chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: RAB
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: Presented for 3rd pre-exposure Rabies vaccine prior to heading down to work. He stated just after the needle was inserted he felt a sharp pain and burning sensation that didn't change when vaccine was administered. He stated he advised staff but felt he could leave. He went to the waiting room and noted his left arm pain was increasing and had a numb/tingling like sensation from top of shoulder down arm in a band-like fashion, over lateral side of elbow and stopped just on top of his wrist. Sensation did not extend to the fingers, dorsal surface or palmar surface of hand. He has no restrictions in ROM, grip, weakness; no true loss of sensation, no rash, edema, axillary pain, no chest pain, no neck pain, no other systemic symptoms. 1/9/2017 symptoms almost resolved now tingling only at vaccine site.
Age: 57.0
Sex: M
Vaccine: RAB
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Presented for 3rd pre-exposure Rabies vaccine prior to heading down to work. He stated just after the needle was inserted he felt a sharp pain and burning sensation that didn't change when vaccine was administered. He stated he advised staff but felt he could leave. He went to the waiting room and noted his left arm pain was increasing and had a numb/tingling like sensation from top of shoulder down arm in a band-like fashion, over lateral side of elbow and stopped just on top of his wrist. Sensation did not extend to the fingers, dorsal surface or palmar surface of hand. He has no restrictions in ROM, grip, weakness; no true loss of sensation, no rash, edema, axillary pain, no chest pain, no neck pain, no other systemic symptoms. 1/9/2017 symptoms almost resolved now tingling only at vaccine site.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Left deltoid pain, fever to 102.1, vomiting.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Hypertension, Urticaria
Clinical narrative: High blood pressure, full body hives.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Jaundice
Clinical narrative: Severe jaundice.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Patient experienced fever of 102 degrees farenheit and had diarrhea three times. This resolved on its own over the next 24 hours.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, OPV, PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: 102 degree fever, full body hives.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Muscular weakness, Neck pain, Ultrasound Doppler
Clinical narrative: Pain in the inside of the elbow, upper arm where shot was in left arm, shoulder and neck. I went to the Doctor on 1/9/2016 and they gave me prednisone for 3 days and then had me ice the arm and shoulder. I also had trouble eating eggs and weakness in my left hand. Pain did not go away so Dr referred me to another Dr for Nerve Testing. I also started Physical Therapy for 6 weeks. On February 20th as the pain was still there they did a Vascular Ultrasound. The symptoms are still there and I have continual Pain in my left arm, shoulder and neck.
Age: 14.0
Sex: M
Vaccine: HPV9, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mother called on 04/21/2017 at 5:00PM to report that pt had a 3 inch area of redness and 2 inch area of swelling on L arm "at the site of the GARDASIL vaccine." He also had soreness and warmth at the site.  At the time of the call mother had already administered ibuprofen and pt had been applying an ice pack.  She was preparing to administered Benadryl but was calling to specifically ask if there was any other recommendation.  Mother was advised to mark the border of the redness with a pen, and if redness exceeded this marked area to take pt to urgent care that evening.  Pt came in 4/24/17 for an appt to rule out a "sinus infection."  The site was visualized at 3:30PM 04/24/2017 by RN.  There was still approximately 1.5 inches of swelling but redness and warmth had resolved.  Pt denied pain or itching at the site.  Mother reported 04/24/17 @ 3:30PM that pt had a similar reaction in the past to a vaccine but she can't recall which vaccine and when it occurred.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: PT FAINTED FOR ABOUT 5 TO 10 SECONDS AND THEN SHE WAS OK. SHE WARNED US THAT SHE HAD FAINTED WITH A PAST VACCINE BECAUSE OF ANXIETY OF BEING STUCK WITH A NEEDLE. SHE LEFT THE PHARMACY FINE.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Diet refusal, Discomfort, Faeces discoloured, Frequent bowel movements, Grunting
Clinical narrative: Bowel movements turned green & mucousy for 4 weeks, became very frequent (sometimes >1 per hour); child began waking in the night with discomfort/grunting to have bowel movement; three episodes of inconsolable crying and refusal to eat within week of vaccine (had never happened before) - longest episode resulted in not eating for about 7 hours during daytime/evening hours.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Middle insomnia, Mucous stools
Clinical narrative: Bowel movements turned green & mucousy for 4 weeks, became very frequent (sometimes >1 per hour); child began waking in the night with discomfort/grunting to have bowel movement; three episodes of inconsolable crying and refusal to eat within week of vaccine (had never happened before) - longest episode resulted in not eating for about 7 hours during daytime/evening hours.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Angioedema, Pruritus, Pyrexia, Rash vesicular
Clinical narrative: Fever on and off 4/7-4/22 (date seen). 4/11/17 head/neck angio edema (ED-steroid, EPI and anti hist.). Vesicular rash 4/21-4/22. Itchy, on trunk/face total approx 10.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Rash
Clinical narrative: Rash on chest and left arm. Started with a warm red painful rash on right upper arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient had redness and itching at injection site. Patient applied ice but was unwilling to apply or take any medication.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site inflammation, Injection site rash
Clinical narrative: Patient was administered ZOSTAVAX Sat. Apr 15,2017 at 4:30 PM. Patient said she had shingles two different times. On Mon. the patient came in and said she had a reaction to the injection. The area looked inflamed and had a bumpy rash. She went to the doctor on Tues., 4-19-17. The doctor said sometimes people do have a reaction. He prescribed VALTREX GM 21 to be taken every 8 hours.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient was administered ZOSTAVAX Sat. Apr 15,2017 at 4:30 PM. Patient said she had shingles two different times. On Mon. the patient came in and said she had a reaction to the injection. The area looked inflamed and had a bumpy rash. She went to the doctor on Tues., 4-19-17. The doctor said sometimes people do have a reaction. He prescribed VALTREX GM 21 to be taken every 8 hours.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Eye movement disorder, Feeling abnormal, Tremor
Clinical narrative: Patient went to sit down next to mom after vaccines, as soon as she sat down she told mom "she didn't feel good." Patient started to slide down on chair eyes started rolling back and pt. started to shake.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Swelling about 4 inches to injection area and redness for about 1 week. Swelling went away 2nd week, but still come redness. No more soreness.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash papular, Scab, Varicella virus test positive
Clinical narrative: Rash - Scattered vesicular papular eruption that dried to scabs over 1 wk.
Age: 1.08
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Eating disorder, Rash
Clinical narrative: Exposure at home to family member with shingles (rash for family member developed 4/17/2017) VARICELLA vaccine administered to patient on 4/19/17 Rash developed on chest, back, groin, proximal extremities on 4/21/2017 No fevers. Slight decrease eating. Drinking well.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Fatigue, Injection site bruising, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Redness, swelling, bruising (of (L) deltoid/arm), fever, body aches, fatigue, and nausea. Treatment: Cephalexin, apply ice, Ibuprofen po.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Redness, swelling, bruising (of (L) deltoid/arm), fever, body aches, fatigue, and nausea. Treatment: Cephalexin, apply ice, Ibuprofen po.
Age: 1.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Fatigue, Irritability, Pyrexia, Vomiting, Wrong drug administered
Clinical narrative: TRUMENBA given in error instead of PREVNAR 13 on 4-19-17. Dr consulted infectious disease MD Dr. on 4/19/17. Fever started 4-19-17, vomited 4-5x 4/21/17 with fatigue, irritability. All signs and symptoms resolved 4/22/17.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site approximately 2 days after vaccination; went to physician for antibiotic and methylprednisolone.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient was given flu vaccine in right deltoid muscle. Approximately 1 minute later patient fainted. She was responsive approximately 5 seconds after she fainted. Patient was stable after event. Her father was notified and was brought to the ED for evaluation.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Eye swelling, Hypersensitivity, Injection site swelling, Swelling face
Clinical narrative: Mom c/o that when she received the varicella vaccine the child's left eye, cheeks, and arm swelled up. Allergic.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity, Pyrexia, Rash generalised, Staphylococcal infection, Surgery
Clinical narrative: Had rash-generalized all over body, fever highest at 103 and vomiting-occurred 3 days after MMR immunization. Allergic. Secondary infection of staph infection had surgery.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Had rash-generalized all over body, fever highest at 103 and vomiting-occurred 3 days after MMR immunization. Allergic. Secondary infection of staph infection had surgery.
Age: 1.75
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: R thigh redness swelling minimal pain no induration 1 day after immunizations. Lesion on DTaP and varicella site. Likely from DTaP.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Eye swelling, Eyelid oedema, Hypersensitivity, Rhinorrhoea
Clinical narrative: Approximately 10 minutes post vaccine administration bilateral lower eyelid swelling and runny nose noted. 15-20 minutes post administration marked peri orbital swelling noted. Allergic.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site reaction, Type III immune complex mediated reaction
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 596538). This spontaneous report refers to a 11 year old male patient. The patient's concurrent illnesses, medical history and prior vaccinations were not reported. On 16-SEP-2015 the patient was vaccinated with GARDASIL 9, lot # L014415, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with ADACEL (lot# U5241AA, dose 1, intramuscularly in right arm) and MENACTRA (lot# U4986AA, dose 1, intramuscularly in right arm). On 17-SEP-2015, the patient experienced injection site reaction and type iii immune complex mediated reaction. Arthus reaction of right arm at injection site. The outcome of injection site reaction and type iii immune complex mediated reaction was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 597214). This spontaneous report refers to a 11 year old male patient. The patient's concurrent illnesses and medical history were reported as none. On 30-JUL-2015 the patient was vaccinated with GARDASIL 9 for prophylaxis (dose, lot# and route were not reported). On the same day, the patient was vaccinated with BOOSTRIX (dose, lot# and route were not reported) and MENACTRA (dose, lot# and route were not reported). On 30-JUL-2015, the patient experienced injection site erythema and injection site swelling. Arm where Tdap and MCV4 was given became red and swollen after vaccination. It lasted a few days. No hospitalization or office visit required. The outcome of injection site erythema and injection site swelling was reported as recovered. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Fear, Muscle twitching, Posture abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 601752). This spontaneous report refers to a 11 year old female patient. The patient's concurrent illnesses was reported as none. The patient's medical history was not reported. On 07-OCT-2015 the patient was vaccinated with GARDASIL 9, lot # L013429, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with MENACTRA (lot# U5178AA, dose 1, intramuscularly in left arm) and ADACEL (lot# U5264AA, dose 1, intramuscularly in right arm). On 07-OCT-2015, the patient experienced fall, posture abnormal, muscle twitching and fear. Few minutes after vaccine administration, patient slumped in chair, fell to floor, and patient's mother described twitching of arms and legs. Nurse came to evaluate, patient was conscious, placed on exam table, given supplemental oxygen. Patient stated that she was feeling better, but was visibly sea red. Emergency department team transferred patient to emergency department where report was full resolution after observation with no further intervention. Oxygen Saturation was 100% on 5L. Other Medications were denied. The outcome of fall, posture abnormal, muscle twitching and fear were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 602446). This spontaneous report refers to a 13 year old female patient. The patient's concurrent illnesses was reported as none and prior vaccinations were not reported. The patient's historical drug included BACTRIM. On 05-OCT-2015 the patient was vaccinated with GARDASIL 9, lot # L014415, dose 3, intramuscularly in the right arm for prophylaxis. On the same day, the patient also vaccinated with FLUZONE (lot# U1423AA, intramuscularly in right arm). On 06-OCT-2015, the patient experienced injection site erythema and injection site warmth. Right upper arm width 4.5 cm x 4.5 cm erythematous patch slightly warm. The outcome of injection site erythema and injection site warmth was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram head, Fall, Head injury, Spinal X-ray, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 621641). This spontaneous report refers to a 12 year old female patient. Information on the patient's other medications was not reported. Patient had no concurrent illness and medical history. On 26-JAN-2016, the patient was vaccinated with GARDASIL 9 lot # L017407, dose 2 (unspecified dose and frequency), intramuscularly in the left arm for prophylaxis. After vaccination, patient waited in the room approximately 10 minutes with her dad and stated that she felt ok. Later patient went to scheduling window to schedule GARDASIL 9 dose 3 and stood behind her dad and fainted, fell back and hit her head. Lab data included computerized tomogram (CT) head and neck/cervical X-ray. The patient was taken to emergency room. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not reported. Agency considered the case to be serious as these events led to hospitalization. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Fatigue, Loss of consciousness, Paraesthesia, Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 623259). This spontaneous report refers to a 25 year old female patient. Patient had no concurrent illnesses, medical history and other medications. On 10-FEB-2016, the patient was vaccinated with GARDASIL 9 (lot # not reported), dose 3, intramuscularly in the right arm for prophylaxis. Moments after leaving the doctors office, patient felt very tired and low of energy. She then noticed something was wrong, her body started to tingle all over and her vision became blurry. Patient released her foot from the gas pedal and that was when she blacked out while driving. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Agency considered the case to be serious as these events lead to hospitalization. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Epistaxis, Immune thrombocytopenic purpura, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 624373) on 18-APR-2017. This spontaneous report refers to a 14 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 03-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L019297, dose 2 via intramuscular route in the right arm for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with FLUZONE lot/batch# UI503AB, dose 12 via intramuscular route in the left arm for prophylaxis (dosage unspecified). On 27-FEB-2016, the patient experienced nose bleeds, decreased platelet count (8000), immune thrombocytopenic purpura, petechiae rash and received immunoglobulin therapy. The outcome of platelet count decreased, immune thrombocytopenic purpura, epistaxis, immunoglobulin therapy and petechiae was unknown. The causality assessment was not reported. The agency considered the case serious due to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 28.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Underdose
Clinical narrative: Pediatric dose given in error.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMR, DTAP, MMR
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: Patient received an MMR on 4-18-17. Vaccine expired on 4-10-17. Patient did not experience any symptoms.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMR, DTAP, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an MMR on 4-18-17. Vaccine expired on 4-10-17. Patient did not experience any symptoms.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, PPV, RVX
Symptoms: Apnoea, Cyanosis, Hypotonia, Pallor, Pyrexia
Clinical narrative: Apnea, limpness, color change (gray color, pale, blue lips), fever.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, PPV, RVX
Symptoms: Skin discolouration
Clinical narrative: Apnea, limpness, color change (gray color, pale, blue lips), fever.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates since October 2016, the patients were vaccinated with a dose of PNEUMOVAX 23 (dosage, route of administration, lot # and expiry date were not provided) which were improperly-monitored. No adverse experience was reported. The temperatures, when recorded, were always within the recommended storage range. There was a period, when the temperature would not be recorded for 3 or 4 days and there were occasions when the temperature would be recorded only once a day. There was no previous temperature excursion reported. Digital data logger was not involved. No product quality complaint was involved. Follow up information has been received from an unspecified reporter referring to a 63 year old female patient on 11-APR-2017. The first dose of PNEUMOVAX 23 was vaccinated in October 2016. On 06-FEB-2017, the patient was vaccinated with the second dose of PNEUMOVAX 23 (Inappropriate schedule of vaccine administered) (dose and expiration date unknown, lot# M036678, left deltoid) intramuscularly for prophylaxis. There was potential compromise of PNEUMOVAX 23 due to multiple in monitoring refrigerator temperature. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA012462: US-009507513-1704USA012461: US-009507513-1704USA012459: US-009507513-1704USA012460.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 1-year-old male patient. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On 04-APR-2017, the patient received a properly stored dose of M-M-R II (albumin status rHA) (dose and route of administration were not provided), lot # L011528, expiration date 03-APR-2017. No adverse effects were reported. Additional information is not expected as there was no consent for further contact.
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 18 year old female patient. There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications provided. On an unspecified date in 2017, the patient was vaccinated with GARDASIL 9, (dose, route of administration, lot # and expiration date were not provided) for the prevention of HPV. The physician reported that the patient, upon being vaccinated "a couple of weeks ago", passed out. It was reported that the patient was not injured. The office protocol had the patient taken to an emergency room, "to ensure something else was not going on with the patient". The patient was diagnosed with a vasovagal response at the emergency room. The patient's symptoms fully resolved the same day as the vaccination. The relatedness between the events and therapy with GARDASIL 9,was not provided by the 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 an unspecified number of patients of unknown age and gender. From 24-MAR-2017 to 06-APR-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M042497, expiration date: 17-MAR-2019 for prophylaxis. The patients experienced no adverse effects. Administered doses of vaccines experienced the temperature excursion of -14 to -10 degrees Celsius for 7 hours 30 minutes.  Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA012312:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX (strength, dose, route of administration, lot number and expiration date were not reported)  for prophylaxis, however no adverse effects were reported. It was reported that the vaccine were exposed to temperature of 4 centigrade degrees for a time frame of 2 hours and 55 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA012144: US-009507513-1704USA012143: US-009507513-1704USA012141: US-009507513-1704USA012142:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ with lot # L033693 and expiration date of 31-MAY-2017 (strength and dose were not reported) for prophylaxis, however no adverse effects were reported. It was reported that multiple unspecified doses of the vaccine were exposed to room temperature of 47 Fahrenheit degrees (°F) to 77 °F for a time frame of 3 hours. The temperature excursion was not recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash, Varicella
Clinical narrative: Information had been received on 14-APR-2017 from a field representative who reported from a physician that about four weeks ago (unspecified date), a 65 year old female patient came into the office to receive her ZOSTAVAX subcutaneous injection for prevention of shingles (dosage not reported). The physician stated that the patient came back to their office about two weeks later (unspecified date) with complaints of "a rash" at the injection site and on her other arm (did not specify which arm was the injection site arm). The physician stated that it was concluded that the patient "developed chicken pox" as a result of the Zoster Vaccine Live (ZOSTAVAX) injection. The physician stated they instructed the patient to take diphenhydramine (BENADRYL) and use calamine lotion. Outcome of chicken pox was not reported. No other information was given on this matter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Cellulitis, Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a Registered nurse, referring to a 5 year old male patient. The patient's concurrent conditions included chronic ear infections since unspecified dates and penicillin allergy. On 10-APR-2017, the patient was vaccinated with a dose of PROQUAD subcutaneously, which had a lot # M031565 and expiration date on 24-DEC-2017, (dose, and Anatomical location of administration were unknown) as a routine vaccine. Concomitant therapies included fluticasone propionate (FLONASE). On 11-APR-2017, the patient developed a "rash that was red, raised and painful" and he was seen in the office. However, no laboratory tests were performed. Subsequently, the patient was prescribed with sulfamethoxazole, trimethoprim (BACTRIM) as a treatment. On 13-APR-2017, the patient returned to the office and he was diagnosed with cellulitis. At the reporting time, the patient had not recovered from the event. No causal relationship was provided between vaccination with PROQUAD and cellulitis. Upon internal review, cellulitis was considered as a medically significant event.   Additional information has been requested.
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a Register Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On 22-APR-2014, the patient received first dose of M-M-R II (route of administration, lot number, expiration date, and anatomical location were unknown) for prophylaxis, reconstituted with sterile diluent (MRK) (lot number and expiration date were unknown); later on 22-APR-2014 received a second dose of M-M-R II with lot number H017435 and expiration date 20-SEP-2014 (route of administration and anatomical location were unknown) for prophylaxis, reconstituted with sterile diluent (MRK) with lot number J002745 (expiration date was unknown). There were no adverse effects reported. Lot number J002745 is an invalid lot number for sterile diluent (MRK). There was not Product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Colitis ulcerative, Condition aggravated
Clinical narrative: This spontaneous report has been received from a nurse practitioner referring to a male patient of unknown age with colitis ulcerative. The patient's medical history and drug reactions/allergies were not reported. Concomitant medications included infliximab (REMICADE).  In December 2016, the patient was vaccinated with ZOSTAVAX (strength, dose, lot #, expiration date or anatomical location were not reported) subcutaneously as prevention of shingles. On an unknown date, the patient experienced an increase in "ulcerative colitis" after receiving the vaccine. No additional adverse event information was reported. The outcome of the event and the causal relationship with the suspect therapy were not provided. Upon internal review the colitis ulcerative was considered as a medically significant event. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from an office manager via a company representative refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly (dose, lot# and expiration date were not provided), for prevention of Human Papillomavirus. On an unknown date, the patient experienced an unspecified adverse event that required hospitalization. The patient recovered on an unknown date. The relatedness between the unspecified adverse event and GARDASIL 9 was not provided. Additional information is not expected, as there was no consent to contact the physician.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 01-JAN-2012, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-JUN-2016, the patient was treated in Emergency department for a painful rash that was diagnosed as severe case of shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: Information was received on 19-APR-2017 from an attorney in the from of an initial legal complaint regarding a female patient (age not reported). Medical history, concurrent condition and concomitant therapy were not reported. On 02-NOV-2012 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevent of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-MAY-2016 the patient was treated at a physician's office for an ongoing painful rash and persistent nerve pain which was then diagnosed as a shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical treatment. As a further proximate result the patient suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 25-NOV-2013, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused a persistent strain of herpes zoster. On or about 10-OCT-2014, the patient was treated for an ongoing painful rash and persistent nerve pain which was diagnosed as shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients may had received an improperly stored doses of PNEUMOVAX 23 (dose and route were not reported) lot # M043424, the expiration date: 06-JUN-2018 for prophylaxis. No adverse effects reported. There was no concomitant medication provided. The temperature excursion was reported between 32°F to 35°F during 1 Hour 12 Minutes. The call was made due to "data logger" and there was no previous temperature excursion reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 20-APR-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 19-APR-2012 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-DEC-2013, the patient was treated by a physician for a painful rash that was diagnosed as shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 01-DEC-2014, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-JUL-2016, the patient was seen at a hospital for a painful rash that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information was requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 20-APR-2017 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 20-JUL-2007 by a physician as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-NOV-2012, the patient was treated by a physician for a painful rash that was diagnosed as shingles. While shingles is an incurable viral condition, the patient has been prescribed unspecified antivirals and valacyclovir hydrochloride (VALTREX) to manage his symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 15 month old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was accidentally vaccinated with an expired dose of M-M-R II (dose, strength, frequency, route of administration and anatomical location were not provided) (lot # L010488 with expiration date 26-MAR-2017), for prophylaxis. No adverse effects were reported. This is one of 2 reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA011927:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 30-MAY-2012, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-DEC-2013, the patient was treated for a painful rash that was diagnosed as shingles. On or about 24-APR-2015, the patient was treated again for ongoing and worsening symptoms of a shingles outbreak. While shingles is an incurable viral condition, she was prescribed acyclovir to manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 29-APR-2015, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-JUN-2016, the patient was treated for a painful rash that was diagnosed as herpes zoster dermatome. On or about 26-JUL-2016, the patient was treated for postherpetic neuralgia. On or about 09-AUG-2016, he was treated for a condition diagnosed as a complication of herpes zoster. While shingles and post herpetic neuralgia is an incurable condition, he was prescribed acyclovir to manage his symptoms outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 11-NOV-2016 at local pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JUL-2016 (conflicting dates), the patient was treated by physician for an ongoing painful rash which was diagnosed as shingles with a cellulitis infection. Although shingles is a incurable viral condition the patient was prescribed gabapentin and VALTREX for management of his symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 20-SEP-2013 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-JUN-2016, the patient was treated at a hospital for a painful rash that was diagnosed as a severe case of shingles. It was reported, that although shingles is an incurable condition, the patient was prescribed valaciclovir and hydrocodone for management of his symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: Information was received on 20-APR-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. It is alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine on or about 20-MAY-2014 at a medical clinic, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-MAY-2014, the patient was treated at an urgent care center for a painful rash which was diagnosed as shingles with ophthalmic complications (meaning the shingles had spread to the eyes). Herpes zoster in the eyes can cause long-term damage and permanent blindness. Although shingles is an incurable viral condition, the patient was prescribed valacyclovir for management of his symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Upon internal review, ophthalmic herpes zoster was determined to be medically significant. Additional information has been requested.