chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Herpes virus infection, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Burning sensation to right side of head with rash, stiff neck, & enlarge lymph nodes. Came to office on 9/20/16 with crusted herpetic lesions, burning sensations, and swollen post-auricular lymph node - treated with valacyclovir and doxycycline. Symptoms gradually improving. Held second dose of varicella vaccine (due in 2 weeks) and will recheck varicella titer in 1 month.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic, Varicella
Clinical narrative: Rash developed over the next 3 days and continued to spread.  It was also itchy. Pt. dx with varicella disease.  Treated with steroids.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: INJECTED SITE IS RED, HAS INFLAMMATION AND WARM.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: (sharp excruciating pain at moment of injection in high upper arm), strong aching arm pain next day and significant range-of-motion limitation due to sharp pain, greater pain at nights, pain and range-of-motion limitation persists until today (eight days later), Tylenol helps only a little.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Croup infectious, Pyrexia, Rash, Upper respiratory tract infection
Clinical narrative: Rash, fever acute URI and croup, went to Emergency Dept, was instructed to give Benadryl, children's Tylenol or Ibuprofen.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swollen and red and hurting, feels tired, diagnosed with cellulitis at ER.
Age: 1.01
Sex: M
Vaccine: FLU4, MMR, PPV, VARCEL
Symptoms: Crying, Eye movement disorder, Generalised tonic-clonic seizure, Laboratory test
Clinical narrative: Pt cried after the shot, was quiet for less than a minute, then had tonic clonic seizure with eye deviation to the left.  Did not appear to be a breath holding spell.  Occurred less than a minute after the vaccines.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient described extreme pain in her arm that vaccines were administered; no relief with pain "killers" that she takes daily due to back surgery. Patient stated she cannot sleep at night due to pain, cannot sign her name,or take her dog walking due to extreme pain in her arm. Says she has applied cold and warm compresses with no relief.
Age: 45.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Chills, Fatigue, Injection site cellulitis, Injection site warmth
Clinical narrative: CHILLS, FATIGUYE, WARMTH AROUND INJECTION SITE. DIAGNOSED WITH CELLULITIS.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Swelling, Urticaria
Clinical narrative: Initial unsolicited report received from a nurse on 09 September 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of FLUZONE QIV MDV (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecifie date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, post vaccination, patient experiecend allergic reaction, hives and swelling. Laboratory investigations and corrective treatment were not reported. The outcome of the events was not reported. List of documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: REDNESS ITCHING AT SITE STILL PERSISTING ON 9/20/2016.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Diet refusal, Haematochezia, Hypersomnia, Intussusception
Clinical narrative: Crying, grabbing throat, excessive sleeping. Would not eat and vomiting. Blood in Pamper.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Oropharyngeal pain, Vomiting
Clinical narrative: Crying, grabbing throat, excessive sleeping. Would not eat and vomiting. Blood in Pamper.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal tenderness, Decreased appetite, Enema administration, Intussusception, Lethargy
Clinical narrative: Crying, grabbing throat, excessive sleeping. Would not eat and vomiting. Blood in Pamper.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Therapeutic procedure
Clinical narrative: Crying, grabbing throat, excessive sleeping. Would not eat and vomiting. Blood in Pamper.
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Depressed mood, Pyrexia, Rash
Clinical narrative: High fever, rash, sore joints, melancholy.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain
Clinical narrative: Sore, red, local pain.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Hypersensitivity, Injection site erythema, Malaise
Clinical narrative: Arm is red around injection site and was spreading, chills, and just feeling overall sick.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Headache, Pain, Pyrexia
Clinical narrative: Fever - 102.3, Headache, body ache, joint aches.  Later that night experienced itchy rash on chest and low grade fever.  Next day had pain in lower back and was sensitive to touch.  Advised to take Tylenol & Benadryl and call if symptoms got worse.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash pruritic, Tenderness
Clinical narrative: Fever - 102.3, Headache, body ache, joint aches.  Later that night experienced itchy rash on chest and low grade fever.  Next day had pain in lower back and was sensitive to touch.  Advised to take Tylenol & Benadryl and call if symptoms got worse.
Age: 38.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Dizziness, Headache
Clinical narrative: Patient felt light headed within 5 minutes and developed a headache. Patient took 2 regular strength Tylenol for the headache.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Induration, Pain, Skin discolouration
Clinical narrative: First HPV caused induration that lasted 2-3 weeks,  second HPV induration, blue color and pain persisting 4 months later.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Feeling abnormal, Injected limb mobility decreased, Pain, Tension
Clinical narrative: Patient reported can't lift arm that had Flu and PNEUMOVAX 23 injections, tense back, neck, shoulder, chills, aches, hives. Had immunizations at 10am 9-9-16 felt bad at 3:30 same day, reported to Pharmacy 9-10-16, saw doctor 9-12-16.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Urticaria
Clinical narrative: Patient reported can't lift arm that had Flu and PNEUMOVAX 23 injections, tense back, neck, shoulder, chills, aches, hives. Had immunizations at 10am 9-9-16 felt bad at 3:30 same day, reported to Pharmacy 9-10-16, saw doctor 9-12-16.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Pain at site of injection, still present after 8 days of vaccine administration. No doctor's vist required so far, only Motrin 1-2x/day.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Pyrexia, Tremor
Clinical narrative: Tired, shakes, chills, fever.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus, Rash macular
Clinical narrative: Pt came back down to vaccine rooms to let me know she was feeling itchy on her arm and had some red blotches on her neck and shoulders she came down at 1:50pm.
Age: 7.0
Sex: F
Vaccine: HPV9
Symptoms: Abasia, Arthralgia, Injection site pain, Injection site swelling, Musculoskeletal pain
Clinical narrative: Within 10 mins of injection, site was swollen and painful. Unable to walk for 30 mins. Leg painful more than other vaccines x 2 days. On 7/15/2003 sudden onset of intense "stabbing" nerve-like pain in face, neck, and head for 45 seconds. One week later, same pain in shoulder area. Multiple episodes of this same pain in shoulder, upper arm, hands, and wrist since this time, sometimes multiple times a day, not experienced everyday.
Age: 7.0
Sex: F
Vaccine: HPV9
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Within 10 mins of injection, site was swollen and painful. Unable to walk for 30 mins. Leg painful more than other vaccines x 2 days. On 7/15/2003 sudden onset of intense "stabbing" nerve-like pain in face, neck, and head for 45 seconds. One week later, same pain in shoulder area. Multiple episodes of this same pain in shoulder, upper arm, hands, and wrist since this time, sometimes multiple times a day, not experienced everyday.
Age: 1.42
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Child woke up to a 8 mm blister on injection site where varicella was given.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Redness, Swelling of bottom portion of upper arm, Hot to touch, Headache, Fever.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, Swelling of bottom portion of upper arm, Hot to touch, Headache, Fever.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Received a phone call from patient stating her arm is red and swollen.
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: Patient developed rash, swelling, and itching throughout her entire arm.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Dizziness, Heart rate increased, Lethargy
Clinical narrative: 9/19 dizzy, rapid pulse, lightheaded. 9/20 - 2:00 am diarrhea, lethargy. 9/20 10am phoned personal physician. 9/20 currently 7pm -diarrhea continued, vomiting any food intake. Trying to maintain hydration. Weak and lethargic.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: 9/19 dizzy, rapid pulse, lightheaded. 9/20 - 2:00 am diarrhea, lethargy. 9/20 10am phoned personal physician. 9/20 currently 7pm -diarrhea continued, vomiting any food intake. Trying to maintain hydration. Weak and lethargic.
Age: 11.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Mother first reported daughter complained of problems with immunizations given on 8-16-16.  However, mother declined to elaborate regarding problems. On 9-20-16 mother requested lot numbers for vaccines administered to her daughter. Mother also stated that her daughter was still complaining of a left sore arm and left foot, including some mild numbness to left toe. Mother also denied any seizures, fevers, or fainting after immunizations were administered.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Feeling hot, Swelling
Clinical narrative: Swelling, heat, chills - treated with ice and Benadryl.
Age: 29.0
Sex: M
Vaccine: DTAP
Symptoms: Muscle spasms
Clinical narrative: Periodic spasms of the back muscles; mostly around the thoracic region. Persisted intensely for 36 hrs, symptoms gone by 5 days.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Feeling hot, Pain, Swelling
Clinical narrative: Swelling, pain, and heat- Received steroid shot from walkin clinic.
Age: 86.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Feeling hot, Swelling
Clinical narrative: Severe swelling, heat - treated with ice, BENADRYL, and CLARITIN.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug dispensed to wrong patient, No adverse event
Clinical narrative: The wrong student was vaccinated.  Staff went to a classroom and called for someone to get her flu vaccine. Patient got up and the VAR was handed to her.  She went to the nurse, who called her by name, and she was vaccinated.  The child that was to be vaccinated was also the same name but was not in the classroom that staff went to.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Arthropod bite, Burning sensation, Flushing, Pruritus, Pruritus generalised
Clinical narrative: The patient initially came into the clinic with complaints of bug bites on both her arms. She was unsure where she received the bug bites.  I asked if she had any allergies and she stated her allergies were almonds and walnuts but no known drug allergies. Patient stated that she had allergy testing a few years ago and was given an EPI-pen, but was never shown how to use the device. She states that she has been diagnosed with asthma. I provided her 1 tab Loratadine and the Td immunization because she stated that she doesn't remember how long it has been since she received any immunizations. Approximately 1 hour later, I Spoke with patient while on a floor warehouse walk. She reports c/o itching and burning of skin all over. She c/o throat itching as well. She states that, "It feels like I drank an energy drink." TM states that she did not bring her EPI- pen with her.  She asked if she should bring her EPI- pen to work with her everyday and I confirmed, yes. I escorted her to the clinic for further evaluation. Vital Signs stable  B/P: 124/70, P: 94, T: 98.4, Respiration 24, No SOB, no audible wheezing, no hives.  TM A&O x4, Skin throughout extremities appeared flushed. No hives present around immunization area of her right deltoid or any where else on the skin. Lung sounds clear bilat at bases and apices, no obvious use of accessory muscles.  I recommended that she goes to the ED via ambulance - Emergent 911 Referral - TM declined the use of the ambulance 911 transport and signed an AMA for transport for emergency care. She stated after her shift she will have her friend drive her. I directed her to go to the closest ED and to go straight there when she is done with her shift. She states that she is familiar with where it is located as she is a resident of city. I asked again if I could call an ambulance to come and bring her to the hospital. She declined again. She requested an antihistamine and I provided her loratadine as requested. I asked her again if I can call the ambulance and the TM declined again. She then left to go and speak to her manager (OM) to notify of her whereabouts and to gather her personal things because it was 10 minutes to the end of her shift (1600). I waited for TM to return through the lobby and provided TM with paperwork for authorization for treatment prior to her walking out of the warehouse.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Skin burning sensation, Throat irritation
Clinical narrative: The patient initially came into the clinic with complaints of bug bites on both her arms. She was unsure where she received the bug bites.  I asked if she had any allergies and she stated her allergies were almonds and walnuts but no known drug allergies. Patient stated that she had allergy testing a few years ago and was given an EPI-pen, but was never shown how to use the device. She states that she has been diagnosed with asthma. I provided her 1 tab Loratadine and the Td immunization because she stated that she doesn't remember how long it has been since she received any immunizations. Approximately 1 hour later, I Spoke with patient while on a floor warehouse walk. She reports c/o itching and burning of skin all over. She c/o throat itching as well. She states that, "It feels like I drank an energy drink." TM states that she did not bring her EPI- pen with her.  She asked if she should bring her EPI- pen to work with her everyday and I confirmed, yes. I escorted her to the clinic for further evaluation. Vital Signs stable  B/P: 124/70, P: 94, T: 98.4, Respiration 24, No SOB, no audible wheezing, no hives.  TM A&O x4, Skin throughout extremities appeared flushed. No hives present around immunization area of her right deltoid or any where else on the skin. Lung sounds clear bilat at bases and apices, no obvious use of accessory muscles.  I recommended that she goes to the ED via ambulance - Emergent 911 Referral - TM declined the use of the ambulance 911 transport and signed an AMA for transport for emergency care. She stated after her shift she will have her friend drive her. I directed her to go to the closest ED and to go straight there when she is done with her shift. She states that she is familiar with where it is located as she is a resident of city. I asked again if I could call an ambulance to come and bring her to the hospital. She declined again. She requested an antihistamine and I provided her loratadine as requested. I asked her again if I can call the ambulance and the TM declined again. She then left to go and speak to her manager (OM) to notify of her whereabouts and to gather her personal things because it was 10 minutes to the end of her shift (1600). I waited for TM to return through the lobby and provided TM with paperwork for authorization for treatment prior to her walking out of the warehouse.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Erythema, Hypersensitivity, Hypoaesthesia, Pain in extremity
Clinical narrative: Pain in fingers & arm, numbness, Swelling, redness, warm to touch. Went to ER. He said their diagnosis was an allergic reaction. He was given steriods, Benadryl, antibiotic, and pain relievers.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Pain in fingers & arm, numbness, Swelling, redness, warm to touch. Went to ER. He said their diagnosis was an allergic reaction. He was given steriods, Benadryl, antibiotic, and pain relievers.
Age: 75.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, pain, heat in injection arm - Was treated with antibiotics.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Eye pain, Fatigue, Headache
Clinical narrative: She received vaccine on Saturday. The next day she had a headache that didn't go away. On Monday she became very ill and called the ER who said it sound like she was having a reaction to the flu vaccine.  She had symptoms of fatigue, weakness, pain behind eyes, temp of 102 F, vomiting, can't keep anything down, felt like arm was paralyzed, body aches especially on the left side of body starting in neck all the way down to leg. (Vaccine was given in right deltoid). Followed up with patient Tuesday, she felt a little better but has to stay laying down or she has to throw up. Feels really nauseous.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Monoplegia, Nausea, Pain, Vaccination complication
Clinical narrative: She received vaccine on Saturday. The next day she had a headache that didn't go away. On Monday she became very ill and called the ER who said it sound like she was having a reaction to the flu vaccine.  She had symptoms of fatigue, weakness, pain behind eyes, temp of 102 F, vomiting, can't keep anything down, felt like arm was paralyzed, body aches especially on the left side of body starting in neck all the way down to leg. (Vaccine was given in right deltoid). Followed up with patient Tuesday, she felt a little better but has to stay laying down or she has to throw up. Feels really nauseous.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: She received vaccine on Saturday. The next day she had a headache that didn't go away. On Monday she became very ill and called the ER who said it sound like she was having a reaction to the flu vaccine.  She had symptoms of fatigue, weakness, pain behind eyes, temp of 102 F, vomiting, can't keep anything down, felt like arm was paralyzed, body aches especially on the left side of body starting in neck all the way down to leg. (Vaccine was given in right deltoid). Followed up with patient Tuesday, she felt a little better but has to stay laying down or she has to throw up. Feels really nauseous.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Heart rate increased, Injection site pain, Injection site swelling
Clinical narrative: PATIENT BEGAN TO FEEL CHILLS, HEADACHE, INCREASED HEART RATE. THE INJECTION SITE WAS PAINFUL TO TOUCH AND HOT WITH SWELLING AROUND THE ARM.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth
Clinical narrative: PATIENT BEGAN TO FEEL CHILLS, HEADACHE, INCREASED HEART RATE. THE INJECTION SITE WAS PAINFUL TO TOUCH AND HOT WITH SWELLING AROUND THE ARM.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysgeusia, Dyspnoea, Wheezing
Clinical narrative: After pt was given the shot, pt experienced metallic taste in her mouth. Approximately 5 minutes later, she started wheezing, coughing and gasping for air. Pt also used her albuterol inhaler to help her breathe better. She has history of severe asthma. She was given a dose of adult EPIPEN at the pharmacy and paramedic was called. After paramedic arrived, her oxygen sat was 99%. She was given a breathing treatment and was taken to the hospital.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: The patient came in today to ask about the injection site because it is red and inflamed.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swelling, redness, hot, and pain.
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Pt said has a red rash and pain at injection site. Told patient to apply cold packs and take Tylenol. Pt said rash has gone down from half dollar size to quarter size but still painful.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient came in on 9/20/16 to show me that her injection site was red, hot to the touch and hard. Only the left arm where the PREVNAR 13 was given, the right arm (FLUZONE HD) had no reaction.
Age: 62.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Administration site induration, Administration site swelling, Injection site erythema, Injection site pruritus
Clinical narrative: Per patient: Itchiness, redness, swelling, hard bulky 2.5 inch rectangular area around site of administration.
Age: 48.0
Sex: F
Vaccine: FLUR3
Symptoms: Abdominal pain upper, Dizziness
Clinical narrative: Patient began complaining of extreme dizziness and stomach cramps.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Patient called at approximately 9:45 PM and stated that she felt uneasy walking (dizziness) throughout the day after the vaccine and was unsure if it was related to the vaccine or the heat of the day. She stated she had never had any reactions to vaccines in the past, but wanted to discuss this.
Age: 82.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Lip pain, Lip swelling, Rash
Clinical narrative: Swollen painful lip, rash. Pt took Benadryl. I suggested going to doctor but daughter told me today she refused but will encourage her to go again tomorrow.
Age: 41.0
Sex: F
Vaccine: FLUR3
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: Itching on back, neck, and arms.  Redness and blotchiness on same areas. Administered Benadryl 25mg PO and symptoms resolved within 30 minutes.
Age: 20.0
Sex: M
Vaccine: HEP, MMR, TDAP
Symptoms: Loss of consciousness, Seizure, Syncope
Clinical narrative: Syncope, loss of consciousness, mild convulsions for about 80 seconds.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthenia, Dizziness
Clinical narrative: Pt was feeling dizzy and weakness.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLUX, PPV, RVX
Symptoms: Dyskinesia, Sleep terror
Clinical narrative: Neurologic - involuntary movement of shoulder to cheek. Developed after 4 hrs. Night terrors that last approx 4-5 days.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature, Decreased activity, Decreased appetite, Rash vesicular
Clinical narrative: This spontaneous report was received from an assistant director of a laboratory and refers to a 3 year old female patient. The patient was enrolled in the Varicella Zoster Virus (VZV) Identification Program (VZVIP) to identify if VZV was present and if it was present, to identify if it was associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. The patient had acute lymphoblastic leukemia. The patient was receiving chemotherapy and she was immunocompromised. The patient was not exposed to chickenpox and shingles and she had no prior history of allergies, chickenpox, herpes zoster and herpes zoster ophthalmicus. On an unknown date, the patient was vaccinated with a dose of VARIVAX (dose, route of administration, anatomical location, lot # and expiration date were not provided). The patient's concomitant medications included doxorubicin (manufacturer unknown), vincristine sulfate, ZANTAC, BACTRIM. On approximately September 2016, the patient was hospitalized. On 05-SEP-2016, the patient experienced decreased appetite, decreased activity, and 6 lesions type rash vesicular on thigh, face, scalp and back. It was reported that the patient's maximum temperature was 38.8 degree C. Therefore, she was hospitalized on an unspecified date in September 2016. On 12-SEP-2016, the patient was recovered from the events. The relationship between the events and the vaccination with VARIVAX was unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68-year-old female patient with allergy to sulfa drugs and history of vaccination with PREVNAR 13 on 23-NOV-2015. On 14-SEP-2016, the patient was subcutaneously vaccinated with a dose of PNEUMOVAX 23 injection (lot# M003027, expiry date 21-JUN-2017; exact dose was not reported) in her left arm. It was also reported that at the same time, the patient was vaccinated with an unspecified influenza vaccine (dose and route of administration were not reported). Concomitant therapies included CRESTOR. On 14-SEP-2016, the patient experienced an adverse effect described as a softball-size swelling at the injection site of the left arm and redness, which later spread to the elbow. On an unknown date in September 2016, the patient sought medical attention at an unspecified urgent care center and was prescribed KEFLEX 500 mg three times per day and unspecified steroid creams as treatment of the events by an unspecified provider. The pharmacist reported that the patient sought medical attention again on 16-SEP-2016, in an emergency room, because the redness had spread past her elbow into the forearm. It was reported that the patient was most likely going to be admitted into the hospital because of the events. No diagnostic lab studies were performed in regard to the events. The reporting pharmacist requested a lot check for PNEUMOVAX 23 (lot# M003027, expiry date 21-JUN-2017). The outcome of the events was reported as not recovered. The relatedness between PNEUMOVAX 23 and the events was not provided. Upon internal review, the events of softball-sized swelling at the injection site and redness were determined to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # M013156 with expiration date 15-OCT-2017, or lot # M005287 expiration date 18-OCT-2017, dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected because we are not allowed to contact the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot # L015460, expiration date 20-JUL-2017, dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected because we are not allowed to contact the reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L008660 with expiration date of 10-NOV-2016, lot # M000442 with expiration date 31-MAR-2018, lot # L033343 with expiration date 13-SEP-2017, dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected because we are not allowed to contact the reporter.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site mass, Pain, Sensitisation
Clinical narrative: Information has been received from a physician via a company representative referring to a 13 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 16-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot # M016193, expiration date, route and dose not reported). In August 2016 (reported as "following administration of GARDASIL 9"), the patient developed a red lump at the injection site with a ring around it. The patient complained of sensitivity and pain. The patient was not hospitalized but sought care at physician's clinic for follow up. It was unknown if treatment was given for the events. The outcome of the events was unknown. The causality between GARDASIL 9 and the events was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients received an improperly stored dose of (Oka/Merck) VARIVAX (lot # M006731, expiration date 09-FEB-2018l; lot# M017291, expiration date 07-APR-2018, dose and route were unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Altered state of consciousness, Dizziness
Clinical narrative: This solicited report was received from the patient's mother concerning to her daughter of unknown age who was enrolled in a marketed research program. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the subject was vaccinated with the third dose of GARDASIL (lot #, expiration date, dose, frequency and route were not provided). On an unknown date, after vaccination with the third dose of GARDASIL, the patient got lightheaded and almost passed out. The outcome of the events and the causality between them and GARDASIL were unknown. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of unspecified patients. No medical history or concurrent conditions were included. Since 06-SEP-2016, the patients had been administered doses of GARDASIL 9 (lot#, expiration date, dose, route unspecified) which were improperly stored. No adverse effects reported. This is one of the reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: Information has been received from a nurse via a field service representative referring to a 5 or 6 years old male patient. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 23-AUG-2016, the patient was vaccinated with a dose of M-M-R II (strength, dose, frequency, lot number and expiration date were unknown) subcutaneously. It was reported that the kindergarten age child had been vaccinated with M-M-R II, but might have developed mumps in 2016. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This initial report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in May 2015, unspecified number of patients received improperly stored VARIVAX, lot number reported as L003216 with expiration date on 30-APR-2016 (dose, strength and frequency were not provided). On an unspecified date in July 2015, unspecified number of patients received improperly stored VARIVAX, lot number reported as L015416 with expiration date on 01-AUG-2016 (dose, strength and frequency were not provided). On an unspecified date in October 2015, unspecified number of patient received improperly stored VARIVAX, lot number reported as K002918 with expiration date on 26-FEB-2016 (dose, strength and frequency were not provided). On an unspecified dates, unspecified number of patient received improperly stored VARIVAX, lot number reported as L006384 with expiration date on 25-FEB-2017 and lot number as J014812 with expiration date 20-FEB-2016 (dose, strength and frequency was not provided). According to the reporter, there were no previous temperature excursions and the temperature and time frame excursions were reported as: -11.2C for 360 hours, -11.1C for 480 hours and -10.7C for 1296 hours. Lot numbers L015416, L003216 and J014812 were verified as invalid lot numbers for VARIVAX. At the reporting time, the patients outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M004116 with expiration date 12-OCT-2017, or lot # L028083 with expiration date 03-SEP-2017, or lot # L040164 with expiration date 20-FEB-2018, or lot # L045700 with expiration date 22-FEB-2018, dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected because we are not allowed to contact the reporter.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Upper arm swelled, heat, itching, redness.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. Patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of oral ROTATEQ, lot # L042215, expiration date:02-JUN-2017 , lot E M019707, expiration date:25-OCT-2017 or lot# L048854, expiration date:31-AUG-2017, (strength and dose were not reported). Patients' concomitant medication was not provided. No adverse effects were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Eyelid oedema, Hypersensitivity, Lip swelling, Peripheral swelling, Skin reaction
Clinical narrative: Patient was admitted to hospital for severe allergic reaction. Both hands, lips and eyelids swollen-after vaccine was given.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9, MENB
Symptoms: Injection site erythema, Pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: 9/20/2016 Patient visit for reaction to MENB shot Right arm with redness, swelling and pain. Accompanied by mom. 13 YO received the following vaccinations three days ago: In Right arm: TRUMENBA In Left arm: GARDASIL and FLUZONE. Since then the vaccinations sites on both arms have been tender, swollen and red, Right>Left side. No fever, nausea, dizziness. Mother gave her BENADRYL before bed last night. Using TYLENOL for pain. Using cool compresses to sites. Redness is less today but pain persists R>L side with use of the arm.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site erythema, Peripheral swelling, Pyrexia
Clinical narrative: Fever, chills on 9/19. (L) arm is red, swollen and tender. Redness extends down to the (L) elbow and across the (L) shoulder and chest, temp today is 98.6 F. Treated with ZYRTEC Q 24; Hydrocortisone cream and cold compresses.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Fever, chills on 9/19. (L) arm is red, swollen and tender. Redness extends down to the (L) elbow and across the (L) shoulder and chest, temp today is 98.6 F. Treated with ZYRTEC Q 24; Hydrocortisone cream and cold compresses.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a male patient (pt) of unknown age who on an unspecified date, received ZOSTAVAX (route and lot number not provided). Medical history and concomitant medications were not provided (pt refused to answer). On an unspecified date, the pt developed shingles. The pt stated he was going to contact his lawyer because "I had ZOSTAVAX and got the shingles anyway". The outcome of the event was not provided. Additional information is not expected as the pt did not provide his contact information.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, induration, itching entire (L) upper arm from shoulder to elbow - almost circumferential.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies and medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as M019232, expiration date 17-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. These vaccines were exposed to 28 degrees Fahrenheit for 14 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: Patient reported adverse effect 9/20/16 at approx. 4:45 pm. She received shot 9/19/16 however experiencing reaction today at 2pm.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Injection site: rash, redness, warm, tender, swollen (2 inches). Pt statees got worse/larger next day.
Age: 60.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left arm red swollen warm. Shot given 9-15-16. Pt went to urgent care 9/17/16. Had been using Clindamycin and BENADRYL.
Age: 1.67
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Differential white blood cell count, Dyskinesia, Enterovirus test, Eye movement disorder, Full blood count
Clinical narrative: 09/06/16 - fever 09/07/16 - fever 09/08/16 - fever 09/09/16 - 1st seizure at 4:30pm 09/10/16 - 10 seizures 09/11/16 - 4 seizures 09/12/16 - 2 seizures 09/13/16 - 8 seizures 09/14-17 - 8 seizures 09/18/16 - 30 seizures 09/19-20/16 - 10 seizures. Pt's eye roll upward, eyelids almost close, mouth shifts to side and freezes cannot move.
Age: 1.67
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Laboratory test, Polymerase chain reaction, Pyrexia, Seizure, Urine analysis
Clinical narrative: 09/06/16 - fever 09/07/16 - fever 09/08/16 - fever 09/09/16 - 1st seizure at 4:30pm 09/10/16 - 10 seizures 09/11/16 - 4 seizures 09/12/16 - 2 seizures 09/13/16 - 8 seizures 09/14-17 - 8 seizures 09/18/16 - 30 seizures 09/19-20/16 - 10 seizures. Pt's eye roll upward, eyelids almost close, mouth shifts to side and freezes cannot move.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Pt received ZOSTAVAX 9/13/16. Called 9/14/16 complaining of redness on injection site. Told to mark area and note progression. After 1 week, mostly resolved.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dry eye, Dyspnoea, Ocular hyperaemia
Clinical narrative: Dry red eyes, shortness of breath 90 minutes after receiving vaccine, pt. used Albuterol inhaler. Recommended oral BENADRYL and to go to ER if symptoms persist/worsen.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a physician referred to two patients of unknown age and gender. The patients' pertinent medical history, concomitant medication and drug allergies/ reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (dose, strength, route were not reported, Lot number: M006726, Expiry date: 08-Feb-2018. No adverse symptoms were reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Redness/Rash near injection site.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On unknown date, the patients were vaccinated with improperly stored doses of oral ROTATEQ, lot # L020865, expiration date:16-JUN-2017 and Lot# L020865, expiration date:09-FEB-2016) that went to 46.6 F for 8 hours. A data logger was use and there were no prior excursions. The vaccines are back in range. No adverse effects were reported.  This is one of two reports received from the same reporter. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized reaction to (L) deltoid. Pt c/o pain, redness, swelling. Mom spoke to MD on call.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to 4 year old female patient with no known drug allergy. The patient had no illness at time of vaccination. The patient's birth weight was 7lb 5oz. Concomitant therapies included KINRIX and VARIVAX. On 02-MAY-2016 at 10:36, the patient was vaccinated with M-M-R II lot # L026553 dose 2, subcutaneously in the left thigh. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Localized reaction on (L) thigh, red, swollen area approx. 5".
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized reaction to (L) thigh, red, swollen area approx. 4x6".
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Localized reaction on (L) thigh. Presented with large, red swollen area to MD office. Approx 4x6".
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient had redness, soreness and heat from injection site down past elbow for 1 week.
Age: 58.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Dizziness, Vaccination site haemorrhage
Clinical narrative: Appx 3:45 p.m. pt. received .5ml BOOSTRIX, IM RT. delt. and .5ml MMR SC. RT. Arm. Pt. had no adverse events at 3:45 p.m. Pt. returned saying felt dizzy, was bleeding from vaccine site. I laid pt. down in exam room with her feet up and her knees drawn up. I explained the situation to head RN. RN went to exam room and took vitals. After 5 min. pt. told RN she felt better. We offered pt. to lie down longer, pt. refused saying she had a cab waiting for her. RN advised warning signs or symptoms if she has any of them pt. is to go to the emergency room. All pts vital were normal before pt. left the clinic at 4:30 p.m. on 9-13-16.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Muscle twitching, Pallor
Clinical narrative: Became light headed, pale, lost consciousness. Patient felt like he was going through a time-warp. He described twitching. This started immediately after vaccines were given. Pt rested about 5 minutes - his head was raised (pt was in an exam table). He was talking and interacting. He became pale and his head was lowered. He had generalized twitching for about 5 seconds.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: Aches, chills, diarrhea next day and into following week. Congestion URI 4d later, still achy z 1 1/2wks.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Respiratory tract congestion, Upper respiratory tract infection
Clinical narrative: Aches, chills, diarrhea next day and into following week. Congestion URI 4d later, still achy z 1 1/2wks.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients whose on an unknown date, were vaccinated with an improperly stored doses of PNEUMOVAX 23  (lot # M022085, expiry date 09-OCT-2017). The vaccine was exposed to 51 degree F for 7 hours and 30 minutes. No adverse effects were reported. This is one of two reports from the same reporter source (linked to MARRS# WAES1609USA009020). Additional information is expected.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Pt passed out at first check out desk within 3-5 min or receiving HPV # 1 and flu vaccine in right deltoid. Pt hit left side of forehead on wall and slid to the ground. I did not witness this. Pt taken to exam room #3 by doctors and pt placed in supine position, ice applied to forehead and pt given apple juice. B/P obtained. Pt in supine position for 10 min. Pt felt fine and left the office accompanied by mother and sister. Pt with syncopal episode at front desk. I arrived as she was lying prone and rousing with eyes opening and nodding yes when name called. SI diaphoretic with strong radial pulse of 88. Kept her lying supine for several minutes followed by sitting for several then standing with support. She walked to exam room where she had BP HR check while supine and then sitting drank 2 4 oz cans juice. With second stable BP she was released to leave the office with her mother and sister without further difficulty.