chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant concening a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 03-MAY-2017, the patient  received improperly stored dose of VARIVAX (dose, frequency not reported) (Lot: M041513, expiry date: 11-OCT-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA000291: US-009507513-1706USA000288: US-009507513-1706USA000289: US-009507513-1704USA014383:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant concerning a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 05-MAY-2017, the patient  received improperly stored dose of VARIVAX (dose, frequency not reported) (Lot: M041513, expiry date: 11-OCT-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014383: US-009507513-1706USA000288: US-009507513-1706USA000289: US-009507513-1706USA000290:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant concerning a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-APR-2017, the patient received an improperly stored dose of PROQUAD (dose, frequency not reported) (Lot: M043306, expiry date: 24-APR-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA000847: US-009507513-1706USA000301: US-009507513-1706USA000302: US-009507513-1706USA000303.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives and fever for 2.5 days.
Age: 21.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Rash erythematous, Skin warm
Clinical narrative: PT STATES THAT A FEW HOURS AFTER SHE RECIEVED THE VACCINES, A SMALL, RED, WARM RASH APPEARED ON HER LEFT ARM.  THE REDNESS SPREAD OVER THE COURSE OF 2 DAYS AND SHE RAN A FEVER OF 102 LAST NIGHT.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling, Tenderness
Clinical narrative: Within hours of vaccine developed local redness and swelling at site of injection. Next day presented to office with 3.5 x 5 cm area of tenderness redness and swelling no drainage, no regional adenopathy.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient developed large area of redness and warmth on left arm/deltoid area and kept spreading the next day.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mom called and states she has a red bump where shot was given, mild tenderness, no drainage, no fever. Bump persisted was seen in office 06/01/2017, has FROM, no s/s of infection. Reassurance provided.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site reaction, Rash vesicular, Viral test negative
Clinical narrative: Vesicular rash at site of HIB injection left thigh.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Crying - inconsolable after imms. 05-30-17. No further complaints over last 2 days.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Immediate post-injection reaction
Clinical narrative: Miscarriage immediately after flu shot. Had ultrasound that morning an hour before the vaccine, baby was fine at 11 weeks.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Condition aggravated, Injection site rash, Rash
Clinical narrative: Mom reports a small rash was present prior to the administration of the vaccines. Today, mom reports that the rash had spread from her trunk to her legs and face.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Pallor, Rash generalised
Clinical narrative: Rash at injection site and whole body blanching rashes that evolved over the day.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported that she had a bruise to site of injection from Zoster vaccination. Patient also complained of pain, swelling, and redness to site left arm from Pneumococcal vaccine.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: Patient reported that 3 weeks after having the FLUZONE HD vaccine she started to experience muscle pain in the same area as the injection.  Since then she reports that the pain has worsened and has difficulty now raising her arm as well as sleeping due to the pain.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chest discomfort, Dizziness, Fatigue, Feeling hot
Clinical narrative: Feeling warm, lightheadedness, fatigue.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: Feeling warm, lightheadedness, fatigue.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Blood immunoglobulin G increased, Blood thyroid stimulating hormone increased, C-reactive protein increased, Complement factor C3
Clinical narrative: 57 yo patient received 10 year TDaP booster on Thursday 4/13/2017 about 1330. Later that day, about 1500 hr (3.5 hr later) while at home he C/O his vision began to blur and he was experiencing other migraine like S/S such as photophobia and soreness to neck muscles similar to past migraines. But these symptoms - sore muscles in neck and pain with moving eyes did not progress as his past migraines did, he didn't take abortive migraine meds. He was a bit fatigued and went to bed early (930pm) feeling achy all over and just "not right". He awoke about 430 AM with severe migraine (pain in temporal region bilaterally) and every joint in his body both large and small "on fire". He rated pain as 8/10 unrelieved with meds (MAXALT, TYLENOL). He went to work but left early (11am) and his wife took him to ER at 1430 hr where he was told "he was okay" and that this was some "type of migraine". ER labs show normal CBC and CRP was 14.5 with ESR of 3. He was treated with a pain med cocktail with some relief but pain did not resolve. He recalls when he shook ER MD hand when discharged, his elbow was extremely painful (never felt like this before). Pain was described as a sharp jabbing pain. He advised his past CRP done in Nov 2014 was 5 (5-9.9). Last ESR in 2008 and 2014 were both 1. (labs verified in database). Over next few days, his joint pain (to bilateral hips, knees, ankles, shoulders, elbows, wrists, fingers, neck) and diffuse temporal HA persisted with intensity waxing and waning 6-8/10. He was able to perform his duties at work and saw HCP today-4/18/2017. Pain was given a 5-7/10 depending on joint hurting (especially hips) or if head hurting - he admits to chronic pain syndrome with normal daily pain at 3-4/10 since 2010 MVA (run over by SUV with multiple Fx's). He questions if symptoms were related to receipt of TDaP vaccination as he has not had this degree of pain since 2010 MVA.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Complement factor C4, Complement factor normal, Eye pain, Fatigue, Feeling abnormal
Clinical narrative: 57 yo patient received 10 year TDaP booster on Thursday 4/13/2017 about 1330. Later that day, about 1500 hr (3.5 hr later) while at home he C/O his vision began to blur and he was experiencing other migraine like S/S such as photophobia and soreness to neck muscles similar to past migraines. But these symptoms - sore muscles in neck and pain with moving eyes did not progress as his past migraines did, he didn't take abortive migraine meds. He was a bit fatigued and went to bed early (930pm) feeling achy all over and just "not right". He awoke about 430 AM with severe migraine (pain in temporal region bilaterally) and every joint in his body both large and small "on fire". He rated pain as 8/10 unrelieved with meds (MAXALT, TYLENOL). He went to work but left early (11am) and his wife took him to ER at 1430 hr where he was told "he was okay" and that this was some "type of migraine". ER labs show normal CBC and CRP was 14.5 with ESR of 3. He was treated with a pain med cocktail with some relief but pain did not resolve. He recalls when he shook ER MD hand when discharged, his elbow was extremely painful (never felt like this before). Pain was described as a sharp jabbing pain. He advised his past CRP done in Nov 2014 was 5 (5-9.9). Last ESR in 2008 and 2014 were both 1. (labs verified in database). Over next few days, his joint pain (to bilateral hips, knees, ankles, shoulders, elbows, wrists, fingers, neck) and diffuse temporal HA persisted with intensity waxing and waning 6-8/10. He was able to perform his duties at work and saw HCP today-4/18/2017. Pain was given a 5-7/10 depending on joint hurting (especially hips) or if head hurting - he admits to chronic pain syndrome with normal daily pain at 3-4/10 since 2010 MVA (run over by SUV with multiple Fx's). He questions if symptoms were related to receipt of TDaP vaccination as he has not had this degree of pain since 2010 MVA.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Full blood count normal, Headache, Immune complex assay, Impaired work ability, Laboratory test
Clinical narrative: 57 yo patient received 10 year TDaP booster on Thursday 4/13/2017 about 1330. Later that day, about 1500 hr (3.5 hr later) while at home he C/O his vision began to blur and he was experiencing other migraine like S/S such as photophobia and soreness to neck muscles similar to past migraines. But these symptoms - sore muscles in neck and pain with moving eyes did not progress as his past migraines did, he didn't take abortive migraine meds. He was a bit fatigued and went to bed early (930pm) feeling achy all over and just "not right". He awoke about 430 AM with severe migraine (pain in temporal region bilaterally) and every joint in his body both large and small "on fire". He rated pain as 8/10 unrelieved with meds (MAXALT, TYLENOL). He went to work but left early (11am) and his wife took him to ER at 1430 hr where he was told "he was okay" and that this was some "type of migraine". ER labs show normal CBC and CRP was 14.5 with ESR of 3. He was treated with a pain med cocktail with some relief but pain did not resolve. He recalls when he shook ER MD hand when discharged, his elbow was extremely painful (never felt like this before). Pain was described as a sharp jabbing pain. He advised his past CRP done in Nov 2014 was 5 (5-9.9). Last ESR in 2008 and 2014 were both 1. (labs verified in database). Over next few days, his joint pain (to bilateral hips, knees, ankles, shoulders, elbows, wrists, fingers, neck) and diffuse temporal HA persisted with intensity waxing and waning 6-8/10. He was able to perform his duties at work and saw HCP today-4/18/2017. Pain was given a 5-7/10 depending on joint hurting (especially hips) or if head hurting - he admits to chronic pain syndrome with normal daily pain at 3-4/10 since 2010 MVA (run over by SUV with multiple Fx's). He questions if symptoms were related to receipt of TDaP vaccination as he has not had this degree of pain since 2010 MVA.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Migraine, Myalgia, Pain, Photophobia, Red blood cell sedimentation rate normal
Clinical narrative: 57 yo patient received 10 year TDaP booster on Thursday 4/13/2017 about 1330. Later that day, about 1500 hr (3.5 hr later) while at home he C/O his vision began to blur and he was experiencing other migraine like S/S such as photophobia and soreness to neck muscles similar to past migraines. But these symptoms - sore muscles in neck and pain with moving eyes did not progress as his past migraines did, he didn't take abortive migraine meds. He was a bit fatigued and went to bed early (930pm) feeling achy all over and just "not right". He awoke about 430 AM with severe migraine (pain in temporal region bilaterally) and every joint in his body both large and small "on fire". He rated pain as 8/10 unrelieved with meds (MAXALT, TYLENOL). He went to work but left early (11am) and his wife took him to ER at 1430 hr where he was told "he was okay" and that this was some "type of migraine". ER labs show normal CBC and CRP was 14.5 with ESR of 3. He was treated with a pain med cocktail with some relief but pain did not resolve. He recalls when he shook ER MD hand when discharged, his elbow was extremely painful (never felt like this before). Pain was described as a sharp jabbing pain. He advised his past CRP done in Nov 2014 was 5 (5-9.9). Last ESR in 2008 and 2014 were both 1. (labs verified in database). Over next few days, his joint pain (to bilateral hips, knees, ankles, shoulders, elbows, wrists, fingers, neck) and diffuse temporal HA persisted with intensity waxing and waning 6-8/10. He was able to perform his duties at work and saw HCP today-4/18/2017. Pain was given a 5-7/10 depending on joint hurting (especially hips) or if head hurting - he admits to chronic pain syndrome with normal daily pain at 3-4/10 since 2010 MVA (run over by SUV with multiple Fx's). He questions if symptoms were related to receipt of TDaP vaccination as he has not had this degree of pain since 2010 MVA.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Thyroxine decreased, Vision blurred
Clinical narrative: 57 yo patient received 10 year TDaP booster on Thursday 4/13/2017 about 1330. Later that day, about 1500 hr (3.5 hr later) while at home he C/O his vision began to blur and he was experiencing other migraine like S/S such as photophobia and soreness to neck muscles similar to past migraines. But these symptoms - sore muscles in neck and pain with moving eyes did not progress as his past migraines did, he didn't take abortive migraine meds. He was a bit fatigued and went to bed early (930pm) feeling achy all over and just "not right". He awoke about 430 AM with severe migraine (pain in temporal region bilaterally) and every joint in his body both large and small "on fire". He rated pain as 8/10 unrelieved with meds (MAXALT, TYLENOL). He went to work but left early (11am) and his wife took him to ER at 1430 hr where he was told "he was okay" and that this was some "type of migraine". ER labs show normal CBC and CRP was 14.5 with ESR of 3. He was treated with a pain med cocktail with some relief but pain did not resolve. He recalls when he shook ER MD hand when discharged, his elbow was extremely painful (never felt like this before). Pain was described as a sharp jabbing pain. He advised his past CRP done in Nov 2014 was 5 (5-9.9). Last ESR in 2008 and 2014 were both 1. (labs verified in database). Over next few days, his joint pain (to bilateral hips, knees, ankles, shoulders, elbows, wrists, fingers, neck) and diffuse temporal HA persisted with intensity waxing and waning 6-8/10. He was able to perform his duties at work and saw HCP today-4/18/2017. Pain was given a 5-7/10 depending on joint hurting (especially hips) or if head hurting - he admits to chronic pain syndrome with normal daily pain at 3-4/10 since 2010 MVA (run over by SUV with multiple Fx's). He questions if symptoms were related to receipt of TDaP vaccination as he has not had this degree of pain since 2010 MVA.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash
Clinical narrative: Rash on cheeks day of vaccines. No fever.
Age: 1.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site mass
Clinical narrative: Orange sized lump appeared at injection site. Ice applied and pressure. No discoloration noted at site. Site evaluated by Dr.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Blood culture negative, Chills, Full blood count normal, Headache, Metabolic function test normal
Clinical narrative: Received vaccine at 1600, 3 hours later child c/o shivering, HA, body aches, nausea. Was instructed to go to ER-IV started and IV bolus, BENADRYL, ZOFRAN and COMPAZINE given. ER doctor thought it may be more of viral illness vs. vaccine reaction.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pain, Vaccination complication, Viral infection
Clinical narrative: Received vaccine at 1600, 3 hours later child c/o shivering, HA, body aches, nausea. Was instructed to go to ER-IV started and IV bolus, BENADRYL, ZOFRAN and COMPAZINE given. ER doctor thought it may be more of viral illness vs. vaccine reaction.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Eye pruritus
Clinical narrative: Patient had eye itching and shortness of breath. Was seen in urgent care. Had vaccine on 3/28/17 presented to urgent care 4/1/17. Plan take BENADRYL.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Warmth/erythema/tenderness at and around injection site (R arm only).
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired driving ability, Nausea, Pain in extremity, Peripheral swelling, Pruritus generalised
Clinical narrative: Started with left arm swelling and pain, T=102 and "all over body itching with a rash/hives" and very nauseated. Had someone else drive her that day=unable to drive her own motorcycle.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Started with left arm swelling and pain, T=102 and "all over body itching with a rash/hives" and very nauseated. Had someone else drive her that day=unable to drive her own motorcycle.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: T 98.4 Vaccine was administered on 5/23/2017. He woke up on 5/24/17 with swelling and pain and redness of (R) upper arm at injection site and from shoulder to elbow. Arm red, tender and warm. Examined on 5-25-17 - Tx with KEFLEX and BENADRYL.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Eye movement disorder, Feeling abnormal, Muscle spasms, Pallor, Posture abnormal
Clinical narrative: Patient stated 3-4 times that she did not like needles. I administered a MENACTRA in her right deltoid, then a BEXSERO in her left deltoid, then a GARDASIL 9 in her left deltoid. Around 30 seconds after the GARDASIL 9 patient said she "felt funny". Her eyes rolled back and she slumped in her chair. I put my arms around her to hold her steady just before she fainted. After 30 seconds or so, her limbs spasmed and she woke up. She was pale. I had her bend and put her head by her knees and take deep breaths. Then I had her sit up and breathe deeply. The color returned to her face. When she stood w/o dizziness, I escorted her to the waiting room and had her sit for a while before she left. I did suggest to her mother to call her MD.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Syncope
Clinical narrative: Patient stated 3-4 times that she did not like needles. I administered a MENACTRA in her right deltoid, then a BEXSERO in her left deltoid, then a GARDASIL 9 in her left deltoid. Around 30 seconds after the GARDASIL 9 patient said she "felt funny". Her eyes rolled back and she slumped in her chair. I put my arms around her to hold her steady just before she fainted. After 30 seconds or so, her limbs spasmed and she woke up. She was pale. I had her bend and put her head by her knees and take deep breaths. Then I had her sit up and breathe deeply. The color returned to her face. When she stood w/o dizziness, I escorted her to the waiting room and had her sit for a while before she left. I did suggest to her mother to call her MD.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Epistaxis, Face injury, Fall
Clinical narrative: Vaccination with TDaP, MCV4, HPV9. All three given, visiting with client for approx. 1 minute post when fell face first off exam table. Immediately resp. to verbal stimuli. Epistaxis (R) nare. Stopped w/in 5 min with pressure. Monitored HR, orthostatic BP x 40 min. Water provided. Parent called for pick up and discharge instructions.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypoaesthesia, Inflammation, Joint range of motion decreased, Pain in extremity
Clinical narrative: Fever approximately 100 degrees. Red and inflamed down arm. Numb/pain down to fingers. Cannot raise arm. Very hot on arm/fever in arm.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Fever approximately 100 degrees. Red and inflamed down arm. Numb/pain down to fingers. Cannot raise arm. Very hot on arm/fever in arm.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: TDaP given to pt. before RN noted that he had received a TDaP in 2015. No adverse reaction noted.
Age: 82.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacy technician concerning an unspecified number of patients of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (dose, frequency and route were not reported) lot # M013156 with expiration date of 15-OCT-2017, for prophylaxis. The temperature of the PNEUMOVAX23 was 47 °F for a time frame of 15 minutes. Also, a prior temperature excursion occurred and the temperature was 50 °F for a time frame of 12 hours. No adverse effects were reported. The excursions were called due to data logger. Additional information has been requested. Follow-up call was placed to the pharmacy technician and answered by the pharmacist. The pharmacist stated that two patients were vaccinated (with PNEUMOVAX23) and provided patient initials, date of birth and vaccination date. Please see MARRS case # 1704USA005193. No further information was available. This is one of two cases. Additional information is not available or expected. Sender's Comments:  US-009507513-1704USA005193.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Electrocardiogram, Injection site pain, Nausea, Road traffic accident
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 # 653100) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old female patient. The patient's medical history included congenital aortic stenosis and asymptomatic migraines. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and other medications were not reported. On 18-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M016193, expiration date: 24-APR-2018 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included MENACTRA. On 18-AUG-2016, the patient felt nauseated and as though she might faint when stopped at red-light and planned to pull into adjacent parking lot as soon as the light turned green, but had syncopal episode and drove through the light, veering into the opposing traffic lanes, hitting 3 cars. No injuries, no airbag deployment and did not hit head. The patient denies any pain other than some soreness at injection site. Lab date included EKG  and repeat vital signs. The patient was examined in doctor's office (emergency room visit). The outcome of dizziness, syncope, road traffic accident, nausea, injection site pain and electrocardiogram was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: 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 # 653100) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old female patient. The patient's medical history included congenital aortic stenosis and asymptomatic migraines. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and other medications were not reported. On 18-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M016193, expiration date: 24-APR-2018 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included MENACTRA. On 18-AUG-2016, the patient felt nauseated and as though she might faint when stopped at red-light and planned to pull into adjacent parking lot as soon as the light turned green, but had syncopal episode and drove through the light, veering into the opposing traffic lanes, hitting 3 cars. No injuries, no airbag deployment and did not hit head. The patient denies any pain other than some soreness at injection site. Lab date included EKG  and repeat vital signs. The patient was examined in doctor's office (emergency room visit). The outcome of dizziness, syncope, road traffic accident, nausea, injection site pain and electrocardiogram was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 68 years-old female patient. The patient's pertinent medical history was unknown by the reporter. Concomitant medications included levothyroxine (manufacturer unknown), ezetimibe (manufacturer unknown), paroxetine, amlodipine and progesterone (manufacturer unknown). The patient had drug reactions or allergies to nitrofurantoin (manufacturer unknown), sulfadiazine (SULFA) and to quinolones (unspecified). On 19-MAY-2017, the patient was vaccinated with PNEUMOVAX23 injection with lot # N003997 and expiration date on 20-OCT-2018 (strength, dose, route of administration and anatomical location were nor reported), for immunization. On 20-MAY-2017 (reported as "on following day"), the patient experienced swollen, hardened area in the arm and affected area was painful to touch but these reactions were not directly over the injection site but rather, reactions traveled down, somewhere down to patient's lower bicep area, a little bit away from the injection site (Extensive swelling of vaccinated limb/Induration /Myalgia). She did not seek medical attention; so no laboratory diagnostics studies were performed but it was unknown if treatment was given for the events. At the reporting time, the patient had not recovered from the extensive swelling of vaccinated limb, induration and myalgia. The relatedness between the extensive swelling of vaccinated limb, induration and myalgia with the PNEUMOVAX23 was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001026:
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 68 years-old female patient. The patient's pertinent medical history was unknown by the reporter. Concomitant medications included levothyroxine (manufacturer unknown), ezetimibe (manufacturer unknown), paroxetine, amlodipine and progesterone (manufacturer unknown). The patient had drug reactions or allergies to nitrofurantoin (manufacturer unknown), sulfadiazine (SULFA) and to quinolones (unspecified). On 19-MAY-2017, the patient was vaccinated with PNEUMOVAX23 injection with lot # N003997 and expiration date on 20-OCT-2018 (strength, dose, route of administration and anatomical location were nor reported), for immunization. On 20-MAY-2017 (reported as "on following day"), the patient experienced swollen, hardened area in the arm and affected area was painful to touch but these reactions were not directly over the injection site but rather, reactions traveled down, somewhere down to patient's lower bicep area, a little bit away from the injection site (Extensive swelling of vaccinated limb/Induration /Myalgia). She did not seek medical attention; so no laboratory diagnostics studies were performed but it was unknown if treatment was given for the events. At the reporting time, the patient had not recovered from the extensive swelling of vaccinated limb, induration and myalgia. The relatedness between the extensive swelling of vaccinated limb, induration and myalgia with the PNEUMOVAX23 was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001026:
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: PATIENT EXPERIENCED PAIN ON THE WHOLE LEFT BODY AND LOW GRADE FEVER.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Dermatitis, Rash pruritic
Clinical narrative: Information has been received from an approximately 71 year old male patient reporting on himself. The patient reported that he was highly allergic to penicillin and that he did not know his concomitant medications. The patient reported that he had a case of shingles many years ago, where he developed a "massive shingles outbreak". The patient said his symptoms cleared up about 6 months later after he developed this shingles outbreak; he also stated that he waited about a full year after his shingles symptoms had completely cleared up and then he got vaccinated (also reported as "pertinent medical history: None"). The patient's concomitant therapies were not reported.  In approximately 2012 (reported as "about 5 years ago"), the patient was vaccinated with an unspecified dose of ZOSTAVAX (dose, lot number and expiration date were not reported), route of administration reported as intramuscular, his physician suggested to him to get vaccinated with ZOSTAVAX, primarily to "mitigate the severity of future outbreaks" that could potentially would occur as a result of his previous case of shingles. Other suspected therapies included sterile diluent, intramuscularly (dose, lot number and expiration date were not reported). In approximately 2016 (reported as about one year ago), the patient reported that he started to develop "small patches" of a very itchy rash and every couple of months that went by, the patches of the rash "were expanding" eventually to the point where he had an outbreak of the rash, which occurred "all over the back from the neck down" including both his legs, arms and top of his feet. The patient added that his outbreak consisted of "small blisters" all over his body as well. The reporter said that he saw a dermatologist who thought initially he had a bad case of dermatitis and the patient was put on therapy with doxepin to help relieve his severe itching and rash but the treatment "did not do anything" to help with his symptoms. The patient said he was prescribed a corticosteroid cream (unspecified) which seemed to help relieve some of his itching but his rash did not go away. The patient said he also tried two other topical products called "Vani-Cream" and "Sarna-Cream" to help treat his adverse event symptoms. At the time of the reporting, the patient had not recovered from his adverse reaction and continued to be seen by his physician. The causal relationship between the event and therapy with ZOSTAVAX and sterile diluent were not reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse (L.V.N) refers to a 64 year old female patient. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD recombinant human albumin (rHA) (lot M044022; expiry date 01-MAY-2018, dose and route of administration were not reported) reconstituted with a sterile diluent. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 08-MAY-2017, the patient was vaccinated with improperly stored doses of VAQTA injection, lot # N003194, expiry date 28-OCT-2017 (dose, route and site were not specified) and RECOMBIVAX HB injection, lot # N002920, expiry date 30-SEP-2018 (dose, route and site were not reported). The administered doses of VAQTA and RECOMBIVAX HB underwent temperature excursion at 9-25 Celsius degrees (47-77 Fahrenheit degrees; 10.8 Celsius degrees) for 30 min. No adverse events were reported. Product quality complaint (PQC) was not involved.  Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N003703, expiration date 29-OCT-2019 (dose, route and site of administration were not reported) from a box of GARDASIL 9 that was on the counter and intended to be shipped to Merck. There was no adverse effect reported. It was unknown what kind of temperature excursion administered dose of vaccine experienced and for how long it was stored improperly. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information had been received on 17-MAY-2017 from a field representative who reported that a female patient (age unknown) of a nurse practitioner mentioned she received ZOSTAVAX subcutaneous injection (date of vaccination, lot#/expiration and dose not reported). Patient also informed nurse practitioner that she "never had chicken pox". On an unspecified date after receiving the shot, the patient has "come down with a case of shingles". No additional adverse events have been reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and referred to 7 patients of unknown ages and genders. The patients' relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose, frequency, and route of aministration were not reported; lot number M008551 with an expiration date 02-JUN-2018 and lot number M032649 with an expiration date 11-NOV-2018) for prophylaxis. The vaccine data logger measured a temperature of 25°C for a total time frame of 23 hours. Previous temperature excursion measured 25°C for a total time frame 57 minutes. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015158: US-009507513-1705USA015159: US-009507513-1705USA015157:
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to a male patient of unknown age. The patient's medical history, concurrent condition, concomitant therapy, drug and allergy history were not reported. On 09-JAN-2014, when the patient was 16 years old, was vaccinated with the first dose of GARDASIL injection and on 13-JUL-2015, he received the second dose. Vaccinations were for prophylaxis (administration route, lot numbers and expiration dates were not provided). No adverse effects were reported.  Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and referred to 2 patients of unknown ages and genders. The patients' relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, frequency and route of administration were not reported; lot number M035486 with an expiration date 05-JUN-2019 and lot number M041990 with an expiration date 28-JUN-2019) for prophylaxis. The vaccine data logger measured a temperature of 25°C for a total time frame of 23 hours. Previous temperature excursion measured 25°C for a total time frame 57 minutes. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015158: US-009507513-1705USA015159: US-009507513-1705USA011313:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 30-MAY-2017, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # L018002, expiration date 19-MAY-2017 (strength, dose and route were unknown) for prophylaxis. It was reported that the vaccine was used with an sterile diluent with lot and expiration date unknown. There were no adverse effects reported.    Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant concerning a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-MAY-2017, the patient received an improperly stored dose of PROQUAD (dose, frequency not reported) (Lot: M043306, expiry date: 24-APR-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000847: US-009507513-1706USA000300: US-009507513-1706USA000301: US-009507513-1706USA000303:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant concerning a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-MAY-2017, the patient received an improperly stored dose of PROQUAD (dose, frequency not reported) (Lot: M043306, expiry date: 24-APR-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA000302: US-009507513-1706USA000301: US-009507513-1706USA000300: US-009507513-1705USA000847.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 17 year old female patient. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. Concomitant medications were not provided. In 2014, the patient was vaccinated with an unspecified dose of GARDASIL for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). Then, on 31-MAY-2017, the patient was vaccinated with an unspecified dose of GARDASIL 9 for prophylaxis (lot number M034780 with an expiration date of 15-APR-2019) (dosage, route and anatomical location were not reported). No adverse effects were 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 medical assistant, referring a patient of unknown age and gender. Information on medical history, concomitant medications and drug allergies was not provided.   On an known date, the patient was vaccinated with a dose of improperly stored PROQUAD (lot# M039448, expiration date 20-MAR-2018) for prophylaxis (dose and route of administration were not reported). The temperature of storage for PROQUAD was above -10 Celsius and below 8 Celsius for 1 hour and 2 minutes (2 excursions). A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA011638: US-009507513-1706USA000481: US-009507513-1706USA000482: US-009507513-1703USA002284: US-009507513-1706USA000487: US-009507513-1706USA000488: US-009507513-1706USA000489: US-009507513-1706USA000490: US-009507513-1706USA000491: US-009507513-1706USA000492:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were not reported. On unknown dates in August and December 2016 the patient was vaccinated with first and second dose of GARDASIL 9 (lot # and expiry date was not reported) for prophylaxis and no symptoms were reported (no adverse event). The pharmacist reported that the patient will be returning to the pharmacy on 24-MAY-2017 to receive third Dose of GARDASIL 9. The outcome of the events was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Asthenia, Mobility decreased, Pain in extremity
Clinical narrative: Patient having L arm pain, weakness, and trouble moving arm.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Balance disorder, Dizziness, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: Patient states rib pain, soreness at site redness measure on Left arm 9x6cm, Headaches, difficulty breathing, joint stiffness and dizziness Right leg feels numb and imbalance.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Joint stiffness, Musculoskeletal chest pain
Clinical narrative: Patient states rib pain, soreness at site redness measure on Left arm 9x6cm, Headaches, difficulty breathing, joint stiffness and dizziness Right leg feels numb and imbalance.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling warmth left arm below the site of the injection from mid upper arm to mid forearm, fever to 100°, arthralgias, fatigue.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Redness swelling warmth left arm below the site of the injection from mid upper arm to mid forearm, fever to 100°, arthralgias, fatigue.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was inadvertently administered a dose of VARIVAX lot # M037643, expiration date 01-SEP-2018 (dose and route of administration were not reported) instead of a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). The vaccine was reconstituted with sterile diluent (DILUENT MRK) lot # M016885, expiration date 07-DEC-2018 (dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Stomatitis
Clinical narrative: Patient states she developed a rash and sore inside her mouth. She went to her doctor and discovered she developed shingles.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site pustule, Ophthalmic herpes zoster, Rash pustular
Clinical narrative: Patient states she developed a rash and sore inside her mouth. She went to her doctor and discovered she developed shingles.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was given, no adverse reaction.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Frank blood in stool 3 days after the administration of ROTATEQ.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients medical history, concurrent condition, drug and allergy history were not reported.  On 17-MAY-2017, the patient was vaccinated with an improperly storaged dose of M-M-R II lot # M032487, expiration date 05-JUL-2018,(strength, dose and route were not reported)for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent(manufacturer unknown) The patients concomitant therapies were not reported. On an unspecified date, the digital data logger registered a temperature of 9.6°Celsius (°C) during a time frame of five hours which was called by the data logger, with no previous temperature excursion. In addition, adverse effects were not reported. Additional information has been requested.