chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US007135 is a combined initial spontaneous report received from a physician's assistant on 08 Apr 2014 and a follow-up received on 09 Apr 2014 with a follow up information received from the physicians' assistant on 05 May 2014. This case was reported as a batch report of 2 patients and upon follow up the identifiers were reported. This report refers to a 10 years old male patient. His medical history included allergy to penicillin. His concomitant medications were not reported. He was vaccinated with initial dose of MENVEO (batch number: X13015/X13059) intramuscularly on 26 Mar 2014. It was reported that MenA lyophilized conjugate component reconstituted with a sterile diluent other than MenCYW-135 liquid conjugate. No adverse event was reported after the administration error. Follow up information received from physician's assistant on 05 May 2014: Patient demographics (initial, age, gender, weight and height) medical history and date of vaccination were updated.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Tenderness
Clinical narrative: Case number PHEH2014US006297 is an initial spontaneous report received from a nurse on 28 Mar 2014, and with a follow up received on 22 Apr 2014. This report refers to an 11 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A13014) intramuscularly and Tdap (other manufacturer, batch number: not reported); both vaccines administered in the left arm on 25 Mar 2014. It was reported that MENVEO was administered in the same area as that of Tdap vaccine. It was reported that patient had minor reaction to the vaccination which was further described as redness and tenderness and there was no swelling. It was reported that the reaction started on the same day of vaccination and the patient went to physician's office on 28 Mar 2014 as the symptoms did not improve. The seriousness and causality were not reported. Follow up received on 22 Apr 2014. Update vaccination date and patient details (height and weight).
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health professional and refers to a patient of unknown age and gender. Information on patient's concurrent conditions, medical history and drug reactions was not reported. On 14-AUG-2015, the patient received the first  dose of GARDASIL 9 , injection (concentration, dose, anatomical location, not repreoted) which has a lot # reported as K006117 with expiration date on 14-JAN-20176. On 16-OCT-2015, the patient received the second dose of GARDASIL 9 and on 22-DEC-2016, the patient received the third dose respectively (inappropriate schedule of drug administration). At the reporting time, no adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional and refers to a patient of unknown age and gender. Information on patient's concurrent conditions, medical history and drug reactions was not reported. On 14-AUG-2015, the patient received the first dose of GARDASIL 9, injection (concentration, dose, anatomical location not reported) which had a lot # reported as K006117 with expiration date on 14-JAN-2017. On 16-OCT-2015, the patient received the second dose of GARDASIL 9 and on 22-DEC-2015, the patient received the third dose respectively (inappropriate schedule of drug administration). At the reporting time, no adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 17-May-2016, the patient was vaccinated with a dose of PEDVAXHIB lot number reported as M001813 and expiration date 14-OCT-2018 (route of administration, dose, dosage number and anatomical location were unknown) instead of an intended dose of ENGERIX-B. Concomitant or co-suspect therapies were not provided. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. On 18-MAY-2016, the patient was vaccinated with an expired dose of ZOSTAVAX vial 19400 PFU, (dose, route and lot # were not provided). The expiration date was reported as 15-MAR-2016. It was unknown if the product had any previous temperature excursion. No adverse symptoms reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Hypoaesthesia, Injection site urticaria
Clinical narrative: Patient complains of hives at injection site (HPV9). They are still occurring daily, 1 month after the injection. He also c/o numbness of his face, it gets worse when the hives appear.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/ allergies were reported. On 13-May-2016, the patient was vaccinated with expired PNEUMOVAX 23 (which had a lot # K019561 and an expiration date of 20-APR-2016; however, dose, dosage number, route of administration and anatomical location were not reported). No concomitant medications were reported. Despite being vaccinated with an expired dose of the vaccine, no adverse effects were reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Day after varicella vaccine administered site became erythematic, hardened, and warm to touch. Treatment with antibiotics and allergy medications. As of 5-20-16 redness moved further down arm and lump became bigger.
Age: 34.0
Sex: M
Vaccine: HEPAB
Symptoms: Immediate post-injection reaction, Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site burning in a 34-year-old male patient who received TWINRIX adult (batch number 2JN4N, expiry date unknown). Co-suspect products included TWINRIX adult. On 22nd October 2013, the patient received the 1st dose of TWINRIX adult. On 4th December 2013, the patient received the 2nd dose of TWINRIX adult. On 22 October 2013, immediately after receiving TWINRIX adult and not applicable after receiving TWINRIX adult, the patient experienced injection site burning. On 4th December 2013, the patient experienced drug dose administration interval too long. On 22 October 2013, the outcome of the injection site burning was recovered/resolved. On an unknown date, the outcome of the dose administration interval too long was unknown. The reporter considered the injection site burning to be related to TWINRIX adult. Additional details were provided as follows: The reporter believed this report might have already reported to GlaxoSmithKline in 2013, but was not sure. The nurse reported that, no other vaccines were administered by the patient on the day in October and he did not have other medications listed. The gentleman patient received 1st dose of TWINRIX adult by injection and during the push of the vaccine, he reported burning. The patient was monitored for about 30 minutes after the vaccination and the issue was resolved. On 4th December 2013, the patient returned to complete the schedule and received 2nd dose of TWINRIX adult, which led to lengthening of the vaccination schedule. On 7th May 2014, the patient received 3rd dose of TWINRIX adult without any incident and complaint.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 52-year-old male patient who received BOOSTRIX (batch number KP95K, expiry date 3rd December 2017). On 11th February 2016, the patient received BOOSTRIX .5 ml. On an unknown date, less than a year after receiving BOOSTRIX, the patient experienced injection site pain, injected limb mobility decreased and weakness of arms. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased and weakness of arms were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and weakness of arms to be related to BOOSTRIX. Additional details were provided as follows: The reporter stated that, the patient had severe reactions to BOOSTRIX. The patient was vaccinated in the left arm and was having trouble using his left arm till the time of reporting. No other information was provided and not all questions were asked.
Sex: U
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: This case was reported by a other health professional and described the occurrence of hives in a patient who received BOOSTRIX. On 2nd February 2016, the patient received BOOSTRIX. On an unknown date, less than a year after receiving BOOSTRIX, the patient experienced hives. The patient was treated with steroids nos. On an unknown date, the outcome of the hives was recovered/resolved. It was unknown if the reporter consider the hives to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received BOOSTRIX and experienced hives on entire body, which lasted a total of 5 weeks after taking steroids. The other healthcare professional would like to know whether BOOSTRIX contained golden mercury.
Age: 58.0
Sex: F
Vaccine: MENB, PNC13
Symptoms: Drug administered to patient of inappropriate age, Immediate post-injection reaction, Injection site pain, Lymphadenopathy
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received BEXSERO (batch number 149001A, expiry date September 2016). Concomitant products included PREVENAR. On 2nd May 2016, the patient received BEXSERO .5 ml. On 2nd May 2016, immediately after receiving BEXSERO, the patient experienced injection site pain and inappropriate age at vaccine administration. On 6th May 2016, the patient experienced lymphadenopathy. On 11th May 2016, the outcome of the injection site pain and lymphadenopathy were recovered/resolved. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the injection site pain and lymphadenopathy to be related to BEXSERO. Additional details were provided as follows: The 58 years old patient received BEXSERO in left arm and PREVENAR in the right arm. This led to inappropriate age at vaccine administration. The patient experienced left arm soreness immediately after receiving BEXSERO and 4 days later she experienced swollen lymph nodes in left armpit, neck, and upper shoulder area between collarbone and neck. On 11th May 2016, the patient was feeling better and the side effects were resolved. No other side effects were reported.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Mobility decreased, Pain, Swelling, X-ray
Clinical narrative: 2 hrs. after vaccine pt states pain constant 10/10 w/shooting pain, swelling, and decreased ROM.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Pt received ZOSTAVAX inj on 5/18/2016. Presented on 5/20/16 with large swelling at site of inj. Swelling at site 3" x 4 1/2" with what appears to be small blisters at injection sites. Progressively worsened, starting in AM of 5/19/16. Blisters developed around 11 AM, very itchy. Oral BENADRYL. If worsens, directed toward medical attn.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Electrocardiogram, Eye movement disorder, Laboratory test, Seizure
Clinical narrative: Seizure, 100. F, eye balls rolled back.
Sex: M
Vaccine: HEP
Symptoms: Seroconversion test negative
Clinical narrative: This spontaneous report was received from a nurse referring to a male patient of unknown age. Information regarding the patient's concurrent conditions and medical history was not provided. On an unspecified dates, the patient was vaccinated with 3 complete series of unspecified hepatitis b vaccine (manufacturer unknown) (lot #, route and dosage information were not provided) at unspecified facilities. Information regarding the patient's concomitant medication was not provided. The nurse reported that after the administration of the unspecified hepatitis b vaccine (manufacturer unknown) was administered, then the patient had titers drawn which also exhibited results that suggest the patient did not seroconvert. The patient's outcome was unknown at the time of reporting. The causal relationship between unspecified hepatitis b vaccine (manufacturer unknown) and the aforementioned event was not provided. This is one of 2 reports concerning the same patient. 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 and refers to multiple unspecified patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # L039660, expiry date 04-FEB-2018 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccines were stored at temperatures from 46.9 to 55.8 degrees Fahrenheit, for 24 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Viral test negative
Clinical narrative: This spontaneous report was received from a nurse referring to a male patient of unknown age. Information regarding the patient's concurrent conditions and medical history was not provided. On an unspecified dates, the patient was vaccinated (at unspecified facilities) with 2 doses of VARIVAX (lot #, route and dosage information were not provided). Information regarding the patient's concomitant medication was not provided. The reporter stated that the patient had titers drawn "recently" which exhibited a "negative" results. The patient's outcome was unknown at the time of reporting. The causal relationship between VARIVAX, and the aforementioned event was not provided. This one of several reports concerning the same patient. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, HEPA, JEVX, VARZOS
Symptoms: Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: This spontaneous report was received from a nurse of unknown age who reported on herself. The patient's pertinent medical history included hypertension, hypothyroidism and blood cholesterol increased. On 02-MAY-2016, the patient was vaccinated in the arm with a dose of ZOSTAVAX vial 19400 PFU (dose, frequency, route of administration and lot # were not reported). On the same day, the patient was vaccinated in the opposite arm with a dose of VAQTA and Japanese encephalitis virus vaccine (dose, frequency, route of administration, indication and lot # were not reported). Concomitant therapies included simvastatin (manufacturer unknown), losartan potassium (manufacturer unknown), aspirin (manufacturer unknown) and SYNTHROID. The nurse reported that she experienced "pain, a softball size welt measuring 5 inches in diameter which is red and warm" at the injection site on unspecified date approximately in May 2016. The nurse reported that the unspecified pharmacist who administered the vaccine "may not have put in the correct site, it was on the back of my arm not in the middle deltoid area but lower". The nurse reported that she did report this to her primary care physician (demographics not provided) on an unspecified date. The nurse reported that she applied ice to the site and took 50 mg of BENADRYL on an unspecified date. The nurse reported that she felt "it is getting bigger and worse". The outcome of the events was reported as not recovered/not resolved. The causality between the events and ZOSTAVAX, VAQTA and Japanese encephalitis virus vaccine was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, HEPA, JEVX, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: This spontaneous report was received from a nurse of unknown age who reported on herself. The patient's pertinent medical history included hypertension, hypothyroidism and blood cholesterol increased. On 02-MAY-2016, the patient was vaccinated in the arm with a dose of ZOSTAVAX vial 19400 PFU (dose, frequency, route of administration and lot # were not reported). On the same day, the patient was vaccinated in the opposite arm with a dose of VAQTA and Japanese encephalitis virus vaccine (dose, frequency, route of administration, indication and lot # were not reported). Concomitant therapies included simvastatin (manufacturer unknown), losartan potassium (manufacturer unknown), aspirin (manufacturer unknown) and SYNTHROID. The nurse reported that she experienced "pain, a softball size welt measuring 5 inches in diameter which is red and warm" at the injection site on unspecified date approximately in May 2016. The nurse reported that the unspecified pharmacist who administered the vaccine "may not have put in the correct site, it was on the back of my arm not in the middle deltoid area but lower". The nurse reported that she did report this to her primary care physician (demographics not provided) on an unspecified date. The nurse reported that she applied ice to the site and took 50 mg of BENADRYL on an unspecified date. The nurse reported that she felt "it is getting bigger and worse". The outcome of the events was reported as not recovered/not resolved. The causality between the events and ZOSTAVAX, VAQTA and Japanese encephalitis virus vaccine was not reported. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pronounced (but non-allergic-appearing) swelling, redness, soreness at injection site.
Age: 55.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Headache, Injection site pain, Musculoskeletal stiffness, Nausea
Clinical narrative: Severe headache, stiff neck, nausea, pain at injection site (possibly migraine).
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Erythema, Fatigue, Pain, Swelling
Clinical narrative: Pain, discomfort with moving, redness, and swelling, as well as profound fatigue.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain in extremity, Swelling
Clinical narrative: Really sore arm, bump resembling a mosquito bite. She continued to experience stiffness in her arm up to her neck. The sore arm persisted even after a cold compress. Doctor prescribed voltaren to help with possible inflamed bursa.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, hot, some welling, slight itching of the right arm where the shot was injected.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site movement impairment, Vaccination site pain
Clinical narrative: Significant pain and motion limitation at vaccination site (upper right arm) -- has lasted for two days at this writing, though seems to gradually be getting better.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Injection sit reaction.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Nonspecific reaction
Clinical narrative: Pharmacist Administered Immunization.  Administered At Time of Dispensing.  Patient took Benadryl and 2x Ibuprofen 200mg Tablets at around 4PM 5/19/2016.  Went to Emergency Room at 12 Noon 5/20/16
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Sore, swollen, red and warm to the touch. Patient took TYLENOL and BENADRYL.
Age: 50.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Drooling, Loss of consciousness, Musculoskeletal stiffness, Seizure, Syncope
Clinical narrative: Patient fainted; appeared to have seizure; stiffening muscles, drool etc.
Age: 62.0
Sex: F
Vaccine: HEPAB, PPV, TDAP
Symptoms: Myalgia, Nodule
Clinical narrative: Left arm muscle soreness and a "knot" on upper arm.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Local swelling
Clinical narrative: Swelling and pain in armpit on left side.
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Rotavirus test positive, Vaccination failure
Clinical narrative: Information has been received from the authors in a published literature article regarding 8 children of unknown age and gender. On an unknown date, the patients received 3 doses of ROTATEQ. Concomitant medications were not provided. In this article was reported Group A rotaviruses (33 complete RVA) genomes collected in multiple cities in the country during 2006-2009. Out of the 33 strains, 8 were from children known to have received 3 doses of ROTATEQ, who developed acute gastroenteritis which was demonstrated in the fecal specimens. Additionally, these strains were referred to as vaccine failure (VF) strains. Finally, all the vaccine failure strains also shared one substitution in VP7 gene and 10 substitutions in VP4 gene, which may lead to potential evasion of vaccine induced immunity. The outcome of vaccination failure and gastroenteritis rotavirus was unknown. Upon internal review the gastroenteritis rotavirus was considered as a medically significant event. The reporter considered vaccination failure and gastroenteritis rotavirus to be related to ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (therapy type: Digital data logger) (lot # L033343 with expiry date of 13-SEP-2017), at a temperature of 33 F for a time frame of 8 hrs 20 min cumulatively (incorrect product storage). The physician reported there was a previous temperature excursion, which was cumulative total since unspecified time in March 2016. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients received doses of improperly stored GARDASIL (lot # K006960, expiration date: 19-FEB-2017; dose and route were not provided. The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 47.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead referring to a 47-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L035881, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in deltoid (a dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: HEP, PNC13
Symptoms: Erythema, Injection site induration, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: (R) deltoid induration, warmth, tenderness. Area of about 2 1/2 x 3 1/2 in. Per patient, red streaks up to neck yesterday, mild fever. Resolved with ice and NSAIDS.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Health care worker and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of ROTATEQ orally, (which had a lot # of L035276 and an expiration date of 09-JUN-2017; however, dosage number and route of administration were not reported). Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 724 hours (30 days): 24 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. 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 physician refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (therapy type: Digital data logger) (lot # L035276 with expiry date of 09-JUN-2017), orally, at a temperature of 33 F for a time frame of 8 hrs 20 min cumulatively. The physician reported there was a previous temperature excursion, which was cumulative total since unspecified time in March 2016. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown darte the patients were vaccinated with improperly stored GARDASIL 9 (therapy type: digital data logger) (lot # L017407 with expiry date of 15-AUG-2017), at a temperature of 33 F for a time frame of 8 hrs 20 min cumulatively (incorrect product storage). The physician reported there was a previous temperature excursion, which was cumulative total since unspecified time in March 2016. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead referring to a 19-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L035881, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in right deltoid (a dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients received doses of improperly stored GARDASIL 9 (lot # L016429, expiration date: 08-AUG-2017; lot # L037339, expiration  date: 08-FEB-2018; lot # L027282, expiration date 21-SEP-2017; dose and route were not provided. The vaccine underwent temperature excursion of -1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored does of GARDASIL 9 (lot # L023230, expiration date 28-JUL-2017) (exact dose and route of administration were not reported). There was no adverse effect reported. Administered doses experienced the temperature excursion of 48.7 degrees Fahrenheit for 24 hours. There was no previous temperature excursions. A date logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored with LIQUID PEDVAXHIB (therapy type: Digital data logger) (lot # L012838 with expiry date of 10-MAR-2018), at a temperature of 33 F for a time frame of 8 hrs 20 min cumulatively. The physician reported there was a previous temperature excursions, which was cumulative total since unspecified time in March 2016. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant were not reported. On 12-MAY-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K018528, expiry date: 14-APR-2016) (route and dose not provided). No adverse effects were reported. No Product quality complain (PQC) involved. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient had no drug reactions or allergies. The patient's pertinent medical history was not reported. On an unknown date approximately in 2012 (reported as about four years ago), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. On an unknown date approximately in 2016 (reported as approximately 4 years after receiving ZOSTAVAX), the patient developed a moderate case of shingles. The patient sought medical attention (an office visit) and received an unspecified treatment for the event. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Skin irritation, Skin ulcer
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 71 year old female patient. No information regarding the patient's medical history or concurrent conditions was provided. On 09-FEB-2016, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX injection (dose, lot # and expiry date were not reported). There were no concomitant therapies reported. On approximately 04-MAY-2016, reported as two weeks ago, the patient experienced skin irritation, skin ulceration and an eruption at the injection site. The patient sought medical attention and she was referred to a dermatologist. The reporting physician provided a photograph of the patient's reaction. The outcome of the events was not reported. The relatedness between ZOSTAVAX and the events was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients. The patient's medical history was not reported. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX (lot#, expiration date, dose, route and site of administration were not reported) in an area other than the deltoid region because she did not agree that ZOSTAVAX should be administered into the deltoid area. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Depressed mood, Fatigue, Feeling abnormal
Clinical narrative: Information has been received from a female subject of unknown age reporting about herself enrolled in a study. The subject's concurrent condition, historical conditions and concomitant medications were not reported. On an unknown date, the subject was vaccinated with PNEUMOVAX 23 (dosage regimen was not reported). On an unknown date the subject enquired if it was normal to feel run down (depressed mood) and tired (fatigue) after getting PNEUMOVAX 23. The outcome of depressed mood and fatigue was not reported. The causality between the events depressed mood and fatigue and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HIBV, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown demographics. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients received doses of improperly stored LIQUID PEDVAXHIB (lot # K004540, expiration date: 03-DEC-2016; lot # L014429, expiration date: 15-MAR-2018; dose and route were not provided). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported) subcutaneously. The pharmacist reported that on an unknown date, the patient experienced an injection site reaction to the vaccine ZOSTAVAX. The patient experienced significant redness, bruising and swelling at the injection site. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse practitioner refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (which had a lot # of L013429 and an expiration date of 21-JUL-2017; however, dosage number and route of administration were not reported). Nevertheless, no adverse effects were reported. The vaccine experienced the following temperature excursions on an unspecified cumulative period of time since January 2016: 0.5 grades centigrade. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified multiple patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 injection, lot # L017265, expiry date 10-FEB-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the improperly stored vaccines experienced three different temperature excursions (1.6 degrees Celsius for 3 hours and 54 minutes, 1.6 degrees Celsius for 1 hour and 22 minutes and 1.5 degrees Celsius for 1 hour and 22 minutes). No adverse effects were reported. No product quality complain (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified multiple patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with GARDASIL injection, lot # K010574, expiry date 08-APR-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the improperly stored vaccines experienced three different temperature excursions (1.6 degrees Celsius for 3 hours and 54 minutes, 1.6 degrees Celsius for 1 hour and 22 minutes and 1.5 degrees Celsius for 1 hour and 22 minutes). No adverse effects were reported. No product quality complain (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a patient of unknown age and gender. Patient's medical history, concurrent conditions, and concomitant medications were not provided. On 12-MAY-2016, the patient was vaccinated with an expired dose of ROTATEQ, (lot # K001832, expiry date: 20-NOV-2014) (route, dose and frequency not reported). No adverse effect reported. No product quality (PQC) involved. No further information provided. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Itchiness, redness w/ swelling in 4" circle at injection site; 48 hrs later, slight breathing issue. Pt saw PCP on 05/20/16, and she stated this is a side effect and recommended cold compress. Pt states the swelling and redness are decreasing; but it is still very painful.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown demographics. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients received doses of improperly stored PNEUMOVAX 23 (lot # L018503, expiration date: 16-MAR-2017; lot # L012521, expiration date: 01-FEB-2017; dose and route were not provided). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 07-MAY-2016, the patient was vaccinated with an expired dose of GARDASIL (lot # J006850 and expiration date 31-MAR-2016, dose and route of administration was not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, PPV, TDAP
Symptoms: Condition aggravated, Crohn's disease, Erythema, Fatigue, Immunodeficiency
Clinical narrative: PNEUMOVAX 23 given Rt deltoid 5/19/16. Pt has Crohn's - immunocompromised. 5/21/16 6" red raised warm reaction Rt arm/fatigue.
Age: 11.0
Sex: M
Vaccine: MNQ, PPV, TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: PNEUMOVAX 23 given Rt deltoid 5/19/16. Pt has Crohn's - immunocompromised. 5/21/16 6" red raised warm reaction Rt arm/fatigue.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a female patient of unknown age. The patient's medical history was not provided. In 2012, the patient was vaccinated with the third dose of GARDASIL (lot #, expiration date, route and site of administration were not reported) 0.5 ml and completed vaccination series with GARDASIL. The second and third dose of GARDASIL were administered to the patient one month apart, which is out of recommended series dosing schedule. No adverse effect was reported. Additional information is not expected because the physician cannot be contacted.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccines administered 5/18/16. Redness and swelling noted on (L) upper arm this afternoon. 7 x 7 cm area of erythema. No tenderness.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical Nurse and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 16-MAY-2016, the patient was accidentally vaccinated with two doses of M-M-R II 0.5 ml each dose, subcutaneously (lot #, expiration date and route of administration were not reported). Concomitant medications were not mentioned. Nevertheless, no adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medial assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 18-MAY-2016, the patient was vaccinated with an expired dose of M-M-R II lot #K007106, expiration date 16-MAY-2016 (dose and route of administration were not reported). The vaccine did not undergo any previous temperature excursions. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored GARDASIL 9 lot # M003659 with expiration date: 20-SEP-2017 (dose, route of administration and vaccination site were not reported). Administered doses of GARDASIL 9 underwent temperature excursion at 28.6 Fahrenheit degrees, for 4 hours. Digital data logger was involved. There was no previous temperature excursion. No adverse effects were reported. 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 was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates the patients received doses of improperly stored ROTATEQ orally, lot # L027076 with expiration date: 25-MAY-2017 and lot # L033543 with expiration date: 30-MAY-2017 (dose and vaccination site were not reported). Administered doses of ROTATEQ underwent temperature excursion at 28.6 Fahrenheit degrees, for 4 hours. Digital data logger was involved. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.42
Sex: M
Vaccine: HIBV, DTAP, HIBV, IPV, PNC13
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 07-MAY-2016, the patient was inadvertently vaccinated with improperly stored PEDVAXHIB (lot # L042835 and expiration date 19-AUG-2018, dose and route of administration were not reported). Concomitant therapy was not reported. The temperature of excursion was 31.5F and the time frame was 11 hours. There was no previous temperature excursion and the call was because of the data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.