chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 22 year old male patient. The patient had none pertinent medical history. The patient as an infant received unspecified acellular pertussis vaccine and had a reaction of fever and lethargy. The nurse practitioner reported that, on an unspecified date a patient was administe5red a dose of (Oka/Merck) VARIVAX subcutaneous (dose, , lot # and expiration date were not provided) and, on 05-AUG-2014, a second dose of (Oka/Merck) VARIVAX subcutaneous (dose was not provided) (lot # J014960, expiration date: 26-NOV-2015). The reporter stated that, on 06-AUG-2014, the patient experienced a 5 centimeter in diameter, tender, knot and induration at the site of (Oka/Merck) VARIVAX administration in posterior left arm. There was no treatment given for adverse event and no lab diagnostic studies performed. The outcome of the events was reported as not recovered. The relatedness between the events and (Oka/Merck) VARIVAX was unknown. The patient sought medical attention at the office of nurse practitioner on 07-AUG-2014. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: This spontaneous report as received from a 67 year old female patient refers to herself with blood pressure and anxiety. The patient's medical history included heart attack 5 years ago. A week ago, on 08-AUG-2014 the patient was vaccinated with PNEUMOVAX23 (dose, route and lot # not reported) in the left arm. It was reported that the next day on 09-AUG-2014, the patient developed sore muscles and aches in her joints, shoulders, knees and arms. The patient was treated with ADVIL. There was no lab diagnostics studies performed. The outcome of the events was reported as not recovered/not resolved. The patient did not seek any  medical attention. Additional information is not expected. There is no HCP's contact information.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Gait disturbance, Headache, Hyperhidrosis
Clinical narrative: Right after shot, arm very sore. Later in the evening started more severe adverse response of headache, dizziness, sweating, severe cramping/pain of major muscle groups such as calves, thighs, back and neck muscles-- some difficulty walking.  Continued through the next day 8-21-14.  Improved but not abolished with 3 regular strength Tylenol every 4 hours.  By 8-22-14-- better only mild headache, general body ache, fatigue, arm is still sore, sweating, slightly light headed.  I have put a call into my doctor's office.  I received the vaccination at my work site which is a medical outpatient clinic. I was not able to work on 8-21-14.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Muscle spasms, Myalgia, Pain, Pain in extremity
Clinical narrative: Right after shot, arm very sore. Later in the evening started more severe adverse response of headache, dizziness, sweating, severe cramping/pain of major muscle groups such as calves, thighs, back and neck muscles-- some difficulty walking.  Continued through the next day 8-21-14.  Improved but not abolished with 3 regular strength Tylenol every 4 hours.  By 8-22-14-- better only mild headache, general body ache, fatigue, arm is still sore, sweating, slightly light headed.  I have put a call into my doctor's office.  I received the vaccination at my work site which is a medical outpatient clinic. I was not able to work on 8-21-14.
Age: 1.22
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash, Rash erythematous, Rash pustular
Clinical narrative: Rash around mouth and tummy. Pinpoint red bumps with pus in the mild.  Does not itch, child does not notice it. Mom states this is his only symptom.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Convulsion, Dizziness, Eye movement disorder, Loss of consciousness
Clinical narrative: Light headed, loss of consciousness, eyes rolled back and about 3 seconds of slight convulsions.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Redness, Swelling at site, Itching, Fever, Chills.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Although we knew to expect some swelling and redness at the injection site, within 30 minutes, there was an inch wide ring around the site. Within 6 hours, the redness increased to 2" in diameter. By the next morning (7/15/14), the diameter was 4" and the redness had deepened. By 3 pm that day, the site was an angry red, 6" in diameter, raised, hardened, and itchy. On the 3rd and 4th days (7/16-7/17/14), it covered his entire upper shoulder....so approximately 8" in diameter. The redness, itching, and swelling gradually subsided, but it took almost 2 weeks!
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report as received from a 64 years of female patient with drug allergy/reaction to amoxicillin. On 18-AUG-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency and route of administration were not provided). Concomitant therapy was blood thinner (unspecified) medication. On 19-AUG-2014 (also reported as about 24  hours after receiving ZOSTAVAX vaccination), the patient experienced lump and redness at injection site. Action taken with respect to ZOSTAVAX was not applicable. Product quality complaint (PQC) was not involved. The outcome of lump and redness at injection site was unknown. Causality was not provided. Caller did not want to provide any contact information. Additional information is not expected.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 76 year old male patient with hyperacidity and with no drug reactions or allergies reported. Approximately in 2011 (reported as "about 3 years ago"), the patient was vaccinated with a dose of ZOSTAVAX, 1 time injection (dose, route of administration, lot# and expiry date unspecified). Concomitant therapies included NEXIUM. The patient stated that he had shingles in February 2014, after getting the ZOSTAVAX vaccine. He stated it was on his right buttock, and was the size of "a half dollar". He also stated that he had a second outbreak of shingles in July 2014, in the same location. The patient sought medical attention and received the  treatment, he was put on unspecified antibiotics. No laboratory tests were provided. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a licensed practical nurse refers to a 21 year old female patient with no  pertinent medical history or drug reactions/allergies. On oy-AUG-2014 the patient was accidentally vaccinated intramuscularly with a 0.5 ml dose of M-M-R II (lot number reported as J00020R). Concomitant therapy included iron (unspecified (+) minerals (unspecified ) (+) vitamins (unspecified) (prenatal vitamins). At the time of the report (13-AUG-2014), the patient was 31 weeks pregnant. The patient's Last Menstrual Period (LMP) was: 08-JAN-2014, Estimated Date of Conception 22-JAN-2014 and Estimated Delivery Date (EDD) 15-OCT-2014. Initial exposure to M-M-R II was at 30 week of pregnancy. The reporter stated that the patient needed to receive M-M-R II for an unspecified "paperwork" but should not had received with M-M-R II due to being pregnant. No adverse effect reported. No lab diagnostics studies performed. No treatment was given for the events. The patient did  not seek any medical attention. Lot number J00020R is an invalid lot number for M-M-R II. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 15-AUG-2014 the patient was inadvertently vaccinated with a dose of M-M-R II (lot # H014977, expiration date 09-AUG-2014, 0.5ml) subcutaneous which had expired on 09-AUG-2014. No adverse events were reported. Additional information is not expected.
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Off label use
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 13 year old patient of unknown gender. On 12-AUG-2014 the patient was vaccinated with the first dose of VAQTA adult dose (route not reported), lot # reported as 9654607 was not a valid lot number for VAQTA. No adverse symptoms reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Antibody test negative, Viral titre
Clinical narrative: This spontaneous report as received from a nurse refers to an approximately 7 year old male patient with no pertinent medical history and no drug reactions/allergies. On 23-AUG-2007 the patient was vaccinated with the first dose of (Oka/Merck) PROQUAD lot # 656887/0150U, expiration date 11-JUL-2008, 0.5 ml, subcutaneously in left thigh and a second dose of (Oka/Merck) PROQUAD lot reported as "0651Z" (which is an invalid lot # for (Oka/Merck) PROQUAD), 0.5 ml, subcutaneously in the right arm on 25-OCT-2010. No concomitant medications were taken. The result of a varicella titer done on an unspecified date in August 2013 was negative. No treatment was given. On 12-AUG-2014 the patient sought medical attention at the office of nurse for an unspecified reason. The outcome of the event was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Inappropriate schedule of drug administration, Malaise
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old female patient. No information regarding pertinent medical history or drug reactions/allergies was provided.  On 07-AUG-2014 the patient ws vaccinated with her first dose of GARDASIL (dose, route not reported, lot#J011272, expiration date 21-APR-2016) and on 19-AUG-2014 the patient was vaccinated with her second does of GARDASIL (dose, route not reported, lot# J010668, expiration date 29-APR-2016). No concomitant medications were provided.  The nurse reported that the patient received second dose of GARDASIL only 2 weeks after her first dose. The patient's mom called the office and reported that on 19-AUG-2014 patient did not feel well and complained of fatigue after receiving the second dose of GARDASIL. No treatment was given for the adverse events. No lab diagnostics studies were performed. The patient had sought medical attention by calling office. Outcome of "patient did not feel well and complained of fatigue" was reported as not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Malaise
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old female patient. No information regarding pertinent medical history or drug reactions/allergies was provided.  On 07-AUG-2014 the patient ws vaccinated with her first dose of GARDASIL (dose, route not reported, lot#J011272, expiration date 21-APR-2016) and on 19-AUG-2014 the patient was vaccinated with her second does of GARDASIL (dose, route not reported, lot# J010668, expiration date 29-APR-2016). No concomitant medications were provided.  The nurse reported that the patient received second dose of GARDASIL only 2 weeks after her first dose. The patient's mom called the office and reported that on 19-AUG-2014 patient did not feel well and complained of fatigue after receiving the second dose of GARDASIL. No treatment was given for the adverse events. No lab diagnostics studies were performed. The patient had sought medical attention by calling office. Outcome of "patient did not feel well and complained of fatigue" was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient (who was a physician at the office of nurse) of unknown age. Current condition reported was penicillin allergy. ON an unknown date (as reported as a child) the patient was vaccinated with (Oka/Merck) VARIVAX (dose, strength and route was not reported). No concomitant medication was reported. The nurse stated that within the last month the physician had her varicella titers drawn and the results were negative. The outcome of the results were negative was not recovered. No PQC was involved. The causality between (Oka/Merck) VARIVAX and event was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Induration, Macule, Pruritus, Rash
Clinical narrative: Rash began and blossomed to larger indurated, pruritic macule 48 hours following the vaccination.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dysphagia, Headache, Pyrexia
Clinical narrative: Fever, headache, difficulty swallowing. Benadryl, Tylenol and pushed fluids...slowly recovering!!
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Pharyngeal oedema, Pyrexia
Clinical narrative: Fever, headache, difficulty swallowing. Benadryl, Tylenol and pushed fluids...slowly recovering!!
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Diarrhoea, Dyspepsia, Myalgia
Clinical narrative: He received anthrax immunization 2002-2004 and his chronic joint/muscle pain throughout his body, heartburn and diarrhea. Symptoms: Rash, oth nonspecific skin eruption, Generalized Pain, Dizziness and giddiness, Malaise and fatigue, Disturbance of skin sensation.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning an unknown number of patient, of an unknown gender and age. Medical history and concurrent medications were not reported. On an unknown date the patient was vaccinated with a dose of COMVAX (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported.  Pharmacist reported that, on an unknown date, an unspecified number of patients received improperly stored COMVAX. No symptoms reported.  This is one (1) of 3 (three) reports from the same source (MARRS 1408USA009356, 1408USA013073 and 1408USA013074). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning an unknown number of patients, of an unknown gender and age. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of ROTATEQ (dose, dose number, lot number and expiration date were not reported) oral route, oral liquid. Co suspect and concomitant therapies were not reported. The nurse reported that an unknown number of patients were inadvertently administered ROTATEQ that had been improperly stored. No adverse effects reported. This is one (1) of 2 (two) reports from the same source  (MARRS 1408USA009360 and 1408USA013091). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning an unknown number of patients, of an unknown gender and age. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL. Co-suspect and concomitant therapies were not reported. The nurse reported that an unknown number of patients were inadvertently administered GARDASIL that had been improperly stored. No adverse effects reported. This is one (1) of 2 (two) reports from the same source (MARRS 1408USA009360 and 1407USA013091). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 20-AUG-2014 the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular (lot # not reported) that underwent a temperature excursion. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 19-AUG-2014 the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular, (lot # not reported) that underwent a temperature excursion. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-AUG-2014 the patient was vaccinated with expired dose of PNEUMOVAX23 (lot # J009827, expiration date 10-AUG-2014) (dose and route of administration not provided). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV, FLU3, PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and demographics. Patient's medical history and drug reactions or allergies were not reported. On 21-AUG-2014 the patient was intramuscularly vaccinated with expired dose of PNEUMOVAX23 (dose: 0.5ml, lot #J009827, expiration date: 10-AUG-2014, anatomical location not provided). Concomitant medications were not reported. No adverse effect reported. The pharmacist also stated that there was a second patient who received an expired dose of PNEUMOVAX23 (lot # J009827, expiration date 10-AUG-2014; 0.5 ml, intramuscular, anatomical location not provided) on the same day (21-AUG-2014). This case is linked to MARRS#1408USA012807 via the same reporter link. Additional information has been requested.
Sex: U
Vaccine: PPV, FLU3, PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and demographics. Patient's medical history and drug reactions or allergies were not reported. On 21-AUG-2014 the patient was intramuscularly vaccinated with expired dose of PNEUMOVAX23 (dose: 0.5ml, lot #J009827, expiration date: 10-AUG-2014, anatomical location not provided). Concomitant medications were not reported. No adverse effect reported. The pharmacist also stated that there was a second patient who received an expired dose of PNEUMOVAX23 (lot # J009827, expiration date 10-AUG-2014; 0.5 ml, intramuscular, anatomical location not provided) on the same day (21-AUG-2014). This case is linked to MARRS#1408USA012807 via the same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning an unknown number of patient, of an unknown gender and age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of M-M-R II (dose, dose number, lot number, expiration date and route were not reported. Co-suspect and concomitant therapies were not reported. Pharmacist reported that, on an unknown date, an unspecified number of patients received improperly stored M-M-R II. No symptoms reported.  This is one (1) of 3 (three) reports from the same source (MARRS1408USA009356, 1408USA13073 and 1408USA013074). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and demographics. Patient's medical history and drug reactions or allergies were not reported. On 21-AUG-2014 the patient was intramuscularly vaccinated with expired dose of PNEUMOVAX23 (dose: 0.5ml, lot# J009827, expiration date: 10-AUG-2014, anatomical location not provided). Concomitant medications were not reported. No adverse effect reported. The pharmacist also stated that there was a second patient who received an expired dose of PNEUMOVAX23 (lot # J009827, expiration date: 10-AUG-2014; 0.5 ml, intramuscular, anatomical location not provided) on the same day (21-AUG-2014). This case is linked to MARRS#: 1408USA013059 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning an unknown number of patient, of an unknown gender and age. Medical history and concurrent conditions were not reported.  On an unknown date the patient ws vaccinated with a dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported.   Pharmacist reported that, on an unknown date, an unspecified number of patients received improperly stored GARDASIL. No symptoms reported. This is one (1) of 3 (three) reports from the same source (MARRS 1408USA009356, 1408USA009356, 1408USA013073, and 1408USA013074). Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: Woke up with fever, chills, body aches, and overall feeling of malaise.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SOME SWELLING UNDER BANDAIDE OF INJECTIONS.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Heart rate increased, Injection site induration, Injection site infection, Injection site rash
Clinical narrative: Lightheadness rapid heart beat dizziness rash 4 inches by 8 inches oval at injection site arm hard at injection site.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Lightheadness rapid heart beat dizziness rash 4 inches by 8 inches oval at injection site arm hard at injection site.
Age: 60.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Diarrhoea, Pruritus, Urticaria, Vitreous floaters
Clinical narrative: 8/9 started taking Typhoid vaccine. 2nd dose on 8/11. Next morning had mild diarrhea, felt itchy and started scratching, broke out in hives around groin, midriff, and back. Called doctor who recommended BENADRYL and followed with a CLARITIN. Medicine took care of hives. Did not take 4th dose. Today has unsettled stomach still. 8/21 develop something like a floater on left eye, read that they form as possible autoimmune reaction. Has follow-up appointment with doctor next week.
Age: 16.0
Sex: F
Vaccine: HEP, HPV4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Hyperhidrosis, Loss of consciousness, Nausea, Pallor
Clinical narrative: 1-2 minutes after last immunization approximately 5 sec LOC, pale, diaphoretic, nauseous recovered completely 10 min.
Age: 0.01
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eye movement disorder, Tremor
Clinical narrative: Mom reports she was at grocery store, infant in car seat, noticed his face, arms, legs shaking for few seconds, picked him up and did it again. No cry. Was awake. Placed in car to go to ER, mom noticed eyes crossed once. Event occurred about 15-20 min after leaving office.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Noted left arm - red raised area approximately six hours after injection 3 by 2 1/2 inches. Ice applied to area.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site induration, Injection site swelling, Joint range of motion decreased, Myosclerosis
Clinical narrative: Left arm became very sore on 8/11/14, right after BOOSTRIX given to left deltoid. That night, left deltoid became swollen and hard, his skin was red and hot to touch. Mom calls our office 8/15/14 to let us know his left arm is much better. No longer red or hot, but is still warm and muscle is still hard. ROM is back fully.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Left arm became very sore on 8/11/14, right after BOOSTRIX given to left deltoid. That night, left deltoid became swollen and hard, his skin was red and hot to touch. Mom calls our office 8/15/14 to let us know his left arm is much better. No longer red or hot, but is still warm and muscle is still hard. ROM is back fully.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Altered state of consciousness, Dizziness
Clinical narrative: After patient received MENACTRA vaccine, about 2 minute she felt dizzy and almost passed out. After 2-3 minutes she recovered.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Chest X-ray normal, Emotional distress, Full blood count normal, Irritability, Urine analysis normal
Clinical narrative: Approximately 21  hours after shot (9 AM on 8/12) baby became fussy, irritable, unconsolable for 8 hours was seen in the office by my partner no source seen for irritability episode lasted 8 hours then got better over next 12 hours.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Dyspnoea
Clinical narrative: Vaccine administered 8/15/14 - Friday evening patient noted: fever 102 degrees F, weakness, nausea, dizziness, chills/sweats, shortness of breath, loss of appetite. Redness and swelling on arm with lymph nodes under arm and neck. All symptoms except swelling ceased by Sunday 8/17/14 evening.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Hyperhidrosis, Local swelling, Lymphadenopathy, Nausea
Clinical narrative: Vaccine administered 8/15/14 - Friday evening patient noted: fever 102 degrees F, weakness, nausea, dizziness, chills/sweats, shortness of breath, loss of appetite. Redness and swelling on arm with lymph nodes under arm and neck. All symptoms except swelling ceased by Sunday 8/17/14 evening.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Vaccine administered 8/15/14 - Friday evening patient noted: fever 102 degrees F, weakness, nausea, dizziness, chills/sweats, shortness of breath, loss of appetite. Redness and swelling on arm with lymph nodes under arm and neck. All symptoms except swelling ceased by Sunday 8/17/14 evening.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Pt states 24 hours after injection, site began to get painful with a burning sensation and itchy.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Rash, Skin irritation
Clinical narrative: Rash on arm and trunk of body. Itching and mildly irritating.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Wrong technique in drug usage process
Clinical narrative: On 8/15/14 one of our clinical nurses noted an extra MENVEO diluent in the box. 4 doses of this vaccine had been given 8/14/14 by 3 different nurses. On 8/15 the times the vaccine was given were researched to know which 4 may have received the powder only. This client was one of the 4. No nurse working could be 100% sure that they gave the vaccine correctly (possibly using a sterile diluent) all 4 clients were notified by the supervisor who recommended revaccination. Plant to band vaccines and diluent has been implemented and double checking before giving the vaccine.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Rash
Clinical narrative: Red, tender, hot spot on arm where vaccine administered. Rash appeared 1 day after given and still present 48 hours after.
Age: 12.0
Sex: U
Vaccine: HPV4, MNQ, TDAP
Symptoms: Wrong technique in drug usage process
Clinical narrative: On 8/15/14 one of or clinical nurses noted an extra MENVEO diluent in the box. 4 doses of this vaccine were given 8/14/14 by 3 different nurses and 8/15 the times of the vaccines were established and to  know the 4 clients who may have received the powder only. This client was one of the 4. No nurse working could be 100% sure that they gave the vaccine correctly using sterile diluent was one of diluent supplied. All 4 were notified by the supervisor who recommended re vaccination. Plans to blend vaccine and diluent are now in place - to double check vaccine before giving.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Electrocardiogram, Loss of consciousness
Clinical narrative: Pt states he passed out 1-2 min after inj. Clinician and doc were not in room at the time. Vitals, EKG, and doctor eval were done. Pt also given crackers and water as he stated he had not had lunch.
Age: 41.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Injection site irritation, Injection site swelling
Clinical narrative: Client called into clinic today and reported that she received Tdap and MMR vaccines on August 12, 2014 to her left arm. Starting Sunday August 17 she's been having swelling under her left arm and slight irritation that comes and goes, no fever hsa been reported.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Erythema, Malaise, Pruritus, Swelling
Clinical narrative: Extreme itching, hives all over body, swelling, redness, overall feeling terrible. Still have no energy and not feeling well after 8 days. Treatment: given an IV and prescriptions.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Extreme itching, hives all over body, swelling, redness, overall feeling terrible. Still have no energy and not feeling well after 8 days. Treatment: given an IV and prescriptions.
Age: 1.64
Sex: F
Vaccine: DTAP, HIBV, IPV, MMRV
Symptoms: Pyrexia, Varicella
Clinical narrative: On the 8/16/2014 in the evening my daughter broke out with about 10 chicken pox on her arms and legs.  Then on 08/20/2014 in the evening developed a fever that reached 102.6 F. She still has a fever, however today it is around 100.5 F.  She has no other symptoms of sickness.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Vaccination site swelling
Clinical narrative: QUARTER SIZED SWELLING AT VARICELLA VACCINATION SITE (RIGHT BACK OF THE ARM). HAS SINCE SWELLED TO 40MM IN DIAMETER. NO TREATMENT OR MEDS AT THIS TIME.
Age: 42.0
Sex: F
Vaccine: IPV, MNQ, TYP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt visited health unit today c/o numbness/tingling to left arm since early am (8/22/14). The tingling is more pronounced in hands. Wanted to know if this was caused by the immunizations she received on 8/18/14? Meds: none; PMH: None. Received Polio & Menactra R arm on 8/18/14 & Typhim VI on L Arm on same date.
Age: 10.0
Sex: M
Vaccine: HEP, IPV, MMRV, TD
Symptoms: Blood pressure increased, Fall, Head injury, Hypotonia, Tachycardia
Clinical narrative: Patient was in the immunization clinic receiving four vaccines for school: polio, hepatitis B, Td, and Proquad (MMRV). He received all four vaccines without showing any signs of reaction or problem; however, about three minutes after all the vaccines were administered, he suddenly became limp and slipped off the chair onto the floor, bumping the left side of his head against the cabinetry in the process. Immediately he was assisted off the floor and placed into a reclining chair. A rapid head-to-toe assessment was performed followed by a blood pressure and pulse assessment. Upon examination, the patient showed no evidence of contusions, swelling, fracture, or broken skin. He maintained consciousness and denied "any head pain".  Initial pulse reading was 180 bpm. Initial blood pressure reading was difficult to ascertain, but a second reading at 1:40 p.m. revealed 122/90, with a pulse of 120 bpm. Patient was instructed to continue relaxing in the chair for further observation.  Throughout this time, the patient maintained a patent airway with rapid respirations starting at 32 breaths per minute at 1:20 p.m. and decreasing to 20 breaths per minute at 1:40 p.m.  He maintained full color throughout face and body with no evidence of cyanosis or pallor.  Around 1:30 p.m. he was offered a box of apple juice to drink as well as a package of crackers; he drank the juice but declined eating the crackers despite his father commenting "that he hasn't had anything to eat in awhile".  After approximately fifteen more minutes, the patient appeared calm, relaxed, and showed no signs of distress.  He once again denied having "any head pain or difficulties".  Thereupon seeing no further evidence of injury, the patient was allowed to leave with his parents.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 24 hours after receiving the Pneumovax injection, I developed fever, rigors, body pain and tenderness with redness at injection site within 24 hours.  Fever and rigors not controlled with Tylenol or Motrin. Progressed with symptoms requiring hospitalization for 4 days.  Arm redness extended to elbow with swelling.  LFT's elevated upon admission, along with WBC's 17,000. Antibiotics started upon admission 7/20/2014.  Fever and rigors stopped by 7/22/2014.  Arm redness and swelling resolved by 7/26/2014 but tenderness and restriction of movement persisted for another 10 days.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Liver function test abnormal, Pain, Pyrexia, White blood cell count increased
Clinical narrative: 24 hours after receiving the Pneumovax injection, I developed fever, rigors, body pain and tenderness with redness at injection site within 24 hours.  Fever and rigors not controlled with Tylenol or Motrin. Progressed with symptoms requiring hospitalization for 4 days.  Arm redness extended to elbow with swelling.  LFT's elevated upon admission, along with WBC's 17,000. Antibiotics started upon admission 7/20/2014.  Fever and rigors stopped by 7/22/2014.  Arm redness and swelling resolved by 7/26/2014 but tenderness and restriction of movement persisted for another 10 days.
Age: 0.2
Sex: M
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site induration
Clinical narrative: Thigh area where vaccine was given was reported hardened and bruised. No fever, no other concerns.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Hepatitis, Injection site abscess, Injection site cellulitis, Injection site reaction, Myositis
Clinical narrative: Pt developed cellulitis and severe myositis and abscess of L upper arm requiring IV abx for 2 weeks plus.  He also developed a Hepatitis seconadry to serum sickness vs reaction to staph toxins from infection.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Serum sickness, Staphylococcal infection
Clinical narrative: Pt developed cellulitis and severe myositis and abscess of L upper arm requiring IV abx for 2 weeks plus.  He also developed a Hepatitis seconadry to serum sickness vs reaction to staph toxins from infection.
Age: 0.13
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt reported swelling and redness of left thigh immunizaton administration area. Was seen 8/1/14 by same provider, no fever, no complications, Tylenol given in case of fever and discomfort.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain at injection site.  Excess redness.  Patient took diphenhydramine and ibuprofen.  Redness decreased and so did swelling and pain.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Dyskinesia, Immediate post-injection reaction, Loss of consciousness, Seizure like phenomena
Clinical narrative: Immediately after administration of Tdap, patient c/o dizziness then had loss of consciousness and and jerking/ seizure like movements. Ammonia inhalent used, consciousness regained. While transferring in wheelchair, loss of consciousness occurred again.  Ammonia inhalent used, consciousness regained. VS: B/P-104/68 P-52. Gingerale and crackers given, able to tolerate. VS rechecked 15 mins later: B/P- 110/68 P-72. Pt discharged home with parents.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Local swelling, Pain in extremity, Pruritus
Clinical narrative: Swelling of whole right arm with pain and itching.
Age: 1.27
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: High fever, malaise, skin rash.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: LEFT DELTOID AREA OF INJECTION SHOWED SWELLING, REDNESS, WARM AND PAIN. ADVISED WARM PACKS, IBUPROFEN/TYLENOL, BENADRYL CREAM OR ORALS. F/U IF NO IMPROVEMENT.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA, PPV
Symptoms: Decreased appetite, Gait disturbance, Injection site pain, Irritability, Malaise
Clinical narrative: Painful leg causing patient to limp, fever, extreme fussiness, malaise, loss of appetite.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA, PPV
Symptoms: Pyrexia
Clinical narrative: Painful leg causing patient to limp, fever, extreme fussiness, malaise, loss of appetite.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Patient woke up this morning complaining of hot, itchy pain at injection site.  There is also a red spot which is 4 inches in diameter at injection site.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: IMM INJECTION SITE, LEFT DELTOID WITH SWELLING, REDNESS AND PAIN. ADVISED WARM COMPRESSION PACKS, IBUPROFEN/TYLENOL, BENADRYL CREAM/ORAL.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy to metals, Arthralgia, Autoimmune disorder, Bacterial infection, Carpal tunnel syndrome
Clinical narrative: Autoimmune response, itching, hives, hypersensitiviy to many beauty products, allergens, and food. Joint pain, swelling, rash, allergic reactions, allergy to deodorants with aluminum, unspecified inflammatory polyarthropathy, unspecified mixed connective tissue disease, unspecified diffuse connective tissue disease, Raynaud's Phenomenon, erythema, myelopathy, neuropathy, carpel tunnel, tremors, muscle pain, myalgia, fever, numerous bacteria and parasitic infections, skin ulcerations, cough, massive GI bleed.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Connective tissue disorder, Cough, Erythema, Food allergy, Gastrointestinal haemorrhage
Clinical narrative: Autoimmune response, itching, hives, hypersensitiviy to many beauty products, allergens, and food. Joint pain, swelling, rash, allergic reactions, allergy to deodorants with aluminum, unspecified inflammatory polyarthropathy, unspecified mixed connective tissue disease, unspecified diffuse connective tissue disease, Raynaud's Phenomenon, erythema, myelopathy, neuropathy, carpel tunnel, tremors, muscle pain, myalgia, fever, numerous bacteria and parasitic infections, skin ulcerations, cough, massive GI bleed.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Infection parasitic, Laboratory test, Mixed connective tissue disease, Myalgia
Clinical narrative: Autoimmune response, itching, hives, hypersensitiviy to many beauty products, allergens, and food. Joint pain, swelling, rash, allergic reactions, allergy to deodorants with aluminum, unspecified inflammatory polyarthropathy, unspecified mixed connective tissue disease, unspecified diffuse connective tissue disease, Raynaud's Phenomenon, erythema, myelopathy, neuropathy, carpel tunnel, tremors, muscle pain, myalgia, fever, numerous bacteria and parasitic infections, skin ulcerations, cough, massive GI bleed.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Myelopathy, Neuropathy peripheral, Polyarthritis, Pruritus, Pyrexia
Clinical narrative: Autoimmune response, itching, hives, hypersensitiviy to many beauty products, allergens, and food. Joint pain, swelling, rash, allergic reactions, allergy to deodorants with aluminum, unspecified inflammatory polyarthropathy, unspecified mixed connective tissue disease, unspecified diffuse connective tissue disease, Raynaud's Phenomenon, erythema, myelopathy, neuropathy, carpel tunnel, tremors, muscle pain, myalgia, fever, numerous bacteria and parasitic infections, skin ulcerations, cough, massive GI bleed.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Raynaud's phenomenon, Skin ulcer, Swelling, Tremor
Clinical narrative: Autoimmune response, itching, hives, hypersensitiviy to many beauty products, allergens, and food. Joint pain, swelling, rash, allergic reactions, allergy to deodorants with aluminum, unspecified inflammatory polyarthropathy, unspecified mixed connective tissue disease, unspecified diffuse connective tissue disease, Raynaud's Phenomenon, erythema, myelopathy, neuropathy, carpel tunnel, tremors, muscle pain, myalgia, fever, numerous bacteria and parasitic infections, skin ulcerations, cough, massive GI bleed.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Autoimmune response, itching, hives, hypersensitiviy to many beauty products, allergens, and food. Joint pain, swelling, rash, allergic reactions, allergy to deodorants with aluminum, unspecified inflammatory polyarthropathy, unspecified mixed connective tissue disease, unspecified diffuse connective tissue disease, Raynaud's Phenomenon, erythema, myelopathy, neuropathy, carpel tunnel, tremors, muscle pain, myalgia, fever, numerous bacteria and parasitic infections, skin ulcerations, cough, massive GI bleed.
Age: 76.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Burning sensation, Eye pruritus, Eyelid margin crusting, Eyelids pruritus
Clinical narrative: Tiny blisters (burning, itching) on R ankle, thumb, L. forearm. Next day on R palm, fingers, L fingers, both elbows.  1 week later severe itching both eyes/eyelids, crusty eyes.
Age: 76.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus
Clinical narrative: Tiny blisters (burning, itching) on R ankle, thumb, L. forearm. Next day on R palm, fingers, L fingers, both elbows.  1 week later severe itching both eyes/eyelids, crusty eyes.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Local swelling, Pain in extremity, Pyrexia
Clinical narrative: High fever, arm swelled, pain in arm to shoulder.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Confusional state, Depression, Dizziness, Fatigue
Clinical narrative: After 1st shot felt sick, headache, vomiting, fever, dizzy. After 2nd shot, same but worse. After 3rd shot, bed ridden entire next day, vomiting, migranes, dizzy, confusion, depression. Vomited randomly since first shot to present. Muscle aches since shots, random bouts of dizziness since shots, fatigue since shots. 2013-bagan having symptoms of MS. Present day- symptoms worsening, numbness, feeling like skin is on fire, itching, altered vision, headaches daily.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Migraine, Multiple sclerosis, Myalgia
Clinical narrative: After 1st shot felt sick, headache, vomiting, fever, dizzy. After 2nd shot, same but worse. After 3rd shot, bed ridden entire next day, vomiting, migranes, dizzy, confusion, depression. Vomited randomly since first shot to present. Muscle aches since shots, random bouts of dizziness since shots, fatigue since shots. 2013-bagan having symptoms of MS. Present day- symptoms worsening, numbness, feeling like skin is on fire, itching, altered vision, headaches daily.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Skin burning sensation, Visual impairment, Vomiting
Clinical narrative: After 1st shot felt sick, headache, vomiting, fever, dizzy. After 2nd shot, same but worse. After 3rd shot, bed ridden entire next day, vomiting, migranes, dizzy, confusion, depression. Vomited randomly since first shot to present. Muscle aches since shots, random bouts of dizziness since shots, fatigue since shots. 2013-bagan having symptoms of MS. Present day- symptoms worsening, numbness, feeling like skin is on fire, itching, altered vision, headaches daily.
Age: 14.0
Sex: M
Vaccine: MNQ, RUB, TDAP
Symptoms: Convulsion, Dyskinesia, Hypertension, Syncope
Clinical narrative: Fainting, jerking, seizure, high blood pressure.
Age: 0.24
Sex: M
Vaccine: DTAP, IPV, RV5
Symptoms: Aspartate aminotransferase increased, Barium enema abnormal, Bowel movement irregularity, Decreased appetite, Enema administration
Clinical narrative: Intussusception, vomiting.
Age: 0.24
Sex: M
Vaccine: DTAP, IPV, RV5
Symptoms: Intussusception, Irritability, Somnolence, Urine output decreased, Vomiting
Clinical narrative: Intussusception, vomiting.
Age: 0.24
Sex: M
Vaccine: DTAP, IPV, RV5
Symptoms: White blood cell count decreased, X-ray gastrointestinal tract abnormal
Clinical narrative: Intussusception, vomiting.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Induration, Pruritus
Clinical narrative: Red, hot, hard, itchy.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Pallor, Vomiting
Clinical narrative: Pt was vomiting, turned extremely pale. All symptoms resolved within 15 min. Never completely passed out.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness, Seizure like phenomena
Clinical narrative: Pt passed out within 1 min of vaccine and he also experienced "seizure like" activity for 5-10 secs.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Patient has baseball-sized whelp on injection site. Red and hard to the touch.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender.  It was reported that the patient received GARDASIL 120, intramuscularly on 31-JUL-2013 and on 23-JUN-2014. No known adverse effects. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction, Limb discomfort, Pyrexia
Clinical narrative: This spontaneous report as received from a 61 year old female consumer reporting on herself. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) in the arm (dose, strength and lot number were not reported). Secondary and concomitant therapies were not reported. Patient reported that in the past (time unspecified) she had numerous adverse reactions including "low grade fever and feeling of a punch in the arm" to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  Outcome of the events was  not reported. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: ANTH, HEP, MNQ, TYP
Symptoms: Arteriogram carotid normal, Cold-stimulus headache, Headache, Nuclear magnetic resonance imaging brain normal, Vertigo
Clinical narrative: He received 3 anthrax vaccinations in 2008, 2009. He developed a mild headache following the 1st dose that lasted a few days. After the 2nd and 3rd doses the headache was more severe and occurred 2-3 times per day for the next couple of years. Now, they are 3 times per week and feel like a severe brain freeze. The intensity is 7/10 and seem to occur at random. He is troubled occasionally by vertigo and he has found that a headache will develop immediately after.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. The pharmacist reported that on 21-AUG-2014, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX via 19400 PFU, 0.65ml subcutaneous, (lot # and expiration date were not provided). No adverse experience reported. Additional information has been requested.