chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Inflammation, Peripheral swelling
Clinical narrative: This spontaneous report was received from a reporter via agency (Control # 60341), concerning a 66 year old male patient with allergy to statin drug, thyroid medications and PROSCAR. Co-suspect and concomitant therapies were not reported. On 24-NOV-2014 at 11:47, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose number and route were not reported) lot # K008410, expiration date 26-FEB-2016. The reporter stated that on 25-NOV-2014, patient's arm was very inflamed and swollen. He was in much discomfort. His arm was swollen from his shoulder to elbow. Patient seek for medical attention and was prescribing antihistamine and cold compresses as treatment. At the time of the report the outcome was unknown. This is one (1) of three (3) reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a reporter via agency (Control # 60341), concerning a female patient of an unknown age. Co-suspect and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose number and route were not reported) lot # K008410, expiration date 26-FEB-2016. The reporter stated that on an unknown date patient received her injection and she also had a severe reaction. At the time of the report the outcome was unknown. This is one (1) of three (3) reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients. Medical history and concurrent conditions were not reported. On unspecified dates the patients were vaccinated with ZOSTAVAX (route, dosage, dose number and lot number unknown). The pharmacist reported that "injection site reactions are common" with ZOSTAVAX, and he observed many injection site reactions that he did not report as AEs. He did not recall any specific details about any of these other injections site reactions at the time of this report. The outcome of the injection site reactions was unknown. This is one of three reports on the same source. Follow up information was received on 16-DEC-2014 from the pharmacist. The pharmacist states he had no access to the Lot number for the ZOSTAVAX vaccine he and wife received. The pharmacist also stated he had no patient identifiers, Lots numbers or dates of vaccinations for the other patients he referred to in the original report. The pharmacist had no information to share at this time. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Weight decreased
Clinical narrative: This spontaneous report as received from a female consumer of unknown age reporting of herself. Medical history and concurrent conditions were not reported. In March 2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date were not provided). Other suspect therapies included influenza virus vaccine (manufacturer unknown) the reporter stated ("almost died after getting it"). Concomitant therapies included aspirin. In March 2014 (after receiving the vaccine), the patient developed shingles. The consumer stated "I only have a few blisters bit it's very painful and I've lost 20 pounds. The consumer stated she saw her physician, on an unspecified date, in regards to the reaction. The physician prescribed Acyclovir for treatment. The consumer stated the Acyclovir "isn't working out too well". When asked if any laboratory or diagnostic studies were performed the consumer stated "my doctor takes blood tests all the time." The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date were not provided). There was no concomitant medication. On an unknown date, the patient developed shingles after receiving ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 10 and half months old infant patient of unknown gender. Pertinent medical history, drug reactions and allergies was not reported. On an unknown date the patient was vaccinated with VAQTA, a 0.5 mL dose. (Lot# and expiration date was not provided). Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via physician via other agency (US14-046394) refers to a 53 year old female patient. Medical history and concurrent conditions were not reported. On 21-NOV-2014, the patient was vaccinated with a once dose of ZOSTAVAX 0.65 ml, subcutaneous lot # J013138, expiry date 17-JAN-2015. Concomitant therapies included LIPITOR, Atenolol, amlodipine and lisinopril (manufacturer unknown). On 22-NOV-2014, the patient experienced that her injection site was really hurting and she took TYLENOL, but pain was increasing. On 24-NOV-2014, the patient having reaction coming up at her injection site which included being puffed up to the size of an orange, hot to touch and painful. It was unknown if there was any relevant laboratory data. At the time of the report it was unknown if the patient will continue to take ZOSTAVAX. The patient continued to experienced her injection site really hurting and a reaction coming up at the injection site which include being puffed up to the size of an orange, hot to touch and painful. Relatedness between the therapy with ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Left arm red and warm to touch from elbow to shoulder. Redness extends 3/4 way around arm. Pt states no pain and minimal itching. Still a little red 12/17.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria papular
Clinical narrative: Papular urticaria to ankles of knees (R) shoulder lack.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a 67 year old female patient reporting on herself during an interview as part of a marketing research program for ZOSTAVAX. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, strength and lot number not provided). Co-suspect or concomitant therapies were not provided. On an unknown date, according to reporter, patient had the ZOSTAVAX and then ended up in the ER (emergency room) (no hospitalization reported). At the time of the report, the outcome of the event was unknown. The causal relationship between ZOSTAVAX and the event was unknown. Additional information is not expected since no consent for follow up was given.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation
Clinical narrative: This spontaneous report was received from a reporter via other company (Control # 60341), concerning a 70 year old female patent with no allergies. Co-suspect and concomitant therapies were not reported. On 24-NOV-2014 at 12:06, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose number and route were not reported) lot # K008410, expiration date 26-FEB-2016. The reporter stated that on 25-NOV-2014, the patient's arm was also inflamed. Patient was told use ice packs on the area as treatment. At the time of the report the outcome was unknown. This is one (1) of three (3) reports from the same source. Additional information has been requested,
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: A ZOSTAVAX vaccine was given on 12/9/14 in the left arm. Patient reported that on 12/11/14 she noticed that the sight was red and a "little itchy". BENADRYL was recommended and to report if it gets worse.
Age: 43.0
Sex: M
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: Rash on forearms bilaterally. Started 24-36 hours after he received 1st Hep B immunization.
Sex: U
Vaccine: DTAP
Symptoms: Aphonia, Cyanosis, Hyperhidrosis, Loss of consciousness
Clinical narrative: Heavy sweating. Turn blue in the face. Lost voice, stopped making sense. Lost consciousness.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age. Medical history and current condition of the patient was unknown. On an unknown date the patient was vaccinated with (Merck) VARIVAX lot # K009756, expire date reported as 09-JUL-2016, 0.5 ml, subcutaneous. Concomitant medication was unknown. On an unknown date unspecified amount of doses of (Merck) VARIVAX went temperature excursion were administered to an unspecified amount of patients and no adverse effect reported. The outcome was not reported. This is one of the two reports from the same source. (Same reporter link) (MARRS# 1412USA002940). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown demographics. Patient's pertinent medical history and drug reactions were not reported. On an unknown date patient received first and second dose of GARDASIL (dose, frequency, therapy route, lot#, expiry date unspecified). On 14-AUG-2014, patient was due for this third dose of GARDASIL. Reporting nurse stated that the patient was in the office on 15-DEC-2014 to receive the third dose of GARDASIL "which is now 4 months delayed". No adverse effects were reported. Outcome of the event was not reported. No product quality complaint (PQC) was reported. Reporter considered the event to be not related to GARDASIL. Additional information has been requested.
Age: 1.34
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse concerning to a 1 year old male patient. Patient's concurrent conditions and relevant medical history was not reported. On 11-NOV-2014, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number: K005185 with expiry date of 10-APR-2016). Concomitant medications were not reported. The temperature excursion for (Oka/Merck) VARIVAX was a supported excursion with long term stability data. No adverse symptoms were reported. The nurse reported that there have been no reports of adverse events following administration and there was no need for revaccination. The outcome of the events was unknown. The causality of the events with (Oka/Merck) VARIVAX was not reported. This case is linked to #1411USA007182 via same reporter link. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Full blood count, Influenza virus test, Neck pain, Pain in extremity
Clinical narrative: Erythema size of baseball. Moderate to severe (L) arm pain extending up to neck. Fever 101 aboot 24 hours later, currently 102.5 being treated today.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Erythema size of baseball. Moderate to severe (L) arm pain extending up to neck. Fever 101 aboot 24 hours later, currently 102.5 being treated today.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The reporter stated that a patient was administered a third dose of (Oka/Merck) VARIVAX (dose, route, lot number and expiry date were not reported) instead to a second dose of MMR II (dose, route, lot number and expiry date were not reported). No adverse events were reported. The outcome of the events was unknown. Additional information has been requested.
Age: 84.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to an 84 year old patient of unknown gender. No medical history or concurrent conditions were reported. On 14-DEC-2014, the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneous (dose, frequency, strength and lot number not provided). Co-suspect or concomitant therapies were not provided. The patient was inadvertently administered with (Oka/Merck) VARIVAX rather than ZOSTAVAX. 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 nurse refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of LIQUID PREDVAXHIB (strength, route of administration, dose and lot # were not reported). It was reported that the vaccine was not mentioned for unspecified period of time and there were no temperature logs available. The reporter was not aware of any adverse experiences at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: Two days of fever and aches with Tmax 104.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash erythematous
Clinical narrative: This spontaneous report as received from a nurse (also reported as health care worker) via field representative refers to a 84 year old female patient. The patient medical history and current condition was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX. Other co-suspects and concomitant medication was not reported. On an unknown date the patient experienced patient developed shingles after receiving ZOSTAVAX. Reporter also stated in her own words that the patient had five small red raised bumps on spine, one week later, patch under arm. Also reported as burning continues. The outcome of the events was reported as not recovered/not resolved. Causality was not assessed by the reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Medication error
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female of unknown age. Patient's pertinent medical history and drug reactions were not reported. In 2012 (reported as on an unspecified date, approximately 2 years ago) the patient was vaccinated with ZOSTAVAX (dose, frequency, therapy route lot #, expiry date unspecified). Concomitant medications were not reported. The patient reported that during vaccination, some of the vaccine dripped down her arm. No adverse experience was reported. Outcome of the event was not reported. No product quality complaint (PQC) was reported. Reporter considered the event to be not related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (healthcare worker) refers to a unspecified number of patients of unknown age. Current conditions and medical history was not reported. On 29-NOV-2014, the patients were vaccinated with (Oka/Merck) VARIVAX injection lot number K003414, expiry date 06-MAR-2016 (dose, route and frequency were not reported). Concomitant medications were not reported. Starting on 24-NOV-2014, the doses of (Oka/Merck) VARIVAX were exposed to a supported temperature excursion of 17.8 F for 93 hours. According to the Prescribing Information for (Oka/Merck) VARIVAX, the (Oka/Merck) VARIVAX should be stored frozen between-58 f (-50 C). Based on the information and assessed data, these (Oka/Merck) VARIVAX to temperatures colder than-58 F (-50 C). Based on the information and assessment data, these (Oka/Merck) VARIVAX should be used within three months. No adverse effects were reported. The outcome was unknown. Product quality complaint was not reported. No additional information was provided. This is one of the 2 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 registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 09-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Urticaria
Clinical narrative: Severe local reaction which developed into systemic urticaria.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of GARDASIL (strength, route of administration, dose and lot # were not reported). It was reported that the vaccine was not monitored for unspecified period of time and there were no temperature logs available. The reporter was not aware of any adverse experiences at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location, lot number were not reported) that was exposed to temperatures above the recommended storage range. The reporter was not aware of any adverse experiences. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug dose omission, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient missed an unspecified dose of GARDASIL (dose, route and lot number were not reported) due to a product defect. No adverse effect was reported. Product quality complaint was filed. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: This spontaneous report was received from a female patient of unknown age, regarding herself. Patient's pertinent medical history and drug reactions were not reported. On 12-OCT-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous (dose, frequency, lot #, expiry date unspecified). Concomitant medications were not reported. In 2014 (reported as sometimes after getting the shot) the patient experienced severe muscle and joint pain in arm after receiving ZOSTAVAX. Patient reported that she felt a sharp pain when she lifted her arm. Outcome of the event was reported as not recovered. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Pain, Vaccination site pain
Clinical narrative: This spontaneous report was received from a female patient of unknown age, regarding herself. Patient's pertinent medical history and drug reactions were not reported. On 12-OCT-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous (dose, frequency, lot #, expiry date unspecified). Concomitant medications were not reported. In 2014 (reported as sometimes after getting the shot) the patient experienced severe muscle and joint pain in arm after receiving ZOSTAVAX. Patient reported that she felt a sharp pain when she lifted her arm. Outcome of the event was reported as not recovered. No product quality complaint (PQC) was reported. Causality assessment was not provided. 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 concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 10-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Age: 1.19
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Vaccination failure, Varicella post vaccine
Clinical narrative: On 9/6/14 seen with varicella. Had varicella vaccine #1 on 4-25-14. (Failure to vaccine)
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Medical assistant reported that since 13-NOV-2014 patient have been administered GARDASIL (dose, route and lot numbers were not provided) that underwent a supported temperature excursion. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARCEL
Symptoms: Biopsy skin abnormal, Granulomatous dermatitis, Laboratory test normal, Vaccination complication, Vaccination site reaction
Clinical narrative: This literature marketed report as received from a other health professional concerning to a 77 year old female patient with breast cancer, acoustic neuroma, hearing loss and hypertension. The patient's medical history included lumpectomy and radiation therapy. On an unknown date the patient was vaccinated with VARIVAX (Merck) (manufacturer unknown) (dose, frequency and route unspecified). Concomitant medications were not reported. On an unknown date the patient developed VZV vaccination induced granulomatous dermatitis occurring at the site of VZV vaccination. A skin biopsy specimen from the plaque on the upper aspect of her left arm was taken. Histopathological examination showed an interstitial dermal inflammatory infiltrate composed of lymphocytes, histiocytes, eosinophils, plasma cells, and numerous giant cells. There was focal dermal fibrosis and collections of perivascular plasma cells. No evidence of foreign body was noted by polarized light examination and viral cytopathic effect was not identified. A VZV immunostain was negative for VZV antigen expression. Acid-fast bacillus, Fite, and periodic acid-Schiff stains were negative for infectious organisms. The outcome of the events was unknown. The causality of the events with VARIVAX (Merck) was considered to be related. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: This literature marketed report as received from a other health professional concerning to a 77 year old female patient with breast cancer, acoustic neuroma, hearing loss and hypertension. The patient's medical history included lumpectomy and radiation therapy. On an unknown date the patient was vaccinated with VARIVAX (Merck) (manufacturer unknown) (dose, frequency and route unspecified). Concomitant medications were not reported. On an unknown date the patient developed VZV vaccination induced granulomatous dermatitis occurring at the site of VZV vaccination. A skin biopsy specimen from the plaque on the upper aspect of her left arm was taken. Histopathological examination showed an interstitial dermal inflammatory infiltrate composed of lymphocytes, histiocytes, eosinophils, plasma cells, and numerous giant cells. There was focal dermal fibrosis and collections of perivascular plasma cells. No evidence of foreign body was noted by polarized light examination and viral cytopathic effect was not identified. A VZV immunostain was negative for VZV antigen expression. Acid-fast bacillus, Fite, and periodic acid-Schiff stains were negative for infectious organisms. The outcome of the events was unknown. The causality of the events with VARIVAX (Merck) was considered to be related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from health care worker refers to a patient of unknown age. Medical history and current condition of the patient was unknown. On an unknown date the patient was vaccinated with ZOSTAVAX lot # K015308, expire date 17-DEC-2015, 0.65 ml, subcutaneous. Concomitant medication was unknown. On an unknown date unspecified amount of doses of ZOSTAVAX went temperature excursion were administered to an unspecified amount of patients and no adverse effect reported. The outcome was not reported. This is one of the two reports received from the same source. (Same reporter link). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a female patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was inadvertently vaccinated with two doses of PNEUMOVAX 23 (dose, route, lot# were not reported) within a 5 year time frame. Concomitant therapy was not reported. Also reported that on an unknown date, after the second administration of the PNEUMOVAX 23 the patient experienced itchiness and swelling at the injection site. No Product Quality Complaint (PQC) was involved. Action taken with PNEUMOVAX 23 was not applicable (also reported as therapy continued). The outcome of inadvertently administered two doses of PNEUMOVAX 23 within a 5 year time frame and itchiness and swelling at the injection site was unknown. Causality assessment of events itchiness and swelling at the injection site was not provided by the 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 registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported 26 patients received doses of VARIVAX  (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a certified nurse assistance regarding an 11 year old female patient who was administered GARDASIL (lot # J008423) injection intramuscular 0.5ml in left deltoid on 21MAR2014. The GARDASIL was involved in a temperature excursion. No adverse event was reported. Please see additional information for other cases reported by same provider. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 10-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown age and gender. Medical history and current conditions were not reported. On an unknown date, 3 improperly stored doses of VARIVAX (Merck), 0.5 ml, subcutaneous (lot number and expiration date were not reported) were administered to unspecified patients. Concomitant medication was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-DEC-2014, the patient was vaccinated with expired dose of PNEUMOVAX 23 (dose and route unspecified). Lot number was reported as J014401 and expiry date was 26-NOV-2014. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PNEUMOVAX 23 was not reported. Product quality complaint was not reported. No further information reported. This is one of the 2 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with VARIVAX (Merck) injection (lot number and expiry date unknown) (dose 0.5 ml, frequency unknown) subcutaneously which on an unknown date had undergone a temperature excursion (details unspecified). No adverse events were reported. No product quality issue was reported. The action taken with the VARIVAX (Merck) therapy and the outcome of the events was unknown. The relatedness of the events to the therapy with VARIVAX (Merck) was unknown. Follow up information has been received on 09-DEC-2014. The reporter provided the lot numbers. This case includes lot number # K006138, expiration: 29-APR-2016 and doses to be returned 10. This case is linked to the case 1412USA008276 and 1411USA011908 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with VARIVAX (Merck) injection (lot number and expiry date unknown) (Dose 0.5 ml, frequency unknown) subcutaneously for an unknown indication which on an unknown date had undergone a temperature excursion (details unspecified). No adverse events were reported. No product quality issue was reported. The action taken with the VARIVAX (Merck) therapy and the outcome of the events was unknown. Follow up information has been received on 9-DEC-2014. The reporter provided the lot numbers. This case includes Lot number # K00294, expiration date: 26-FEB-2016 and doses to be returned 20. This case is linked to the case 1412USA008275 and 1411USA011908 (same reporter link). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous retrospective pregnancy report was received from female patient (nurse) of an unknown age regarding herself. The patient's drug allergies and pertinent medical history was unspecified. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency and route were not reported) when she was approximately 12 weeks pregnant. Concomitant medications were not reported. The LMP and EDD were not known. Initial exposure to GARDASIL was at 12 week(s). The patient delivered a female infant on an unknown date. The pregnancy outcome was live birth. The patient and her daughter did not had any adverse effects due to the GARDASIL. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneous (dosing regimen unspecified). No concomitant therapy was reported. On an unknown date after vaccination with a dose of ZOSTAVAX experienced shingles. The outcome of shingles is unknown. Causality assessment was not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist, reporting on his wife, a 56 year old female patient. On 17-OCT-2013 the patient was vaccinated with ZOSTAVAX (subcutaneous in the arm; dosage, dose number and lot number unknown). The pharmacist reported that on an unspecified date in 2013 he (MARRS case no. 1411USA005274) and his wife experienced an injection site reaction that "was mild" when they received ZOSTAVAX. He stated that they received the same lot number of ZOSTAVAX on the same day, but he does not have access to the documentation of the lot number report. He states that he and his wife both experienced a "quarter-sized" injection site redness with no pain or swelling. Neither he nor his wife sought medical attention nor received treatment. The outcome of the injection site redness was reported as recovered in an unspecified date in 2013 (reported as: within a couple of days). This is one of three reports from the same source. Follow up information has been received from a pharmacist on 16-DEC-2014. The pharmacist stated he has no access to the lot number for the ZOSTAVAX vaccine he and his wife received. The pharmacist also stated he had no patient identifiers, lots numbers or dates of vaccinations for the other patients he referred to in the original report. The pharmacist had no information to share at this time. Additional information has been requested. Narrative was updated.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report, as received from a physician refers to a 61 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number reported as K010630, expiry date 30-OCT-2015) (dosing and route unknown). Concomitant medications were not reported. The lot number of the diluent was reported as K010822, with expiry date 16-MAY-2017. On 11-DEC-2014 the patient experienced erythema and rash at the injection site after administration of ZOSTAVAX. The outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not provided. On 02-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 (dose/frequency: 0.5 ml) intramuscularly which was expired on 22-AUG-2014 (lot # not reported). No adverse effects were reported. No product quality complaint (PQC) was reported for PNEUMOVAX 23. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Lymphadenopathy
Clinical narrative: Developed redness and edema at site of injection 1 day after vaccination. 2 days after vaccination developed swollen axillary lymph node.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test normal, Hypotonia, Nuclear magnetic resonance imaging normal
Clinical narrative: Baby turned hypotonic, about 10 minutes after administration of PEDIARIX. Hypotonia lasted probably 3-4 minutes. No H/O baby turning blue or difficulty breathing, vitals-normal.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Anaphylactic reaction, Hypotension, Hypoxia, Urticaria
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of anaphylaxis in a 3-year-old male patient who received KINRIX (batch number 9AB77, expiry date unknown). Co-suspect products included MMR. Concurrent medical conditions included milk allergy and egg allergy. On 25th October 2013, the patient received KINRIX and MMR vaccine. On an unknown date, unknown after receiving KINRIX, the patient experienced anaphylaxis (serious criteria GSK medically significant), hypoxia (serious criteria GSK medically significant), hypotension and hives. On an unknown date, the outcome of the anaphylaxis, hypoxia, hypotension and hives were unknown. It was unknown if the reporter considered the anaphylaxis, hypoxia, hypotension and hives to be related to KINRIX. Additional information was provided: The patient was taken to emergency room for observation. No further information was available.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient says her arm hurts and is disabled from the vaccine.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient says her arm hurts and is disabled from the vaccine.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Pyrexia
Clinical narrative: Patient reported discomfort at site of injection and stated she noticed a large indurated area at the site about 12 days after the injection date. I measured the induration on 11/3/14 at about 30mm horizontally.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Cellulitis, Injection site discomfort, Injection site induration
Clinical narrative: Patient reported discomfort at site of injection and stated she noticed a large indurated area at the site about 12 days after the injection date. I measured the induration on 11/3/14 at about 30mm horizontally.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Limb discomfort, Muscular weakness, Pain in extremity
Clinical narrative: I received the shot on 11/13/14 and my arm is still in pain. There are times it goes completely numb and I have to move arm with other hand. Sleeping has become impossible. It is even hard to dress and even worse undress if I have to pull something over my head.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Activities of daily living impaired, Hypoaesthesia, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: I received the shot on 11/13/14 and my arm is still in pain. There are times it goes completely numb and I have to move arm with other hand. Sleeping has become impossible. It is even hard to dress and even worse undress if I have to pull something over my head.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Confusional state, Dizziness, Eye movement disorder, Loss of consciousness, Tremor
Clinical narrative: Almost immediately after receiving the vaccination, my daughter felt lightheaded, knelt down and then passed out. Her eyes rolled in the back of her head, and she shuttered.  She came to within a few minutes.  She was confused at first as to what was going on and where she was.  After about 5-10 minutes, she recovered and seemed fine.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Allergy test negative, Chest X-ray normal, Cough, Paranasal sinus hypersecretion, Productive cough
Clinical narrative: Heavy sinus drainage with severe coughing and wheezing. Only 10% of coughs result in producing mucus to spit.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Heavy sinus drainage with severe coughing and wheezing. Only 10% of coughs result in producing mucus to spit.
Age: 28.0
Sex: M
Vaccine: YF
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Patient states he had a sore left tricep.  Patient states the injection site began to itch, get red, and develop a rash.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever of 101.6; Body aches; Chills; Headache.
Age: 24.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Dyspnoea, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: Injection site is red and warm to the touch.  She felt feverish, SOB, lightheaded, nauseous.
Age: 24.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Injection site is red and warm to the touch.  She felt feverish, SOB, lightheaded, nauseous.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Sinusitis, Urinary incontinence, Urinary retention
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of acute disseminated encephalomyelitis in a 8-year-old male patient who received HAVRIX pediatric (batch number 4B299, expiry date 17th December 2016) and (batch number 4B299, expiry date unknown). Concomitant products included amoxicillin, azithromycin and ceftriaxone. On 23rd September 2014, the patient received HAVRIX pediatric. On an unknown date, the dose was an unknown dose. On 24th October 2014, 31 days after receiving HAVRIX pediatric, the patient experienced headache and fever. On 3rd November 2014, the patient experienced acute disseminated encephalomyelitis (serious criteria hospitalization, disability, GSK medically significant and clinically significant/intervention required), leg pain (serious criteria hospitalization and disability), numbness (serious criteria hospitalization, disability and clinically significant/intervention required), urinary retention (serious criteria hospitalization, disability, GSK medically significant and clinically significant/intervention required), muscle disorder (serious criteria hospitalization, disability and clinically significant/intervention required), bladder incontinence (serious criteria hospitalization, disability and clinically significant/intervention required) and tingling (serious criteria hospitalization, disability and clinically significant/intervention required). On an unknown date, the outcome of the acute disseminated encephalomyelitis, leg pain, numbness, muscle disorder, fever and tingling were recovering/resolving and the outcome of the headache was recovered/resolved and the outcome of the urinary retention and bladder incontinence were unknown. The reporter considered the acute disseminated encephalomyelitis, headache, leg pain, numbness, urinary retention, muscle disorder, fever, bladder incontinence and tingling to be possibly related to HAVRIX pediatric. Additional details provided: Pharmacist reports a patient who started experiencing a fever and headache about 1 month after receiving a HAVRIX vaccine. He went to the ER and it was thought that he had sinusitis and was given oral antibiotics. The headache and fever continued and he was admitted to the hospital on 11/3/2014 with leg pain, numbness and tingling and bladder incontinence. The patient was diagnosed with acute disseminated encephalomyelitis (ADEM) and started on steroid therapy. The patient was still complaining of poor muscle control and tingling. He has a Foley in place so the pharmacist was unable to evaluate how the bladder was progressing. She considered some of these symptoms to be disabling because he was not able to move around and be mobile because of the poor muscle control, tingling and poor bladder control. She considered the patient jeopardized because there were concerns that the tingling and poor muscle control, as well as the MRI abnormalities meant he might no longer be able to walk, so he was started on steroid therapy as an intervention.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness
Clinical narrative: Patient and spouse reports received Fluzone HD during a drive-thru flu clinic. Reports 3 hours later patient had lost hearing. Incident was reported to health department on 12/17/2014.
Age: 15.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Nasal congestion, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Started with vomiting, then fever. Took to pediatrician. Vomiting and fever stopped after a couple of days. Then sore throat which has been persistent. Then, clogged nose and cough that hasn't gone away.
Age: 37.0
Sex: F
Vaccine: PNC13
Symptoms: Abscess, Cellulitis, Haematoma, Induration, Nodule
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This is third of the three reports from the same pharmacist. A 37-years-old female patient received PREVNAR 13, single dose, on unknown date. Concomitant medication included BYSTOLIC, trazodone, levothyroxine, ADVAIR, PROTONIX, propranolol and LEXAPRO. On unknown date the patient experienced a huge terrible bad reaction. She had cellulitis, rash on her arm with a hard knot, hematoma and abscess. The patient had to have surgery. The pharmacist mentioned that this is the third patient who had had a very bad reaction to PREVNAR 13. According to the pharmacist the reported events were due to PREVNAR 13.
Age: 37.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Surgery, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This is third of the three reports from the same pharmacist. A 37-years-old female patient received PREVNAR 13, single dose, on unknown date. Concomitant medication included BYSTOLIC, trazodone, levothyroxine, ADVAIR, PROTONIX, propranolol and LEXAPRO. On unknown date the patient experienced a huge terrible bad reaction. She had cellulitis, rash on her arm with a hard knot, hematoma and abscess. The patient had to have surgery. The pharmacist mentioned that this is the third patient who had had a very bad reaction to PREVNAR 13. According to the pharmacist the reported events were due to PREVNAR 13.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Patient got her Imz on 11/4/14. She stopped by the pharmacy on 12/16/14 to report muscle soreness since getting IMZ. She went to dr which was going to order xray and possible physical therapy.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Clonic convulsion, Cough, Decreased appetite, Feeling cold, Gait disturbance
Clinical narrative: 4 hours after vaccine became very cold and shaky. Stumbling gait. Hyperventilating due to shaking. Seizure activity - clonic. Loss of appetite. Cough.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperventilation, Tremor
Clinical narrative: 4 hours after vaccine became very cold and shaky. Stumbling gait. Hyperventilating due to shaking. Seizure activity - clonic. Loss of appetite. Cough.