chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: This information has been received from a consumer concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with GARDASIL 9 (dose, strength, frequency, route of administration, anatomical location, lot# and expiration date were not provided), for prophylaxis. The reporter stated that GARDASIL 9 was "killing people", but did not clarify whether she knew of any specific patients who died after receiving GARDASIL 9. Neither the cause of death nor whether an autopsy was performed was reported. Upon internal review, the event of death was considered to be medically significant. Reported Cause(s) of Death: unknown cause of death.
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 17 year old female patient. On an unknown date the patient was vaccinated with PROQUAD for prophylaxis. On 01-AUG-2017 the patient experienced drug administered to patient of inappropriate age. On an unknown date the patient experienced no adverse event. The outcome of drug administered to patient of inappropriate age and no adverse event is unknown. The reporter considered drug administered to patient of inappropriate age and no adverse event to be not related to PROQUAD.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates in July-2017 (reported as 'in the week of 24-JUL-2017'), the patients were vaccinated with improperly stored VAQTA (lot # N005274, expiry date: 03-APR-2018) (route: intramuscular) (incorrect product storage). The vaccine was stored at a temperature of 32°F to 35°F (34.4 F) for 15 minutes. The vaccine did not underwent previous temperature excursion. Digital data logger was involved. No other adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA001330:
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 78 year old male patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # M041086, expiry date: 31-JAN-2018) (route: subcutaneous) reconstituted with DILUENT (unknown Lot/Exp). On an unknown date, (reported as 2 weeks later), the patient experienced itchy rash that looked like dermatitis on one side of his back. VZV packet not offered. The patient did not seek any medical attention. The outcome of the events was reported as not recovered. The causality of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 01-AUG-2017, the patient was inadvertently received second dose of PROQUAD (lot # M004897, expiry date: 26-JUL-2017) (route: subcutaneous) that was past its expiration date (inappropriate schedule of vaccine administration). No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 31-JUL-2017 the patient was vaccinated with VARIVAX lot # L023594 for prophylaxis.       On 31-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to VARIVAX.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unspecified dates in July 2017, the patients were vaccinated with improperly stored ROTATEQ (lot# M038208, expiration date 04-MAY-2018, lot# M031805, expiration date 07-APR-2018, lot# N000172, expiration date 10-JUN-2018; oral; dose unknown) for prophylaxis. The vaccines were stored under 35F for 1.5 hours. There was previous temperature excursion under 35F for 3.5 hours and 34F for 2 hours. The call was because of a data logger. No adverse effects reported. The storage occurred between 07-JUL-2017 and 31-JUL-2017. This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1708USA000547:
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received nurse via company representative and refers to a patient of unknown age and gender. The patient's medical history, concomitant medication and concurrent conditions were not reported. On 15-DEC-2015, the patient was vaccinated with first dose of GARDASIL (dosing details and lot# not reported) for prophylaxis. Then on 01-SEP-2016, the patient received a second dose in the series which was GARDASIL 9 (Interchange of vaccine products and wrong drug administered). No adverse effects reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates in July-2017 (reported as 'in the week of 24-JUL-2017'), the patients were vaccinated with improperly stored ROTATEQ (lot # M041181, expiry date: 31-MAY-2018) (route: oral) (incorrect product storage). The vaccine was stored at a temperature of 32°F to 35°F (34.4 F) for 15 minutes. The vaccine did not underwent previous temperature excursion. Digital data logger was involved. No other adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA001258:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # M043306, exp. date: 24-APR-2018; M044719, exp. date: 07-MAY-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccines were stored under temperature -14 Celsius degrees (C) to -10 C with timeframe 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA001467.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M047660, exp. date: 02-DEC-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccines were stored under temperature -14 Celsius degrees (C) to -10 C with timeframe 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA001338.
Sex: F
Vaccine: PNC13
Symptoms: Fungal infection
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A 74 year-old female patient of unspecified race and ethnicity received PREVNAR 13 at single dose via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. After the vaccination the patient went to the emergency room (ER) with what she thought was hives. The ER doctor said that she had a fungal infection and not an adverse event to pneumococcal 13-val conj vac (dipht crm197 protein). Outcome was unknown.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Acne, Bacterial infection, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Developed redness and warmth of right arm from elbow to shoulder and swelling circumvents arm, no pain, pimple heads at injection sites, fever. Sent to ER and diagnosed with bacterial infection and placed on Clindamycin 11mg PO Q8 hours x 7 days. On 7-15-17 at 3:10 pm arm looks better, much less swelling per mom.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Developed redness and warmth of right arm from elbow to shoulder and swelling circumvents arm, no pain, pimple heads at injection sites, fever. Sent to ER and diagnosed with bacterial infection and placed on Clindamycin 11mg PO Q8 hours x 7 days. On 7-15-17 at 3:10 pm arm looks better, much less swelling per mom.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Pruritus, Rash
Clinical narrative: First day patient broke out in rashes and had itching. Couple days later she had a rash at the site of injection that spread down the left arm, was warm to touch and had swelling.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pain, Presyncope
Clinical narrative: This spontaneous report as received from a nurse via a physician through a company representative refers to an approximately 12 year old male patient. The patient's medical history was not reported. It was unknown if the patient had any drug reactions/allergies. On 25-JUL-2017, the patient was vaccinated with GARDASIL 9 (Strength, frequency and route were not reported) of lot # N012093 with an expiry date of 13-JAN-2020 in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX administered in the right arm and MENVEO administered in the left arm (Vaccine administered at inappropriate site). Approximately, on an unknown date in July 2017, the patient experienced pain. Approximately, on an unknown date in July 2017, after all three injections, the patient experienced a "vagal response". The physician monitored the patient . On an unknown date in July 2017, the patient's blood pressure was checked. The results were not provided. The patient was given water along with "something to eat". There was no product quality complaint involved. The outcome of the events was reported to be recovered, approximately on July 2017 after leaving the physician's office. The causality assessment was not provided. Lot number (N012093) has been verified to be a valid lot number for GARDASIL 9.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received from a nurse referring to an unknown number of unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were administered doses of improperly stored M-M-R II injection, recombinant human albumin (rHA) (lot# M039913, expiration date 26-SEP-2018; lot# M042846, expiration date 21-OCT-2018) (Strength, dose, frequency, anatomical location and route were not reported) for prophylaxis. The concomitant therapy included sterile diluent which was used to reconstitute M-M-R II injection, was stored properly. The vaccines were exposed to 47 to 77 Fahrenheit degree (F) for 2 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects was reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Lot number (M042846) has been verified to be a valid lot number for M-M-R II.; Sender's Comments: US-009507513-1707USA012152: US-009507513-1707USA012416: US-009507513-1707USA012417: US-009507513-1707USA012418: US-009507513-1707USA012419:
Sex: U
Vaccine: RV5
Symptoms: Metabolic disorder
Clinical narrative: This spontaneous report was received from a pharmacist 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 an unknown date, the patient was vaccinated with a dose of ROTATEQ (dose, lot #, expiration date were not reported) orally. Then, on an unknown date the patient was vaccinated with the second dose of ROTATEQ (dose, lot #, expiration date were not reported) orally. The reporter stated that the patient received a total of 2 doses of ROTATEQ and was subsequently hospitalized in an unspecified hospital on an unknown date. The pharmacist reported also that on an unknown date, the patient was diagnosed with unspecified metabolic disorder. The outcome of the adverse event as well as the relatedness were not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare professional refers to 2 patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as N009774, expiration date 20-SEP-2018. The sterile diluent used to reconstitute the PROQUAD was properly stored. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of -9 degrees Celsius for 7 hours. Data logger was involved. There were no previous excursions reported.
Age: 4.0
Sex: M
Vaccine: MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 4 year old male patient with prophylaxis. On 02-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M038863 for prophylaxis. Other suspect therapies included VARIVAX and sterile diluent (MRK). On 02-AUG-2017, 1 day after onset of therapy the patient experienced wrong drug administered. On an unknown date the patient experienced no adverse event. Lot number N015478 has been verified to be a valid lot number for sterile diluent (MRK). Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable nurse reported for two patients. This nurse reported similar events for 2 patients. This is the 2nd of 2 patients. An 88-year-old female patient received PREVNAR 13 (lot number R94917, expiration date 23May2018) at 0.5 ml single dose intramuscular on 23Jun2017 for risk of pneumonia. Medical history and concomitant medications were not reported. In Jun 2017 the patient had swelling at the injection site that resolved spontaneously. It was described also as red, ball like, hot to touch, erythematous and resolved slowly with oral BENADRYL. The patient also went to Urgent care. The reporting nurse mentioned that the patient may have also taken Prednisone for the swelling and redness, but unsure. Final outcome was reported as recovering. Sender's Comments: Linked Report(s): US-PFIZER INC-2017334461 same reporter, drug and AE, different patient.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Pt started with redness and pain in the left upper arm was diagnosed with Cellulitis on 7/26/2017 was prescribed BENADRYL 25mg 2 tabs every 8 hrs x 10 days, Ibuprofen 400mg 1 tab every 6 hrs x 10 days, and BACTRIM DS 800-160mg 1 tab twice a day x 10 days.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Skin warm, Swelling
Clinical narrative: Allergic reaction. Swelling, warm to the touch.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Excessive vomiting with green bile. No fever. No diarrhea.
Age: 0.42
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RVX
Symptoms: Aphasia, Autism spectrum disorder, Constipation, Developmental delay, Incorrect dose administered
Clinical narrative: After my son received 4 year old shots he stopped cooing, his motor skills weren't great his milestones took longer than normal kids his age. At 12 mo he was still and up to date non verbal! Diagnosed with severe autism at 22 mo. He's taking speech therapy and soon starting ABA therapy. I am the mother of patient on November 17th, 2015 my son went in for a 2 month well check in which he was weighed, measured and evaluated also given 3 vaccines and 1 oral medication for chronic constipation. Everything went well. February came around and my son was once again due for a well check (4 months old). We went in same routine and once again he was given 3 shots and 1 oral medication. After all was done the administrator or head of health center came in and apologized and informed me that the nurse saw and caught that at our previous visit my son was given the wrong shot. I was hurt and confused and till this day I still am, my son was given a 4 year old shots supposedly when he was  2 months old. That day she gave me a sheet and she said that it was for my record to show they weren't hiding anything. I left and switched my son's pediatrician. Fast forward 19 months later I went in to that clinic to sign off on medical records for my personal use and after a small hassle I realized I was lied to by the administrator! In the form she gave me the "wrong shots" weren't listed because they were not given when he was 2 months old they were given when he was 4 months old. And the lady who helped me get his records on 7/27/17 confirmed it for me. My son was severely impacted by these vaccines that were actually given when he was 4 months old. My son stopped cooing his motor skills were not good and his milestones took time to reach and on 7/5/17 my son was diagnosed with Autism Spectrum Disorder. My son is non verbal has severe constipation problems he wasn't the same baby after that. He now takes speech therapy thru program and is soon to start ABA therapy my son to this day is non-verbal! I never heard my son coo after that day. I'm seeking the help of VAERS because someone recommended you guys to help me with this misfortune I was lied to and when I tried to report it they said "things like this happen a lot" and that I couldn't do anything about it. I will be sending some proof that I got from the clinic and his immunization record I hope to hear from you guys with a solution all I want is justice for my baby who isn't the same since then. This left us with a financial burden me not able to work and left patient's dad to bring in the income.
Age: 0.42
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RVX
Symptoms: Psychomotor skills impaired, Regressive behaviour, Speech disorder
Clinical narrative: After my son received 4 year old shots he stopped cooing, his motor skills weren't great his milestones took longer than normal kids his age. At 12 mo he was still and up to date non verbal! Diagnosed with severe autism at 22 mo. He's taking speech therapy and soon starting ABA therapy. I am the mother of patient on November 17th, 2015 my son went in for a 2 month well check in which he was weighed, measured and evaluated also given 3 vaccines and 1 oral medication for chronic constipation. Everything went well. February came around and my son was once again due for a well check (4 months old). We went in same routine and once again he was given 3 shots and 1 oral medication. After all was done the administrator or head of health center came in and apologized and informed me that the nurse saw and caught that at our previous visit my son was given the wrong shot. I was hurt and confused and till this day I still am, my son was given a 4 year old shots supposedly when he was  2 months old. That day she gave me a sheet and she said that it was for my record to show they weren't hiding anything. I left and switched my son's pediatrician. Fast forward 19 months later I went in to that clinic to sign off on medical records for my personal use and after a small hassle I realized I was lied to by the administrator! In the form she gave me the "wrong shots" weren't listed because they were not given when he was 2 months old they were given when he was 4 months old. And the lady who helped me get his records on 7/27/17 confirmed it for me. My son was severely impacted by these vaccines that were actually given when he was 4 months old. My son stopped cooing his motor skills were not good and his milestones took time to reach and on 7/5/17 my son was diagnosed with Autism Spectrum Disorder. My son is non verbal has severe constipation problems he wasn't the same baby after that. He now takes speech therapy thru program and is soon to start ABA therapy my son to this day is non-verbal! I never heard my son coo after that day. I'm seeking the help of VAERS because someone recommended you guys to help me with this misfortune I was lied to and when I tried to report it they said "things like this happen a lot" and that I couldn't do anything about it. I will be sending some proof that I got from the clinic and his immunization record I hope to hear from you guys with a solution all I want is justice for my baby who isn't the same since then. This left us with a financial burden me not able to work and left patient's dad to bring in the income.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MNQ, VARCEL
Symptoms: Fatigue, Vaccination site erythema
Clinical narrative: Mom states patient developed red area around where vaccine was given. Area was about 3" long and 2 " wide. Mom called MD and he recommended BENADRYL - patient received 3 doses of BENADRYL over a time interval. No breathing difficulties. Patient felt fatigued after the vaccine.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Erythema, Eyelid oedema, Nausea, Peripheral swelling
Clinical narrative: Per Emergency Report and after speaking to patient the left arm became swollen, red and hot and her eyelids began to swell in the evening mentioned  about 7 hours after the injection. Patient stated also feeling nauseated and lightheaded for several hours. Patient received IV Benadry and Solu Medrol and was in the ED for approximately 2.5 hours under observation.  She was then released and has been taking Benadryl by mouth three times per day. On this day patient says her arm is quite a bit better but still having some eyelid swelling though improved.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Skin warm
Clinical narrative: Per Emergency Report and after speaking to patient the left arm became swollen, red and hot and her eyelids began to swell in the evening mentioned  about 7 hours after the injection. Patient stated also feeling nauseated and lightheaded for several hours. Patient received IV Benadry and Solu Medrol and was in the ED for approximately 2.5 hours under observation.  She was then released and has been taking Benadryl by mouth three times per day. On this day patient says her arm is quite a bit better but still having some eyelid swelling though improved.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Nausea, Pallor, Syncope
Clinical narrative: Syncope after receiving vaccines. Approximately 5 min. after receiving vaccines, while waiting in exam room, patient was observed sitting on exam table and looking pale and feeling nauseated. RN used ammonia inhalant on patient. Patient responded by verbalizing that she felt better. Patient remained in room lying down with father for additional 15 minutes.
Age: 41.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Arthralgia, Impaired work ability, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: After Tdap injection, right upper arm became extremely sore, Currently almost 2 full days later, soreness like being punched all the way up to shoulder, elbow, wrist and finger soreness. Difficult to move arm. Had to call in 4 hours for work 8/2/17 because job requires typing as telephonic nurse case manager. Attempted to notify NP office at 2:39 8/2/17 but no return call. Left arm is sore, but right arm is notably swollen and sore. As aforementioned, extremely tender to touch and painful to move. I had never had the pertussis part of the vaccine before because I had had childhood febrile seizures and it was contraindicated. I had pertussis as a nurse but did not have the paperwork to prove. I needed the vaccine to do my preceptorship for my Master's of Science in Nursing is why I took the full vaccine. Currently arm is not painful if right at my side or if I am applying firm pressure but otherwise, fingers, wrist, elbow, site of injection and shoulder are extremely painful.
Age: 41.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Pain in extremity, Tenderness
Clinical narrative: After Tdap injection, right upper arm became extremely sore, Currently almost 2 full days later, soreness like being punched all the way up to shoulder, elbow, wrist and finger soreness. Difficult to move arm. Had to call in 4 hours for work 8/2/17 because job requires typing as telephonic nurse case manager. Attempted to notify NP office at 2:39 8/2/17 but no return call. Left arm is sore, but right arm is notably swollen and sore. As aforementioned, extremely tender to touch and painful to move. I had never had the pertussis part of the vaccine before because I had had childhood febrile seizures and it was contraindicated. I had pertussis as a nurse but did not have the paperwork to prove. I needed the vaccine to do my preceptorship for my Master's of Science in Nursing is why I took the full vaccine. Currently arm is not painful if right at my side or if I am applying firm pressure but otherwise, fingers, wrist, elbow, site of injection and shoulder are extremely painful.
Age: 12.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Syncope
Clinical narrative: Client received 2 immunizations. Was walking back out to waiting room with his mother and fainted. Nurse helped him to floor. Legs were elevated. Client came to and was offered water. Sat in clinic for 15-20 minutes and then went home with his mother. Nurse called and checked in later and mother reported client was fine.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to five patients of unknown age and gender. On an unknown date, the patients were vaccinated with M-M-R II lot # M039913, expiration date 62-SEP-2018 for prophylaxis, reconstituted with sterile diluent (manufacturer unknown). On an unspecified date, the vaccines and sterile diluent (manufacturer unknown) were exposed to temperature ranges between 47° Fahrenheit (F) to 77°F during a time frame of 12 hours 30 minutes. There was not previous temperature excursion. The temperature excursion was not called by a data logger. Adverse effects were not reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician concerning an unspecified amount of patients.  The patients' medical histories, concurrent conditions and concomitant medications were not provided.  On unspecified dates, unspecified patients were administered improperly stored VAQTA, lot # M047658, expiration date 28-OCT-2017  (route not specified) and RECOMBIVAX HB, lot# M042322, expiration date 21-FEB-2019 (route not specified). The temperature excursion for both vaccines: 47 degrees F to 77 degrees F.  Time Frame:  44 minutes. Previous temperature excursion for VAQTA : 48 degrees F for 76 minutes. Previous temperature excursion for RECOMBIVAX HB: 48 degrees F for 45 minutes. A data logger was involved. No adverse events were reported. The  outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a patient (age and gender not specified). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 12-JUL-2017 the patient was administered a dose of improperly stored VARIVAX, lot # M047660, expiration date  02-DEC-2018, for prophylaxis. Temperature: -9 degrees C to 8 degrees C. Time frame: 3 hours. No previous temperature excursions. Digital data logger was involved. The sterile diluent (manufacturer unknown) that was used to reconstitute the vaccine was properly stored. The outcome of the event was unknown. Additional information has been requested.; Sender's Comments: US-009507513-1708USA001658:
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unknown number of unspecified adult patients of unknown gender. Since an unknown date, the patients were vaccinated with two pediatric doses of VAQTA injection, 25/0.5 (units not provided) (lot number, expiration date and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager regarding an approximately 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-MAY-2017, the patient was vaccinated with one dose of improperly stored M-M-R II, lot # M029230 with expiration date 08-JUN-2018 (dose and route were not reported), for prophylaxis in combination with sterile diluent (Manufacturer unknown) (lot #, expiration date, dose and route were not reported). The storage temperature and time frame for M-M-R II was 47 to 77F for 11 days. There was no previous temperature excursion and the call was because of a data logger. The sterile diluent did not underwent a temperature excursion. No adverse effect was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 28-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # M041510 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On 28-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date, the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to ZOSTAVAX.      Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified patients pf unknown age and gender. On an unknown date patients were vaccinated with M-M-R II lot # M039904 expiration date of 26-SEP-2018 for prophylaxis. On an unknown date, the vaccine was incorrectly storage at a temperature of 11.8 °C. There was no previous temperature excursion. Data logger was involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA001111: US-009507513-1708USA001110.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA lot number reported as M005274 and expiration date of 03-APR-2018 for prophylaxis. On an unknown date was reported incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA001111:  US-009507513-1708USA000453:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ lot # M043562 expiration date of 03-JUN-2018 for prophylaxis. On an unknown date, the vaccine was incorrectly storage at a temperature of 11.8 °C. There was no previous temperature excursion. Data logger was involved. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA000453: US-009507513-1708USA001110:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse 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 since 03-JUL-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot# M040143, expiration date 27-MAR-2018 and lot# reported as N001490, expiration date 12-JUL-2018 (dose, route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 15 degrees Fahrenheit and 46 degrees Fahrenheit (also reported as 32.5 degrees Fahrenheit) for 30 minutes. Data logger was not involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-00507513-1708USA001605: US-00507513-1708USA001606.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse 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 since 03-JUL-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot# N012618, expiration date 21-APR-2019 and lot# M041080, expiration date 06-OCT-2018 (dose, route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 15 degrees Fahrenheit and 46 degrees Fahrenheit (also reported as 32.5 degrees Fahrenheit) for 30 minutes. Data logger was not involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-00507513-1708USA001511: US-00507513-1708USA001606:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse 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 since 03-JUL-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot# M041511, expiration date 08-JAN-2018 (dose, route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 15 degrees Fahrenheit and 46 degrees Fahrenheit (also reported as 32.5 degrees Fahrenheit) for 30 minutes. Data logger was not involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-00507513-1708USA001511: US-00507513-1708USA001605:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 01-AUG-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient was inoculated with ZOSTAVAX vaccine (dosage and lot#/expiration not reported) in September 2014 at a primary care center, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-JUN-2015, the patient was treated by a physician at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a patient (age and gender not specified). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 12-JUL-2017 the patient was administered a dose of improperly stored VARIVAX, lot # M047660, expiration date 02-DEC-2018, for prophylaxis. Temperature: -9 degrees C to 8 degrees C. Time frame: 3 hours. No previous temperature excursions. Digital data logger was involved. The sterile diluent (manufacturer unknown) that was used to reconstitute the vaccine was properly stored. The outcome of the event was unknown. Additional information has been requested. This is one of two reports from the same source. Sender's Comments: US-009507513-1707USA005555.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable nurse reported for 2 patients. This is Report 1 of 2, for a 88 years female patient. An 88-year-old female patient received PREVNAR 13 (lot number R94917, expiration date 23May2018) at 0.5 ml single dose intramuscular on 21Jul2017 for risk of pneumonia. Medical history and concomitant medications were none. In Jul2017 the patient had swelling at the injection site that resolved spontaneously.   It was described also as red, ball like, hot to touch, erythematous and resolved slowly with oral Benadryl. The patient also went to Urgent care. Final outcome was reported as recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017334556 same reporter, drug and AE, different patient.
Age: 39.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Starting 5 days after vaccine developed increased swelling and redness around site. Over two day increasingly pruritic and sore, with development of maculopapular red rash around the previously swollen area.  SKin warm in whole upper posterior arm.  Diameter of rash reaction 8cm.
Age: 39.0
Sex: F
Vaccine: YF
Symptoms: Injection site warmth, Rash erythematous, Rash maculo-papular
Clinical narrative: Starting 5 days after vaccine developed increased swelling and redness around site. Over two day increasingly pruritic and sore, with development of maculopapular red rash around the previously swollen area.  SKin warm in whole upper posterior arm.  Diameter of rash reaction 8cm.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Started with nausea and vomiting this morning. Had stopped vomiting by 9am, nausea was receding.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Delayed local reaction (redness on upper left arm).
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Listless, Nuclear magnetic resonance imaging, Paralysis, Pyrexia
Clinical narrative: Temporary paralysis lasting 4 days. 102.5 fever. Listless.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: I am a new immunizations nurse. I reconstituted this vaccine with regular diluant, not realizing that there was a liquid component.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: Patient felt lightheaded and dizzy. Patient felt like he was going to faint. Patient stated that he had not eaten anything yet for the day. Patient felt fine after about 15 minutes.
Age: 16.0
Sex: M
Vaccine: HPV4, MMR
Symptoms: Erythema, Injection site erythema, Injection site swelling, Mass, Pain
Clinical narrative: Mother reported redness, swelling, pain and large hot red lump on 08/02/2017, advised to bring in for eval, which she did that day. Also reported some tingling down left arm as well. MMR injection site lower and posterior to HPV injection site. The lower site was red with large area of swelling. No "Lump" noted. Was given Rx of Cephalexin 500mg TID x5 days.
Age: 16.0
Sex: M
Vaccine: HPV4, MMR
Symptoms: Paraesthesia, Skin warm, Swelling
Clinical narrative: Mother reported redness, swelling, pain and large hot red lump on 08/02/2017, advised to bring in for eval, which she did that day. Also reported some tingling down left arm as well. MMR injection site lower and posterior to HPV injection site. The lower site was red with large area of swelling. No "Lump" noted. Was given Rx of Cephalexin 500mg TID x5 days.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Client received second Varicella vaccine on 07/24/2017 and the first varicella vaccine was given on 06/26/2017. When asked if pregnant or thinking about becoming pregnant client reported No and was not thinking of becoming pregnant at either visit. Vaccines were given per protocol. The client returned to office on 08/03/2017 and reported a home pregnancy test taken on 08/02/2017 that was positive. Unknown how many weeks pregnant.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Drug administered at inappropriate site, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Moderate to severe muscular pain beginning in left arm radiating up neck and then later felt down left leg. Left side of body numb and weakness limiting use of left arm. Then all muscles involved. Moderate headache and extreme fatigue. This was debilitating and interfered with daily life. Symptoms peaked on the 3rd day and by day 6 only issue is still soreness around injection site.  There was never any redness or visible swelling at injection site.  Injection itself was barely felt when administered by did seem to be slightly closer to the top of the shoulder than in prior vaccinations.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Loss of personal independence in daily activities, Musculoskeletal disorder, Myalgia, Neck pain
Clinical narrative: Moderate to severe muscular pain beginning in left arm radiating up neck and then later felt down left leg. Left side of body numb and weakness limiting use of left arm. Then all muscles involved. Moderate headache and extreme fatigue. This was debilitating and interfered with daily life. Symptoms peaked on the 3rd day and by day 6 only issue is still soreness around injection site.  There was never any redness or visible swelling at injection site.  Injection itself was barely felt when administered by did seem to be slightly closer to the top of the shoulder than in prior vaccinations.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Moderate to severe muscular pain beginning in left arm radiating up neck and then later felt down left leg. Left side of body numb and weakness limiting use of left arm. Then all muscles involved. Moderate headache and extreme fatigue. This was debilitating and interfered with daily life. Symptoms peaked on the 3rd day and by day 6 only issue is still soreness around injection site.  There was never any redness or visible swelling at injection site.  Injection itself was barely felt when administered by did seem to be slightly closer to the top of the shoulder than in prior vaccinations.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling face, Urticaria
Clinical narrative: Patient broke out into hives after vaccination. Per mother the next morning patient had swollen face and urticaria.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Constipation
Clinical narrative: Severe and prolonged constipation.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received from a nurse via a company representative and refers to patients of unknown age and gender. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On unspecified dates, it was reported that unspecified patients may have received improperly stored doses of GARDASIL (lot number, dosage and temperature unknown). The temperature and time frame were unknown by the reporter. The reporter also stated that it was unknown if there was a previous temperature excursion or if it was because of a data logger. No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 13-JUL-2017 from a medical assistant who was reporting on behalf of a physician concerning an unspecified patient of unknown age and gender. No medical history or concomitant medications were reported. On an unspecified date, the unspecified patient received a dose of improperly stored VARIVAX (lot N012132, expires 17-APR-2019) reconstituted with properly stored sterile water diluent. No adverse effects were reported. No further details were provided. The vaccine was exposed to temperature 15 degrees F. to 46 degrees F. for 48 hours. There was no previous temperature excursion and it was not as a result of a data logger. Additional information has been requested.