chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient has redness and swelling at the injection site that started this morning. She has been advised to place compress on the site and it should subside in a few days.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient had 2 vaccines on 03/09/2016.  He had Boostrix and Meninigitis.  Where the meninigitis shot was given, it was 14 mm, red and hot to the touch and itchy.  The Boostrix measured 5.5 mm and was also red, hot and itchy.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: The child's mother reported to the Nurse Site Supervisor at some point, days following the vaccines; reporting the child's leg was swollen. No additional complications/concerns reported. Immunization nurse called the Patient's Mother on 3/2/16 for follow up. At that time, the Mother shared her daughters legs (at administration sites) were swollen and tender for a few days after her appointment. No additional signs/symptoms reported. At this time the swelling was resolved. The parent declined initial f/u with PMD as she did not feel it was needed.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site. Worst on 3/8 improving on 3/9. No evidence of infection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin lesion, Skin lesion excision
Clinical narrative: Patient described development of many round, flat bumps that began on her back and spread to her arms and hands. She said that some of the bumps "popped up like a wart" forming mole-like lesions. She said that several of these lesions had to be removed. She denied presence of pain but described them as being very itchy.
Age: 39.0
Sex: F
Vaccine: PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event from Prevnar 13, only delay in getting PPSV 23 which is appropriate for asthma.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Mom reports that evening after shots that the patient's right quad became swollen, warm to touch, and fever present.  Mom brought child into health dept today 3/11/16.  T97.9 auxillary. No SOB and lungs clear.  Top of right quad swollen 2-3+, tight, and warm to touch. Mom reports edema is increasing.  Referred to Dr. and will be seen today.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Her left arm became red warm and swollen.
Age: 0.45
Sex: F
Vaccine: DTAP, IPV
Symptoms: Retching, Vomiting
Clinical narrative: Baby heaved and threw up about 10-12 times in 3-4 hours. The first several were breastmilk, the next 4 or 5 were bile, the next several were dry heaving, then there was one more bile, before she fell asleep.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Parent brought child in for vaccines.  Noted on L deltoid large reddened area aprox the size of an orange warm to the touch.  Posterior side of right forearm small red area size quarter.
Age: 1.28
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Pyrexia
Clinical narrative: On 3/8/2016 patient developed a rash on his left thigh. 3/11/2016 at 1100 patient developed a fever. Patient seen 3/11/2016 at Urgent Care where he presents with fever of 101.7. Advised to take ibuprofen and Tylenol alternating to control fever and follor up if worsening or not better.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: PAINFUL DURING THE VACCINATION.  AT THE SITE OF THE INJECTION MY ARM WAS VERY SORE AND WORSEN FROM MARCH 9- MARCH 11TH  PAINFUL WITHOUT TOUCH AND WAS SWOLLEN. MARCH 11TH- PM - LESS PAIN AND MY SWOLLEN SITE WAS REDUCED.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Prevnar 13 - PAINFUL DURING THE INJECTION AND HAD PAIN AND SWOLLEN ARM FOR ~1 1/2 DAYS.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Gait disturbance, Injection site pain
Clinical narrative: Inconsolable crying. Injection site soreness. Injection in leg, sudden onset of pain with limping and crying.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Bursitis, Injected limb mobility decreased, Injection site pain, Musculoskeletal disorder
Clinical narrative: Received shot to right shoulder.  It was painful and the pain has never left. Pain continued to increase until right arm is painful and can no longer be used for every day activities.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Received shot to right shoulder.  It was painful and the pain has never left. Pain continued to increase until right arm is painful and can no longer be used for every day activities.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Body temperature increased, Conjunctivitis, Ear pain, Eye pruritus, Eyelids pruritus
Clinical narrative: The patient received LAIV on 3 Dec 2015 (lot# FK2037) and 6-8 hours later developed facial edema, severe pruritus to eyes, especially lids, rhinitis, conjunctivitis, flushing to face and lips, minor wheezing and urticaria to her chest. She had generalized pruritus. They deny dyspnea, chest pain, nausea or emesis. She was seen in ER and given oral steroids, BENADRYL, and antiinflammatories. They report she has continued to have intermittent episodes typically 2-3 times per week, managed with BENADRYL. She had such severe pruritus she 'pulled all her eyelashes and some of her brows out.' She has recurrent headaches and has a neurology referral. She had one episode of similar dermatology symptoms after body wash and shampoo brands were changed. She also has increased temperatures, with a high of 100, although had a cold that day. She has continued increased nasal blockage. She has continued increased ear pain. She was referred for allergy evaluation for alternate etiologies, as delayed timing, identification of an alternate trigger and continued recurrence do not support the LAIV as causal, although may have exacerbated conjunctival symptoms.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Face oedema, Flushing, Headache, Nasal congestion, Pruritus generalised
Clinical narrative: The patient received LAIV on 3 Dec 2015 (lot# FK2037) and 6-8 hours later developed facial edema, severe pruritus to eyes, especially lids, rhinitis, conjunctivitis, flushing to face and lips, minor wheezing and urticaria to her chest. She had generalized pruritus. They deny dyspnea, chest pain, nausea or emesis. She was seen in ER and given oral steroids, BENADRYL, and antiinflammatories. They report she has continued to have intermittent episodes typically 2-3 times per week, managed with BENADRYL. She had such severe pruritus she 'pulled all her eyelashes and some of her brows out.' She has recurrent headaches and has a neurology referral. She had one episode of similar dermatology symptoms after body wash and shampoo brands were changed. She also has increased temperatures, with a high of 100, although had a cold that day. She has continued increased nasal blockage. She has continued increased ear pain. She was referred for allergy evaluation for alternate etiologies, as delayed timing, identification of an alternate trigger and continued recurrence do not support the LAIV as causal, although may have exacerbated conjunctival symptoms.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Rhinitis, Trichotillomania, Urticaria, Wheezing
Clinical narrative: The patient received LAIV on 3 Dec 2015 (lot# FK2037) and 6-8 hours later developed facial edema, severe pruritus to eyes, especially lids, rhinitis, conjunctivitis, flushing to face and lips, minor wheezing and urticaria to her chest. She had generalized pruritus. They deny dyspnea, chest pain, nausea or emesis. She was seen in ER and given oral steroids, BENADRYL, and antiinflammatories. They report she has continued to have intermittent episodes typically 2-3 times per week, managed with BENADRYL. She had such severe pruritus she 'pulled all her eyelashes and some of her brows out.' She has recurrent headaches and has a neurology referral. She had one episode of similar dermatology symptoms after body wash and shampoo brands were changed. She also has increased temperatures, with a high of 100, although had a cold that day. She has continued increased nasal blockage. She has continued increased ear pain. She was referred for allergy evaluation for alternate etiologies, as delayed timing, identification of an alternate trigger and continued recurrence do not support the LAIV as causal, although may have exacerbated conjunctival symptoms.
Age: 49.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dehydration, Malaise, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: October 12, 2015, flu vaccine. On Oct 14 I became very ill, unable to get out of bed for a week. Went to ER for I.V./dehydration at this time my arm and shoulder started aching very badly. This frozen shoulder has never quit hurting.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis
Clinical narrative: October 12, 2015, flu vaccine. On Oct 14 I became very ill, unable to get out of bed for a week. Went to ER for I.V./dehydration at this time my arm and shoulder started aching very badly. This frozen shoulder has never quit hurting.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Injection of ZOSTAVAX administered on 3/2/16. Patient called and came in to pharmacy 3/11/16 to show pharmacist area of redness (circular 1 1/2 - 2" diameter).
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Patient was given vaccines and after approx. 1 min began to faint in chair, mother and nurse assisted patient with safety, nurse cooled patient with cool paper towels and fanned patient. Patient became more alert and was given saltines and 7.5 oz cherry cola.
Age: 30.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: State she had a fever that night 3/8/16 of 103. Site is hot, red, and swollen. States she is taking amoxicillin for another condition. Has been taking Ibuprofen and doing warm compresses. Declined to see MD at this time. Was given flu shot in (R) arm that day with no issues.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Vomiting projectile
Clinical narrative: Within 24 hrs after vaccine administration, patient with several episodes of projectile vomiting. Patient seen at local emergency department and followed up with PCP today.
Age: 25.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Injection site rash, Rash
Clinical narrative: Patient reports breaking out with rash on left upper arm and lower and upper back after 1st dose of HPV vaccine. Patient reported this on 3/9/16 when she came in for second vaccine dose.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Pruritus, Throat irritation
Clinical narrative: Pt left pharmacy and returned about an hour later and eyes were puffy and swollen, arms and throat were itchy. Patient took BENADRYL (a few doses) to get rid of the symptoms.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Laboratory test abnormal, Oropharyngeal pain, Pain, Rash
Clinical narrative: Two wks after receiving both Flu shot and TB test x 2, I came down with a very bad sore throat, runny nose, headache and body ache. A rash appeared on my neck dark in color then spread to my underarm area where it's still present.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Rhinorrhoea
Clinical narrative: Two wks after receiving both Flu shot and TB test x 2, I came down with a very bad sore throat, runny nose, headache and body ache. A rash appeared on my neck dark in color then spread to my underarm area where it's still present.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Biopsy muscle, Biopsy peripheral nerve, Blood test, Dyspnoea
Clinical narrative: Muscular weakness, muscular aches, back aches, started 2014 to present. Currently being treated with monthly IVIG via hospitalization, difficulty breathing and moving, hypersensitivity throughout whole body.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Electromyogram, Hypersensitivity, Immunoglobulin therapy, Lumbar puncture, Mobility decreased
Clinical narrative: Muscular weakness, muscular aches, back aches, started 2014 to present. Currently being treated with monthly IVIG via hospitalization, difficulty breathing and moving, hypersensitivity throughout whole body.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Muscular weakness, muscular aches, back aches, started 2014 to present. Currently being treated with monthly IVIG via hospitalization, difficulty breathing and moving, hypersensitivity throughout whole body.
Age: 4.0
Sex: F
Vaccine: RAB
Symptoms: Injection site mass
Clinical narrative: Lump at vaccine site. Possible fibroma.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: On 3/1/16, pt noticed redness and pain of the entire left deltoid area w/ severe pain.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Fatigue, Pain in extremity, Vomiting
Clinical narrative: A few hours after receiving vaccine, pt c/o extreme arm pain, temp 100.5, abd pain, and vomited 3 times. Woke up next day with fatigue.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Erythema, Induration, Pain in extremity
Clinical narrative: 3 cm erythema induration in (L) arm w/arm pain.
Age: 18.0
Sex: F
Vaccine: FLUN4, MENB
Symptoms: Pain in extremity, Rash, Rash erythematous
Clinical narrative: The day after vaccine pt c/o intense arm pain w/red rash spreading down the arm in the shape of an "S".
Age: 16.0
Sex: M
Vaccine: FLUN4, HPV9, MENB, MNQ
Symptoms: Abnormal behaviour, Crying, Fatigue
Clinical narrative: Mom states that pt was seen yesterday and received vaccines. Pt had very unusual behavior last night. He cried for hours for no reason. He was also very fatigued. Seems to be better today but still tired.
Age: 36.0
Sex: F
Vaccine: FLU4, HEP, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: On 3/11/16 at 330 pm pt reported/nurse viewed red raised, sore to touch area of injection site for Hep-B and Tdap. Varicella site c/o itching. Tdap 7cm induration, Hep B 5cm induration, Varicella 5cm induration. Ice, TYLENOL.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Large erythematous, tender induration on (L) deltoid.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Hive developed immediately at varicella injection site. 5 minutes later also at MMR injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 09-FEB-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 10-MAR-2016, the patient was vaccinated with a dose of PROQUAD (Merck) subcutaneously (dose, lot #, expiry date and anatomical location were not specified). Other suspect therapies included VARIVAX (Merck) (dose, lot #, expiry date, route of administration and anatomical location were not reported) administered on the same day. This was outside of the labeled recommendations in both the PROQUAD and VARIVAX (Merck) prescribing information. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 02-MAR-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck). It was reported that the vaccine was stored at -13.7 degree centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients medical histories and concurrent conditions were not reported. On an unknown date, the patients received either VAQTA (Lot# L023232; expiration date 25-FEB-2017) or RECOMBIVAX HB (Lot# L033343; expiration date 13-SEP-2017) or ROTATEQ oral (Lot# L023870; expiration date 26-APR-2017) that were improperly stored on an temperature of 1.1C degrees for an hour and 5 minutes. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 18-FEB-2016 the patient was vaccinated with am improperly stored dose of PROQUAD (Merck) (lot # L044055, expiration date 02-MAY-2017. dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 04-FEB-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 28-JAN-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 29-JAN-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. 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: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 25-JAN-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L030587, expiration date 10-FEB-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report was received from a 64 year old female patient reporting on herself. The patient's concurrent conditions, medical history or allergy/drug reactions were reported as none. In approximately July 2015, reported as 8 months ago, the patient was vaccinated with ZOSTAVAX (dose, route, frequency, lot # and expiration date were not provided). No concomitant medications were reported. Since vaccination, the patient has been experienced fever blisters in her nose and mouth "every 6 weeks". No treatment was given to the patient. No laboratory tests were performed. At the reporting time, the outcome of fever blisters in nose and mouth was unknown. Additional information is not expected as no contact information was provided.
Age: 13.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 13 year old patient of an unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 09-MAR-2016, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot # L029483 and expiration date 06-NOV-2016) (route was not provided) instead of VARIVAX (Merck) (lot number, expiration date and route of administration were not provided). There were no concomitant medications reported. No adverse effects were reported. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 22-FEB-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 10-FEB-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 17-FEB-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 24-FEB-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. 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: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 15-FEB-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L030587, expiration date 10-FEB-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 25-FEB-2016, the patient was vaccinated with the first dose of M-M-R II (dose, route of administration, lot# and expiration date were not reported). There were no symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On 25-FEB-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L042846 and expiry date 15-SEP-2017) (dosing details unspecified) which underwent specific temperature excursion of: Temperature: 47F, Time frame: 35 hours, Data logger: There was no previous temperature excursion. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On 25-FEB-2016, the patient was vaccinated with improperly stored VAQTA (lot # L048460 and expiry date 14-JAN-2017) (dosing details unspecified) and improperly stored RECOMBIVAX HB (lot # L042846 and expiry date 15-SEP-2017) (dosing details unspecified) which underwent specific temperature excursion of: Temperature: 47F, Time frame: 25 hours, Data logger: There was no previous temperature excursion. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 17-AUG-2015, the patient was vaccinated with a first dose of GARDASIL (lot# K004204, exp. date: 12-JAN-2017). On 28-DEC-2015, the patient was vaccinated with a second dose of GARDASIL (reported lot# L014198, exp. date: 05-SEP-2017). On 29-FEB-2016, the patient came into the office to receive the third dose of GARDASIL 9. The nurse stated, that she did not intend to administer this dose. No adverse effect was reported. Lot# L014198 was determined as not valid for GARDASIL but valid for GARDASIL 9. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Injection site bruising, Injection site pain
Clinical narrative: This spontaneous report was received from a non-pregnant 23 year old female patient with no drug reactions or allergies and no pertinent medical history, who was reporting on herself. The patient stated that she received three doses of GARDASIL, 0.5 ml, intramuscularly, (lot number and expiration date were not provided). The first dose was administered on 27-OCT-2015, the second dose was received on 01-DEC-2015 and the third dose was administered on 02-MAR-2016. There were no concomitant medications reported. The patient stated that since the last dose, she had felt fatigued, experienced injection sire soreness and bruising (on 02-MAR-2016). The patient did not seek medical attention. No laboratory diagnostic studies were performed. No treatment was given for the events. The outcome of injection site soreness and bruising and feeling fatigued was reported as not recovered. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with improperly stored dose of M-M-R II injection, lot # L024265, expiration date 01-JUL-2017 (dose and route of administration were not reported). No adverse symptoms were reported. The vaccine was exposed to temperature 47.1 Fahrenheit (F) for 4 minutes with previous excursion 46.8 F for 1 hour and 45 minutes. This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a Licensed Nurse Practitioner (L.P.N) via a company representative refers to a currently 15 years old unpregnant female patient. There was no concomitant medication, pertinent medical history or drug allergy/reaction. On an unknown date the patient was vaccinated with GARDASIL 9 (dose, route, lot# and expiration date were not reported). On an unknown date developed hives after she received the second dose and the third dose of the product. The patient called her doctor. No lab diagnostics studies were performed. The outcome of hives was reported as recovering/resolving. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to four patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, injection, lot # L019297, expiration date 18-AUG-2017 (dose and route of administration were not reported). No adverse symptoms were reported. The vaccine was exposed to temperature 47.1 Fahrenheit (F) for 4 minutes with previous excursion 46.8 f for 1 hour and 45 minutes. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. Since 01-FEB-2016, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, orally, lot # L013204, expiration date 28-JAN-2017 (dose was not reported). No adverse symptoms were reported. The vaccine was exposed to temperature 47.1 Fahrenheit (F) for 4 minutes with previous excursion 46.8 F for 1 hour and 45 minutes. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. Since 01-FEB-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot# L029631 with expiration date 14-AUG-2017, lot# L027733 with expiration date 13-SEP-2017 and lot# L023387 with expiration date 22-JUN-2017 (dose and route of administration were not reported). No adverse symptoms were reported. The vaccine was exposed to temperature 47.1 Fahrenheit (F) for 4 minutes with previous excursion 46.8 for 1 hour and 45 minutes. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to six patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, three patients were vaccinated with improperly stored doses of ROTATEQ oral solution, orally, lot # L013206, expiration date 29-JAN-2017 (dose was not reported), two patients were vaccinated with improperly stored doses of ROTATEQ oral solution, orally, lot # L026067, expiration date 06-APR-2017 (dose was not reported), and one patient was vaccinated with improperly stored dose of ROTATEQ oral solution, orally, lot # L035508, expiration date 12-MAY-2017 (dose was not reported). No adverse symptoms were reported. The vaccine was exposed to temperature 47.1 Fahrenheit (F) for 4 minutes, with previous excursion 46.8F for 1 hour and 45 minutes. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (lot # K026247, expiry date: 06-MAR-2017) (lot# L013429, expiry date: 21-JUL-2017) (dose and route unspecified), which had been improperly stored under 10 degree Centigrade for 72 hours, and later under 1 degree Centigrade for 8 hours (incorrect product storage). Other suspect and concomitant therapies were not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patient were vaccinated with doses of RECOMBIVAX HB (lot # L022261, expiry date: 01-APR-2016) (dose and route unspecified), which had been improperly stored under 10 degree centigrade for 72 hours, and later under 1 degree centigrade for 8 hours. Other suspect and concomitant therapies were not reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of ROTATEQ (lot # L008054, expiry date: 30-NOV-2016) (dose unspecified) orally, which had been improperly stored under 10 degree centigrade 72 hours, and later under 1 degree centigrade for 8 hours. Other suspect and concomitant therapies were not reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of VAQTA (lot # L013380, expiry date: 04-NOV-2017) (lot # L022259, expiry date: 06-APR-2017) (dose and route unspecified), which had been improperly stored under 10 degree centigrade for 72 hours, and later under 1 degree centigrade for 8 hours. Other suspect and concomitant therapies were not reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 10-FEB-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 22-FEB-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. 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: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 02-FEB-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L030587, expiration date 10-FEB-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. 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: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 15-FEB-2016 the patient as vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L030587, expiration date 10-FEB-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. 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: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 25-JAN-2016 the patient as vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L030587, expiration date 10-FEB-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from a healthcare worker (pharmaceutical salesman) via another company's representative, concerning to a female patient of unknown age. The patient's concurrent and historical conditions were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (strength reported as INJ 25/0/5 Y) (lot number, expiration date, dose, route and anatomical location were not provided. The patient's concomitant medications were unspecified. On an unknown date, the patient experienced an unspecified allergic reaction after receiving a PNEUMOVAX 23. At the time of the report, the outcome of hypersensitivity was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Local swelling, redness, and pain progressively worsening over 3 day period.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a office manager, via a company representative, referring to a female patient of unknown age. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. Approximately in 2013 (reported as about 3 years ago), the patient developed shingles. The outcome of herpes zoster was unknown at the time of this report. The reporter did not provide a causality assessment between the event and therapy with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL (lot # K006124, expiry date: 02-FEB-2017)(lot# K009482, expiry date: 06-MAR-2017)(dose and route unspecified), which had been improperly stored under 10 degree centigrade for 72 hours, and later under 1 degree centigrade for 8 hours. Other suspect and concomitant therapies were not reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 08-JAN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA) (dose and route of administration were not provided) lot # L012479, expiry date 10-APR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 15-FEB-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L030587, expiration date 10-FEB-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 15-JAN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA) (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 16-DEC-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA) (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 14-JAN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA) (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 16-FEB-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (lot # L030587, expiration date 10-FEB-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.