chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site urticaria, Loss of consciousness
Clinical narrative: Information has been received from a physician referring to a 16 year old female patient. On 14-OCT-2014, the patient was vaccinated with the first dose of GARDASIL (route and lot number not provided) for prevention HPV. Physician reported the patient received MENVEO (GlaxoSmithKline), in the left upper arm, and then received GARDASIL 9, (lot#L043213/unspecified exp. date), in the left upper arm, as the second dose of he GARDASIL vaccination series, on 25-MAR-2016. Physician reported the patient "passed out immediately", recovered rapidly and received oral fluids and rested before leaving the office. Physician reported the patient experienced hives on the left upper arm, down to elbow, on 26-MAR-2016. There were no diagnostics studies lab performed. Physician reported the patient's mother was quite upset and patient was seen in the office on 26-MAR-2016. Patient had been treated with BENADRYL, CLARITIN and a topical steroid cream. Physician reported hives recur, intermittently. The outcome of urticarial was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with and improperly stored dose of PNEUMOVAX 23 lot # L038669 with expiration date of 11-AUG-2017 (anatomical route of vaccination and dose number were not provided). The patient's concomitant medications were not reported. No adverse event were reported due to vaccination with PNEUMOVAX 23 and no product quality issue was involved. The certified medical assistant (C.M.A.), stated that PNEUMOVAX 23 was exposed to 18 degree C on a time frame of 1.5 hours on an unspecified date, additionally it was reported that the vaccine was not involve in previous temperature excursions. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: HIBV, HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse (L.V.N.) referring to a 15 month old patient. The patient's medical history and concurrent condition were not reported. On 07-APR-2016, the patient was inadvertently vaccinated with GARDASIL 9 lot # L020015; expiration date 16-AUG-2017 (dose and route of administration were not reported) instead of an intended dose of LIQUID PEDVAXHIB (Lot#, expiration date, dose and route of administration were not reported). Concomitant medication was not reported. The nurse reported that hpv was confused with LIQUID PEDVAXHIB, although she did not know the specific reason why the confusion occurred. LIQUID PEDVAXHIB was not administered. No adverse effect 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, referring to two patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. It was reported that improperly stored doses of VARIVAX (Merck) Lot # L029466 with expiration date on 06-AUG-2017 and Lot # L024367 with expiration date on 08-SEP-2017, (dose and route were not reported), were given to the patients on 04-APR-2016. It was unspecified which of the above lots the patients received. No adverse symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 25-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, which had a lot # of L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 F for a time frame of 7 hours. This excursion was found due to a data logger. Additionally, it was stated that no previous temperature excursions had occurred.  This is one of the several cases received from the same reporter. Additional information has ben requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain, Skin warm, Tenderness
Clinical narrative: Patient has reported significant pain in shoulder, warm, tender when trying to move her arm to do some daily functions. Symptoms started about 1-2 hours after immunizations.
Age: 1.04
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: PROQUAD. Pt waited 15 minutes. When I went to check injection site, pt had a welt and redness near injection area.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Dysstasia, Movement disorder
Clinical narrative: I feel weak. I cannot either stand or sit for a long time.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Dysstasia
Clinical narrative: I feel weak. I cannot either stand or sit for a long time.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Intense pain and swelling to size of baseball around injection site. Injection was painful. Swelling started 1-2 hrs after injection. Pain/swelling lasted 3-4 days.
Age: 60.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Muscle spasms
Clinical narrative: This spontaneous report was received from a nurse who is the wife of the patient concerning her 60 year old husband. The patient's concurrent conditions included pituitary tumor since 1990, which was under control with an unspecified medication, high blood pressure and thyroid, cholesterol and heart issues. On 14-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not provided). On the same date, the patient also received a shot of PCV (manufacturer unknown). The patient's concomitant medications were not provided. The patient's wife reported that since receiving ZOSTAVAX, since approximately March 2016, the patient had experienced severe cramping in his legs, especially the calves and ankles, causing patient to stand up to obtain more relief. Cramping of the legs was worse in evening than daytime. The patient's wife reported that patient experienced spasms in his fingers, which lasted two hours, on 09-APR-2016. No treatment was given for the patient's adverse event. The patient had no contacted primary care physician. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Abdominal pain, Bacterial test negative, Basophil count normal, Basophil percentage, Chest X-ray normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year -old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number-U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Chest pain, Confusional state, Constipation, Crying, Dermatitis atopic
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year -old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number-U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Dysarthria, Dyspnoea, Eosinophil count normal, Eosinophil percentage, Flatulence
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year -old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number-U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Full blood count, Glucose urine absent, Granulocyte percentage, Haematocrit normal, Haemoglobin normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year -old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number-U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Lip oedema, Lip swelling, Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year -old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number-U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Mental status changes, Monocyte count normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year -old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number-U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Monocyte percentage, Nervousness, Neutrophil count normal, Neutrophil percentage, Nitrite urine absent
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year -old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number-U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Platelet count normal, Protein urine absent, Red blood cell count normal, Red blood cells urine positive, Red cell distribution width normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year -old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number-U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Specific gravity urine normal, Speech disorder, Tachypnoea, Urinary sediment present, Urine analysis
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year -old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number-U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Urine bilirubin decreased, Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine, White blood cell count normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year -old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number-U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: White blood cells urine negative, pH urine normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year -old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number-U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Dysarthria, Dyspnoea, Full blood count, Mental status changes, Urine analysis
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year -old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number-U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Dyskinesia, Hypotonia, Pallor
Clinical narrative: She became pale, limp, and jerking movements in head minutes after injections. Immediately alert and oriented when moved to exam table and laid down. Vital Signs stable. Monitored for 30 minutes post injection.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Received PNEUMOVAX 04/07/2016. Developed R upper arm soreness on Thursday. Developed a 2X2" blotch of redness and warmth at site on Friday. Sxs resolved in full by Monday. Pt did not experience any inflammation or fever. Wants this noted in his record, "I seemed to have reacted to it more than prescribed from what I read."
Age: 26.0
Sex: F
Vaccine: MMR, TD
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: None known.....patient received an MMR and a Td. Patient is 10 weeks pregnant and should not have received a live vaccine and should have received a Tdap not Td to ensure protection against pertussis.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Vasovagal syncopal episode; no loss of consciousness.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare worker refers to an unspecified number of patients of unknown age. The pertinent medical history and concurrent conditions of patients were not reported. On an unknown dates, the patients were vaccinated with incorrectly stored VARIVAX lot # L037561, expiry date 29-SEP-2017 (dose and route not reported). The vaccine was exposed to the temperature of -10 degree Centigrade for 10 days. There were no previous excursion reported. The reporting healthcare worker was not aware of any adverse events. No additional information was reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to three patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (lot# M000386; dose, route of administration and expiry date were not reported). There were no concomitant therapies reported. On unknown dates, the patients experienced rash, swollen and sore arm at the injection site. The outcome of the events was not reported. The relatedness between PNEUMOVAX 23 and the events was not provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 67 year old female patient. No information regarding the patient's medical history or concurrent conditions was provided. The patient was not pregnant. On 11-APR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot# M000386; dose, route of administration and expiry date were not reported). There were no concomitant therapies reported. On 11-APR-2016, also reported as "soon", the patient experienced rash, swollen and sore arm at the injection site. The patient did not seek medical attention. No treatment was given for the event. It was stated that therapy with PNEUMOVAX 23 was not discontinued and not reintroduced. The outcome of the events was not reported. The relatedness between PNEUMOVAX 23 and the events was not provided. This one of two reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 64 year old patient of unknown gender. The patient's concurrent conditions included penicillin allergy and his concomitant medications included aspirin. None pertinent medical history was reported. On 13-APR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (subcutaneously; dose, lot # and expiration date were not reported). On an unknown date in April 2016, the patient developed redness, swelling and warmth at the vaccination site. On 14-APR-2016, the patient sought medical attention via returning to the office. The patient was advised for the treatment to use warm/cold compresses to the affected area and to take ibuprofen as needed. None lab diagnostics studies were performed. The outcome of the adverse events was unknown. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 64 year old patient of unknown gender. The patient's concurrent conditions included penicillin allergy and his concomitant medications included aspirin. None pertinent medical history was reported. On 13-APR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (subcutaneously; dose, lot # and expiration date were not reported). On an unknown date in April 2016, the patient developed redness, swelling and warmth at the vaccination site. On 14-APR-2016, the patient sought medical attention via returning to the office. The patient was advised for the treatment to use warm/cold compresses to the affected area and to take ibuprofen as needed. None lab diagnostics studies were performed. The outcome of the adverse events was unknown. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction, Interchange of vaccine products
Clinical narrative: This report was received from Pfizer Inc and was assigned a manufacturer report number (2016118776) for PREVNAR 13. It was reported by a physician referring to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On 17-AUG-2015, the patient was vaccinated with PREVNAR 13. On 07-FEB-2016, the patient was vaccinated with PNEUMOVAX 23 (anatomical location, dose number, lot number and expiration date were not reported). The patient's concomitant medications were not reported. This is one of two cases from the same reporter. (1603USA010586). Additional information has been requested.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse referring to a patient of unknown age and gender. Information regarding medical history, drug reactions and concurrent conditions was not reported. On 01-FEB-2016, the patient was inadvertently vaccinated with a dose of PEDVAXHIB (lot number L030872 and expiration date 11-JUN-2018) and with a dose of PENTACEL; however, dose number, dose and route of administration were not provided for any of these vaccines. Concomitant therapies were not reported. No adverse effects were reported and there was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a 13 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 28-MAR-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (dose, unit and route not reported, lot # L046506 and Exp. date 17-MAY-2017) (inappropriate schedule of drug administration). No adverse effect was reported. This report is linked with 1603USA013691 (sibling and same reporter). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a 18 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 28-MAR-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (dose, unit and route not reported, lot # L046506 and Exp. date 17-MAY-2017) (inappropriate schedule of drug administration). No adverse effect was reported. This report is linked with 1603USA013691 (sibling and same reporter). Additional information has been requested.
Age: 0.92
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 11 months old patient of unknown gender. On 02-AUG-2007 (also reported as 02-AUG-2006) the patient was vaccinated with the first dose of VARIVAX (dose, route and lot # were not reported). This was 12 days before the patients first birthday which was before the recommended age. On 18-AUG-2010, the patient received the second dose of VARIVAX. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medication was provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, injection site, lot# and expiration date were not provided). On an unknown date (also reported as later), the patient developed shingles. The patient sought medical attention (unspecified). The outcome of the event was unknown. The relatedness between the shingles and ZOSTAVAX was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
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 patient's concurrent conditions, medical history and concomitant medications were not reported. On 11-APR-2016, the patient was vaccinated with expired PNEUMOVAX 23, expiry date 23-MAR-2016 (dose, route and site of administration and lot # were not reported). No adverse symptoms were reported. Additional information is not expected, as no contact details were provided.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse refers to a 3 year old male patient. Concomitant medications, pertinent medical history and allergy/drug reactions were none. On 27-SEP-2001 the patient was vaccinated with VARIVAX. On 10-AUG-2004, the patient developed shingles. On an unknown date, the patient sought medical attention which included an office visit. On an unknown date, the patient was treated with KEFLEX. There were no lab tests done. The Nurse reported that on patient chart, it was noted that the patient grandmother has a case of shingles on an unknown date approximately in June 2004 (reported as 2 months prior) to patient diagnosis of shingles and Nurse suspected that patient came in contact with his grandmother. The outcome of the event was reported as recovered. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. 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 certified medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with the improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017; dose and route of administration were not reported). The vaccine was stored in 22.6 degrees of Celsius for 2 hours and 40 minutes. No adverse effects and no previous temperature excursion were reported. The call was made because of the data logger. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Paraesthesia, Pruritus
Clinical narrative: Left upper arm slightly swelling, erythematous, tired, left arm tingling 6" x 4" area, itchy, warm to touch tx: ZYRTEC and OTC steroid cream.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Left upper arm slightly swelling, erythematous, tired, left arm tingling 6" x 4" area, itchy, warm to touch tx: ZYRTEC and OTC steroid cream.
Sex: U
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX, (lot #, expiry date, dose, frequency and route of administration not reported). The patient experienced "tinnitus with in 24 hours of getting the dose". The outcome of the event was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: DTAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: PATIENTS REFERS TO OBSERVE IN THE MORNING RASH, HIVES, ITCHING, ON CHEST AND BACK.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 21-year-old female patient. The patient's medical history was not reported. On approximately 21-MAR-2016 (reported as two weeks ago), the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscular in the arm (lot number not reported). In approximately March 2016, the patient developed redness and swelling of injection-site arm after receiving PNEUMOVAX 23. The patient sought medical attention and received unspecified treatment for the events. The outcome of the events was reported as recovered/resolved (unspecified date in 2016) (also reported as recovering). The relationship between PNEUMOVAX 23 and the events was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Confusional state, Decreased appetite, Diarrhoea, Incoherent
Clinical narrative: 4/14 - pt's son reports that the patient has had diarrhea, stomach pains, loss of appetite and confusion. He described her as incoherent. He had to "physically make her eat." By afternoon, she had improves some. Advised watching and monitoring - seeking help if the condition worsens.
Age: 1.02
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient broke out with the chickenpox.
Age: 26.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema
Clinical narrative: RED PATCHES AROUND VACCINATION SITE.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Papule, Rash, Rash pruritic
Clinical narrative: Patient noted onset of mildly pruritic rash (erythematous papules) over bilateral hands and fingers which started on 11 April. On 30 March he received ACAM2000 vaccine (first dose), and on 18 March he had received his first dose of Anthrax, first dose of HPV9, and second dose of JE vaccine. He denies arthralgias, myalgias, fever/chills, chest pain, malaise, fatigue, headache, pulmonary, CV, and GI symptoms. He indicates he has kept ACAM2000 vaccination site covered as directed and denies generalized rash. He denies a personal history of atopic dermatitis/eczema and any prior adverse vaccine reactions.Patient given high potency topical corticosteroid to apply to affected areas.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Pain from start, lump soon after.
Sex: F
Vaccine: HEP, HEP
Symptoms: Adverse event following immunisation, Arthralgia, Myalgia, Paralysis, Psoriasis
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Information about the patient's pertinent medical history and drug reactions/allergies was not reported. On an unspecified date in 1990, the patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided). Concomitant medications were not reported. The reporter stated that, following the administration of the hepatitis B vaccine (recombinant) (manufacturer unknown), the patient had a terrible reaction (adverse event following immunization), partial paralysis, muscle and joint pain (myalgia, arthralgia), which all lasted about a year then resolved. Additionally, it was unspecified when those events occurred. It was also reported that, the hepatitis B vaccine (recombinant) (manufacturer unknown), on an unspecified date, triggered the start of plaque psoriasis. However, the location of where the psoriasis developed was not specified. The patient was prescribed, for the past years, DOVONEX cream and ointment as treatment for the plaque psoriasis. The reporter confirmed that the patient's psoriasis was still present. The reporter considered the partial paralysis a significant disability. Upon internal review the paralysis was considered serious as medically significant. Additional information has been requested.
Sex: F
Vaccine: HEP, HEP
Symptoms: Arthralgia, Myalgia, Paralysis, Psoriasis, Vaccination complication
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Information about the patient's pertinent medical history and drug reactions/allergies was not reported. On an unspecified date in 1990, the patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided). Concomitant medications were not reported. The reporter stated that, following the administration of the hepatitis B vaccine (recombinant) (manufacturer unknown), the patient had a terrible reaction (adverse event following immunization), partial paralysis, muscle and joint pain (myalgia, arthralgia), which all lasted about a year then resolved. Additionally, it was unspecified when those events occurred. It was also reported that, the hepatitis B vaccine (recombinant) (manufacturer unknown), on an unspecified date, triggered the start of plaque psoriasis. However, the location of where the psoriasis developed was not specified. The patient was prescribed, for the past years, DOVONEX cream and ointment as treatment for the plaque psoriasis. The reporter confirmed that the patient's psoriasis was still present. The reporter considered the partial paralysis a significant disability. Upon internal review the paralysis was considered serious as medically significant. Additional information has been requested.
Sex: F
Vaccine: HEP, HEP
Symptoms: Adverse event following immunisation, Arthralgia, Myalgia, Paralysis, Psoriasis
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Information about the patent's pertinent medical history and drug reactions/allergies was not reported. On an unspecified date in 1990, the patient was vaccinated with hepatitis b vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided). Concomitant medications were not reported. The reporter stated that, following the administration of the hepatitis b vaccine (manufacturer unknown), the patient had a terrible reaction, partial paralysis, muscle and joint pain, which all lasted about a year then resolved. Additionally, it was unspecified when those events occurred. It was also reported that, the hepatitis b vaccine (manufacturer unknown), on an unspecified date, triggered the start of plaque psoriasis. However, the location of where the psoriasis developed was not specified. The patient was prescribed, for the past years, DOVONEX cream and ointment as treatment for the plaque psoriasis. The reporter confirmed that the patient's psoriasis was still present. The reporter considered the partial paralysis a significant disability. Upon internal review the paralysis was considered serious as medically significant. Additional information has been requested.
Sex: F
Vaccine: HEP, HEP
Symptoms: Arthralgia, Myalgia, Paralysis, Psoriasis, Vaccination complication
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Information about the patent's pertinent medical history and drug reactions/allergies was not reported. On an unspecified date in 1990, the patient was vaccinated with hepatitis b vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided). Concomitant medications were not reported. The reporter stated that, following the administration of the hepatitis b vaccine (manufacturer unknown), the patient had a terrible reaction, partial paralysis, muscle and joint pain, which all lasted about a year then resolved. Additionally, it was unspecified when those events occurred. It was also reported that, the hepatitis b vaccine (manufacturer unknown), on an unspecified date, triggered the start of plaque psoriasis. However, the location of where the psoriasis developed was not specified. The patient was prescribed, for the past years, DOVONEX cream and ointment as treatment for the plaque psoriasis. The reporter confirmed that the patient's psoriasis was still present. The reporter considered the partial paralysis a significant disability. Upon internal review the paralysis was considered serious as medically significant. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 11-APR-2016, the patient was vaccinated intramuscularly with an expired dose of PNEUMOVAX 23, 0.5 ml, once (lot # K009874, expiration date: 19-MAR-2016). No adverse effects were 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 refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The nurse reported that the patients received improperly stored (temperature excursion; 15 F, time frame: 12 hours) doses of VARIVAX of lot/batch # L021214 with expiry date 06-OCT-2017, lot/batch # L034370 with expiry date 08-SEP-2017 and lot/batch # L042817 with expiry date 10-JUN-3017 (Dose, strength, dose number, vaccination site and route of administration not provided) on unspecified date. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of two reports from same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an elderly patient of unknown gender in his/her 70's. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not specified by the reporter. In approximately 2015 (reported as "about a year ago"), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not specified). On an unknown date, the patient developed a mild case of shingles and had been on an anti-viral therapy (unspecified medications) up until approximately January 2016 (reported as about 2 months ago). It was also reported that the patient had a shingles like rash on the forehead when it was first reported to the pharmacist by the unspecified patient on an unspecified date after the vaccination was administered. It was not specified if the patient sought any medical attention. A sample for Varicella Zoster Virus Identification Program (VZVIP) was not send. The pharmacist had read through unspecified materials but they did not really apply to him in his position. He said that "in his position he will not really remove a scab or lesion and send it in." The pharmacist also stated that he originally received the information because he spoke with a company representative and told him that he had seen patients that sometimes get shingles after vaccination. The outcome of the adverse event was reported as recovered on an unspecified date. Causality assessment was not provided. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: HPVX
Symptoms: Dysphagia, Myalgia, Oropharyngeal pain, Product colour issue
Clinical narrative: Information has been received from a consumer referring to her 28 year old non-pregnant daughter. The patient had no concomitant medication, pertinent medical history or drug allergies/reactions. On 12-APR-2016 the patient was vaccinated with a dose of unidentified Merck hpv vaccine (name, lot number, dose and route unspecified). The reporter initially reported an suspicious color of the GARDASIL or GARDASIL 9 that was administered. As a precaution a product quality complaint (PQC) was filed. A few hours later, on the same date, the patient started experiencing a sore throat; problem swallowing and muscular aches around her neck area. The patient did not seek for medical attention. No lab diagnostics study was performed. The reporter administered an unspecified dose of BENADRYL to her daughter and the symptoms subsided. The vaccine series was not discontinued. Additional information has been requested.
Sex: U
Vaccine: HEP
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 and gender. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 10-APR-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot# reported as K0045078, expiration date: 01-APR-2016, dose and route were not provided). No adverse effects reported. Additional information has been requested.