chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 21-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K008884, expiration date 20-SEP-2015. The patient was again vaccinated on 21-SEP-2015, with another dose of ZOSTAVAX lot # L011535, expiration date 03-JUL-2016, as well (extra dose administered) (vaccine administration routes and dosage regimens were not provided). No concomitant therapies were reported. 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 healthcare worker referring to an unspecified number of patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the unspecified patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L004006, expiry date 05-AUG-2016) (dosage, strength and route were not reported). There were totally 10 patients administered with 2 incorrectly stored vaccine and the exact number of patients on PROQUAD (Merck) was unknown. At the time of the report, no adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.07
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 12 month old male patient. There was no medical history or drug reaction/allergies reported. On 24-AUG-2015, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (lot # K007983 with expired date 03-JUN-2016, 0.5 ml) subcutaneously in the right arm. The vaccine was improperly stored. No concomitant medication was provided. No adverse effects were reported. Additional information is not expected since the reporter refused to be contacted.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 13 years old male patient. On 24-JUL-2015 10:30 AM, the patient was vaccinated with GARDASIL 9 (first dose, lot # K026246, expiration 28-JAN-2017, dose unknown, intramuscular), which was exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because requested follow up information has already been received.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Ear infection, Irritability, Pyrexia, Rash generalised, Rash macular
Clinical narrative: Information has been received from a nurse practitioner referring to a 12 month old male patient with mild anaemia and no drug allergies. The patient's medical history included failure to thrive. On 04-SEP-2015 the patient was vaccinated with 0.5 ml single dose of MMR II (therapy type: rHA) (lot # K016154, expiration date 24-SEP-2016) subcutaneously for routine vaccination. Concomitant therapy included POLY-VI-SOL WITH IRON DROPS (reported as "POLY-VI-SOL WITH IRON"). On 04-SEP-2015, the patient was diagnosed with an ear infection during the examination at the same office visit. On 05-SEP-2015 the patient experienced a rash and was seen by the physician who described the rash as a "blanching, pink, macular rash, generalized on the body". No treatment was given for the rash. The nurse practitioner was informed by the patient's mother that since 05-SEP-2015, the patient also experienced "fevers on an off, up to 101F". The patient did not receive AUGMENTIN which was prescribed on 04-SEP-2015 for the ear infection, until 08-SEP-2015. When the patient was seen on 17-SEP-2015, the rash that began on 05-SEP-2015 had resolved and the patient had no fever. However the patient was experiencing a villiform rash on trunk, which had spread over the body including the face, palms of hands and soles of feet. No treatment was provided for the rash on 17-SEP-2015. No lab diagnostics studies were performed. Outcome of the event ear infection and rash generalised was unknown. The nurse practitioner described the patient as "happy, irritable and stable". Causality assessment was not provided. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a nurse practitioner referring to a 12 month old male patient with mild anaemia and no drug allergies. The patient's medical history included failure to thrive. On 04-SEP-2015 the patient was vaccinated with 0.5 ml single dose of MMR II (therapy type: rHA) (lot # K016154, expiration date 24-SEP-2016) subcutaneously for routine vaccination. Concomitant therapy included POLY-VI-SOL WITH IRON DROPS (reported as "POLY-VI-SOL WITH IRON"). On 04-SEP-2015, the patient was diagnosed with an ear infection during the examination at the same office visit. On 05-SEP-2015 the patient experienced a rash and was seen by the physician who described the rash as a "blanching, pink, macular rash, generalized on the body". No treatment was given for the rash. The nurse practitioner was informed by the patient's mother that since 05-SEP-2015, the patient also experienced "fevers on an off, up to 101F". The patient did not receive AUGMENTIN which was prescribed on 04-SEP-2015 for the ear infection, until 08-SEP-2015. When the patient was seen on 17-SEP-2015, the rash that began on 05-SEP-2015 had resolved and the patient had no fever. However the patient was experiencing a villiform rash on trunk, which had spread over the body including the face, palms of hands and soles of feet. No treatment was provided for the rash on 17-SEP-2015. No lab diagnostics studies were performed. Outcome of the event ear infection and rash generalised was unknown. The nurse practitioner described the patient as "happy, irritable and stable". Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 10-AUG-2015, the patient was inadvertently vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L012038, expiration date 17-APR-2017,d ose and route were unknown) instead of an intended dose of ZOSTAVAX. ZOSTAVAX was not administered. No adverse effect reported. No product confusion reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Oral herpes
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. The concurrent condition included high blood pressure. The medical history was not reported. On 14-SEP-2015, the patient was vaccinated with ZOSTAVAX (lot # L007222, Expiry: 03-JUN-2016). The concomitant medication was not reported. On 15-SEP-2015, the patient developed a cold sore on her lip. The patient sought medical attention by visiting the pharmacist. The patient was administered an unspecified antiviral medication on the same day to treat the event. The patient then developed a flat, red circle about the size of a half dollar at the injection site on 16-SEP-2015. No lab tests were performed. No rash was present. No treatment was given for the flat, red circle at the injection site. The action taken with the vaccine was not applicable. The outcome of oral herpes and injection site erythema was not resolved. The causality was not specified. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes virus infection, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. The concurrent condition included high blood pressure. The medical history was not reported. On 14-SEP-2015, the patient was vaccinated with ZOSTAVAX (lot # L007222, Expiry: 03-JUN-2016). The concomitant medication was not reported. On 15-SEP-2015, the patient developed a cold sore on her lip. The patient sought medical attention by visiting the pharmacist. The patient was administered an unspecified antiviral medication on the same day to treat the event. The patient then developed a flat, red circle about the size of a half dollar at the injection site on 16-SEP-2015. No lab tests were performed. No rash was present. No treatment was given for the flat, red circle at the injection site. The action taken with the vaccine was not applicable. The outcome of oral herpes and injection site erythema was not resolved. The causality was not specified. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 19-SEP-2015 the patient was vaccinated with a dose of ZOSTAVAX (route, lot# and expiration date not reported). On an unknown date in September 2015 after the vaccination, the patient reported a 3 inch by 3 inch swollen, red area around the injection site. The pharmacist reported that the area was warm to the touch. Outcome of the events was unknown. Causality assessment was not reported. Additional information is not expected as the pharmacist did not want to participate in this report.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored LIQUID PEDVAXHIB, lot # I002867, expiration date 11-NOV-2017 (dose strength was unknown). No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 36.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 36 year old patient (gender unknown), who was a healthcare student. Pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 16-SEP-2015, the patient came into the office to receive MMR II titer and was mistakenly administered (Oka/Merck) VARIVAX, for prophylaxis, (lot #, dose, frequency and route not provided). Reporter did not know if the patient had chicken pox in the past or if the patient was previously vaccinated with (Oka/Merck) VARIVAX. No adverse symptoms reported. No product quality complaint (PQC) was involved. No further information provided. Additional information has  been requested.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Local swelling, Pain
Clinical narrative: 9/14 - called complained bump in area and a little sore. 9/16 - called her in am. Bump went down but bruising shoulder to elbow on 9-15 when she woke up. 9-16 - called her 1 pm and said she was fine but bruised.
Age: 0.73
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) leg swelling and red as recalled by mother on date of vaccine admin. (2/25/15).
Age: 14.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Nephrotic syndrome
Clinical narrative: TRUMENBA administered 5/15/15 (will go to boarding school). Nephrotic syndrome diagnosed approximately 6/11/15-symptoms present for.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions reported. The reporter stated that since 08-JUN-2015, the patients were vaccinated with an unspecified number of improperly stored doses of MMR II injection (lot # K011188 with expiration date 12-AUG-2016, albumin status RHA (recombinant human albumin), Lot# K012473 with expiration date 26-AUG-2016 albumin status RHA, and Lot# K020189 with expiration date 11-SEP-2016 albumin status HSA human serum albumin; dose, and route were not provided). There was no concomitant medication. It was unknown if the patients sought medical attention. Product quality complaint was not involved. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (Lot numbers K026384; expiration date 15-DEC-2016 and L002870; expiration date 17-JAN-2017) dose, route, frequency and anatomical location were not provided. No concomitant medications were specified. No adverse effect was reported. This is one of two cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored of PROQUAD (Merck), (Lot numbers L005297; expiration date 17-AUG-2016 and lot number reported as L023112; expiration date 24-DEC-2016) dose, route, frequency and anatomical location were not provided. No concomitant medications were specified. No adverse effect was reported. This is one of two cases from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The concurrent condition, medical history and concomitant medication was not reported. On 17-SEP-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J012660, 10-JAN-2015) subcutaneously (expired product administration). No adverse effect was reported. No product quality issue was involved. 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 other health professional regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored M-M-R II, lot # K012473, expiration date- 26-AUG-2016 and lot # K011189, expiration date- 12-AUG-2016, (dose strength was unknown). No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 10-AUG-2015, he patient was inadvertently vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L012038, expiration date 17-APR-2017, dose and route were unknown) instead of an intended dose of ZOSTAVAX. ZOSTAVAX was not administered. No adverse effects reported. No product confusion reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9, lot # I004741, expiration date 04-MAR-2017 (dose strength was unknown). No concomitant medication was reported. No adverse event was reported. No PQC was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified patients of unknown ages and genders. Concurrent condition and medical history were not reported. On an unknown date, the patients were vaccinated with 3 doses improperly stored GARDASIL 9 injection, 0.5 ml, lot # L011846, expiration date on 16-JUN-2017 (strength, dose #, route of administration and anatomical location were not reported. There was no product quality complaint (PQC) involved. No adverse effects was reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Injection site pain, Muscular weakness, Myalgia
Clinical narrative: 9/21 left arm swollen and weak. Today, 9/22, circle around vaccination area, 5 inches in diameter, rash, burning hot, arm is weak. In general, lightheaded, muscle aches all over, joints are very weak. Site of injection is painful
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Vaccination site rash, Vaccination site warmth
Clinical narrative: 9/21 left arm swollen and weak. Today, 9/22, circle around vaccination area, 5 inches in diameter, rash, burning hot, arm is weak. In general, lightheaded, muscle aches all over, joints are very weak. Site of injection is painful
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Most likely an injection site reaction. Red, swollen, itchy, hard, about 1 1/2 in. diameter. Patient used ice. Swelling and redness did go down after about 1 week.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: PCV 13 - developed redness from injection site down bicept.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Throat irritation, Urticaria
Clinical narrative: Hives, itchy throat about 1 1/2 days after injection.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Musculoskeletal disorder, Pain
Clinical narrative: Extreme pain at injection site, radiating into shoulder and back, caused patient to be unable to use his left arm, and miss several days of school.
Age: 23.0
Sex: M
Vaccine: PPV
Symptoms: Differential white blood cell count, Full blood count, Injection site pain, Peripheral swelling
Clinical narrative: Shortly after vaccination pain started around inj site. Pain grew worse and arm started to swell. Pt called dr and pt was evaluated following day. CBC with diff drawn and pt started cephalosporin for prophylaxis.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to 4 patients of unknown ages and genders. Concurrent conditions and medical history were not reported. On 01-SEP-2015, the patients were vaccinated with a dose, which were exposed to temperatures outside of the recommended range of GARDASIL lot # K010215, expiration date on 05-MAY-2017 (strength, dose #,  dose, anatomical location and route of administration were not informed). There was not a product quality complain (PQC) involved. No adverse experience was reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. Concurrent conditions and medical history were not reported. The pediatrician reported that, on an unknown date, the mother overseas, who did not know that was pregnant, was inadvertently vaccinated with a dose of MMR II (Lot number, expiration date, route and dose were not reported). Concomitant medication were not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 10-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX, (dose, lot number and expiration date were not reported) intramuscularly rather than subcutaneously. There was no concomitant medication provided. In approximately September 2015, the patient called the pharmacy after receipt of the ZOSTAVAX and complained of a little rash and swelling around the injection site. The patient was recommended to put ice over the site. The outcome of rash and injection site swelling was reported as recovered (unspecified date in September 2015). Relatedness between the therapy was ZOSTAVAX and the events was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age with no medical history, drug reactions or allergies. The patient's concurrent conditions were not reported. On 14-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, lot number L006380, expiration date 25-MAY-2016, (dose and anatomical location were not reported) for zoster vaccination. There was no concomitant medication reported. On 15-SEP-2015, the patient experienced a reddened area of 1.5 to 2 inches in diameter at the injection site. The reddened area was swollen, warm and hard to the touch. The patient sought medical attention by calling the pharmacist. No treatment was given and none laboratories were performed. At the time of the report, the outcome of the reddened area of 1.5 to 2 inches in diameter at the injection site, the reddened area was swollen and hard to the touch were reported as no recovered. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician, via a company representative, refers to an approximately 76 years old male patient. Information about the patient's medical history and concurrent conditions was not provided. Approximately in 2011 (reported as "about 4 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The patient was seen in the physician office "about 1 week ago", on approximately 11-SEP-2015, due to an outbreak of shingles. The outcome of herpes zoster was reported as not recovered at the time of this report. The reporter did not provide a causality relationship assessment between the event and vaccination with ZOSTAVAX. Additional information is not expected, since there is no consent to contact the physician.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been from a health professional referring to a 6 month old female patient. On 24-JUL-2015 10:00 AM, the patient was vaccinated with oral, ROTATEQ (dose 3, lot number K0023157 is an invalid lot number, oral, however, Lot number K023157 is valid, dose unknown) orally, which was exposed to temperatures outside of the recommended range. Concomitant therapies included PREVNAR and PEDIARIX. No adverse effects were reported. This is of several reports received from the same reporter. Additional information is not expected because reported follow up information has already been received.
Age: 3.0
Sex: M
Vaccine: HEPA, HIBV, MMRV
Symptoms: Rash, Urticaria
Clinical narrative: Rash to both arms, occurs continuously. Hives started following the vaccines at night.
Age: 4.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Injection site erythema, Vaccination site cellulitis, Vaccination site warmth
Clinical narrative: (R) thigh 3 x 3 cms red warm/cellulitis surrounding vaccine site placed on AUGMENTIN.
Age: 10.0
Sex: M
Vaccine: PNC13
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on skin.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: C/o fever, chills, headache, achy all over approx 8 hrs post vaccine. Symptoms lasted approx 24-36 hrs. Pt. advised to not receive pertussis vaccine again.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Borrelia test negative, Full blood count normal, Rash pruritic, Red blood cell sedimentation rate normal
Clinical narrative: Itchy rash for 1 1/2 wks.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt rec'ed PCV13 on 9-15-15. Pt noticed area was sore - red - hot - painful - had office visit 9-23-15.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Suture insertion, Syncope
Clinical narrative: Patient had syncope episode. 3 sutures in (R) chin. Vital signs were WNL.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 18-AUG-2015, the patients were vaccinated with improperly stored MMR II lot # J013316, expiration date 22-OCT-2015 and lot # K005175, expiration date 10-APR-2016. No concomitant medication was reported. No adverse event was reported. No PQC was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were received doses of improperly stored RECOMBIVAX HB (lot # K008986, expiration date: 01-APR-2016, route and dose were unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # J014407, expiry date 13-NOV-2015) (lot # L000454, expiry date 06-JAN-2017) (dose, route and dose number were unspecified). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 30-JUL-2015, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # J013370, expiration date 03-FEB-2016 and lot number J0110613, expiration date 11-JUN-2015. No concomitant medication was reported. No adverse event was reported. No PWC (product quality complaint was involved). The outcome of the event was unknown. This is one of several reports receive 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 registered nurse referring to a patient of unknown age and gender. On unknown dates, the patient was vaccinated with unspecified number of improperly stored (Oka/Merck) VARIVAX (dose and route not reported). Lot information of (Oka/Merck) VARIVAX was provided as lot# J014131, expiration date: 07-NOV-2015 and/or lot# K016132, expiration date: 24-SEP-2016. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 07-AUG-2015, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # L008664, expiration date 03-NOV-2016 and lot # K008409, expiration date 04-MAR-2016 and lot # K018528, expiration date 14-APR-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. 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 regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 20-AUG-2015, the patients were vaccinated with improperly stored MMR II lot # J013316, expiration date 22-OCT-2015 and lot # K005175, expiration date 10-APR-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. 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 regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 26-AUG-2015, the patients were vaccinated with improperly stored MMR II lot # J013316, expiration date 22-OCT-2015 and lot # K005175, expiration date 10-APR-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. 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 regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 04-AUG-2015, the patients were vaccinated with improperly stored MMR II lot # J013316, expiration date 22-OCT-2015 and lot # K005175, expiration date 10-APR-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nursery regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 09-SEP-2015, the patient were vaccinated with improperly stored PNEUMOVAX 23 lot # L008664, expiration date 03-NOV-2016 and lot # KK008409, expiration date 04-MAR-2016 and lot # K018528, expiration date 14-APR-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 30-JUL-2015, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # L008664, expiration date 03-NOV-2016 and lot # K008409, expiration date 04-MAR-2016 and lot # K018528, expiration date 14-APR-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 08-SEP-2015, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # L008664, expiration date- 03-NOV-2016 and lot # K008409, expiration date- 04-MAR-2016 and lot # K018528, expiration date- 14-APR-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been from a health professional referring to a 6 month old female patient. On 24-JUL-2015 10:00 AM, the patient vaccinated with oral, ROTATEQ (dose 3, lot number K012457 is an invalid lot number for rotavirus vaccine, however, it is valid for Hepatitis A Vaccine, Inactivated, dose unknown) orally, which was exposed to temperatures outside of the recommended range. Concomitant therapies included PEDIARIX. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because requested follow up information has already been received.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the first dose of GARDASIL 9 injection (dose, lot # and route were not reported). On an unknown date, the patient was inadvertently administered a dose of GARDASIL (dose, lot # and route were not reported) instead of an intended second dose of GARDASIL 9. No adverse effect was reported. No product confusion was reported. Additional information has been requested.
Age: 1.49
Sex: F
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been from a registered nurse referring to a 18 month old female patient. On 24-JUL-2015 10:30 AM, the patient was vaccinated with VAQTA (dose 2, lot # K012457, dose unknown, intramuscular)in the left buttock, which was exposed to temperatures outside of the recommended range (incorrect product storage). Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because requested follow up information has already been received.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable consumer. A 67 year-old female patient received a single dose of PREVNAR 13 subcutaneous in the middle area between her shoulder and her elbow on 03Feb2015 at 12:30. She had read the information on how to administer the vaccine and it stated that it should be given in the deltoid or butt area in the muscle. At the time of the vaccination there were not any other relevant medications or medical conditions. No other vaccines were given on same date along with the suspect vaccine or four weeks prior. The patient began to experience pink area at the injection site about 3 hours after she received the shot, at 15:30. She stated she was not recovered from the reported event, injection site was still pink but she did not have fever and it was not bothering her. Follow-up (13Mar2015): Follow-up attempts completed. No further information expected.
Age: 99.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Rash erythematous, Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable nurse calling on behalf of her mother. A 99 year-old female patient received the first dose of PREVNAR 13 via an unspecified route of administration in the right arm on 23Jan2015 at 0.5 ml single. The patient medical history was not reported. Concomitant medications were not specified, it was only mentioned that she was taking her unspecified regular medications at the time of the event. The patient did not receive any other vaccines on 23Jan2015. The patient has never had a problem with the pneumonia shot before. On an unspecified date in Jan2015 she complained of shoulder being sore, she developed a blood red rash that did not blanch when pressed, and it itched. The rash was from about 2 inches below her shoulder to about 1 1/2 inches above the fold in her elbow. The patient went to the doctor, he put her on antibiotics and told her to take BENADRYL and PEPCID AC. When the rash got bigger, he went to the emergency room, where they gave her a prescription for a prednisone dose pack for 4 days and they told her to continue taking the antibiotics that her doctor had given her. She was not admitted to the hospital. Rash has still not resolved. It has not worsened further but it has not improved either. Outcome of sore shoulder was unknown. Follow-up (13Mar2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age and ethnicity received PREVNAR 13 (Lot Number: J67646; Expiration Date: Mar2016), intramuscular on 02Feb2015 at 12:18 PM at 0.5 ml single dose in the left arm. The patient's medical history and concomitant medications were not reported. On 02Feb2015, the patient experienced redness and swelling in arm at the injection site. There was no treatment given for the events. The events did not require an emergency room visit or physician visit. The clinical outcome of the events, redness and swelling in arm at the injection site, was recovered on an unknown date in 2015. The pharmacist assessed the causality between the events, redness and swelling in arm at the injection site, and PREVNAR 13, as possibly related. Follow-up (21Jan2015): New information received from the same contactable pharmacist includes; patient demographics (gender), suspect product data, reaction data (onset of event), outcome (recovered), treatment (No), and causality (related). Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable nurse (from physician's office) via a Pfizer sale representative. This nurse reported events for three patients. This is one of the three reports. An elderly (over 65 years of age), male patient of an unspecified ethnicity started to received PREVNAR 13 (lot J67647), via an unspecified route of administration, on an unspecified date, as a single dose. Medical history and concomitant medications were not reported. The patient experienced severe itching and little bumps at the injection site on an unspecified date; per the reporting nurse there was no redness and no swelling. The clinical outcome of severe itching and little bumps at the injection site was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable nurse who reported from physician's office via a Pfizer Sale Representative. This contactable nurse reported similar events for 3 different patients. This is one of 3 reports. An elderly female patient (over 65 years old) received PREVNAR 13 (lot number J67647) on unknown date, at single dose. Medical history and concomitant medications were not provided. One week later the patient called back and said that she had severe itching and little bumps at the injection site since unknown date and nurse also reported that there was not redness and no swelling. Events outcome was unknown at the time of report.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Health Care Professional (medical assistant) who was calling on behalf of a physician. A 62-year-old female patient received, on 30Jan2015 at 08:52 in the morning, the first dose of PREVNAR 13 (Lot. J20346, Expiration Date: 31May2016) intramuscular on left arm, 0.5 ml, single dose. The medical assistant mentioned tat the patient received PREVNAR 13 because her medical history included chronic cardiac disease, chronic pulmonary disease, renal disorder, diabetes, chronic liver disease. The medical assistant mentioned that no other vaccines was given four weeks prior to the day of suspected vaccine. On an unspecified date (in 2015), the patient experienced rash, swelling redness, itching and tenderness at the site of injection. The medical assistant mentioned that no emergency room visit was required. Clinical outcome of the events was unknown at time of this report.
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This is a spontaneous report from the non-clinical study program "IBCC (Inbound Call Center for HCP's). A contactacble pharmacist reported that a male patient had a reaction with PREVNAR13 last year and want to know if he would get the same reaction with PREVNAR13. Pharmacist stated the patient had a four days of 104 Fahrenheit fever and swelling on injection site.
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction, Hypersensitivity
Clinical narrative: This is a spontaneous report obtained from a non-contactable physician. A patient of an unspecified age and ethnicity received, on an unknown date, PREVNAR 13 single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient had some allergy or some other reaction on PREVNAR 13. No causality was provided. No follow up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction
Clinical narrative: This is a spontaneous report from a cont actable office assistant (other HCP) via a sale representative. A patient of unspecified age, ethnicity, and gender received PREVNAR13, intramuscular on an unspecified date at 0.5 ml single. The patient medical history and concomitant medications were not reported. The patient experienced local injection site reaction on an unspecified date with outcome of not recovered.
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site pain
Clinical narrative: A female patient of an unspecified age and ethnicity received PREVNAR13, intramuscular in her right arm on 03FEB2015 at 0.5 ml single. She did not receive any other vaccine's at the same time The patient medical history and concomitant  medications were not reported. On 03FEB2015 she had soreness at injection site and on an unknown date in FEB2015 hard where the injection was given. The outcome of the events was not recovered.
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction
Clinical narrative: This is a spontaneous report from a contactable nurse. A 61 years old female patient received on 17DEC2014, the first dose of PREVNAR13 at 0.5 ml single, intramuscular, in the arm. No other vaccines were given on the same date along with suspect vaccine. Medical history was not provided. The nurse stated the patient was on so many medications and was in a hurry, so the medications were not provided to the caller. Within an hour after receiving the product, on 17DEC2014, there was a golf ball sized injection site reaction. The patient returned to the doctor on 19DEC2014 after the reaction worsened and got bigger extending from her shoulder to her elbow. At the time of the report the event was not resolved.
Sex: F
Vaccine: PNC13
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of unknown age received PREVNAR 13, single dose intramuscular on unknown date. Relevant medical history included a slight episode of pneumonia 2 weeks before this report and received a 5 days course of antibiotics, unspecified, and the pneumonia resolved. The patient reported that she experienced a slight headache when she woke up in the morning after the vaccine. Follow-up (03Mar2015): New information received from a contactable consumer includes: patient's and physician details.
Sex: F
Vaccine: PNC13
Symptoms: Full blood count, Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: This is a spontaneous report from Non Clinical Study Program (Pfizer Customer Service) for a contactable nurse practitioner who reported for a patient. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date for infection. The patient medical history and concomitant medications were not reported. On 06Feb2015 the patient experienced injection site redness, injection site swelling, injection site pain/tenderness, injection site hives around the site to the skin/like hives around the skin, with outcome of not recovered. The patient underwent lab tests and procedures on an unspecified date which included full blood count, metabolic function test, red blood cell sedimentation rate, on results provided. The nurse mentioned that she saw the patient and the adverse reactions gone worst from onset date on 11Feb2015. Therapeutic measures were taken as a result of the events included prednisone, BENADRYL, ibuprofen and applied ice.
Sex: F
Vaccine: PNC13
Symptoms: Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: This is a spontaneous report from Non Clinical Study Program (Pfizer Customer Service) for a contactable nurse practitioner who reported for a patient. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date for infection. The patient medical history and concomitant medications were not reported. On 06Feb2015 the patient experienced injection site redness, injection site swelling, injection site pain/tenderness, injection site hives around the site to the skin/like hives around the skin, with outcome of not recovered. The patient underwent lab tests and procedures on an unspecified date which included full blood count, metabolic function test, red blood cell sedimentation rate, on results provided. The nurse mentioned that she saw the patient and the adverse reactions gone worst from onset date on 11Feb2015. Therapeutic measures were taken as a result of the events included prednisone, BENADRYL, ibuprofen and applied ice.