chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 30-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 with expiry date: unspecified for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012685 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 20-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified)  for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012690 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 20-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012691 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Sex: U
Vaccine: HPV9, MMRV, RV5, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant (MA) referring to an unspecified amount of patients (demographics not reported).  Medical history and concomitant medications were not provided.  The MA reported that an unspecified number of doses of improperly stored vaccines were administered to unspecified patients.   The vaccines involved were: ROTATEQ, (lot M012495; expiration 08-OCT-2017 and lot M011832; expiration 25-JAN-2018), GARDASIL 9 (lot M024261; expiration 30-JUL-2018 and lot M009378; expiration 23-APR-2018), PROQUAD (lot M037011; expiration 21-FEB-2018, lot M031943; expiration 27-DEC-2017 and lot M035145; expiration 30-JAN-2018), and VARIVAX (lot M027345; expiration 01-JUN-2018, lot M020900; expiration 27-APR-2018; lot M033212; expiration 13-JUL-2018, lot M034586; expiration 27-JUL-2018 and lot M027885; expiration 03-JUN-2018). Temperature: ROTATEQ and GARDASIL 9 were stored at 28 degrees Fahrenheit (F).  PROQUAD and VARIVAX were stored between 5 degrees F and 14 degrees F. Time frame: ROTATEQ and GARDASIL 9 were improperly stored for seven days.  PROQUAD and VARIVAX were improperly stored for 48 hours. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not provided. Approximately in August 2016 (reported as: August-September 2016 time range), the patient was vaccinated with the first dose of combined vaccine with hepatitis A and hepatitis B, possibly a TWINRIX. Approximately in September 2016 (reported as: some unspecified time in September 2016, "about 5 weeks from first dose"), the patient inadvertently received a dose of VAQTA (dose, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis (interchange of vaccine products; wrong vaccine administered). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age an gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The medical assistant reported that on 27-JAN-2017, an expired dose of ROTATEQ lot # L013197, expiration date 26-JAN-2017 (dose and route were not reported) for prophylaxis, was administered to the patient. No adverse effects were reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a nurse concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2013 (reported as: 4 years ago at age 70), the patient was vaccinated with PNEUMOVAX 23 (dose, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis. Other suspect therapies included PREVNAR 13 administered to the patient in October 2013. On an unspecified date, the patient had a titer ran and was not immune (antibody test negative). On 30-JAN-2017, the patient was vaccinated with another dose of PNEUMOVAX 23 (drug use for unapproved schedule). At the time of reporting, the outcome of the antibody test negative was unknown. Additionally, the relatedness between the event and PNEUMOVAX 23 was not provided. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist, referring to (two) unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with a dose of ZOSTAVAX (strength, dose, anatomical location, administration route, lot number and expiration date were not reported) for immunization. On unspecified dates, the patients experienced a rash around injection site after receiving the dose of ZOSTAVAX, and also developed 5 or 6 bumps around injection site. The reporting pharmacist recommended using hydrocortisone (manufacturer unknown) cream for the rash and when she followed up with patients, both patients reported that rash was resolved with the treatment. It was reported that the unspecified patients did not seek medical attention. The outcome of the 5 or 6 bumps around injection site was not reported. The causality between the vaccination with therapy with ZOSTAVAX and the events was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse who was also an administrator and refers to a patient of unknown age (reported as over the age of 18) and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. Approximately in January 2017 (reported as "within the last month"), the patient was vaccinated with a dose of PROQUAD injection (exact dose, route of administration, lot # and expiry date were not reported) instead of separate doses of VARIVAX and M-M-R II. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Activities of daily living impaired, Bone disorder, Inflammation, Limb discomfort, Mobility decreased
Clinical narrative: This spontaneous report was received from a physician referring to a 15 year old female patient, with TYLENOL WITH CODEINE as concomitant therapy, none pertinent medical history nor drug reactions or allergies. The patient had received the first and second dose of GARDASIL 9 on 13-JUN-2016 and 23-AUG-2016 respectively, for prophylaxis (dose, route, lot /batch number and expiration date were not reported). On 16-JAN-2017, the patient received the third dose of GARDASIL 9 for prophylaxis (with lot # M034195, expiration date 14-APR-2019) (dose and route were not reported). In approximately 2017 reported as unspecified date after receiving the vaccination, the patient had experienced "increasing and severe discomfort so bad she can't lift her arm" (limb discomfort). Physician stated that the patient was referred to an orthopedic surgeon who then performed an XRAY on 27-JAN-2017 (results unknown) and a Magnetic Resonance Imaging (MRI) on 01-FEB-2017 showing inflammatory reaction right adjacent to the bone involving the periosteum (bone disorder) and muscle tissue (myositis), has linear tissue involvement consistent with recent injection". The reporter stated that the orthopedic surgeon prescribed a "MEDROL dose pack" which the patient began taking on 01-FEB-2017. The reporter stated that the patient, on an unknown date in 2017, was also experiencing tingling (paraesthesia). It was reported that the patient "could not get dressed on her own" and the events were not considered to be life threatening. The outcome of bone disorder, paraesthesia, inflammation, limb discomfort and myositis was unknown. Upon internal review, the events of bone disorder, myositis and inflammation and muscle tissue (myositis) were considered to be medically significant events. Additionally, all the events were considered serious due to patient's disability. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Myositis, Nuclear magnetic resonance imaging abnormal, Paraesthesia, X-ray limb abnormal
Clinical narrative: This spontaneous report was received from a physician referring to a 15 year old female patient, with TYLENOL WITH CODEINE as concomitant therapy, none pertinent medical history nor drug reactions or allergies. The patient had received the first and second dose of GARDASIL 9 on 13-JUN-2016 and 23-AUG-2016 respectively, for prophylaxis (dose, route, lot /batch number and expiration date were not reported). On 16-JAN-2017, the patient received the third dose of GARDASIL 9 for prophylaxis (with lot # M034195, expiration date 14-APR-2019) (dose and route were not reported). In approximately 2017 reported as unspecified date after receiving the vaccination, the patient had experienced "increasing and severe discomfort so bad she can't lift her arm" (limb discomfort). Physician stated that the patient was referred to an orthopedic surgeon who then performed an XRAY on 27-JAN-2017 (results unknown) and a Magnetic Resonance Imaging (MRI) on 01-FEB-2017 showing inflammatory reaction right adjacent to the bone involving the periosteum (bone disorder) and muscle tissue (myositis), has linear tissue involvement consistent with recent injection". The reporter stated that the orthopedic surgeon prescribed a "MEDROL dose pack" which the patient began taking on 01-FEB-2017. The reporter stated that the patient, on an unknown date in 2017, was also experiencing tingling (paraesthesia). It was reported that the patient "could not get dressed on her own" and the events were not considered to be life threatening. The outcome of bone disorder, paraesthesia, inflammation, limb discomfort and myositis was unknown. Upon internal review, the events of bone disorder, myositis and inflammation and muscle tissue (myositis) were considered to be medically significant events. Additionally, all the events were considered serious due to patient's disability. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: The patient has been diagnosed with HPV after all doses of GARDASIL vaccines; This spontaneous report as received from a consumer via a product quality control employee refers to a 23 year old female patient. The patient did not have pertinent medical history or concurrent conditions. On an unknown date the patient was vaccinated with GARDASIL injection, the patient received all three doses on an unspecified dates (dose, application site, frequency and lot # were not reported). The patient was not receiving concomitant medications. On an unknown date the patient was diagnosed with HPV (Papilloma viral infection).    The outcome of papilloma viral infection was reported as not recovered. The patient did not seek medical attention, did not received any treatment, and labs were not performed. Additional information is not expected since the reporter denied further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medial assistant and refers an unknown number of patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The reporter stated that on an unknown dates since 12-JAN-2017, the patients received an improperly stored doses of VARIVAX (lot # M023379 with expiration date at 11-MAY-2018, lot # reported as M037643 with expiration date at 01-SEP-2018 and lot # L021214 with expiration date at 10-JUN-2017; dose and route of administration were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature over 14 degrees Fahrenheit (F) and below 46 degrees Fahrenheit (F) for 1 hour and 40 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004067: US-009507513-1702USA004072: US-009507513-1702USA004069: US-009507513-1702USA004070: US-009507513-1702USA004071: US-009507513-1702USA000822: US-009507513-1702USA004068.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medial assistant and refers an unknown number of patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The reporter stated that an unknown dates since 12-JAN-2017, the patients received an improperly stored doses of GARDASIL (lot # L012190 with expiration date at 13-APR-2017; dose and route of administration were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of 46 and 77 (unit nor provided) for 39 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1702USA004067: US-009507513-1702USA004072: US-009507513-1702USA000822: US-009507513-1702USA004070: US-009507513-1702USA004071: US-009507513-1702USA004066: US-009507513-1702USA004068:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medial assistant and refers an unknown number of patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The reporter stated that an unknown dates since 12-JAN-2017, the patients received an improperly stored doses of PNEUMOVAX 23 (involved lot numbers: L014458 with expiration date at 11-FEB-2017, M029680 with expiration date at 17-JAN-2018; dose and route of administration were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of 46 and 77 (unit not provided) for 39 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004067: US-009507513-1702USA004072: US-009507513-1702USA004069: US-009507513-1702USA000822: US-009507513-1702USA004071: US-009507513-1702USA004066: US-009507513-1702USA004068.
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for 2 patients. This is the 1st of 2 reports. An over 65 years old male patient of unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. A couple weeks later the patient came into the store and said that experienced arm soreness around injection site on an unspecified date with outcome of recovered. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017052155 Same reporter/drug/event different patient.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Arthritis, Injection site erythema, Injection site swelling, Injection site warmth, Tendonitis
Clinical narrative: Flu vaccine given 11-8-16 1300- On 11/10 pt called and reported that site was swollen, red and hot, size of golf ball. Never had reaction to flu shot before, but had reaction to pneumonia before , (had rash, cp, swelling and pain). States did have arthritis and tendonitis in the arm she got the flu shot. Instructed to apply ice pack few minutes and repeat.
Age: 2.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient given adult flu dose instead of pediatric dose.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Bronchospasm, Chest discomfort, Dizziness, Pruritus
Clinical narrative: THROAT TIGHTNESS/CHEST TIGHTNESS/ITCHINESS/LIGHTHEADEDNESS THE DAY OF AND TREATED IN EMERGENCY ROOM 3 DAYS LATER, DEVELOPED BRONCHOSPASMS DX LATER WITH ALLERGIST TO BE ASTHMA.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness
Clinical narrative: THROAT TIGHTNESS/CHEST TIGHTNESS/ITCHINESS/LIGHTHEADEDNESS THE DAY OF AND TREATED IN EMERGENCY ROOM 3 DAYS LATER, DEVELOPED BRONCHOSPASMS DX LATER WITH ALLERGIST TO BE ASTHMA.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Disability, Injected limb mobility decreased, Injection site pain, Periarthritis, X-ray limb
Clinical narrative: Flu shot given in right arm. Experienced right upper arm pain, migrated to right shoulder, decreased mobility right shoulder. Diagnosed with right frozen shoulder, am undergoing physical therapy.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Dry skin, Injection site discolouration, Injection site dryness, Injection site erythema, Injection site reaction
Clinical narrative: Skin around injection site got very red and eventually began to dry out and get rough and the slough off. Still has discoloration at the injection site, it is whiter than the rest of her skin.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Skin exfoliation
Clinical narrative: Skin around injection site got very red and eventually began to dry out and get rough and the slough off. Still has discoloration at the injection site, it is whiter than the rest of her skin.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Red, itchy patch underneath vaccine site appearing day after vaccine administration. First time for patient to receive high-dose flu vaccine.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Angiogram, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness, Nerve conduction studies
Clinical narrative: Tingling in palms of hands and bottoms of feet. Tingling and numbness, weakness progressed eventually up to both knees and past elbows. Had 15 infusions of GAMMAGARD from Oct. 15, 2015 to Nov. 2016.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Tingling in palms of hands and bottoms of feet. Tingling and numbness, weakness progressed eventually up to both knees and past elbows. Had 15 infusions of GAMMAGARD from Oct. 15, 2015 to Nov. 2016.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abasia, Arthralgia, Swelling, Urticaria
Clinical narrative: 5 days after receiving KINRIX and PROQUAD he developed hives, joint pain and swelling. He was not able to walk due to pain. His condition improved with BENADRYL and steroids.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Urticaria
Clinical narrative: (R) arm cellulitis - underneath injection site. 3" long-width of arm. Hive on torso.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None noted.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Grip strength decreased, Muscular weakness
Clinical narrative: After receiving flu vaccine, noticed increased weakness in hands bilaterally. Inability to open IV bags, twist tops. Weakness has not improved.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 20-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012717 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 20-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012718 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Incorrect dose administered
Clinical narrative: Information has been received on 10-JAN-2017 from a physician regarding a 61 year old male patient with diabetes mellitus. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 30-DEC-2004, the patient was vaccinated with RECOMBIVAX HB (lot number and expiration not reported), unknown route for prophylaxis. On 05-JAN-2017, the patient had titers drawn for his job and the hepatitis B titer came back as negative for surface antibody. On 10-JAN-2017 the patient was seen in the physician's office and was inadvertently administered a dialysis dose of RECOMBIVAX HB (lot number and expiration not reported) instead of the regular adult dose. The outcome of hepatitis b surface antibody negative and incorrect dose administered was reported as recovered/resolved. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (RN) referring to multiple, unspecified patients (demographics not reported).  Medical history and concomitant medications were not provided. Between 13-DEC-2016 and 06-JAN-2017, multiple, unspecified patients received improperly stored VARIVAX. Lot numbers involved were: M028553 expiration 07-JUN-2018, M030138 expiration 15-JUN-2018, M036272 expiration 17-JUN-2018 and M034586 expiration 27-JUL-2018. Temperature: >14 degrees Fahrenheit to < or = to 46 degrees Fahrenheit range. Time frame: 2 hours, 36 minutes. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information had been received on 18-JAN-2017 from a nurse practitioner who reported that female patient (age unknown) received an expired dose of VAQTA (lot# L042039, expiration 14-JAN-2017) 50/1.0 U/ml intramuscularly in right deltoid on 18-JAN-2017. The patient has not reported an adverse effect. No additional information was provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 61 year old female patient. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 25-JAN-2017, the patient was vaccinated with PNEUMOVAX 23 injection, intramuscularly, lot # M036161, expiry date 06-MAY-2018, 1 shot every 5 years (anatomical location was not specified) for prophylaxis. It was reported that initially the patient went home "alright". On 26-JAN-2017 (reported as "day after she received the vaccine"), in the evening, the patient's hand (unspecified if it was the right or left) became swollen and red. In January 2017, the patient sought medical attention and saw the physician at an unspecified urgent care. The patient received treatment with prednisone (manufacturer unknown) and Z-PAK due to the events. The pharmacist reported that, on 27-JAN-2017 (reported "as of today"), the swelling and redness was significantly reduced to the point where he declared it recovered. The reporter considered the events to be adverse reactions to PNEUMOVAX 23. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around injection site (11x13cm) on Right anterior thigh - 2 days after vaccine. Treatment- BENADRYL 12.5-25mq Q6h, Prednisolone 22.5 mg BID x 4 days.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Per mom, child showed her his arm the evening after getting the shot. Mom unsure of what time the reaction actually started. Red, hot to touch, and swelling noted from elbow to shoulder.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Hypersensitivity, Rash generalised, Swelling face, Urticaria
Clinical narrative: 2/17/17 Patient went to ER with generalized hives on whole body and across head. Given prednisolone 15mg/5mL 15mg in ER and sent home with ORAPRED 15mg/5mL 15mg Dailey. 2/8/17 Patient brought back to ER Mom states she is much worse generalized hives and facial swelling given BENADRYL, DECADRON, prednisolone. Mother states that child had several immunization shots yesterday. Woke with hives all over body and head today. 19-month-old female brought in for evaluation of a rash with hives all over the body. As per mom a day ago had immunization shots. Denies kid having any difficulty breathing or wheezing. Also denies any nausea vomiting diarrhea or other symptoms. Kid still drinking and wetting diapers. Pt. presents with generalized hives on whole body and facial swelling. Pt seen here yesterday for same reaction but improved with steroids. Mom states today reaction is much worse. 19-month-old kid brought in back with recurrence of rash. As per mother the rash was gone in the night but returned in the morning. No other specific complaints. Kid still eating and drinking and not in any respiratory distress. Denies any fever chills vomiting diarrhea difficulty breathing or other symptoms. No other specific complaints.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Mother noticed redness and warmth at injection site the evening of the injection.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: Received pneumonia shot 2 days ago in that area. Tonight she had onset of pain and redness. She noticed the pain first and when she looked it was red.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Pruritus generalised, Vision blurred
Clinical narrative: DIZZINESS, LIGHTHEADEDNESS, ITCHY ALL OVER BODY (NO HIVES), BLURRED VISION.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, IPV, MMR, TDAP, TYP, YF
Symptoms: Mass, Neck pain, Pain, Tenderness
Clinical narrative: 2/8/17 Pt stated her neck started to feel sore but not on the inside.  Denies SOB and difficulty swallowing but neck is tender to touch and uncomfortable when she moves and looks up. 2/9/2017 spoke to pt again approx. 1130 and she states there is now a palable tender lump at the base of her throat.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Mobility decreased, Pain
Clinical narrative: Pain, limited mobility of joint/arm.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity, Vaccination site pain
Clinical narrative: FLUVIRIN PFS administered 10/13/16-pt experienced post vaccine site pain for 1-2 days after: 10/25/16. Pt calls the Pharmacy saying she woke up with arm pain and bruising. She reported no other symptoms. Time between vaccine related arm pain and 10/25 report of pain she was fine with no arm pain. No other reports from pt. since 11/3/16. Per pt.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse and refers to unspecified patients of unknown ages and genders. There was no information about patient's concurrent conditions, medical history or concomitant medications. On multiple unknown dates, the patients were most likely vaccinated with a dose of improperly stored GARDASIL 9 lot # M020103 and expiration date of 15-FEB-2018, (route of administration and anatomical location were not reported) for prophylaxis, which was stored at a lowest recorded temperature of 32 Fahrenheit (0 Celsius) and a highest temperature of 36 Fahrenheit (2.2 Celsius) for 34 days, the entire 24 hours each day, and a lowest recorded temperature of 46F (7.7 Celsius) and a highest 77F (25 Celsius) for 24 hours. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA002770: US-009507513-1702USA002768: US-009507513-1702USA002769.
Sex: U
Vaccine: MMRV
Symptoms: Antibody test abnormal, Local reaction, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a physician referring to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patients was vaccinated with PROQUAD (strength, dose frequency, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patients developed either a "localized reaction", a fever, an unspecified rash (unspecified location of body), and the "antibody levels were not as high". At the reporting time, the outcome of the events was unknown. The causality between the events and PROQUAD was not reported. Additional information is not expected because there was no consent to contact physician.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself. A 59-year-old female patient of an unspecified race received pneumococcal 13-val conj vac (dipht crm197 protein) for immunization on unknown date at single dose via an unspecified route of administration. Relevant medical history and concomitant medication were not reported. On unknown date the patient experienced an allergic reaction. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for 2 patients. This is the second of 2 reports. An over 65 years old female patient of unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single in the arm, for immunisation. Medical history and concomitant medications were not reported. A couple weeks later the patient came into the store and said that experienced arm soreness around injection site on an unspecified date. Outcome was recovered. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017052137 same reporter/drug/event different patient.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper arm red, inflamed hot to touch and swollen extends down to elbow.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Febrile convulsion, Screaming, Seizure
Clinical narrative: Grandmother put her down for a nap, heard a scream went to check on her and found her having a seizure. Grandmother called 911. Paramedics came to check her and stated she was stable enough to transport by car to ER where she was DX with febrile seizure.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Angioedema, C-reactive protein normal, Full blood count normal, Laboratory test normal, Red blood cell sedimentation rate normal
Clinical narrative: Developed angioedema - tongue swelling. Seen in ER, given IM SOLUMEDROL and diphenhydramine, SXS resolved.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Swollen tongue
Clinical narrative: Developed angioedema - tongue swelling. Seen in ER, given IM SOLUMEDROL and diphenhydramine, SXS resolved.
Age: 4.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Pruritus, Rash, Rash maculo-papular
Clinical narrative: Maculopapular rash on back with itching. Started 6 hours after vaccination.
Age: 4.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Rash
Clinical narrative: Maculopapular rash on back with itching. Started 6 hours after vaccination.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, FLU4, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was given Pediatric Influenza Sanofi Pasteur 0.25cc instead of PREVNAR as indicated at 2 months of age. Pt has been fine with no symptoms.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Gingival bleeding, Gingival pain
Clinical narrative: Throbbing & bleeding gums, dizziness, complete face numbness, difficulty breathing, throat closing up, elevated & pounding heart rate, arm & feet numbness & tingling, fever, hives, tongue numbness, elevated blood pressure.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Heart rate increased, Hypoaesthesia, Hypoaesthesia oral, Palpitations, Paraesthesia
Clinical narrative: Throbbing & bleeding gums, dizziness, complete face numbness, difficulty breathing, throat closing up, elevated & pounding heart rate, arm & feet numbness & tingling, fever, hives, tongue numbness, elevated blood pressure.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Throat tightness, Urticaria
Clinical narrative: Throbbing & bleeding gums, dizziness, complete face numbness, difficulty breathing, throat closing up, elevated & pounding heart rate, arm & feet numbness & tingling, fever, hives, tongue numbness, elevated blood pressure.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia, Pain in extremity, Secretion discharge
Clinical narrative: ZOSTAVAX was administered on 01/28/2017. On 02/06/2017 visited Dr. because of severe pain and a skin lesion over his right gluteal area with secretions and blisters since the day before. Shingles was diagnosed and started treatment with FAMVIR 500 mg po TID for 7 days and ULTRAM 50 mg po PRN for pain. Pain on left leg had been reported and treated with TORADOL/NORFLEX IM and ZANAFLEX orally. MEDROL Dose Pack was taken 1-19-17 to 1-25-17 (24 mg on Day 1 down to 4 mg on Day6).
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: ZOSTAVAX was administered on 01/28/2017. On 02/06/2017 visited Dr. because of severe pain and a skin lesion over his right gluteal area with secretions and blisters since the day before. Shingles was diagnosed and started treatment with FAMVIR 500 mg po TID for 7 days and ULTRAM 50 mg po PRN for pain. Pain on left leg had been reported and treated with TORADOL/NORFLEX IM and ZANAFLEX orally. MEDROL Dose Pack was taken 1-19-17 to 1-25-17 (24 mg on Day 1 down to 4 mg on Day6).
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Drug dose omission, Extra dose administered
Clinical narrative: PREVNAR 13, Hepatitis A, PROQUAD and ActHib ordered. PROQUAD was not given, and ACTHib was given twice.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Dysphagia, Headache, Heart rate increased, Lacrimation increased, Malaise
Clinical narrative: Pulsatile Tinnitus, trouble swallowing, headache, malaise, fast heartbeat, eyes tearing. Tinnitus persists (has not resolved to date), while the other symptoms have resolved.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Tinnitus
Clinical narrative: Pulsatile Tinnitus, trouble swallowing, headache, malaise, fast heartbeat, eyes tearing. Tinnitus persists (has not resolved to date), while the other symptoms have resolved.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blister, Headache, Joint swelling, Nausea
Clinical narrative: Acute viral syndrome, nausea, vomiting, generalized rash, headache, body aches, painful swollen joints, sore throat, uvulitis, blisters on hands, profound neutropenia.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Neutropenia, Oropharyngeal pain, Pain, Rash generalised, Uvulitis
Clinical narrative: Acute viral syndrome, nausea, vomiting, generalized rash, headache, body aches, painful swollen joints, sore throat, uvulitis, blisters on hands, profound neutropenia.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Viral infection, Vomiting
Clinical narrative: Acute viral syndrome, nausea, vomiting, generalized rash, headache, body aches, painful swollen joints, sore throat, uvulitis, blisters on hands, profound neutropenia.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: The patient presented with a nickel sized welt on his right thigh where the MMR vaccine was injected 5 minutes after the immunization was administered. The physician was immediately alerted to the adverse reaction and monitored his vitals. They were normal. We had the patient and his mom stick around in the office for 20 minutes. His vitals were rechecked where they remained normal. The patient was then released and mom was informed to call the office or seek emergency care if he developed any breathing issues.
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator calling on behalf a physician, concerning a female patient of unknown age. The patient's medical history, concurrent conditions, allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 intramuscularly (IM) for prophylaxis (lot # M031557, expiration date 07-APR-2019) (dose, frequency, and batch # were not reported). There were no adverse effects reported. The dose of the vaccine was exposed to a temperature of > 46 degree Fahrenheit (F) but <77 degree F. There were no previous temperature excursions. A digital data logger was involved. Furthermore, no product quality complaint (PQC) was involved. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 88 year old female patient. The patient did not have pertinent medical history, concurrent conditions or concomitant therapies. On 09-JAN-2017, the patient was vaccinated with PNEUMOVAX23 (dose and anatomical location were not reported), lot # M038216, exp date 09-MAY-2018, intramuscular for prophylaxis. The pharmacist reported that the patient went back into the pharmacy on 10-JAN-2017 and presented with "redness and swelling at the injection site." On an unspecified date after administration, the patient went to the hospital because it was unresolved and was hospitalized for "2 nights" and was diagnosed with cellulitis around the injection site. The patient was treated with "antibiotics". The pharmacist reported that the patient is fully recovered on an unspecified date, but did not know the date of recovery. Upon internal review, the event cellulitis was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 01-FEB-2017 and on 02-FEB-2017, the patients were vaccinated with improperly stored doses of M-M-R II (lot number reported as M028130 (rHA) and expiration date 03-JUN-2018, dose and route were not reported) for prophylaxis.   The temperature exposure was from 8 Celsius degrees to 25 Celsius degrees for 2 hours and 23 minutes. There was not previous excursions or data logger involved. No adverse effects were reported. A product quality complaint was not involved.   Additional information has been requested.  This is one of the several reporters received from the same source.; Sender's Comments:  US-009507513-1702USA003521:Original Case : 1702USA001003 US-009507513-1702USA003523:Original Case : 1702USA001003 US-009507513-1702USA003520:Original Case : 1702USA001003 US-009507513-1702USA003522:Original Case : 1702USA001003
Age: 1.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 26-JAN-2017, the patient was vaccinated with M-M-R II (lot # M016233 with expiration date 31-MAR-2018) (dose, dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 8°F but less than 25 °F for 7 hours 54 minutes without any previous temperature excursion. No data logger issue and no adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA001057.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection (dose, strength, and route of administration were not reported) (lot # M042599, expiration date 17-JUN-2018) for prophylaxis. According to the reporter, PNEUMOVAX 23 doses were exposed to the following temperatures excursions: 5 hours and 9 minutes between 0 degrees Celsius (C) and a maximum of 2 C, and for 20 hours and 22 minutes below 0 C with a minimum at -3.7 C. No adverse effects were reported. A digital data logger was involved. There was no product quality complaint involved. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache
Clinical narrative: After having the Flu shot I have had a 24/7 headache since the end of September. I have started my 5th month with this headache. I have spoken to a couple other people who have had the same side effect.
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Abdominal X-ray, Cough, Crying, Decreased appetite, Enema administration
Clinical narrative: PT PRESENTED TO ER WITH INCONSOLABLE CRYING AND VOMITING, LOSS OF APPETITE, DECREASED URINE OUTPUT, FEVER AND MUCOID BLOODY STOOL IN ER. WAS HAVING COUGH CONGESTION FOR 3 DAYS. ULTRASOUND DONE SUGGESTED INTUSUSSCEPTION. CONTRAST ENEMA WAS DONE.
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Intussusception, Mucous stools, Pyrexia, Respiratory tract congestion
Clinical narrative: PT PRESENTED TO ER WITH INCONSOLABLE CRYING AND VOMITING, LOSS OF APPETITE, DECREASED URINE OUTPUT, FEVER AND MUCOID BLOODY STOOL IN ER. WAS HAVING COUGH CONGESTION FOR 3 DAYS. ULTRASOUND DONE SUGGESTED INTUSUSSCEPTION. CONTRAST ENEMA WAS DONE.