chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a patient of unknown age and gender. There was no pertinent medical history or drug allergies/drug reactions described. The physician reported that on 18-JUL-2013, the patient was vaccinated with the first dose in the series of three of GARDASIL and on 13-AUG-2014, the second dose of GARDASIL was administered, (doses, route, lot numbers and expiration dates were not provided). There was no concomitant medication described. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant regarding a patient of unknown age and gender. The patient's medical history, drug reactions, allergies and concurrent conditions were not reported. On 22-JUN-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL, (dose, route, anatomica location, lot number and expiration date were not reported). There was no concomitant medication reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical histories, drug reactions or allergies provided. On an unknown dates, 7 improperly stored doses of (Oka/Merck) VARIVAX (lot# K026386, expiration date 15-DEC-2015, dose, frequency, site and route of administration were not reported) were administered to unspecified number of patients. No adverse events were reported. No product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.55
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a 6 months old infant of unknown gender. Pertinent medical history and drug reactions/allergies were not reported. On 03-AUG-2015, the infant received an improperly stored dose of ROTATEQ (lot# K023535, dose and expiration date were not reported) orally. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Pruritus, Urticaria
Clinical narrative: Information has been received from a pharmacist referring to a 37 year old male patient who was allergic to penicillin (PCN). The patient was a physician himself. He was not allergic to eggs to latex. The patient had never had serious reactions after receiving a vaccine and was not sick at the time of vaccination. In the past 4 weeks, the patient did not receive any vaccinations. He had no long-term health problem, blood disorder, seizure, brain or nerve problem, immune problem and did not take steroids, anti-cancer drugs or X-ray treatments. During the past year the patient dd not receive transfusion of blood or blood product, or immune (gamma) globulin. The patient had had shingles twice previously in his lifetime. In the noon of 08-AUG-2015 the patient was vaccinated with 0.65ml dose of ZOSTAVAX (lot # L006381, expiration date 25-MAY-2016), subcutaneously (SQ) in the right deltoid (RD). After vaccination, the patient aware of potential reactions. On 09-AUG-2015, the patient had local injection site erythema and whelp. His both legs and opposite arm had wheals max of 10. The patient also experienced itchy. There was nothing on the trunk and the body. The patient treated with ZYRTEC for itch. The outcome of the events was unknown. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The healthcare worker reported that doses of PROQUAD (Merck) (lot # K011316, expiry date 14-FEB-2016; lot # K005195, expiry date 10-OCT-2015; lot # was reported as K007977, expiry date 03-JUN-2016) (lot # K007977 is an invalid lot number for PROQUAD (Merck)) which was exposed to temperatures outside of the recommended range, had been administered to the unspecified patients on unspecified dates since 20-JUL-2015. At the time of the report, no adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an 8 year old female patient. The patient's medical history was not reported. On 01-AUG-2015, the patient was vaccinated outside the prescribing information with a dose of GARDASIL lot # K016966, expiration date reported as 10-MAY-2017 (dose, route and site of administration were not reported). Concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The healthcare worker reported that doses of ZOSTAVAX (lot # L006392, expiry date 25-MAY-2016) which were exposed to temperatures outside of the recommended range, had been administered to the unspecified patients on unspecified dates since 20-JUL-2015. At the time of the report, no adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concomitant medications and medical history were not reported. The patient was prescribed VARIVAX (Merck). On 25-AUG-2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml once, subcutaneous instead of VARIVAX (Merck) (Wrong drug administered). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician via field representative refers to unspecified number of patients of unknown age and gender. The patient's concomitant medications and medical history were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL (unknown strength, lot and dose) outside the recommended intervals. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple number of patients (also reported as "a lot") of unknown age and gender. The patients' relevant medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified series of M-M-R II (therapy type, dose, dose number, intervals, anatomical location and route of administration were not reported). On unknown dates, the patients who had received a M-M-R II "were testing negative for titers of some of the antigens". The reporter also stated, that "some of the soldiers were receiving 3 to 5 doses of M-M-R II" for revaccination on unknown dates. The outcome of the event of "negative titers of some of the antigens" was unknown. The relatedness between the event of event of "negative titers of some of the antigens" and M-M-R II was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concomitant medications and medical history reported. On 11-AUG-2015, the patient was inadvertently vaccinated with expired PNEUMOVAX23, (expire date 05-AUG-2015) (dose, route, lot not reported). This was supported. No adverse effects 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 health care professional refers to seven unspecified patients of unknown demographics. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K024533; expiry: 15-APR-2017) (dose #, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 24-AUG-2015 the patient was inadvertently vaccinated with a dose of expired PNEUMOVAX23 (lot # K009809, expiration date 16-MAY-2015, dose and route not provided). No adverse effect reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a 61 year old female patient. The patient's concurrent condition and medical history were not reported. On 15-AUG-2015 the patient was vaccinated with the third dose of RECOMBIVAX HB (lot # L008660, expiration date 10-NOV-2015, dose and route were unknown), the patient was inadvertently administered the pediatric formulation rather than the adult formulation of the RECOMBIVAX HB. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 21-AUG-2015 the patient was vaccinated with an improperly stored of oral, ROTATEQ (lot# K024700, expiration date 30-JUL-2016) (strength, dose and route were not reported). No adverse effect reported. It was unknown if the patient sought medical attention. 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 as received from a healthcare worker refers to unspecified number of patients of unknown age. No information on concurrent conditions and medical history was reported. On an unspecified dates since 15-JUN-2015 the patients were vaccinated with improperly stored MMR II (unknown route, strength and dose) lot #' K021152 with an expiry date of 02-NOV-2016 and lot # J013316 (expiration unspecified) stored at improper temperatures (high temperatures of 51.8 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to male patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 23-JUN-2015 the patient was vaccinated with improperly stored MMR II (unknown strength, route and dose) lot # K007107 with an expiry date of 16-MAY-2016, stored at improper temperature (< 46 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A 20-year-old male patient of an unspecified ethnicity received TRUMENBA (Lot # UH906AA and Expiration Date Jun2016), via an unspecified route of administration on 01Jul2015 at 0.5 ml, single. The patient medical history and concomitant medications were not reported. The patient developed meningitis symptoms such as headache which required hospitalization, vomiting, nausea, stiff neck in Jul2015, all over body ache on 02Jul2015, fatigue and chills in Jul2015. Meningitis was not confirmed but there was definite meningeal irritation present on an unspecified date in 2015. The patient received ADVIL as treatment for headache, all over body ache and fatigue. No treatment received for vomiting, nausea, stiff neck and chills. The outcome of the event meningeal irritation was unknown while the patient recovered from all the other reported events. Follow up (21Aug2015): New information reported from a contactable consumer includes: patient details, vaccine information and events information provided, new event added and outcome updated.
Age: 20.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Hyperhidrosis, Musculoskeletal stiffness, Nausea, Neck pain, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A 20-year-old male patient of an unspecified ethnicity received TRUMENBA (Lot # UH906AA and Expiration Date Jun2016), via an unspecified route of administration on 01Jul2015 at 0.5 ml, single. The patient medical history and concomitant medications were not reported. The patient developed meningitis symptoms such as headache which required hospitalization, vomiting, nausea, stiff neck in Jul2015, all over body ache on 02Jul2015, fatigue and chills in Jul2015. Meningitis was not confirmed but there was definite meningeal irritation present on an unspecified date in 2015. The patient received ADVIL as treatment for headache, all over body ache and fatigue. No treatment received for vomiting, nausea, stiff neck and chills. The outcome of the event meningeal irritation was unknown while the patient recovered from all the other reported events. Follow up (21Aug2015): New information reported from a contactable consumer includes: patient details, vaccine information and events information provided, new event added and outcome updated.
Age: 20.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chills, Fatigue, Headache, Meningism, Meningitis
Clinical narrative: This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A 20-year-old male patient of an unspecified ethnicity received TRUMENBA (Lot # UH906AA and Expiration Date Jun2016), via an unspecified route of administration on 01Jul2015 at 0.5 ml, single. The patient medical history and concomitant medications were not reported. The patient developed meningitis symptoms such as headache which required hospitalization, vomiting, nausea, stiff neck in Jul2015, all over body ache on 02Jul2015, fatigue and chills in Jul2015. Meningitis was not confirmed but there was definite meningeal irritation present on an unspecified date in 2015. The patient received ADVIL as treatment for headache, all over body ache and fatigue. No treatment received for vomiting, nausea, stiff neck and chills. The outcome of the event meningeal irritation was unknown while the patient recovered from all the other reported events. Follow up (21Aug2015): New information reported from a contactable consumer includes: patient details, vaccine information and events information provided, new event added and outcome updated.
Age: 20.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A 20-year-old male patient of an unspecified ethnicity received TRUMENBA (Lot # UH906AA and Expiration Date Jun2016), via an unspecified route of administration on 01Jul2015 at 0.5 ml, single. The patient medical history and concomitant medications were not reported. The patient developed meningitis symptoms such as headache which required hospitalization, vomiting, nausea, stiff neck in Jul2015, all over body ache on 02Jul2015, fatigue and chills in Jul2015. Meningitis was not confirmed but there was definite meningeal irritation present on an unspecified date in 2015. The patient received ADVIL as treatment for headache, all over body ache and fatigue. No treatment received for vomiting, nausea, stiff neck and chills. The outcome of the event meningeal irritation was unknown while the patient recovered from all the other reported events. Follow up (21Aug2015): New information reported from a contactable consumer includes: patient details, vaccine information and events information provided, new event added and outcome updated.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site urticaria, Ultrasound scan normal
Clinical narrative: Patient received pneumococcal polysaccharide vaccine (Pneumovax-23) injection in the left arm on 8/3/2015. Patient developed red welt/wheal of left upper extremity at vaccination site. Patient was sent to ultrasound on 8/6/15 due to appearance of arm. Ultrasound soft tissue of left arm negative for abscess.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Induration
Clinical narrative: Localized erythema and induration (3x4 inches) non tender to palpation.  Dad unsure of onset, first notice but nurse around 2 and seen at the clinic at 4:30. Treatment cool compresses and Ibuprofen.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Myalgia, Pain, Pyrexia
Clinical narrative: Pneumovax vaccine administered on R deltoid Monday 8/24/15. Experiencing notable pain at injection site and with movement of R arm, onset Monday night, stable pain since then. Today noted red bumps (appx 5-6) around injection site. Complains of muscle aches. Low grade fever 100*F by report (99.7 today in office). No pruritus at site. Gets influenza vaccine annually, no issues with this. No issues with other vaccines that she is aware of. NKDA. Denies symptoms of anaphylaxis including angioedema, wheezing, SOB, any airway issues; denies vomiting.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Pneumovax vaccine administered on R deltoid Monday 8/24/15. Experiencing notable pain at injection site and with movement of R arm, onset Monday night, stable pain since then. Today noted red bumps (appx 5-6) around injection site. Complains of muscle aches. Low grade fever 100*F by report (99.7 today in office). No pruritus at site. Gets influenza vaccine annually, no issues with this. No issues with other vaccines that she is aware of. NKDA. Denies symptoms of anaphylaxis including angioedema, wheezing, SOB, any airway issues; denies vomiting.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Pain in extremity, Peripheral swelling
Clinical narrative: Initial pruritus, redness, 5 dime sized welts around the injection site; Arm pain, feels swollen.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Initial pruritus, redness, 5 dime sized welts around the injection site; Arm pain, feels swollen.
Age: 25.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia, Ultrasound scan abnormal
Clinical narrative: Patient had persistent fever/temperature spikes. Patient also had induration, warmth, and erythema on left upper extremity. Per MD, fevers possibly secondary to cellulitis evolving at site of vaccine administration on LUE. Ultrasound of left upper extremity suggestive of cellulitis but revealed no collection/abscess per MD. Patient received Tdap IM at 0515 and Pneumovax SC at 1407 the previous day.
Age: 25.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Vaccination site cellulitis
Clinical narrative: Patient had persistent fever/temperature spikes. Patient also had induration, warmth, and erythema on left upper extremity. Per MD, fevers possibly secondary to cellulitis evolving at site of vaccine administration on LUE. Ultrasound of left upper extremity suggestive of cellulitis but revealed no collection/abscess per MD. Patient received Tdap IM at 0515 and Pneumovax SC at 1407 the previous day.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Blister, Rash, Rash pustular, Secretion discharge
Clinical narrative: Skin blistering and bumps. Pustules and serous discharge. Rash on both arms, legs, back and chest.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Crying, Nausea, Papule, Rash, Scleral discolouration
Clinical narrative: Pt received MMR, Varivax, Kinrix. Within 10- 15 minutes, she felt nauseated, vomited, mother noticed little bumps on her face. MD examined her, was crying, had no LOC, she had 2-6 mm flesh colored papules with welted appearance scattered over face, especially cheeks, and smaller ones scattered over upper arms. A few on trunk as well, 1-2 mm. Her lungs were clear, she had no stridor or difficulty breathing, tongue and mucous membranes, lips ok. Left eye with sclera pink, not swollen. she was given Benadryl, 18.75 mg, observed. Ate a popsicle, rash gone on arms in about 25 minutes, face mostly cleared and eye not red. She was playing and happy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Pt received MMR, Varivax, Kinrix. Within 10- 15 minutes, she felt nauseated, vomited, mother noticed little bumps on her face. MD examined her, was crying, had no LOC, she had 2-6 mm flesh colored papules with welted appearance scattered over face, especially cheeks, and smaller ones scattered over upper arms. A few on trunk as well, 1-2 mm. Her lungs were clear, she had no stridor or difficulty breathing, tongue and mucous membranes, lips ok. Left eye with sclera pink, not swollen. she was given Benadryl, 18.75 mg, observed. Ate a popsicle, rash gone on arms in about 25 minutes, face mostly cleared and eye not red. She was playing and happy.
Age: 10.0
Sex: M
Vaccine: MEA
Symptoms: Expired product administered
Clinical narrative: None. Vaccine was expired.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives, that spread to the whole body, Given medications in ER and given different types of medications to take home. Antihistamine (not Benadryl) can't remember what IV drugs were given. Took a couple of weeks to go away. Not hospitalized.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Apprx at the time of onset, pt reports extreme pain with flu vaccine in her dominant arm, R arm.  As of 3/21/2015 when pt came to me, pt has decreased weakness 4/5 and 10/10 pain with light touch.  Pt unable to move arm actively and passive movement increases pain.  Pain is disporportionate to touch.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Patient has a bruise that is starting to fade.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Vaccination error
Clinical narrative: A report has been received from a Physician concerning a 7 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). The patient's concurrent diseases(s) included arthritis and she was immune compromised. Concomitant medications included methotrexate. FLUMIST QUADRIVALENT started on an unknown date. Patient was received FLUMIST QUADRIVALENT but she was immune compromised on 27-Oct-2014. The outcome of the event of patient received FLUMIST QUADRIVALENT but is immune compromised was unknown. The report was considered to be non-serious by the reporter.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Fatigue, Guillain-Barre syndrome, Mobility decreased, Pain
Clinical narrative: Pt unable to wake up and move.  Pt had total body weakness.  Had to have someone help her to take her to ER.
Age: 1.75
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Seizure
Clinical narrative: Seizure x > 2 hours.
Age: 70.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, tenderness around the site of injection. Patient reports Tmax 100 F x 2. She was seen and treated on 08/28/2015.
Age: 70.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness, swelling, tenderness around the site of injection. Patient reports Tmax 100 F x 2. She was seen and treated on 08/28/2015.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red area left deltoid (area of injection site).
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema
Clinical narrative: Red area left deltoid (area of injection site).
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Asthma, Cough, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling in arm at location of injection; red raised 8 inches x 5 inches swelling; painful in back of left arm in area where varicella vaccine was administered; experienced 'asthma' cough; throat was itchy; used inhaler to reduce symptoms, no interference with daily activities.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Throat irritation
Clinical narrative: Swelling in arm at location of injection; red raised 8 inches x 5 inches swelling; painful in back of left arm in area where varicella vaccine was administered; experienced 'asthma' cough; throat was itchy; used inhaler to reduce symptoms, no interference with daily activities.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Eye movement disorder
Clinical narrative: Got really quiet and weak and eyes rolling back but responsive and follows commands. O2 saturation was 99%, HR=78/min, BP=110/60.RR=20. BP before vaccination was 108/62. Child was placed in supine position. By 5:30 PM, she was laughing at picture on her phone and talking loudly. At that point she was discharged home.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Pain around injection site. Redness and swelling occurred entire upper left arm.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9, PNC13
Symptoms: Amnesia
Clinical narrative: Mom states pt had immunizations and that pt "had a loss of memory for 12 hours."  Pt could not remember taking a driving test. Mom took pt to ER but left after being told wait would be about 4 hours. Pt recovered the next day but per mom pt still cannot remember the day of vaccines.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Edema, erythema localized at injection site.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Itching in spots all over body. Feels like poison oak, but with no red spots or raised lesions.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: Swelling, warm to the touch pain.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Joint crepitation
Clinical narrative: Patient became lightheaded and knees buckled as he walked across the room.  Patient was caught by staff and patient's father and laid onto the exam table.  His legs were elevated and a cool, wet cloth laid across his forehead.  Overhead was used to page a physician who came and assessed the situation.  Patient did not fall onto the floor or hit his head.  After 5 minutes patient was feeling much better so his head was elevated.  After another 5 minutes he walked to the chair.  His blood pressure and pulse were then taken and were as follows:  BP 188/72 and P 78. After a total of 15 minutes patient was feeling much better and left the room.  No follow up is needed.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: LEFT UPPER ARM PAIN, REDNESS AND SWELLING.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Differential white blood cell count normal, Full blood count normal, Herpes zoster, Injection site erythema, Injection site reaction
Clinical narrative: It was red and swollen around the injection site.  On the July 30th there was a red rash around the swollen red area. On August 4th I stopped at the Pharmacy for the Pharmacist to look at it.  She said the rash looked like a light case of Shingles.  On August 19th I noticed I had a red rash on the front of both legs which seemed to spread to the rest of my body.  I was able to see my PCP He ordered a COMPLETE BLOOD COUNT WITH AUTO DIFFERENTIAL - Details.  He didn't believe my rash was shingles because I didn't the rash didn't itch or have the fluid filled bumps. I'm to follow up with the doctor in 2 weeks if not improved. I believe the rash all over my body has something to do with the Shingles Vaccine.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash, Rash erythematous, Rash generalised
Clinical narrative: It was red and swollen around the injection site.  On the July 30th there was a red rash around the swollen red area. On August 4th I stopped at the Pharmacy for the Pharmacist to look at it.  She said the rash looked like a light case of Shingles.  On August 19th I noticed I had a red rash on the front of both legs which seemed to spread to the rest of my body.  I was able to see my PCP He ordered a COMPLETE BLOOD COUNT WITH AUTO DIFFERENTIAL - Details.  He didn't believe my rash was shingles because I didn't the rash didn't itch or have the fluid filled bumps. I'm to follow up with the doctor in 2 weeks if not improved. I believe the rash all over my body has something to do with the Shingles Vaccine.
Age: 66.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PATIENT PRESENTED TO PHARMACY 8 DAYS POST IMMUNIZATION WITH REDNESS AND NOTICABLE SWELLING AT PREVNAR 13 INJECTION SITE. INSTRUCTED PT. TO USE COLD COMPRESS, DIPHENHYDRAMINE AND ACETAMINOPHEN IF NEEDED. INSTRUCTED PT. TO SEEK MEDICAL ATTENTION IF NO IMPROVEMENT OR WORSENING.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Adverse reaction, Burning sensation, Erythema, Infection, Pruritus
Clinical narrative: Red arm, itchy, burning, Red spreading down arm, warm arm.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Red arm, itchy, burning, Red spreading down arm, warm arm.
Age: 18.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Deafness, Dizziness, Dyspnoea
Clinical narrative: He became very light headed and couldn't breathe or hear. Gasping for breath.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Electroencephalogram, Immediate post-injection reaction, Seizure, Syncope
Clinical narrative: Immediately went into seizure and then fainted.  Woke up within 2-3 minutes.  No treatment necessary at that time.  Waited 20 minutes to leave. In process of getting treatment for ongoing seizures since shot.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Enema administration, Intussusception, Pain, Screaming, Ultrasound abdomen abnormal
Clinical narrative: Baby screaming with pain intermittently and vomiting. Seen in ED on 8/22 had intussusception, reduced by air enema and observed overnight inpatient x 24hr.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Baby screaming with pain intermittently and vomiting. Seen in ED on 8/22 had intussusception, reduced by air enema and observed overnight inpatient x 24hr.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Exfoliative rash, Rash generalised
Clinical narrative: Small spots on left arm 1st week. Week 1-7 large spots all over body. Scaly rash.
Sex: F
Vaccine: FLUN4
Symptoms: Foetal exposure during pregnancy, Neonatal pneumonia
Clinical narrative: A report received from a health professional concerning a neonate, female patient, height: 18.5 centimeters; weight: 8.0 pounds. No information regarding relevant history and concomitant disease was provided. Concomitant medications included ascorbic acid, biotin, minerals nos., nicotinic acid, retinol, tocopherol, vitamin B nos., vitamin D nos. The patient received transplacental FLUMIST QUADRIVALENT when the mother received FLUMIST QUADRIVALENT (intranasal) on 17-Nov-2014. The patient experienced newborn pneumonia of maternal abruption which occurred on 06-Aug-2015. The outcome of the event of newborn pneumonia of maternal abruption was unknown. The outcome of the pregnancy was reported to be a non-healthy baby. The AZ physician identified the event newborn pneumonia of maternal abruption from the source document and assessed as serious due to hospitalization.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 14 year old male patient. On 20-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (lot # and route unknown). On 26-AUG-2015, the patient was in the office to be vaccinated with second dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Flushing, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Leg pain, red and warm. Itching. Flushed cheeks. Area to left thigh raised.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Skin warm
Clinical narrative: Leg pain, red and warm. Itching. Flushed cheeks. Area to left thigh raised.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 14-AUG-2015, the patient was vaccinated with LIQUID PEDVAXHIB (dose, route, lot# were not reported) and PENTACEL on the same day (overdose). No concomitant medications reported. No adverse effect reported. 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 certified medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL lot# K023432, expiration date: 18-JUN-2016 and lot# K007828, expiration date: 03-MAR-2017 (dose and route not reported). 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: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates since 15-JUL-2015, the patients were vaccinated with an unspecified number of improperly stored doses of (Oka/Merck) VARIVAX (dose, route, lot# and expiration date were not reported). Concomitant drug was not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 24-FEB-2015, the patient was vaccinated with improperly stored MMR II (therapy type and dose not provided, lot number #K005431, expiration date 15-APR-2016) for routine vaccination. No adverse effects were reported. This is one of several received from the same source. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative
Clinical narrative: Information has been received from a licensed practical nurse referring to an approximately 51 year old female patient with codeine allergy. The patient had none pertinent medical history. The patient might have received MMR II (strength, route, dose were unknown) previously and had a titer drawn in January 2015. The titer showed that the patient had immunity to rubella, but not measles and mumps. On 02-FEB-2015 the patient was adminsitered a dose of MMR II (lot # J008728, expiration date: 26-JUL-2015, 0.5 ml, subcutaneous). Concomitant therapies included SYNTHROID. On an unspecified date after 02-FEB-2015, a titer was drawn again and the patient had negative immunity to rubeola. The patient did not give treatment to the negative immunity to rubeola. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot# L006545, expiration date: 27-NOV-2017 (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.13
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to female patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 14-JUL-2015 the patient was vaccinated with improperly stored M-M-R II (unknown strength, route and dose) lot # K004949 with an expiry date of 04-APR-2016, stored at improper temperature (< 46 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ lot# K016261, expiration date: 23-JUN-2016, route defaulted to oral, dose was not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 13 year old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 21-AUG-2015, the patient was inadvertently vaccinated with the dose of M-M-R II (0.5 ml, lot # L008684 expiration date 13-MAR-2017) intramuscularly rather than subcutaneously. The pharmacist was not sure if this M-M-R II dose was the patient's first dose or a booster dose. No adverse effects were reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Rash, Rash macular, Rash pruritic
Clinical narrative: This spontaneous report as received from a physician assistant via company representative refers to a 63 year old female patient. On 17-JUL-2015 the patient was vaccinated with ZOSTAVAX vial (lot # L011534 and expiry date not reported) of dose 0.65 milliliter (ml) once, subcutaneous to prevent shingles. Concomitant therapies included unspecified thyroid medication, TOPIRAMATE, FOSAMAX and probiotics. On 18-JUL-2015, the patient developed rash with "macular lesions that wrapped around her lower left extremity, it was itchy, warm to the touch, red and burning". On the same day of 18-JUL-2015, the physician assistant instructed the patient to put hydrocortisone cream (manufacturer unspecified) on the rash as treatment however "it made the rash worse" (captured in MARRS # 1508USA011725). The patient sought for the medical attention and was then seen again by the physician assistant on 21-JUL-2015 and she was prescribed Acyclovir (manufacturer unspecified) and Betamethasone cream (manufacturer unspecified) as treatment. No laboratory details were provided. The outcome of rash with macular lesions that wrapped around her lower left extremity, itchy, warm to the touch, red and burning was unknown. The causality of the reported events was unknown. No product quality complaint (PQC) was filed. This is one of the two reports of the same patient. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: This spontaneous report as received from a physician assistant via company representative refers to a 63 year old female patient. On 17-JUL-2015 the patient was vaccinated with ZOSTAVAX vial (lot # L011534 and expiry date not reported) of dose 0.65 milliliter (ml) once, subcutaneous to prevent shingles. Concomitant therapies included unspecified thyroid medication, TOPIRAMATE, FOSAMAX and probiotics. On 18-JUL-2015, the patient developed rash with "macular lesions that wrapped around her lower left extremity, it was itchy, warm to the touch, red and burning". On the same day of 18-JUL-2015, the physician assistant instructed the patient to put hydrocortisone cream (manufacturer unspecified) on the rash as treatment however "it made the rash worse" (captured in MARRS # 1508USA011725). The patient sought for the medical attention and was then seen again by the physician assistant on 21-JUL-2015 and she was prescribed Acyclovir (manufacturer unspecified) and Betamethasone cream (manufacturer unspecified) as treatment. No laboratory details were provided. The outcome of rash with macular lesions that wrapped around her lower left extremity, itchy, warm to the touch, red and burning was unknown. The causality of the reported events was unknown. No product quality complaint (PQC) was filed. This is one of the two reports of the same patient. 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 certified medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot# L006384, expiration date: 25-FEB-2017 (dose and route not reported). 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 registered nurse refers to four patients of unknown demographics. Pertinent medical history and concomitant therapies were not reported. On unknown dates, the patients received improperly stored (Oka/Merck) VARIVAX (lot # L006385, expiry date 25-FEB-2017, dose and route not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Bacterial test negative, Blister, Body temperature increased, Burning sensation, Cough
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 15 month old female patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine strain. On 21-APR-2015, the patient was vaccinated with (Oka/Merck) VARVIAX (lot #K002045, expiry date 10-FEB-2016) 0.5 ml in the left arm. On 20-JUL-2015, three months after vaccination, the patient experienced cough, nasal congestion and maximum body temperatures was 102.0 Fahrenheit. The patient also experienced rash which was blistering and burning, diagnosis was made to herpes zoster. The patient was prescribed acyclovir 200 mg/5ml for the treatment and was given counseling. On 20-JUL-2015, the patient had varicella zoster detected by immune-fluorescent monoclonal antibody staining in spin amplified shell vial culture, no herpes simplex virus (HSV) was isolated in the HSV culture. On the same day, aerobic bacterial culture had no growth in 36-48 hours. An examination was performed including the  scalp (including hair inspection) head (including face), lips but not teeth and gums, neck, chest, abdomen, back, right upper extremity, left upper extremity, and inspection and palpation of digits and nails. Findings all the examinations was normal. The reporter stated that the lesions should be treated within 48 hours of onset with anti-virus therapy. The patient's recovered from the events on an unspecified date in 2015. The reporter did not provide the relatedness of the events with (Oka/Merck) VARIVAX. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Herpes simplex serology negative, Herpes zoster, Nasal congestion, Rash, Skin lesion
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 15 month old female patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine strain. On 21-APR-2015, the patient was vaccinated with (Oka/Merck) VARVIAX (lot #K002045, expiry date 10-FEB-2016) 0.5 ml in the left arm. On 20-JUL-2015, three months after vaccination, the patient experienced cough, nasal congestion and maximum body temperatures was 102.0 Fahrenheit. The patient also experienced rash which was blistering and burning, diagnosis was made to herpes zoster. The patient was prescribed acyclovir 200 mg/5ml for the treatment and was given counseling. On 20-JUL-2015, the patient had varicella zoster detected by immune-fluorescent monoclonal antibody staining in spin amplified shell vial culture, no herpes simplex virus (HSV) was isolated in the HSV culture. On the same day, aerobic bacterial culture had no growth in 36-48 hours. An examination was performed including the  scalp (including hair inspection) head (including face), lips but not teeth and gums, neck, chest, abdomen, back, right upper extremity, left upper extremity, and inspection and palpation of digits and nails. Findings all the examinations was normal. The reporter stated that the lesions should be treated within 48 hours of onset with anti-virus therapy. The patient's recovered from the events on an unspecified date in 2015. The reporter did not provide the relatedness of the events with (Oka/Merck) VARIVAX. Additional information has been requested.