chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified dates, an unknown number of patients were inadvertently administered improperly stored dose of GARDASIL (lot # J006850, expiration date 31-MAR-2016; lot # K008931, expiration date 04-MAR-2017) (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored M-M-R II lot # K024825, expiration date- 20-DEC-2016. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a three patients of unknown ages and genders. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients received unspecified improperly stored doses of VARIVAX (Merck) 0.5 ml, lot number L019124, expiration date 27-MAY-2017, (anatomical location were not reported). VARIVAX (Merck) was administered by intramuscular injection, instead of subcutaneous injection. There were not concomitant medications provided. No adverse effects were 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 Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified dates, an unknown number of patients were inadvertently administered improperly stored M-M-R II (lot # K007107, expiration date 16-MAY-2016) (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Injection site pain, Injection site reaction, Skin discolouration
Clinical narrative: Information has been received from a 69 year old female patient with auto immune disease/overactive immune system, who also suffered from narcolepsy and acid reflux. She had drug reactions/allergies to unspecified medications. The physician advised the patient to get a booster Pneumonia vaccination. The patient did not know if she was previously vaccinated with the PNEUMOVAX 23 or not. On 11-NOV-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 for vaccination (dose, dose #, lot #, route and application site were not reported). Concomitant therapies included aspirin, beta blocker, narcolepsy and acid reflux medications. On 11-NOV-2015, after receiving the PNEUMOVAX 23 vaccination the patient had an adverse experience. The vaccine burned as she received the vaccination The patient suffered from injection site reaction and tightness in her chest. The patient's second toe on her right foot turned black and blue on the back and is now spreading around to the front of the toe. No treatment was given for events. The patient had scheduled an appointment with physician. The outcome of events was reported as not recovered/not resolved by the time of this report. The causality was not 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 the health care worker refers to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 10-NOV-2015 the patient was vaccinated with improperly stored PNEUMOVAX23, lot# L013428, expire date 03-FEB-2017, (dose number, frequency, route not reported). No adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates since 08-OCT-2015, the unspecified patients were vaccinated with doses of RECOMBIVAX HB (lot # L004754, expiration date 10-NOV-2016 and lot # L014418, expiration date 13-APR-2017) (dosage, strength and route were not reported), which were exposed to temperatures outside of the recommended range. There was no concomitant medication reported. No adverse experience had been reported. This is one of several reports 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 Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates since 08-OCT-2015, the unspecified patients were vaccinated with doses of GARDASIL (lot # K023432, expiration date 18-JUN-2016, dosage, strength and route were not reported), which were exposed to temperatures outside of the recommended range. There was no concomitant medication reported. No adverse experience had been reported. This is one of several reports 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 an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, these patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL (lot # K008931 with expiration 04-MAR-2014; dose, frequency and route were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. In November 2015 (during the time frame of 05-NOV-2015 through 15-NOV-2015), the patient were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # J006681, expiry date 05-DEC-2015; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness to site and swelling.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccination.
Age: 44.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Gait disturbance, Hypoaesthesia, Paraesthesia, Walking aid user
Clinical narrative: After receiving PCV-13 vaccine experienced left arm tingling and numbness which then turned into B/L LE symptoms on 10/26.-> Pins/needles and weakness with difficulty walking - currently using crutches.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus, Swelling
Clinical narrative: Patient received Zoster vaccine on 11/18/15 as part of her office visit. She called the office on 11/20/15 as was seen for (L) arm redness and pain which started the day after injection was administered. No fever, chills, sweats, no fatigue. Started on KEFLEX 500mg every 6 hours. Count 40 seen 11/23/15 for c/o continued pain and itchiness in (L) arm. Erythema and swelling better compared to 11/20/15. KEFLEX continued.
Age: 6.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Decreased appetite, Eye irritation, Eye swelling, Headache, Nightmare
Clinical narrative: High fever (103.8); headache; leg pain; mouth pain; burning eyes; left eye red and swollen; lack of appetite; nightmare.
Age: 6.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Ocular hyperaemia, Oral pain, Pain in extremity, Pyrexia
Clinical narrative: High fever (103.8); headache; leg pain; mouth pain; burning eyes; left eye red and swollen; lack of appetite; nightmare.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patients right upper arm became swollen, hot to the touch, "raised white lumps".
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Abdominal discomfort, Erythema, Pruritus, Tongue pruritus
Clinical narrative: Itching tongue and palms, red ears, upset stomach, grandmother stated occurred within a "short" time, pt arrived about 40 mins to clinic with s/s was immediately instructed to go to ER. BENADRYL and steroid packs.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site nodule
Clinical narrative: Patient's mother reported to up on 11/10/15 that patient's arm where injection was given had a "knot" and was going numb when she laid down". Call to pt on 11/12/15 pt states this began on 11/4/15, lasted one week, then got better.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cyst, Vulva cyst
Clinical narrative: Host of cyst on various parts of my body. Left cheek, left scapular, vulva area.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature decreased, Crying, Listless, Pain, Pallor
Clinical narrative: 2 1/2 days after vaccine the child woke up with a 1-2 period of "painful crying". Not her usual cry. Then became pale and listless with ax temp of 95 degrees. Was wrapped in blankets - between 1-2 hr later she was back to normal.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient had a red rash at the injection site.
Sex: U
Vaccine: MMR
Symptoms: Erythema, Incorrect route of drug administration, Underdose, Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On 18-NOV-2015, the patient was inadvertently vaccinated with the dose of M-M-R II injection, 0.1 ml, lot# reported as L024265 with expiration date 01-JUL-2017, intradermally. On an unspecified date in November 2015, the patient experienced redness around the wheal, which resolved after application of a cold compress (unspecified date in November 2015). The causality between the adverse events and M-M-R II was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a 66 year old female patient with high blood pressure, high blood cholesterol and drug allergy to KEFLEX and codeine. The patient's medical history was not provided. On 18-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date and dose were not reported), intramuscular. Concomitant therapies included unspecified medications for high blood pressure and high blood cholesterol. On 18-NOV-2015, about 4 to 5 hours after receiving PNEUMOVAX 23, the patient experienced extreme pain in her arm. The pain was in the front of her arm, not at the injection site. On 19-NOV-2015 (reported as "the following day"), the patient had difficulty in moving her arm. There was no labs diagnostics studies performed. The patient contacted the pharmacy where she received PNEUMOVAX 23 and her arm was treated with ice. The patient also took an unspecified dose of ALEVE for pain relief. The patient also contacted her unspecified, primary physician and left a message, but has not heard back from him yet. The outcome of adverse events was reported as not recovered. The relatedness between adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Informaiton has been received from an office manager referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K006960, expiration date 19-FEB-2017 and/or lot# L006549, expiration date 06-APR-2017, dose and route not provided (Incorrect product storage). 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 as received from a healthcare professional refers to 2 unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection (lot # L009445, expiration date 01-JUN-2017, doses and routes of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old male patient. The patient had no history of drug allergies or reactions. The patient's concurrent conditions and medical history were not reported. The patient had received PNEUMOVAX approximately in May 2015 (reported as 6 months ago). On 10-NOV-2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml, (lot # L012475 and expiry date of 10-JUL-2016), subcutaneous. The patient developed a headache within two hours of receiving a dose of ZOSTAVAX on 10-NOV-2015. The patient developed redness at the ZOSTAVAX injection site was well as unspecified low grade fever on 11-NOV-2015 (reported as yesterday). The pharmacist stated that the patient had been experiencing soreness at the injection site since 10-NOV-2015 (since receiving the ZOSTAVAX). The patient sought medical attention and called the pharmacist on 11-NOV-2015. No treatment was received in response to the events. The outcome of the events was not resolved. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified dates, an unknown number of patients were inadvertently administered improperly stored COMVAX (lot # J013884, expiration date 19-AUG-2016) (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Local reaction, Rash, Urticaria
Clinical narrative: This spontaneous report was received from a Bachelor of Science in Nursing (B.S.N) via Pfizer (manufacturer control #2015383080), concerning a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23, (route, dose, anatomical location, lot/batch # were not reported). Co-suspect therapies or concomitant medications were not provided. On an unknown date, the patient experienced severe local reaction reported as large welts and rash to PNEUMOVAX 23. The outcome of urticaria was unknown. The reporter considered urticaria to be related to PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, these patients were vaccinated with an unspecified number of improperly stored doses of RECOMBIVAX HB (lot # L001456 with expiration 22-OCT-2016; lot # L014419 with expiration 15-APR-2017; dose, frequency and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of VAQTA (lot # K009954 with expiration date 13-NOV-2015 and lot # L014068 with expiration date 02-NOV-2017; dose and route of administration were not reported). No adverse effects were reported. It was also provided that during the previous call on 23-OCT-2015 (no adverse event were reported at that time), the medical assistant reported a vaccine temperature excursion and inquired about the stability of M-M-R II, PROQUAD (Merck), VARIVAX (Merck) and ZOSTAVAX, but none of these vaccines have been administered to the patients. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Off label use
Clinical narrative: Information has been received from a certified medical assistant referring to a male patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with GARDASIL 1 dose (dose, route, lot# and expiration date were not reported) for the first dose in the human papillomavirus vaccine (HPV) series and then was administered GARDASIL 9 (dose, route, lot# and expiration date were not reported) for the second and third doses in the HPV series (interchange of vaccine products). This was outside the labeled recommendations in both the GARDASIL and GARDASIL 9 prescribing information (off label use). No adverse effect was reported. Outcome of the events and the causality were not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 which expired on 05-NOV-2015 (lot#, strength, dose and route were unknown). The patient's concomitant medication was not reported. No adverse effects were 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 Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. There were no medical history or concurrent condition reported. On unspecified dates since 08-OCT-2015, the unspecified patients were vaccinated with doses of M-M-R II (lot # K021151, expiration date 02-NOV-2016 and lot # K009192, expiration date 27-JUN-2016) (dosage, strength and route were not reported), which were exposed to temperatures outside of the recommended range. There was no concomitant medication reported. No adverse experience had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, these patients were vaccinated with an unspecified number of improperly stored doses of PNEUMOVAX 23 (lot # L005563 with expiration 03-NOV-2016; dose, frequency and route were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a 53 year old male pharmacist, who was reporting on himself. The patient had no pertinent medical history and no drug reactions or allergies. On 26-JUN-2015, the patient was vaccinated subcutaneously with an unknown dose of ZOSTAVAX (lot # and expiry date were not reported). No concomitant medications were administered. On 08-NOV-2015, the patient experienced shingles, which started in the center of his chin, then spread to his left cheek, the right corner of his mouth and near his right eye. The patient did not experience pain. Subsequently, the patient saw his physician, who prescribed a seven-day course of VALTREX, which was finished on 17-NOV-2015 (reported as "yesterday"). No lab diagnostics studies were performed. The outcome of the event was reported as recovering. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 09-NOV-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J005067 with expiry date 17-JAN-2015; dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patient were vaccinated with the improperly stored doses of RECOMBIVAX HB (lot # J013394 with expiration date 25-AUG-2016 and lot # K019502 with expiration date 04-FEB-2016; dose and route of administration were not reported. No adverse effects were reported. It was also provided that during the previous call on 23-OCT-2015 (no adverse event were reported at that time), the medical assistant reported a vaccine temperature excursion and inquired about the stability of MMR II, (Oka-Merck) PROQUAD, (Oka/Merck) VARIVAX and ZOSTAVAX, but none of these vaccines have been administered to the patients. This is one of several reports received 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 pharmacy technician refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated orally with unknown doses of ROTATEQ (lot # K022995 with expiry date 22-JUL-2016), which were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified dates, an unknown number of patients were inadvertently administered improperly stored VARIVAX (Merck) (lot #K018961, expiration date 15-OCT-2016) (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no medical history or drug reactions/allergies reported. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L013188 with expired date 02-NOV-2016, oral, dose was unknown). No concomitant therapy was provided. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. In November 2015 (during the time frame of 05-NOV-2015 through 15-NOV-2015), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L007560, expiry date 15-JUN-2017; dose and route were not reported). 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: This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with doses of M-M-R II (lot number K021151 and expiration date 02-NOV-2016, lot number K005431 and expiration date 15-APR-2016, lot number K011189 and expiration date 12-AUG-2016, lot number K000737 and expiration date 16-JAN-2016, lot number K012473 and expiration date 26-AUG-2015, dose, therapy type and route of administration were not reported) which were exposed to temperatures outside of the recommended range. Concomitant therapy was not reported. No adverse experience was reported. This is one of the two 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 medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. In November 2015 (during the time frame of 05-NOV-2015 through 15-NOV-2015), the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot #, expiry date, dose and route were not reported). No adverse effects were reported. This is one of several reports received 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 unspecified patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated orally with doses of oral ROTATEQ (lot number K011952 and expiration date 17-JUN-2016, lot number L008997 and expiration date 04-DEC-2016, lot number reported as L013232 and expiration date 27-JAN-2017, lot number L008053 and expiration date 30-NOV-2016, lot number L000431 and expiration date 11-AUG-2016, lot number K006456 and expiration date 08-MAR-2016, dose was not reported) which were exposed to temperatures outside of the recommended range. Concomitant therapy was not reported. No adverse experience was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). Later on the same day, the patient experienced injection site itching. The reporter noted that no rash had developed. The patient sought medical attention (spoke to the reporting pharmacist). The outcome of injection site itching was reported as not recovered. The relatedness between the adverse event and the suspect vaccine 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 healthcare worker refers to 2 patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unspecified dates, the patients were vaccinated with doses of improperly stored ZOSTAVAX (unknown route and strength) lot # L006380 and expiry date of 25-MAY-2016. No adverse effects were reported. There was no product quality complaint involved. 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 pharmacy technician refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # reported as L003347 (an invalid lot number for GARDASIL) and expiry date 23-JUL-2017; dose and route not reported). No adverse effects were reported. This one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates the patients were vaccinated with doses of improperly stored oral, ROTATEQ (lot # was reported as L006184, expiry date 13-DEC-2016; lot # was reported as L008054, expiry date 30-NOV-2016) (oral, dose and dose number were unspecified). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L017407, expiry date 15-AUG-2017; lot # L013429, expiry date 21-JUL-2017) (dose, route and dose number were unspecified). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pemphigoid
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 75 year old female patient. The patient's pertinent medical history included hypertension and high cholesterol. The patient's concomitant medications included multiple unspecified medications. On 03-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX dose, route and site of administration, lot#, expiry date were not reported for prevention of shingles. On an unknown date in 2015, reported as "since receiving the ZOSTAVAX", the patient was diagnosed with bullous pemphigoid. The patient received unspecified prednisone treatment for the bullous pemphigoid. The outcome of pemphigoid was unknown. The patient sought medical attention by going to the physician. The relatedness between the event and the ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to unspecified patients of unknown age and gender. The medical history and drug reactions/allergies of the patients were not reported. On an unspecified date in 2006, the unspecified patients were vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported) and, on an unknown date, the patients were revaccinated with another dose of ZOSTAVAX. No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Urticaria, Vomiting
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 25 year old female patient. The patient's medical history and drug reactions/allergies were not reported. On 14-OCT-2015, the patient was vaccinated with the first dose of GARDASIL in the left arm (dose, route, lot # and expiration dates were not reported). No concomitant medications were reported. On 15-OCT-2015 (reported as the first day after injection), the patient experienced nausea, vomiting and headache. Two to three more days later in October 2015, the patient experienced full body hives that lasted two weeks. At the time of the report, the outcome of nausea, vomiting, headache and urticaria was unknown. The relatedness between the events and the GARDASIL vaccine was not provided. No product quality complaint was involved. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Blood glucose normal, Confusional state, Disorganised speech, Dysarthria, Generalised tonic-clonic seizure
Clinical narrative: 10:45 AM on 11/4/15 - Patient had Grand Mal seizure activity for 2 minutes. Patient was postictal with confusion, lethargy, slurred and garbled speech until EMS arrived. Vitals 136/96, 108 pulse, Ox 100%, Blood sugar was 116 mg/dl.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Postictal state
Clinical narrative: 10:45 AM on 11/4/15 - Patient had Grand Mal seizure activity for 2 minutes. Patient was postictal with confusion, lethargy, slurred and garbled speech until EMS arrived. Vitals 136/96, 108 pulse, Ox 100%, Blood sugar was 116 mg/dl.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: Within 24 hours of HPV in (L) arm with pain at site devel. pain down to elbow then (L) hip and (L) leg. Exam 11/3/15 NL except pain perception. No clear nerve distribution sxs most c/w Complex Physical Pain - following (fam hx similar pain issues).
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased
Clinical narrative: 2 days post shot pt cannot lift up arm. Shot was uneventful not painful. But was placed in upper 1/3 of deltoid.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Musculoskeletal pain, Nausea, Neck pain, Pain
Clinical narrative: Left deltoid pain, swelling, redness and pain radiates up into left shoulder and neck and scapula and has pain when lifting left arm 60 degrees flexion or abduction. Also, note, EE developed nausea and vomiting, dry heaves also.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Peripheral swelling, Retching, Vomiting
Clinical narrative: Left deltoid pain, swelling, redness and pain radiates up into left shoulder and neck and scapula and has pain when lifting left arm 60 degrees flexion or abduction. Also, note, EE developed nausea and vomiting, dry heaves also.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site reaction, Rash morbilliform
Clinical narrative: Morbilliform rash at injection site.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Middle insomnia, Myalgia
Clinical narrative: Patient complained of pain below the injection in the muscle that stated immediately after the injection. Pain is worse at night. Takes TYLENOL #3 and MOTRIN for relief. Also uses warm compresses. Says wakes her up all night.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: -Redness, itching near neck area. -Started about 4 weeks after administer date. -"Pimple like" bumps/blister. -Instructed to use BENADRYL.
Age: 0.24
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Body temperature increased, Culture urine, Full blood count, Urinary tract infection, Urine analysis
Clinical narrative: Temp 101.9 ax pre grandmother - on call phone call - Instructed to take to ER Temp increased 104 at ER - given ROCEPHIN, IV flds dx with UTI - urine cultures - negative.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to an adult patient of unknown age and gender. No concurrent or historical conditions were reported. On 09-NOV-2015, the patient was vaccinated with a pediatric dose of VAQTA (lot # K012457, expiration date 04-JUN-2017) 0.5 ml, intramuscularly (anatomical location not reported), instead of the recommended 1.0 ml adult dose. No concomitant medication was reported. No adverse effects were reported. No PQC was involved. This is one of two cases received from the same source. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Nodule, Rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 48 year old female patient , who was a smoker (tobacco user). The patient's pertinent medical history was not reported. The patient had no relevant drug history. On 03-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were unknown) once, in the right arm, because she was a smoker (tobacco user). Concomitant therapies included influenza virus vaccine (unspecified) in the left arm. On 03-NOV-2015, after PNEUMOVAX 23 was given to the patient, she developed rash on the arm, below the injection site, with redness, swelling, warm to the touch and a hard knot has developed. It was stated that it was very cellulitis like. It was stated that on 04-NOV-2015, cellulitis has worsened because it had spread form the mid to the arm to the inner arm. There were no relevant laboratory data. It was also reported that a specific doctor did not prescribe this vaccine, it was a standing order at the pharmacy. At the time of the report, the outcome of cellulitis was not recovered. Additional information is not expected.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 48 year old female patient , who was a smoker (tobacco user). The patient's pertinent medical history was not reported. The patient had no relevant drug history. On 03-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were unknown) once, in the right arm, because she was a smoker (tobacco user). Concomitant therapies included influenza virus vaccine (unspecified) in the left arm. On 03-NOV-2015, after PNEUMOVAX 23 was given to the patient, she developed rash on the arm, below the injection site, with redness, swelling, warm to the touch and a hard knot has developed. It was stated that it was very cellulitis like. It was stated that on 04-NOV-2015, cellulitis has worsened because it had spread form the mid to the arm to the inner arm. There were no relevant laboratory data. It was also reported that a specific doctor did not prescribe this vaccine, it was a standing order at the pharmacy. At the time of the report, the outcome of cellulitis was not recovered. Additional information is not expected.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. In approximately September 2015 (reported as "approximately 2 months ago"), the patient was vaccinated with the second dose of GARDASIL 9 (lot #, expiry date, dose and route were not reported). Concomitant medications were not reported. In September 2015, immediately after vaccination, the patient became light headed and dizzy. The patient recovered before leaving the office (in September 2015). It was unknown if additional vaccinations took place. The relatedness between the event and GARDASIL 9 was not reported. This is one of two 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 worker (certified medical assistant) refers to a multiple unspecified patient of unknown demographics. On an unknown dates, the patients received improperly stored PNEUMOVAX 23 lot # L005563 with expiration date: 03-NOV-2016, (strength, dose number, dose, and route was not reported). Concomitant medication was not reported. No adverse effect was reported. PQC was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, patients were vaccinated with a doses of improperly stored PROQUAD (Merck) (route, dose and frequency were not reported) lot # L014401 expiration date 23-OCT-2016 (also reported as "23-OCT-2106"), lot # L024123 expiration date 30-DEC-2016 and lot # L021601 expiration date 10-DEC-2016. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, patients were vaccinated with a doses of improperly stored VARIVAX (Merck) (route, dose and frequency were not reported) lot # L015048 expiration date 29-APR-2017, lot # L013395 expiration date 16-APR-2017 and lot # L020002 expiration date 02-JUN-2017. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Burning sensation, Injection site pain, Injection site reaction, Skin tightness
Clinical narrative: This spontaneous report was received from a pharmacist regarding a male patient of unknown age. No historical or concurrent conditions were reported. On 04-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L012215, expiry 13-JAN-2017). No concomitant medications were reported. On an unknown date approximately in 2015, the patient experienced tightness at injection site as well as a burning sensation and pain throughout the entire deltoid region after receiving the PNEUMOVAX 23. The patient also experienced an elevated body temperature as high as 102F shortly after receiving the PNEUMOVAX 23 on an unknown date in 2015. The patient was prescribed prednisone for the soreness and tightness in the arm on an unspecified date. The pharmacist has requested a lot # check for PNEUMOVAX 23. The outcome of the events were reported as fully recovered. Causality assessment was not provided. 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. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored dose of ROTATEQ oral liquid, lot# K009753 with expiration date 28-APR-2016 and lot# K001196 with expiration date 22-OCT-2015, orally (dose was not reported). No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot# K008213 with expiration date 17-DEC-2016, lot# K009105 with expiration date 21-JAN-2016, lot# K008931 with expiration date 04-MAR-2017 (reported as 2107) and lot# K006191 with expiration date 09-FEB-2017 (dose and route of vaccination were not reported). No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a multiple unspecified patients of unknown demographics. On an unknown dates, the patients received improperly stored GARDASIL 9 lot # L014198 with expiration  date: 05-SEP-2017; lot # L016428 with expiration date: 30-JUL-2017, (strength, dose number and dose was not reported). concomitant medication was not reported. No adverse effects was reported. PQC was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 12 hrs after vaccine administered, developed erythema, induration, heat, tenderness in (L) deltoid at site.
Age: 1.32
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Blister, Cough, Haemorrhage, Nasopharyngitis, Papule
Clinical narrative: Developed fever, cough and cold symptoms. On Friday, lost fever last night. Developed a few spots as on chest yesterday, more today - scattered on trunk but a few on neck, leg, arm some papules, some blisters, 2 scabbed, one scratched/bleeding.
Age: 1.32
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Scab, Scratch
Clinical narrative: Developed fever, cough and cold symptoms. On Friday, lost fever last night. Developed a few spots as on chest yesterday, more today - scattered on trunk but a few on neck, leg, arm some papules, some blisters, 2 scabbed, one scratched/bleeding.