chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 18-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, once, subcutaneous, lot # J004266 expiry date 12-JUL-2014. Concomitant medications were not reported. The pharmacist reported that the patient was administered expired ZOSTAVAX. No adverse event 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: Blood glucose decreased, Cold sweat, Dizziness, Hyperhidrosis, Visual impairment
Clinical narrative: Customer had shot then within 5 minutes became sweating, clammy, dizziness with visual disturbances. She believed she had low blood sugar. 911 called and appeared pt had low blood sugar. She never lost consciousness and was aware at all times.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient had not none drug reaction and allergies. Medical history were not reported. On 20-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml in the right arm, lot # J005067, expiry date 17-JAN-2015, (route was not reported0. Other suspect therapies included FLUZONE on the right arm (dose, route, lot number and expiry date were not reported). On 20-OCT-2014, the patient received PNEUMOVAX 23 and FLUZONE HIGH DOSE in the same arm, and the injections were given "close together" on the right arm. The reporter stated that the dose was administered by another pharmacist. It was also reported that the patient called the pharmacy and reported that the injection site area was "Bright red" and severely swollen, the patient stated that the swelling was "6 inches in diameter". The patient sought medical attention calling the pharmacy, did not received treatment and none lab diagnostics studies were performed. The outcome of the events were reported as not recovered. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash.
Age: 1.41
Sex: M
Vaccine: DTAP
Symptoms: Febrile convulsion, Pyrexia, Tremor
Clinical narrative: High fever, febrile seizures, on and off for two days (did not have seizures, had tremors per pt's mother).
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test abnormal
Clinical narrative: This spontaneous report as received from a physician via a sales representative refers to a 22-year-old female patient. Information about concurrent conditions and medical history was not provided. On 20-JUL-2009 the patient was vaccinated with the first dose of GARDASIL (route, lot, batch # and expiration date not reported) as routine administration. Patient's second dose was on 14-SEP-2009 and third dose was 29-DEC-2009. Co-suspect and concomitant therapies were not reported. On 07-JAN-2014, 1633 days after onset of therapy, an unspecified test result showed she had a high risk for HPV after receiving the 3 series doses of GARDASIL. The patient sought medical attention. The outcome was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Exposure during pregnancy
Clinical narrative: Gave MMR (live vaccine) to 26 wk pregnant employee.
Age: 1.61
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Convulsion, Febrile convulsion, Feeling abnormal
Clinical narrative: Pt. was given vaccines and w/i 24 hours he experienced a seizure and was "lifeless" per mother. Taken to ER and took 2 hours to recover. Diagnosed with febrile seizure but never had a fever.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of VARIVAX (lot # not reported) that were improperly stored on 04-SEP-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported and doses were administered to patients since 04-SEP-2012. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. Medical history and concurrent conditions were reported as none. On 18-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous, lot # K008880 expiry date 20-SEP-2015 (also reported as 09-SEP-2014), (dose was not reported). Concomitant medications were reported as none. The pharmacist reported that the patient presented to the pharmacy on 20-OCT-2014, with a 2.5 inch in diameter, red, hard injection site reaction from ZOSTAVAX also reported as adverse event onset date as 18-OCT-2014. Pharmacist stated that the patient would treat with a topical cortisone cream. It was verified that this was an injection site reaction and not a rash. The patient sought medical attention and none laboratory diagnostics were performed. The outcome of 2.5 inch in diameter, red, hard injection site reaction was reported as not recovered at the time of the report. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 07-NOV-2014 the patient was inadvertently administered a partial dose of M-M-R II (exact dose, units, route of administration, anatomical location, lot number were not reported) due to a syringe that leaked during administration. No PQC (product quality complaint). The physician stated that the patient was immediately administered half of a dose from another M-M-R II (exact dose, units, route of administration, anatomical location, lot number were not reported) vial to compensate but the patient may have received more than a full dose altogether. No adverse effects reported. 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 certified medical assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 27-OCT-2014 (also reported as "today"), doses of PNEUMOVAX 23 that were exposed to a supported excursion were administered to unspecified patients (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse experience has been observed or reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 29-OCT-2014, the patient was vaccinated with a expired dose of ZOSTAVAX, lot # H022152, expiration date 18-MAR-2014. Dose and route were not reproted. No adverse effects had been reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patients of unknown age. Medical history and concurrent conditions were not reported. On 20-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date were not reported). Concurrent medications were not provided. On 22-OCT-2014, the patient presented to the pharmacy with "a red, 1 inch diameter, circle around the injection site. Pharmacist reported that "there was no raised area or rash present". Pharmacist stated that the patient received the ZOSTAVAX at another unspecified pharmacy. The patient sought medical attention visiting the pharmacy. The outcome of a red, 1 inch in diameter, circle around the injection site was reported as not recovered. Additional information is not expected, because the pharmacist does not wish to be contacted regarding this patient.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on trunk of body (back and abdomen) and on thighs - large in size, also c/o itching, took OTC BENADRYL 10/11/14 and 10/12/14. Saw PCP 10/13/14 received "shot" and advised to cont. BENADRYL. 10/14/14 AM hives and itching gone. No problems since.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 23-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml/once, subcutaneous, lot # J004266 expiry date 12-JUL-2014. Concomitant medications were not reported. The pharmacist reported that the patient was administered expired ZOSTAVAX. The ZOSTAVAX expired on 12-JUL-2014. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Pt got vaccinated with ZOSTAVAX. 2 weeks later pt was at dermatologist and Dr said pt. had chicken pox.
Sex: U
Vaccine: HEPA
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. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 01-OCT-2014, the unspecified number of patients had been vaccinated with doses of VAQTA (lot#, dose, route and frequency were not provided), which had underwent supported and unsupported temperature excursions, (on unspecified dates of 2014). No adverse effect was reported. This is one of several reports received from the same source. 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. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 01-OCT-2014, the unspecified number of patients had been vaccinated with doses of oral, ROTATEQ (lot#, dose and frequency were not provided), which had underwent supported and unsupported temperature excursions, orally (on unspecified dates of 2014). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 01-OCT-2014, the unspecified number of patients had been vaccinated with doses of M-M-R II (lot#, dose, route and frequency were not provided), which had underwent supported and unsupported temperature excursions, (on unspecified dates of 2014). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, 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. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 01-OCT-2014, the unspecified number of patients had been vaccinated with doses of GARDASIL (injection, lot#, dose, route and frequency were not provided), which had underwent supported and unsupported temperature excursions, (on unspecified dates of 2014). No adverse effect was reported. This is one of several reports received from the same source. 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 physician via company representative refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not provided. The reporter stated that the patient received GARDASIL outside the recommended dosing schedule. The patient received GARDASIL dose 1 on 04-AUG-2011, dose 2 on 01-AUG-2012 and dose 3 on 28-AUG-2014 (dosage, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information is not expected because the reporter refused additional contact.
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 unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 20-OCT-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous (dose, dose number, route, anatomical location, lot number and expiration date were unspecified), that was improperly exposed to 33.3F for 51 hours. No known adverse effects were reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. On an unspecified date, since 05-MAY-2014 an unspecified number of patients were vaccinated with VARIVAX (Merck). The reporter stated that on 05-MAY-2014 onwards her refrigerator and freezer units began to have temperature excursions and VARIVAX (Merck) was improperly exposed to temperatures above 5F as listed in the following sentences. VARIVAX (Merck) Lot # K007783 (expiration: 28-MAY-2016) was improperly exposed to 22F for 144 hours. All of the data listed here was reconfirmed with the reporter. No further information was available at the time of this report. No product quality compliant was involved. 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 pharmacist refers to a patient of unknown age and gender. On 16-SEP-2014, the patient received a dose of improperly stored VARIVAX (Merck) (batch/lot#, dose and route were not reported). The stability of VARIVAX (Merck) was unable to be evaluated at the time of the call due to lack of excursion timeframe details. No adverse symptoms were reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Dysphonia, Erythema, Fatigue, Headache, Induration
Clinical narrative: This spontaneous report was received from a 55 year old female patient referring on herself. The patient had no pertinent medical history nor drug/reaction allergies. On 20-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 in the right arm. Dose, route, lot number and expiration date were not reported. There was no concomitant medication. The patient reported that after receiving the PNEUMOVAX 23 she experienced injection site reaction 3 inches in diameter on her right arm that evening on (20-OCT-2014). The patient further reported that her right arm had become red, hard, swollen and hot (on 20-OCT-2014). This continued for the next 48 hours and she experienced headaches, sore throat, raspy sounding voice, general fatigue and sleeplessness (approximately on 22-OCT-2014). The patient was also unable to use her right arm (approximately on 20-OCT-2014). The outcome of adverse events was reported as recovering. The patient was treated with Arnica montana gel. No lab diagnostics studies were performed. The patient sought medical attention, called physician office. Additional information is not expected. No allowed to contact physician.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Insomnia, Oropharyngeal pain, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 55 year old female patient referring on herself. The patient had no pertinent medical history nor drug/reaction allergies. On 20-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 in the right arm. Dose, route, lot number and expiration date were not reported. There was no concomitant medication. The patient reported that after receiving the PNEUMOVAX 23 she experienced injection site reaction 3 inches in diameter on her right arm that evening on (20-OCT-2014). The patient further reported that her right arm had become red, hard, swollen and hot (on 20-OCT-2014). This continued for the next 48 hours and she experienced headaches, sore throat, raspy sounding voice, general fatigue and sleeplessness (approximately on 22-OCT-2014). The patient was also unable to use her right arm (approximately on 20-OCT-2014). The outcome of adverse events was reported as recovering. The patient was treated with Arnica montana gel. No lab diagnostics studies were performed. The patient sought medical attention, called physician office. Additional information is not expected. No allowed to contact physician.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: This spontaneous report was received from a 55 year old female patient referring on herself. The patient had no pertinent medical history nor drug/reaction allergies. On 20-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 in the right arm. Dose, route, lot number and expiration date were not reported. There was no concomitant medication. The patient reported that after receiving the PNEUMOVAX 23 she experienced injection site reaction 3 inches in diameter on her right arm that evening on (20-OCT-2014). The patient further reported that her right arm had become red, hard, swollen and hot (on 20-OCT-2014). This continued for the next 48 hours and she experienced headaches, sore throat, raspy sounding voice, general fatigue and sleeplessness (approximately on 22-OCT-2014). The patient was also unable to use her right arm (approximately on 20-OCT-2014). The outcome of adverse events was reported as recovering. The patient was treated with Arnica montana gel. No lab diagnostics studies were performed. The patient sought medical attention, called physician office. Additional information is not expected. No allowed to contact physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. On an unspecified date, since 05-MAY-2014 an unspecified number of patients were vaccinated with PROQUAD. The reporter stated that on 05-MAY-2014 onwards her refrigerator and freezer units began to have temperature excursions and PROQUAD was improperly exposed to temperatures above 5F as listed in the following sentences. PROQUAD Lot #: K006219 (expiration: 29-OCT-2015) was improperly exposed to 22F for 2000 hours. All of the data listed here was reconfirmed with the reporter. No further information was available at the time of this report. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 07-NOV-2014, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # J007855, exp. date 28-SEP-2014, dose, route of administration and anatomical location were not reported). No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a non-pregnant female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL intramuscularly (dose, lot# and expiration date were not provided). Then, on an unkonwn date the patient felt faint. No treatment was given for the event. No laboratory diagnostic was performed. The patient recovered on an unspecified date. Relatedness between the event and GARDASIL was not provided. 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. On 25-AUG-2014 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. On an unspecified date, since 05-MAY-2014, an unspecified number of patients were vaccinated with VARIVAX (Merck). The reproter stated that on 05-MAY-2014 onwards her refrigerator and freezer units began to have temperature excursions and VARIVAX (Merck) was improperly exposed to temperatures above 5F as listed in the following sentences. VARIVAX (Merck) Lot # J009727 (expiration: 07-AUG-2015) was improperly exposed to 22F for 4224 hours. All of the data listed here was reconfirmed with the reporter. No further information was available at the time of this report. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Left arm cellulitis. 19/11.5 cm pain, red, and swollen.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was inadvertently vaccinated with a dose of VARIVAX (Merck) (dose, route, lot# and expiration date were not provided) which was improperly stored. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unknown number of patients of unknown gender and age. On an unknown date, the patients were vaccinated with an unknown number of doses of PEDVAXHIB (lot/batch number, expiration date, route, dose, dose number and frequency were not reported) that were exposed to temperatures of 0 Celsius (C) for 15 minutes. No adverse effect were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unknown number of patients of unknown gender and age. On an unknown date, the patients were vaccinated with an unkown number of doses of GARDASIL injection (lot/batch number, expiration date, route, dose, dose number and frequency were not reported) that were exposed to temperatures of 0 Celsius (C) for 15 minutes. No adverse effect were reported. No product quality complaint (PQC) involved. 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 physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. On an unspecified dates since 05-MAY-2014, an unspecified number of patients received VARIVAX (Merck) which was improperly exposed to temperature above 5F. No known adverse effects reported. No product complaint was reported for VARIVAX (Merck). This case is linked to 1411USA001655, 1411USA004432, 1411USA004433, 1411USA004434, 1411USA004435, 1411USA004436, 1411USA004437, 1411USA004438, 1411USA004439, 1411USA004441 and 1411USA004442 (same reporter link). 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 physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. On an unspecified dates since 05-MAY-2014, an unspecified number of patients received VARIVAX (Merck) (lot #K007783 and expiry date: 28-MAY-2016) which was improperly exposed to 22F for 144 hours. No known adverse effects reported. No product complaint was reported for VARIVAX (Merck). This case is linked to 1411USA001655, 1411USA004432, 1411USA004433, 1411USA004434, 1411USA004435, 1411USA004436, 1411USA004437, 1411USA004438, 1411USA004439, 1411USA004440 and 1411USA004442 (same reporter link). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a Nurse Practitioner for VARIVAX (Merck), a Pregnancy Registry product, refers to a 15 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with VARIVAX (Merck) (lot # not reported) on 17-AUG-2012. It was reported that the patient may be pregnancy. The Nurse Practitioner did not know the date  of the patient's first dose of VARIVAX (Merck). The Nurse Practitioner provided a urine pregnancy test for the patient which was positive for pregnancy. The test was repeated and was found to be positive for pregnancy. No adverse experience has been reported or observed. No other co-suspects were reported. There were no concomitant medications were reported. The patient with an LMP of July 2012 ("late July") and EED of approximately 07-MAY-2013. The patient was exposed to VARIVAX (Merck) during trimester 1. The patient sought unspecified medical attention. Follow up information has been received on 11-NOV-2014. A phone call was placed to the reporting nurse who was no longer at facility. The facility was unable to share the patient information without a signed consent form. Reporter information has been updated. Additional information is not expected.
Sex: U
Vaccine: RV5
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 and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unspecified date the patients were vaccinated with doses of improperly stored oral, ROTATEQ (lot#, dose and frequency were not provided) orally. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unspecified date the patients were vaccinated with doses of improperly stored GARDASIL (lot#, dose, route and frequency were not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On 11-NOV-2014 the patient was vaccinated with an expired dose of oral, ROTATEQ, expiration date August 2014 (dose number, site and route of administration, lot# not reported). No adverse effects were noted. 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 physician refers to an unspecified number of patients of unknown demographics. Since 05-MAY-2014 the patients were vaccinated with Oral, ROTATEQ. The reporter stated that on 05-MAY-2014 onwards her refrigerator and freezer units began to have temperature excursions and Oral, ROTATEQ was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range), and also to 49F for 12 hours. No known adverse effects. Lot # and expiration date of Oral, ROTATEQ was unspecified. All of the data listed here was reconfirmed with the reporter. No further information was available at the time of this report. No product quality compliant was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unkonwn demographics. On an unspecified date, since 05-MAY-2014 an unspecified number of patients were vaccinated with PROQUAD (Merck). The reporter stated that on 05-MAY-2014 onwards her refrigerator and freezer units began to have temperature excursions and PROQUAD (Merck) was improperly exposed to temperatures above 5F as listed in the following sentences. PROQUAD (Merck), Lot # K007799 (expiration: 29-NOV-2015) was improperly stored to 22F for 1920 hours. All of the data listed here was reconfirmed with the reporter. No further information was available at the time of this report. No product quality complaint was involved. 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 certified medical assistant (C.M.A.) refers to an unknown number of patients of unknown gender and age. On an unknown date, the patient were vaccinated with an unknown number of doses of VARIVAX (Merck) (lot/batch number, expiration date, route, dose, dose number and frequency were not reported) that were exposed to temperatures of -14 Celsius (C) for 5 minutes. No adverse effect were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, Injection site reaction, Local reaction
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified amount of patients of unknown age and gender. On an unknown dates the patients were vaccinated with doses of PNEUMOVAX 23 that underwent temperatures excursions. On an unknown dates, unspecified amount of patients developed 'localized reactions' at the injection site after receiving PNEUMOVAX 23. The patients did not seek medical attention. No treatment was given for the events. The outcome of 'localized reactions' at the injection site was unknown. Relatedness between 'localized reactions' at the injection site and PNEUMOVAX 23 was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Autism, Pyrexia, Rash generalised
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient (her daughter) of unknown age with penicillin allergy and sensory issues/problems such as not eating. On 03-OCT-2011 the patient was vaccinated with the first dose of M-M-R II, lot# reported as 10582, dose and route not reported, in the left arm. On an unknown date, the patient was vaccinated with VAQTA in right arm, (dose, route and lot# not reported). The reporter questioned if M-M-R II in 2011, or currently, had any thimerosal in it. The reporter stated her daughter was vaccinated with M-M-R II on 03-OCT-2011 and post vaccination had fever of 102F and rash from head to toe on an unknown date. Rash and fever resolved on an unknown date. The reporter stated her daughter had sensory issues such as not eating, etc., prior to M-M-R II vaccination, but her daughter's sensory issues seemed to increase post vaccination with M-M-R II. Her daughter had a psychological evaluation and was determined to be autistic at 2 years of age. The reporter stated her daughter was due for a second dose of M-M-R II and she wanted to make sure there was no mercury in the product. The outcome of sensory issues seemed to increase and autistic at 2 years of age was unknown. No further details was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a pharmacist refers to patients. On unspecified date, patients was vaccinated with ZOSTAVAX (strength, dose, frequency, route, lot # and indication were not provided). The pharmacist also reported that the pharmacy administers ZOSTAVAX to patients under the age of 50 years old if the patients have a prescription. Information on how many patients received ZOSTAVAX that were under the age of 50 years old is unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 33 years old female patient with no medical history and no drug allergies. On 30-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot # was unknown). Concomitant therapies included VITAFOL ULTRA, SYNTHROID and folic acid. The patient was currently breastfeeding. No adverse effect reported. No lab was performed. AE did not given the treatment. The outcome of events was unknown. This is one of several reports received from the same source. 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. On 11-NOV-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose, route not reported, lot # J004080, expiration date 22-AUG-2014). Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection
Clinical narrative: This spontaneous report as received from a pharmacist via Company Representative refers to a female patient of unknown age. On approximately 27-OCT-2014 "about 2 weeks ago" the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported) in the arm (dosage and route not reported). The pharmacist reported that a patient experienced an injection-site infection after receiving ZOSTAVAX. The pharmacist reported that the patient sought medical attention at an unspecified urgent care clinic in an unspecified city. The pharmacist learned of the patient's adverse experience when he filled a prescription for an unspecified antibiotic for treatment of the injection-site infection on an unspecified date that the patient was given at the urgent care clinic. The representative states that the pharmacist did not specify whether or not the patient did or did not develop a rash. The representative did not know if the patient had notified her primary healthcare provider, and she did not have any additional information. The outcome of injection site infection was reported as recovering/resolving. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Fall, Influenza like illness, Pyrexia
Clinical narrative: Patient reported developing extreme chills and fever within 24 hours of vaccination and had to be taken to ER where she was examined and released.  Patient reported feeling like she had the flu for 3 days and was weak resulting in a fall on day 4.  She has recovered but still feels weak.
Age: 0.61
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HIBV, PNC13, RV5
Symptoms: Incorrect dose administered, Wrong drug administered
Clinical narrative: Incorrect vaccine administered. Pentacel, Hep B, Rota, PCV ordered but Pentacel, HIB, Rota, PCV given so child got 2 doses of HIB and missed a dose of Hep B.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dyspnoea, Fall, Hot flush, Syncope
Clinical narrative: Shortness of breath, cold clammy followed by hot flash, fainted and fell.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain, Vaccination site pain
Clinical narrative: Vaccination location very sore. Pain continually worsened to the point where shoulder and upper arm muscle pained when used. Inability to lift arm over head or lift items with the vaccinated arm due to weakness. Three days after finishing a prescribed prednisone medication the pain in the upper arm and shoulder have returned.
Age: 0.32
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Large number of hives, including a grouping of hives that was approximately 6 inches in length and 2-3 inches wide on her left inner thigh (opposite leg of injection site), hives on her stomach, and other smaller groupings on her legs. Later remembered that a small amount of hives had been noticed on her left ankle on 11/11/2014 at approximately 7:00 PM, though I didn't initially realize they were hives. Contacted doctor upon finding the large amount of hives on 11/12/2014 who advised to administer Benadryl if there was no fever and no difficulty breathing.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Pain warmth and edema in the arm vaccine was administered.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Increased pain in shoulder joint and arm- pain intensifies in PM.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Insomnia, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: 10/22/2014:  Shot administered by pharmancy. 10/22/2014:  Begining experiencing usual and severe pain within 3 days. 10/29/2014: Returned to pharmacy to find out why so much pain in shoulder and down arm. 11/03/2014:  Went to doctor and told about severe pain:  Checked mobility and prescribed Steroid pack and Trodal: No relief or help from medicine. 11/11/2014:  Returned to doctor and told him I need a referral for a MRI, which I am waiting on now. Doctor prescribed:  Meloxicam and Tramadol/APAP 37.5mg / 325 MG tab.  THESE PROVIDE NO RELIEF. 11/12/2014:  Called doctor and left message that MRI cannot see me till Monday 11/17/14 and I could not wait that long living with this severe pain.  Have not heard back yet. 11/13/2014:  Still living with severe to almost unbearable pain in left shoulder down to fingers. I have limited mobility in my left arm:  Daily activities are almost impossible if my left arm is needed. I cannot lift anything higher than chest high. I cannot open a kitchen cabinet door and take down a bowl with my left arm.  Getting dressed is nearly impossible with assistance.  Washing my hair, blowing my hair, and putting on makeup is a real chore and I experience high level of pain doing it.  Sleeping is nearly impossible because i can't find a position to place my arm that is pain free. It seems that while in bed I experience the most pain. I cannot put the telephone on my left shoulder and hold it with my head, this is totally impossible because I drop by phone and bend over in unbelievable pain. I have to pick my arm up with my other arm to position it when I am working or in bed. I have had a flu shot every year for probably 6 years and have never experienced anything other than a couple of days of being sore. This is the worse pain I have ever had and I need to get this fixed so I can have my life back.  I hope this will help you all find a way that this does not happen to any other person. If you need any other information, please call me.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Blister, Swelling
Clinical narrative: Area is swollen and blistering.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Lethargy, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Patient reports cough, sore throat, lethargy, cold sx.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Lethargy, Oropharyngeal pain, Pain in extremity
Clinical narrative: Sore throat, cough, lethargy, rhinorrhea, chills, sore arm.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Sore throat, cough, lethargy, rhinorrhea, chills, sore arm.
Age: 49.0
Sex: F
Vaccine: FLUC3
Symptoms: Computerised tomogram head, VIIth nerve paralysis
Clinical narrative: Right side facial paralysis; Started on Prednisone/Valtrex for diagnosis of Bell's Palsy.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Balance disorder, Chest pain, Feeling abnormal, Pyrexia, Tremor
Clinical narrative: Per patient's report, he was shaking so hard that he had to sit on his hands.  The next day his chest hurt due to all the shaking. Fever of 103 evening of the vaccine.  Felt unsteady and "terrible" for 2 weeks post vaccine administration.
Age: 98.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site infection, Injection site reaction, Lymph gland infection, Lymph node pain
Clinical narrative: From the clients email message: "I thought I should make someone aware that I had an issue from getting the flu shot on 11/3/14. Tuesday 11/4 evening I noticed that about 3 inches below the injection site there was a large 4"x3" raised red welt. The next morning I called the Nurses line on our insurance card and she said to call my doctor right away. I did that and saw Dr at 9:30 Wednesday 11/5. He diagnosed this as an infection directly related to the break in the skin from the injection. When I got the flu shot the nurse did use a newly packaged needle but when I had a drop of blood at the site she reached quickly and grabbed a piece of gauze to wipe it then opened a band aid and covered the site. I do not think the piece gauze was newly opened. Also no alcohol was wiped on the area after it bled. Dr placed me on a 7 day antibiotic. The infection had gotten into the small lymph nodes under my arm but not in the larger ones under the arm pit although it would have quickly done so if I had not gone to the doctor. He ordered me home for 2 days with my arm elevated and iced for the swelling. This was not a pleasant experience and those lymph nodes were very uncomfortable. I am letting you know so that someone can be aware and look into their sanitary practice."
Age: 98.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria, Wrong technique in drug usage process
Clinical narrative: From the clients email message: "I thought I should make someone aware that I had an issue from getting the flu shot on 11/3/14. Tuesday 11/4 evening I noticed that about 3 inches below the injection site there was a large 4"x3" raised red welt. The next morning I called the Nurses line on our insurance card and she said to call my doctor right away. I did that and saw Dr at 9:30 Wednesday 11/5. He diagnosed this as an infection directly related to the break in the skin from the injection. When I got the flu shot the nurse did use a newly packaged needle but when I had a drop of blood at the site she reached quickly and grabbed a piece of gauze to wipe it then opened a band aid and covered the site. I do not think the piece gauze was newly opened. Also no alcohol was wiped on the area after it bled. Dr placed me on a 7 day antibiotic. The infection had gotten into the small lymph nodes under my arm but not in the larger ones under the arm pit although it would have quickly done so if I had not gone to the doctor. He ordered me home for 2 days with my arm elevated and iced for the swelling. This was not a pleasant experience and those lymph nodes were very uncomfortable. I am letting you know so that someone can be aware and look into their sanitary practice."
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Culture throat, Culture urine negative, Pyrexia, Urine analysis normal
Clinical narrative: Fever to 103.8F.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Blood test, Chills, Hyperhidrosis, Injection site pain, Pyrexia
Clinical narrative: First began to experience fever, burning at site of injection traveling down to just above mid arm area. Fever peaked at 101.8 and would break after approx 90min. Sweats would then begin followed by a short non symptom feeling of normalcy. Right after that, chills would begin for 90min. This cycle would continue for approx 6 days, reducing in severity as the days passed. I was scheduled an appointment on 15 Oct at medical and diagnosed with serum sickness. Bloodwork was taken.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Serum sickness
Clinical narrative: First began to experience fever, burning at site of injection traveling down to just above mid arm area. Fever peaked at 101.8 and would break after approx 90min. Sweats would then begin followed by a short non symptom feeling of normalcy. Right after that, chills would begin for 90min. This cycle would continue for approx 6 days, reducing in severity as the days passed. I was scheduled an appointment on 15 Oct at medical and diagnosed with serum sickness. Bloodwork was taken.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: Swollen painful right armpit lymph node nearest injection site (in upper right arm). Joint skin and muscle pain throughout body. Fatigue and drowsiness. Treated with ibuprofen and rest. Symptoms remain extant at this reporting.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pain of skin, Somnolence
Clinical narrative: Swollen painful right armpit lymph node nearest injection site (in upper right arm). Joint skin and muscle pain throughout body. Fatigue and drowsiness. Treated with ibuprofen and rest. Symptoms remain extant at this reporting.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives behind both knees.  Noticed after dinner, and the sight became extremely itchy.  Hives may have developed earlier, but the itchiness became overwhelming after drinking beer.  Placed ice packs to subside the itchiness.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling, Pain in extremity, Skin warm
Clinical narrative: Patient reported very sore and swollen arm with pain. He presented with fever in arm and what he thought was a mild systemic fever with mild aching. By the time he and I spoke, he felt much better but was concerned about the reaction. He did not remember having any previous reaction to any previous flu shot in years past.