chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Patient's medical history and concurrent condition was not reported. On 10-FEB-2015 the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD 0.5 ml, subcutaneously (lot # K008579, expiry date: 13-DEC-2015). No adverse experienced has been reported. No product quality complaint (PQC) involved. 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: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Patient's medical history and concurrent condition was not reported. On 11-FEB-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) 0.5 ml, subcutaneously (lot # not reported as K005429, expiry date: 15-APR-2016). No adverse effects reported. No product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with doses of improperly stored PROQUAD (route, strength, dose and frequency were unknown). No adverse effect 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 healthcare worker referring to a patient of unknown age and gender. Patient's medical history and concurrent condition was not reported. On 23-FEB-2015 the patient was vaccinated with a dose of improperly stored PROQUAD 0.5 ml, subcutaneously (lot # K008579, expiry date: 13-DEC-2015). No adverse effects reported. No product quality complaint (PQC) involved. This is one of several reports received form the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from an office manager refers to a 23 year old female patient. On 20-FEB-2015 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot# not reported). 06-MAR-2015 the patient was vaccinated with the second dose of GARDASIL (lot # K008931, dose and route not reported) which was only 2 weeks after she received her first dose. No adverse effects reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 65 year old patient. Patient's medical history and concurrent conditions was not reported. On 06-MAR-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J014851, expiry date: 24-OCT-2014) (dose, route unspecified). No adverse experience has been reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Patient's medical history and concurrent condition was not reported. On 13-FEB-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) 0.5 ml, subcutaneously (lot # K008579, expiry date: 13-DEC-2015). No adverse effects reported. No product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Patient's medical history and concurrent condition was not reported. On 24-FEB-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) 0.5 ml, subcutaneously (lot # K008579, expiry date: 13-DEC-2015). No adverse effects reported. No product quality complaint (PQC) involved. This is one of several reports received  from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions was not reported. On 19-FEB-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) 0.5 ml, subcutaneously (lot # K008579, expiry date: 13-DEC-2015). No adverse effects reported. No product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Patient's medical history and concurrent condition was not reported. On 24-FEB-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) 0.5 ml, subcutaneously (lot # K008579, expiry date: 13-DEC-2015). No adverse effects reported. No product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Patient's medica history and concurrent condition was not reported. On 17-FEB-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (0.5 ml, subcutaneously (lot # K008579, expiry date: 13-DEC-2015). No adverse effects reported. No product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a female patient of unknown age. Concurrent conditions, medical history and allergies of the patient were not reported. The patient received her first dose of GARDASIL (lot #, expiry date, dose, route unspecified) five years ago (in 2010) on an unspecified date. On 11-MAR-2015 the patient was in the physician's office asking to receive her second dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Patient's medical history and concurrent condition was not reported. On 10-FEB-2015 the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD 0.5 ml, subcutaneously (lot # K008579, expiry date: 13-DEC-2015). No adverse effects reported. No product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Full blood count normal, Hyperhidrosis, Pyrexia, Rash morbilliform
Clinical narrative: Morbilliform rash on face, trunck and extremitites, fever to 101 degrees F, sweats.
Age: 35.0
Sex: M
Vaccine: ANTH, HEP, IPV, MMR, TYP, VARCEL
Symptoms: Feeling hot, Flushing, Malaise, Pain, Piloerection
Clinical narrative: Malaise. Facial flushing/bosy flushing. Body aches. Feeling hot. Has goosebumps.
Age: 61.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Hypoaesthesia, Pain in extremity, Rash
Clinical narrative: This 61yo presents to ER with c/o rash/redness and pain in (L) arm. Pt states he received tetanus and shingles vaccinations both in (L) arm on Monday and noticed symptoms on Tuesday. Pt denies difficulty breathing/swallowing denies rash to any other part of his body. Has had some numbness on ulnar aspect forearm with pain. Diphenhydramine 25 mg prn.
Age: 0.38
Sex: F
Vaccine: DTAP, RV5
Symptoms: Crying, Fatigue, Middle insomnia, Peripheral coldness
Clinical narrative: Background: I have b/g twins, born at 36w5d. We declined all vaccines and injections at the hospital, asked our pediatrician about a delayed and selective schedule and she seemed on board initially.  At their 3-mo. check we were pressured into getting some of the vaccines "they were most at risk of" and agreed to the DTaP and Rotavirus.  At their 4-mo. check I pressured again to get them "caught up" on their vaccines, and I declined.  The doctor suggested the second dose of the vaccines they had received, and I was still hesitant. She persisted, stating there had been no adverse reactions, and these were two that we were likely to come into contact with.  So against my intuition I agreed. They slept most of the afternoon, I checked on them regularly, and they seemed fine, just tired.  That evening everything was normal until bedtime.  Starting at 10:00 p.m. they would sleep for an hour and be awake crying for an hour.  At 3:00 a.m. we gave them each a dose of Tylenol (which I now know better), and we swaddled both of them in fleece swaddle sacks before they would calm down (my daughter normally HATED being wrapped).  At this point we had them in bed with us so we could all get some sleep. An hour later my son is awake again, screaming and crying, so go ahead and nurse him, and my partner woke also and was sitting up in bed with me, and he looks over to see our daughter sleeping in the center of the bed.  He reached over and brushed her cheek with his finger, and she doesn't move.  Normally a pretty light sleeper she would react in some way to being touched, but this time nothing happened.  So I reach my hand over and lay it on the side of her face, and she is cold!  I grabbed her, ripping the swaddle off of her, and yelling for her to "PLEASE WAKE UP!" After about 2 minutes of trying to wake her, she opened her eyes and made a slight fuss!  I woke her enough to nurse, and everything was pretty "normal" for the rest of the morning, but it was a scary night!
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Notices itchy, red rash on left forearm.
Age: 35.0
Sex: F
Vaccine: MMR, TD
Symptoms: Pruritus, Rash
Clinical narrative: Pt states that she was itching and showed some type of rash on both arms and anterior thighs, and some in the flank area.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Dehydration, Diarrhoea, Insomnia, Rhinorrhoea
Clinical narrative: Pt developed Rotavirus after full series of Rotavirus vaccines. Yellow diarrhea, vomiting, dehydration, decreased appetite, not sleeping, runny nose.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rotavirus infection, Rotavirus test positive, Stool analysis abnormal, Vomiting
Clinical narrative: Pt developed Rotavirus after full series of Rotavirus vaccines. Yellow diarrhea, vomiting, dehydration, decreased appetite, not sleeping, runny nose.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Had a fever of 100.0-102 since getting Hep A vaccine. Has been alternating Tylenol and Ibuprofen Q4hrs.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Client developed hives.
Age: 79.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Chills, Laboratory test, Pain
Clinical narrative: Patient's wife called with concerns that patient was complaining of chills and his entire body hurting.
Age: 79.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: Patient's wife called with concerns that patient was complaining of chills and his entire body hurting.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Burning sensation, Erythema, Flushing, Pain
Clinical narrative: EE stated received annual flu vaccine and about 1 hr later her face began to sting/burn and was flushed. Took Benadryl 25 mg at that time.  The next day, had eval itching was reported 1 hr after the flu vaccine across cheeks and chin no forehead involvement. No throat swelling or tongue enlg. Denies any other systemic symptoms.  Impression from ARNP Angioedema-likely from influenza injection, dut to timing onset. Continue Benadryl 25mg po qhs add Claritin 10mg 1 po q am until erythema resolved.  EE was also instructed to follow up with her PCP, since she has been told in the past she needed allergy testing. Strongly recommended she accomplish this prior to next years flu season.  EE denies allergies with history and physical.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: EE stated received annual flu vaccine and about 1 hr later her face began to sting/burn and was flushed. Took Benadryl 25 mg at that time.  The next day, had eval itching was reported 1 hr after the flu vaccine across cheeks and chin no forehead involvement. No throat swelling or tongue enlg. Denies any other systemic symptoms.  Impression from ARNP Angioedema-likely from influenza injection, dut to timing onset. Continue Benadryl 25mg po qhs add Claritin 10mg 1 po q am until erythema resolved.  EE was also instructed to follow up with her PCP, since she has been told in the past she needed allergy testing. Strongly recommended she accomplish this prior to next years flu season.  EE denies allergies with history and physical.
Sex: U
Vaccine: FLU3, HEPA
Symptoms: No adverse event, Product packaging confusion
Clinical narrative: This spontaneous report was received from a nurse and it concerns a potential product confusion. The reporter stated that she heard of many healthcare providers almost mistaking VAQTA pre-filled syringes with FLUZONE for patients 3 years of age and older as the products look very similar. The reporter was not aware of any instances in which product was administered to a patient as a result of this confusion. No adverse effects were reported. This is one of the two reports received from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus generalised
Clinical narrative: EE complained of generalized itching approximately 24 hours after the flu vaccine. She took Benadryl 25mg at bedtime that evening with some relief however took 50mg of Benadryl on next consecutive bedtimes with improved relief.  EE sought treatment on 10/7 she stated she had itching. No rash or excoriations on the skin and denies any change inpersonal, laundry, or environmental products and denies any changes in medications.  EE was instructed to continue Benadryl 25 mg po nightly and add Claritin 10 mg 1 po daily in the am.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: NO rash but itching at site of injection.
Age: 88.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Client came into DOH 3/11/15 and rec'd 2 vaccines TDAP and pneumonia. Client stated next day 3/12/15 (R) arm was sore red and warm to touch. Client went to clinic today 3/13/15 and they told her to come back to DOH. Client stated that redness and warmth in (R) arm was spreading. Client rec'd both injections (R) deltoid. Redness and warmth starts from (R) shoulder area and goes down to just above elbow. Attempted to call clients MD but got answering service. Instructed client to go to ER for evaluation. Vital signs: Temp 101 degrees, pulse 84, Resp 16, B/P 132/79, Wgt-128. Client stated she would go to ER for evaluation. 3/16/15 Called client this am to f/u from Friday 3/13/15. Client stated she went to ER and they instructed her to take TYLENOL and put ice pack on (R) arm for 20 minutes at a time. Client stated she did this all day Saturday. Client stated that her arm is better today except for a little red mark.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Crying, Febrile convulsion, Generalised tonic-clonic seizure, Poor quality sleep, Pyrexia
Clinical narrative: Febrile seizure.  Mom noticed child acting fussy while asleep.  Checked forehead and felt warm.  Woke up startled and then had a generalized tonic clonic seizure x 1 minute.  Called 911 and went to ER - had fever documented in the ER.  Acted appropriately after stopped crying.  Sent home without work-up.  H/o febrile seizures in family including brother and father's side.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Skin warm
Clinical narrative: Febrile seizure.  Mom noticed child acting fussy while asleep.  Checked forehead and felt warm.  Woke up startled and then had a generalized tonic clonic seizure x 1 minute.  Called 911 and went to ER - had fever documented in the ER.  Acted appropriately after stopped crying.  Sent home without work-up.  H/o febrile seizures in family including brother and father's side.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Musculoskeletal pain, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: He received a flu shot during his appointment on 9/19/14.  He was sent by his primary MD to see us (after having x-rays and a MRI) because of continued pain in the shoulder since his injection. The patient was seen by Dr. and was given a cortisone injection for shoulder bursitis.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling within 6 hrs of admin.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Dysgeusia, Immediate post-injection reaction, Musculoskeletal discomfort
Clinical narrative: Immediately after injection tasted "metallic taste tip of tongue", felt weak and throat tense. Breathing OK and dizzy weakness went away so I walked about store with 5 min. I was a runner but after injection experienced weakness, lack strength and muscle aches and increased joint discomfort. It continues as of March 2015 and is getting worse. Symptoms have diminished some now, but continue to recover.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Throat tightness
Clinical narrative: Immediately after injection tasted "metallic taste tip of tongue", felt weak and throat tense. Breathing OK and dizzy weakness went away so I walked about store with 5 min. I was a runner but after injection experienced weakness, lack strength and muscle aches and increased joint discomfort. It continues as of March 2015 and is getting worse. Symptoms have diminished some now, but continue to recover.
Age: 0.92
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash papular, Rash vesicular, Skin lesion
Clinical narrative: Papular rash, resembling chicken pox appeared on head and back on 3/5/15. 10-15 total lesions seen.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Gait disturbance, Musculoskeletal pain, Pain in extremity
Clinical narrative: Next day while running legs extrmely tired 2nd day legs painful progressed 2wks severe leg pain. Barely able to walk. Pain spread to arms and shoulders over period since receiving injection of vaccine. Consulted physician when pain progressed in February 2015 and now referred to Neurologist for evaluation.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Headache, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema and swelling around injection site starting about 24 h after injection. Has also had HA, fever and sweaty. (L) deltoid/upper arm with 8x10cm red elevated wheal, mildly tender.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site urticaria, Pyrexia
Clinical narrative: Erythema and swelling around injection site starting about 24 h after injection. Has also had HA, fever and sweaty. (L) deltoid/upper arm with 8x10cm red elevated wheal, mildly tender.
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous reprot as received from a pharmacist refers to a female patient of unknown age. The patient was not a pregnant. The patient pertinent medical history and drug allergies were unspecified. On an unknown date in 2014 (reported as approximately one year ago) the patient was vaccinated with PNEUMOVAX23 (dose, frequency and route were unspecified). Concomitant medications were unspecified. On an unspecified date the patient experienced anaphylaxis with unspecified symptoms. The outcome of anaphylaxis was unknown. The causality of anaphylaxis was not reported. No product quality complaint (PQC) was reported for PNEUMOVAX23. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, pain.
Sex: U
Vaccine: RV5
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. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ oral, Lot # K004795 expiration date 11-FEB-2016 and Lot # reported as J012670, expiration date 15-APR-2015 (dose and route were not reported). No adverse effects reported. No product quality complaint (PQC) was reported. This is one of several report received from the same source. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Migraine, Nausea, Pyrexia
Clinical narrative: Low grade fever, nausea and migraine. Fever and migraine lasted one day. Nausea lasted for two days.
Age: 16.0
Sex: M
Vaccine: HPV4, IPV
Symptoms: Rash
Clinical narrative: Rash to arms and trunk.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Right shoulder pain that progressed.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Ear discomfort, Pain in jaw
Clinical narrative: Left jaw pain and left ear fullness developed.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Electromyogram, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging spinal
Clinical narrative: Numbness in the feet, then progressed to the legs, hands, arms, face and lips.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Injection site haemorrhage, Injection site nodule, Musculoskeletal stiffness, Pain
Clinical narrative: Pt states felt sore on date of vaccination (3/12/15), but became worse the next day, running a fever of 102, experiencing stiffness in her neck, developed a knot at injection site which bled after a shower, began experiencing generalized itching, blurred vision, and dizziness; denies any difficulty breathing or swallowing at any time; visited ER on 3/15/15; was treated with Benadryl 25mg and Ibuprofen 800mg; told to continue taking Benadryl 25-50 mg q 6 hrs until S/Sx have been relieved x 24 hrs; pt states she is feeling much better today except for some continued itching on her right hand and the presence of the knot at the injection site.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus generalised, Pyrexia, Vision blurred
Clinical narrative: Pt states felt sore on date of vaccination (3/12/15), but became worse the next day, running a fever of 102, experiencing stiffness in her neck, developed a knot at injection site which bled after a shower, began experiencing generalized itching, blurred vision, and dizziness; denies any difficulty breathing or swallowing at any time; visited ER on 3/15/15; was treated with Benadryl 25mg and Ibuprofen 800mg; told to continue taking Benadryl 25-50 mg q 6 hrs until S/Sx have been relieved x 24 hrs; pt states she is feeling much better today except for some continued itching on her right hand and the presence of the knot at the injection site.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Febrile convulsion, Seizure
Clinical narrative: SEIZURE.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, tenderness, and pain around the site of the injection.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Dysphagia, Headache, Musculoskeletal stiffness
Clinical narrative: Within 10 minutes after vaccine, patient complained of difficulty swallowing, some neck muscle stiffness, and mild headache. Treated with Benadryl 25 mg PO given and Gatorade. Patient observed in urgent care for 1 hour.
Age: 1.26
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Moaning, Pain, Pyrexia, Retching
Clinical narrative: Pain immediately after the shot and continuing, with shaking, moaning, fever (101), and vomiting starting around 3:15 PM. I had given her Motrin around 12:30 pm for the pain, and dosed her again around 4:30 after she had vomited three times. She then retched and dry heaved without producing any vomit.
Age: 1.26
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Tremor, Vomiting
Clinical narrative: Pain immediately after the shot and continuing, with shaking, moaning, fever (101), and vomiting starting around 3:15 PM. I had given her Motrin around 12:30 pm for the pain, and dosed her again around 4:30 after she had vomited three times. She then retched and dry heaved without producing any vomit.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Dysstasia, Fall, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Patient had experienced progressing weakness and tingling in limbs and finally fell at home on 12/12/14 when she went to the emergency room and was admitted to the hospital. She was diagnosed with Guillain-Barre either during her stay or shortly after and has been receiving physical therapy, occupational therapy, has had IVIG infusions, and is currently using a wheelchair as she is unable to walk or stand on her own.  She is in an assisted living facility currently.  Disability level is unknown at this time.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Paraesthesia, Wheelchair user
Clinical narrative: Patient had experienced progressing weakness and tingling in limbs and finally fell at home on 12/12/14 when she went to the emergency room and was admitted to the hospital. She was diagnosed with Guillain-Barre either during her stay or shortly after and has been receiving physical therapy, occupational therapy, has had IVIG infusions, and is currently using a wheelchair as she is unable to walk or stand on her own.  She is in an assisted living facility currently.  Disability level is unknown at this time.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN
Symptoms: Abdominal pain upper, Fatigue, Full blood count normal, Lethargy, Mononucleosis heterophile test negative
Clinical narrative: Fever greater than 102 for two days then it has been low grade ever since. Very lethargic, fatigued, muscle weakness, stomach pain. She is still symptomatic and it has been 5 days.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: Fever greater than 102 for two days then it has been low grade ever since. Very lethargic, fatigued, muscle weakness, stomach pain. She is still symptomatic and it has been 5 days.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN
Symptoms: Abdominal pain upper, Fatigue, Lethargy, Muscular weakness, Pyrexia
Clinical narrative: Fever greater than 102 for two days then it has been low grade ever since. Very lethargic, fatigued, muscle weakness, stomach pain. She is still symptomatic and it has been 5 days.
Age: 2.0
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia, Rotavirus infection, Vomiting
Clinical narrative: Information has been received from a physician via a field representative referring to a 2 years old male patient. On an unknown date the patient was vaccinated with ROTATEQ (strength, dosage and lot# not reported) orally. On 18-FEB-2015 (reported as "about 2 weeks ago") the patient experienced fever, vomiting, diarrhea and was diagnosed with oral, ROTATEQ. The patient went to seek medical attention and unspecified tests were performed. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.52
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Local reaction, Vaccination complication
Clinical narrative: Localized redness, swelling and induration on the right arm.
Age: 82.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Angioedema, Blister, Lip swelling
Clinical narrative: Swollen lips and bullae to right upper extremity. No noted respiratory distress or rash. Angioedema. Prednisone 20 mg every day, diphenhydramine 50 mg QID, ranitidine 150 mg BID.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician via a field representative referring to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ (strength, dosage and lot# not reported) orally. On an unknown date the patient was diagnosed with ROTATEQ. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a licensed practical nurse refers to two unspecified patients of unknown age and gender who on unknown date were vaccinated with two improperly stored of (Oka/Merck) VARIVAX (dose, lot #, expiration date and route of administration were not reported). No adverse effects reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. Follow up information has been received on 05-MAR-2015 from a licensed practical nurse refers to a male patient of unknown age. On 26-JAN-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # K09758, expiration date 26-JAN-2016) that had experienced a temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a physician referring to a female patient of unknown age. On an unknown date the patient was vaccinated with three doses of GARDASIL (lot# and dose not reported). It was confirmed the product was GARDASIL and not GARDASIL9. In approximately October 2014 (reported as about four to five months ago) the patient came into the office and tests (details not specified) showed abnormal squamous cells after receiving all three GARDASIL vaccinations. No product quality complaint (PQC) was reported. The outcome of the event was unknown. 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 registered nurse concerning an unspecified number of patients of an unknown gender and age. Medical history and current conditions were not reported. On an unknown date, the unspecified patients were vaccinated with doses of ZOSTAVAX (dose, dose number and route were not reported), (lot # K003598, expiration date 13-MAR-2015), which were improperly stored. The nurse stated that since the time of administration of the vaccinations there had been no reports of adverse events and the office would be contacting the patients who received the vaccinations to return to the office for revaccination. The nurse did not provide specific patient identification information. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 1.36
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of walking difficulty in a 16-month-old male patient who received INFANRIX (batch number 5A425, expiry date 27th February 2017). Concomitant products included PEDVAXHIB and PREVNAR-13. On January 2015, the patient received the 4th dose of INFANRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On 23rd January 2015, 1 days after receiving INFANRIX, the patient experienced walking difficulty and fever. On 25th January 2015, the outcome of the walking difficulty was recovered/resolved. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the walking difficulty to be related to INFANRIX. The reporter considered the fever to be possibly related to INFANRIX.
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. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # reported as K004552, expiration date 19-AUG-2015 (dose and route were not reported). No adverse effects reported. No product quality complaint (PQC) was reported. This is one of several report received from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Blood test, Syncope
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a teenage male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route and lot # not reported). Concomitant therapies included MENACTRA. The physician's assistant reported that on an unknown date during his office visit, the patient fainted (syncope) after receiving GARDASIL, MENACTRA and underwent a blood draw. The outcome of syncope was unknown. The patient did not receive treatment for the adverse event. Additional information is not expected. There is no permission to contact the physician.
Age: 1.29
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Musculoskeletal stiffness, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of walking difficulty in a 15-month-old male patient who received INFANRIX (batch number 9D7CM, expiry date 27th February 2017). Concomitant products included PEDVAXHIB and PREVNAR-13. On 5th February 2015, the patient received the 4th dose of INFANRIX (intramuscular) .5ml. On 5th February 2015, the dose was .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On 6th February 2015, 1 days after receiving INFANRIX, the patient experienced walking difficulty, fever and limbs stiffness. On an unknown date, the outcome of the walking difficulty, fever and limbs stiffness were unknown. It was unknown if the reporter considered the walking difficulty and limbs stiffness to be related to INFANRIX. The reporter considered the fever to be possibly related to INFANRIX.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a female consumer of unknown demographics refers to herself. Patient medical history and current condition was not reported. Patient reported that she was pregnant and on an unknown date during a recent visit to her physician's office, she was vaccinated with GARDASIL (strength, dose and frequency not reported). Due date, pregnancy outcome date and Gestational age at pregnancy outcome were not reported. Other co-suspects and concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug administered to patient of inappropriate age, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a female consumer of unknown demographics refers to herself. Patient medical history and current condition was not reported. Patient reported that she was pregnant and on an unknown date during a recent visit to her physician's office, she was vaccinated with GARDASIL (strength, dose and frequency not reported). Due date, pregnancy outcome date and Gestational age at pregnancy outcome were not reported. Other co-suspects and concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients. On unspecified dates the patients were vaccinated with doses of ROTATEQ (dose, lot number and expiry date not reported) orally that had been improperly stored. No adverse effects reported. This one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist referring to a 28 year old female patient. The patient was not pregnant. Concomitant therapies and medical histories were not reported. On 06-FEB-2015 the patient was vaccinated with a dose of M-M-R II (lot # K005574, expiration date 17-APR-2016, 0.5 ml) subcutaneously. Concomitant therapies were not reported. In the morning of 23-FEB-2015, the patient broke out in a rash on both of her arms. No treatment was given for the adverse events. None lab diagnostics were performed. The patient sought medical attention by calling her pharmacist on 23-FEB-2015. The outcome of the event was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a 65 year old female patient, regarding herself. The patient's medical history and concurrent conditions were not reported. On 15-FEB-2015, the patient was vaccinated with ZOSTAVAX in the left arm (administration route, lot number and expiration date were not provided). Concomitant therapies included trazodone hydrochloride, acyclovir and tramadol hydrochloride (+) ketorolac tromethamine as needed. On 23-FEB-2015, the patient experienced a "break out on an unspecified area of her body" it was not specified what kind of breakout did the patient experienced. On 04-MAR-2015 the patient had a new "outbreak". The outcome of the events was unknown at the time of this report. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 90 year old female patient. There was no pertinent medical history provided. The patient was allergic to penicillin (unspecified), sulfa and gabapentin. Concomitant therapies included pravastatin, imipramine and omeprazole (manufacturer unknown). On 11-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (route subcutaneous, lot # K020185, expiration date 27-JAN-2016, dose not reported). In an approximately February 2015 (reported as since receipt of ZOSTAVAX), the patient has been recently written prescriptions for FLUTICASONE, the "Z-PAK" and methylprednisone. The reporter noted that the medications might be possibly treatment for a sinus infection. On an unknown date, the patient sought for medical attention. There was no lab diagnostics and studies reported. The patient's outcome was not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
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. On an unknown date, the patients were vaccinated with improperly stored GARDASIL Lot # K006960, expiration date 19-FEB-2017 (dose and route were not reported). No adverse effects reported. No product quality complain (PQC) was reported. This is one of several report received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients. On unspecified dates the patients were vaccinated with doses of RECOMBIVAX HB (dose and route not reported) that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
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. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (Lot # reported as K012469, expiration date 14-APR-2016 and Lot #J013394, expiration date 25-AUG-2016 (therapy type, dose and route were not reported). No adverse effects reported. No product quality complaint (PQC) was reported. This is one of several report received from the same source. 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the unspecified number of patients were vaccinated with doses of ZOSTAVAX, (dose, frequency, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of two reports received from the same reproter. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a licensed practical nurse refers to two unspecified patients of unknown age and gender who on unknown dates were vaccinated with two improperly stored doses of VARIVAX (Merck) (dose, lot #, expiration date and route of administration were not reported). No adverse effects reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. Follow up information has been received on 05-MAR-2015 from a licensed practical nurse refers to a male patient of unknown age. On 26-JAN-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K009758, expiration date 26-JAN-2016) that had experienced a temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: TDAP
Symptoms: Arthralgia, Erythema, Gait disturbance, Headache, Myalgia
Clinical narrative: Patient had redness and swelling x 1 wk. Headache, joint and muscle pain. There is still pain in the knee and hard to walk.
Age: 62.0
Sex: U
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Patient had redness and swelling x 1 wk. Headache, joint and muscle pain. There is still pain in the knee and hard to walk.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients. On unspecified dates the patients were vaccinated with doses of VAQTA (dose, route and lot number not reported) that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients. On unspecified dates the patients were vaccinated with doses of GARDASIL (confirmed not GARDASIL 9) (dose and route not reported) that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. The patient's current condition, drug allergic reactions and medical history were unknown. On 10-MAR-2015 the patient was inadvertently vaccinated with PNEUMOVAX 23, (dose number, lot number and expiry date unknown) which expired on 06-MAR-2015 intramuscularly. This was supported. No adverse effects were reported. The outcome of event was unknown. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 27-FEB-2015 the patient was vaccinated with expired dose of ZOSTAVAX (lot # J014567 and expiry date: 18-FEB-2015) 0.65 ml subcutaneously. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a licensed practical nurse refers to two unspecified patients of unknown age and gender who on unknown dates were vaccinated with two improperly stored doses of VARIVAX (Merck) (dose, lot #, expiration date and route of administration were not reported). No adverse effects reported. It was unknown if the patients sought medical attention. Product quality complain (PQC) was not involved. Follow up information has been received on 05-MAR-2015 from a licensed practical nurse refers to a female patient of unknown age. On 26-JAN-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K009758, expiration date 26-JAN-2016) that had experienced a temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.9
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 359 days (reported as 6 days before 1 year old) male patient. The patient pertinent medical history was not reported. On 02-FEB-1999 the patient was vaccinated with M-M-R II and VARIVAX (Merck), which was 6 days before the patient turned 1 year old. No adverse effect was reported. No product quality complaint (PQC) was reported for M-M-R II and VARIVAX. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 0.9
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 359 days (reported as 6 days before 1 year old) male patient. The patient pertinent medical history was not reported. On 02-FEB-1999 the patient was vaccinated with M-M-R II and VARIVAX (Merck), which was 6 days before the patient turned 1 year old. No adverse effect was reported. No product quality complaint (PQC) was reported for M-M-R II and VARIVAX (Merck). This is one of the two reports received from the same reporter. Additional information has been requested.