chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site warmth, Prostate infection
Clinical narrative: Patient reports (not witnessed) extreme swelling at injection site. Flu like symptoms-stiff neck-sore joints-(shoulders/elbows/back). Duration at 48hrs.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Prostatitis
Clinical narrative: Patient reports (not witnessed) extreme swelling at injection site. Flu like symptoms-stiff neck-sore joints-(shoulders/elbows/back). Duration at 48hrs.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Autoinflammatory disease, Influenza like illness, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports (not witnessed) extreme swelling at injection site. Flu like symptoms-stiff neck-sore joints-(shoulders/elbows/back). Duration at 48hrs.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Joint swelling, Prostatitis
Clinical narrative: Patient reports (not witnessed) extreme swelling at injection site. Flu like symptoms-stiff neck-sore joints-(shoulders/elbows/back). Duration at 48hrs.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information was obtain during a telephone call to the licensed practical nurse, on 23-JAN-2015. The licensed practical nurse did not have lot numbers and expiration dates readily available for PROQUAD, and reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from the licensed practical nurse on 18-MAR-2015, concerning a currently 5 years old patient of unknown gender, who was vaccinated with PROQUAD lot number K009894, expiration date not reported. This is one of several reports from the same reporter. Additional information is not expected, since all the information needed to complete the case has been received.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information was obtain during a telephone call to the licensed practical nurse, on 23-JAN-2015. The licensed practical nurse did not have lot numbers and expiration dates readily available for PROQUAD (Merck), and reported that no adverse event had been reported following administratoin of vaccinations. Follow up information has been received from the licensed practical nurse on 18-MAR-2015, concerning a currently 5 years old patient of unknown gender, who was vaccinated with a dose of PROQUAD (Merck) lot number K009894, expiration date not reported. This is one of several reports received from the same reporter. Additional information is not expected, as all the information needed to complete the case has been received.
Age: 54.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Paraesthesia, Sensation of foreign body, Urticaria
Clinical narrative: 4:45 pm - Pt returned to clinic c/o hives. States he is not having any difficulty breathing. Reports face feels "tingly". Pt shows no apparent distress. Urticarial rash on bilateral UEs and upper back. No erythema or edema of pharynx. Lungs CTA. 4:50 pm Order given for diphenhydramine 50 mg IM and 80 mg (2 mL of 40 mg/mL) Depo Medrol IM now. 5:00 pm, Pt reports feeling a "lump in my throat". EpiPen Auto-Injector administered. 5:20 pm Reports still feels the lump in his throat, but it is no worse. Denies throat itching or difficulty breathing. Denies drowsiness. BP 140/72 in L arm (sitting). Apical pulse 80. Pt alert and oriented x 4. No apparent distress. No erythema or edema of pharynx. Lungs CTA. No spread of urticarial rash. Pt released to drive home. Advised he may continue OTC Benadryl every 4-6 hours (pt reports a supply at home). Pt advised Depo Medrol may increase his blood sugar. Pt advised to call PCP in the morning for f/u and go immediately to ER with difficulty breathing.
Age: 8.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Unnecessary vaccine given.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Cardiac stress test, Echocardiogram, Electrocardiogram, Extrasystoles, Headache
Clinical narrative: Headaches, missed heartbeats after receiving pcv 13.
Age: 54.0
Sex: F
Vaccine: IPV, PPV
Symptoms: Body temperature increased, Erythema, Fatigue, Headache, Injection site pain
Clinical narrative: Severe headache, severe nausea, pain at site of injection, redness, swelling, temperature 101 Fahrenheit, body aches, exhaustion. Pt took Bayer aspirin and Nyquil the next few days with no relief of symptoms.
Age: 54.0
Sex: F
Vaccine: IPV, PPV
Symptoms: Nausea, Pain, Swelling
Clinical narrative: Severe headache, severe nausea, pain at site of injection, redness, swelling, temperature 101 Fahrenheit, body aches, exhaustion. Pt took Bayer aspirin and Nyquil the next few days with no relief of symptoms.
Age: 0.44
Sex: F
Vaccine: RV1
Symptoms: Carbon dioxide, Dehydration, Diarrhoea, Laboratory test abnormal, Vomiting
Clinical narrative: Vomiting, diarrhea for 5 days, dehydration.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dyskinesia, Facial asymmetry, Lacrimation increased, VIIth nerve paralysis
Clinical narrative: Increased left eye watering, inability to smile on left, noticed more facial asymmetry by the next morning- Bell's Palsy.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Headache, Pyrexia, Tremor
Clinical narrative: Fever 102-103 degrees the night of vaccine through 4/12/15, + dizziness, headache and shaking through 4 days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: (1) Swollen, bump, red from shoulder to elbow (per patient observation). (2) Warm to touch (per patient observation). *No trouble breathing or fever, no reaction to other shots before.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Extreme pain in left arm (site of vaccine) to the point I was unable to lift my arm. The pain has subsided somewhat (it is still present when I move my arm) and I am unable to ascertain the actual degree of pain because I am taking medication to deal with the fibromyalgia pain. One day when I did not take my medication, the pain was significantly worse. Neither heat nor ice seem to impact the pain, and it does not go away entirely with the pain medication I am taking (tramadol, gabapentin, acetaminophen).
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Rash, Vaccination site irritation
Clinical narrative: Irritation and redness on vaccination site; Rash on hands, around neck, and chest.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Rash with blisters on abdomen and back.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain, Fatigue, Influenza like illness, Rash
Clinical narrative: Per phone call into office patient developed a rash on upper arm, flu-like symptoms fatigue and abdominal pain for 3 days.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Infection, Peripheral swelling, Skin warm
Clinical narrative: Large area of arm red and swollen and warm. Reaction worsened on day 2 after vaccine. Pt sought treatment at E.R. Treated as allergy and infection. Prescribed MEDROL dose pack and BENADRYL for allergy and CLEOCIN 300 mg QID x 7d for infection.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Expired product administered, Underdose
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 34-year-old male patient who received ENGERIX B pediatric (batch number 4HX57, expiry date 5th March 2015). On 30th March 2015, the patient received ENGERIX B pediatric (intramuscular) .5 ml. On 30th March 2015, an unknown time after receiving ENGERIX B pediatric, the patient experienced expired vaccine used, vaccine underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used, vaccine underdose and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the expired vaccine used, vaccine underdose and inappropriate age at vaccine administration to be related to ENGERIX B pediatric. Additional information received: An adult was given a pediatric dose (0.5ml) which expired on 05 March 2015.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza in a 55-year-old female patient who received Influenza vaccine (batch number unknown, expiry date unknown). The patient's past medical history included breast cancer, surgery (breast tumor removed) and pulmonary embolism. Previously administered products included radiation therapy and ADVAIR DISKUS with an associated reaction of drug ineffective. Concurrent medical conditions included depression, post-traumatic stress disorder, difficulty breathing, chronic bronchitis and allergic asthma. Concomitant products included ADVAIR DISKUS, BREO ELLIPTA, LAMICTAL, AMBIEN, CELEXA, KLONOPIN, SEROQUEL, ABILIFY, Albuterol, COUMADIN, hydrocodone, metformin and Nebulized Albuterol. In November 2014, the patient received Influenza vaccine. On an unknown date, the dose was an unknown dose. On 6th February 2015, 61 days after receiving Influenza vaccine, the patient experienced influenza. The patient was treated with TAMIFLU and Steroids. On an unknown date, the outcome of the influenza was recovering/resolving. It was unknown if the reporter considered the influenza to be related to Influenza vaccine. Additional details were reported as follows: On 6 February 2015, 2 or 3 months after receiving Influenza vaccine, the patient caught the flu. She went to the emergency room and was given steroids and TAMIFLU. She did not have to be hospitalized. Lack of effect of influenza vaccine was reported but the GSK criteria of vaccination failure were not met. Please refer to case US2015GSK029684 for tolerance to ADVAIR DISKUS, BREO ELLIPTA and LAMICTAL.
Age: 31.0
Sex: F
Vaccine: YF
Symptoms: Chest discomfort, Eye swelling, Feeling abnormal, Throat tightness, Wheezing
Clinical narrative: Developed swelling of the eyes, tightness in her throat and chest with associated wheezing and raspy feeling in chest. Advised to go to ER and pt received BENADRYL 50 mg IM.
Age: 1.8
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 21 month old patient of unknown gender who on 26-MAR-2015 was vaccinated with a dose of PROQUAD (Merck) (lot # K022445, expiration date 13-MAY-2016) 0.5 ml, subcutaneous in the left thigh, concomitantly with a dose of VARIVAX (Merck) (lot # K015969, expiration date 23-SEP-2016) (dose and route were not reported) in the left thigh (overdose). No adverse effects were reported. The patient did not seek medical attention. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of rash in a 33-year-old male patient who received Hepatitis B. In 2015, the patient received the 1st dose of Hepatitis B. On an unknown date, an unknown time after receiving Hepatitis B, the patient experienced rash, itchy skin ad skin red. On an unknown date, the outcome of the rash, itchy skin and skin red were not reported. It was unknown if the reporter considered the rash, itchy skin and skin red to be related to Hepatitis B. Additional information was provided: GSK has received the consumer's wife call on 09 April 2015. The man 33 years of age and recently has been vaccinated with hepatitis B. He was rashed, the skin became itchy and red. It is unknown which company's vaccine has been used, it was the first dose. According to wife's words her husband visited the doctor, no recommendations received. She does not know if her husband has any concomitant diseases.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information was obtain during a telephone call to the licensed practical nurse, on 23-JAN-2015. The licensed practical nurse did not have lot numbers and expiration dates readily available for PROQUAD (Merck), and reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from the licensed practical nurse on 18-MAR-2015, concerning a currently 5 years old patient of unknown gender, who was vaccinated with a dose of PROQUAD (Merck) lot number K011313, expiration date not reported. This is one of several reports received from the same reporter. Additional information is not expected, since all the information needed to complete the case has been already received.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information was obtain during a telephone call to the licensed practical nurse, on 23-JAN-2015. The licensed practical nurse did not have lot numbers and expiration dates readily available for PROQUAD (Merck), and reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from the licensed practical nurse on 18-MAR-2015, concerning a currently 6 years old patient of unknown gender, who was vaccinated with a dose of PROQUAD (Merck) lot number K011313, expiration date not reported. This is one of several reports from the same reporter. Additional information is not expected, since all the information needed to complete the case has been already received.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information was obtain during a telephone call to the licensed practical nurse, on 23-JAN-2015. The licensed practical nurse did not have lot numbers and expiration dates readily available for PROQUAD (Merck), and reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from the licensed practical nurse on 18-MAR-2015, concerning a currently 5 years old patient of unknown gender, who was vaccinated with a dose of PROQUAD (Merck) lot number K011313, expiration date not reported. This is one of several reports from the same reporter. Additional information is not expected, since all the information needed to complete the case has already been received.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information was obtain during a telephone call to the licensed practical nurse, on 23-JAN-2015. The licensed practical nurse did not have lot numbers and expiration dates readily available for PROQUAD (Merck), and reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from the licensed practical nurse on 18-MAR-2015, concerning a currently 5 years old patient of unknown gender, who was vaccinated with a dose of PROQUAD (Merck) lot number K009894, expiration date not reported. This is one of several reports received from the same reporter. Additional information is not expected, since all the information needed to complete the case has been already received.
Sex: U
Vaccine: RV5, RV5, RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history and drug reactions/allergies were not reported. The patient had received all three doses in the series of ROTATEQ orally (dose and lot# were not reported), which was at the correct dosing intervals on unspecified dates. On unspecified date, the patient developed rotavirus after receiving all three doses in the series of ROTATEQ and was hospitalized in a hospital at the reporting time. The physician stated that this was the second patient that developed rotavirus after receiving all three doses of ROTATEQ. The outcome of the event and the causality were not reported. This is one of two reports (MARRS# 1504USA011404 and 1504USA011252) from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5, RV5, RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician referring to a patient of unknown gender and age. The patient's medical history and drug reactions/allergies were not reported. The patient had received all three doses in the series of ROTATEQ orally (dose and lot# were not reported) on unspecified dates. On unspecified date, the patient developed rotavirus after receiving all three doses of ROTATEQ. The outcome of the event and the causality were not reported. This is one of two reports (MARRS# 1504USA011252 and 1504USA011404) from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information was obtain during a telephone call to the licensed practical nurse, on 23-JAN-2015. The licensed practical nurse did not have lot numbers and expiration dates readily available for PROQUAD (Merck), and reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from the licensed practical nurse on 18-MAR-2015, concerning a currently 5 years old patient of unknown gender, who was vaccinated with a dose of PROQUAD (Merck) lot number K009894, expiration date not reported. This is one of several reports from the same reporter. Additional information is not expected, since all the information needed to complete the case has been already received.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 31-JUL-2013 the patient might have received VARIVAX (Merck) (lot # H019449, expiration date 25-OCT-2014, 0.5 ml, subcutaneously, dose in series unspecified) one month too early (Inappropriate schedule of vaccine administered). No adverse effects reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician assistant referring to a 18 year old female patient. In March 2011 ("4 years ago"), the patient was vaccinated with the first dose of GARDASIL and on 16-MAR-2015 was vaccinated with the second dose (dose, frequency, route and lot number not provided for both doses). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. Concurrent conditions, medical history of the patients were not reported. Since 16-MAR-2015, improperly stored PROQUAD (Merck) (lot # K008579, expiry date: 13-DEC-2015) (dose, route unspecified) was administered to unspecified patients. Other suspect and concomitant therapies were not reported. No adverse effects were noted. No product quality complaint (PQC) involved. This is one of several reports received 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 as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information was obtain during a telephone call to the licensed practical nurse, on 23-JAN-2015. The licensed practical nurse did not have lot numbers and expiration dates readily available for PROQUAD (Merck), and reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from the licensed practical nurse on 18-MAR-2015, concerning a currently 5 years old patient of unknown gender, who was vaccinated with a doe of PROQUAD (Merck) lot number K009894, expiration date not reported. This is one of several reports from the same reporter. Additional information is not expected, since all the information needed to complete the case has been received.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information was obtain during a telephone call to the licensed practical nurse, on 23-JAN-2015. The licensed practical nurse did not have lot numbers and expiration dates readily available for PROQUAD (Merck), and reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from the licensed practical nurse on 18-MAR-2015, concerning a currently 5 years old patient of unknown gender, who was vaccinated with a dose of PROQUAD (Merck) lot number K011313, expiration date not reported. This is one of several reports from the same reporter. Additional information is not expected, since all the information needed to complete the case has been already received.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information was obtain during a telephone call to the licensed practical nurse, on 23-JAN-2015. The licensed practical nurse did not have lot numbers and expiration dates readily available for PROQUAD (Merck), and reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from the licensed practical nurse on 18-MAR-2015, concerning a currently 11 years old patient of unknown gender, who was vaccinated with a dose of PROQUAD (Merck) lot number K011313, expiration date not reported. Additional information is not expected, since all the information needed to complete the case has been already received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. Concurrent conditions, medical history of the patients were not reported. Since 16-MAR-2015 (therapy started date was estimated as an unknown date in 2015), improperly stored VARIVAX (Merck) (lot # K003423, expiry date: 06-MAR-2016) (dose, route unspecified) was administered to unspecified patients. Other suspect and concomitant therapies were not reported. No adverse effects were noted. No product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-MAR-2015 the patient was vaccinated with an expired dose of M-M-R II (batch# H018948, lot # 1646AA, expire date 18-OCT-2014, 0.5 ml) subcutaneously. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with a 0.5ml dose of PROQUAD (Merck) subcutaneously (lot # K009891, expiration date: 11-JAN-2016), which was post supported excursion. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician concerning unspecified number of unspecified patients. On unspecified dates since 30-JAN-2015, the unspecified number of unspecified patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB (dose, strength and lot# were not reported, intramuscularly). No adverse effects were reported. This case was one of the three cases received from the same reporter. (Other two case were 1504USA002465 and 1503USA010732). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysgeusia, Nausea, Photophobia, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with allergy to thimerosal. The patient had no pertinent medical history. On 30-MAR-2015, the patient was vaccinated in upper left arm, in the shoulder area with a dose of ZOSTAVAX (lot # K023624, expiration date: 19-FEB-2016) (dose: 0.65 ml, frequency was unknown, indication reported as "vaccination") by pharmacist's colleague. The reporting pharmacist was not sure if the vaccination was given subcutaneous or intramuscularly. No concomitant medication was reported. On approximately 02-APR-2015, also reproted as within 72 hours post vaccination, the patient experienced warmth and rash at the injection site of left arm, had a metallic taste in her mouth, felt lightheaded, and had light sensitivity. The patient sought medical attention. She came into pharmacy on 02-APR-2015. Pharmacist stated that she did not have a fever, a red streak, nor infection. The patient took over the counter TYLENOL. No laboratory test was performed. No product quality complaint (PQC) was reported. The outcome of "warmth and rash at the injection site", "metallic taste in her mouth", "feeling lightheaded", and "having light sensitivity" was recovering (she felt somewhat better, but was not recovered). The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Dysgeusia, Injection site rash, Injection site warmth, Photophobia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with allergy to thimerosal. The patient had no pertinent medical history. On 30-MAR-2015, the patient was vaccinated in upper left arm, in the shoulder area with a dose of ZOSTAVAX (lot # K023624, expiration date: 19-FEB-2016) (dose: 0.65 ml, frequency was unknown, indication reported as "vaccination") by pharmacist's colleague. The reporting pharmacist was not sure if the vaccination was given subcutaneous or intramuscularly. No concomitant medication was reported. On approximately 02-APR-2015, also reproted as within 72 hours post vaccination, the patient experienced warmth and rash at the injection site of left arm, had a metallic taste in her mouth, felt lightheaded, and had light sensitivity. The patient sought medical attention. She came into pharmacy on 02-APR-2015. Pharmacist stated that she did not have a fever, a red streak, nor infection. The patient took over the counter TYLENOL. No laboratory test was performed. No product quality complaint (PQC) was reported. The outcome of "warmth and rash at the injection site", "metallic taste in her mouth", "feeling lightheaded", and "having light sensitivity" was recovering (she felt somewhat better, but was not recovered). The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Constipation, Herpes simplex, Hypoaesthesia, Urinary retention
Clinical narrative: Information has been received from 66 year old female patient concerning herself. The patient's medical condition included hypertension and allergy to aspirin and penicillin. On 05-NOV-2014, the patient was vaccinated with ZOSTAVAX (route, dose and strength unknown). Concomitant therapies included Lisinopril (manufacturer unknown), LEVOXYL and CRESTOR. On 10-FEB-2015 (also reported as unspecified dates), the patient experienced internal lesions, numbness in my vaginal area, constipation and pain in the back part of my thigh" after receiving the ZOSTAVAX injection. She also said she had to be rushed to Emergency Room on unspecified date because she could not urinate after receiving ZOSTAVAX as well. Unspecified lab work was performed and the result was not provided. It was unknown if the patient had to be admitted. Her physician diagnosed her as having "Herpes Simplex Virus Type II". She was treated with VALTREX and did not currently have an outbreak. The outcome of the events was unknown. Follow up information was received 10-APR-2015. It was confirmed that the patient started experiencing various symptoms on 10-FEB-2015, which included all the symptoms. The patient did not have exact dates as to when each of these individual symptoms started. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Constipation, Herpes simplex, Hypoaesthesia, Pain in extremity, Urinary retention
Clinical narrative: Information has been received from 66 year old female patient concerning herself. The patient's medical condition included hypertension and allergy to aspirin and penicillin. On 05-NOV-2014, the patient was vaccinated with ZOSTAVAX (route, dose and strength unknown). Concomitant therapies included Lisinopril (manufacturer unknown), LEVOXYL and CRESTOR. On 10-FEB-2015 (also reported as unspecified dates), the patient experienced internal lesions, numbness in my vaginal area, constipation and pain in the back part of my thigh" after receiving the ZOSTAVAX injection. She also said she had to be rushed to Emergency Room on unspecified date because she could not urinate after receiving ZOSTAVAX as well. Unspecified lab work was performed and the result was not provided. It was unknown if the patient had to be admitted. Her physician diagnosed her as having "Herpes Simplex Virus Type II". She was treated with VALTREX and did not currently have an outbreak. The outcome of the events was unknown. Follow up information was received 10-APR-2015. It was confirmed that the patient started experiencing various symptoms on 10-FEB-2015, which included all the symptoms. The patient did not have exact dates as to when each of these individual symptoms started. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaginal lesion
Clinical narrative: Information has been received from 66 year old female patient concerning herself. The patient's medical condition included hypertension and allergy to aspirin and penicillin. On 05-NOV-2014, the patient was vaccinated with ZOSTAVAX (route, dose and strength unknown). Concomitant therapies included Lisinopril (manufacturer unknown), LEVOXYL and CRESTOR. On 10-FEB-2015 (also reported as unspecified dates), the patient experienced internal lesions, numbness in my vaginal area, constipation and pain in the back part of my thigh" after receiving the ZOSTAVAX injection. She also said she had to be rushed to Emergency Room on unspecified date because she could not urinate after receiving ZOSTAVAX as well. Unspecified lab work was performed and the result was not provided. It was unknown if the patient had to be admitted. Her physician diagnosed her as having "Herpes Simplex Virus Type II". She was treated with VALTREX and did not currently have an outbreak. The outcome of the events was unknown. Follow up information was received 10-APR-2015. It was confirmed that the patient started experiencing various symptoms on 10-FEB-2015, which included all the symptoms. The patient did not have exact dates as to when each of these individual symptoms started. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Developed swelling, erythema and pain at the site and chest tightness.
Age: 58.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immunoglobulin therapy, Infection, Influenza, Malaise
Clinical narrative: This consumer report (initial receipt 01-Apr-2015) concerns a 58 year-old female patient. On an unspecified date in September 2014 or October 2014, the patient received a Influenza virus vaccine (manufacturer and batch number not provided). The patient also received HIZENTRA (batch number not provided) when she was enrolled in a post-marketing study (see 2015050191). On an unspecified date in November 2014, the patient experienced the flu. She continued to get sick with various infections. On an unspecified date in January 2015, she became very sick and was in the hospital for four days. In response, the doctor increased the patient's weekly dose and the patient felt that this helped her significantly. The outcome was not reported.
Age: 58.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Infection, Influenza, Malaise
Clinical narrative: This consumer report (initial receipt 01-Apr-2015) concerns a 58 year-old female patient. On an unspecified date in September 2014 or October 2014, the patient received a Influenza virus vaccine (manufacturer and batch number not provided). The patient also received HIZENTRA (batch number not provided) when she was enrolled in a post-marketing study (see 2015050191). On an unspecified date in November 2014, the patient experienced the flu. She continued to get sick with various infections. On an unspecified date in January 2015, she became very sick and was in the hospital for four days. In response, the doctor increased the patient's weekly dose and the patient felt that this helped her significantly. The outcome was not reported.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Grimacing, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Information has been received from a physician referring to a 70 year old male patient with cardiomegaly and diabetes mellitus. There were no known drug reactions or allergies for the patient. On 06-APR-2015 the patient was vaccinated with ZOSTAVAX (lot number, dose and route were unknown) in his left upper arm. Concomitant therapies included metformin, fluticasone, digoxin, losartan potassium (manufacturer unknown) and RITALIN. On 07-APR-2015 the patient experienced muscle pain in his right leg. On 08-APR-2015 the muscle pain also started in his left leg, and then on 09-APR-2015, the muscle pain started in his buttocks. The patient sought medical attention via office visit on 10-APR-2015, and he continued to experience pain in his bilateral legs and buttocks. Also the doctor noted the patient grimacing with pain upon walking. No lab diagnostics studies were performed. The physician stated he was going to prescribe prednisone and tramadol to treat the patient's symptomatically. At the time of report, the patient was not recovered from the events. The events were considered to be disabling. The causality between ZOSTAVAX and the events was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a physician referring to a 70 year old male patient with cardiomegaly and diabetes mellitus. There were no known drug reactions or allergies for the patient. On 06-APR-2015 the patient was vaccinated with ZOSTAVAX (lot number, dose and route were unknown) in his left upper arm. Concomitant therapies included metformin, fluticasone, digoxin, losartan potassium (manufacturer unknown) and RITALIN. On 07-APR-2015 the patient experienced muscle pain in his right leg. On 08-APR-2015 the muscle pain also started in his left leg, and then on 09-APR-2015, the muscle pain started in his buttocks. The patient sought medical attention via office visit on 10-APR-2015, and he continued to experience pain in his bilateral legs and buttocks. Also the doctor noted the patient grimacing with pain upon walking. No lab diagnostics studies were performed. The physician stated he was going to prescribe prednisone and tramadol to treat the patient's symptomatically. At the time of report, the patient was not recovered from the events. The events were considered to be disabling. The causality between ZOSTAVAX and the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Blindness transient, Blindness unilateral
Clinical narrative: Information has been received from a physician via field representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the third dose of GARDASIL (lot number and dose were unknown) intramuscularly. The day after the vaccination of GARDASIL, the patient experienced "lost of vision in one eye for a brief period". The patient sought medical attention via telephone call to the physician. No lab diagnostics studies were performed and no treatment was given for the event. The patient was recovered from the event on an unspecified date. The causality between GARDASIL and the event was unknown. Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Lymphadenectomy, Lymphadenopathy
Clinical narrative: Information has been received from a pharmacist concerning a currently 86 year old female patient. On unspecified date "many years ago", the unknown aged patient was vaccinated with Pneumococcal Vaccine (manufacturer unknown) (dose, strength, lot # and route were not reported). Other suspect therapy included unspecified flu shot. On unspecified date, the patient experienced her lymph nodes swollen, which resulted in the removal of some lymph nodes. The outcome of the event was not reported. The reporter considered the vaccines caused the lymph nodes swollen. Upon our internal review, the removal of some lymph nodes was determined to be medical significant. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report as received from a Licensed Practical Nurse refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. The reporting nurse stated that on an unspecified date the patient, who was pregnant (last menstrual period and estimated delivery date were unknown), was vaccinated with a dose of M-M-R II or VARIVAX (Merck) (it was not clear which one did the patient received) (dose, administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The nurse reported that the patient experienced an abortion spontaneous on an unspecified date. The outcome of abortion spontaneous was unknown at the time of the report. The reporter did not provide a causality assessment for the event of abortion spontaneous. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates these patients received improperly stored GARDASIL (dose, frequency and lot# were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. 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 demographics. No concurrent conditions or medical history were provided. On 14-APR-2015 (reported as "today"), the patient was vaccinated with an expired dose of PNEUMOVAX23 injection (lot # K005957 with expiry date: 08-MAR-2015; strength, dose and route of administration unspecified). No concomitant medications were reported. No adverse experience was observed or reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 13 unspecified patients of unknown age and gender who on an unknown dates received doses of improperly stored VAQTA (doses, route, lot# and expiration dates were not provided). No adverse effect reported. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV, TD
Symptoms: Insomnia, Pain in extremity, Productive cough, Respiratory tract congestion
Clinical narrative: 2 days later started coughing, congestion on chest, a lot of mucus. Was in terrible shape, affected immune system for at least 2 weeks. Called the doctor but no medicine given; took natural cough syrup; it helped a little but it was hard to sleep because of the cough. Arm sore for a couple of days as well. Today no more congestion, cough is gone, has more energy, no more mucus. Patient is very upset that doctor did not provide vaccine specifics as it relates to the ingredients before the vaccination.
Age: 7.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria, Local reaction
Clinical narrative: Patient given vaccines on Friday 4/10/15, called and returned to clinic 4/13/15. Patient had local reaction, large "hive" at site. Mother stated that reaction occurred with previous vaccines, advised icing. Patient's reaction improving as of 4/13/15.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient returned to the pharmacy saying her arm hurts real bad and it is swollen.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Gaze palsy, Loss of consciousness, Tonic clonic movements
Clinical narrative: After vaccines administered, while performing routine blood draw, patient passed out. Patient came back to within 2 minutes / developed fixed (R) lateral gaze and 2 tonic-clonic bilateral arm movements before regaining consciousness.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Fever, rash, hives.
Age: 86.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning an 86 year old female patient with hypoactive thyroid. On unspecified date many years ago, the patient received unspecified Flu shot and Pneumonia shot (manufacturer unknown) which caused her lymph nodes to swell resulting in the removal of some of lymph nodes (MARRS# 1504USA014504). The patient had no drug reactions and allergies. The patient's other medical history included arrythmia and thyroid disorder. On 30-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, strength and frequency were not reported, lot # L000450, expiration date: 09-MAR-2016, subcutaneous). Concomitant therapies included digoxin, levothyroxine sodium (manufacturer unknown) and metoprolol. On 31-MAR-2015, the patient called the pharmacy and complained of a red, warm, painful area (the size of a quarter) at the injection site of the ZOSTAVAX. On 01-APR-2015, the patient came to the pharmacy and the pharmacist noted that the size of the reaction had gotten bigger and was about 2 inches by 1.5 inches in diameter at the time of reporting. There was no treatment given for the events. There was no lab diagnostics performed. The patient had sought medical attention via calling and visiting the pharmacy. The outcome of the events was reported as not recovered. Causality between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.