chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: TYP, YF
Symptoms: Ataxia, Clonus, Hallucinations, mixed
Clinical narrative: Ataxia, visual and auditory hallucinations, and clonic movements of lower extremities.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site swelling, Local reaction, Swelling
Clinical narrative: Information is entered at follow-up provider's request. Information relates to patient vaccinated elsewhere and is based on parent reporting. Provision and date of DTaP admin as reported by parent is consistent with information in state immunization registry.   Patient seen for suture removal today. Mother reported child had #3 DTaP at the ED when these were placed. Time of vaccination is unknown. Mother reports child had erythema and swelling following this dose. On exam today, provider documentation relates "no erythema but had circumferential swelling of left thigh consistent with local reaction. Mother reports that she did put oil on the area yesterday and redness then resolved."
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling, Rash
Clinical narrative: Redness, irritation, swelling, and pain around injection site on L deltoid where Tdap and Gardasil was given. Also had rash on L side of face which itched.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash pruritic
Clinical narrative: Redness, irritation, swelling, and pain around injection site on L deltoid where Tdap and Gardasil was given. Also had rash on L side of face which itched.
Age: 63.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Pt reports arm was a little sore but nothing unusual. Pt repots yesterday noticed a small rash on her chest. red, flat, pin point. Denies itching, wheals, "not like hives". Pt reports woke this am and arm where given vaccines was hot, red, swollen and hard. Size of baseball. Pt reports putting ice 20 min that cooled and softened knot but still red and swollen. Pt denies any SOB, wheezing, fever, red streaking from site. Pt reports has never had allergic reaction to vaccines in past.
Age: 63.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pain in extremity, Rash, Rash erythematous
Clinical narrative: Pt reports arm was a little sore but nothing unusual. Pt repots yesterday noticed a small rash on her chest. red, flat, pin point. Denies itching, wheals, "not like hives". Pt reports woke this am and arm where given vaccines was hot, red, swollen and hard. Size of baseball. Pt reports putting ice 20 min that cooled and softened knot but still red and swollen. Pt denies any SOB, wheezing, fever, red streaking from site. Pt reports has never had allergic reaction to vaccines in past.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt. noticed left deltoid was raised, red, warm and itching on 6-30-15.  Felt that it looked like bug bites at first but then recalled he had a vaccination there.  Site measures 7cmx7cm and is raised, warm and red.  Mom had given Benadryl on 7-1-15 evening. APRN assesses sight and orders pt. to take Benadryl at HS and Claritin during the day.  Site outlined with marker and instruct if any worsening or no improvement to go to ER or clinic. Mom and pt verbalize understanding.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Eosinophil count increased, Eosinophilia, Injection site erythema, Injection site swelling, Rash generalised
Clinical narrative: LOCAL SWELLING & REDNESS AT INJECTION SITE A FEW HOURS AFTER ADMINISTRATION. GENERALIZED PRURITIC RASH, STARTING THE NEXT DAY.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Rash pruritic
Clinical narrative: LOCAL SWELLING & REDNESS AT INJECTION SITE A FEW HOURS AFTER ADMINISTRATION. GENERALIZED PRURITIC RASH, STARTING THE NEXT DAY.
Age: 1.12
Sex: F
Vaccine: HIBV, HPVX, MMR, PPV, VARCEL
Symptoms: Eczema, Pyrexia, Swelling
Clinical narrative: Fever for 3 days, swollen body for about a week, and an outbreak of eczema that covered whole body and did not go away until food allergies were discovered.
Age: 17.0
Sex: F
Vaccine: DTAP
Symptoms: Headache
Clinical narrative: I had a wicked headache and I know it was from the vaccine I got years ago.
Age: 95.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Around the date above she started having some redness at the vaccine site. When she saw me 7/2/15 it was 16 x 6 cm.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fall, Head injury, Loss of consciousness, Musculoskeletal stiffness, Mydriasis
Clinical narrative: The patient was standing with her mother at the front desk/ nurses station scheduling an appointment.  The patient suddenly fell backwards, hitting her head on the floor.  She had a brief loss of consciousness and her pupils dilated and her arms stiffened and shook for less than 10 seconds.  Vital signs were monitored and she was examined by the ARNP and given an ice pack for her head.  She was able to ambulate to her mother's car without difficulty.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chest X-ray abnormal, Lobar pneumonia, White blood cell count increased
Clinical narrative: Patient developed vague symptoms of generalized weakness for about a week before she was ultimately diagnosed with left upper lobe pneumonia and hospitalized for this.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Decreased appetite, Fatigue, Insomnia, Mood altered, Pyrexia
Clinical narrative: Tired, poor mood, poor appetite, fever, mouth sores, difficulty sleeping.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Stomatitis
Clinical narrative: Tired, poor mood, poor appetite, fever, mouth sores, difficulty sleeping.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Erythema, Injection site swelling, Mobility decreased, Musculoskeletal pain
Clinical narrative: Swelling around injection site in shoulder down to elbow. Pain in shoulder, elbow and finger joints. Itchiness, redness on skin. Limited mobility in arm.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Swelling around injection site in shoulder down to elbow. Pain in shoulder, elbow and finger joints. Itchiness, redness on skin. Limited mobility in arm.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 14-year-old patient. The patient's gender, medical history, concurrent conditions, drug reactions and allergies were not reported. On 24-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (dose, route of administration, anatomical location, lot# and expiration date were not reported). No adverse events were reported. This is one of the two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning an unknown number of patients (demographics unknown) on unknown dates the patients were vaccinated with improperly stored doses of M-M-R II (dose, route and lot # not provided). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 6/29 - 7/2 Red, itchy and swollen at injection site.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Feeling hot, Papule
Clinical narrative: Localized adverse reaction. 7cm surrounding erythematous 3cm erythematous papule center. Warmth present.
Age: 11.0
Sex: F
Vaccine: HEP, HPV4, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling, Skin warm
Clinical narrative: Client received vaccines on 6/29/15. Presents back to clinic on 7/1/15 c/o right upper arm pain and swollen. Arm assessed, warm to touch swollen area 4 in long, 2 1/2 inches wide, temp 98.1. Seen by FNP and instructed to take BENADRYL 25 mg BID as needed, and ibuprofen 600 mg every 6-8 hrs prn pain as needed, apply cold compresses & seek medical attention if condition worsens.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: The patient came to the pharmacy to fill an antibiotic. Upon questioning what the particular indication was for the medication the patient informed us that it was due to her ZOSTAVAX injection on her right arm. It did not look to be the typical reaction to this particular vaccine. Patient was being treated for cellulitis.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning an unknown number of patients (demographics unknown). On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (dose, route, lot # not provided). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Bone pain, Erythema, Injection site discolouration, Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 57 year old female patient. The patient's medical history included herpes zoster (for five times) and pain (shingles pain). ON 04-JUN-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, lot # L006379, route of administration and anatomical location was not reported). ON an unknown date in  June 2015, post vaccination, the patient developed redness, swelling, "black and blue" color at injection site. On 24-JUN-2015, the patient south medical attention by visiting an unspecified physician's office and received unspecified antibiotics as the patient's arm had a red bump, was warm and arm was swollen till elbow and the patient was unable to move her arm barely. On the same day the patient returned to pharmacist again to inform pharmacist of progression since first contact. The patient felt that the arm was getting worse and was unable to move. The patient reported to pharmacist that the pain was 20 times worse than any shingles pain that she had experienced earlier. The reporter states that as per the patient, the pain was almost like bone pain. The patient's physician had ordered blood work and results were unknown. The outcome of the events was reported as not recovered/not resolved. The casual relationship between the events and zoster vaccine live was not reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Local swelling, Mobility decreased, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 57 year old female patient. The patient's medical history included herpes zoster (for five times) and pain (shingles pain). ON 04-JUN-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, lot # L006379, route of administration and anatomical location was not reported). ON an unknown date in  June 2015, post vaccination, the patient developed redness, swelling, "black and blue" color at injection site. On 24-JUN-2015, the patient south medical attention by visiting an unspecified physician's office and received unspecified antibiotics as the patient's arm had a red bump, was warm and arm was swollen till elbow and the patient was unable to move her arm barely. On the same day the patient returned to pharmacist again to inform pharmacist of progression since first contact. The patient felt that the arm was getting worse and was unable to move. The patient reported to pharmacist that the pain was 20 times worse than any shingles pain that she had experienced earlier. The reporter states that as per the patient, the pain was almost like bone pain. The patient's physician had ordered blood work and results were unknown. The outcome of the events was reported as not recovered/not resolved. The casual relationship between the events and zoster vaccine live was not reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning unspecified number of patients of unknown age and gender. Patient's medical history and concurrent conditions were not reported. Between 06-APR-2014 and 30-APR-2015, unspecified number of patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (dose, lot # and route were not reported. No adverse effects were reported. Follow up information has been received from a receptionist during a phone call on 02-JUN-2015. The reporter could not supply patient identifiers, lot number or dates of vaccination.  Follow up information was received on 15-JUN-2015 from a nurse practitioner. The reporter provided the names, dates, and lot numbers with expiration dates of the patients who received (Oka/Merck) VARIVASX which was incorrectly stored. A total of 22 patients received the improperly stored vaccine between the dates of 06-APR-2015 and 30-APR-2015. On 20-APR-2015, a female patient of unknown age received (Oka/Merck) VARIVAX (lot number K021936, expiration date 10-NOV-2016. The vaccine was reported as improperly stored. No adverse event was reported. Follow up information was received on 16-JUN-2015 from a nurse practitioner. Multiple patients received the (Oka/Merck) VARIVAX which was exposed to higher than normal temperature. All vaccines were completed before the date required by the manufacturer. As of 16-JUN-2015 no vaccines were left from the event. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning unspecified number of patients of unknown age and gender. Patient's medical history and concurrent conditions were not reported. Between 06-APR-2014 and 30-APR-2015, unspecified number of patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (dose, lot # and route were not reported. No adverse effects were reported. Follow up information has been received from a receptionist during a phone call on 02-JUN-2015. The reporter could not supply patient identifiers, lot number or dates of vaccination.  Follow up information was received on 15-JUN-2015 from a nurse practitioner. The reporter provided the names, dates, and lot numbers with expiration dates of the patients who received (Oka/Merck) VARIVASX which was incorrectly stored. A total of 22 patients received the improperly stored vaccine between the dates of 06-APR-2015 and 30-APR-2015. On 20-APR-2015, a female patient of unknown age received (Oka/Merck) VARIVAX (lot number K021936, expiration date 10-NOV-2016. The vaccine was reported as improperly stored. No adverse event was reported. Follow up information was received on 16-JUN-2015 from a nurse practitioner. Multiple patients received the (Oka/Merck) VARIVAX which was exposed to higher than normal temperature. All vaccines were completed before the date required by the manufacturer. As of 16-JUN-2015 no vaccines were left from the event. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning unspecified number of patients of unknown age and gender. Patient's medical history and concurrent conditions were not reported. Between 06-APR-2014 and 30-APR-2015, unspecified number of patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (dose, lot # and route were not reported. No adverse effects were reported. Follow up information has been received from a receptionist during a phone call on 02-JUN-2015. The reporter could not supply patient identifiers, lot number or dates of vaccination.  Follow up information was received on 15-JUN-2015 from a nurse practitioner. The reporter provided the names, dates, and lot numbers with expiration dates of the patients who received (Oka/Merck) VARIVASX which was incorrectly stored. A total of 22 patients received the improperly stored vaccine between the dates of 06-APR-2015 and 30-APR-2015. On 20-APR-2015, a female patient of unknown age received (Oka/Merck) VARIVAX (lot number K021936, expiration date 10-NOV-2016. The vaccine was reported as improperly stored. No adverse event was reported. Follow up information was received on 16-JUN-2015 from a nurse practitioner. Multiple patients received the (Oka/Merck) VARIVAX which was exposed to higher than normal temperature. All vaccines were completed before the date required by the manufacturer. As of 16-JUN-2015 no vaccines were left from the event. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers a patient of unknown age with no pertinent medical history/drug allergies or drug reactions reported. On 20-MAY-2015, the patient was vaccinated with an unspecified dose of improperly stored (Oka-Merck) PROQUAD (route and anatomical location were not reported), lot # K022448 expiration date 13-MAY-2016. There was no concomitant therapy reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age with no pertinent medical history/drug allergies or drug reactions reported. On 27-MAY-2015, the patient was vaccinated with an unspecified dose of improperly stored PROQUAD (route and anatomical location were not reported), lot # K012918 expiration date 28-FEB-2016. There was no concomitant therapy reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age with no pertinent medical history/drug allergies or drug reactions reported. On 29-MAY-2015, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD (route, dose and anatomical location were not reported), lot # K022448 expiration date 13-MAY-2016. There was no concomitant therapy reported. No adverse effects reported. This is one of 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 as received from a healthcare worker and nurse refers to unspecified patients. Medical history and concomitant medications were unknown. The nurse reported that improperly stored doses of GARDASIL were given to unspecified patients on unspecified dates. No adverse experiences were reported. No product quality complaint (PQC) was involved. The outcome was unknown. The case is also related to 1506USA009859, 1507USA001113 and 1507USA001115 (same reporter link). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site induration
Clinical narrative: 14 cm induration L deltoid.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Injection site erythema, Myalgia, Nausea
Clinical narrative: Pt developed muscle/back ache, nausea and redness at LT deltoid (injection site) this AM. Injection given 7/1/15.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV, MMRV, PNC13
Symptoms: Extra dose administered
Clinical narrative: Pt. was given PENTACEL and Acthib. 7 types vaccine-5 shots 1 dapable (ACTHIB).
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Chills, Decreased appetite, Irritability, Pyrexia, Rash
Clinical narrative: Fever, rash and shivering. Fussy, decreased appetite. MOTRIN suspension 10mg/kg PO once. BENADRYL 12.5 mg PO once.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender with no pertinent medical history, drug reaction or allergies reported. Since 03-JUN-2015, (specific dates unknown), the patients were administered doses of ZOSTAVAX subcutaneous (dose, lot number and expiration date were not provided) which underwent a temperature excursion. Concomitant therapy was not reported. No adverse effects were reported. This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender with no pertinent medical history, drug reaction or allergies reported. Since 03-JUN-2015, (specific dates unknown), the patients were administered doses of (Oka/Merck) VARIVAX subcutaneous (dose, lot number and expiration date were not provided) which underwent a temperature excursion. Concomitant therapy was not reported. No adverse effects were reported. This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender with no pertinent medical history, drug reaction or allergies reported. Since 03-JUN-2015, (specific dates unknown), the patients were administered doses of (Oka/Merck) VARIVAX subcutaneous (dose, lot number and expiration date were not provided) which underwent a temperature excursion. Concomitant therapy was not reported. No adverse effects were reported. This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age gender with no pertinent medical history, drug reaction or allergies reported. Since 03-JUN-2015, (specific dates unknown), the patients were administered doses of (Oka-Merck) PROQUAD subcutaneous (dose, lot number and expiration date were not provided) which underwent a temperature excursion. Concomitant therapy was not reported. No adverse effects were reported. This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from other health professional refers to an unspecified patients of unkonwn age and gender. On an unkonwn date, an unspecified number of unspecified patients received improperly stored oral, ROTATEQ (lot # K015841 and expiration date 01-MAY-2016 and lot# K013861 and expiration date 18-MAY-2016 and lot  # K011947 and expiration date 07-JUN-2016) (dose and route were not reported). No adverse effect reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Register Nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 29-MAY-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (route, dose, and anatomical location were not reported), (lot # J014228 expiration date 08-NOV-2015). There was no concomitant therapy reported. NO adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Register Nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 01-JUN-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (route, dose and anatomical location were not reported), (lot # J014228 expiration date 13-MAY-2016). There was no concomitant therapy reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients unknown age and gender. No concurrent conditions and medical history were reported. The nurse practitioner reported that, on an unknown date, the patient's received improperly stored doses of (Oka/Merck) VARIVAX (lot # L006384, expiration date 25-FEB-2017 and lot # reported as K023008, expiration date 25-SEP-2017)which were exposed to temperature range of 90F to 100F (route and dose were not reported). No concomitant medication were reported. No adverse effects were reported. Lot # K023008 is not valid for (Oka/Merck) VARIVAX. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a t3 year old female patient referring to herself. The patient's medical history was not reported. The patient did not have drug reactions/allergies. On 22-JUN-2015 (reported as 4 days ago) the patient was vaccinated with ZOSTAVAX (lot #, expiration date, route and dose were unknown), 1 time vaccine) in the left ar. Concomitant therapies included metoprolol. On 25-JUN-2015 (reported as yesterday), the patient experienced "about a silver dollar sized, red, raised lump, with fever", at the insertion site, on her left arm. The patient did not seek for medical attention. The outcome of the event was unknown. Additional information is not expected as there is no contact information.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning an unknown number of patients (demographics unknown) On unknown dates the patients were vaccinated with improperly stored doses of VAQTA (dose, route and lot # not provided). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose 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 current conditions and medical history were provided. On an unspecified date, the patient was vaccinated with the first and second doses of GARDASIL (Lot Number and expiration date were not provided) 0.5ml, intramuscular. On an unspecified date, in May 2015, the patient was vaccinated with the third dose of GARDASIL (Lot Number and expiration date were not provided) 0.5ml, intramuscular. On 25-JUN-2015 the patient was vaccinated with the fourth dose of GARDASIL (Dose, Lot Number and expiration date were not provided), intramuscular. There was no concomitant medication provided. No adverse effect was reported. 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 physician concerning an unknown number of patients (demographics unknown). On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL (dose, route and Lot# not provided). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vomiting
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a female patient of unknown age. No pertinent medical history or concurrent conditions were reported, the patient was not reported to be pregnant. On 11-JUN-2015, the patient was vaccinated with her first dose of GARDASIL 0.5 ml through an unspecified route. No concomitant medications were reported. The reporter confirmed that patient received GARDASIL and not GARDASIL 9. On 11-JUN-2015, after receiving the first dose of vaccine, the patient felt woozy and experienced vomiting before leaving the office. The patient sought medical attention with her doctor but did not receive treatment for the events. The outcome of the events wooziness and vomiting was unknown. The reporter did not assess the causality of the events with GARDASIL. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No concurrent conditions or medical history were reported. On 04-DEC-2014, the patient was vaccinated with the first dose of RECOMBIVAX HB 10/1.0 mcgr/ml, (lot number and expiration date were not reported) intramuscular. On an unknown date, the patient was vaccinated with a second dose of RECOMBIVAX HB (lot number, expiration date, dose, and route were not reported). On 09-JUN-2015, the patient was vaccinated with an improperly stored third dose in the series of RECOMBVIVAX HB (lot number, expiration date, strength and route were not reported). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning an unknown number of patients (demographics unknown). On  unknown dates the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, route and lot # not provided). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Register Nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 29-MAY-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (route, dose and anatomical location were not reported), (lot # reported as L001329 expiration date 13-JAn-2017). There was no concomitant therapy reported. No adverse effects reported. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning an unknown number of patients (demographics unknown). On unknown dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route and Lot# not provided). No adverse symptoms were reported. This is one of several reports received from the same source. 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 health care professional refers to unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with ROTATEQ (dose, route, frequency and lot # unspecified). No concomitant medications were reported. On an unknown date unspecified patients received doses of improperly stored ROTATEQ or ROTATEQ (related case). Patient did not experience any adverse effects. No further information was provided. There was no Product Quality Complaint (PQC) involved. The outcome of incorrect product storage was unknown. This case is linked to: 1506USA002097. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored VAQTA (lot number, strength, dose and route were not reported). No adverse effects were reported. The outcome of the patients event was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from other health professional refers to an unspecified patients of unknown age and gender. On an unknown date, an unspecified number of unspecified patients received improperly stored PEDVAXHIB (lot # K011078 and expiration date 31-MAR-2017 and lot# K025005 and expiration date 21-JUL-2017 and lot # K026533 and expiration date 07-AUG-2017) (dose and route were not reported). No adverse effect reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. 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 healthcare worker and nurse refers to unspecified patients. Medical history and concomitant medications were unknown. The nurse reported that improperly stored doses of ROTATEQ were given to unspecified patients on unspecified dates. No adverse experiences were reported. No product quality complaint (PQC) was involved. The outcome was unknown. The case is also related to 1506USA009859, 1507USA001114 and 1507USA001115 (same reporter link). Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning unspecified number of patients of unknown age and gender. Patients' medical history and concurrent conditions were not reported. Between 06-APR-2015 and 30-APR-2015, unspecified number of patients were vaccinated with a dose of improperly stored VARIVAX (Merck) (dose, lot# and route were not reported). No adverse effects were reported. Follow up information has been received from a receptionist during a phone call on 02-JUN-2015. The reporter could not supply patient identifiers, lot numbers or dates of vaccination. Follow up information was received on 15-JUN-2015 from a nurse practitioner. The reporter provided the names, dates and lot numbers with expiration dates of the patients who received VARIVAX (Merck) which was incorrectly stored. A total of 22 patients received the improperly stored vaccine between the dates of 06-APR-2015 and 30-APR-2015. On 09-APR-2015, a male patient of unknown age received VARIVAX (Merck) (lot number K018963, expiration date 15-OCT-2016). The vaccine was reported as improperly stored. No adverse event was reported. Follow up information was received on 16-JUN-2015 from a nurse practitioner. Multiple patients received the VARIVAX (Merck) vaccine which was exposed to higher than normal temperature. All vaccines were completed before the date required by the manufacturer. As of 16-JUN-2015, no vaccines were left from the event. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning unspecified number of patients of unknown age and gender. Patients' medical history and concurrent conditions were not reported. Between 06-APR-2015 and 30-APR-2015, unspecified number of patients were vaccinated with a dose of improperly stored VARIVAX (Merck) (dose, lot# and route were not reported). No adverse effects were reported. Follow up information has been received from a receptionist during a phone call on 02-JUN-2015. The reporter could not supply patient identifiers, lot numbers or dates of vaccination. Follow up information was received on 15-JUN-2015 from a nurse practitioner. The reporter provided the names, dates and lot numbers with expiration dates of the patients who received VARIVAX (Merck) which was incorrectly stored. A total of 22 patients received the improperly stored vaccine between the dates of 06-APR-2015 and 30-APR-2015. On 09-APR-2015, a male patient of unknown age received VARIVAX (Merck) (lot number K021936, expiration date 10-NOV-2016). The vaccine was reported as improperly stored. No adverse event was reported. Follow up information was received on 16-JUN-2015 from a nurse practitioner. Multiple patients received the VARIVAX (Merck) vaccine which was exposed to higher than normal temperature. All vaccines were completed before the date required by the manufacturer. As of 16-JUN-2015, no vaccines were left from the event. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from other health professional refers to an unspecified patients of unknown age and gender. On an unknown date, an unspecified number of unspecified patients received improperly stored GARDASIL (lot # K007264 and expiration date 02-MAR-2017 and lot# K007828 and expiration date 02-MAR-2017) (dose and route were not reported). No adverse effect reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. 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 healthcare worker and nurse refers to unspecified patients. Medical history and concomitant medications were unknown. The nurse reported that improperly stored doses of PEDVAXHIB were given to unspecified patients on unspecified dates. No adverse experiences were reported. No product quality complaint (PQC) was involved. The outcome was unknown. The case is also related to 1506USA009859, 1507USA001114 and 1507USA001113 (same reporter link). Additional information has been requested.
Age: 0.53
Sex: F
Vaccine: PNC13, DTAPIPVHIB, HEP, PNC13
Symptoms: Abscess drainage, Injection site abscess, Laboratory test abnormal, Staphylococcus test positive, Surgery
Clinical narrative: Information has been received from a pharmacist via Pfizer (Manufacturer control number US-PFIZER INC-2015168393) on 29-JUN-2015 referring to a 6 month old female patient who had received a first and second doses of PREVNAR 13 on 15-DEC-2014 and 17-FEB-2015 respectively. On 20-APR-2015 the patient was vaccinated with RECOMBIVAX HB dose 3 (lot number reported as KZ9ZC which is not a valid one), intramuscular in the right leg. Other suspect therapies on the same date included PREVNAR 13 dose 3 (lot number reported as L04912, expiration date July 2016) 0.5 ml intramuscular in the left leg and PENTACEL dose 3 (lot number reported as C4742AA) intramuscular in the left leg. There was no illness at time of vaccination. On unspecified date 2015 the patient experienced an abscess at site of PREVNAR 13 and positive for Methicillin-resistant Staphylococcus aureus (MRSA) and was hospitalized. The patient stayed in the hospital for 2 days. The patient had not received immunization again. On unknown date in 2015 the patient recovered from the events. The reporter considered the events to be not related to PREVNAR 13. The causality between the events with RECOMBIVAX HB and PENTACEL was not provided. Additional information has been requested.
Age: 0.53
Sex: F
Vaccine: PNC13, DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site abscess, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: Information has been received from a pharmacist via Pfizer (Manufacturer control number US-PFIZER INC-2015168393) on 29-JUN-2015 referring to a 6 month old female patient who had received a first and second doses of PREVNAR 13 on 15-DEC-2014 and 17-FEB-2015 respectively. On 20-APR-2015 the patient was vaccinated with RECOMBIVAX HB dose 3 (lot number reported as KZ9ZC which is not a valid one), intramuscular in the right leg. Other suspect therapies on the same date included PREVNAR 13 dose 3 (lot number reported as L04912, expiration date July 2016) 0.5 ml intramuscular in the left leg and PENTACEL dose 3 (lot number reported as C4742AA) intramuscular in the left leg. There was no illness at time of vaccination. On unspecified date 2015 the patient experienced an abscess at site of PREVNAR 13 and positive for Methicillin-resistant Staphylococcus aureus (MRSA) and was hospitalized. The patient stayed in the hospital for 2 days. The patient had not received immunization again. On unknown date in 2015 the patient recovered from the events. The reporter considered the events to be not related to PREVNAR 13. The causality between the events with RECOMBIVAX HB and PENTACEL was not provided. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Chest X-ray normal, Injection site erythema, Neuralgia
Clinical narrative: Began with redness at site and no itching with low grade temp 3-4 hours after vaccine. No wheals. She then developed a sharp neuralgia like pain under her right arm and into her chest. This has lasted about 10 days and is improving.
Age: 76.0
Sex: F
Vaccine: PNC
Symptoms: Chondrocalcinosis pyrophosphate, Erythema, Full blood count normal, Injected limb mobility decreased, Red blood cell sedimentation rate normal
Clinical narrative: 4 days after vaccine arm left arm became red and difficult to move up the arm. Looked like a cellulitus, although sed rate CBC ok. Placed on Bactrim and NSAID and resolved after a week. Then 6/29/15 had redness again and unable to move arm, xray showed some pseudogout.
Age: 76.0
Sex: F
Vaccine: PNC
Symptoms: X-ray abnormal
Clinical narrative: 4 days after vaccine arm left arm became red and difficult to move up the arm. Looked like a cellulitus, although sed rate CBC ok. Placed on Bactrim and NSAID and resolved after a week. Then 6/29/15 had redness again and unable to move arm, xray showed some pseudogout.
Age: 77.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pruritus, Rash, Skin warm
Clinical narrative: Redness, itching, rash, arm felt warm.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Decreased appetite, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Loss of appetite, swelling/pain at site, mild fever, headache, fatigue, pain for 4 days, loss of sleep for 2 days.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Insomnia, Pain, Pyrexia
Clinical narrative: Loss of appetite, swelling/pain at site, mild fever, headache, fatigue, pain for 4 days, loss of sleep for 2 days.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Decreased appetite, Dizziness, Fall, Fatigue
Clinical narrative: Loss of appetite, swelling/pain at site, mild fever, headache, fatigue, pain for 4 days, loss of sleep for 2 days.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Gait disturbance, Headache, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Loss of appetite, swelling/pain at site, mild fever, headache, fatigue, pain for 4 days, loss of sleep for 2 days.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: Loss of appetite, swelling/pain at site, mild fever, headache, fatigue, pain for 4 days, loss of sleep for 2 days.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, soreness and redness on injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Large rash on arm that immunization was given in.  Possible rash near eye (unknown if shingles).
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: At 1:34pm employee states was feeling a little nauseated. Several minutes later employee had the urge to vomit. She went to vomit in women's restroom. Per employee vomited a little bit it was yellow. Donor states might have been her lunch (12:20). After vomiting she felt better no longer feeling nauseated.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Patient has "bubbles" at site of where the varicella vaccine was given on 6/24/2015.
Age: 1.26
Sex: M
Vaccine: MMR, PNC13
Symptoms: Dehydration, Diarrhoea, Listless, Pyrexia, Respiration abnormal
Clinical narrative: Patient had multiple vomiting episodes overnight following vaccination. The following day and night, the patient had fevers ranging from 99 degrees F to 104.5 degrees F with some listlessness and ragged breathing. Patient was seen in urgent care where a strep test was performed (test was negative). Patient was given alternating doses of ibuprofen and Tylenol in an attempt to control the fever. The patient was taken to the emergency room on Saturday (6/20/2015) for a fever of 104.5 and was given Tylenol with observation. The next day, on Sunday (6/62/2015) the patient's fever had broken but he began experiencing multiple diarrhea episodes which gave rise to concerns for dehydration. Patient was taken back to emergency room at around 5 or 6 pm due to no wet diapers produced during the day along with no tears when crying. Patient had fluids administered orally under the observation of the ER physician and was discharged in the same evening.
Age: 1.26
Sex: M
Vaccine: MMR, PNC13
Symptoms: Streptococcus test negative, Vomiting
Clinical narrative: Patient had multiple vomiting episodes overnight following vaccination. The following day and night, the patient had fevers ranging from 99 degrees F to 104.5 degrees F with some listlessness and ragged breathing. Patient was seen in urgent care where a strep test was performed (test was negative). Patient was given alternating doses of ibuprofen and Tylenol in an attempt to control the fever. The patient was taken to the emergency room on Saturday (6/20/2015) for a fever of 104.5 and was given Tylenol with observation. The next day, on Sunday (6/62/2015) the patient's fever had broken but he began experiencing multiple diarrhea episodes which gave rise to concerns for dehydration. Patient was taken back to emergency room at around 5 or 6 pm due to no wet diapers produced during the day along with no tears when crying. Patient had fluids administered orally under the observation of the ER physician and was discharged in the same evening.
Age: 0.39
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Muscle twitching, Screaming, Tremor
Clinical narrative: Patient started high pitched screaming off and on for 48 hours. She could not be amused for that time, normally she was a happy, giggling, smiling baby. She began twitching and shaking her arms back off and on for the 48 hours as well. I called the Dr office on the 17th and they said what I was describing was normal as long as it didn't persist. Baby began acting more normal after 6pm the 17th and so I did not call the Dr back.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 5 days later patient comes in the pharmacy present with swallow arm and redness at the site that vaccine was given. Patient also stated she was feeling tired/weakness on the 2nd day. Treatment to take pain reliever and if the doesn't get better to contact your Dr. or hospital.