chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse reported that an unspecifed number of patients (ages and genders not reported) were vaccinated on unspecified dates with a dose of PEXVAX "over the last 5 years" that were exposed to temperature excursions outside of te proper storage range. No adverse effects were reported.  This is one of several reports received from the same source.  All telephone attempts to obtain follow-up information have been unsuccessful. Addiitonal information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. On 25-JUL-2014, the patient was vaccinated with an expired dose of ZOSTAVAX lot#J000783, expiration date: 30-APR-2014 (dose, dose number, route of administration and indication not reported).  No adverse effects reported. Additional information has been requested.
Age: 1.42
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, 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 genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot number of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 17 months old infant patient of unknown gender. On 16-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, 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 genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 8 weeks old infant patient of unkonwn gender. On 26-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, office manager, refers to an unknown number of patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On unspecified dates the unknown number of patients were vaccinated with doses of PNEUMOVAX23 (injection, lot#, dose, route and frequency were not provided), which were improperly stored. These PNEUMOVAX23 included multi-dose vials that had been opened (or were "in-use"), single-dose and unopened multi-dose vials had been exposed to temperature excursions that were not supported. No adverse effect had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, office manager, refers to an unknown number of patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On unspecified dates the unknown number of patients were vaccinated with doses of ROTATEQ (lot#, dose and frequency were not provided), which were exposed to supported temperatures out of range, orally. No adverse effect had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Fibromyalgia
Clinical narrative: This spontaneous report as received from a healthcare worker via company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of GARDASIL, injection 120 Y (lot#, expiration date, route and dose not reported). The healthcare worker stated that he was contacted by an unknown television station to respond to an adverse event where a patient developed fibromyalgia after receiving GARDASIL. The healthcare worker also mentioned that the television station would be airing a story on the adverse events that occur with GARDASIL, possibly on 30-JUL-2014("tonight"). The outcome of fibromyalgia was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Viral titre decreased
Clinical narrative: this spontaneous report as received from a physician refers to a 35 year old female patient. The patient was allergy to penicillin. On 05-JUN-2014 the patient was vaccinated with the first does of (Oka/Merck) VARIVAX (lot#J005294, expiration date: 30-APR-2014, 0.5 ml) subcutaneous. There was no concomitant therapy. The physician stated lab work (titer) was completed after first dose and result was less than 135. On 10-JUL-2014 (last Thursday), the patient experienced an outbreak of varicella. The patient came in office on 15-JUL-2014 (today) for second dose and was still experiencing outbreak of varicella. No second does was administered. The patient had a long standing diminished immune response to B cells and was unclear if this would be a factor in patient's immune function. No treatment was given for the adverse event. The outcome of above adverse events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 08-JUL-2014 the patient was vaccinated with improperly stored GARDASIL lot # J015378, expiration date: 09-APR-2016. Dose and route of administration were not reported. No adverse effect reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site reaction, Injection site warmth, Neck pain, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old female patient. The patient had no drug reactions/allergies. On 14-JUL-2014 the patient was vaccinated with ZOSTAVAX VIAL (lot # J014810, exp date 21-FEB-2015) 0.65 ml, subcutaneous (S.Q.) in the left arm. On 16-JUL-2014, the patient developed an injection site reaction of a red rash which became itchy, hard and warm to the touch. The patient also told the pharmacist she had pain on the left side of her neck on the same date. The patient visited the pharmacy on 17-JUL-2014 and the pharmacist suggested that she took BENADRYL. No lab diagnostics studies were performed. At the time of the report, the patient did not recover from the events. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old female patient. The patient had no drug reactions/allergies. On 14-JUL-2014 the patient was vaccinated with ZOSTAVAX VIAL (lot # J014810, exp date 21-FEB-2015) 0.65 ml, subcutaneous (S.Q.) in the left arm. On 16-JUL-2014, the patient developed an injection site reaction of a red rash which became itchy, hard and warm to the touch. The patient also told the pharmacist she had pain on the left side of her neck on the same date. The patient visited the pharmacy on 17-JUL-2014 and the pharmacist suggested that she took BENADRYL. No lab diagnostics studies were performed. At the time of the report, the patient did not recover from the events. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Pain in left shoulder region radiating down left arm. Pain when lifting arm above shoulder. Burning sensation in left shoulder. Overall pain at injection site and in left shoulder and arm. Due to lack of health insurance I've not followed up with a physician.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Woke up day after with soreness around the site. Later in the evening presented with hives just under the vaccination site. Ice was applied but still sore, inflamed and hot to the touch. Patient took Benadryl. No other symptoms presented.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient with type 2 diabetes and hypertension. There were no drug reactions/allergies. On 06-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J011335, expiration date December 2014, 0.65 ml, subcutaneous. Concomitant therapy included unspecified oral medications for type 2 diabetes and hypertension. On an unknown date in 2014 the patient experienced "rash on her belly". The patient sought medical attention via visiting physician's office and calling to pharmacy. The outcome of the event was unknown. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Redness, warmth tenderness swelling - cellulitis.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2 days after administration patient called. Swelling, redness and warm at injection site. About size of patient's hand, on left arm, site of ZOSTAVAX.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received PNEUMOVAX 07/29/2014. Developed pain, swelling, redness, and warmth around injection site that spread to elbow region.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Rash papular, Rash pruritic, Rash vesicular, Varicella
Clinical narrative: Rare pruritic papules and vesicles face, arms, trunk - v mild varicella.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Pain, Swelling, Tenderness
Clinical narrative: Reaction result of a vaccine. Common reaction for vaccine as per primary care note on 5/15/14. Local warmth, tenderness and pain; swelling.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Erythema, warmth 20 cm x 20 cm. Swelling of (L) arm extending past elbow.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Cognitive disorder, Computerised tomogram head, Concussion, Head injury, Syncope
Clinical narrative: Patient received GARDASIL vaccine in addition to MVC4. Pt sat in room and talked with mom and siblings for a short time. Pt left room, walked to check out station, fainted and  hit her head on the wall and floor.She did not respond appropriately when answering question. Ambulance called and was transported to hospital where she was diagnosed with a concussion. Pt went home and was rechecked in our office 2 days later.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Urine analysis
Clinical narrative: Patient received GARDASIL vaccine in addition to MVC4. Pt sat in room and talked with mom and siblings for a short time. Pt left room, walked to check out station, fainted and  hit her head on the wall and floor.She did not respond appropriately when answering question. Ambulance called and was transported to hospital where she was diagnosed with a concussion. Pt went home and was rechecked in our office 2 days later.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt received GARDASIL vaccine and Hep A, MENACTRA, ADACEL. Pt waited in room with G-ma for a short time. They came out to front station when G-ma shouted she needed help. Pt. had fainted in front lobby. Staff called her name and she responded. Pt was lifted to a WC, and taken back to a room to lie down. Pt was oriented to place and time. Vitals taken and dr notified. Kept in room for 1/2 hour. Once pt. felt better, she was allowed to leave with G-ma.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: Hives, generalized over body esp trunk and face 5 days after vaccines. Prednisone taper, KENALOG injection and ZANTAC given to patient.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: 1 week after shot developed redness/warmth and swelling approximately 6 cm. Mostly better 7/28/14 - only mild swelling.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site nodule
Clinical narrative: Morning of 7-30-14 child had temp 104. Mother took child to the ED and temp was 105 (TA). Has knots and redness at injection site that are improving. Child is afebrile since 7-30-14 in the afternoon.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Crying, Dizziness, Tremor
Clinical narrative: Pt. stated she was dizzy, then began crying uncontrollably and shaking. Pt continued for over 1-1 1/2 hrs and was then transported to hospital.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Nausea, Skin warm, Vomiting
Clinical narrative: Arm is red and warm to touch. Nausea, vomiting - all started the day after injection. ZOFRAN called in. Advised to put ice on injection area.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Tdap given on 7/28/2014. After shot given, was noted on 1 of 3 records that a Tdap had been given on 5/21/14.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Per mom, "right deltoid red and swollen". Parent took her in to urgent care clinic and was prescribed antibiotic and prednisone.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site streaking
Clinical narrative: Pt called 5 days after shot and said she had red streak/rash at inj.site. Didn't know how long it had been there, someone else noticed it. Wasn't sore and did not itch.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: Pt called 5 days after shot and said she had red streak/rash at inj.site. Didn't know how long it had been there, someone else noticed it. Wasn't sore and did not itch.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of lateral aspect of left upper arm; pink, hard and warm 18 x 15 cm on 7/22/14.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, warm, swollen (8cm x 6cm) - mother gave ibuprofen - symptoms started Wednesday. Mother notified office Thursday. Pt was seen in office Thursday. Mother to continue to monitor. 8/1/14 - mother said red area gone. (No fever per mom).
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Large raised, redden area noted to back and (R) arm, warm to touch, spreading around arm and to lower arm. Client reports hx recurrent staph infections. Tympanic temp - 98.5, referred to PCP, walk-in clinic or to go to ER.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood test, Chest X-ray abnormal, Local swelling, Vaccination complication
Clinical narrative: Pt had arm swelling at the time of adverse event. Treatment occurred at ER under Dr. Chest x-ray revealed immune reaction to PNEUMOVAX. Treatment included BENADRYL, steroids and antibiotics. That night pt was discharged from ER to home with no further events.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Injection site erythema, Injection site swelling, Rash macular
Clinical narrative: Injection site reaction of redness and swelling. "Splotchy" per patient. Also feeling dizzy/lightheaded and sweating. Time course unknown.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: >50mm local redness at injection site (L) deltoid.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Blood glucose normal, Dizziness, Hyperhidrosis
Clinical narrative: 1130 MENACTRA vaccine administered (L) deltoid IM - Pt tol well denies any complaint. 1145 pt ambulated by self out of office with mom in attendance. 1145 pt found sitting in elevator weak, lightheaded and diaphoretic Bp=114/60. 1150 pt moved to laying down position. Blood sugar = 88 - PO fluid offered pt A + O x 3. 1155 Pt remains laying down BP = 106/64 Pulse ox = 98 pulse = 62.Pt to sitting position 1210 pt "feeling better" Bp = 104/62 pulse ox = 99 pulse = 62. 1215 pt to home with mother.
Age: 1.4
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, 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 genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot number of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 16 months old infant patient of unknown gender. On 19-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). In July 2014, the subject received an unspecified dose of KINRIX (unknown route and injection site, batch number not provided). In July 2014, less than 2 weeks after vaccination with KINRIX, the subject experienced swelling injection site and possible injection site cellulitis. This case was associated to a product complaint. This case was assessed as medically serious by GSK. The subject was treated with antibiotics and steroids. At the time of reporting, the outcomes of the events were unspecified. The healthcare professional considered the events were probably related to vaccination with KINRIX. The reporter reported 2 other cases of swelling injection site after vaccination with KINRIX (cases A1083482A and A1083483A). These cases were associated to a product complaint since the reporter said that these cases happened in a relatively short period of time so she was afraid they were related to a specific lot of the vaccine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient's concurrent conditions included diabetes. Approximately on an unknown date in 2008 (reported as about six years ago), the patient received her first dose of unspecified Pneumococcal vaccine (manufacturer unknown) (dosing details unspecified) for unknown indication. On 30-JUL-2014, the patient received her second dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (also reported as PNEUMOVAX23) (lot E J015868, expiry date of 25-FEB-2015), 0.5 ml, intramuscular, immunization. Concomitant therapies included metformin and levothyroxine sodium (manufacturer unknown). On 30-JUL-2014, the patient was keeping her arm in the sling because it hurts and arm fatigue. The patient called the pharmacist and reported that she was having a hard time lifting her arm where she received injection. And the patient reported arm fatigue and that she had been keeping her arm in sling because it hurts. No treatment were given for the event. No lab diagnostics were performed. The patient sought the medical attention and she called to pharmacy. No product quality compliant was reported. The outcome of the events was reported as not recovered. The causality of the event was unknown.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unknown number of patients of unknown age. On an unkonwn date, unknown number of patients were inadvertently administered VARIVAX (Merck), 0.5milliliter (ml), subcutaneously, that had been improperly stored. No concomitant therapy was reported. However, no adverse effects were reported. No product quality complaint was filed. The action taken was assessed as not applicable. The outcome of events was not reported. The causality was assessed as not related to VARIVAX (Merck). Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from registered nurse refers to a female patient of unknown age. Patient's concurrent conditions and relevant medical history was unknown. On 29-APR-2014 the patient was vaccinated with VARIVAX (dose 1, 0.5 ml, subcutaneous) (Lot/Batch number: J014854 with expiry date of 06-DEC-2015) in the left arm. Concomitant medications were not reported. Nurse reported that the patient experienced injection site reaction, that was 30mm x 30mm, erythematous, tender, warm, painful and swollen after receiving the first dose of VARIVAX. Patient sought medical attention by health care provider in the employee health department on 09-MAY-2014. No treatment was provided for the event. The outcome of the events was unknown. The causality of the events with VARIVAX was not reported. Action taken with suspect therapy was not applicable. Product quality issue was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Since 23-MAY-2014 (approximately in 2014, exact date was not reported) unspecified number of patients were vaccinated with unspecified number of doses (Oka-Merck) PROQUAD (lot#K003817 expiration date: 14-SEP-2015) (dose not reported) that were exposed to temperatures outside of ranges on 23-MAY-2014. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Injection site anaesthesia, Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 21-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 28 July 2014, the subject received an unspecified dose of BOOSTRIX (unknown route, left arm). On 29 July 2014, 1 day after vaccination with BOOSTRIX, the subject experienced pain, numbness and muscle weakness at the injection site. The pharmacist considered the events were disabling: the subject could not work due to the pain. The subject went to emergency room due to the pain. The subject was treated with pain medication. At the time of reporting, the events were unresolved.
Age: 1.35
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, 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 genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot number of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 16 months old child patient of unknown gender. On 21-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Age: 32.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Wrong drug administered
Clinical narrative: Hep A adult adminstered rather than Hep B adult.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Disorientation, Hyperhidrosis, Pallor
Clinical narrative: Custodial grandmother states that client became disoriented in hallway outside of clinic and went to the ground just inside the front door to the building. Grandmother states that client did not fall but was lowered to the ground. She did not bump her head and no other injury occurred. Patient was ambulatory back to the clinic. She was pale and diaphoretic. Laid client down and gave water and crackers. She waited fifteen minutes. Color and behavior returned to normal. Client was escorted back to the front door.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Head injury, Swelling, Syncope
Clinical narrative: Fainted after receiving vaccination of meningococcal conjug vaccine IM.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner referring to patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 23-JUL-2014 the patient received improperly stored with M-M-R II [lot # J10993, expiry date 13-SEP-2015], exposed to 9.7 degree for 6 hours 20 minutes and also to temperature of 8.4 degree for 20 minutes subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with cases 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Cold sweat, Dizziness, Pallor
Clinical narrative: A few mins after administration of vaccine pt experienced lightheadedness and was pale and clammy. Had pt sit for several mins. We o/c checked BP 102/65. Felt OK to go home was with parent (mother). Called to follow up a hr later patient said she's OK and lying down on couch.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Expired drug administered
Clinical narrative: Patient injected with (2) expired pediatric doses. Patient is aware and complies to make an appt at local H. dept to receive an adult hepatitis B vaccine to complete his series. MA/provider educated further.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, 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. On an unknown date in April 2014, the patients were vaccinated with unspecified number of doses of (Oka/Merck) VARIVAX (strength, route and lot# not reported) that were improperly stored. No adverse effects reported. The outcome of event was unknown. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 3 year old patient of unknown gender. On an unknown date the patient was vaccinated with the first dose of M-M-R II, (dose, route, lot# and expiration date unknown) at age three years. No adverse effects were noted. Action taken with M-M-R II was not applicable. The outcome of event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as form 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of RECOMBIVAX HB (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reaction/allergies were provided. The nurse practitioner reported that, on unspecified dates, 25 patients were inadvertently administered PEDVAX (lot numbers, doses and routes not provided), and another two vaccines, that had been improperly stored. No adverse effects were reported. This case is linked to cases MARRS # 1408USA001066 and MARRS # 1408USA001206 (same reporter link). Additional information is not expected because there was no consent to follow-up.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant (healthcare worker) regarding an unspecified number of patients. The patients demographics were unkonwn. There was no pertinent medical history and drug reaction or allergies of the patients reported. On unspecified dates, an unspecified patients were vaccinated with an PNEUMOVAX 23 (dose, route, product lot and expiry date was not reported) that might had been improperly stored. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant (healthcare worker) regarding an unspecified number of patients. The patients demographics were unknown. There was no pertinent medical history and drug reaction or allergies of the patients reported. On unspecified dates, an unspecified patients were vaccinated with VAQTA (dose, route, product lot and expiry date was not reported) that might had been improperly stored. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to 3 unspecified patients of unknown demographics. No medical history was reported. The reporter stated that the 3 unspecified patient were administered RECOMBIVAX (dose, route and frequency unspecified) that was stored improperly. No concomitant medications were reported. Nurse was then placed on the line to answer additional questions regarding event. No adverse effects were reported. No further information was provided. This is one of the two reports received from the same reporter and linked to case (1407USA012797). All Telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Age: 1.43
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, 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 genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old infant patient of unknown gender. On 25-JUN-2014 the 17 month old patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot # J016188, expiration date 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner referring to patients of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patients received improperly stored RECOMBIVAX HB exposed to 9.7 degree for 6 hours 20 minutes (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, and 1408USA000848. Additional information has been requested.
Age: 1.27
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, 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 genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion; Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 15 months old child patient of unkonwn gender. On 12-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Exposure during pregnancy, Ovarian cyst, Pregnancy test negative, Ultrasound antenatal screen
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 17 year old female patient with medical history of mild asthma and no allergies. On 03-JUN-2014, the patient was vaccinated with third dose of GARDASIL (dose, frequency, route of administration: not reported) (lot #, exp date: unknown) for HPV prevention. No concomitant medication was reported. On 03-JUN-2014 reported as "on this date", a pregnancy test was given with negative results. The patient sought medical attention on 05-JUL-2014. She visited an unspecified emergency room and released the same day. The patient had been experiencing abdominal pain on unspecified dates. On an unknown date in approximately 2014, the patient was given an ultrasound and determined to be pregnant on an unknown date. The Last Menstrual Period (LMP) and Estimated date of delivery (EDD) were unknown. The patient was also diagnosed with ovarian cysts on an unknown date. No treatment was given to the patient for the adverse events. The outcome of ovarian cysts and abdominal pain was unknown. Relatedness between ovarian cysts and abdominal pain and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning 2 patients of unknown age. On 12-MAR-2014, the patients received the 1st dose of RECOMBIVAX HB (lot number and other details unspecified), the 2nd dose of RECOMBIVAX HB on 24-APR-2014 and the 3rd dose of RECOMBIVAX HB on 30-MAY-2014. No concomitant therapy was reported. It was reported that, "the spacing between the 2nd and 3rd dose was too close". However, no adverse effects were reported. The action taken was assessed as not applicable. The outcome of event was not reported. The causality was assessed as not related to RECOMBIVAX HB. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site urticaria
Clinical narrative: Pt received #1 MENACTRA 7/28/14. Developed hives at site 3 days later. Hives progressed next day. Went to ED 8/3/14. Received prednisone and BENADRYL. As of 5/4/14 still with some hives.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of 12 months age. It was reported that there was no pertinent medical history or drug allergies. No concomitant medications were reported. The reporter stated that on 20-JUL-2014 the patient was vaccinated with PNEUMOVAX 23, route intramuscular. No known adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information is not expected as the reporter refused additional contact.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning 2 patients of unknown age. On 12-MAR-2014, the patients received the 1st dose of RECOMBIVAX HB 10 Y (lot number and other details unspecified), the 2nd dose of RECOMBIVAX HB on 24-APR-2014 and the 3rd dose of RECOMBIVAX HB on 30-MAY-2014. No concomitant therapy was reported. It was reported that, "the spacing between the 2nd and 3rd dose was too close". However, no adverse effects were reported. The action taken was assessed as not applicable. The outcome of event was not reported. The causality was assessed as not related to RECOMBIVAX HB. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 02-AUG-2011 the patient was vaccinated with the first 0.5ml dose of GARDASIL (lot# and strength unspecified), intramuscularly. On 28-JUL-2014 the patient was vaccinated with the second 0.5ml dose of GARDASIL (lot# and strength unspecified), intramuscularly. No adverse effects reported. The outcome of the event was unknown. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On 25-JUL-2014, the patient was administered an expired dose of VARIVAX (merck) injection 0.5 ml, subcutaneously (lot # H013398, expiry date: 10-JUL-2014; indication unspecified). No concomitant medications were reported. No adverse events were reported. Additional information has been requested.
Age: 1.72
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecficied number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot number of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old infant patient of unknown gender. On 25-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Age: 1.35
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, 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 genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 16 months old child patient of unknown gender. On 21-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse pracitioner referring to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 22-JUL-2014 patient received improperly stored MMR II [lot # lot J010933/exp. date 09/06/2015], exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The outcome of the event was unknown. No PQC reported. The case has been linked with cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.