chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date beyond the recommended date in the vaccination schedule, the patient was vaccinated with the second dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported). There was no adverse effect reported. The nurse practitioner asked when should the patient receive the third dose of GARDASIL. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient's unspecified allergic reaction to Penicillin and macrolides. On 27-JAN-2016, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route and indication were not reported) for prevention of shingles at an unspecified physician's office. Concomitant medications were not reported. On an unknown date in 2016, the patient experienced a small nodule at the injection site. The patient informed that she had no rash. The patient sought medical attention by contacting the pharmacist and no treatment was given for the event. Product quality complaint was not involved. The outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Rash
Clinical narrative: This spontaneous report was received from a physician via a company representative regarding a 54 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated a dose of ZOSTAVAX (dose and lot # were not reported) intradermally instead of the recommended subcutaneous route. On an unknown date (reported as a while ago), the patient had an unspecified rash from an unspecified cause. The patient's outcome was unknown. The relatedness between the event and therapy with to ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. No historical or concurrent conditions were reported. On an unknown date, an unspecified number of patients received vaccination dose with improperly stored MMR II (lot # L020188, expiry: 30-JUN-2017); (lot# L012480, expiry: 10-APR-2017). The reporter reported a temperature excursion for the product. There was high temperature excursion at 9.5 degrees Celsius for a time frame of 31 minutes and low temperature excursion at 0.5 degrees Celsius for a time frame a 20 hours and 45 minutes. There was no previous temperature excursion. No concomitant medications were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was reported. This is one of several reports received from the same reporter (MARRS# 1602US007729). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. No historical or concurrent conditions were reported. On an unknown date, an unspecified number of patients received vaccination dose with improperly stored RECOMBIVAX HB (lot # L027733, expiry: 13-SEP-2017). The reporter reported a temperature excursion for the product. There was high temperature excursion at 9.5 degrees Celsius for a time frame of 31 minutes and low temperature excursion at 0.5 degrees Celsius for a time frame of 20 hours and 45 minutes. There was no previous temperature excursion. No concomitant medications were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was reported. This is one of several reports received from the same reporter (# 1602USA006329). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a company representative's friend referring to his or her approximately 15 year old daughter. The patient was not pregnant. There was no pertinent medical history and drug reactions or allergies. On unknown dates, the patient was vaccinated with first and second doses of GARDASIL or GARDASIL 9 (the vaccine was not confirmed by the reporter) (both lot number, expiration date and route were unknown, 0.5 ml). There was no adverse events with the first or second shot of the vaccine. On 12-FEB-2016 the patient was vaccinated with the third dose of GARDASIL or GARDASIL 9 (lot number, expiration date and route were unknown, 0.5 ml). Concomitant medications were unspecified. Later on 12-FEB-2016, the patient broke out in a rash. On 13-FEB-2016 (the following day), the rash was gone. But on 14-FEB-2016, the patient broke out in rash again from head to toe. The patient was planning on going to visit the doctor on 15-FEB-2015. No treatment was given for the event. The outcome of the event "rash from head to toe" was unknown. The causality between the event and suspect therapy was unspecified. Additional information is not expected because there was no contact details.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 15-FEB-2016 the patient was inadvertently vaccinated with a dose of expired PROQUAD (Merck) (lot # K010209, expiration date 17-JAN-2016; strength and route not reported). No adverse effects were reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 12.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Swelling
Clinical narrative: Within a few hours of receiving the vaccine she began to have severe pain in that arm. 48 hours later she still cannot move her arm without pain. Even the weight of a t-shirt or coat hurts. Acetaminophen doesn't help. Minimal redness. Some swelling.
Age: 1.05
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash maculo-papular, Rash morbilliform
Clinical narrative: Rash on arms, legs, cheeks/face. Morbilliform rash and fever. Immunization administered on 2/5/2016. MMR. Maculopapular eruption with fever. Temperature 102.1 (F).
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles within 1 week of vaccine PCP prescribed antiviral medication.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient's arm began hurting more than expected about an hour after receiving the vaccine. The next day, most of the upper arm was red and warm to the touch. Patient will self treat and monitor for now.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Chest pain, Cough, Dyspnoea, Fatigue
Clinical narrative: Difficulty breathing, sputum, cough, chest pain, tiredness initially. BP raised, HR raised. Later, only sputum and tiredness. (One-two weeks after).
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Heart rate increased, Productive cough
Clinical narrative: Difficulty breathing, sputum, cough, chest pain, tiredness initially. BP raised, HR raised. Later, only sputum and tiredness. (One-two weeks after).
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pain, Somnolence
Clinical narrative: Body aches, chills, having trouble waking up.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt reported redness, swelling, pain, and itching at injection site. Pt advised to apply ice and contact MD if does not get better after applying ice, entire "red" upper arm.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 10-SEP-2008, the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, exact dose and route of administration were not reported). On 07-JAN-2009, the patient received the second dose of GARDASIL (lot #, expiration date, exact dose and route of administration were not reported). On 24-MAR-2009, the patient was vaccinated with the third dose of GARDASIL (lot #, expiration date, exact dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Breath holding, Immediate post-injection reaction, Injection site pain, Syncope
Clinical narrative: Immediate syncope episode consistent with breath holding secondary to pain from needle. 20-30 seconds syncope patient responded and was very withdrawn for 5 min.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 16-JAN-2015, the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route, lot # and expiration date were not reported). On 16-FEB-2015, the patient was vaccinated with the second dose of RECOMBIVAX HB (dose, route, lot # and expiration date were not reported). On 17-MAR-2015, the patient was vaccinated with the third dose of RECOMBIVAX HB (dose and route were not reported, lot # K020218, expiration date 24-OCT-2016), what was outside of the recommendations per the RECOMBIVAX HB prescribing information. There was no adverse effect reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Pruritus, Rash generalised
Clinical narrative: Patient reports after 2 weeks her injection site is still red, sore and she has a rash all over her body. She is very itchy.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of RECOMBIVAX HB (lot # L023387, expiration date 22-JUN-2017) (dose, frequency and route not provided). No adverse effect was reported. The minimum of temperature was 0.8 degree C and the time frame was unspecified. There was no previous temperature excursion. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Physician Assistant regarding a 4 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On 15-FEB-2016, the 4 year old patient was inadvertently administered with ZOSTAVAX, 0.65 ml, subcutaneous, lot number-L036822, expiration date-24-DEC-2016, this is outside the recommendations per the prescribing information. No adverse event was reported. The outcome of event was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a improperly stored PNEUMOVAX 23, timeframe 16 hours, temperature of 34F, (strength, dose, route, and frequency were not provided) (lot# L018503, expiration date 16-MAR-2017). Concomitant therapies were not provided. The registered nurse did not reported adverse effects. No product quality complaint was involved. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On unspecified dates in February 2016, starting on or after 04-FEB-2016, patients were vaccinated with an unspecified number of improperly stored doses of oral, ROTATEQ (lot # L013202 and expiration date 27-JAN-2017, dose was not reported). The temperature of the excursion was 46.9F with the time frame of 16 hours. There was no previous excursion and it was not a data logger. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report have been reported from a female patient of unknown age, who was reporting on herself. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown) injection (reported as "Pneumonia vaccine"; dose and route of administration were not reported) and with a dose of an unspecified influenza virus vaccine (reported as "flu shot"; dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the patient experienced some unspecified adverse reactions. There was no product quality complaint involved. The outcome of the event was not reported. The relatedness between the event and the suspect vaccines was not provided. Additional information is not expected as the patient declined to take part in the adverse event report.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 08-FEB-2016, the patient was vaccinated with a improperly stored VAQTA, time frame 16 hours, a temperature of 34F, (strength, dose, route, and frequency were not provided) (lot# reported as L026037, expiration date 17-JAN-2018). Concomitant therapies were not provided. The registered nurse did not reported adverse effects. No product quality complaint was reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Administration site swelling, Injection site erythema, Pain, Pruritus, Swelling
Clinical narrative: Administration site is red and swollen about 4 inches in diameter. Pt advised to take ibuprofen for pain/swelling and BENADRYL for the itch. Also advised to notify primary care doctor.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On unspecified dates in February 2016, starting on or after 04-FEB-2016, patients were vaccinated with an unspecified number of improperly stored doses of RECOMBIVAX HB (lot # L027733 and expiration date 13-SEP-2017, dose and route of administration were not reported). The temperature of the excursions was 46.9F with the time frame of 16 hours. There was no previous excursion and it was not a data logger. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: Case number PHEH2015US016313, is an initial spontaneous report from a physician assistant received on 17 August 2015. This report refers to a 21-year-old female patient. Medical history included meningitis (about 6 years ago). No other health problems were reported to the patient. Concomitant medications included BCPs. The patient was vaccinated with MENVEO (batch number: M15018, expiration date: 01 May 2016) on 10 Aug 2015. In Aug 2015, after vaccination the patient experienced intermittent headaches. The headaches come and go and the patient went to the doctor's office to see her HCP about the headaches. Final outcome, seriousness and causality were not reported.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On 02-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection (lot # L018351 with expiration date 11-AUG-2017: dose and route were not provided). The vaccine was exposed to temperature of 47.10F for 96 hours. There was no previous temperature excursion. The call was not because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive
Clinical narrative: 2/16/16 - Patient called to report a recent diagnosis of congestive heart failure that she is relating to the shingles vaccination she received in 8/28/2014.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Electromyogram, Imaging procedure, Injection site pain
Clinical narrative: Pt reports localized pain to left deltoid persists. Has had imaging and EMG, Neurology consult, PMNR and no resolution so far.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Blood test, Discomfort, Headache, Injection site pain, Mass
Clinical narrative: Pt reports localized pain to left deltoid persists. Has had imaging and EMG, Neurology consult, PMNR and no resolution so far.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Monoplegia, Neck pain, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Pt reports localized pain to left deltoid persists. Has had imaging and EMG, Neurology consult, PMNR and no resolution so far.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Sleep disorder, X-ray
Clinical narrative: Pt reports localized pain to left deltoid persists. Has had imaging and EMG, Neurology consult, PMNR and no resolution so far.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Discomfort, Headache, Neck pain, Neoplasm skin, Pain
Clinical narrative: Pt reports localized pain to left deltoid persists. Has had imaging and EMG, Neurology consult, PMNR and no resolution so far.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Pt reports localized pain to left deltoid persists. Has had imaging and EMG, Neurology consult, PMNR and no resolution so far.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 15-FEB-2016, the patient inadvertently received dose of ZOSTAVAX, lot # L035283, expiry date 15-DEC-2016 (Strength, dose, route and site of administration were not reported) instead of intended dose of VARIVAX (Merck). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Visiting Nurse (L.V.N.) concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 15-FEB-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (Lot # L031602; 18FEB-2017), which was improperly stored and was exposed to several  defrost cycles. No adverse symptoms reported. This is one of several cases from the same reporter (MARRS # 1507USA010811). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On 02-FEB-2016, the patient was vaccinated with an improperly stored dose of oral, ROTATEQ (lot# L023866 with expiration date 24-MAR-2017; dose was not provided). The vaccine was exposed to temperature of 47.10F for 96 hours. There was no previous temperature excursion. The call was not because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. this is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to the patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant medications were not reported. On an unspecified date, ROTATEQ (lot # L013204, expiration date 28-JAN-2017) was improperly stored to 32.7 degrees Fahrenheit for 90 minutes. Then on unspecified dates since 04-JAN-2016, unspecified patients received the improperly stored doses of ROTATEQ by oral route (dose was unspecified). No adverse effects had been reported. It was unknown if the patients sought medical attention. No product quality complaint (PQC) was involved. This is one of two reports from the same source. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Off label use
Clinical narrative: Case number PHEH2015US009759 is an initial spontaneous report from a pharmacist received on 18 May 2015. This report refers to a 61-year-old male patient who was inadvertently vaccinated with MENVEO (batch number: X13014) intramuscularly on 02 Feb 2014. No adverse event reported following this medication error (off label use).
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received BOOSTRIX (batch number 7B222, expiry date 23rd April 2017). On 26th December 2015, the patient received BOOSTRIX (intramuscular), .5 ml. On an unknown date, less than a month after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter if the reporter considered the injection site pain to be related to BOOSTRIX. Additional details were received as follows: At the time of reporting, the patient was continuing to experience soreness at the injection site. The patient was seen by her primary care physician and had physical therapy for the reported symptom.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: (L) - 11 in (R) - 9 3/4 in. Pneumococcal (PNEUMOVAX 23) given in (L) deltoid on 2/11/16 at about 8:00AM - soreness noted at noon - redness/sore noted at 5PM. Presented to clinic at 10:20AM on 2/12/16 with swelling, rash, hot to touch area in outer/inner aspect of upper (L) arm. (T) - 98.3. 2/13/16 8:30AM Temp: 97.3 B/P 148/74 (R) arm (sitting) P: 76 Reg. Patient returns for recheck of PNEUMOVAX 23 adverse reaction. (Vaccine given 2/11/16. Pt. to clinic 2/12/16 for adverse reaction). Today (L) arm measures 10 1/2 inches. (2/12/16 measured 11"). (L) arm not as swollen. Upper (L) arm - deltoid - not as reddened or warm to touch as on 2/12/16. Redness of inner (L) arm increased from 2/12/16. On 2/12/16 was to elbow, today 3 1/2" below elbow. Pt states arm is feeling better, and inner (L) arm itching. Pt states she had BENADRYL x 2 on 2/12/16 with last dose approx. at 11:00 pm. Pt also has been applying ice to (L) arm. Dr. informed of above information and saw pt. Dr. instructed pt to return Monday if any problems or area not improved.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Vaccination complication
Clinical narrative: (L) - 11 in (R) - 9 3/4 in. Pneumococcal (PNEUMOVAX 23) given in (L) deltoid on 2/11/16 at about 8:00AM - soreness noted at noon - redness/sore noted at 5PM. Presented to clinic at 10:20AM on 2/12/16 with swelling, rash, hot to touch area in outer/inner aspect of upper (L) arm. (T) - 98.3. 2/13/16 8:30AM Temp: 97.3 B/P 148/74 (R) arm (sitting) P: 76 Reg. Patient returns for recheck of PNEUMOVAX 23 adverse reaction. (Vaccine given 2/11/16. Pt. to clinic 2/12/16 for adverse reaction). Today (L) arm measures 10 1/2 inches. (2/12/16 measured 11"). (L) arm not as swollen. Upper (L) arm - deltoid - not as reddened or warm to touch as on 2/12/16. Redness of inner (L) arm increased from 2/12/16. On 2/12/16 was to elbow, today 3 1/2" below elbow. Pt states arm is feeling better, and inner (L) arm itching. Pt states she had BENADRYL x 2 on 2/12/16 with last dose approx. at 11:00 pm. Pt also has been applying ice to (L) arm. Dr. informed of above information and saw pt. Dr. instructed pt to return Monday if any problems or area not improved.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with improperly stored dose of oral ROTATEQ (lot # L008059, expiry date 18-DEC-2016) (lot # K023532, expiry date 21-JUN-2017) (lot # L008053, expiry date 28-FEB-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that there was no previous temperature excursions. It was reported that Lot # L008059, expiry date 18-DEC-2016 was exposed to cumulative temp of 48 Fahrenheit (F) for 16 hours, Lot # K023532, expiry date 21-JUN-2017 was exposed to cumulative temp of 52.3 F for 72 hours and Lot # L008053, expiry date 28-FEB-2017 was exposed to temp of 41.8 F for 16.5 hours. It was reported that this report was reported due to a data logger. No adverse effects were reported. The action taken with the therapy with oral ROTATEQ was unknown. The outcome of the event was unknown. There was no product quality complaint reported. This case is linked to case number 1602USA008168 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with improperly stored dose of VARIVAX (Merck) (lot # L017146, expiry date 13-MAY-2017), (Lot # L024256, expiry  01-JUL-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that there was no previous temperature excursions. It was reported that lot # L017146, expiry date 13-MAY-2017 was exposed to a temperature of 13.2 Fahrenheit (F) for 53 hours and 14 minutes and lot #L024256, expiry date 01-JUL-2017 was exposed to a temperature of 20.3 F for 72 hours. It was reported that this report was reported due to a data logger. No adverse effects were reported. The action taken with the therapy with VARIVAX (Merck) was unknown. The outcome of the event was unknown. There was no product quality complaint reported. It was reported that GARDASIL 9 was supported by prescribing information (details unspecified). This case is linked to case number 1602USA007298 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a registered nurse via company representative regarding an unspecified patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with ZOSTAVAX, lot number-1709X, expiration date- May 2010. No concomitant medication was reported. On an unknown date the patient experienced a mild rash that they believe was shingles. The outcome of shingles was unknown. Additional information is not expected because physician does not want to get contacted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. There was no pertinent medical history, drug reactions or allergies reported. On 12-FEB-2016, the patient was vaccinated with PEDVAXHIB (dose, route and site not reported) lot # L030867, expiration date 09-JUN-2018, that was improperly stored. It was noted that the PEDVAXHIB was expose to 34.2 F temperature for two hours and fifty minutes. The PEDVAXHIB was not expose to previous temperature excursion. There were not adverse effects reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 14 year old female patient. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patient as an infant was administered the three-dose series of RECOMBIVAX HB (exact dose, route of administration, lot #, expiration date, anatomical location and frequency were not reported). There were no concomitant medications reported. On an unknown date (reported as "just recently"), the patient was tested for hepatitis B immunity and her results came back as "indeterminant".  The outcome of the event was unknown. The relatedness between the event and RECOMBIVAX HB was not provided. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Off label use
Clinical narrative: Case number PHEH2015US009940, is an initial spontaneous report from a physician received on 21 May 2015. This report refers to a 12-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with MENVEO (batch number: not reported) on 09 Oct 2014 and again received MENVEO (batch number: M14125) intramuscularly on 18 May 2015 erroneously. No adverse event was reported.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Malaise, Pyrexia, Vomiting
Clinical narrative: Case number PHEH2015US015786, is an initial spontaneous report from a health care professional received on 12 Aug 2015. This report refers to a 17 year old male patient. The patient had a history of past gluteal maximus cancerous tumor removal otherwise he was a healthy teen. Concomitant medications were none. The patient was vaccinated with MENVEO (batch number: not reported) on 03 Aug 2015. On 11 Aug 2015 the patient developed malaise, headache, fever and vomiting. Outcome of the events was unknown. Seriousness criteria and causality of the event were not reported.
Age: 13.0
Sex: F
Vaccine: HPV2, MNQ
Symptoms: Epistaxis, Product preparation error
Clinical narrative: Case number PHEH2015US005064, is an initial spontaneous report received from a nurse on 13 Mar 2015 and with follow-up information from a nurse received on 28 Apr 2015. This report refers to a 13-year-old female patient. Past medical history and concomitant medication were not reported. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X14040, expiry date: Jan 2017), intramuscularly into right arm without being reconstituted with Men A lyophilized conjugate vaccine component on 11 Mar 2015 at 10:57. On the same day, the patient was also vaccinated with HPV (batch number unknown, other manufacturer). On an unknown date, after vaccinations, the patient presented with bloody bad nose. Outcome, seriousness and causality of the event were not reported. Follow-up information from a nurse received on 28 Apr 2015: New event (blood nose), patient's demographics (weight and height), vaccine details (site, time, expiry date), new suspect vaccine (HPV), new reporter details and other clinically relevant information updated in the narrative.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of Oral, ROTATEQ (lot # L010837, expiration date 16-FEB-2017) (dose, frequency and route not provided) (incorrect product storage). No adverse effect was reported. The minimum of temperature was 0.8 degree C and the time frame was unspecified. There was no previous temperature excursion. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL 9 (lot # L016428, expiration date 30-JULY-2017) (dose, frequency and route not provided). No adverse effect was reported. The minimum of temperature was 0.8 degree C and the time frame was unspecified. There was no previous temperature excursion. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL (lot # K011325, expiration date 08-APR-2017, lot number # K014191, expiration date 10-MAY-2017) (dose, frequency and route not provided) (incorrect product storage). No adverse effect was reported. The minimum of temperature was 0.8 degree C and the time frame was unspecified. There was no previous temperature excursion. M-M-R II appeared in the product list since it was involved in the excursion; however no improperly stored doses of M-M-R II were administered. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a consumer referring to her daughter, a 15 year old female patient with none drug reactions/allergies and none pertinent medical history. On unknown dates, the patient was vaccinated with her first and second injections of GARDASIL series. On 12-FEB-2016, unidentified Merck HPV vaccine was administered (name and lot number not provided) to the patient (injection, the third dose, route and dose were unknown). There was none concomitant medication. About 5 hours after receiving the third dose, the patient experienced hives from the neck. The patient called to pediatrician for medical attention. Unspecified BENADRYL was given to treat the event. None lab diagnostics studies were performed. The patient's hives was recovered in February 2016. On 14-FEB-2016 (also reported as on Sunday), the patient's hives recurred and again early on the morning of 15-FEB-2016. The patient had not had any reaction to the first two injections in the GARDASIL series. She was watched for several days. The outcome of hives was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site rash
Clinical narrative: Redness, warmth, tenderness and swelling (L) upper arm. Temp: 99.7. 1/27/16: Seen by staff. Dx. cellulitis and treated with cephalexin. TYLENOL and Ibuprofen for discomfort. Mother here with daughter for re-eval,. from 1/27/16. Mother states, she still has swelling, and pain. But the warmth is going away. Pt. says, it doesn't hurt where the swelling is. Is also still finishing up her antibiotics. 4 yo F comes in with mom for the following: After receiving DTaP, IPV, MMRV on 1/25/16-> developed erythema, swelling, and pain in the (L) arm (deltoid area)-> the DTaP/IPV were given in the left deltoid. Seen in walk in on 1/27 and started on KEFLEX yesterday. Currently has much improvement in symptoms. Per mom, no hives or rash developed anywhere else and pain has subsided and pt using arm well. Per provider note, rash was seen "shoulder down to middle of humerus erythema and hot to touch with mild edema and some pain". Mom denies trouble breathing, swelling in lips, fever, or any other rash. Eating and drinking well.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, tenderness and swelling (L) upper arm. Temp: 99.7. 1/27/16: Seen by staff. Dx. cellulitis and treated with cephalexin. TYLENOL and Ibuprofen for discomfort. Mother here with daughter for re-eval,. from 1/27/16. Mother states, she still has swelling, and pain. But the warmth is going away. Pt. says, it doesn't hurt where the swelling is. Is also still finishing up her antibiotics. 4 yo F comes in with mom for the following: After receiving DTaP, IPV, MMRV on 1/25/16-> developed erythema, swelling, and pain in the (L) arm (deltoid area)-> the DTaP/IPV were given in the left deltoid. Seen in walk in on 1/27 and started on KEFLEX yesterday. Currently has much improvement in symptoms. Per mom, no hives or rash developed anywhere else and pain has subsided and pt using arm well. Per provider note, rash was seen "shoulder down to middle of humerus erythema and hot to touch with mild edema and some pain". Mom denies trouble breathing, swelling in lips, fever, or any other rash. Eating and drinking well.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a registered nurse of unknown age referring to herself. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot number and indication not provided) and then had developed shingles afterwards. The outcome of herpes zoster was unknown. The reporter declined to be connected over to a medication therapy management (MTM). She called inquiring about "what medications should she use to make her shingles pain go away". There was no product quality issue (PQC) involved. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Case number PHHY2015US024059, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549789) website on 03 Feb 2015. This report refers to a 58-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1412401) along with PNEUNOVAX 23 (other manufacturer, batch number: K004485), intramuscularly in the left arm on an unknown date. On an unknown date, after vaccination she experienced arm redness and hot to touch. She was sent to urgent care facility and took AUGMENTIN 875 tablet twice daily. The outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2015US024063, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549824) website on 03 Feb 2015. This report refers to a 50-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1411601) in the left arm on 16 Sep 2014. On the same date, after vaccination he experienced pain to left arm. The outcome of the event reported as continued for 5 weeks after vaccination. The patient was informed to see the physician. The event reported as non-serious. The causality of the event was not reported.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2015US0224065, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549827) website on 03 Feb 2015. This report refers to a 40-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1411601) in the left deltoid on 16 Sep 2014. On the same date, after vaccination he experienced pain at left deltoid. The outcome of the event reported as continued for 5 weeks after vaccination. The patient was informed to see the physician. The event reported as non-serious. The causality of the event was not reported.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2015US024073, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549829) website on 03 Feb 2015. This report refers to a 32-year-old female patient. She was vaccinated with FLUVIRIN (batch number; 1411601) in the left arm on 16 Sep 2014. On the same date, after vaccination he experienced pain in left arm. The outcome of the event reported as continued for couple of weeks after vaccination. The patient was informed to see the physician and placed on anti inflammatories. The event reported as non-serious. The causality of the event was not reported.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Extensive swelling of vaccinated limb, Feeling hot, Pruritus, Pyrexia
Clinical narrative: Case number PHHY2015US024381, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference  number: 549975) website on 03 Feb 2015. This report refers to a 79 year old female patient. Medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN (batch number: 1412201) IM into left arm on 17 Oct 2014. On the same day post vaccination the patient had swelling from shoulder to her elbow. She also experienced hot, red appearance spreading onto chest as well, itching and low grade fever. Final outcome of the events recovered. Causality assessment was not reported. Events were reported as non-serious.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Case number PHHY2015US023675, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549995) website on 03 Feb 2015. This report refers to a 59 year old male patient. No known allergies. Concomitant medications included HUMALOG, KWIKPEN and LANTUS. He was vaccinated with FLUVIRIN (batch number: 1414001) IM into right arm on 24 Oct 2014. On the same day post vaccination he developed soreness at the injection site and also down the arm. Final outcome of the event was unknown. Causality assessment was not reported. Event was reported as non-serious.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Rash erythematous
Clinical narrative: Case number PHHY2015US023718, is an initial spontaneous report received from the vaccines adverse events reporting system (VAERS reference number: 550147) on 03 Feb 2015. This report refers to a 60 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1412031) intramuscularly in left arm on 25 Oct 2014. On same day after vaccination she experienced slight headache and red/purple rash under left armpit. The outcome of the events was reported as unknown. The events were reported as non-serious and causality of the events was not reported.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Case number PHHY2015US023727, is an initial spontaneous report received from the vaccines adverse events reporting system (VAERS reference  number: 550149) on 03 Feb 2015. This report refers to a 24 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1411301) intramuscularly in the left arm on 24 Oct 2014. On 26 Oct 2014, she experienced large red round rash around injection site about 5-6 inches in diameter. She was advised to apply cool compress and BENADRYL and contact immunization advisor. The outcome of the events was reported as complete recovery. The events were reported as non-serious and causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site pain
Clinical narrative: Case number PHHY2015US023620, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550330) website on 03 Feb 2015. This report refers to a female patient of unknown age. Current condition included chronic high blood pressure and concomitant medication included blood pressure medication. She was vaccinated with FLUVIRIN (batch number: 66521011710) on 04 Oct 2014. On the same day post vaccination she developed severe pain and fist sized hematoma at the injection site. On 17 Oct 2014, she went to the hospital seeking assistance. She was taking ibuprofen as prescribed but the pain persisted. Final outcome of the events was condition unchanged as on 21 Oct 2014. Causality assessment was not reported. Events were reported as non-serious.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Case number PHHY2015US023638, is an initial spontaneous report received form the Vaccine Adverse Event Reporting System (VAERS reference number: 550387) website on 03 Feb 2015. This report refers to a 51-year-old female patient. Medical history included asthma. Past medications included penicillin and sulfa. Concomitant medications included Albuterol and SYMBICORT. The patient was vaccinated with FLUVIRIN (batch number: 1412601) intramuscularly into the right arm on 15 Oct 2014. On the same day approximately one hour after vaccination, the patient experienced generalized itching and hives rash to face neck, and cheeks. The final outcome of the events was recovered. The events were reported as non-serious. Causality was not reported.