chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Syncope, Tonic clonic movements
Clinical narrative: Information has been received via company representative from a consumer referring to her daughter, a currently 16 years old female patient. The patient's medical history included syncope when she had menstruating. In approximately 2013, when the patient was 13 year old she had her first dose of GARDASIL (route, lot# and dose were unknown) and following the administration she experienced syncope. She fainted and had a tonic clonic, vasovagal reaction. Shortly after the episode the patient was sat up too soon and had another spell and was therefore sent to the emergency room of an unspecified medical center. The patient received unspecified treatment and was released without being admitted to the hospital. No further doses of GARDASIL were administered to the patient. The outcome of the events was reported as recovered/resolved. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored LIQUID PEDVAXHIB (dose, route of administration, injection site, lot# and expiration date were not reported). Administered doses of LIQUID PEDVAXHIB underwent temperature excursions at 47 Fahrenheit degrees, for unknown times frames. Information about the previous temperature excursion was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored GARDASIL (dose, route of administration, injection site, lot# and expiration date were not reported). Administered doses of GARDASIL underwent temperature excursions at 47 Fahrenheit degrees, for unknown time frames. Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown age and gender. No information regarding patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored M-M-R II (dose, route of administration, injection site, lot# and expiration date were not reported). Administered dose of M-M-R II underwent temperature excursions at 47 Fahrenheit degrees, for unknown time frames. Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.26
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 a 15 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On 01-FEB-2016, the patient was vaccinated with an improperly stored of (Oka/Merck) VARIVAX lot # L027288, expiry date 21-JUL-2017 (dose, route of administration and anatomical location were not specified). No adverse experience was reported. On 13-JAN-2016, the administered dose of the (Oka/Merck) VARIVAX underwent temperature excursion at 5 Fahrenheit degrees for 21 hours and at 14.0 Fahrenheit degrees for 15 minutes. No previous treatment excursions were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple patients received doses of improperly stored PNEUMOVAX 23 underwent temperature excursions at 47 Fahrenheit degrees, for unknown time frames. Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports receiving 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 healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates these patients were vaccinated with doses of improperly stored oral, ROTATEQ (Lot# L020861 with expiration 25-JAN-2017; Lot# L013204 with expiration 28-JAN-2017, dose and frequency were not reported) orally. The vaccine was stored in the temperature of 33 F (Minimum) and 55F (Maximum) for 12 hours. No adverse event was reported. No product quality complaint was involved. This is one of two cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates these patients were vaccinated with doses of improperly stored GARDASIL (lot # K010215 with expiration 05-MAY-2017, dose and frequency were not reported) (incorrect product storage). The vaccine was stored in the temperature of 33 F (Minimum) and 55F (Maximum) for 12 hours. No adverse event was reported. No product quality complaint was involved. This is one of two cases received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a female patient of unknown age. The patient's concurrent conditions, past medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, dose number, vaccination site, route, # lot, expiry date unspecified). A few months later, the patient experienced shingles (date unspecified). The patient sought the medical attention (unspecified). Product quality complaint was not reported. The outcome of shingles was unknown. Causality assessment was not provided. No additional information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a male patient of unknown age. The patient's concurrent conditions, past medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, dose number, vaccination site, route, # lot, expiry date unspecified). A few months later, the patient experienced shingles (date unspecified). The patient sought the medical attention (unspecified). Product quality complaint was not reported. The outcome of shingles was unknown. Causality assessment was not provided. No additional information was provided. This is one of two 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 certified medical assistant referring to a three unspecified patients of unknown ages and gender. No medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L017142 expiration date 13-MAY-2017) (dose and route were not provided). Concomitant medication was not reported. No adverse effects were reported and it was also reported that no product quality complaint was involved, temperature was 20 F, time frame was 108 hours, it was not previous temperature excursion and the call was not because of a "data logger". 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 regarding multiple (unspecified) patients. Patient demographics were not provided. Information on their concurrent conditions, medical history and drug allergies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX from either lot # L019999, expiry date 02-JUN-2017 or lot# L034367, expiry date 08-SEP-2017 (route, anatomical location dose number, dose and units were unspecified). Concomitant medication were not reported. No adverse events were reported. There was no Product Quality Complaint (PQC) involved. Varicella virus vaccine (Oka/Merck) VARIVAX-L034367, expiry date- 08-SEP-2017 was stored at temperature: -8.9C, Time frame: multiple excursions totaling 4h 10 minutes between 07-JAN-2016 to 21-JAN-2016, no previous temperature excursion were performed. Varicella virus vaccine live (Oka/Merck) VARIVAX-Lo019999 expiry date-02-JUN-2017 was stored at temperature: -8.1C, Time frame: multiple excursions totaling 36h 42 minutes between 29-NOV-2015 to 21-JAN-2016, no previous temperature excursion were performed. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL K007264, expiry date 02-MAR-2017. No adverse effects were reported. This is one of the 4 reports received from the same reporter. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: (L) shoulder redness, swelling, warm to touch. Patient states painful to touch.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 01-FEB-2016, the patient was vaccinated with an expiry dose of ZOSTAVAX (lot # K014834, exp. 14-DEC-2015, subcutaneous, dose not provided). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: HIV test negative, Hepatitis B surface antigen negative, Hepatitis C test negative, Injury associated with device, Treponema test negative
Clinical narrative: Case number PHEH2015US021631 is an initial spontaneous report received from a nurse on 15 Oct 2015. This report refers to a 26 year old female patient who was a nurse. Past medical history and concomitant medications were not reported. It was reported that on 11 Oct 2015 she accidentally stuck herself with the smaller of the two needles that comes with RABAVERT (batch number: not reported) after injecting the patient. The nurse was trying to recap the needle when she got stuck. She did not report the incident until 13 Oct 2015. The reporter stated that the needles provided with RABAVERT were not safety needles which allowed the incident to occur. The outcome, seriousness and causality of the events were not reported. Follow-up information received on 22 December 2015: In 2015, HIV test, RPR test, Hepatitis B and C antigen test were negative. On an unknown date, the outcome of the accidental needle stick was recovered/resolved.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Patient's pertinent medical history and drug reaction were not reported. On 28-JAN-2016 the patient was vaccinated with a second dose of  RECOMBIVAX HB lot # L026037, expiration date on 17-JAN-2018 (dose, frequency, route of administration and anatomical location were not provided), which was later than the recommended dosing schedule (inappropriate schedule of drug administration) (Date of first dose was not provided). No adverse reaction was reported. Product quality complaint was not filled.  Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer referring to her 84 year old male partner. The patient's medical history included bypass surgery. Drug reactions/allergies: penicillin and lisinopril. On an unknown date (also reported as a couple of years ago) the patient was vaccinated with ZOSTAVAX, route: injection, frequency: one time injection. No concomitant medications were reported. The reporter was the patient's wife. She was reporting that on 23-NOV-2015 the patient got shingles after getting the ZOSTAVAX vaccine. Treatment given was gabapentin 300mg. Patient sought medical attention. No further information was provided for documentation. The outcome the event was reported as resolving. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a physician- a non-pregnant female patient in her 50's via a company representative. The patient's concurrent conditions and medical history were not reported. On an unknown date (reported as "within the last 6 months"), the patient was vaccinated with ZOSTAVAX 0.65 ml, once (lot #, expiration date, route of administration and anatomical location were not reported). There were no concomitant medications provided. On an unknown date (reported as "within the last 6 months"), the patient experienced swelling around the injection site, after she received ZOSTAVAX. Treatment was not given for adverse event. She did not seek medical attention and there were no lab diagnostics studies performed. The outcome of the event was unknown (reported as "the representative believed that the physician had since recovered"). The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age and gender. The patient's concurrent condition and medical history were not provided. On 08-JUL-2015 the patient received the one dose of GARDASIL (strength, frequency and lot number were not reported). Concomitant medications were not provided. On 06-NOV-2016 and 18-JAN-2016 the patient received GARDASIL 9 (dose 1 and dose 2 respectively, strength, frequency and lot number were not reported) to complete their hpv series (inappropriate schedule of drug administration) (wrong drug administered). No adverse effects reported. Causality assessment was not provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Erythema, Hypersensitivity, Pain, Peripheral swelling
Clinical narrative: Pt. received vaccines 2/1 430 pm. 2/2 8:15 AM mom reported child feeling achy all over. Pt had gone to school, no c/o arms except soreness. No fever. After school arms very sore with some redness/swelling - lime size. Advised Ibuprofen and circling swollen area. 2/3 AM swelling whole shoulder, axilla. Treated with KEFLEX. 2/4 2AM to ER for increased swelling and pain. ? cellulitis - IV CEFTIN - home with PO. 2/4 - on CEFTIN PO.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot# L019287, 14-SEP-2017, L037339 09-FEB-2018, L013429 21-JUL-2017. No adverse effects were reported. This is one of the 4 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report 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 01-FEB-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K019388, expiry date 20-JAN-2016; dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Vaccine licensed through age 12 was administered to a 16 year old child. No adverse side effects experienced.
Sex: U
Vaccine: HEPA
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 demographics. On an unknown dates (time frame: 21-DEC-2015 to 05-JAN-2016), the patients were vaccinated with improperly stored doses of VAQTA lot # K018181, expiry: 04-JUN-2017 and lot#: L039659, expiry: 15-MAR-2017. No previous temperature excursion reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 28-JUL-2015, the patients were vaccinated with their first doses of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On 12-JAN-2016, the patient were vaccinated with their second dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On 01-FEB-2016, the patients were vaccinated with their third doses of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown demographics. On an unknown dates (time frame: 21-DEC-2015 to 05-JAN-2016), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L027733, expiry: 13-SEP-2017. No previous temperature excursion reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of oral ROTATEQ lot # K022995, 22-JUL-2015, L009119, 17-DEC-2016, L006184 13-DEC-2016, L013203 28-JAN-2017. No adverse effects were reported. This is one of the 4 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown demographics. On an unknown dates (time frame: 21-DEC-2015 to 05-JAN-2016), the patients were vaccinated with improperly stored doses of GARDASIL lot # K011325, expiry: 08-APR-2017. No previous temperature excursion reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of MMR II, K010318 22-JUL-2016, K003806 13-MAR-2016, K024036 26-NOV-2016, K010318 22-JUL-2016. No adverse effects were reported. This is one of the 4 reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Dizziness, Feeling abnormal, Vision blurred
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning a 18 year old female patient. The patient's concurrent conditions, medical history or allergy/drug reactions were reported as none. On 18-SEP-2015, the patient was vaccinated with GARDASIL 9 injection, 0.5 ml/once, intramuscular route, lot # L013429, exp.:21-JUL-2017. Concomitant therapy was not reported. On 19-SEP-2015, the, patient experienced severe stomach pain that lasted 2 to 3 months, "weird fluttery feeling in her head, blurry vision and feeling light headed". No treatment was give for the symptoms and no laboratory tests were performed. At the time of this report, the outcome of severe stomach pain, weird fluttery feeling in her head, blurry vision and feeling light headed was not informed. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report received from a health care student refers to a 16 year old male patient. No pertinent medical history was reported. No drug allergy/reactions was reported. On 15-DEC-2013 the patient was vaccinated with GARDASIL Quadrivalent (dose 1; dose, route and frequency: unknown) for immunization. On 24-NOV-2015, the patient was vaccinated with GARDASIL 9; dose 2; dose, route and frequency: unknown; lot number: L028083; expiry date: 03-SEP-2017) as the second dose (interchange of vaccine products and inappropriate schedule of drug administration). No adverse effects were reported. The outcome of interchange of vaccine products was unknown. The causality of interchange of vaccine products is not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
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 demographics. On an unknown dates (time frame: 21-DEC-2015 to 05-JAN-2016), the patients were vaccinated with improperly stored doses of Oral, ROTATEQ lot # L013203, expiry: 28-JAN-2017. No previous temperature excursion reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Left deltoid - redness, pain and itching. Started 2/03/16 at about 5 pm size 3 in in diameter. Recommended cool compresses. Started hydroxyzine 10 mg/5mL 1 teaspoon every 6 to eight hours as needed for 7 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) regarding two unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 22-DEC-2015, the patients were vaccinated with two doses of VARIVAX, Lot # K026385, (dose and route of administration not provided), which were improperly stored. There were no concomitant medications reported. There were no adverse effects reported. This is one of several cases from the same source (MARRS # 1601USA011654, 1602USA002863, 1602USA002864 and 1602USA002865). Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm injection site swelling and redness, pain, hot feeling, sweating, wheezing.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Wheezing
Clinical narrative: (R) arm injection site swelling and redness, pain, hot feeling, sweating, wheezing.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 03-FEB-2016 the patient was vaccinated with expired dose of RECOMBIVAX HB (Lot 3 J012520, expiration date 30-JAN-2016) pediatric/adolescent formulation of 5 mcg, 0.5 ml, intramuscular, anatomical location was unspecified. No concomitant medications were reported. The reporter noted it was unspecified when this patient was administered the first dose of RECOMBIVAX HB but she stated that the dose administered on 03-FEB-2016 was not the first dose. No adverse effect reported, no further information was provided, no product quality complaint was involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Asthenia, Diplegia, Full blood count normal, Injected limb mobility decreased
Clinical narrative: Day 1: Suffer debilitating pain/weakness in left arm about three hours after PNEUMOVAX injection. Shooting pains up and down the left arm and virtual paralysis of the arm. Cold packs, NSAIDS. Day 2-5: heat and NSAIDS. Hot, red, spot below pneumonia shot spot on inner upper arm on day three persists through day 5. Cannot lift arm above waist. Cannot dress and undress myself. Day 5: visit urgent care. Emergency Department recommended. See #12 on VAERS reporting system form for results of ED visit. Elevated ESR = 67. Receive MEDROL DOSEPACK 4 mg oral tablets, 21 tabs taken over 6 days. Days 6 - 11: continued MEDROL, symptoms abate, can move arm. Soreness and weakness continue. Day 14: visit internist and receive order for physical therapy.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Metabolic function test normal, Muscular weakness, Pain
Clinical narrative: Day 1: Suffer debilitating pain/weakness in left arm about three hours after PNEUMOVAX injection. Shooting pains up and down the left arm and virtual paralysis of the arm. Cold packs, NSAIDS. Day 2-5: heat and NSAIDS. Hot, red, spot below pneumonia shot spot on inner upper arm on day three persists through day 5. Cannot lift arm above waist. Cannot dress and undress myself. Day 5: visit urgent care. Emergency Department recommended. See #12 on VAERS reporting system form for results of ED visit. Elevated ESR = 67. Receive MEDROL DOSEPACK 4 mg oral tablets, 21 tabs taken over 6 days. Days 6 - 11: continued MEDROL, symptoms abate, can move arm. Soreness and weakness continue. Day 14: visit internist and receive order for physical therapy.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Red blood cell sedimentation rate increased, X-ray limb abnormal
Clinical narrative: Day 1: Suffer debilitating pain/weakness in left arm about three hours after PNEUMOVAX injection. Shooting pains up and down the left arm and virtual paralysis of the arm. Cold packs, NSAIDS. Day 2-5: heat and NSAIDS. Hot, red, spot below pneumonia shot spot on inner upper arm on day three persists through day 5. Cannot lift arm above waist. Cannot dress and undress myself. Day 5: visit urgent care. Emergency Department recommended. See #12 on VAERS reporting system form for results of ED visit. Elevated ESR = 67. Receive MEDROL DOSEPACK 4 mg oral tablets, 21 tabs taken over 6 days. Days 6 - 11: continued MEDROL, symptoms abate, can move arm. Soreness and weakness continue. Day 14: visit internist and receive order for physical therapy.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 26-JAN-2016, the patient was vaccinated with one dose of VARIVAX (Merck), Lot # K026385, (dose and route of administration not provided), which was improperly stored. There were no concomitant medications reported. There were no adverse effects reported. This is one of several cases from the same source (MARRS # 1601USA011654, 1602USA002862, 1602USA002863 and 1602USA002864). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 29-DEC-2015, the patient was vaccinated with one dose of VARIVAX (Merck), Lot # K026385, (dose and route of administration not provided), which was improperly stored. There were no concomitant medications reported. There were no adverse effects reported. This is one of several cases from the same source (MARRS # 1601USA011654, 1602USA002862, 1602USA002863 and 1602USA002865). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 13-SEP-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 29-DEC-2015, the patients were vaccinated with two doses of PROQUAD (Merck), Lot # L014401, (dose and route of administration not provided), which was improperly stored. There were no concomitant medications reported. There were no adverse effects reported. This is one of several cases from the same source (MARRS # 1601USA011654, 1602USA002862, 1602USA002864 and 1602USA002865). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Paraesthesia oral, Pharyngeal oedema, Pruritus
Clinical narrative: Pt noticed an itching sensation within a few minutes. Pt began noticing her tongue and throat feeling "funny - as if they were swelling" she took BENADRYL and it helped. After that she developed a large welt at where injection was given. Welt went away yet reappeared 72 hours later and was sore. Advised to inform her PCP.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Pt noticed an itching sensation within a few minutes. Pt began noticing her tongue and throat feeling "funny - as if they were swelling" she took BENADRYL and it helped. After that she developed a large welt at where injection was given. Welt went away yet reappeared 72 hours later and was sore. Advised to inform her PCP.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Amenorrhea.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right arm swelling, pain on touch and redness noted. No fever/limitation of movement.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Soreness at site, redness and itching lasting (6) six days. Resolved without treatment.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician regarding to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L011846, expiration date 16-JUN-2017; lot # L016429, expiration date 09-AUG-2017; dose and route were unknown). The temperature excursion for the vaccine was 47 F, time frame was 36 hours. There was no previous temperature excursion. It was not because of a "data logger". No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N.) referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 29-JAN-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (Lot# K007825; expiration date 13-JAN-2016) (dose and route of administration were not reported). Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (routes, doses, frequency and anatomical place of vaccinations were not provided), lot # K026532, expiration date 07-AUG-2017). The doses of the vaccine were exposed to 47.6 degrees F for 85 minutes before been administered. Concomitant therapies were not provided. No adverse effects reported. There was not product quality complaint involved. This is one of several reports from the same source.
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Mydriasis, Tremor
Clinical narrative: This spontaneous report was received from a nurse practitioner, via a company representative, referring to a male patient of unknown age. The patient's medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 0.5 ml, intramuscular. Concomitant medication was not reported. The patient passed out in the healthcare professional's office after receiving the GARDASIL 9 injection. The patient's pupils were dilated and the patient began shaking. The patient sought medical attention as the adverse events occurred in the office. The outcome and causality of tremor, mydriasis and loss of consciousness were unknown. Additional information is not expected the reporter did not authorize further contact with the physician.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On an unknown date the patients were vaccinated with improperly stored doses of oral ROTATEQ (lot # L013193, expiration date 20-JAN-2017, dose and route were unknown). The temperature excursion for the vaccine was 47 F, time frame was 36 hours. There was no previous temperature excursion. It was not because of a "data logger". No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On an unknown date the patients were vaccinated with improperly stored doses of VAQTA (lot # L030442, expiration date 19-DEC-2016; lot # L032749, expiration date 04-NOV-2016; dose and route were unknown). The temperature excursion for the vaccine was 47 F, time frame was 36 hours. There was no previous temperature excursion. It was not because of a "data logger". No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On an unknown date the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L002866, expiration date 10-NOV-2017, dose and route were unknown). The temperature excursion for the vaccine was 47 F, time frame was 36 hours. There was no previous temperature excursion. It was not because of a "data logger". No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 05-MAY-2015 the patient was vaccinated with the first dose of VAQTA (dose, route, lot# and expiration date were unknown). On 13-OCT-2015, the patient was vaccinated with the booster dose of VAQTA (dose, route, lot# and expiration date were unknown). Concomitant therapies were not reported. No adverse effects were reported. Additional information is not expected as we have no consent to contact the physician.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number reported as L026599, expiration date 22-JUN-2017, dose and route were unknown). The temperature excursion for the vaccine was 47 F, time frame was 36 hours. There was no previous temperature excursion. It was not because of a "data logger". No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL (lot # J009788, expiration date 17-MAR-2016, dose and route were unknown). The temperature excursion for the vaccine was 47 F, time frame was 36 hours. There was no previous temperature excursion. It was not because of a "data logger". No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: HIBV, IPV, PPV, RVX, TD
Symptoms: Blister, Dermatitis bullous, Malaise, Nausea, Pyrexia
Clinical narrative: Case number PHHY2014US032522, is an initial literature report received on 14 Mar 2014. The authors in the article described about a child with diffuse cutaneous mastocytosis who developed vaccination induced severe bullous eruption. This report refers to a 5 month-old male child. He was diagnosed with diffuse cutaneous mastocytosis (DCM) at 3 months of age based on the peau d'orange appearance of his skin with positive Darier sign. Total tryptase was 64 ng/ml with mature fraction of 3.1 ng/ml, urinary histamine 873 mcg/gr creatinine. Skin biopsy revealed a patchy band-like infiltrate of mononuclear cells in the dermis positive for tryptase and CD117. Therapy with H1 and H 2-antagonists and topical sodium cromoglycate was initiated. On an unknown date, he received routine scheduled vaccinations with Hib (manufacture and batch number unknown; therefore conservatively considered as VAXEMHIB); diphtheria and tetanus toxoid vaccine (manufacture and batch number unknown: therefore conservatively considered as Td-pur INN); IPV (manufacture and batch number unknown; therefore conservatively considered as IPV-VIRELON); rotavirus vaccine (other manufacturer and batch number unknown) and conjugated pneumococcal vaccine (other manufacturer and batch number unknown) at five months of age. A day after vaccination, he experienced systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fevers and generalized malaise. Treatment was rendered with 0.5 mg/kg oral steroids for five days. The final outcome of the events was complete recovery with no residual skin changes. The authors concluded vaccinations are an under-recognized trigger for blistering in children with DCM. Premedication and vaccine administration on one-at-a-time basis may reduce the severity. On 25 January 2016, this case was identified as a duplicate of case B0801578A and will be deleted. All future information will be added to case B0801578A which stands as a case of record for this patient.
Age: 0.4
Sex: M
Vaccine: HIBV, IPV, PPV, RVX, TD
Symptoms: Vaccination complication, Vomiting
Clinical narrative: Case number PHHY2014US032522, is an initial literature report received on 14 Mar 2014. The authors in the article described about a child with diffuse cutaneous mastocytosis who developed vaccination induced severe bullous eruption. This report refers to a 5 month-old male child. He was diagnosed with diffuse cutaneous mastocytosis (DCM) at 3 months of age based on the peau d'orange appearance of his skin with positive Darier sign. Total tryptase was 64 ng/ml with mature fraction of 3.1 ng/ml, urinary histamine 873 mcg/gr creatinine. Skin biopsy revealed a patchy band-like infiltrate of mononuclear cells in the dermis positive for tryptase and CD117. Therapy with H1 and H 2-antagonists and topical sodium cromoglycate was initiated. On an unknown date, he received routine scheduled vaccinations with Hib (manufacture and batch number unknown; therefore conservatively considered as VAXEMHIB); diphtheria and tetanus toxoid vaccine (manufacture and batch number unknown: therefore conservatively considered as Td-pur INN); IPV (manufacture and batch number unknown; therefore conservatively considered as IPV-VIRELON); rotavirus vaccine (other manufacturer and batch number unknown) and conjugated pneumococcal vaccine (other manufacturer and batch number unknown) at five months of age. A day after vaccination, he experienced systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fevers and generalized malaise. Treatment was rendered with 0.5 mg/kg oral steroids for five days. The final outcome of the events was complete recovery with no residual skin changes. The authors concluded vaccinations are an under-recognized trigger for blistering in children with DCM. Premedication and vaccine administration on one-at-a-time basis may reduce the severity. On 25 January 2016, this case was identified as a duplicate of case B0801578A and will be deleted. All future information will be added to case B0801578A which stands as a case of record for this patient.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Pain, Rash pruritic, Urticaria
Clinical narrative: Case number PHHY2015US029090, is an initial spontaneous report received from a physician via Vaccine Adverse Event Reporting System (VAERS reference number: 545934) website on 05 Mar 2015. This report refers to a 65 year old female patient. Historical conditions were not provided. Concurrent conditions include seasonal allergy, hypertension and drug hypersensitivity to LEVAQUIN. Concomitant medications include PROZAC, ZYRTEC and BENICAR. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported), along with pneumococcal vaccine (manufacturer and batch number: unknown) and ZOSTAVAX (batch number: not reported) subcutaneously on 31 Oct 2007. On 02 Nov 2007, the patient developed hives with a human hand all over body. Approximately on 26 Dec 2007, the patient developed a rash across both sides of her left arm. The rash was itchy but had no blisters and the rash was painful. She stated that they have been reoccurring since 2007 and currently the patient had hives. The event hives was treated with doxepin hydrochloride 25 mg. No lab diagnostics studies were performed. The patient would see a dermatologist in a few days. The outcome of the events was not recovered. The events were reported as non-serious. The causality assessment of the events was not reported.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US029090, is an initial spontaneous report received from a physician via Vaccine Adverse Event Reporting System (VAERS reference number: 545934) website on 05 Mar 2015. This report refers to a 65 year old female patient. Historical conditions were not provided. Concurrent conditions include seasonal allergy, hypertension and drug hypersensitivity to LEVAQUIN. Concomitant medications include PROZAC, ZYRTEC and BENICAR. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported), along with pneumococcal vaccine (manufacturer and batch number: unknown) and ZOSTAVAX (batch number: not reported) subcutaneously on 31 Oct 2007. On 02 Nov 2007, the patient developed hives with a human hand all over body. Approximately on 26 Dec 2007, the patient developed a rash across both sides of her left arm. The rash was itchy but had no blisters and the rash was painful. She stated that they have been reoccurring since 2007 and currently the patient had hives. The event hives was treated with doxepin hydrochloride 25 mg. No lab diagnostics studies were performed. The patient would see a dermatologist in a few days. The outcome of the events was not recovered. The events were reported as non-serious. The causality assessment of the events was not reported.