chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On approximately 30-JUN-2015 (reported as either 30-JUN-2015 or 01-JUL-2015), the patient was vaccinated with one dose of VARIVAX (Merck) (lot# L002214, expiration date 21-JAN-2017; route unknown) after it had a temperature excursion (incorrect product storage). Information regarding the concomitant medication was unknown. It was unknown if there was any relevant laboratory data. At the time of this report, it was unknown if the patient would ever get the VARIVAX (Merck) again and the outcome of the VARIVAX (Merck) being given after an excursion was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Guillain-Barre syndrome, Intensive care, Lumbar puncture normal, Muscular weakness, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Progressive neurologic weakness.  Likely Guillain-Barre Syndrome.  Admitted in PICU currently.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging spinal normal
Clinical narrative: Progressive neurologic weakness.  Likely Guillain-Barre Syndrome.  Admitted in PICU currently.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, redness and swelling in left arm.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives. ER visit, oral steroid given.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site pain, Mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Excruciating pain in left shoulder and arm and numbness in hand. Restricted range of motion. 6 weeks of physical therapy. Pain is greatly diminished but motion is still restricted.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Periarthritis, Rotator cuff syndrome, Tendonitis, X-ray
Clinical narrative: Excruciating pain in left shoulder and arm and numbness in hand. Restricted range of motion. 6 weeks of physical therapy. Pain is greatly diminished but motion is still restricted.
Age: 24.0
Sex: F
Vaccine: HPVX
Symptoms: Asthenia, Frequent bowel movements, Respiratory rate increased, Syncope
Clinical narrative: 10-15 minutes after vaccine administration: Vasovegal syncope; Increasingly rapid respiration, fainting, bowel movement. Decreased energy for next several days.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Feeling abnormal, Feeling of body temperature change, Injection site pain, Pyrexia
Clinical narrative: Symptoms:  Intractable Vomiting, felt hot/cold, temperature 100 F, fatigue "wiped out" and pain at the injection site. Time Course: low grade fever and vomiting 36 hours, soreness at injection site and fatigue continued. Treatment: clear liquids, white soda and soda crackers.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Symptoms:  Intractable Vomiting, felt hot/cold, temperature 100 F, fatigue "wiped out" and pain at the injection site. Time Course: low grade fever and vomiting 36 hours, soreness at injection site and fatigue continued. Treatment: clear liquids, white soda and soda crackers.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Band neutrophil count increased, Blood culture negative, Pain, Pain in extremity, Pyrexia
Clinical narrative: A few days after receiving PREVNAR 13, pt experienced fever, body aches, not chills. Arm soreness. Fever up to 101.6 (self), and fevers up to 100 persisted for a few days.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: White blood cell count normal
Clinical narrative: A few days after receiving PREVNAR 13, pt experienced fever, body aches, not chills. Arm soreness. Fever up to 101.6 (self), and fevers up to 100 persisted for a few days.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Head injury, Syncope, Vomiting
Clinical narrative: Pt. received vaccine and immediately after was fine. Approx. 1-2 min. after pt. checking out and fainted hitting head on side of wall. Pt. remained lying for a few minutes. Able to describe what occurred, name, date, etc. Pt. sat up and fainted again. Pt. B/P stable. Pt. remained in supine position for 10 min before sitting for 10 more min and then moved to exam room. Vomited x1. Pt received PO fluids, ice packand rested. No subsequent HA in office or bleeding. In office 60 min. Advised to call back if any changes and to rest. Pt. felt normal when left. MD immediately notified and present. Examined pt. Made note in chart for pt. to have subsequent vaccines administered while lying down and to remain seated for several min after.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Hyperventilation, Vomiting
Clinical narrative: After receiving vaccinations patient "felt dizzy" hyperventilated and vomited. She was placed in supine position on exam table, cool compress applied to forehead. BP 84/54. Stated she felt better prior to leaving.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: C-reactive protein increased, Cellulitis, Erythema, Induration, Injection site erythema
Clinical narrative: Tdap and Varicella vaccines administered in left upper am on 7/8/15. Parent noticed redness and itchiness to LUA same day. The next day, 7/9/15, the area looked more red and was more painful. Also became hot to touch, unable to sleep on left side due to pain. Patient followed up in the office 7/10/15 and diagnosed with cellulitis-noted to have a 2inch diameter warm, erythematous area with tenderness to touch, firm, indurated, no fluctuance. Central area of swelling, paleness.  Bactrim was prescribed for patient.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Insomnia, Pallor
Clinical narrative: Tdap and Varicella vaccines administered in left upper am on 7/8/15. Parent noticed redness and itchiness to LUA same day. The next day, 7/9/15, the area looked more red and was more painful. Also became hot to touch, unable to sleep on left side due to pain. Patient followed up in the office 7/10/15 and diagnosed with cellulitis-noted to have a 2inch diameter warm, erythematous area with tenderness to touch, firm, indurated, no fluctuance. Central area of swelling, paleness.  Bactrim was prescribed for patient.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Platelet count increased, Skin warm, Swelling, Tenderness
Clinical narrative: Tdap and Varicella vaccines administered in left upper am on 7/8/15. Parent noticed redness and itchiness to LUA same day. The next day, 7/9/15, the area looked more red and was more painful. Also became hot to touch, unable to sleep on left side due to pain. Patient followed up in the office 7/10/15 and diagnosed with cellulitis-noted to have a 2inch diameter warm, erythematous area with tenderness to touch, firm, indurated, no fluctuance. Central area of swelling, paleness.  Bactrim was prescribed for patient.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Myalgia, Pain in extremity, Rash, Rash pruritic
Clinical narrative: Arm ached, back rash that itched, hip joints in pain, thigh muscle ache. Today's date is 07/13/2015 and hip joints, thigh muscle pain has not diminished. Joint pain is worse, so took an Advil.
Age: 90.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Patient reports feeling extreme arm pain, difficulty moving arm, and nausea while attending church at approximately 6:00 PM. Reported to Emergency Department where he was examined and released later that night with a sling for his arm.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On 06-JUL-2015, the patient received an expired 2 ml dose of ROTATEQ lot # K010219, expiration date 02-JUN-2015, orally. No adverse effects were reported. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous, Rash pruritic, Swelling face
Clinical narrative: Red itchy Bumps on my face, neck, ears and arms. It got worse and my entire face got swollen three days after the onset date.
Age: 26.0
Sex: F
Vaccine: DTP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site, pain, itching, redness, hot to touch.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Patient stated she had pain in muscle that was just beginning to subside (7/13/15) pt stated she was still feeling sore but that it was a lot better.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Rash, Scarlet fever, Skin warm
Clinical narrative: Intermittent arm swelling, redness and warmth that lasted for 2 days.  Better with cold compress.  Then developed some hives/rash.  Seen in office and diagnosed with scarlatina.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Streptococcus test positive, Urticaria
Clinical narrative: Intermittent arm swelling, redness and warmth that lasted for 2 days.  Better with cold compress.  Then developed some hives/rash.  Seen in office and diagnosed with scarlatina.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, Pain in extremity
Clinical narrative: This spontaneous report was received from a Healthcare worker refers to an unspecified patients of unknown demographics. It was reported that on an unknown date since December 2014 the patients were vaccinated with improperly stored PNEUMOVAX23 (dose, route, lot # and frequency unspecified). No concomitant medications were reported. Healthcare worker stated that on an unknown date, some complaints may have ben made with regards to sore arms but that was nothing out of the ordinary. Healthcare worker could not provide information regarding any specific patient(s) who may have experienced the symptom. She stated that they "always" received complaints regarding sore arms after administration of vaccines. No further information was provided. The outcome of sore arm and incorrect product storage was unknown. Causality assessment for the event sore arm not reported. There was no product quality complaint involved. This is one of several reprots received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse refers to a 4 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 17-JUN-2015, the patient received VARIVAX (Merck) 0.5 ml, subcutaneous, first dose, in nurse's office (Lot number, expiration date, dose and strength were not reported). Dose was subject to defrost cycling. No adverse effects were reported. Outcome was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 22 year old patient. Medical history and drug reaction were not reported. On 01-JUN-2015 the patient was inadvertently administered a 0.5ml dose of VAQTA (0.5ml, intramuscularly). No adverse effects were reported. There was no concomitant medication reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 29-JUL-2014 the patient was vaccinated with the first dose of GARDASIL intramuscularly (dose and lot# were not reported). On 11-APR-2015, the patient was vaccinated with the second dose intramuscularly (dose and lot# were not reported)(inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a certified medical assistant (C.M.A) referring to an unspecified number of patients. On unspecified dates since 02-JUN-2015, these patients were administered an unspecified number of improperly stored doses of (Oka/Merck) VARIVAX, lot # K009757, subcutaneously. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 15-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature exucrsion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: Viral type flu.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Raised, red, itchy, 4 x 8 cm patch near injection site.  Advised treatment with OTC hydrocortisone cream.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Fever 101 and localized arm swelling at site of injection.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Tenderness
Clinical narrative: BLISTERY RASH ON LOWER RIGHT SIDE OF BACK.  PAINFUL TO THE TOUCH.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, Pain in extremity
Clinical narrative: This spontaneous reprot was received from a Healthcare worker refers to an unspecified patients of unknown demographics. It was reported that on an unknown date since December 2014 the patients were vaccinated with improperly stored GARDASIL (dose, route, lot # and frequency unspecified). No concomitant medications were reported. Healthcare worker stated that on an unknown date, some complaints may have been made with regards to sore arms but that's nothing out of the ordinary. Healthcare worker could not provide information regarding any specific patient(s) who may have experienced the symptom. She stated that they "always" received complaints regarding sore arms after administration of vaccines. No further information was provided. The outcome of sore arm and incorrect product storage was unknown. Causality assessment for the event sore arm not reported. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 15-JUN-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 13-MAY-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Local reaction, Urticaria
Clinical narrative: Local reaction erythema at injection site with associated generalized hives without resp. distress.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Induration, Injection site pain, Urticaria
Clinical narrative: Pt received PREVNAR 13 IM to right deltoid 07/09/15. Returned to clinic 07-13-15 with c/o localized induration, pain at injection site. Hives extending to tricep area.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions and concomitant medications were not reported. On an unknown date, the patient received a dose  (Oka/Merck) VARIVAX (Lot number, expiration date, dose and strength were not reported). On unspecified dates, dose was subjected to defrost cycling. No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Achy, fever, redness and hot to touch. Swelling at site. Redness 13cm x 15cm.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Achy, fever, redness and hot to touch. Swelling at site. Redness 13cm x 15cm.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, three unspecified patients were vaccinated with improperly stored (exposed to 11 Fahrenheit (F) for 15.5 hours) ZOSTAVAX, 0.65 ml once, subcutaneous (strength and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. The outcome of the event was unknown. No further information was provided. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: 8x6 cm erythematous lesion on the injection site. No pain. No fever. No itch. Recovered in 3 days.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: 8x6 cm erythematous lesion on the injection site. No pain. No fever. No itch. Recovered in 3 days.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, Pain in extremity
Clinical narrative: This spontaneous report was received from a Healthcare worker refers to an unspecified patients of unknown demographics. It was reported that on an unknown date since December 2014 the patients were vaccinated with improperly stored MMR II (dose, route, lot # and frequency unspecified). No concomitant medications were reported. Healthcare worker stated that on an unknown date, some complaints may have been made with regards to sore arms but that's nothing out of the ordinary. Healthcare worker could not provide information regarding any specific patient (s) who may have experienced the symptom. She stated that they "always" received complaints regarding sore arms after administration of vaccines. No further information was provided. The outcome of sore arm and incorrect product storage was unknown. Causality assessment for the event sore arm not reported. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pain to (L) deltoid started 23 hrs after vaccine and got progressively worse until 2 1/2 days  later. 5 cm raised tender rash around vaccine area started 36 hrs after vaccine. MOTRIN with relief prn. Rash is tender and warm.
Age: 71.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: Bacterial infection
Clinical narrative: Monday receive the pneumococcal conjugate vaccine. Tues. call the doctor office on the 6/23/15 nurse told me to buy BENADRYL for allergies / was not seen. Wed. saw Dr. He said I had a bacterial infection not an allergy. Cephalexin take 1 tablet orally every 6 hours 500mg tablets.
Age: 71.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Monday receive the pneumococcal conjugate vaccine. Tues. call the doctor office on the 6/23/15 nurse told me to buy BENADRYL for allergies / was not seen. Wed. saw Dr. He said I had a bacterial infection not an allergy. Cephalexin take 1 tablet orally every 6 hours 500mg tablets.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm red, swollen, and warm to touch. Recommended cold pack times 20 minutes as tolerated. Also BENADRYL and ibuprofen as directed.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Spouse called a few hours post-immunization, saying her tongue was swelling - advised to take immediate treatment - pt taken the hospital and treated and kept overnight.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: 6-16-received Tdap. 6-20-pain and redness at injection site. 6-24-because of increasing erythema placed on cephalexin. 6-29-resolved.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Diarrhoea, Eye pain, Headache, Vision blurred, Vomiting projectile
Clinical narrative: Patient reports headache with stabbing pain behind left eye which lasted a week. Right eye had blurry vision for 1-2 days. That evening had projectile vomiting and has had a touch of diarrhea off and on since then.
Age: 0.09
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Hep B dose #2 given 2 weeks after Hep B #1.
Age: 1.05
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Vaccination failure, Varicella post vaccine
Clinical narrative: Varicella rash on 7/6/2015. Failed vaccine-already had VARIVAX x2.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Blood glucose decreased, Dizziness, Syncope
Clinical narrative: Patient fainted for less than a minute, about 7-8 mins after receiving the vaccine. Patient was conscious right after and said she was fine, except felt dizzy. Paramedics evaluated patient and found vitals to be normal but blood glucose low.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Palpitations, Poor quality sleep
Clinical narrative: 7/8/15 Employee reports on 6/8/15 for 2nd dose of RECOMBIVAX HB. States he had side effects from first dose and does not wish any further doses. States that within 10 days after 1st dose felt fatigued, spells of dizziness, extreme fatigue and on one particular day his heart was racing the entire day. Had poor nights sleep the night before. States he is getting better the past few days. States he did not miss any work and he has not seen his physician. Referred to primary care physician.
Age: 1.04
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Pt. was given MMRV instead of MMR and unnecessary VARIVAX.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Eye pruritus, Headache, Lacrimation increased, Listless
Clinical narrative: Severe symptoms not all simultaneous: sore throat, runny nose, constant dull headache, listlessness, dry cough, itchy red watery eyes, wet cough, feeling feverish (but not having fever).
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Productive cough, Pyrexia, Rhinorrhoea
Clinical narrative: Severe symptoms not all simultaneous: sore throat, runny nose, constant dull headache, listlessness, dry cough, itchy red watery eyes, wet cough, feeling feverish (but not having fever).
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 3-year-old patient of an unknown gender. No information about patient's concomitant medications, pertinent medical history, drug reactions or allergies was provided. On 24-SEP-2013, the patient received an unspecified dose of (Oka/Merck) VARIVAX (route of administration, lot# and expiration date not reported). On 07-OCT-2013, less than 28 days apart as per spacing guidelines for live vaccines, the patient was vaccinated with an unspecified doses of MMR II (route of administration, lot# and expiration date not reported). No adverse effects were noted. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Pruritus
Clinical narrative: Reaction in the site of injection. The skin in the site of injection is red, hard and hot. The patient feel itchy. TX: Hydrocortisone cream 1% QID, and BENADRYL 25mg PO QD.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K015816 (expiration dates, dose, route and site of administrations were reported) that were exposed tot temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a unspecified number of neonate patients of unknown gender. The patient's concurrent conditions and medical history were not reported. It was reported that on an unspecified dates, prior to child's birth, nurse's leave RECOMBIVAX HB at room temperature before the vaccine was administered (unknown strength, route and dose). No adverse effects were reported. Concomitant medications were not reported. The outcome of the event was unknown. Additional information is not expected as the reporter did not wish further contact.
Age: 78.0
Sex: F
Vaccine: PNC
Symptoms: Discomfort, Fatigue, Feeling abnormal, Local swelling, Musculoskeletal stiffness
Clinical narrative: Extremely fatigued, affected area swollen, itching and painful. Stiffness setting in the neck and back. Slept a deep and restless sleep that night. Awoke early next AM and upon arising I discovered that the pain had spread to the whole side of the body affected. I had pain even in my toes. My head felt 'fuzzy' and my affected arm had doubled in size. My NP suggested for me to take Tylenol and use heat on my arm to ease my discomfort but I'm allergic to Tylenol. I used ice every hour to ease my arm and it has worked!
Age: 78.0
Sex: F
Vaccine: PNC
Symptoms: Pain, Pain in extremity, Peripheral swelling, Poor quality sleep, Pruritus
Clinical narrative: Extremely fatigued, affected area swollen, itching and painful. Stiffness setting in the neck and back. Slept a deep and restless sleep that night. Awoke early next AM and upon arising I discovered that the pain had spread to the whole side of the body affected. I had pain even in my toes. My head felt 'fuzzy' and my affected arm had doubled in size. My NP suggested for me to take Tylenol and use heat on my arm to ease my discomfort but I'm allergic to Tylenol. I used ice every hour to ease my arm and it has worked!
Age: 1.13
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Autism, Cytogenetic analysis, Electroencephalogram, Exanthema subitum, Nuclear magnetic resonance imaging
Clinical narrative: THE MOTHER OF THE GIRL STATED THAT AFTER THE GIRL WAS VACCINATED SHE DEVELOPED A HIGH FEVER AND WAS EXAMINED BY ANOTHER PHYSICIAN WHO TOLD THE MOTHER THAT THE CHILD HAD A THROAT INFECTION. HOWEVER OTHER PEDIATRICIAN GAVE THE MOTHER A DIAGNOSIS OF ROSEOLA INFARTUM.  THE MOTHER ALSO STATED THAT THE GIRL HAS CONTINUED WITH CONVULSIONS AND THAT HER GENETICIST TOLD HER THAT THE GIRL HAD A 4% AUTISM.
Age: 1.13
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pharyngitis, Pyrexia, Seizure
Clinical narrative: THE MOTHER OF THE GIRL STATED THAT AFTER THE GIRL WAS VACCINATED SHE DEVELOPED A HIGH FEVER AND WAS EXAMINED BY ANOTHER PHYSICIAN WHO TOLD THE MOTHER THAT THE CHILD HAD A THROAT INFECTION. HOWEVER OTHER PEDIATRICIAN GAVE THE MOTHER A DIAGNOSIS OF ROSEOLA INFARTUM.  THE MOTHER ALSO STATED THAT THE GIRL HAS CONTINUED WITH CONVULSIONS AND THAT HER GENETICIST TOLD HER THAT THE GIRL HAD A 4% AUTISM.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a health care professional refers to an approximately 20 years old female patient. Medical history and allergies were none. On an unspecified date in 1995 the patient was vaccinated with first dose of VARIVAX (Merck) (dose, route, frequency and lot # unspecified). On an unspecified date in 2008 the patient was vaccinated with second dose of VARIVAX (Merck) (dose, route, frequency and lot # unspecified). No concomitant medications were reported. It was reported that the result of an unspecified blood test was negative immunity to chickenpox on an unspecified date about two weeks ago in June 2015 (antibody test negative). Patient sought medical attention by visiting pharmacy and speaking to healthcare professional on 25-JUN-2015. The outcome of antibody test negative was unknown. Causality assessment as not reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling and redness in left & right deltoid and mild fever. Went to ED, seen and released with Cephalexin.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Bacterial test negative, Diarrhoea, Enterovirus test negative, Pyrexia, Rotavirus test positive
Clinical narrative: Developed fever, vomiting and watery diarrhea. Still hospitalized currently (7/13/2015). (dont have exact time of onset)
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Viral test negative, Vomiting
Clinical narrative: Developed fever, vomiting and watery diarrhea. Still hospitalized currently (7/13/2015). (dont have exact time of onset)
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Chest discomfort, Chills, Dizziness
Clinical narrative: Headache, severe joint/muscle pain, dizziness, nausea/vomiting, temp of 102.5, tightness in chest/ difficulty breathing, fatigue chills, aches...all lasted 36 hours. Pain, swelling and redness at injection site lasted 5 days.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Headache, severe joint/muscle pain, dizziness, nausea/vomiting, temp of 102.5, tightness in chest/ difficulty breathing, fatigue chills, aches...all lasted 36 hours. Pain, swelling and redness at injection site lasted 5 days.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Myalgia, Nausea, Pain, Vomiting
Clinical narrative: Headache, severe joint/muscle pain, dizziness, nausea/vomiting, temp of 102.5, tightness in chest/ difficulty breathing, fatigue chills, aches...all lasted 36 hours. Pain, swelling and redness at injection site lasted 5 days.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: HIVES ON UPPER TORSO, BACK, ARMS. PATIENT USED TRIAMCINOLONE CREAM WITH IMPROVEMENT AND NOTIFIED PHARMACY ON 7/12/15 AT 5:55 PM AND I RECOMMENDED PATIENT ALSO TAKE ORAL BENADRYL. UPON FOLLOW-UP ON 7/13/15, PATIENT REPORTED MORE IMPROVEMENT AND I SUGGESTED SHE CONTINUE WITH THE STEROID CREAM AND BENADRYL AND TO SEE DOCTOR IF CONDITION WORSENS OR NO MORE IMPROVEMENT.
Age: 41.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pain, Swelling
Clinical narrative: Pt has soreness, swelling and severe pain.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Ejaculation failure, Erectile dysfunction
Clinical narrative: Can't get fully hard and can't complete. Got the flu cannot have fully ejaculation weak orgasm.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site rash
Clinical narrative: Rash (size of palm) at injection site, inflammation, redness, itch.  No reports of system side effects.  Adverse reaction has been ongoing as of 07/12/2015 and per patient, has no improved.
Age: 20.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 20 year old patient of unknown gender. Information on concurrent conditions and concomitant medications was not provided. The nurse stated that a patient received the first dose in the series of three of GARDASIL on an unspecified day in July 2013, and received the second dose on 10-JUL-2015 (intramuscular, dose, site of administration and lot # not provided). No adverse events were reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Feeling hot, Injection site infection, Pain, Swelling
Clinical narrative: Local infection at site of ZOSTAVAX shot. Swelling, pain, heat.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Left arm that received vaccination: could not raise arm and had chills for 3 days. Arm hurt when raised arm for 3 months. Arm hurts when raise arm very high at this time.
Age: 1.14
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site scab
Clinical narrative: Rash reported as starting 7/2/15 6-8 red raised bumps in a row on right thigh. Crusty but no weepy this AM. Mom to monitor for varicella rash.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Pain, Pyrexia, Wheezing
Clinical narrative: C/o wheezing, fever and body aches with chills on 6/26/15. Pt. evaluated by NP. Treated with azithromycin and prednisone and OTC ROBITUSSIN. Returned to office on 7/6/15 and was redosed with same meds for not feeling completely better. Pt also using SYMBICORT. 7/13/15 pt. follow up - better but not completely. Gave a nebulizer Rx.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 23-JUN-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Anion gap increased, Blood chloride decreased, Blood glucose increased, Blood sodium decreased, Body temperature increased
Clinical narrative: Call received 2/16/15 reporting leg pain, temp to 101.1, erythema around site, trouble sleeping, night terrors, poor appetite. Call back 2/19/15 reports 2 days of fever and leg erythema. Symptoms had resolved. Follow up visit 3/15 reported ongoing anorexia, wt loss, labs revealed IDDM.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Carbon dioxide decreased, Decreased appetite, Injection site erythema, Insomnia, Pain in extremity
Clinical narrative: Call received 2/16/15 reporting leg pain, temp to 101.1, erythema around site, trouble sleeping, night terrors, poor appetite. Call back 2/19/15 reports 2 days of fever and leg erythema. Symptoms had resolved. Follow up visit 3/15 reported ongoing anorexia, wt loss, labs revealed IDDM.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Sleep terror, Type 1 diabetes mellitus, Weight decreased
Clinical narrative: Call received 2/16/15 reporting leg pain, temp to 101.1, erythema around site, trouble sleeping, night terrors, poor appetite. Call back 2/19/15 reports 2 days of fever and leg erythema. Symptoms had resolved. Follow up visit 3/15 reported ongoing anorexia, wt loss, labs revealed IDDM.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 19-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administratio not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history was reported. On 25-JUN-2015, the patient was vaccinated with improperly stored ZOSTAVAX (lot # L000450 and expiration date 09-MAR-2016) 0.65 ml once, subcutaneous. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Rash
Clinical narrative: Before shingles vaccine, outbreak only about once a year; 2 small spots. After vaccine, outbreaks constant and continual, on many different areas of the body, lasting sometimes 2 months at a time. Was never told anything could be done.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history was reported. On 05-JUN-2015, the patient was vaccinated with improperly stored ZOSTAVAX (lot # L000450 and expiration date 09-MAR-2016) 0.65 ml once, subcutaneous. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Dermatitis contact, Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Had vaccine 7-10-15. Developed itchy red rash on feet and legs on 7-10-15 evening / 7-11-15 day. Spread to back and arms by 7-13-15. Took to pediatrician and was diagnosed per guardian with allergies to new soap and given allergy medicine (liquid).
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history was reported. On 16-JUN-2015, the patient was vaccinated with improperly stored ZOSTAVAX (lot # L000450 and expiration date 09-MAR-2016) 0.65 ml once, subcutaneous. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. 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 healthcare worker refers to a patient of unknown age and gender who on 24-JUN-2015 was vaccinated with a dose of GARDASIL lot # K006960 (dose and route were not provided) which was exposed to temperatures outside of the recommended range during 63 hours excursion (incorrect product storage). No adverse effects had been observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: MMR given 6-30-15. Low grade temp 7-8-15. Rash pinpoint -> pea sized 7-10-15.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Paraesthesia, Vaccination site rash, Vaccination site swelling
Clinical narrative: Retired patient received routine ZOSTAVAX vaccine on July 9, 2015 (manufacture - MSD and lot #K015311) subcutaneously to left tricep region. He reported no adverse reactions until wife noted site red on Friday evening (1 day after vaccination). This site was pink and warm to touch. Over the next 24 hours this site became bright red with paler pink area surrounding the vaccine site to encompass 1/3 of his arm. He complains of intermittent tingling to his entire left hand - mostly in fingertips depending on arm position for 1-2 days. He has no tingling at this visit. He stated both the redness and tingling are already better by Sunday (yesterday). He denies any loss in ROM, weakness to left arm/grip, neck/shoulder pain, fever, headache, rash/hives, difficulty breathing, or any other systemic symptoms. He denied any trauma to area and was doing routine yard/pool maintenance when reaction occurred. He denied being bite by mosquitoes, or any insect. General overall feeling. No pain, no fever, and no chills. Neurological symptoms intermittent tingling left hand-fingertips depending on arm position. Skin symptoms rash, redness, swelling to left triceps region at vaccine site.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Rash macular, Skin warm
Clinical narrative: 60 yo male advised he received a PNEUMOVAX vaccine per recommendations of Dr. sometime in 2009. He advised vaccine was given following one of his routine asthma evaluations with her. He advised MD on 9/21/2009 exam that he had experienced "systemic reactions to PNEUMOVAX". He describes this systemic reaction as his right deltoid and upper arm (2/3 of lateral surface of arm) being hot to touch, very swollen, tender to touch, site being red blotchy and itched. It took 3-4 days for this reaction to resolve and was treating with NSAIDs. He advised his wife looked at the VIS form he was provided and said "you have all the side effects listed", but as it was a Saturday, the clinic was closed and he did not advise anyone till later. He denied any SOB other than his typical asthma, no fever, headaches, myalgia, arthralgia (other than site pain), rash/hives elsewhere on body, or any other systemic reaction. He advised he continued to receive other vaccines while working to include Hepatitis B series, Tetanus diphtheria (unsure if Tdap) about 2013, and yearly influenza vaccines at local pharmacy without reactions (2009-2014).
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Swelling, Tenderness, Vaccination complication
Clinical narrative: 60 yo male advised he received a PNEUMOVAX vaccine per recommendations of Dr. sometime in 2009. He advised vaccine was given following one of his routine asthma evaluations with her. He advised MD on 9/21/2009 exam that he had experienced "systemic reactions to PNEUMOVAX". He describes this systemic reaction as his right deltoid and upper arm (2/3 of lateral surface of arm) being hot to touch, very swollen, tender to touch, site being red blotchy and itched. It took 3-4 days for this reaction to resolve and was treating with NSAIDs. He advised his wife looked at the VIS form he was provided and said "you have all the side effects listed", but as it was a Saturday, the clinic was closed and he did not advise anyone till later. He denied any SOB other than his typical asthma, no fever, headaches, myalgia, arthralgia (other than site pain), rash/hives elsewhere on body, or any other systemic reaction. He advised he continued to receive other vaccines while working to include Hepatitis B series, Tetanus diphtheria (unsure if Tdap) about 2013, and yearly influenza vaccines at local pharmacy without reactions (2009-2014).
Age: 0.49
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Brain neoplasm, Herpes zoster disseminated, Immunodeficiency, Immunology test, Rash papular
Clinical narrative: This spontaneous report as received from a physician refers to a 9 year old female patient with residual pain hypopituitary and sulfa and vancomycin allergies. The patient did not have recent Varicella Zoster Virus (VZV) exposure to chickenpox or shingles. On 27-APR-2006, at 5 months age, the patient was vaccinated with a first dose of VARIVAX (Merck) (route, lot # and expiration date were not provided). Then on 22-JUN-2011, at five years old, the patient was vaccinated with a second dose of VARIVAX (Merck) (also reported as PROQUAD) batch reported as "0141Z". Concomitant therapies included SYNTHROID, CORTEF, somatropin (manufacturer unknown) and DDAVP. On an unknown date in 2011, the patient had a remote history of brain cancer/tumor resected in 2011 and her last chemotherapy was in 2012. On 01-JUL-2015, the patient experienced herpes zoster referred as disseminated shingles, rash type "vesicles and papules", she was also afebrile. The patient presented less than 100 lesions distributed over the trunk, extremities, hands, palms and soles. On 04-JUL-2015, the immunocompromised child was hospitalized and a sample from a vesicle/lesion was collected. Direct Fluorescent Antibody (DFA) was done from lesion on "7.2" that was positive for varicella zoster virus (VZV) dermatome diffuse and discarded. The rash did not occur at the site of injection post-vaccination. It was also stated that the patient did not experience pneumonitis or hepatitis. The patient was intravenously treated with acyclovir (manufacturer unknown). On an unknown date in July 2015, the outcome of herpes zoster was recovered and the brain cancer was considered as recovered in 2012. The physician stated that the child may be discharged from the hospital on 06-JUL-2015 but it was unknown whether she was discharged or not. Upon internal review, the brain cancer/tumor was considered as other important medical event. Additional information has been requested.