chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 05-JUN-2015, the patient was administered with improperly stored dose of M-M-R II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 6 month old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 17-JUN-2015, the patient (who was 6 months old) was vaccinated with a dose of VAQTA, 0.5 ml, intramuscular (drug administered to patient of inappropriate age) (lot number and expiration date were not provided). No concomitant therapies were reported, neither was any adverse experience. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 02-JUN-2015, the patient was administered with improperly stored dose of M-M-R II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly, stored PNEUMOVAX23 (dose strength and route was unknown) (incorrect product storage). No concomitant medication was reported. Patient experienced no adverse event. No product quality complaint was involved. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse event was reported. The action taken with the therapy with ROTATEQ was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with ROTATEQ was unknown. There was no product quality issue reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 26-MAY-2015, the patient was administered with improperly stored dose of M-M-R II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 56 year old female patient. The pertinent medical history and drug allergies/reactions were unspecified by the reporter. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dose and lot details not specified). The concomitant therapies included unspecified hormone patch and anti-inflammatory medications. On an unknown date, the patient experienced redness, warmth and lump around the injection site. No treatment was advised for the events. The action taken with ZOSTAVAX was not applicable. All the events resolved by itself in six days. The causality was not specified. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. There was no information about concomitant medications and pertinent medical history reported. On an unknown date, at the physician's office the patient was vaccinated with dose of ZOSTAVAX dose, route, lot #, expiration date were not provided. On an unknown dates, after administration of ZOSTAVAX, the patient experienced shingles an unspecified number of times. The patient sought medical attention from physician and received as a treatment of shingles unspecified anti-viral medication, on unknown date. The outcome of event was reported as not recovered/not resolved from current diagnosis of shingles. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 03-APR-2015, the patient was vaccinated with GARDASIL 9 (Lot#, dose and route of administration were not reported). On 03-JUN-2015, the patient received GARDASIL (Lot#, dose and route of administration were not reported) who was intended to receive GARDASIL 9. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Amenorrhoea, Injection site pain
Clinical narrative: This spontaneous report as received from a consumer and refers to herself of unknown age. The patient started her period 13 years ago (from 2002). On an unknown date, the patient was vaccinated with first dose of GARDASIL in the arm (lot number, dose, frequency and route of administration not reported). On an unknown date, the patient missed her period for the first time. From 19-MAY-2015 (reported as last 3 weeks), the patient was experiencing injection site pain every time when she lifts her arm to pick something up. The patient likened the pain to a muscular "Charlie horse pain". The patient did not sought for the medical attention. The outcome of missed period and injection site pain was reported as not recovered/not resolved. The causality was not reported. No product quality complaint (PQC) was filed. Additional information is not expected as no reporter details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 16-JUN-2015 the patient was vaccinated with one dose of improperly stored VARIVAX (Merck) (lot # L000454, expiration date: 06-JUN-2017, route and dose were unknown). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical assistant refers to a female patient of unknown age. On 29-MAY-2015, the patient was vaccinated with an expired dose of MMR II (injection; lot#J006185; exp date: 24-MAY-2015) (dose and route not reported). No adverse effects reported. No PQC involved. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a 35 year old female patient with no pregnancy concerning herself. The patient had no medical history and drug reactions /allergies. On an unknown date in November 2012 and another unknown date in December 2012, the patient was vaccinated with her first and second doses of VARIVAX (Merck) (dose, strength, lot # and route were not reported), respectively. No concomitant therapies were reported. On an unknown date, the physician confirmed the patient was immune to chickenpox. On an unknown date in 2015 (reported as "recently"), the physician tested the patient again and confirmed that she was no longer immune to chickenpox. No treatment was given for the event. Unspecified blood test was performed. The patient did not seek medical attention. The outcome of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 06-JUN-2015 the patient was vaccinated with ZOSTAVAX, subcutaneous (lot #: L000447; expiry: 08-MAR-2016) (dose and frequency unspecified). Pharmacist reports that on 06-JUN-2015 a dose of improperly stored ZOSTAVAX was administered to patient. No adverse reaction was reported. The outcome of medication error was unknown. No product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from nurse via the company representative refers to a patient of unknown age and demographics. No concurrent condition and medical history reported. On an unknown date, the patient was vaccinated with GARDASIL, subcutaneous. On an unknown date, the patient experienced syncope after being vaccinated with GARDASIL. The patient sought medical attention (details unspecified). Action taken with the suspect product was not applicable. The outcome of syncope was unknown. Causality was not reported. No product quality complaint reported. Additional information is not expected as the reporter contact information is not available.
Age: 31.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 31 year old female patient who on 16-JUN-2015 was inadvertently vaccinated with PROQUAD (Merck), subcutaneous (dose, lot # and expiration date were not provided) instead of M-M-R II and VARIVAX (Merck) (wrong drug administered). No adverse effects reported. Additional information is not expected as the reporter refused additional contact.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender with rheumatoid arthritis. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB, 1 ml, intramuscular (lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. The nurse reported that the patient had titers drawn at unspecified time which were negative for hepatitis B. The outcome of hepatitis B surface antibody negative was unknown. The causality was not reported. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning unspecified number of patients of unknown age and gender. The reporter stated that doses of VARIVAX (dose, frequency and route were unknown, lot# K021933, expiration date 11-OCT-2015) which had been exposed to temperatures outside of the recommended range, had been administered to unspecified patients on unspecified dates since 22-APR-2015. No adverse effect had been reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 4 year old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 15-JUN-2015 the patient was vaccinated with 0.5ml dose of VARIVAX (unspecified lot# but could included lot # K026386, expiration date 15-DEC-2016 or lot# K020757, 31-OCT-2016) which had been exposed to temperatures outside of the recommended range, subcutaneously. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. On an unknown dates, the patients received improperly stored doses of PNEUMOVAX 23 (batch/lot #, dose, route and site of administration were not reported). No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 01-JUN-2015, the patient was administered with improperly stored dose of MMR II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 27-MAY-2015, the patient was administered with improperly stored dose of M-M-R II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Pruritus
Clinical narrative: This spontaneous report was received from an approximately 65 year old non pregnant female patient with no drug reactions or allergies and no medical history. The patient's concurrent conditions included asthma and degenerative arthritis. In December 2013 (exact date not provided), the patient was vaccinated with a dose (reported as 1 shot) of ZOSTAVAX, (dose, lot number, expiration date, route of administration and injection site were not reported). No concomitant medications were reported. In January 2014 (exact date not provided), the patient experienced "an itch in the lower rib area with no rash or eruption of the skin". The patient sought medical attention via visiting an unspecified dermatologist on an unspecified date in January 2014. Lab diagnostic studies included "complete blood work". No results were provided. No treatment for the event was given. The outcome of "an itch in the lower limb area with no rash or eruption of the skin" was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to an unspecified patients of an unknown age and unknown gender. On an unknown date in 2015 (reported as past week), the unspecified patients were vaccinated with improperly stored M-M-R II (Lot# K006141 and expiry date: 29-APR-2016) (dose, frequency and route were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported for M-M-R II. This is one of the several reports from the same reporter. Additional information is not expected as the reporter did not wish to contact.
Age: 0.5
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a 4 week old male patient. Medical history and concurrent conditions were not provided. On 14-SEP-1994, the patient was vaccinated with the first dose of RECOMBIVAX HB strength: 5/0.5 micro-g/ml, 0.5 ml, intramuscular (lot number and expiry date were not reported). On 17-OCT-1994, the patient received the second dose (inappropriate schedule of drug administration) and on 14-MAR-1995, the patient received the third dose. There was no concomitant medication provided. On 16-JUN-2015, the patient had a negative Hepatitis B antibody titer (values and units not reported). The patient sought medical attention, visited the office and did not received a treatment. It was also reported that the therapy was no discontinued. The outcome of Hepatitis B antibody negative was unknown at the time of the report. The relatedness between the event and RECOMBIVAX HB was not provided. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 15-JUN-2015, the patient was administered with improperly stored dose of M-M-R II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored VAQTA (dose strength and route was unknown). No concomitant medication was reported. Patient experienced no adverse event. No product quality complaint was involved. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse refers to two unspecified patients of unknown demographics. The patients pertinent medical history and drug reactions/allergies were not reported. The nurse reported that the patients were administered VARIVAX (Merck), (Lot number, expiration date, dose and strength were not reported), which had been subject to defrost cycling on unspecified dates. No concomitant medications were reported. No adverse effects were reported. Outcome was unknown. No product quality complaint (PQC) was involved. The case is related to MARRS#1505USA001814 (same reporter). Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist, refers to a 63 year old female patient. The patient had no pertinent medical history nor drug reactions and allergies. On 28-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # L000448, expiration date 08-MAR-2016), subcutaneously, in the left arm (dose was not reported). On the same day, the patient was concomitantly vaccinated with a dose of PNEUMOVAX 23 (lot # L003188, expiration date 06-JUL-2016), in her right arm via an unspecified route (dose was not reported) and with ADACEL in her right arm, at a different injection site than PNEUMOVAX 23. Concomitant therapies included atorvastatin, vitamin D, oxybutynin (manufacturer unknown), lisinopril (+) hydrochlorothiazide (manufacturer unknown), CIPRO, promethazine w/DM and sulindac (manufacturer unknown). On 30-MAY-2015, the patient developed redness and a pus-filled blister at the ZOSTAVAX injection site. No injection site reaction was reported for either PNEUMOVAX 23 or ADACEL injection sites. No lab diagnostic studies were performed and no treatment was given for the adverse events. The patient's present status was reported as not recovered. The patient sought medical attention - she visited the pharmacist. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old patient of an unknown gender. On 15-JUN-2015, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23 lot # K009809, expiration date: 16-MAY-2015, 0.5 ml, intramuscular. No adverse effects was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 15-JUN-2015, the patient was administered with improperly stored dose of MMR II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a health care professional refers to an approximately 66 year old female patient. Pertinent medical history; hypothyroidism, Vitamin D deficiency, high cholesterol prior to PNEUMOVAX23. Drug reactions/allergies: rash from atorvastatin calcium (LIPITOR). On 28-MAY-2015 the patient was vaccinated with PNEUMOVAX23 injection (lot # K021030: expiry date: 27-JUN-2016) (dose, route and frequency unspecified). Concomitant therapies included aspirin, BIOTEN, omega-3 marine triglycerides (OMEGA-3), VITAMIN DF (Unspecified) and levothyroxine sodium (manufacturer  unknown). ON 28-MAY-2015, patient experienced extreme pain that was debilitating and achiness described as she had decrease3 range of motion in the shoulder joint of the upper arm area. Nurse reported the pain was localized to the general area in the shoulder joint of the upper arm. Nurse reported she rated her pain as a 10 out of 10. Nurse reported patient also had localized edema in an unspecified location. As treatment, patient alternated hot and cold compresses and took nonsteroidal anti-inflammatory drug (NSAIDS) analgesics. No lab tests done. Patient sought medical attention and spoke to nurse. The outcome of  joint range of motion decreased, asthenia, localized edema and musculoskeletal pain was reported as resolving. Causality assessment was not reported. The case is linked to: 1506USA009447 (same reporter link). Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Joint range of motion decreased, Localised oedema, Musculoskeletal pain, Pain
Clinical narrative: This spontaneous report was received from a health care professional refers to an approximately 66 year old female patient. Pertinent medical history; hypothyroidism, Vitamin D deficiency, high cholesterol prior to PNEUMOVAX23. Drug reactions/allergies: rash from atorvastatin calcium (LIPITOR). On 28-MAY-2015 the patient was vaccinated with PNEUMOVAX23 injection (lot # K021030: expiry date: 27-JUN-2016) (dose, route and frequency unspecified). Concomitant therapies included aspirin, BIOTEN, omega-3 marine triglycerides (OMEGA-3), VITAMIN DF (Unspecified) and levothyroxine sodium (manufacturer  unknown). ON 28-MAY-2015, patient experienced extreme pain that was debilitating and achiness described as she had decrease3 range of motion in the shoulder joint of the upper arm area. Nurse reported the pain was localized to the general area in the shoulder joint of the upper arm. Nurse reported she rated her pain as a 10 out of 10. Nurse reported patient also had localized edema in an unspecified location. As treatment, patient alternated hot and cold compresses and took nonsteroidal anti-inflammatory drug (NSAIDS) analgesics. No lab tests done. Patient sought medical attention and spoke to nurse. The outcome of  joint range of motion decreased, asthenia, localized edema and musculoskeletal pain was reported as resolving. Causality assessment was not reported. The case is linked to: 1506USA009447 (same reporter link). 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 medical assistant and refers to a patient of unknown age and gender. On 19-MAY-2015, the patient was vaccinated with improperly stored M-M-R-II (route of administration and dose were not reported) (lot number reported as: K016152, expiry date: 24-SEP-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 14 years old patient of unknown gender. No information on patient's medical history or concurrent conditions were provided. On 09-JAN-2015, the patient was vaccinated with a dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition or medical history reported. On 10-MAR-2015, the patient was vaccinated with improperly stored ZOSTAVAX (lot # K010628, expiration date: 30-OCT-2015) 0.65 ml, subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The concurrent condition and medical history was not reported. On 12-OCT-2010, the patient was vaccinated with GARDASIL dose 1. The concomitant medications were not reported. On 15-JUN-2015, the patient was vaccinated with GARDASIL dose 2 (inappropriate schedule of vaccine administration). Both the vaccines were confirmed to be GARDASIL and not GARDASIL 9. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. On 01-JUN-2015, the patient was vaccinated with improperly stored GARDASIL (route of administration and dose were not reported) (lot # K023432, expiry date: 18-JUN-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. On 18-MAY-2015, the patient was vaccinated with improperly stored M-M-R II (route of administration and dose were not reported) (lot number reported as: K016152, expiry date: 24-SEP-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. On 03-JUN-2015, the patient was vaccinated with improperly stored M-M-R II (route of administration and dose were not reported) (lot number reported as: K016152, expiry date: 24-SEP-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. On an unknown dates, the patients received improperly stored doses of ROTATEQ (batch/lot #, dose, route and site of administration were not reported). No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a pharmacist and a medical assistant via a company representative referring to two unspecified patients of unknown age and gender. There was no information about pertinent medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with a dose of PNEUMOVAX23 (lot # L003188, expiration date 06-JUL-2016, route and dose were unknown). No concomitant medication was reported. On unknown dates the patients experienced redness, warmth and scoreness at injection site. The patients were seen by an unspecified healthcare provider to seek medical attention. The action taken with PNEUMOVAX23, outcome of the event and causality were unknown. This report is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 09-JUN-2015, the patient was vaccinated with ZOSTAVAX (lot # K026365, expiration date: 15-MAR-2016, route and dose were not reported), that had a temperature excursion. No adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. Approximately in 2013 (also reported as about 2 years ago) the patient was vaccinated with first series shots of GARDASIL dose 1, 2 and 3 intramuscular injection (dose and lot # unspecified). No concomitant medications were reported. Approximately in 2013 the patient fainted (duration unspecified) and experienced a headache for two (2) weeks. The patient was referred to a neurologist, but no treatment was given, and the headache went away on its own on an unknown date. Action taken was not applicable also reported as the therapy was discontinued (date unspecified). The outcome of both the events was reported as resolved. Causality assessment was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient allergic to penicillin. The patient's pertinent medical history was not reported. On 12-JUN-2015, the patient was vaccinated was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous  (lot number was reported as : L000447 with expiration date: 08-MAR-2016). Concomitant therapies included unspecified thyroid and blood pressure medications. On the morning of 18-JUN-2015, the patient developed redness at the injection site (injection site erythema). The patient went to see the pharmacist who noticed a 3 cm oval area of redness. The area was not raised, did not have a rash or lesion present. The outcome of injection site erythema was report4ed as not recovered. The reporting pharmacist did not provide a causality assessment for the event. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. On unspecified dates, the patients was vaccinated with improperly stored ROTATEQ, oral (lot # K011952 and expiry date of 17-JUN-2016) (unknown strength). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. There was no product quality complaint involved. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of an unknown age and gender. Medical history and drug reactions were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (dose, route of administration, lot # and expiration date were not reported). Concomitant medication was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information  has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 18 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 05-JAN-2015, the patient was vaccinated with a dose of GARDASIL lot # K006191 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ suspension 2, (strength, lot #, dose and frequency were not reported). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. There was no additional information to report. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. Since an unspecified date in May 2015, the patients had been administered with improperly stored doses of GARDASIL (lot number K023432, expiration date 18-JUN-2016, dose was unknown) intramuscularly. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: This spontaneous report was received from a nurse and refers to a 11 year old female patient with drug allergy to RONDEC tablets. There was no concomitant medications and medical history reported. On 10-JUN-2015, the patient was vaccinated with first dose of GARDASIL injection (lot# J006850, expiration date 31-MAR-2016, dose not reported) intramuscularly in an arm. On the same day, other suspect vaccine was given: HAVRIX (dose, frequency, lot#, expiration date were not reported) injected in the same arm. On 11-JUN-2015, the patient experienced redness, warmth and swelling at the site of the vaccination. On 12-JUN-2015, the patient was taken to an emergency room for these symptoms and discharged to home on the same day. The treatment was given and included BENADRYL and an oral steroid. No lab diagnostic studies were performed. On 16-JUN-2015, the patient's symptoms resolved. The relatedness between the events and GARDASIL, HAVRIX was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous report was received from a nurse and refers to a 11 year old female patient with drug allergy to RONDEC tablets. There was no concomitant medications and medical history reported. On 10-JUN-2015, the patient was vaccinated with first dose of GARDASIL injection (lot# J006850, expiration date 31-MAR-2016, dose not reported) intramuscularly in an arm. On the same day, other suspect vaccine was given: HAVRIX (dose, frequency, lot#, expiration date were not reported) injected in the same arm. On 11-JUN-2015, the patient experienced redness, warmth and swelling at the site of the vaccination. On 12-JUN-2015, the patient was taken to an emergency room for these symptoms and discharged to home on the same day. The treatment was given and included BENADRYL and an oral steroid. No lab diagnostic studies were performed. On 16-JUN-2015, the patient's symptoms resolved. The relatedness between the events and GARDASIL, HAVRIX was not reported. 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 medical assistant and refers to a patient of unknown age and gender. On 27-MAY-2015, the patient was vaccinated with improperly stored M-M-R II (route of administration and dose were not reported) (lot number reported as: K016152, expiry date: 24-SEP-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: This literature marketed report was received from a healthcare professional via below mentioned literature article refers to 2 pediatric patients of unknown age and gender. Medical history and concurrent conditions were not reported. Loss of anagen hair follicle immune privilege (HFIP) and changes in the ratio of activating to inhibitory natural killer (NK) cells are important in the pathogenesis of alopecia areata (AA). AA had been reported secondary to vaccination, most commonly following administration of the recombinant hepatitis B vaccine. How vaccination might lead to loss of HFIP was unknown. On an unknown date 2 patients were vaccinated with third dose of hepatitis b vaccine (manufacturer unknown) (dose, route of administration and anatomical location was not reported). Concomitant medications were unspecified by reporter. On an unknown date, 2 weeks after the third dose of vaccination, 2 patients experienced alopecia. Potential mechanisms of loss of HFIP following vaccination include increased interferon levels or an antigen-specific T-cell response. An electronic medical record (EMR) database search revealed an increased frequency of AA among those who receive the hepatitis B virus (HBV) vaccine (or 2.7, p<0.0001). An independent analysis revealed an increased frequency of AA in those receiving interferon-beta treatment (or 8.1, p<0.05). In order to explore whether an antigen-specific T-cell response might be elicited by HBV vaccination, a BLAST search was performed of all potential vaccine peptide fragments (6-mers) to look for identical human sequences. 120 human peptides were found to have exact  sequence homology with part of the vaccine. While none of the 120 peptides appeared to be specific to the hair follicle, two of the three longest peptides (8-mers) were from NK cell inhibitory receptors  KIR3DL2 and KIR3DL 1. Software (RANKPEP) designed to predict major histocompatibility complex (MHC) peptide binding demonstrated that, of the 208 potential 9-mers from the vaccine peptide, this KIR peptide is the most likely to bind HLA-DQ1, third most likely to bind HLA-DRB1 11 04 (DR11), fourth most likely to bind HLA-Cw7 02, and one of only 18 predicted binders for HLA-DRB1 0401, all relevant MHC in AA. This suggests that hepatitis B vaccination has the potential to stimulate an immune response against KIR receptors. The outcome of alopecia was unknown. The author considered alopecia to be related to Hepatitis B vaccine. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 10 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 12-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information or patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 4 year old patient of unknown gender. No relevant medical history or concomitant conditions were reported. On 15-JUN-2015 the patient was vaccinated with 0.5ml dose of VARIVAX (Merck) (unspecified lot# but could included lot # K026386, expiration date 15-DEC-2016 or lot# K020757, expiration date 31-OCT-2016) which had been exposed to temperatures outside of the recommended range, subcutaneously. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: U
Vaccine: HEP, HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a medical assistant referring to a 32 year old patient of unknown gender. On 03-JUN-2015 the medical assistant inadvertently removed the pediatric instead of the adult formulations of VAQTA (strength reported as 25/0.5, unit not reported) and RECOMIBVAX HB (strength reported as 5/0.5 microgram/ml) from the refrigerator. Subsequently on the same day, the patient was vaccinated with the pediatric dose of VAQTA and RECOMBIVAX HB (dose, lot # and route were not reported) (accidental underdose). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patient were vaccinated with improperly stored RECOMBIVAX HB (dose strength and route was unknown). No concomitant medication was reported. Patient experienced no adverse event. No product quality complaint was involved. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patients were vaccinated with improperly stored GARDASIL, (strength, lot #, dose and frequency were not reported). No adverse effects reported. The outcome of events was unkonwn. No product quality complaint (PQC) was involved. There was no additional information to report. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with VARIVAX (Merck) was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VARIVAX (Merck) was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received form a medical assistant and refers to a patient of unknown age and gender. On 03-JUN-2015, the patient was vaccinated with improperly stored M-M-R II (route of administration and dose were not reported) (lot number reported as: K016152, expiry date: 24-SEP-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a pharmacist and a medical assistant via a company representative referring to two unspecified patients of unknown age and gender. There was no information about pertinent medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with a dose of PNEUMOVAX23 (lot # K023328, expiration date 23-JUN-2016, dose and route unknown). No concomitant medication was reported. On unknown dates the patients experienced cellulitis at injection site. The patients were seen by an unspecified healthcare provider to seek medical attention. The action taken with PNEUMOVAX23, outcome of the event and causality were unknown. This report is one of two reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: PPV
Symptoms: Cochlea implant
Clinical narrative: This spontaneous report as received from the registered nurse (R.N) and refers to a 16 year old male patient. No complete demographics of the patient was reported. No medical history and concurrent conditions were reported. In 2002, the patient was vaccinated with PNEUMOVAX23 (lot number, strength, dose, frequency and route of administration was not reported). On an unknown date, the patient was scheduled to undergo a cochlear implant. The action taken of the suspect product was not reported. The outcome of cochlear implant was unknown. The causality was also not reported. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 03-JUN-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # K023159, expiration date 26-JUL-2016) (dose and route were not reported). The vaccine was exposed to 31.1 F for a cumulative time of 411.70 hours. Concomitant medication was not reported. No adverse effect was reported. This is one of two reports received from the same source. Additional information has been requested.