chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported injection site/arm became very itchy, very red, very hot, and somewhat swollen the day following her injection, covering a large portion of her arm. I witnessed it the next day, when the patient stated that the reaction had calmed down somewhat, and it was still very red and covering a large portion of the arm.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient's arm developed some swelling and redness. It peaked a day or so after vaccination and has slowly improved. She received a FLUZONE HIGH DOSE shot in the same arm as well. The shots were administered more than 1 inch apart.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Patient had a seizure 5 minutes following the administration of the flu vaccine.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: A few minutes after vaccinating, the patient felt faint. He did not fall or lose consciousness.  Patient rested and he recovered immediately with no further intervention needed. He had had a small snack before he was vaccinated. He left with his parents and was feeling fine. He are supper when he got home and had no further reaction.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Headache, Hyperhidrosis, Impaired work ability
Clinical narrative: Fever (24 hours+ of over 101), headache, fatigue, extreme nausea, dizziness, 1 episode of loss of consciousness (fainting), profuse sweating, rash covering trunk, neck, arms for 3+ days. 2 days of work missed.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Nausea, Pyrexia, Rash, Syncope
Clinical narrative: Fever (24 hours+ of over 101), headache, fatigue, extreme nausea, dizziness, 1 episode of loss of consciousness (fainting), profuse sweating, rash covering trunk, neck, arms for 3+ days. 2 days of work missed.
Age: 26.0
Sex: M
Vaccine: FLUX
Symptoms: Facial paralysis
Clinical narrative: Right sided facial nerve paralysis consistent with Bell's palsy developed on Friday night 10/27, Saturday morning 10/28 following administration of vaccine on the preceding Wednesday 10/25 in a previously healthy 26 year old male with no past medical history of HSV, Lyme or paralysis of any kind.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Erythema, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: Injection site/arm feels hot to touch, not swollen, red. Pt feels weak. Went to urgent care Rx MEDROL dose pack low-dose steroid inj. in hip.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Localized arm swelling and inflammation from site to elbow - patient took TYLENOL and BENADRYL - ADVIL finally helped.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain upper, Back pain, Diarrhoea, Discomfort, Dizziness
Clinical narrative: Dizziness, nausea, pain in arm, pain feels like it went into shoulder, stomach upset, gas, belching, rash/hives, worsening pain. Mom took her to nutritionist, said she was "zapped with cold lasers."
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Flatulence, Immediate post-injection reaction, Loss of personal independence in daily activities, Nausea, Nerve injury
Clinical narrative: Dizziness, nausea, pain in arm, pain feels like it went into shoulder, stomach upset, gas, belching, rash/hives, worsening pain. Mom took her to nutritionist, said she was "zapped with cold lasers."
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pain in extremity, Rash, Rash pruritic, Vomiting
Clinical narrative: Dizziness, nausea, pain in arm, pain feels like it went into shoulder, stomach upset, gas, belching, rash/hives, worsening pain. Mom took her to nutritionist, said she was "zapped with cold lasers."
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal discomfort, Dizziness, Eructation, Flatulence, Musculoskeletal pain
Clinical narrative: Dizziness, nausea, pain in arm, pain feels like it went into shoulder, stomach upset, gas, belching, rash/hives, worsening pain. Mom took her to nutritionist, said she was "zapped with cold lasers."
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Nausea, Pain in extremity, Rash, Urticaria
Clinical narrative: Dizziness, nausea, pain in arm, pain feels like it went into shoulder, stomach upset, gas, belching, rash/hives, worsening pain. Mom took her to nutritionist, said she was "zapped with cold lasers."
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Insomnia, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 53-year-old female patient who received FLUARIX Quadrivalent (batch number JC9E9, expiry date 30th June 2018). On 16th October 2017, the patient received the 1st dose of FLUARIX Quadrivalent .5 ml. On 16th October 2017, less than a day after receiving FLUARIX Quadrivalent, the patient experienced pain in arm, joint pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the pain in arm, joint pain and vaccine administered at inappropriate site were unknown. The reporter considered the pain in arm and joint pain to be possibly related to FLUARIX Quadrivalent. Additional details were reported as follows: The patient reported the above experience after receiving FLUARIX Quadrivalent. The patient saw her physician who advised and told that the vaccine was injected in her tendon capsule, which led to vaccination at inappropriate site. The pharmacist was calling to find out whether GlaxoSmithKline had information to know whether the patient should be revaccinated. Warm transferred to Medical Information.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Drug administered at inappropriate site, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 53-year-old female patient who received FLUARIX Quadrivalent (batch number JC9E9, expiry date 30th June 2018). On 16th October 2017, the patient received the 1st dose of FLUARIX Quadrivalent .5 ml. On 16th October 2017, less than a day after receiving FLUARIX Quadrivalent, the patient experienced pain in arm, joint pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the pain in arm, joint pain and vaccine administered at inappropriate site were unknown. The reporter considered the pain in arm and joint pain to be possibly related to FLUARIX Quadrivalent. Additional details were reported as follows: The patient reported the above experience after receiving FLUARIX Quadrivalent. The patient saw her physician who advised and told that the vaccine was injected in her tendon capsule, which led to vaccination at inappropriate site. The pharmacist was calling to find out whether GlaxoSmithKline had information to know whether the patient should be revaccinated. Warm transferred to Medical Information.
Age: 0.17
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a 08-week-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 25-SEP-2017, the patient was vaccinated with improperly stored RECOMBIVAX HB, lot # N006321, expiry date: 08-NOV-2019 and ROTATEQ, lot# M042170, expiry: 22-JUN-2018, (dosing details were not reported) both for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Exercise tolerance decreased, Fatigue, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Fever of 100.5 F, myalgia, fatigue, loss of appetite, inability to exercise due to myalgia, nausea, vasovagal faint on day 4.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Presyncope, Pyrexia, Syncope
Clinical narrative: Fever of 100.5 F, myalgia, fatigue, loss of appetite, inability to exercise due to myalgia, nausea, vasovagal faint on day 4.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling jittery, Photophobia, Urticaria
Clinical narrative: Felt "jittery" and experienced light sensitivity. Was evaluated and released. Two days later presented with acute upper respiratory infection symptoms. The following day experienced onset of urticarial that have persisted to present.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Induration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Got flu shot and pneumonia vaccine on Tuesday-- L arm; Started w/ fever on Tuesday night; Noticed some swelling at injection site, redness and pain; Very warm to touch; T 101-103; Last dose of ibuprofen at 1pm today; AM T 102; Has had flu vaccine before w/o issue; No difficulty breathing; On exam, L arm w/ erythema, induration, warmth and tenderness.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site warmth, Pyrexia, Skin warm, Tenderness
Clinical narrative: Got flu shot and pneumonia vaccine on Tuesday-- L arm; Started w/ fever on Tuesday night; Noticed some swelling at injection site, redness and pain; Very warm to touch; T 101-103; Last dose of ibuprofen at 1pm today; AM T 102; Has had flu vaccine before w/o issue; No difficulty breathing; On exam, L arm w/ erythema, induration, warmth and tenderness.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Hypertension, Oedema peripheral, Periorbital oedema, Swelling
Clinical narrative: 28 YO previously health active duty male presented to my aid station approximately 2-3 hours after receiving immunization with chief complaint of "feeling puffy all over and being red." He denied chest pain or shortness of breath at that time. Upon exam he was remarkably edematous around his eyes, fingers and toes, with some extension proximally - his skin was erythematous in those areas, too. He was tachycardic to the low 110s and mildly hypertensive to 140s/90s. He denied any history of ingestion of new substances, drugs, insect bites, food allergies or drug allergies. I couldn't technically call his reaction anaphylaxis because he didn't have CP/SOB or evidence of hypotension, but I was worried about him progressing to that. I gave him 50 of IM BENADRYL, established a large bore PIV and gave him to liters of fluid, 50 mg oral hydroxyzine and 50 mg of oral prednisone and watched him in our aid station for 6 hours. His swelling improved remarkably, his tachycardia resolved and his blood pressure came down. He was monitored overnight by his battle buddies and appeared completely improved the next day in follow up with me.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Tachycardia
Clinical narrative: 28 YO previously health active duty male presented to my aid station approximately 2-3 hours after receiving immunization with chief complaint of "feeling puffy all over and being red." He denied chest pain or shortness of breath at that time. Upon exam he was remarkably edematous around his eyes, fingers and toes, with some extension proximally - his skin was erythematous in those areas, too. He was tachycardic to the low 110s and mildly hypertensive to 140s/90s. He denied any history of ingestion of new substances, drugs, insect bites, food allergies or drug allergies. I couldn't technically call his reaction anaphylaxis because he didn't have CP/SOB or evidence of hypotension, but I was worried about him progressing to that. I gave him 50 of IM BENADRYL, established a large bore PIV and gave him to liters of fluid, 50 mg oral hydroxyzine and 50 mg of oral prednisone and watched him in our aid station for 6 hours. His swelling improved remarkably, his tachycardia resolved and his blood pressure came down. He was monitored overnight by his battle buddies and appeared completely improved the next day in follow up with me.
Age: 62.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Inflammation, Peripheral swelling, Skin warm
Clinical narrative: Patient returned two days post PNEUMOVAX and flu shot to seek advice for redness and swelling of arm. From upper arm to lower arm, it was inflamed and warm to the touch. I advised him to take BENADRYL, ice it and see a physcian. He did and received cephalexin.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Syncope
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse via company representative and refers to a 16-year-old female patient. No information regarding the patient's medical history and concurrent conditions was provided. The patient received no concomitant medications. On an unknown date (reported as "over the summer months"), the patient was vaccinated with GARDASIL 9 first injection in the series, as a HPV prevention (route of administration, lot# and expiration date were not provided). On an unknown date (reported as "later"), the patient found out that she was pregnant. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) were not known. On an unknown date (reported as "while receiving the GARDASIL 9 , the patient fainted in the medical office. The patient regained consciousness after she was treated with ice packs (also reported as "no treatment was received"). The pregnancy outcome was outcome pending. The causal relationship between the event of fainted and GARDASIL 9 was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, 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 regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 25-JAN-2017, the patient was vaccinated with GARDASIL 1st dose (route of administration, lot# and expiration date were not provided). On 25-FEB-2017, the patient received GARDASIL 9 2nd dose, lot# L038917, expiration date: 20-FEB-2018 (route of administration was not provided). On 03-OCT-2017, the patient returned to the office for GARDASIL 9 3rd dose, lot# L038917, expiration date: 20-FEB-2018 (route of administration was not provided). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (MERCK) lot number M023935 with expiration date on 08-DEC-2018 (it was reported that the improperly stored vaccine was reconstituted with properly stored sterile diluent (MERCK). On 02-OCT-2017, the patient was vaccinated with an improperly storage dose of ZOSTAVAX lot # M042851, with expiration date on 18-OCT-2018 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccine had a temperature excursion of 6 Fahrenheit (°F) to 14° F, during a time frame of 2 hours and 30 minutes. It was confirmed that the vaccine had previous temperature excursions of 15° F to 46° F for 2 hours and a digital data logger was involved.
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report was received from a certified registered nurse practitioner, concerning a 32 year old female patient. The patient had not medical history, drug allergies, previously drug reactions and concurrent conditions reported, and her concomitant medication included PRENATAL PLUS, as prenatal vitamins. The Last Menstrual Period date (LMP), date of conception and estimated delivery date (EDD) were not reported. On 03-OCT-2017, when she was 27 weeks of gestation, the patient was vaccinated with a dose of GARDASIL 9 in the left deltoid, lot number N017542 with expiration date in 21-NOV-2019 (strength and route of administration were not provided) instead of TDAP, for prophylaxis. The reporter confirmed that this event was not a result of product confusion but a result of human error, no treatment was given to the patient and no laboratory diagnostics or studies were performed. At the time of the report, the pregnancy outcome was pending and the fetal outcome was unknown. No adverse effect was reported.
Age: 66.0
Sex: U
Vaccine: FLUA3, VARZOS
Symptoms: Extra dose administered, No adverse event, Product storage error
Clinical narrative: Initial and follow up information has been received from a pharmacist, concerning a 66 year old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions and concurrent conditions were not reported. On 24-APR-2015, the patient was vaccinated with a first dose of ZOSTAVAX (strength, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis. Then, on 03-OCT-2017, the patient stated that he had not received ZOSTAVAX, therefore the patient requested to get immunization and on the same day, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX lot number N013274 with expiration date in 04-JUL-2018 (strength, anatomical location and route of administration were not provided) that was reconstituted with one dose of sterile diluent (MRK), for prophylaxis. Upon notified the patient's primary care physician (PCP), the PCP confirmed that the patient was already vaccinated. On the same day, the patient was also vaccinated with FLUAD and his/her concomitant medications included simvastatin (manufacturer unknown) and levocetirizine. No adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 06-SEP-2017, 21-SEP-2017 and 27-SEP-2017, the patients were vaccinated with improperly stored doses of VARIVAX with lot # M027344 with expiration date on 06-JAN-2018 (strength, dose, route of administration, and anatomical location were not provided) which were reconstituted with properly store sterile diluent (manufacturer unknown). The storage temperature was reported as 15 to 46 degrees Fahrenheit (°F) (14.5 °F) for an unknown time frame. Regarding the temperature excursions, it was reported that since 05-SEP-2017 to 02-OCT-2017, the doses of VARIVAX with lot # M027344 were exposed to storage temperatures from 5.5 to 17.5 (°F) and the maximum time frame of exposure was reported as 1 hour 45 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 03-OCT-2017, the patient was vaccinated with PNEUMOVAX 23, 1 dose, lot# reported as R73811, expiration date: 18-MAY-2018, for prophylaxis (route of administration was not reported). Other suspect therapies included ROTATEQ 1 dose, orally, lot# M038717, expiration date: 26-SEP-2019, for prophylaxis. No adverse effects were reported. The vaccines experienced a temperature excursion between 32 Fahrenheit degrees and 35 Fahrenheit degrees within the average temperature of 33.1 Fahrenheit degrees for 14 hours. Digital Data Logger was not involved. There was no previous temperature excursion. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA002363.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous initial report was received from a medical assistant, via a company representative, regarding a 17 year old male patient (also reported as female). Patient's medical history, current conditions and concomitant medications were not reported. The medical assistant reported that on 06-OCT-2017, the patient was vaccinated a dose of GARDASIL 9 intramuscular, in the patient's right arm, lot #N004798, expiration date 31-OCT-2019 (strength and dose not reported), for prophylaxis, before the medical assistant realizaed that the patient had already already completed a GARDASIL or GARDASIL 9 series a few years ago. It was also reported that none other vaccines were administered within 4 weeks prios the vaccination. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63-year-old female patient. The patient's medical history, concomitant medications and drug allergies were not specified. On 01-OCT-2017 the patient was vaccinated with ZOSTAVAX subcutaneously (dose and injection site unknown), lot # N021172, expiration date 01-NOV-2018 for prevention of shingles. Other suspect therapies included sterile diluent lot # K026802, expiration date 21-OCT-2017. On 03-OCT-2017 the patient began experiencing "warmth and redness" at unspecified injection site. On 04-OCT-2017 the patient was prescribed KEFLEX (dose, frequency, route of administration not provided) by physician. The outcome of the events was unknown. The relatedness between ZOSTAVAX, sterile diluent and the events was not specified.
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from the patient's mother, referring to her son, who was an 18 year old male patient. The reporter refused to provide information concerning the patient's pertinent medical history, concurrent conditions or concomitant medications. On unspecified dates, the patient received the first and second dose of GARDASIL 9 according to schedule, and the third dose 5 months after the first dose. Additionally, it was mentioned that the patient received a fourth dose of GARDASIL 9 in the left arm on 09-OCT-2017 (lot# and route of administration were unspecified for all doses) all of them for prophylaxis. It was also reported that after fourth dose, the patient began experiencing soreness and redness at injection site on left arm (injection site pain and injection site erythema), and that he was using ice to treat these conditions. The patient was not hospitalized and there were no intervention to prevent serious criteria. The patient's conditions were not significant disability or incapacity or life threatening. At the time of the report, the outcome of injection site pain and injection site erythema was unknown. The relatedness assessment between GARDASIL 9 and the aforementioned adverse events was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that on 09-OCT-2017 the patient was inadvertently vaccinated with VARIVAX 0.5 ml, with lot number M027886 and expiration date on 03-JUN-2018 (dose number and anatomical location were not provided), administered subcutaneously for prophylaxis instead of the prescribed ZOSTAVAX. It was reported that VARIVAX was reconstituted with the sterile diluent (MERCK). No adverse effects were reported.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: This spontaneous report as received from a other health professional refers to a 9 week old female patient. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 16-OCT-2017, the patient was vaccinated with ROTATEQ lot # N005617 expiration date OCT-20, orally via a bottle nipple cap (strength and dose # were not provided) for prophylaxis. The patient received all the vaccine, according to dose, in the plastic squeeze vial. This administration allowed the patient to receive all of the vaccine without coughing, sputtering or drooling out the vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Pruritus
Clinical narrative: This spontaneous report was received from a physician via a field representative, concerning a 67 year old male patient. The patient's medical history, concurrent conditions, drug reactions or allergies were unknown by the reporter. His concomitant medications included atorvastatin, gabapentin, furosemide (manufacturer unknown), meloxicam, SINGULAIR, omeprazole, doxycycline, and tramadol hydrochloride. In about April 2017, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, strength, dose, route of administration, and anatomical location were not provided), for prophylaxis; concomitantly administered with a sterile diluent (manufacturer unknown). On an unspecified date in 2017, after vaccination, the patient developed an itching feeling on his trunk and what felt like a band tie around his chest feeling; so he sought medical attention and had a physician office visit but no treatment was given for the events and no laboratory diagnostic studies were performed. No product quality complaint (PQC) was involved. At the time of this report, the patient had recovered from the pruritus and the chest discomfort. The causal relationship between the pruritus and chest discomfort with ZOSTAVAX was not provided.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Adverse drug reaction, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse and refers to a 90 year old female patient with dementia. The patient's medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not reported) and a dose of influenza virus vaccine (unspecified) (strength, dose, route, frequency, indication, lot/batch # and expiration date were not reported) during the same office visit on an unknown date. On an unknown date, after receiving the PNEUMOVAX 23 and influenza virus vaccine (unspecified), the patient developed "a reaction at the injection site", the injection site "swelled up, became red, and looked puffy". The patient went to an unspecified emergency department and received BENADRYL (lot, expiration date, manufacturer and dose unknown). It was also reported that "the patient had an unknown reaction to the BENADRYL that they gave her at the emergency department, but the patient got better and recovered in about 1 week". The patient did no required intervention to prevent serious criteria, no life threatening or significant disability or incapacity was presented. The outcome of adverse drug reaction, injection site erythema, injection site swelling, injection site reaction and drug hypersensitivity was reported as recovered/resolved. The causality between adverse drug reaction, injection site erythema, injection site swelling, injection site reaction and drug hypersensitivity with PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an adolescent patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 25-SEP-2015, at the age of 14 years, the patient received the first dose of GARDASIL injection (dose, route of administration, lot # and expiration date were not reported). On 28-APR-2017, the patient was vaccinated with the second dose in the HPV vaccination series, which was GARDASIL 9 injection (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Nerve injury, Pain in extremity, Spinal pain, X-ray
Clinical narrative: This spontaneous report as received from (controlled) female consumer of 69year old. The patient's medical history included kidney problems and bipolar disorder. The patient's drug allergies/reactions and concomitant therapies were not provided. On the fall 2016, the patient was vaccinated with ZOSTAVAX, subcutaneously for vaccination (strength, dose, frequency, lot # and expiration date were not reported) while she was recovering from the flu. On an unknown date 2016 (also reported as 3 weeks after onset of therapy), the patient experienced pain in her legs and spine.  On an unspecified date, an unknown physician diagnosed her with unspecified nerve damage, so he prescribed physicial therapy, "a gel for pain" and tramadol (doses and frequencies not specified). On an unknown date, X-rays were performed (results not provided). The patient sought medical attention with her physician. The patient stated that she may need surgery on her spine to treat her condition and considered this as significant disability or incapacity. There was no intervention to prevent serious criteria. At the time of reporting, the outcome of spinal pain, nerve damage and pain in extremity was reported as not recovered. Additionally, the causality assessment between pain in extermity, spinal pain and nerve damage with ZOSTAVAX was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a currently 12 year old patient of an unknown gender. On 31-JUL-2018 (Incorrect future date), the patient was vaccinated with improperly stored PROQUAD (lot # N013270, expiry date: 25-OCT-2018, lot # N014947 expiry date: 11-NOV-2018) (dose, route and anatomical location not reported) for prophylaxis, that was reconstituted with sterile diluent (MRK INJ) (lot#, expiration, route, dose and anatomical location not reported). The vaccine was stored at a temperature of 32 degree Fahrenheit (F) for unknown period of time (reported as "ongoing excursion"). The previous temperature excursion included multiple 6 degree Fahrenheit (F) to 14 degree Fahrenheit (F) for a total of 6.5 hours. The call was because of the data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000128: US-009507513-1708USA010196: US-009507513-1710USA011202: US-009507513-1710USA011199: US-009507513-1710USA011203.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to one-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 16-SEP-2017, the patient was vaccinated with improperly stored M-M-R II, lot # M045392 17-NOV-2018, and VAQTA, lot # N008823, expiry date: 26-MAY-2018; dosing details were not reported, both for prophylaxis. The lot # of M-M-R II was reconstituted with properly stored sterile diluent. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Age: 1.17
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 15-SEP-2017, the patient was vaccinated with improperly stored VAQTA lot # N008823, expiry date: 26-MAY-2018, and M-M-R II lot # M045392, expiry date: 17-NOV-2018; dosing details were not reported, both for prophylaxis. The lot of M-M-R II was reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Age: 0.17
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a 09-week-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 28-SEP-2017, the patient was vaccinated with improperly stored RECOMBIVAX HB, lot # N006321, expiry date: 08-NOV-2019 and ROTATEQ, lot # M042170, expiry: 22-JUN-2018; dosing details were not reported, both for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 25-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. All lots of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 21-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. The lot of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 27-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. The lot of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 27-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. All lots of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. The lot of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 26-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. The lot of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. The lot of M-M-R II were reconstituted with properly stored sterile diluent (DILUENT MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. The lot of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. All lots of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14--NOV-2018) for prophylaxis (incorrect product storage). The lot of M-M-R II were reconstituted with properly stored sterile diluent (DILUENT MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000054: Original Case : 1709USA000054.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report Was received from a nurse refers to a 2-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 31-AUG-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045392, expiry date: 17-NOV-2018) for prophylaxis (incorrect product storage). The lot of M-M-R II was reconstituted with properly stored sterile diluent (DILUENT MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000054: Original Case : 1709USA000054.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to 12-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 31-AUG-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045392, expiry date: 17-NOV-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to 12-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 31-AUG-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045392, expiry date: 17-NOV-2018) for prophylaxis. The lot of M-M-R II was reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: S-009507513-1709USA000054.