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 nurse via Company Representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (start date, lot#, route and dosage not reported). Nurse reported that expired ZOSTAVAX was administered to a patient. No adverse effects were reported. Additional information is not expected since it is not able to connect caller due to technical difficulties.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to an unspecified number of patients of unknown age and gender. On an unknown date, more than 1 patient was vaccinated with ZOSTAVAX (dose, route, site of administration and lot# were not reported). On an unknown date, more than 1 patient developed red bump at the injection site after administration of ZOSTAVAX. The patient sought unspecified medical attention. The outcome of events was not reported. The relatedness between adverse events and ZOSTAVAX was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to 2 patients of unspecified age and gender. On an unknown date, two patients were vaccinated with a dose of ZOSTAVAX (dose, route, site of administration and lot# were not reported). On an unknown date, the patients developed a shingles-like rash. The patients sought unspecified medical attention. The outcome of shingles-like rash was not reported. The relatedness between shingles-like rash and ZOSTAVAX was not reported. This is one of several reports 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 as received from a healthcare professional refers to a patient of unknown age and gender. On 06-NOV-2014, the patient was administered with expired dose of ZOSTAVAX lot # J014851, expiration date: 21-OCT-2014 (dose and route of administration were not provided). No adverse effect has been observed or reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Swelling, Wrong technique in drug usage process
Clinical narrative: Came in on 11-5 after 6 days said swollen/red/fever about 2 x 4 size. Advised pt. to see MD and came back to say it was technique of administration and did not give pt. any meds since it subsided.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 60 year old patient of unknown gender. On 26-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot number JD13137 is an invalid lot number for zoster vaccine live, expiration date 31-JAN-2015), in the right arm (dose and route not reported). The pharmacist reported that approximately in September 2014, the patient experienced localized redness that formed a circle approximately "the size of a palm" following administration of the vaccination of ZOSTAVAX on 26-SEP-2014. The reaction took approximately one week to resolve. The patient did not seek treatment for the reaction or not have any additional reactions. This is one of several reports received from the same reporter (this case concerns patient 2). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a License Practical nurse regarding a three patients of unknown age and gender. On unknown dates the patients received doses of (Oka/Merck) VARIVAX (dose, lot #, expiration date and route not reported), that were exposed to temperatures outside of the proper storage. No adverse effect reported. It was unknown in the patients sought medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On 01-OCT-2014 the patient was vaccinated with dose 1 GARDASIL (Injection, lot # K009811, exp 16-JUN-2016). The patient's mother called the physician's office and spoke to the anonymous nurse to report that the patient had a stomach ache and leg pain after receiving the GARDASIL injection. The mother reported that the patient would no longer receive any further GARDASIL therapy. The patient did not receive treatment. The outcome of leg pain and the patient had a stomach ache was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. Nurse reported improperly stored ROTATEQ (dose, route and frequency, lot# were not reported) was inadvertently administered to an unspecified number of patients. No adverse effects reported. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# unknown). On an unknown date the patient experienced an unspecified adverse event. The outcome of the event was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report was received from a 64 year old female patient reporting herself with no drug reactions/allergies. The patient's medical history included shingles (8 years ago, in approximately October 2006). In approximately October 2010 (4 years ago), the patient was vaccinated with a single dose of ZOSTAVAX, (dose, frequency, lot number not provided). Concomitant therapies were unspecified by reporter. In approximately September 2014 (about a month ago), the patient developed shingles. No lab diagnostics studies were performed. The patient sought medical attention and was treated with VALTREX, MOTRIN and hydrocodone (dosage, frequencies, manufacturer unknown). The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 years old patient of unknown gender. On 14-OCT-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008579, expiration date 13-DEC-2015, (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from certified medical assistant regarding unspecified patients of unknown age and gender. On unknown dates the patients received improperly stored PNEUMOVAX23 (doses, lot #s, Expiration dates and routes not reported), exposed to 22 F hours. No adverse effects were reported. It was unknown if the patients sought medical attention. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Malaise, Pruritus, Swelling, Urticaria
Clinical narrative: This spontaneous report as received from a consumer (the patient's grandmother) refers to a 9 year old male patient. The patient had none pertinent medical history and none drug reactions or allergies. On 29-AUG-2014, the patient was administered with (Oka/Merck) VARIVAX (dose, route of administration, lot number and expiration date were not provided). The patient did not take any concomitant medications. The grandmother stated that, on 07-SEP-2014 (reported as 9 days later), the patient become ill. The patient's body became swollen, itching and broke out into hives. This adverse reaction has been ongoing for the past 9 weeks. The patient sought medical attention, he had been tot he doctor and the Emergency Room twice. An unspecified blood test was performed (results were no provided). The patient received ALLEGRA, ZYRTEC and BENADRYL as a treatment for adverse events. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and the vaccination with (Oka/Merck) VARIVAX was not provided. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 9 month old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 05-NOV-2014, the patient was vaccinated with VAQTA, 0.5 ml, intramuscularly (lot#, exp. date and anatomical location were not provided). No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Hypoaesthesia, Injection site rash, Neck pain, Pain in extremity
Clinical narrative: Fever, chills, arm and leg numbness, pain radiating from the neck to the arms. Patient reported a rash under the injection site.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fever, chills, arm and leg numbness, pain radiating from the neck to the arms. Patient reported a rash under the injection site.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. Nurse reported improperly stored PNEUMOVAX23 (dose, route and frequency, lot# were not reported) was inadvertently administered to an unspecified number of patients. No adverse effects reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patients arm was swollen and red. Patient applied ice, took ADVIL and an anithistamine.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to many unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with a doses of ZOSTAVAX (doses, routes and lot numbers were not reported). The pharmacist reported that over the past several months (in 2014), she had been aware that many unspecified patients who received ZOSTAVAX on unspecified dates experienced injection site reactions described as a little knot surrounded by a big red circle. At the time of the report the patients' outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 years old patient of unknown gender. On 16-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008579, expiration date 13-DEC-2015, (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient (male or female) of unknown age. The pharmacist reported that she administered a dose of ZOSTAVAX, subcutaneous (dose and lot number not reported) to a patient on an unspecified date in October 2014 (reported as last week) and administered ZOSTAVAX to his wife on 21-OCT-2014 (reported as yesterday). The reporter stated that either the husband or the wife called pharmacy on 22-OCT-2014, stating that one of them (she could not specify which patient it was as she did not speak to them) experienced a rash around the injection site (unknown date in October 2014). At the time of the report the outcome of rash around the injection site was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
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, not supported GARDASIL, (anatomical location, lot #, expiration date were not reported) 0.5 ml, was intramuscularly administered, post excursion of -2.3 Celsius degree for 10 hours. This is the one of several reports from the same reporter source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Register Nurse refers to a 11 year old patient, of unknown gender. Medical history and concurrent conditions were not reported. On 30-SEP-2014, the patient was vaccinated with RECOMBIVAX HB lot # J009051, expiration date 26-MAR-2016 (dose, strength, route and frequency were not reported). The patient was vaccinated with improperly stored RECOMBIVAX HB. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient had no pertinent medical history, drug reactions or allergies. On 29-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX lot# reported as K00884, expiration date 20-SEP-2015 (dose number, site and route of administration not reported). Concomitant therapies included valacyclovir hydrochloride (reported as "the patient may have been using valacyclovir at the time of the ZOSTAVAX administration"). On an unknown date in October 2014, the patient experienced burning at injection site and around the injection site, which appeared as though the fat in her arm was being melted. On 30-OCT-2014, the patient visited the pharmacy because of the adverse events and was advised by the reporting pharmacist to treat the reaction with unspecified topical steroid, an unspecified antihistamine and ice. No lab diagnostic studies were performed. The patient was slowly recovering from the adverse events at the time of the report. Relatedness between use of ZOSTAVAX and the adverse events was not reported. This is one of several reports from the same reporter. Lot number K00884 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, HIBV, RV5
Symptoms: Pyrexia
Clinical narrative: 21 hrs after administration of PEDIARIX, Hib, PREVNAR13 and ROTATEQ Pt experienced fever of 103.7. Tylenol improved temp to 100.7.
Age: 9.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9 years old Child, gender was not reported. On 21-AUG-2014, the patient was vaccinated with VAQTA lot # K007791, expiration date 22-AUG-2014 (dose, strength, route and frequency were not reported). Patient received improperly stored VAQTA exposed to 49F for 35 minutes. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Register Nurse refers to a 10 year old patient, of unknown gender. Medical history and concurrent conditions were not reported. On 03-OCT-2014, the patient was vaccinated with RECOMBIVAX HB lot # J009051, expiration date 26-MAR-2016 (dose, strength, route and frequency were not reported). The patient was vaccinated with improperly stored RECOMBIVAX HB. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Register Nurse refers to a 11 year old patient, of unknown gender. Medical history and concurrent conditions were not reported. On 03-OCT-2041, the patient was vaccinated with RECOMBIVAX HB lot # J009051, expiration date 26-MAR-2016 (dose, strength, route and frequency were not reported). The patient was vaccinated with improperly stored RECOMBIVAX HB. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthritis, Asthenia, Pain, Swelling
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding her 17 year old daughter. There was no information on pertinent medical history and drug reactions or allergies. On 17-OCT-2013, the patient was vaccinated with first dose of GARDASIL injection dose reported as 1 dose, route, product lot#, expiry date not reported to prevent strains of HPV. There was no information on concomitant therapy. The reporter states that on an unknown date in March 2014, her daughter was experiencing inflammation in all of her joints, swelling, pain, and weakness after receiving the first dose of GARDASIL. She also stated that all of these symptoms were escalating to the point where the patient was almost debilitated. The patient sought unspecified medical attention and as per physician's recommendation the patient did not receive the second and third doses of GARDASIL. Treatment was given for the adverse events. The treatment medications included unspecified steroids, Doxycycline, Ibuprofen and unspecified anti-inflammatories. Major unspecified laboratory diagnostics studies were performed. There was no product quality complaint involved. The outcome and causality was unknown.
Age: 1.02
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old infant, gender was not reported. On 21-AUG-2014, the patient was vaccinated with VAQTA lot # K007791, expiration date 22-AUG-2014 (dose, strength, route and frequency were not reported). Patient received improperly stored VAQTA exposed to 49F for 35 minutes. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX lot# reported as K00884, expiration date 20-SEP-2015 (dose number, site and route of administration not reported). On an unknown date, the patient experienced reaction with burning at injection site and around the injection site, which appeared as though the fat in their arm was being melted. The outcome of the adverse events was unknown. Relatedness between use of ZOSTAVAX and the adverse events was not reported. This is one of several reports from the same reporter. Lot number K00884 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
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, not supported VAQTA (dose, therapy route, anatomical location, lot #, expiration date were not reported) was administered post excursion of -2.3 Celsius degree for 10 hours. This is the one of several reports from the same reporter source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old patient of unknown gender. On 07-OCT-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008579, expiration date 13-DEC-2015, (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Chest pain, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: Pt. received ENGERIX-B 20 mg/u on 11/11/14 at 8:20 pm, Next day she complain about body burning, nausea, mild chest pain. SOB (mild), sweating, went to ER gave IV BENADRYL.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Paraesthesia
Clinical narrative: Left wrist pain, fingers tingling.
Age: 40.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a 40 year old male patient (who is also a company representative) refers to himself. The patient's medical history included chickenpox twice and shingles. On 06-NOV-2014 the patient was vaccinated with VARIVAX (Merck) subcutaneous (lot number reported as: K002921, dose, units, anatomical location were not reported). Concomitant therapies included ADDERALL and testosterone shot. On 08-NOV-2014, the patient experienced blisters on the arm, trunk and legs, and itchiness on the trunk after receiving VARIVAX (Merck). The patient's symptoms have been confirmed as the chickenpox at that time. There was no treatment given for the adverse event. The patient did not seek medical attention. The outcome of event was reported as not recovered. The relatedness between the event and VARIVAX (Merck) was not reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Infection, Pain in extremity
Clinical narrative: Patient went to MD office with redness and pain in arm. MD diagnosed an infection. MD prescribed cephalexin 250mg.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Vomiting
Clinical narrative: Pt received Tdap, GARDASIL and meningococcal vaccines in our office on 11/11/14 at 10:00 AM. He did not eat before visit. After leaving our office, he vomited and felt dizzy in the parking lot. We brought him into the office and took vital signs. Temperature 98.2, oxygen 96, pulse 84, BP 100/60. He sat in the office for 10 minutes then left.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. On an unknown date, reported as "unspecified time in the past", the unknown number of patients were vaccinated with ZOSTAVAX (lot numbers, expiration dates were not reported). The doses of ZOSTAVAX had been possibly exposed to 41 Fahrenheit degree for 24 hours. No adverse effect was reported. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Pt. received varicella vaccine on 10/29/14, came to clinic c/o redness and warmth the injection site ((L) deltoid) treated for cellulitis.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, lot number, expiration date were not reported). On an unknown ate, the patient's mother in law broke out in shingles. Then the patient broke out in shingles (date was not reported). The outcome of the event was not reported. Causality assessment was not provided. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Large oval red "hot" rash (flat) in area of injection site.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old infant, gender was not reported. On 21-AUG-2014, the patient was vaccinated with VAQTA lot # K007791, expiration date 22-AUG-2014 (dose, strength, route and frequency were not reported. Patient received improperly stored VAQTA exposed to 49F for 35 minutes. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refer to a 3 years old Child, gender was not reported. On 21-AUG-2014, the patient was vaccinated with VAQTA lot # K007791, expiration date 22-AUG-2014 (dose, strength, route and frequency were not reported). Patient received improperly stored VAQTA exposed to 49F for 35 minutes. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 years old Child, gender was not reported. On 21-AUG-2014, the patient was vaccinated with VAQTA lot # K007791, expiration date 22-AUG-2014 (dose, strength, route and frequency were not reported. Patient received improperly stored VAQTA exposed to 49F for 35 minutes. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a male patient of unknown age who on an unspecified date, was vaccinated with a dose of ZOSTAVAX (lot # not reported), the patient was then administered a second dose of ZOSTAVAX (lot # not reported) on an unspecified date approximately 1 month after the first dose. No adverse effects reported. Additional information is not expected. No further information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist refers to a female patient of unknown age. The pharmacist reported that on an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number: K009770; expiry date: 09-OCT-2015) (0.65 ml, subcutaneous) which was improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 10-NOV-2014 the patient was vaccinated IM with a dose of PNEUMOVAX 23 (lot# and dosage not reported). The pharmacist reported that a patient received a dose of PNEUMOVAX 23 from her physician, and directly afterwards went to the pharmacy and had a second dose of PNEUMOVAX 23 on the same day. No adverse effects reported. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 13 years old adolescent, gender was not reported. On 21-AUG-2014, the patient was vaccinated with VAQTA lot # K007791, expiration date 22-AUG-2014 (dose, strength, route and frequency were not reported). Patient received improperly stored VAQTA exposed to 49F for 35 minutes. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 years old patient, gender was not reported. On 21-AUG-2014, the patient was vaccinated with VAQTA lot # K007791, expiration date 22-AUG-2014 (dose, strength, route and frequency were not reported). Patient received improperly stored VAQTA exposed to 49F for 35 minutes. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 years old patient of unknown gender. On 19-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008579, expiration date 13-DEC-2015, (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 11 years old child, gender was not reported. On 21-AUG-2014, the patient was vaccinated with VAQTA lot # K007791, expiration date 22-AUG-2014 (dose, strength, route and frequency were not reported). Patient received improperly stored VAQTA exposed to 49F for 35 minutes. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 10 years old Child, gender was not reported. On 21-AUG-2014, the patient was vaccinated with VAQTA lot # K007791, expiration date 22-AUG-2014 (dose, strength, route and frequency were not reported). Patient received improperly stored VAQTA exposed to 49F for 35 minutes. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Erythema, Local swelling, Skin warm, Urticaria
Clinical narrative: MMR SQ injection (L) thigh - within 5 minutes size of a plum hives - warm/raised/red area. Iced area 30-40 minutes. Resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The nurse reported that on 22-OCT-2014, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J008529, expiration date 12-OCT-2014) (dose number and route not reported). Nurse stated that ZOSTAVAX did not have any previous temperature excursions. ZOSTAVAX was supported with port-expiry data. No adverse symptoms reported. No further information provided. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: 4:30 P pt's mom called clinic stating patient had wok up consonsolable, increased crying, redness and swelling at injection site, left leg.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. Since 09-SEP-2014, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot#, expiration date, dose and route were unknown). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 years old patient of unknown gender. On 21-OCT-2014, the patient was vaccinated with a dose of PROQUAD lot # K008579, expiration date 13-DEC-2015, (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Paraesthesia
Clinical narrative: Left arm 6A next day ring finger pinky finger tingling. Light tingling from shoulder to fingers. Redness around site.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On 12-NOV-2014 the patient was inadvertently vaccinated with a dose of expired VARIVAX (Merck), expiration date 09-OCT-2014( dose, site and route of administration, lot# not reported). No adverse effects were reported. 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 nurse refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. The nurse reported that the patient was administered doses of GARDASIL (injection, intramuscular, 0.5 ml, lot# and expiry date were not provided) outside of the recommended schedule in the prescribing information on 16-APR-2014, 26-AUG-2014 and 07-NOV-2014. No adverse event was reported. Additional information has been requested.
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. On 09-NOV-2014 the patient was vaccinated with an expired dose of ZOSTAVAX, lot # J008432, expiry date 11-OCT-2014, 0.65ml, subcutaneous. No adverse effects were reported. No further information reported. Additional information has been requested.
Age: 94.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Feeling cold, Pain in extremity, Peripheral swelling
Clinical narrative: Vaccine 11/11/14 approximately 3 pm. Swollen legs/feet, thigh pain, dizziness, and a strong cold feeling started 11/12/14 at night and resolved by morning of 11/13/14.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Limb discomfort, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a male patient of unknown age with no drug reactions or allergies. On 05-NOV-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J006887 exp 04-MAR-2015) intramuscularly. There was no concomitant medication. The pharmacist reported that on 05-NOV-2014, the patient experienced warmth in his whole right arm and it was very firm and hard as a rock. The patient experienced discomfort, soreness and redness in the entire right arm. The patient received treatment for the adverse events. At the time of the report, the patient was recovering. Additional information is not expected. There is no contact information.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist refers to a male patient of unknown age. The pharmacist reported that on an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number: K009770; expiry date: 09-OCT-2015) (0.65 ml, subcutaneous) which was improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist refers to a female patient of unknown age. The pharmacist reproted that on an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number: K009770; expiry date: 09-OCT-2015) (0.65 ml, subcutaneous) which was improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Bladder disorder, Dysuria, Herpes zoster
Clinical narrative: This spontaneous report as received from a register nurse refers to his approximately 54 year old wide with Lupus, mood and no drug reactions or allergies. The patient's medical history included shingles six times or more per year over the last ten years. In approximately October 2013 (reported as on an unspecified date nine to twelve months ago in 2013), the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot#, expiration date not reported). Concomitant therapies included gabapentin and atenolol. In approximately 2014, six to twelve months after receiving ZOSTAVAX, the patient had a case of shingles and had had a total of four cases since being administered ZOSTAVAX. Her last case of shingles was three weeks ago, in approximately 10-OCT-2014. She did not have a current case of shingles. The nurse reported that his wife had had bladder problems and difficulty urinating, when shingles occurs on the outer aspects of her thighs, since an unspecified date after receiving ZOSTAVAX. There were no lab diagnostics studies. The patient did not seek medical attention. At the time of reporting, the outcome of the events was unknown. Additional information has been requested.
Age: 1.53
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 months old patient of unknown gender. On 23-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008579, expiration date 13-DEC-2015, (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram head, Deafness unilateral, Ear tube insertion, Myringotomy, Vertigo
Clinical narrative: This medically confirmed spontaneous report (initial receipt 31-Oct-2014) concerns a 49-year-old male patient. The patient had medical history of a drug allergy to dextromethorphan. The patient had received flu vaccine every year at work for last three years without any complaint of an adverse event. The patient was not taking any concomitant medication. On 21-Oct-2014 at 22:00, the patient received intramuscular AFLURIA (batch number T51108) at 0.5 ml. The patient denied receiving any other vaccination on the same or different arm on 21-Oct-2014. The vaccine was administered properly. On 25-Oct-2014, the patient experienced momentary hearing loss and extreme vertigo for approximately 5 minutes. On 26-Oct-2014, the patient experienced extreme vertigo two or three times. On 27-Oct-2014, in the morning, he experienced extreme vertigo and extreme deafness in left ear that continued to persist. He was prescribed treatment with high dose, double strength methylprednisolone dose pack for a total of 12 days instead of 6 days which was started on the 30-Oct-2014. The patient was also going to the MD (medical doctor) for an intratympanic treatment on the 31-Oct-2014. The outcome was reported as not yet recovered. Reporter's comments: The reporter assessed the events as serious (caused a persistent or significant disability/incapacity).
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Deafness, Deafness unilateral, Vertigo
Clinical narrative: This medically confirmed spontaneous report (initial receipt 31-Oct-2014) concerns a 49-year-old male patient. The patient had medical history of a drug allergy to dextromethorphan. The patient had received flu vaccine every year at work for last three years without any complaint of an adverse event. The patient was not taking any concomitant medication. On 21-Oct-2014 at 22:00, the patient received intramuscular AFLURIA (batch number T51108) at 0.5 ml. The patient denied receiving any other vaccination on the same or different arm on 21-Oct-2014. The vaccine was administered properly. On 25-Oct-2014, the patient experienced momentary hearing loss and extreme vertigo for approximately 5 minutes. On 26-Oct-2014, the patient experienced extreme vertigo two or three times. On 27-Oct-2014, in the morning, he experienced extreme vertigo and extreme deafness in left ear that continued to persist. He was prescribed treatment with high dose, double strength methylprednisolone dose pack for a total of 12 days instead of 6 days which was started on the 30-Oct-2014. The patient was also going to the MD (medical doctor) for an intratympanic treatment on the 31-Oct-2014. The outcome was reported as not yet recovered. Reporter's comments: The reporter assessed the events as serious (caused a persistent or significant disability/incapacity).
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Epistaxis, Immediate post-injection reaction, Syncope
Clinical narrative: Customer fainted immediately after vaccnation and also got a nose bleed.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dysphagia, Fatigue, Flushing, Pruritus, Pyrexia
Clinical narrative: BEGAN ON 11/6 WITH FLUSHED FEELING (SHE THOUGHT SHE MIGHT BE FEVERED, FATIGUE ITCHY SKIN WITH NO VISABLE RASH, SUGGESTED SHE TAKE TYLENOL OR IBUPROFEN (HER CHOICE) AND BENADRYL IF HER SKIN CONTINUED TO ITCH. PT LEFT THE PHARMACY AREA AND CONTINUED TO SHOP.  AFTER SHOPPING SHE RETURNED TO PHARMACY AND SAID NOT FEELING BETTER, I ATTEMPTED TO CALL PCP AND SUGGESTED SHE DO SAME, AT THIS POINT RXN WITH EXCEPTION TO ITCH WAS NORMAL RXN TO SHOT. AS THERE WAS NO VISABLE RASHING THOUGHT THAT SHE MIGHT FEEL ITCHY DO TO THE FLUSHING. TRIED TO CALL PCP AFTER CHECKING WITH PATIENT TO VERIFY PCP AND WAS TOLD THEY WERE NO LONGER HER CARE PROVIDER AND I TRIED TO CALL PT AND WAS UNABLE TO REACH HER PROGRESSED TO SWELLING SAID WAS UNDER CHIN AREA AND HAD SOME TROUBLE SWALLOWING UNSURE OF THE TIMES SHE PROGRESSED TO THIS AND WAS HOSPITALIZED.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: BEGAN ON 11/6 WITH FLUSHED FEELING (SHE THOUGHT SHE MIGHT BE FEVERED, FATIGUE ITCHY SKIN WITH NO VISABLE RASH, SUGGESTED SHE TAKE TYLENOL OR IBUPROFEN (HER CHOICE) AND BENADRYL IF HER SKIN CONTINUED TO ITCH. PT LEFT THE PHARMACY AREA AND CONTINUED TO SHOP.  AFTER SHOPPING SHE RETURNED TO PHARMACY AND SAID NOT FEELING BETTER, I ATTEMPTED TO CALL PCP AND SUGGESTED SHE DO SAME, AT THIS POINT RXN WITH EXCEPTION TO ITCH WAS NORMAL RXN TO SHOT. AS THERE WAS NO VISABLE RASHING THOUGHT THAT SHE MIGHT FEEL ITCHY DO TO THE FLUSHING. TRIED TO CALL PCP AFTER CHECKING WITH PATIENT TO VERIFY PCP AND WAS TOLD THEY WERE NO LONGER HER CARE PROVIDER AND I TRIED TO CALL PT AND WAS UNABLE TO REACH HER PROGRESSED TO SWELLING SAID WAS UNDER CHIN AREA AND HAD SOME TROUBLE SWALLOWING UNSURE OF THE TIMES SHE PROGRESSED TO THIS AND WAS HOSPITALIZED.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue, Immediate post-injection reaction, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Immediate pain in arm, swelling, stiffness followed by slowly increasing pain and swelling.  Exhaustion for 48 hours.  Increased joint pain in knees and hands.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Immediate pain in arm, swelling, stiffness followed by slowly increasing pain and swelling.  Exhaustion for 48 hours.  Increased joint pain in knees and hands.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Abdominal pain lower, Appendicectomy, Appendicitis, Asthenia
Clinical narrative: After receiving Flu Shot I went home..felt poorly & very weak, laid down & slept until 8 pm. Upon awakening I had moderate to severe lower back pain & pain in belly button area. The next day, Wednesday, severe pain all the way across lower abdomen. On Thursday pain in lower abdomen that seemed to concentrate on my lower right side in area of appendix.  Went to doctor on Friday morning, less than 72 hours from receiving the Flu Shot, & he sent me to ER.  I had to have an immediate surgery to remove Appendix that was severely inflamed.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Feeling abnormal, Somnolence
Clinical narrative: After receiving Flu Shot I went home..felt poorly & very weak, laid down & slept until 8 pm. Upon awakening I had moderate to severe lower back pain & pain in belly button area. The next day, Wednesday, severe pain all the way across lower abdomen. On Thursday pain in lower abdomen that seemed to concentrate on my lower right side in area of appendix.  Went to doctor on Friday morning, less than 72 hours from receiving the Flu Shot, & he sent me to ER.  I had to have an immediate surgery to remove Appendix that was severely inflamed.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Arthralgia, Dysstasia, Fatigue, Pyrexia
Clinical narrative: Fever, shaking, extreme pain in joints and large muscle groups, extreme fatigue, unable to stand alone, unable to complete adls alone, unable to feed self.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor
Clinical narrative: Fever, shaking, extreme pain in joints and large muscle groups, extreme fatigue, unable to stand alone, unable to complete adls alone, unable to feed self.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Choking sensation, Enlarged uvula, Oedema mouth, Oral mucosal erythema, Pain in extremity
Clinical narrative: Swollen soft palate enlarged uvula and choking sensation when laying down unable to sleep except sitting up and only intermittently. The palate had a rough aspect and besides the swelling was very erythematous.  I stayed home and intermittently dosing off to sleep all day 11/08/2014. The arm ache was bad but nothing compared to the sensation of an edematous soft palate. I took Advil 400 mg x 1 and 30 mg pseudoephedrine q 8 hourly for 24 hours including before bed time on 11/08/2014 when I slept better.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Sleep disorder, Somnolence, Swelling
Clinical narrative: Swollen soft palate enlarged uvula and choking sensation when laying down unable to sleep except sitting up and only intermittently. The palate had a rough aspect and besides the swelling was very erythematous.  I stayed home and intermittently dosing off to sleep all day 11/08/2014. The arm ache was bad but nothing compared to the sensation of an edematous soft palate. I took Advil 400 mg x 1 and 30 mg pseudoephedrine q 8 hourly for 24 hours including before bed time on 11/08/2014 when I slept better.