck pain, headache, vision changes and nausea.  BP up to 147/97, pulse 95, O2 sat 95%. Symptoms seemed to peak and then started to subside. Given Benadryl 25 mg po X1. Observed for about an hour.  Recheck done. Had a little back pain and headache still. Bp 119/75, pulse 64, O2 sat 95%. Released.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Nausea, Neck pain, Pain in extremity, Visual impairment
Clinical narrative: In less than a minute the patient stated he did not feel well. His face flushed to a deep red color. States he felt hot. Had complaint of back pain and pain down the right leg.  He was sweating.  He had neck pain, headache, vision changes and nausea.  BP up to 147/97, pulse 95, O2 sat 95%. Symptoms seemed to peak and then started to subside. Given Benadryl 25 mg po X1. Observed for about an hour.  Recheck done. Had a little back pain and headache still. Bp 119/75, pulse 64, O2 sat 95%. Released.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Head discomfort, Headache, Pain in extremity
Clinical narrative: Had the shot on the 17th.  Arm was bruised and sore for a couple of days.  It's still slightly bruised.  Then on Sunday morning, the 21st, developed a headache.  Took 1-500 mg Tylenol, but the headache continued to get worse.  When the next dose of Tylenol was due, I took another 500 mg Tylenol tablet.  The headache got worse.  At times it feels like my head is being squeezed.  I started taking  2-500 mg Tylenol  tablets every 8 hours ever since.  My head usually gets to feeling better but then by the time the 8 hours is up, I am anxious to get another dose of Tylenol.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling without itching/pain or systemic symptoms on L thigh about 18 hours after injection was administered.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pain
Clinical narrative: Red and sore day after vaccine.  continued to get redder and more inflammed.  spreading down arm
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Depressed mood, Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: When I received the first injection, 3.15.19,I reported to VAERS that I had a reaction.  VAERS ID: 805637 This injection, 7.19.19, right after I received it, I felt a little strange. Went home had dinner. Woke up the next morning and didn't want to get out of bed. Temp that day went up to 102. Very weak and tired. Slept a large part of the day. Could hardly move off couch. The second day after the shot the fever had gone away and was able to be up and around. Felt tired took a nap, which I usually don't do. Was very drepressed, till the 4th day after the shot started feeling like my old self.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: When I received the first injection, 3.15.19,I reported to VAERS that I had a reaction.  VAERS ID: 805637 This injection, 7.19.19, right after I received it, I felt a little strange. Went home had dinner. Woke up the next morning and didn't want to get out of bed. Temp that day went up to 102. Very weak and tired. Slept a large part of the day. Could hardly move off couch. The second day after the shot the fever had gone away and was able to be up and around. Felt tired took a nap, which I usually don't do. Was very drepressed, till the 4th day after the shot started feeling like my old self.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site rash, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: ONSET RIGHT AFTER INJECTION OF LEFT SHOULDER P/STIFFNESS RASH DEVELOPED THE NEXT DAY, ANTERIOR TO INJECTION SITE RIGHT HIP PAIN DEVELOPED ON DAY 2 AFTER INJECTION
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain, Anxiety, Blood test, Chest pain, Constipation
Clinical narrative: Severe headaches, black spots in vision, constipation, severe abdominal pain, rash on face, severe anxiety, rashes, extra salivation, nausea, chest pain, sore throat, diarrea, fatigue, extra persperation.  All started around 9/24/2016 after several doctor appointments and er visits no conclustions came for a reason to the above symptoms for over a year.  One of our ER visits for extreme abdominal pain came back with a Dermoid Cyst in her left ovary that was removed surgically in 5/2018.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Cyst removal, Dermoid cyst, Diarrhoea, Fatigue, Headache
Clinical narrative: Severe headaches, black spots in vision, constipation, severe abdominal pain, rash on face, severe anxiety, rashes, extra salivation, nausea, chest pain, sore throat, diarrea, fatigue, extra persperation.  All started around 9/24/2016 after several doctor appointments and er visits no conclustions came for a reason to the above symptoms for over a year.  One of our ER visits for extreme abdominal pain came back with a Dermoid Cyst in her left ovary that was removed surgically in 5/2018.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Hyperhidrosis, Nausea, Oropharyngeal pain, Rash, Salivary hypersecretion
Clinical narrative: Severe headaches, black spots in vision, constipation, severe abdominal pain, rash on face, severe anxiety, rashes, extra salivation, nausea, chest pain, sore throat, diarrea, fatigue, extra persperation.  All started around 9/24/2016 after several doctor appointments and er visits no conclustions came for a reason to the above symptoms for over a year.  One of our ER visits for extreme abdominal pain came back with a Dermoid Cyst in her left ovary that was removed surgically in 5/2018.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Ultrasound scan, Visual impairment
Clinical narrative: Severe headaches, black spots in vision, constipation, severe abdominal pain, rash on face, severe anxiety, rashes, extra salivation, nausea, chest pain, sore throat, diarrea, fatigue, extra persperation.  All started around 9/24/2016 after several doctor appointments and er visits no conclustions came for a reason to the above symptoms for over a year.  One of our ER visits for extreme abdominal pain came back with a Dermoid Cyst in her left ovary that was removed surgically in 5/2018.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: pt given shot 7/20/19,  on 7/23/19, pt said arm swollen/pain at injection site. On 7/25/19 patient says feels better now,  just a little bit of itch at the area and site pain
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives at injection site, I never reported it to the nurse. It went away a day or two later. Then on June 9th 2019 I broke out in full body hives. I went to the doctor the next day, I mentioned to them that I previously broke out in hives the day of injection but they the two reactions weren't related. They gave me a small bottle of cream to put all over my body. They said it was probably a reaction to the milk I had that day, because we do not usually eat dairy. However, I found this to be untrue because since that reaction I have had dairy and have not had any reaction. My second reaction lasted 3 or 4 days long.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Chills, Confusional state, Lethargy
Clinical narrative: At this date it is three weeks since vaccination. Symptoms begin 24 hrs later. Pain and aches at most body joints along with stuck muscle tissue around joints. Low grade fever 100-101 Chills Lethargy/weakness Mild confusion
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: At this date it is three weeks since vaccination. Symptoms begin 24 hrs later. Pain and aches at most body joints along with stuck muscle tissue around joints. Low grade fever 100-101 Chills Lethargy/weakness Mild confusion
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: patient plays a musical instrument with her left arm primarily so she requested both shots be given in right arm.  the day after, she started having heat, swelling, pain around injection site.  reaction migrated down arm causing redness, heat, swelling in entire upper arm and some of forearm.  Patient said arm is very painful.  Reaction relieved some by diphenhydramine and seems stable as of 7/24.  Counseled pt that it may take time for reaction to subside.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: patient plays a musical instrument with her left arm primarily so she requested both shots be given in right arm.  the day after, she started having heat, swelling, pain around injection site.  reaction migrated down arm causing redness, heat, swelling in entire upper arm and some of forearm.  Patient said arm is very painful.  Reaction relieved some by diphenhydramine and seems stable as of 7/24.  Counseled pt that it may take time for reaction to subside.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: Client had a syncope event four minutes after vaccine administration. Client was standing during syncope event , fell to the floor and hit his head. Client lost consciousness for four to five seconds. Client became responsive and able to answer question .  PA-C evaluated client and ordered 911 call. Client was transported to Medical Center  Emergency Room for evaluation. Client was released the same day with instruction to follow up with pediatrician. Client was seen by PA-C on 7-16-19 and ordered an encephalogram.
Age: 85.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received Boostrix, Pneumovax, (right arm)  and Shingrix (left arm) yesterday 07/24/2019.  Patient called our pharmacy at approximately 5:20pm today 07/25/2019 expressing concern that her arm is swollen.  Her son got on the phone and explained that her arm is swollen from elbow to shoulder, is slightly pink from outside of arm to inside.  Patient was advised to seek medical care.  In meantime, patient was advised to apply cool compresses eveyr 15 minutes careful not to burn the skin, and to take acetaminophen or nonsteriodal pain reliever.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Paraesthesia
Clinical narrative: Pt states extreme tenderness at injection site and pt states he is struggling to move his left arm. Pt also stated tingling of left fingers
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain
Clinical narrative: IN THE MORNING OF 7/25/19, PT'S SON CAME TO TELL ME THAT HIS MOM HAVE "BAD CHILLS" ALL NIGHT AND SEVER PAIN AT SITE OF INJECTION, I TOLD SON TO TELL PT TO TAKE TYLENO, AND DO COLD COMPRESSES.  THE SON ASK ME  SHOULD PT NEED HER SECOND DOSE, I TOLD HIM I WILL DO RESEARCH AND CALL THEM BACK
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Arthropod bite, Injection site hypoaesthesia, Injection site induration, Injection site nodule, Vaccination site pain
Clinical narrative: Patient came into Pharmacy on 7-25-19 to pick up an antibiotic and pain medications.  Pt informed us the antibiotic was for a spider bite (on the left arm, happened 3 days after vaccination) and the pain medication was for tingling, pain, and numbness from the vaccination (in left arm, Boostrix) on 7-15.  The doctor told her to inform the pharmacy and have it reported.  In addition to the symptoms reported above, she reported a hard knot in the arm.  She pointed to 2 red spots on the side of the arm (not in the center of deltoid where boostrix was given).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Heart rate increased, Pyrexia, Somnolence
Clinical narrative: Patient called and reported feeling drowsy, fever, chills, upset stomach, and rapid heartbeat when no adverse effects experienced with first dose.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: patient said she developed an itchy rash on her back and trunk that she noticed this morning (7/25) and went to the doctors shortly after. patient was then instructed to take benadryl and the md ruled out shingles reactivation. patient had not tried anything for the itching so far today. on visual inspection the skin looked slightly raised an blotchy consistent with hives. patient said she was not experiencing any other symptoms at this time.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Headache, fever, shivering, nausea, epigastric pain; symptomatic treatment with Motrin and Pepto-Bismol; all symptoms resolved within 24 hours of onset
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Somnolence
Clinical narrative: Significant Chills  Significant Nauseated Significant Sleepiness next day
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Patient developed redness and swelling around the injection site. Her arm become red and warm.  Condition continued for 4 to 6 days. condition began showing improvement after 5 days. Patient, who a healthcare nurse,  was asked if she she had taken Benadryl or place ice on the site. Patient had not taken any healthcare measures  .  Patient was encouraged to take these  measures to help symptoms subside. Patient will be followed up after 7 days.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Skin exfoliation
Clinical narrative: PATIENT CAME IN PHARMACY STATED SINCE SHE LAST GOT THE SHOT, HER SKIN BEEN PEELING AROUND HER NECK AND EYES, AND ALSO FEELING VERY TIRED STARTED 07/17/2019 TO THE PRESENT , NO TREATMENT YET, PHARMACIST RECOMMENDS TO CALL HER DOCTOR
Age: 62.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: Patient stated he experienced muscle aches and  extreme fatigue the day after receiving the vaccination, but was feeling better after a couple days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Patient mentioned she experienced soreness at site of injection, muscle aches, fever, shivering, and fatigue for a couple days starting the day after receiving the vaccination on 5/23/19
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache, fatigue, joint ache, fatigue, shivering, slight fever
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Lethargy, Mononucleosis heterophile test, Musculoskeletal stiffness, Nausea
Clinical narrative: Sore throat, severe headache, stiff neck, extreme lethargy, nausea
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Oropharyngeal pain, Streptococcus test, White blood cell count
Clinical narrative: Sore throat, severe headache, stiff neck, extreme lethargy, nausea
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: Pt was vaccinated on 7/21/19  and had a reaction on 7/22/19 which she seek medical assistance at an urgent care for (BUT no medication was given).  SE: Swelling, itching, redness that radiated towards the armpit. Patient stated her arm looked 2x larger than normal.  Patient states she took Tylenol for pain and Benadryl to help her sleep and used ice as needed.   On 7/24/19 (when pharmacist spoke to her) - her symptoms have improved.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: tired, shivering, fever,stomach pain with vomiting, headache  symptoms started about 6 hours after the injection and lasted for about 15 hours
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: tired, shivering, fever,stomach pain with vomiting, headache  symptoms started about 6 hours after the injection and lasted for about 15 hours
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: (L) arm pain > than 1 wk redness & swelling 1 day after the  shot
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased appetite, Irritability
Clinical narrative: Fussiness four hours after vaccination Decreased appetite
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Lip swelling, Peripheral swelling, Pruritus, Rash
Clinical narrative: Rash at injection site & Trunk Swelling lips/hand itching all over body
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Eye swelling, Rash
Clinical narrative: -Rash, swollen eyes  -Given: Prednisone 30mg BID x 5 days Zyrtec 10 mg QD Benadryl 25 mg PRN HS -outcome: Patient shows improvement;  no complications
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Immediate post-injection reaction, Intensive care, Loss of consciousness, Pyrexia
Clinical narrative: Patient is said to have started with fever immediately after the vaccines were given and was given motrin without improvement. The baby had two febrile seizures ( first seizure at 7pm and the second was later that night) observed and described as shaking and loss of consciousness. The baby was admitted to PICU at Hospital and released on 7/24/2019.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Tremor
Clinical narrative: Patient is said to have started with fever immediately after the vaccines were given and was given motrin without improvement. The baby had two febrile seizures ( first seizure at 7pm and the second was later that night) observed and described as shaking and loss of consciousness. The baby was admitted to PICU at Hospital and released on 7/24/2019.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Lt arm site redness and itchy.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Injection site pain, Pain in extremity, Rash, Vaccination complication
Clinical narrative: Pain under left arm; Rash on the face; upper back pain; Injection Site Pain; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number C5E43, expiry date 5th August 2021) for prophylaxis.   On 9th July 2019, the patient received the 2nd dose of Shingrix. On 9th July 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On 10th July 2019, the patient experienced axillary pain, rash and upper back pain. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the axillary pain, rash and upper back pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, axillary pain, rash and upper back pain to be related to Shingrix.  Additional details were provided as follows: The nurse reported that, the patient experienced pain under left arm as pain that moves into the upper back and rash as located on the face. The health care professional stated that, njection site pain began immediately following injection and has since completely resolved., resolution date was not provided. The health care professional stated that, pain under left arm and rash, began the day following the injection and has improved but has not completely resolved. The health care professional gave permission to follow up. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Back pain, Immediate post-injection reaction, Injection site pain, Rash
Clinical narrative: Pain under left arm; Rash on the face; upper back pain; Injection Site Pain; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number C5E43, expiry date 5th August 2021) for prophylaxis.   On 9th July 2019, the patient received the 2nd dose of Shingrix. On 9th July 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On 10th July 2019, the patient experienced axillary pain, rash and upper back pain. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the axillary pain, rash and upper back pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, axillary pain, rash and upper back pain to be related to Shingrix.  Additional details were provided as follows: The nurse reported that, the patient experienced pain under left arm as pain that moves into the upper back and rash as located on the face. The health care professional stated that, njection site pain began immediately following injection and has since completely resolved., resolution date was not provided. The health care professional stated that, pain under left arm and rash, began the day following the injection and has improved but has not completely resolved. The health care professional gave permission to follow up. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Limb mass, Peripheral swelling
Clinical narrative: Arm Lump; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th June 2019, 1 days after receiving Shingrix, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was not recovered/not resolved.   It was unknown if the reporter considered the local swelling to be related to Shingrix.  Additional information received were as follows: The caller reported that the patient received 1st dose of Shingrix vaccine in left arm. Next day after vaccination, the patient experienced a lump on left arm. The caller reported that it had been 6 weeks and lump had not gotten smaller, the lump was 6 inches long and 4 inches wide. The caller mentioned that the doctor said it would go away in a month but the patient complained it has not. The caller reported that the size of lump had remained the same. The caller mentioned 2 of her pharmacists said they would contact medical information. The caller was unsure if her adverse event was captured previously.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Limb mass, Swelling
Clinical narrative: Arm Lump; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th June 2019, 1 days after receiving Shingrix, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was not recovered/not resolved.   It was unknown if the reporter considered the local swelling to be related to Shingrix.  Additional information received were as follows: The caller reported that the patient received 1st dose of Shingrix vaccine in left arm. Next day after vaccination, the patient experienced a lump on left arm. The caller reported that it had been 6 weeks and lump had not gotten smaller, the lump was 6 inches long and 4 inches wide. The caller mentioned that the doctor said it would go away in a month but the patient complained it has not. The caller reported that the size of lump had remained the same. The caller mentioned 2 of her pharmacists said they would contact medical information. The caller was unsure if her adverse event was captured previously.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood urine present, Pain, Urinary tract infection
Clinical narrative: Per Daughter, blood in urine, body pain (lasted 2 days),  UTI (treated with cephalexin)
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: Strong flu-like symptoms:  Extreme fatigue, headache, chills, slight fever of 99.1  soreness at injection site
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Strong flu-like symptoms:  Extreme fatigue, headache, chills, slight fever of 99.1  soreness at injection site
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Alcohol poisoning, Decreased eye contact, Disorientation, Gaze palsy, Illusion
Clinical narrative: My son became disoriented, and disillusioned. He did not make eye contact, and would not respond to the sound of my voice. He stared off toward the right, and would gaze for long periods at the ceiling. He appeared "high" and would continuously smile while dazing off in the opposite direction. He also had a difficult time staying awake. It is two days later and he is slowly starting to get back to his typical personality. He still seems disoriented at times.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Personality change, Somnolence, Staring, Unresponsive to stimuli
Clinical narrative: My son became disoriented, and disillusioned. He did not make eye contact, and would not respond to the sound of my voice. He stared off toward the right, and would gaze for long periods at the ceiling. He appeared "high" and would continuously smile while dazing off in the opposite direction. He also had a difficult time staying awake. It is two days later and he is slowly starting to get back to his typical personality. He still seems disoriented at times.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema, Pain, Skin warm, Type III immune complex mediated reaction
Clinical narrative: Arthus reaction: edema, erythema, warm to touch, 3/10 pain.
Sex: F
Vaccine: HPV9
Symptoms: Skin laceration, Syringe issue, Wound haemorrhage
Clinical narrative: she cut the thumb of her right hand on the broken glass of a pre-filled GARDASIL 9 syringe; she cut the thumb of her right hand on the broken glass of a pre-filled GARDASIL 9 syringe; cut the thumb of her right hand on the broken glass; she bled a few drops of blood from the wound; This spontaneous report was received from a 51-year-old non-pregnant female nurse referring to herself. No information regarding her pertinent medical history and concomitant therapies was provided. No drug reactions or allergies were reported. On 27-JUN-2019, the patient cut her thumb of her right hand on the broken glass of a pre-filled hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1602283, expiration date: 18-AUG-2021 (also reported as 16-AUG-2021). No liquid got into the wound. She bled a few drops of blood from the wound and she washed out the wound with an unspecified antiseptic and then put a bandage on it. The patient did not seek medical attention and no laboratory diagnostics were performed. The finger flange itself was broken into 2 large pieces and multiple tiny shards, but he liquid was still inside the syringe. The defect was noticed while the syringe was still in the tray, there was broken glass, the finger and no liquid in the tray. There was a measurable amount of liquid remaining in the syringe. No crack was reported. The finger flange was reported as broken off. It was reported the syringe tip/needle attachment was not affected and the syringe tip or luer lock was not loose nor broken off. The syringe tip cap was attached properly prior to use, the syringe tray and the cellophane cover of the syringe tray were intact and the syringe carton was not damaged. The outcome of product quality issue and syringe issue was unknown. The outcome of events of skin laceration and wound haemorrhage was reported as not recovered. The relatedness between the events and the vaccine was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; an improperly stored dose ofROTATEQ was administered; Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions/ allergies were not provided.   On 26-JUN-2019, the patient received an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number R033256 and expiration date 23-JUN-2020; frequency and dose number were unknown) orally for prophylaxis (product storage error). No adverse effects were reported. No product quality complaint (PQC) was involved.   The time frame was Temperature 65.102 Fahrenheit scale 1 hour. There was no previous temperature excursion. Data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation and referring to a female patient of unknown age. No information was provided regarding medical history, concurrent condition, or concomitant medication.  On an unknown date, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the shingles was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-JUN-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced post herpetic neuralgia. On an unspecified date, the patient was treated by a healthcare provider for post herpetic neuralgia. The outcome of the event post herpetic neuralgia was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: developed "plantar warts" on his hands sometime after the GARDASIL 9 series was completed on an unspecified date.; Information has been received from a patient's mother who is also the medical assistant via a field representative referring to a currently 17 years old (also reported as currently 15 years old) male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown.     In 2013 (reported as when he was eleven years old), 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 # and expiration date were not reported) intramuscularly for prevention of Human Papilloma Virus (HPV) disease and cancers. On 24-JUN-2013, his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (batch/lot # and expiration date were not reported) was administered. On an unspecified date, 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) (batch/lot # and expiration date were not reported).   On an unknown date after the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) series was completed, the patient developed "plantar warts" on his hands. The patient had sought medical attention. The reporter reported treatment included having the plantar warts "shaved off and treated" on unspecified dates. The reporter reported the plantar warts had not resolved and this was an "ongoing issue".  The causality was not reported.
Sex: F
Vaccine: MMR
Symptoms: Maternal exposure before pregnancy, Rubella antibody negative
Clinical narrative: results showing no rubella titres; she received 1 dose of the M-M-R II vaccine on unspecified date in 1987 and 1 dose of   M-M-R II on an unspecified date in an unspecified year and she is pregnant; This spontaneous prospective pregnancy report was received from a certified nurse practitioner of unknown age via company representative regarding herself. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unspecified date in 1987, the patient was vaccinated with one dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) of one dosage form (strength, lot number, expiry date, route of administration were unknown) for vaccination(prophylaxis). On an unspecified date in an unspecified year, the patient was vaccinated with another dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) of one dosage form (strength, lot number, expiry date, route of administration were unknown) for vaccination(prophylaxis). An unspecified test was performed on an unspecified date in 2005 or 2006 with the result showing no rubella titres (rubella antibody negative). The patient became pregnant((maternal exposure before pregnancy), the last menstrual period (LMP) was 12-OCT-2018 and estimated date of delivery (EDD) was 19-JUL-2019. The outcome of the pregnancy was pending at the time of report. No treatment was provided for adverse event. It was unknown whether patient sought medical attention. Outcome and causality assessment were not provided by the reporter. No product quality complaint(PQC) was filed.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 83 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-JUL-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 62 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 10-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated at a clinic for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 75 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Retinal disorder
Clinical narrative: retinal issues; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 63 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 11-JUN-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced retinal issues. On an unspecified date, the patient was treated by a healthcare provider for retinal issues. The outcome of the event retinal issues was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.