chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Biopsy skin, Fungal test negative, Rash, Skin lesion
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 # 604862). This spontaneous report refers to a 14 year old female patient. The patient's had no concurrent illnesses. The patient's medical history was not provided. On 20-JUL-2015 the patient was vaccinated with GARDASIL 9 lot # L007495, dose 3 (route reported as needle and syringe-not specified further) in the left arm for prophylaxis. On 06-SEP-2015, the patient experienced biopsy skin, skin lesion and rash. Early AM the patient noticed a rash on left hand, different sized circles-like lesions. Not raised-flat, no head or edge, not itchy or painful. Next day had a few more spots. This continued for 2 weeks as it went up her left arm. All different sizes. Dermatologist gave steroid and anti-fungal cream. Continued for another week. Second visit to Dermatologist, had biopsy. No definitive answer, but shows not fungal. Lesions have stopped as of 07-OCT-2015. Today 26-OCT-2015 woke with 4 lesions on left side of torso. The patient had an emergency visit. The outcome of biopsy skin, skin lesion and rash was reported as not recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Feeling abnormal, Pallor, Tremor
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 # 607027). This spontaneous report refers to a 13 year old female patient. Information on the patient's concurrent illnesses and medical history were not reported. Other medications included daily ZYRTEC and vitamin D although patient's mom said she did not have them prior to visit on 31-OCT-2015. Patient's mom woke her up for vaccination and she had pretzels for breakfast. On 31-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # L028082, dose 1, intramuscularly in the left arm and FLUZONE QUADRIVALENT lot # UI516AB, dose 15, intramuscularly in the left arm for prophylaxis. After vaccination patient looked fine and asked for a popsicle when offered. Registered nurse was coming back with popsicle when patient's brother came out of room asking for help because patient's arms, legs and feet were shaking. Patient told her mom and brother prior to the shaking that she felt funny. After event patient said that she was dreaming and she wanted to know what happened. Patient's mom was in front of the patient who was sitting in chair where vaccines were given, she helped the patient to exam table after shaking stopped. Patient's vital signs were checked and doctor examined the patient, she was awake the whole time. Patient looked pale during the event and her coloring returned. Checked on the patient later in the day and spoke to patient's dad who said patient was doing better and resting. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLUN4, HPV9, MNQ, TD
Symptoms: Face and mouth X-ray, Headache
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 # 608417). This spontaneous report refers to a 12 year old female patient. Patient had no concurrent illnesses, medical history and other medications. On 28-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # L027282, dose 1, intramuscularly, site: unknown for prophylaxis. On the same day, patient was also vaccinated with MENACTRA lot # U5186AA, dose 1, intramuscularly, site: unknown; FLUMIST QUADRIVALENT lot # 7J2189, intranasal and diphtheria toxoid, tetanus toxoid (manufacturer: sanofi pasteur) lot # C4509AD, intramuscularly, site: unknown for prophylaxis. On 29-OCT-2015, 24 hours later the patient developed a headache and was shifted- symptoms have improved. On same day, the patient had a face and mouth X-ray. Lab data included sinus X-ray. The outcome of the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Erythema, Tenderness
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 # 608491). This spontaneous report refers to a 11 year old female patient. The patient's concurrent illnesses was reported as none. The patient's medical history was not reported. On 04-NOV-2015 the patient was vaccinated with GARDASIL 9 lot # L014415, dose 3, (route: unknown) in the right arm for prophylaxis. On the same day, patient was vaccinated with other suspect therapy included FLUZONE (lot # UI446AA, dose 2, route unknown, in the right arm). On 04-NOV-2015, the patient experienced right arm erythema with large area 7cm x 12cm and tenderness. The outcome of erythema and tenderness was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass
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 # 608822). This spontaneous report refers to a 17 year old female patient. The patient's concurrent illnesses, medical history, other medications and prior vaccinations was not reported. On 27-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L027282, dose 1, (route reported as needle and syringe-not specified further) in the left arm for prophylaxis. On 06-NOV-2015, 10 days after injection patient noticed golf ball size lump at site of injection. The outcome of injection site mass was reported as not recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU3, HEP, HEPA, HPV9, VARCEL
Symptoms: Rash vesicular
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 # 609104). This spontaneous report refers to a 14 year old male patient. The patient's concurrent illnesses was not reported. The patient's medical history included allergic penicillins. On 27-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L013429, intramuscularly in the left arm and VARIVAX, lot # L009203, subcutaneously in the left arm for prophylaxis. On the same day, other suspect therapies included ENGERIX-B (lot # ZXZ75, intramuscularly in the right arm), FLUZONE (lot # U5304AA, intramuscularly in the right arm) and HAVRIX (lot # X22P4, intramuscularly in the left arm). On 10-NOV-2015, experienced varicella like rash. The outcome of rash vesicular was reported as not recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, IPV, MNQ, TD
Symptoms: Dizziness, Immediate post-injection reaction, Pallor, Visual impairment
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 # 609198). This spontaneous report refers to a 11 year old female patient. The patient's concurrent illnesses, and other medications were reported as none. On 05-NOV-2015 the patient was vaccinated with GARDASIL 9 lot # L014415, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, patient was vaccinated with other suspect therapies included IPOL (lot # K1694, dose 3, subcutaneously in the right arm), TENIVAC (lot # U5184CA, dose 1, intramuscularly in the left arm) and MENACTRA (lot # U5058AC, dose 1, intramuscularly in the left arm). On 05-NOV-2015, the patient experienced pallor and visual impairment. Patient had a systemic reaction immediately after last shot was given-HPV9. Became dizzy for 20 minutes. Explained that she had spots in front of her eyes. Became pale but was able to hear instructions. Patient stated no respiratory or throat reaction. Public health nurse suggested to family that it is important to see physician as soon as they can today to report what happened and to obtain physician feedback. The outcome of pallor and visual impairment was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Computerised tomogram head normal, Fall, Laceration, Suture insertion, 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 # 609651) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 11-AUG-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L019286, intramuscularly in the left arm for prophylaxis. Other suspect therapies included MENACTRA (vaccination date: 11-AUG-2015, lot #U5082BA, dose, frequency and lot expiration date were not reported). On 11-AUG-2015, the patient underwent computerised tomogram head normal, and also experienced syncope, laceration and fall. Patient had a syncopal episode and fell off the exam table. Patient required a visit to the ER (emergency room) for stitches due to a head laceration. Lab data included head computerised tomogram (CT) which was normal. The outcome of computerised tomogram head normal, syncope, laceration and fall 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: 14.0
Sex: F
Vaccine: FLU3, HPV9, MNQ, VARCEL
Symptoms: Blood glucose normal, Blood test, Dizziness
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 # 612767) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 14 year old female patient. On 01-DEC-2015, at 12:35pm, patient received her first injection of GARDASIL 9 dose number 1, lot # L013429, (dose, lot expiration date were unknown) intramuscularly in the left arm for prophylaxis along with the other suspect therapies which included MENVEO (vaccinated date: 01-DEC-2015, dose number 1, lot # M15036, intramuscularly in the right arm, dose and lot expiration date unknown), VARIVAX (vaccinated date: 01-DEC-2015, dose number 2, lot # K021936, subcutaneously in the left arm, dose and lot expiration date unknown) and FLUZONE (vaccinated date: 01-DEC-2015, dose number 1, lot # UI440AA, intramuscularly in the right arm, dose and lot expiration date unknown) for prophylaxis. On the same day, patient had her blood work drawn (blood test) in the lab. Patient was checking out when she began to feel lightheaded. Patient sat down in a chair and then was brought back into a room for further evaluation. Patient's blood pressure was taken manually in her left arm while sitting, and was 100/68. Finger stick blood sugar was 73 (blood glucose normal). Patient said that she began to feel better. Patient's mother informed that patient was fasting that day. It was informed to the patient's mother that the patient might have become lightheaded from a combination of the patient not eating, having 4 vaccines, and having blood work drawn. Patient's mother agreed and left the building upon notifying the doctor. The outcome of blood glucose normal, dizziness and blood test was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Blood thyroid stimulating hormone, Coagulation test, Computerised tomogram head normal, Electrocardiogram, Electroencephalogram
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 # 615021). This spontaneous report refers to a 12 year old female patient. Information on patient's concurrent illnesses was not reported. The patient's medical history included attention deficit/hyperactivity disorder (ADHD) and asthma. Other medications included Methylphenidate (Ritalin). On 25-NOV-2015, the patient was vaccinated with GARDASIL 9 lot # L013429 dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient experienced syncope while standing at the check-out desk. On 25-NOV-2015, the patient had blood thyroid stimulating hormone, metabolic function test, full blood count, electroencephalogram, electrocardiogram, computerized tomogram (CT) head and coagulation test. Three weeks later, patient had an episode at home concerning for first time seizure that necessitated emergency room (ER) visit and further workup (ongoing). Lab data included head CT: negative. The outcome of the events was unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Full blood count, Metabolic function test, Seizure, 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 # 615021). This spontaneous report refers to a 12 year old female patient. Information on patient's concurrent illnesses was not reported. The patient's medical history included attention deficit/hyperactivity disorder (ADHD) and asthma. Other medications included Methylphenidate (Ritalin). On 25-NOV-2015, the patient was vaccinated with GARDASIL 9 lot # L013429 dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient experienced syncope while standing at the check-out desk. On 25-NOV-2015, the patient had blood thyroid stimulating hormone, metabolic function test, full blood count, electroencephalogram, electrocardiogram, computerized tomogram (CT) head and coagulation test. Three weeks later, patient had an episode at home concerning for first time seizure that necessitated emergency room (ER) visit and further workup (ongoing). Lab data included head CT: negative. The outcome of the events was unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Local swelling, Pain
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 # 615264). This spontaneous report refers to a 16 year old male patient. The patient's concurrent illnesses and other medications was reported none. The patient's medical history included uncomplicated mild intermittent asthma. On 14-DEC-2015 the patient was vaccinated with GARDASIL 9 lot # L017407, dose 2, intramuscularly in the left arm for prophylaxis. On 15-DEC-2015, the patient experienced erythema, pain and local swelling. The outcome of erythema, pain and local swelling was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HPV9, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: dThis report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 616933). This spontaneous report refers to a 2 month old female patient. The patient had no concurrent illnesses, medical history and other medications. Information on the patient's prior vaccinations was not reported. On 31-DEC-2015, the patient was vaccinated with GARDASIL 9 lot # L020015, dose 1 via intramuscular route in the right thigh for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with ROTARIX batch/lot # A41DB548A, dose 1 orally, PEDIARIX lot/batch# JX792, dose 1 via intramuscular route in the right thigh and PREVNAR 13 lot/batch# JX792, dose 1 via intramuscular route in the right thigh for prophylaxis (dosage unspecified). On 31-DEC-2015, the GARDASIL 9 vaccine was administered inadvertently to 11 week old infant. The drug was administered to patient of inappropriate age. There was no immediate injection reaction, no adverse reaction reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Cough, Dark circles under eyes, Flushing, Pruritus, Rash
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 # 617308). This spontaneous report refers to a 11 year old female patient. The patient had no concurrent illnesses, medical history and other medications. Information on the patient's prior vaccinations was not reported. On 31-DEC-2015, the patient was vaccinated with GARDASIL 9 lot # L028083, dose 1, intramuscular route in the left thigh for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with BOOSTRIX batch/lot# 7XR47, dose 1, intramuscular route in the left thigh, FLUZONE batch/lot# UI516AB, dose 13, intramuscular route in an unknown site and MENVEO batch/lot# X15069, dose 1, intramuscular route in the right thigh for prophylaxis (dosage unspecified). On 31-DEC-2015, the patient experienced cough, sensation of foreign body, rash, pruritus, flushing and dark circles under eyes. The patient had facial flushing and "raccoon eyes" with some lump in her throat feeling. Mild cough, rash on upper chest with some itching around the face and neck and upper chest. The patient required emergency room visit. The patient was treated with oral BENADRYL. The outcome of all the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Sensation of foreign body
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 # 617308). This spontaneous report refers to a 11 year old female patient. The patient had no concurrent illnesses, medical history and other medications. Information on the patient's prior vaccinations was not reported. On 31-DEC-2015, the patient was vaccinated with GARDASIL 9 lot # L028083, dose 1, intramuscular route in the left thigh for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with BOOSTRIX batch/lot# 7XR47, dose 1, intramuscular route in the left thigh, FLUZONE batch/lot# UI516AB, dose 13, intramuscular route in an unknown site and MENVEO batch/lot# X15069, dose 1, intramuscular route in the right thigh for prophylaxis (dosage unspecified). On 31-DEC-2015, the patient experienced cough, sensation of foreign body, rash, pruritus, flushing and dark circles under eyes. The patient had facial flushing and "raccoon eyes" with some lump in her throat feeling. Mild cough, rash on upper chest with some itching around the face and neck and upper chest. The patient required emergency room visit. The patient was treated with oral BENADRYL. The outcome of all the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV9
Symptoms: Pruritus, Throat irritation, Urticaria
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 ID-619655). This spontaneous report refers to a 13 year old male patient. The patient had no medical history, concurrent conditions and concomitant medications. On 30-NOV-2015 the patient was vaccinated with GARDASIL 9 dose 2 (unspecified dose and frequency) intramuscular in the right arm for prophylaxis. Other suspect therapies included FLUMIST, dose 2, through nasal route. On 30-NOV-2015, the patient experienced pruritus, urticarial (reported as hives) and throat irritation. The patient required emergency room visit. The outcome of pruritus, urticaria and throat irritation was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: MEN, MNQ
Symptoms: Erythema, Skin discolouration
Clinical narrative: Initial unsolicited report received from a physician on 20-Apr-2017. This case involves 16-year-old female patient, who was vaccinated with one dose of MENACTRA (Batch number, expiration date, route, dose in series and route of administration were not reported) in the right deltoid on 16-Apr-2017. Medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was none. Illness at the time of vaccination was none. Any other vaccinations within four weeks of vaccinations were unknown. On 16-Apr-2017, immediately following the vaccination the patient had injection site pain on the right arm with redness and small amount of swelling. On an unknown date, following vaccination patient's ear lobes had a mildly purple discoloration bilaterally almost looks like purpura. Patient required emergency room (ER) / doctor visit. Laboratory investigations were none and corrective treatment were not reported. On an unknown date, (also reported as over the next few days), the event vaccination site inflammation was resolved. Outcome of the event purpura was not recovered. It was also reported as no other vital issues or pain anywhere. Documents held by sender: none.
Sex: F
Vaccine: MEN, MNQ
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Purpura
Clinical narrative: Initial unsolicited report received from a physician on 20-Apr-2017. This case involves 16-year-old female patient, who was vaccinated with one dose of MENACTRA (Batch number, expiration date, route, dose in series and route of administration were not reported) in the right deltoid on 16-Apr-2017. Medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was none. Illness at the time of vaccination was none. Any other vaccinations within four weeks of vaccinations were unknown. On 16-Apr-2017, immediately following the vaccination the patient had injection site pain on the right arm with redness and small amount of swelling. On an unknown date, following vaccination patient's ear lobes had a mildly purple discoloration bilaterally almost looks like purpura. Patient required emergency room (ER) / doctor visit. Laboratory investigations were none and corrective treatment were not reported. On an unknown date, (also reported as over the next few days), the event vaccination site inflammation was resolved. Outcome of the event purpura was not recovered. It was also reported as no other vital issues or pain anywhere. Documents held by sender: none.
Sex: F
Vaccine: MEN, MNQ
Symptoms: Skin discolouration, Vaccination site inflammation
Clinical narrative: Initial unsolicited report received from a physician on 20-Apr-2017. This case involves 16-year-old female patient, who was vaccinated with one dose of MENACTRA (Batch number, expiration date, route, dose in series and route of administration were not reported) in the right deltoid on 16-Apr-2017. Medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was none. Illness at the time of vaccination was none. Any other vaccinations within four weeks of vaccinations were unknown. On 16-Apr-2017, immediately following the vaccination the patient had injection site pain on the right arm with redness and small amount of swelling. On an unknown date, following vaccination patient's ear lobes had a mildly purple discoloration bilaterally almost looks like purpura. Patient required emergency room (ER) / doctor visit. Laboratory investigations were none and corrective treatment were not reported. On an unknown date, (also reported as over the next few days), the event vaccination site inflammation was resolved. Outcome of the event purpura was not recovered. It was also reported as no other vital issues or pain anywhere. Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Asthenia, Chills, Crying, Nausea, Pain in extremity
Clinical narrative: Chills, painful legs where child would cry to walk, nausea, blurred vision, weakness. Reported symptoms to doctor on call and was told to keep an eye on them.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Vision blurred
Clinical narrative: Chills, painful legs where child would cry to walk, nausea, blurred vision, weakness. Reported symptoms to doctor on call and was told to keep an eye on them.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a medical assistant via Pfizer, Inc (ref # US17-019244) and refers to a currently 85-year-old patient of unknown gender. No information about the patient's concurrent conditions or concomitant medications was provided. The patient was vaccinated in 2006, with a dose of PREVNAR 7. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot #, expiration date were not reported). The reporter also inquired when they could administer PREVNAR 13. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no information provided about the patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies. On 29-MAR-2017, the patient inadvertently received a dose of injectable PROQUAD (lot number reported as M01508 with expiration date on 09-APR-2018) for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not reported) and injectable VARIVAX for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an adult patient (older than 13 years of age) of unknown gender. There was no information about the patient's pertinent medical history, concurrent conditions, and drug reactions or allergies. The nurse reported that her facility received a shipment of PROQUAD which was mistaken for M-M-R II, and additionally, it was improperly stored on 10-NOV-2016. The temperature was maintained between -9 and 8 Celsius degrees (with a maximum of 6 Celsius degrees) for 143 days. There was no previous temperature excursion. Subsequently on 24-JAN-2017, the adult patient was vaccinated with a dose of PROQUAD lot number: M033612, expiration date: 14-JAN-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided) for prophylaxis, which was reconstituted with a properly stored sterile diluent, instead of a dose of M-M-R II. No adverse effect reported. The call was not because of a "data logger". There was no product quality complaint involved. This is one of four reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014145: US-009507513-1704USA014147: US-009507513-1704USA014146.
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacy technician referring to an 11 year old male patient. Information regarding pertinent medical history, concomitant medication and drug reactions/allergies was not reported. On 04-AUG-2016, the patient was vaccinated with his first dose of GARDASIL 9 intramuscularly for vaccination (dose, lot# and expiration date were unknown). On 27-DEC-2016, the patient was vaccinated with his second dose of GARDASIL 9 intramuscularly for vaccination (dose, lot# and expiration date were unknown). The primary reporter reported the patient experienced "sore arm at injection site". It was unknown whether soreness was after receiving the first dose, second dose or both doses of GARDASIL 9. The outcome of the event and the relationship between the event and GARDASIL 9 were not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: This spontaneous report was received from a female patient (age unknown) referring to herself. There was no information provided about the patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies. On an unspecified date, the patient received a dose of injectable ZOSTAVAX for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). The reporter stated that, she had a bad skin reaction after receiving ZOSTAVAX. At the time of reporting, the outcome for the event and the relationship between ZOSTAVAX and the event of skin reaction were not provided. There was no product quality complaint (PQC) involved. Additional information is not expected because the reporter did not consent for further follow up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patients of unknown age and gender. No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified date, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot# M007307, expiration date 30-NOV-2017) (strength, dose, frequency, route of administration and anatomical location were not reported) orally for prophylaxis. The vaccine dose was exposed to a temperature excursion of 55 degrees Fahrenheit for 3 hours; a digital data logger was involved. There were no previous temperature excursions.  No adverse symptoms were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
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.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse, concerning to a multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were provided. On an unknown date, the reporter stated that multiple unspecified patients were vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. that was reconstituted with a properly stored sterile diluent. No adverse event was reported. The vaccine was stored at a temperature of 47° Fahrenheit to 77° Fahrenheit, time frame of 5 to 15 minutes, no previous temperature excursion was reported. The call was placed because of a Digital Data logger report. Product quality control was no involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: This spontaneous report has been received from a pharmacist regarding a male patient of an unknown age. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. It was reported that on an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis, that was reconstituted with DILUENT MRK (dose, frequency, route of administration, lot number and expiration date were not reported). According to the reporter, the patient developed a swollen red knot at the injection site. There was no further information provided by the reporter. The outcome of vaccination site swelling and vaccination site erythema was unknown. The causality assessment between vaccination site swelling and vaccination site erythema with ZOSTAVAX and DILUENT MRK was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ with lot # M018957 and expiration date of 22-NOV-2017 and lot # M038724 with expiration date on 24-APR-2018 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccines were exposed to temperature of 12 Centigrade degrees (°C) range for a time frame of 24 hours. The temperature excursion was recorded by a data logger and the previous excursions were reported as 9°C to 25°C for 9 hours for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014374: US-009507513-1704USA014372: US-009507513-1704USA014373.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017, the patients were vaccinated with the improperly stored doses of GARDASIL 9 (dose was not reported) (lot # M024261 and expiration date 30-JUL-2018) intramuscularly for prophylaxis. There were no adverse effects reported. On 27-FEB-2017, administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit (57.2 degrees Fahrenheit) for 1 hour and 45 minutes. Additionally, the administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit (50.2 degrees Fahrenheit) for 40 minutes. A data logger was involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a nurse prescriber via a company representative and refers to a 20 year old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported). Then (date not specified), she received a second dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported), both for prophylaxis. On an unknown date, the patient underwent a blood test (in order to proof her immunity) and showed she was not immune to the disease. The reporter planned to give to the patient another dose of VARIVAX but he/she wondered if one dose of the vaccine should be given and then repeat the blood work or just one dose of the VARIVAX should be given and then repeat the dose of the vaccine after 3 months. The outcome of antibody test negative was unknown. The causality between antibody test negative and VARIVAX was not provided. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a Pharmacist Intern, concerning a 12 month old patient of unknown gender. The patient's medical history, concurrent condition or concomitant medication were not provided. On 19-APR-2017, the patient was vaccinated with and expired dose of M-M-R II rHA Albumin status with a lot # L012482 and expiration date 10-APR-2017 (dose, route of administration were not provided) for prophylaxis. No adverse events were reported. Product quality control was no involved. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a 2 month old female patient. The patient's medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On 24-APR-2017, the patient was vaccinated with a properly-stored dose of VAQTA injection (dose and route of administration were not reported) lot number M039202; expiration date 11-MAR-2018 for prophylaxis. No adverse effects were reported. Additional information is not expected as the reporter refused additional contact.
Sex: F
Vaccine: PPV
Symptoms: Asthma, Blood immunoglobulin E, Blood immunoglobulin G decreased, Condition aggravated, FEV1/FVC ratio
Clinical narrative: This case is a report from a spontaneous literature article referring to a 50 Year-old Female patient. This patient was referred for recurrent respiratory infections and poorly controlled asthma including multiple ICU admissions. She had a history of mild asthma and allergic rhinitis but her clinical symptoms worsened significantly in her 40's. Her total IgE was 4 25 mg/dL and specific IgEs were positive to multiple environmental allergens. Her FEV1 was 57% predicted. Omalizumab was started for her severe asthma with improvement in severity of exacerbations, however she continued to have respiratory infections and intermittent need for corticosteroids and antibiotics. Further workup revealed hypogammaglobulinemia (lgG 428 mg/dl). It was reported that the patient was diagnosed with Common variable immunedeficiency(CVID). On an unknown date the patient was vaccinated with PNEUMOVAX23 (dosing regimen and frequency unknown) (lot number and expiry date unknown) for prophylaxis. No concomitant medications were reported. On an unknown date the patient experienced poor pneumococcal vaccine response. The action taken and outcome of the event were not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Hypogammaglobulinaemia, Immunodeficiency common variable, Respiratory tract infection, Therapeutic response decreased
Clinical narrative: This case is a report from a spontaneous literature article referring to a 50 Year-old Female patient. This patient was referred for recurrent respiratory infections and poorly controlled asthma including multiple ICU admissions. She had a history of mild asthma and allergic rhinitis but her clinical symptoms worsened significantly in her 40's. Her total IgE was 4 25 mg/dL and specific IgEs were positive to multiple environmental allergens. Her FEV1 was 57% predicted. Omalizumab was started for her severe asthma with improvement in severity of exacerbations, however she continued to have respiratory infections and intermittent need for corticosteroids and antibiotics. Further workup revealed hypogammaglobulinemia (lgG 428 mg/dl). It was reported that the patient was diagnosed with Common variable immunedeficiency(CVID). On an unknown date the patient was vaccinated with PNEUMOVAX23 (dosing regimen and frequency unknown) (lot number and expiry date unknown) for prophylaxis. No concomitant medications were reported. On an unknown date the patient experienced poor pneumococcal vaccine response. The action taken and outcome of the event were not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a pediatric patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, and drug reactions or allergies. The nurse reported that her facility received a shipment of PROQUAD which was mistaken for M-M-R II, and additionally, it was improperly stored on 10-NOV-2016. The temperature was maintained between -9 and 8 Celsius degrees (with a maximum of 6 Celsius degrees) for 143 days. There was no previous temperature excursion. Subsequently on 06-FEB-2017, the patient was vaccinated with a dose of PROQUAD lot number: M033612, expiration date: 14-JAN-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided) for prophylaxis, which was reconstituted with a properly stored sterile diluent, instead of a dose of M-M-R II. Additionally, on the same date and as a concomitant therapy, the patient was vaccinated with a dose of VARIVAX (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided) which was reconstituted with a properly stored sterile diluent, also for prophylaxis. No adverse effect reported. The call was not because of a "data logger". There was no product quality complaint involved. This is one of four reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA002246: US-009507513-1704USA014147: US-009507513-1704USA014146.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a pediatric patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, and drug reactions or allergies. The nurse reported that her facility received a shipment of PROQUAD which was mistaken for M-M-R II, and additionally, it was improperly stored on 10-NOV-2016. The temperature was maintained between -9 and 8 Celsius degrees (with a maximum of 6 Celsius degrees) for 143 days. There was no previous temperature excursion. Subsequently on 20-FEB-2017, the patient was vaccinated with a dose of PROQUAD lot number: M033612, expiration date: 14-JAN-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided) for prophylaxis, which was reconstituted with a properly stored sterile diluent, instead of a dose of M-M-R II. Additionally, on the same date and as a concomitant therapy, the patient was vaccinated with a dose of VARIVAX (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided) which was reconstituted with a properly stored sterile diluent, also for prophylaxis. No adverse effect reported. The call was not because of a "data logger". There was no product quality complaint involved. This is one of four reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA002246: US-009507513-1704USA014145: US-009507513-1704USA014147:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a pediatric patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, and drug reactions or allergies. The nurse reported that her facility received a shipment of PROQUAD which was mistaken for M-M-R II, and additionally, it was improperly stored on 10-NOV-2016. The temperature was maintained between -9 and 8 Celsius degrees (with a maximum of 6 Celsius degrees) for 143 days. There was no previous temperature excursion. Subsequently on 07-MAR-2017, the patient was vaccinated with a dose of PROQUAD lot number: M033612, expiration date: 14-JAN-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided) for prophylaxis, which was reconstituted with a properly stored sterile diluent, instead of a dose of M-M-R II. Additionally, on the same date and as a concomitant therapy, the patient was vaccinated with a dose of VARIVAX (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided) which was reconstituted with a properly stored sterile diluent, also for prophylaxis. No adverse effect reported. The call was not because of a "data logger". There was no product quality complaint involved. This is one of four reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA002246: US-009507513-1704USA014146: US-009507513-1704USA014145.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 with lot # M024261 and expiration date of 30-JUL-2018, lot # M034780 with an expiration date on 15-APR-2019 and lot # M037770 with expiration date on 01-JUN-2019 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccines were exposed to temperature of 12 Centigrade degrees (°C) range for a time frame of 24 hours. The temperature excursion was recorded by a data logger and the previous excursions were reported as 9 °C to 25 °C for 9 hours for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter.  Additional information has been requested. Sender's Comments: US-009507513-1704USA014373: US-009507513-1704USA014374: US-009507513-1704USA007701.