chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Abdominal pain, Abortion spontaneous, Amniotic cavity infection, Exposure during pregnancy, Foetal disorder
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a patient (fetus). On 07-Nov-2014, the patient received AFLURIA (batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: 2015052681). The mother gave birth to a stillborn 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death.
Sex: U
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Heart rate increased, Hypertension, Laboratory test abnormal, Muscle spasms, Pathology test
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a patient (fetus). On 07-Nov-2014, the patient received AFLURIA (batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: 2015052681). The mother gave birth to a stillborn 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death.
Sex: U
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Premature baby death, Premature labour, Stillbirth
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a patient (fetus). On 07-Nov-2014, the patient received AFLURIA (batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: 2015052681). The mother gave birth to a stillborn 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 55-year old female patient. The patient had medical history of penicillin and cephalosporin allergy- rash. Her current illness included pain. Her concomitant medications included fenofibrate, simvastatin, tiotropium bromide and metoprolol. On 10-Sep-2014, the patient received intramuscular AFLURIA injection (batch number: T57205) into the bursa of the left arm. On 10-Sep-2014, the patient had recurring pain and received a cortisone injection. The pain resolved but the patient was in pain again. It used to hurt to lift arm. The outcome was reported as not recovered. Reporter's comments: The health authority assessed the events as non-serious, and reported that the patient presented at the Emergency Room.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Haemorrhage, Wound
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns an 89 year old female patient. On the 30-Oct-2014, the patient received AFLURIA injection (batch number T51808) via the intramuscular route at an unknown site. On the 01-Dec-2014, the patient went in (to an unspecified location) with a bloody open wound on the arm. She stated that it had been bleeding since receiving the flu shot. It was recommended that she see the doctor. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cold sweat, Lethargy, Pallor
Clinical narrative: Pt was pale, clammy, cold to touch, lethargic, HR 54bpm, for about 20 minutes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warm to touch, swelling at both injection sites (Left & Right thigh) per mother.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Cold sweat, Feeling abnormal, Hypotension, Malaise, Pallor
Clinical narrative: Per MD Ambulatory care note 9/23/11: New patient to clinic who came to first appt. today. She received a Tdap injection and 10 min. or so later was found to be on floor in hallway, alert, but having some distress. She says that she was fine prior to getting the injection. She now c/o feeling tight all over and very sick. She denies chest pain. She's not on any significant meds. O - pt. ashen appearing female, clammy. BP 86/50 sitting; awake, but mentally foggy; O2 sat 99% on RA; lungs - clear; heart - RRR; ext - no edema.  Hypotension. Diphenhydramine dose not documented mg once.
Age: 25.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Impaired driving ability, Mobility decreased, Musculoskeletal disorder, Pain in extremity, Sleep disorder
Clinical narrative: Patient reports worsening pain in left arm after vaccine. Does not have full function or rotation of the arm and states that he "cannot sleep on that side, cannot lift it to shoulder height, and cannot drive with it." It has been ten days since the injection and he feels that it is getting worse.
Age: 25.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Patient reports worsening pain in left arm after vaccine. Does not have full function or rotation of the arm and states that he "cannot sleep on that side, cannot lift it to shoulder height, and cannot drive with it." It has been ten days since the injection and he feels that it is getting worse.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, MMRV, PNC13
Symptoms: Culture throat negative, Erythema multiforme, Pyrexia, Rash, Streptococcus test negative
Clinical narrative: Developed rash and fever, negative strep test on 7/28/15, fever better but rash worsened on 7/29/15.  Rash consistent with erythema multiforme.
Age: 69.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given Pneumovax23 concurrently with Prevnar13.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Pain, Peripheral swelling, Urticaria
Clinical narrative: Broke out in hives for 3 days straight. Arm bruised and raised. Hurt to move arm above head.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, pain, hot to touch and redness at injection site on the right deltoid. Treated with oral Keflex for 7 days and Hydrocortisone 1% topically. Seen again on 7/25/2015 for a follow up in clinic.  No change in treatment.
Age: 1.74
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Muscular weakness, Pyrexia
Clinical narrative: Extreme high fever, severe joint pain several days (7 days later). Followed by muscle weakness. Called Dr. and they said it was OK. Possible arthritis diagnosed but not confirmed. Muscle weakness for few mnts.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Malaise, Pyrexia, Seizure
Clinical narrative: Patient developed fever and began seizing. Diagnosed with otitis media at this time. Has continued to have febrile seizures and had none before given these immunizations.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Angry, Red, swollen area around the injection site. Approx size of an orange and sticking out about one inch. Nausea, fever reported on 07/23/15. Saw primary care physician on 07/24/15. Given rx's for zpak and cetirizine.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Redness, rash, itching, swelling at injection site. Area is 6" around injection site. Left upper arm. Better after 3rd day after applying cortisone cream. Lasted for 2 weeks.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: C-reactive protein increased, CSF glucose normal, Cellulitis, Chills, Headache
Clinical narrative: Pain at injection site, chills and fever tmax 103.8 next day, headache. Went to ER on 7/29/2015 at 4:00 PM. Dx with cellulitis and admitted. Still in hospital.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Pain at injection site, chills and fever tmax 103.8 next day, headache. Went to ER on 7/29/2015 at 4:00 PM. Dx with cellulitis and admitted. Still in hospital.
Age: 36.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Arthralgia, Dizziness, Erythema, Feeling jittery, Limb discomfort
Clinical narrative: Client describes having right arm pain, swelling, redness, and warmth beginning 7/29/2015. She states she became nauseous, dizzy, and jittery feeling. States she also noted swollen lymph nodes in her groin. Also describes generalized joint pain, worst in her hips and lower back. Client states this lasted throughout the day, almost 24 hours. Client denies fever during this time. She took OTC Aleve once on 7/29/2015. Today, client states all symptoms have resolved, except for her arm still has some swelling and discomfort.
Age: 36.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Lymphadenopathy, Nausea, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Client describes having right arm pain, swelling, redness, and warmth beginning 7/29/2015. She states she became nauseous, dizzy, and jittery feeling. States she also noted swollen lymph nodes in her groin. Also describes generalized joint pain, worst in her hips and lower back. Client states this lasted throughout the day, almost 24 hours. Client denies fever during this time. She took OTC Aleve once on 7/29/2015. Today, client states all symptoms have resolved, except for her arm still has some swelling and discomfort.
Age: 1.53
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to injection site.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Cellulitis, Chills, Erythema, Impaired work ability
Clinical narrative: Joint pain swollen on site where shot was given chills.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Local reaction, Pain, Vaccination complication
Clinical narrative: Joint pain swollen on site where shot was given chills.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Neck pain
Clinical narrative: Patient complains of soreness at injection site and neck.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Large baseball size welt at injection site. Patient stated it was hot to touch, did not hurt or itch.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Depressed level of consciousness, Loss of consciousness, Muscle rigidity, Screaming
Clinical narrative: Inconsolable screaming and crying, rigid body, screaming worse if moved, weird pitch and tone of crying. Screamed for several hours straight, passed out then resumed screaming until 10 pm. Screamed from 730pm until 12 am next day, then fell into deep sleep, unarousable until 4 pm next day, total if 16 hrs. Continues with screaming fits and sleepiness.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Seizure, Somnolence
Clinical narrative: Inconsolable screaming and crying, rigid body, screaming worse if moved, weird pitch and tone of crying. Screamed for several hours straight, passed out then resumed screaming until 10 pm. Screamed from 730pm until 12 am next day, then fell into deep sleep, unarousable until 4 pm next day, total if 16 hrs. Continues with screaming fits and sleepiness.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Emotional distress
Clinical narrative: Excessive crying and difficult to console since receiving immunizations.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Skin abrasion, Syncope
Clinical narrative: At 4:03 p.m. Fainted in hallway and causing an abrasion beside his left eye. Wet paper towels applied to face. Patient's legs elevated. Cold pack to abrasion beside left eye. BP was 114/70.
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood glucose normal, Defaecation urgency, Dizziness, Haemoglobin normal, Nausea
Clinical narrative: Syncopal episode following vaccination -was seated and states she felt tingly, dizzy and vision changes and then had brief LOC witnessed by mother and MA staff. She then immediately needed to use the bathroom to have bowel movement and felt nauseous and was pale. She was then seen by the provider in the bathroom appeared pale and advised to take deep breaths, she then went to exam room and layed down and improved. BS and hgb were tested and normal. She noted she only had caffeine/coffee in AM. Episode c/w vasovagal syncope, verbal educ provided, drink fluids and f/u prn. Pt was baseline at time of d/c.
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Pallor, Paraesthesia, Syncope, Visual impairment
Clinical narrative: Syncopal episode following vaccination -was seated and states she felt tingly, dizzy and vision changes and then had brief LOC witnessed by mother and MA staff. She then immediately needed to use the bathroom to have bowel movement and felt nauseous and was pale. She was then seen by the provider in the bathroom appeared pale and advised to take deep breaths, she then went to exam room and layed down and improved. BS and hgb were tested and normal. She noted she only had caffeine/coffee in AM. Episode c/w vasovagal syncope, verbal educ provided, drink fluids and f/u prn. Pt was baseline at time of d/c.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Left arm pain.  More pain with moving arm overhead or getting dressed/undressed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Red, hot, raised and itchy.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Injection site swell up to entire upper arm.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Aphasia, Arthralgia, Back pain, Dizziness, Gait disturbance
Clinical narrative: Continuous cramp in deltoid muscle was initial symptom.  Neck spasms and headache followed later in the day/evening on 7/29/2015.  Hip pain and low back pain by evening and night of 7/29/2015.  All symptoms were on the left side; side of injection.  By 9:00PM on 7/30/2015 cramp involving left thigh lasting 10-15 minutes and making it very difficult to walk.  Headache, neck, low back, and deltoid pain continues to present 7/30/2015 11:10pm. Difficulty finding appropriate wording slight dizziness- 7/30/2015 200mg Advil taken at 11:11 PM 7/30/2015.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Headache, Muscle spasms, Neck pain, Pain in extremity
Clinical narrative: Continuous cramp in deltoid muscle was initial symptom.  Neck spasms and headache followed later in the day/evening on 7/29/2015.  Hip pain and low back pain by evening and night of 7/29/2015.  All symptoms were on the left side; side of injection.  By 9:00PM on 7/30/2015 cramp involving left thigh lasting 10-15 minutes and making it very difficult to walk.  Headache, neck, low back, and deltoid pain continues to present 7/30/2015 11:10pm. Difficulty finding appropriate wording slight dizziness- 7/30/2015 200mg Advil taken at 11:11 PM 7/30/2015.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Seizure like phenomena
Clinical narrative: Information had been received on 29-JUL-2015 from a female consumer via social media who reported that her 12 year old son was given the GARDASIL vaccine yesterday and had a seizure-like adverse reaction to it. The consumer reported, "We were told this is normal and happens 3-4 times a day by the administering nurse. I don't consider seizures to be customary or normal during vaccine administration. I assure you that if there are any negative, short or long-term impacts on my son's life, I will do everything within my means to ensure that this vaccine is removed from the market and that your company faces criminal charges." The outcome of the seizure-like adverse reaction was not reported. Upon internal review, seizure-like adverse reaction was determined to be medically significant. Additional information is not expected.
Age: 1.02
Sex: F
Vaccine: DTAP
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash generalised
Clinical narrative: Very high fever (103 degrees F) (approx. 48 hours) mild hive like rash all over the body (3 days) loss of appetite; grumpy.
Age: 13.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Lip swelling, Malaise, Pyrexia
Clinical narrative: Received Hep A and Varicella, within 1 hr reported low grade fever then upper lip swelling and didn't feel well.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: C/O dizziness, nausea, vomiting a few hours after vaccine.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose normal, Postictal state, Seizure, Urine analysis normal
Clinical narrative: Seizure activity 6 hrs after Tdap-full motor involvement. Was seen at ER. Post-ictal for remainder of day. Pending appointment with neurologist for further evaluation.
Age: 75.0
Sex: F
Vaccine: PNC13, TDAP, PNC13, TDAP
Symptoms: Dysgeusia, Injection site rash, Nausea
Clinical narrative: Nausea and metallic taste 7/23/15. Rash from injection site toward elbow 7/27/15.
Age: 75.0
Sex: F
Vaccine: PNC13, TDAP, PNC13, TDAP
Symptoms: Injection site erythema, Nausea
Clinical narrative: Nausea and metallic taste 7/23/15. Rash from injection site toward elbow 7/27/15.
Age: 75.0
Sex: U
Vaccine: PNC13, TDAP, PNC13, TDAP
Symptoms: Dysgeusia, Injection site rash, Nausea
Clinical narrative: Presented to ED within 24hours with nausea then following returned to clinic with redness from injection site (L) arm toward elbow.
Age: 75.0
Sex: U
Vaccine: PNC13, TDAP, PNC13, TDAP
Symptoms: Injection site erythema, Nausea
Clinical narrative: Presented to ED within 24hours with nausea then following returned to clinic with redness from injection site (L) arm toward elbow.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: ZOSTAVAX given at pharmacy. Pt woke up this morning and states the injection site is itchy. It is red and 50 cm x 55 cm when measuring the red and edematous area. Advised to apply ice.
Age: 2.0
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site approximately 1.5 x 2 inches. No pain or fever noted. MD prescribed 3mL Diphenhydramine HCL.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Painful, red, warm swelling to injection site. Tx: Cephalexin 500mg.
Age: 1.86
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13
Symptoms: Decreased appetite, Flat affect, Pyrexia, Tremor
Clinical narrative: Hands quivering, quiet affect, fever, decreased appetite.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Feeling hot, Helicobacter test negative, Pruritus, Swelling, Tenderness
Clinical narrative: Received vaccines left arm 7/27/15, over next two days developed itching, swelling, tenderness and warmth.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: "Tennis ball" size area of swelling, erythema and warmth at site of injection (left arm). Advised ice and TYLENOL.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Hives developed within 8 hours of administration. He was treated with BENADRYL.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site warmth, Myalgia, Nausea
Clinical narrative: 2" x 2" hot, red to touch localized area of injection since 7/29/15 AM. Pt feels nausea and frontal headaches and feels "sick to her stomach". Muscle aches.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Medication error
Clinical narrative: #1 ROTATEQ given at 17 weeks.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Anxiety, Dizziness, Malaise
Clinical narrative: Client anxious regarding being vaccinated. Waited in lobby 15" post vaccination then departed with grandma for home. At 1600 hrs grandma returned to the health dept to report that pt c/o's dizziness & didn't feel well. Advised to have him lie down with legs elevated cool cloth to back of neck. Call if more questions arise.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Pain in extremity, Paraesthesia
Clinical narrative: Complains of left arm pain and tingling following influenza vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 7/29 2 days after immunizations 10x10 cm erythema (R) thigh at site of KINRIX immunization. Hot and locally tender. No fever, no joint pain. Cool compresses and TYLENOL recommended. Called pt 7/30 AM and resolving/much better. Small 2.5 x 2.5 cm erythema (L) arm at site of Varicella. Hot/tender locally.
Age: 54.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Activities of daily living impaired, Arthralgia, Joint swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: A few days after vaccines, both wrists began to swell, ache and generate heat. About 7/18, some fingers (L) and (R) began to swell, stiffen and ache. Started taking 2 ALEVE in AM, 2 in PM. 7/23 stopped pilates started wearing wrist guards to limit movement. One finger turned purple and very swollen. Rt. wrist swelled to mid-forearm. Alternated heat and cool treatments-by 7/29 purple gone, swelling is subsiding. Worse morning and evening.
Age: 54.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Peripheral swelling, Skin discolouration, Skin warm
Clinical narrative: A few days after vaccines, both wrists began to swell, ache and generate heat. About 7/18, some fingers (L) and (R) began to swell, stiffen and ache. Started taking 2 ALEVE in AM, 2 in PM. 7/23 stopped pilates started wearing wrist guards to limit movement. One finger turned purple and very swollen. Rt. wrist swelled to mid-forearm. Alternated heat and cool treatments-by 7/29 purple gone, swelling is subsiding. Worse morning and evening.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt was given a ZOSTAVAX on 7/28/15 and on 7/29/15 a warm, red, raised area was noted on posterior left arm at vaccine site. Measuring 50 x 35 mm.
Age: 1.04
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Blood test normal, Febrile convulsion, Injection site erythema, Injection site swelling, Irritability
Clinical narrative: 7/13/15-< 15 min from MMRV injection (R) thigh with 3-4 cm erythematous slightly raised patch; fussy, no other s/s. Resolved in 2 hours. 7/22/15-On flight, child had febrile seizure lasting 10 min. Taken to ER. X-ray and blood work negative.
Age: 1.04
Sex: F
Vaccine: HEPA, MMRV
Symptoms: X-ray normal
Clinical narrative: 7/13/15-< 15 min from MMRV injection (R) thigh with 3-4 cm erythematous slightly raised patch; fussy, no other s/s. Resolved in 2 hours. 7/22/15-On flight, child had febrile seizure lasting 10 min. Taken to ER. X-ray and blood work negative.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Large red raised rash 11 x 12 cm distal to injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Approx 9:15A noted redness at site on (L) outer thigh area. Redness approx size of tennis ball and one small dime size slightly raised areas Dr notified and looked at site. Per him advised to give BENADRYL one tsp 4 time a day and monitor for fever or any worsening at site. Contact office or emergency room. V 7-30-15 mom voiced reaction gone.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives beginning on arms and spread to trunk and then from head to foot. Lasted approx. 48 hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Erythema at the site (large diameter-6cm) of PROQUAD injection
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of unspecified patients of unkonwn age and gender. In July 2015 (also reported as unspecified dates since 01-JUL-2015) the patients were administered an unspecified number of improperly stored doses of VAQTA (route, lot#, strength and dose were unknown). No adverse effect was reported. This is one of several reports receive from the same reporter. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Erythema, induration, swelling on the site of administration three inches in diameter, tender to touch. Developed nine days after vaccine administration.
Age: 22.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Anxiety, Chest discomfort, Chest pain, Diarrhoea, Dyspnoea
Clinical narrative: Developed the following conditions in Feb 2010. They began after he had his initial anthrax immunization and continued while received 2 more. He feels illnesses are caused by the anthrax immunization. Daily headaches that can occur one to several times a day. Vertigo with nausea that can occur one to several times a day. Anxiety attacks that cause knife-like pain in anterior, right and left chest pain (sharp with pressure), accompanied by SOB that occur 1 to several times daily. IBS with diarrhea. Fibromyalgia. Thrombocytopenia.
Age: 22.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Fibromyalgia, Headache, Irritable bowel syndrome, Nausea, Thrombocytopenia
Clinical narrative: Developed the following conditions in Feb 2010. They began after he had his initial anthrax immunization and continued while received 2 more. He feels illnesses are caused by the anthrax immunization. Daily headaches that can occur one to several times a day. Vertigo with nausea that can occur one to several times a day. Anxiety attacks that cause knife-like pain in anterior, right and left chest pain (sharp with pressure), accompanied by SOB that occur 1 to several times daily. IBS with diarrhea. Fibromyalgia. Thrombocytopenia.
Age: 22.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Vertigo
Clinical narrative: Developed the following conditions in Feb 2010. They began after he had his initial anthrax immunization and continued while received 2 more. He feels illnesses are caused by the anthrax immunization. Daily headaches that can occur one to several times a day. Vertigo with nausea that can occur one to several times a day. Anxiety attacks that cause knife-like pain in anterior, right and left chest pain (sharp with pressure), accompanied by SOB that occur 1 to several times daily. IBS with diarrhea. Fibromyalgia. Thrombocytopenia.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Concurrent condition and medical history were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of MMR II (albumin status: rHA) (lot # K003806, expiration date 13-MAR-2016; Lot # K024036, expiration date 26-NOV-2015; Lot # K018990, expiration date 15-NOV-2015) (Strength, route and dose were not reported). Concomitant medications were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 17 year old female patient. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose and route were not provided) by error. The patient had not experienced any adverse effects. It was also stated that the patient received a complete series of GARDASIL on 31-OCT-2006 with lot # reported as "0688F"; second dose on 17-JAN-2007 with lot # reported as "0961F" and the third dose on 20-SEP-2007 with unspecified lot #. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from two medical assistants referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of GARDASIL, (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Concurrent condition and medical history were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of PROQUAD (Lot # K011967, expiration date 21-FEB-2016; Lot# K020756, expiration date 30-APR-2016) (Strength, route and dose were not reported). Concomitant medications were not reported. No adverse reactions were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from two medical assistants refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, lot # and route unspecified). Information regarding concomitant medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 15-JUL-2015 the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # K021487, expiration date 03-NOV-2016) (Strength, dose and route were not reported). No adverse reactions were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from two medical assistants referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of VAQTA (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored oral, ROTATEQ (dose, lot # unspecified). Information regarding concomitant medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from two medical assistants referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (dose, lot # and route unspecified). Information regarding concomitant medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from two medial assistants referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of oral, ROTATEQ (dose, dose number, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 21-JUL-2015, the patient was vaccinated with improperly stored doses of MMR II (lot # K003806, expiration date) (Strength, route and dose were not reported); and (Oka/Merck) VARIVAX (Lot # K021487, expiration date 03-NOV-2016) (Strength, dose and route were not reported). No adverse reactions were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown ages and genders. There were no pertinent medical history or drug allergies/drug reactions reported. The nurse stated that on an unspecified dates, the patients could have received improperly stored GARDASIL injection, Lot# K008931 expiration date 19-FEB-2017 (dose and route not provided). There was no concomitant medication described. No adverse effects were reported. This is one of two reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assist concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, unspecified patients were vaccinated with improperly stored doss of (Oka/Merck) VARIVAX (dose, route, Lot No. and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions. The nurse stated that on an unspecified dates, the patients could have received improperly stored ROTATEQ oral liquid, lot# K017575 expiration date 22-MAY-2016 (dose not provided). There was no concomitant medication described. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. Concurrent conditions and medical history were not reported. The nurse reported that on an unknown date, the patients were vaccinated with a improperly stored dose of (Oka/Merck) VARIVAX (lot#L004655, exp. date 11-FEB-2017; Lot # K016132 exp. 24-SEP-2016 and Lot # K003422 exp. date 06-MAR-2015) (Strength, route and dose were not provided). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a researcher, and refers to an unspecified patient of unknown age and gender. Concurrent condition and medical history were not reported. on 04-MAR-2015, the patient received an improperly stored dose of ZOSTAVAX subcutaneously, lot # K007548; Exp date 23-AUG-2015 (strength, dose #, dose and anatomical location were not provide). There was not concomitant medication reported. No adverse experiences were reported. There was not a product quality complaint involved. At the time  of the report, the outcome of incorrect product storage was unknown. This is one of several reports received from the same reporter (1507USA005687 and 1507USA005587). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been receive from a Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (dose, lot # and route unspecified). Information regarding concomitant medications was not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician via a field employee referring to a female patient of unknown age. The patient's pertinent medical history and drug reactions were not reported. On unknown dates, the patient was vaccinated with an unspecified number of doses of GARDASIL (dose, route and lot# were not reported). On an unknown date, the patient was experiencing chronic headaches. On an unknown date, magnetic resonance imaging (MRI) was performed (no result was reported). The outcome of the event was reported as not recovered at the time of reporting. The causality was not reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. In July 2015 (also reported as unspecified dates since 01-JUL-2015) the patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB (route, lot#, strength and dose were unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. Patient's medical history, concurrent conditions and concomitant therapy were not reported. On an unknown date, unspecified number of patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot#L008271, Expiry date: 11-MAR-2017 and lot#L005301, Expiry date: 17-Feb-2017) (dose and route were not reported). No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 23-JUL-2015, the patient was vaccinated with one dose of improperly stored GARDASIL 9, intramuscularly, lot/batch # reported as L004741 (lot# not valid for GARDASIL 9, expiration date: 04-MAR-2017 (strength and dose were not reported). The patient was under the care of a physician during the vaccination. No adverse experiences were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
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. No concurrent or medical history was reported. On unspecified dates the patients were administrated unspecified number of improperly stored doses of MMR II (lot number J006137, expiration date 24-MAY-2015 and lot number K008814, expiration date 19-JUN-2016) (strength, route and dose were unknown). No adverse event was reported. Follow up information has been received from the registered nurse on 27-JUL-2015 concerning a patient of unknown age and gender. On 05-MAR-2015, the patient was vaccinated with improperly stored doses of MMR II (lot# reported as J006137, expiration date: 24-MAY-2015, strength, route and dose were unknown). This is one of several reports received from the same reporter. Additional information has been requested. Patient's information, products and narrative were updated.
Sex: U
Vaccine: MMR
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. No concurrent or medical history was reported. On unspecified dates the patients were administered unspecified number of improperly stored doses of M-M-R II (lot number J006137, expiration date 24-MAY-2015 and lot number K008814, expiration date 19-JUN-2016) (strength, rout and dose were unknown). No adverse event was reported. Follow up information has been received from the registered nurse on 27-JUL-2015 concerning a patient of unknown age and gender. On 06-MAR-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot# reported as J006137, expiration date: 24-MAY-2015, strength, rout and dose were unknown). This is one of several reports received from the same reporter. Additional information has been requested. Patient's information products and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored VARIVAX injection, lot# L005299, exp. date: 17-FEB-2017 and lot# L041326, exp. date: 13-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 27-APR-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose, frequency were not reported) after being stored improperly. No adverse effects were noted. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
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. No concurrent or medical history was reported. On unspecified dates the patients were administrated unspecified number of improperly stored doses of MMR II (lot number J006137, expiration date 24-MAY-2015 and lot number K008814, expiration date 19-JUN-2016) (strength, route and dose were unknown). No adverse event was reported. Follow up information has been received from the registered nurse on 27-JUL-2015 concerning a patient of unknown age and gender. On 21-APR-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot# reported as J006137, expiration date: 24-MAY-2015, strength, route and dose were unknown). This is one of several reports received from the same reporter. Additional information has been requested. Patient's information, products and narrative were updated.