chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On 25-JUN-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # K015816 and expiration date 29-MAR-2016 (dose was not provided). This is one of several reports from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Skin warm
Clinical narrative: On day five following administration patient returned to pharmacy with red area on arm where vaccine administered. Arm was red, warm. Pt did not report itching. Referred to doctor.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Temp of 100.4 after vaccines. No other sx.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 24-JUN-2015, the patient was vaccinated with an improperly stored doses of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Rash generalised
Clinical narrative: Shortness of breath, rash that covered entire body. Patient never seeked medical care nor informed our office at same of adverse reaction.
Age: 56.0
Sex: M
Vaccine: UNK
Symptoms: Ankle fracture, Arthritis, Back pain, Continuous positive airway pressure, Pain
Clinical narrative: (L) ankle fracture - pain with standing/walking wears boot, takes meds. Prosthetic shoe on order. Low back pain arthritis. Sleep apnea uses CPAP.
Age: 56.0
Sex: M
Vaccine: UNK
Symptoms: Sleep apnoea syndrome
Clinical narrative: (L) ankle fracture - pain with standing/walking wears boot, takes meds. Prosthetic shoe on order. Low back pain arthritis. Sleep apnea uses CPAP.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Syringe issue, Underdose
Clinical narrative: This spontaneous report was received from a pharmacist, refers to a 56 year old male patient. The patient's concurrent condition include diabetes and medical history included pneumonia and ex-tobacco user. The patient's past drug history was unknown. On 20-NOV-2015, while the pharmacist was administering the injection, the chamber came apart, and the patient received less than the recommended amount reported as a small amount, possibly none of the 0.5mL of PNEUMOVAX 23 (lot # L008664) intramuscular, (dose was not provided) for prevention. Concomitant therapies were not provided. There was no lab data available. It was reported that the patient continued on PNEUMOVAX 23. Additional information is not expected because the reporter declined to provide additional information.
Age: 83.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Dyskinesia, Electrocardiogram normal, Erythema, Inflammation
Clinical narrative: Redness, inflammation, and itchiness occurred 3 days after injection. Patient experienced uncontrolled icy movements. Experienced chest pain. EKG showed no abnormalities.
Age: 83.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Redness, inflammation, and itchiness occurred 3 days after injection. Patient experienced uncontrolled icy movements. Experienced chest pain. EKG showed no abnormalities.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an unspecified healthcare worker refers to a 11 year old patient of an unknown gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, Lot# L000610 with expiration date 31-JAN-2017, Current Procedural Terminology (CPT) 90651 (dose and route of administration were not provided). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Haematoma, Local reaction
Clinical narrative: Patient local reaction and hematoma about four inches long and one inch wide appeared about 24 hours after vaccine administration. Patient said that there was some pain but it subsided. A week later hematoma is still present but it is starting to go away.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No medical history or concurrent conditions were reported. Since 18-NOV-2015, an unknown number of patients were vaccinated with RECOMBIVAX (lot # L016427, exp date 13-APR-2017) (concentration, frequency and dosage were not reported) which were exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of the 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: Information has been received from a healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L002420, expiration date 23-JUL-2016; Loo8356, 11-SEP-2016, strength, dose and route were unknown). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 1.06
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 months old patient of unknown gender. Concurrent conditions and medical history were not reported. On 24-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L027634 and expiration date 21-JAN-2017, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Localized red rash at site of injection.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Patient began to experience a dull pain on left deltoid on 11/2715/about 3-4 days after PNEUMOVAX vaccination.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis in area of arm where Tdap was given. Treated with KEFLEX.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Bedridden, Cough, Malaise, Respiratory symptom, Sinusitis
Clinical narrative: Admitted 9/29/15 from Emergency Room/Atrial fib. Transesophageal echo and cardioversion done 9/30/15 vaccine given shortly after the above procedures. Attempt to give me vaccine on 9/29/15; declined gave me vaccine when I was medicated from above procedures - respiratory symptoms (severe). Ensued on 10/1/15 for Z Pak x 2 weeks then VIBRAMYCIN - sinus infection/persistent cough - symptoms for approx. 5 weeks/bedridden on cough medicines/very, very ill. Several Dr. appointments. 11/20/15 unable to resume normal activity - still compromised/weak. Also on ADVAIR - PHENERGAN with codeine. I believe this vaccine should not be given to me. I was readied for discharge. The above was reported to infection control.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Received MENACTRA to left arm on 11-3-15 left deltoid mow with about 5 cm x 5 cm round erythema, hot to touch, painful.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Injection site pain, Mobility decreased, Rash, Rhinorrhoea
Clinical narrative: Hives - rash - running nose - headache. Severe pain in arm at site of injection. Limited arm movement. Visit medical center 10-24-15 treatment - prednisone - DEPO-MEDROL 80mg - Toradol (60).
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Hives - rash - running nose - headache. Severe pain in arm at site of injection. Limited arm movement. Visit medical center 10-24-15 treatment - prednisone - DEPO-MEDROL 80mg - Toradol (60).
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Eye pain, Nuclear magnetic resonance imaging normal, Ocular hyperaemia, Optic neuritis, Pain
Clinical narrative: Eye became red on lateral corner and painful to move. Next day vision blurry and reduced vision on same side. Diag. as optic neuritis and have ruled out MS with MRI. Currently less painful (comes and goes), but still no peripheral vision from that eye.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Vision blurred, Visual acuity reduced, Visual field defect
Clinical narrative: Eye became red on lateral corner and painful to move. Next day vision blurry and reduced vision on same side. Diag. as optic neuritis and have ruled out MS with MRI. Currently less painful (comes and goes), but still no peripheral vision from that eye.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had 7 cm x 7 cm red raised area (L) upper arm at injection site. There was a 8 cm x 6 cm red raised area underside of (L) upper arm.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 9 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-JUN-2015 and on 31-AUG-2015, the patient was vaccinated with two separate doses of improperly stored ROTATEQ (doses were not provided) lot # K015816, expiration date: 29-MAR-2016 and lot # K 0123534, expiration date: 22-MAY-2016, orally. No adverse effects were reported. Additional information has been requested.
Age: 0.09
Sex: M
Vaccine: HEP
Symptoms: Faeces discoloured, Lip swelling, Poor feeding infant, Rash macular, Swelling face
Clinical narrative: Baby face puffy, lip swollen, ?wheeze; was in car seat <2 hour after visit. Faded. In evening face was blotchy 6:20 pm. Fed poorly, passed a green stool. No care sought. Called 11/22 and was seen. Normal exam. Breast fed. ? reaction to milk (dairy) or walnuts.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swelling - redness - itching - warm to touch.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Breast pain, Injection site pain, Pain in extremity
Clinical narrative: Administered PNEUMOVAX on 11/7/15 - pt states pain localized at site of left deltoid only - denies swelling or redness. Today pt states pain continues to radiate down arm - had pain under arm, breast.
Age: 1.1
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a female patient of unknown age. No concurrent or historical conditions were reported. On unknown dates, the patient was vaccinated with the first two doses of oral ROTATEQ (lot numbers and expiration dates were not provided) dose, route and anatomical location were unknown. On an unspecified date, the patient was inadvertently administered her third dose of oral ROTATEQ (Lot number reported as L022447, expiration date 26-FEB-2017) at age 13 months. No concomitant medication was reported. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Ear disorder, Erythema, Eye disorder, Immunoglobulins, Injection site pain
Clinical narrative: This spontaneous report was received from a license practical nurse and refers two children of unknown age and gender. The patients' medical history was not provided. It was reported that the children did not have an immune response and it was suggested that the patients received a full dose of PREVNAR. So, on 23-SEP-2015, the patients were vaccinated with the 5th dose of PREVNAR (dose, route of administration, anatomical location, lot number and expiration date were not provided. On 23-OCT-2015, the patients were vaccinated with a dose of PNEUMOVAX 23, lot # K020215 (dose, route of administration, anatomical location and expiration date were not provided). There were no concomitant medications provided. On 23-OCT-2015, the patient experienced a whole arm red, injection site painful and peripheral swelling. The children did not become hospitalized. They were treated with BENADRYL and ice. On an unknown date, in 2015, the patients had immunoglobulin studies (results not provided) done because of continued recurrent problems with chronic ear, eye and nose illnesses. The outcome of erythema, peripheral swelling and injection site swelling was reported as recovered on an unspecified date in 2015. The outcome of eye disorder, nasal disorder and ear disorder was unknown. The reporter did not assess the relatedness of the events with PNEUMOVAX 23. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Nasal disorder, Peripheral swelling
Clinical narrative: This spontaneous report was received from a license practical nurse and refers two children of unknown age and gender. The patients' medical history was not provided. It was reported that the children did not have an immune response and it was suggested that the patients received a full dose of PREVNAR. So, on 23-SEP-2015, the patients were vaccinated with the 5th dose of PREVNAR (dose, route of administration, anatomical location, lot number and expiration date were not provided. On 23-OCT-2015, the patients were vaccinated with a dose of PNEUMOVAX 23, lot # K020215 (dose, route of administration, anatomical location and expiration date were not provided). There were no concomitant medications provided. On 23-OCT-2015, the patient experienced a whole arm red, injection site painful and peripheral swelling. The children did not become hospitalized. They were treated with BENADRYL and ice. On an unknown date, in 2015, the patients had immunoglobulin studies (results not provided) done because of continued recurrent problems with chronic ear, eye and nose illnesses. The outcome of erythema, peripheral swelling and injection site swelling was reported as recovered on an unspecified date in 2015. The outcome of eye disorder, nasal disorder and ear disorder was unknown. The reporter did not assess the relatedness of the events with PNEUMOVAX 23. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K 011804, expiration date 21-AUG-2016; lot # L021215, expiration date 10-JUN-2017, strength, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Crying, Herpes zoster, Pain, Rash, Sleep disorder
Clinical narrative: This spontaneous report was received from the patient's husband regarding a female patient of unknown age. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date (reported as six years ago), the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. In approximately 2015 (reported as a few weeks ago), the patient contracted shingles, there was a severe rash on one shoulder and a slight rash on the other. The patient occasionally wakes up in the middle of the night crying from pain the shoulder with the severe rash. The patient sought medical attention by visiting the physician and she was treated with an unspecified antibiotics. At the time of the report, the outcome of the patient contracted shingles was unknown. Additional information is not expected because no contact details were available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot # K023537, expiration date 22-JUN-2016), (lot # reported as L004453, expiration date 27-MAY-2016) and (lot # reported as L008050, expiration date 09-NOV-2016), doses, routes and anatomical locations were not provided. No concomitant medications were reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health professional referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, these patients were vaccinated with doses of improperly stored VAQTA (lot # reported as 1028666, expiration date: 04-NOV-2016, strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Malaise, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 68 year old female patient. No pertinent medical history or concurrent condition were reported. On 13-OCT-2015, the patient was vaccinated with ZOSTAVAX (lot # L0011529, expiry date 03-JUL-2016) through an unknown route. On 13-NOV-2015, the patient was once more vaccinated with ZOSTAVAX (lot # L026414, expiry date 15-OCT-2016) along with concomitant administration of an unspecified trivalent high dose flu medication. On 14-NOV-2015, the patient contacted the pharmacist with complaints of fever, body aches and eyes feeling weak (like general malaise as per pharmacist). The patient sought medical attention and did not receive any treatment for the events. On 15-NOV-2015, the patient's symptoms were less. The reporter referred the patient to her primary care physician. The outcome of the events were reported as recovering. The reporter did not assess the causality of the events with ZOSTAVAX. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 25-SEP-2015, the patient was vaccinated with an improperly stored dose of PROUAD (Merck) (lot number L027634 and expiration date 21-JAN-2017, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports 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 as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II (unknown route and dose) lot # K005110 with expiry date of 04-APR-2016. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 11 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-JUL-2015 and on 24-SEP-2015, the patient was vaccinated with two separate doses of improperly stored ROTATEQ (doses were not provided) lot # K023534, expiration date: 22-MAY-2016 and lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effect were reported. Additional information has been requested.
Age: 0.22
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 11 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was not provided) lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effects were reported. Additional information has been requested.
Age: 0.14
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 7 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-OCT-2015, the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (dose was not provided) lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effects were reported. Additional information has been requested.
Age: 1.06
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 months old patient of unknown gender. Concurrent conditions and medical history were not reported. On 10-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L010142 and expiration date 24-SEP-2016, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 10 week old patient of unknown gender. Concurrent conditions and medical history were not reported. On 29-JUN-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # K015816 and expiration date 29-MAR-2016) (dose was not provided). No adverse effects were 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 as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Since 18-SEP-2015 an unknown number of patients were vaccinated with PEDVAX HBI (lot # K015462, exp date 10-JUL-2017; lot # K025005, exp date 21-JUL-2017; lot # K019700, exp date 16-JUL-2017; lot # L014426, exp date 08-MAR-2018) which were exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified multiple patients of unknown age and gender. There was no concurrent condition or medical history reported. The nurse reported that improperly stored LIQUID PEDVAXHIB (lot # L012838, expiration date 10-MAR-2018; Lot # K008679, expiration date 05-MAR-2017) (dosage, strength and route not reported) were administered to the unspecified multiple patients on unknown dates. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old female patient. No pertinent medical history or drug allergies were reported. On 05-NOV-2015 the patient was vaccinated with ZOSTAVAX (lot # L021608, expiration date 10-SEP-2016, strength, dose and route unknown). Concomitant therapies included unspecified CELEBREX, MOBIC, cyanocobalamin, ergocalciferol, SYNTHROID, hydrochlorothiazide and clonazepam. Shortly after receiving the vaccine, the patient developed redness and slight warm at the injection site. On 08-NOV-2015, the patient then began to experienced itchiness at the injection site and reached around to scratch it and found that there were bumpy little blisters present. On 09-NOV-2015, the patient called the pharmacy to report the reaction and stated that the blisters had gotten bigger. The reporting pharmacist reported that the patient had 4 blisters that are about the size of an eraser on a pencil and several smaller blisters at the site. The patient reported that the patient's husband drained the blister at the night on 09-NOV-2015 and covered them but by the morning (09-NOV-2015) the blisters had filled back up with fluid. The patient sought medical attention by calling pharmacy. No medication had been administered to treat the reaction and no lab diagnostics studies were performed to the patient. The reporting pharmacist reported that the patient was not experiencing any pain. The outcome of all the events were reported as not recovered. Causality between events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 15 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 30-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L000610, expiration date 31-JAN-2017) (dose and route of administration were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 15-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K023432 expiration date 18-JUN-2016. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 08-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K023432, expiry date 18-JUN-2016) (strength, dose, route and site of administration were not provided). On 11-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L000610, expiry date: 31-JAN-2017) (strength, does, route and site of administration were not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure decreased, Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: This spontaneous report as received from a 65 years old female consumer refers to her. Medical history were none and no concurrent conditions reported. On 06-DEC-2014, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot#, frequency not reported). Concomitant therapies included XANAX and CELEXA. On 06-DEC-2014, after she was received PNEUMOVAX 23 and had an adverse reaction at the injection site. During the report, the patient also mentioned that she was switched from an unspecified dose of XANAX to an unspecified dose of CELEXA. It caused her blood pressure to drop significantly on 21-JUN-2015 and was taken to the emergency room and released. On 29-OCT-2015, again, the patient was vaccinated with PNEUMOVAX 23. The patient reported that "several hours" after receiving PNEUMOVAX 23. The patient reported that "several hours" after receiving PNEUMOVAX 23 at 2PM, she experienced soreness, swelling and redness at the injection site. The patient could not move her arm over her head. The patient reported that the redness spread over an area on the inside of her arm from the shoulder to the elbow. The redness was approximately the size of "two softballs". Previously on 06-DEC-2014, were the patient had received same vaccine, and had an adverse reaction at the injection site, but not to the degree of this year's (29-OCT-2015) reaction. No lab diagnostics studies performed. The patient sought medical attention, the physician on call prescribed an unspecified dose of Ibuprofen. The patient used 5-500 mg tablets of TYLENOL and unspecified doses of Aspirin. The patient also iced the area and used Aloe. The outcome of soreness, swelling and redness at the injection site, could not move her arm over her head and redness spread over an area on the inside of her arm from the shoulder to the elbow were reported as recovering. The outcome of blood pressure to drop significantly and adverse reaction at the injection site were unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # was reported as "L022447", expiration date 26-FEB-2017; lot # L008996, expiration date 01-DEC-2016; lot # L004466, expiration date 02-AUG-2016; lot # L008578, expiration date 14-DEC-2016, strength, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 25-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K023432 expiration date 18-JUN-2016. Concomitant medication was not reported. No adverse effects reported. This is one of several reports 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 nurse refers to multiple unspecified patients of unknown age and gender. On multiple unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck) [Lot# L021211; Expiry date: 10-JUN-2017, Lot# L026407; 15-JUL-2017, Lot# L027287; 21-JUL-2017]. No adverse effect were reported. The nurse also inquired about the stability of M-M-R II; however, M-M-R II did not undergo a temperature excursion. This case is one of two reports from the same reporter. Additional information has been requested.
Age: 0.59
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 7 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was not provided) lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effects were reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pruritus, Injection site swelling, Injection site warmth, Rash
Clinical narrative: This spontaneous report as received from a 54 year old female consumer refers to herself who had allergy to morphine and erythromycin. The patient had shingles multiple times since she was 45 year old (in approximately 2006). On an unspecified date in January 2015, the patient went to an unspecified pharmacist at local pharmacy and was vaccinated with ZOSTAVAX (dose reported as "1 vial", route and lot # not reported), per her physician's recommendation. Concomitant medication included unspecified bipolar medication. It was reported that the vaccination was immediately followed by swelling, and heat radiating in her left arm where she received the vaccine which began to itch 4 days later, although at that time the patient did not present with a rash. No information was provided to determine if these reactions were treated. On 10-NOV-2015, the patient had an outbreak of shingles and had presented with a rash on her face near her eyes and lip. This was the first outbreak of shingles she had had, since receiving ZOSTAVAX. The patient sought medical attention by calling the physician. No lab diagnostics studies were performed. At the reporting time, the patient was under the care of her physician and the physician had prescribed an unspecified dose of VALTREX for the patient. The outcome of the events was unknown. Additional information has been requested.
Age: 1.13
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 13 months old patient of unknown gender. Concurrent conditions and medical history were not reported. On 24-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L027634 and expiration date 21-JAN-2017, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 8 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-JUL-2015 and on 09-OCT-2015, the patient was vaccinated with two separate doses of improperly stored ROTATEQ (doses were not provided) lot # K023534, expiration date: 22-MAY-2016 and lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L008353, expiration date 11-SEP-2016; lot # L03058, expiration date 10-FEB-2017; lot # L032761, expiration date 24-FEB-2017; lot # was reported as "L040415", expiration date 13-APR-2017, strength, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.55
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On 05-JUN-2015, the patient was vaccinated with improperly stored dose of oral, ROTATEQ (lot # K015816 and expiration date 29-MAR-2016 (dose was not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On 18-JUN-2015, the patient was vaccinated with improperly stored dose of oral, ROTATEQ (lot # K009900 and expiration date 04-MAY-2016 (dose was not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an 8 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 13-AUG-32015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) (exact dose and route of administration were not reported), lot # J009987, expiration date: 12-AUG-2015. The dose of VARIVAX (Merck) was expired. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 5 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 03-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L010142 and expiration date 24-SEP-2016, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 06-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K023432, expiration date 18-JUN-2016) (strength, dose and route were not provided). On 08-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot# L000610, expiry date 31-JAN-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 11 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 02-JUL-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K023432 expiration date 18-JUN-2016. On 03-SEP-2015, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (strength, dose and route were not provided) lot # L000610 expiration date 31-JAN-2017. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 10 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was not provided) lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 12 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 28-SEP-2015, the patient was vaccinated with an improperly stored of GARDASIL 9 (lot # L011846 and expiration date 16-JUN-2017) (dose and route of administration were not provided). No adverse effects reported. This is one of several reports 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 was received from a registered nurse refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (Lot L006384 expiry 25-FEB-2017), (Lot K002918 expiry 26-FEB-2016). No adverse event was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 20 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 28-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L011846 and expiration date 16-JUN-2017) (dose and route of administration were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Rash, Swelling, Tenderness
Clinical narrative: Rash and redness, swelling, tenderness.
Age: 1.15
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 13 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 21-AUG-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L010142 and expiration date 24-SEP-2016; dose and route of administration were not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 months old patient of unknown gender. Concurrent conditions and medical history were not reported. On 14-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L010142 and expiration date 24-SEP-2016, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 16 year old patient of unknown gender. The patient medical history and current conditions were not provided. On 22-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K023432 expiration date 18-JUN-2016. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an unspecified healthcare worker refers to a 10 year old patient of an unknown gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On 10-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, Lot # L000610 with expiration date 31-JAN-2017, Current Procedural Terminology (CPT) 90651 (dose and route of administration were not provided). No adverse effects were reported, This is one of the several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 11-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L010142 and expiration date 24-SEP-2016, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: This spontaneous report was received from a 75 year old female patient reporting on herself. No concurrent or historical conditions were reported. On 18-NOV-2015, the patient was vaccinated with PNEUMOVAX 23, (lot number and expiration date were not provided), dose, route and anatomical location were unknown. No concomitant medication were reported. On 18-NOV-2015, the patient reported feeling "achiness all over", and nausea, including vomiting on 19-NOV-2015 (also reported as the day after she received PNEUMOVAX 23. The patient did not seek for medical attention. No product quality complaint was involved. At the time of the report, the outcome of the adverse events was unknown. Additional information is not expected because there is not contact information.