chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a office administrator refers to a 15 years old male patient. The patient was vaccinated with dose 1 GARDASIL (lot #, dose and route not reported) on 17-JUL-2012. On 08-AUG-2012 the patient was vaccinated with dose 2 GARDASIL (lot #, dose and route not reported). No adverse experience had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 5 years old female patient who on 08-AUG-2012, was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (lot number not reported) instead of VARIVAX (Merck). No other co-suspects were reported. Concomitant vaccines included KINRIX and MMR II administered during the same office visit on 08-AUG-2012. The registered nurse reported that on 08-AUG-2012, the patient demonstrated injection site pain, as evidence by"I could hear her screaming down the hall". No treatment was given for the experience. At the time of the report, the registered nurse stated that the patient was stable. It was unspecified if the patient sought medical attention. The relatedness for the patient demonstrated injection pain was unknown for ZOSTAVAX. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 52 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (Lot number 0366AW, exp. date 23-MAR-2012) (Dose and route not reported) on 19-JUN-2012. No other co-suspects were reported. There were no concomitant medications. It was reported that in 2012, the past few weeks since ZOSTAVAX administration, the patient had been experiencing hair loss. There was not treatment given for the event and no Lab Diagnostics were performed. At the time of the report, the patient had not recovered from hair loss. The patient sought unspecified medical attention. The patient spoke to the pharmacist. The relatedness for hair loss was unknown for ZOSTAVAX. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 74 years old male consumer reporting on himself with a history of heart problems and no drug reactions or allergies, who on 11-JUN-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included TOPROL XL tablets, CRESTOR, PROTONIX, ZESTRIL and ferrous. The consumer stated that about a week ago, on approximately 01-AUG-2012, he still developed shingles. DOMEBORO was given as a treatment for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The relatedness for patient still developed shingles was unknown of ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 65 years old female patient who about a month ago, in June 2012, was vaccinated subcutaneously with a 0.5 ml dose of ZOSTAVAX (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that about a month ago, in June 2012, the patient came back to see the pharmacist after she had gotten the vaccine because the back of the arm and the armpit of the arm where she was vaccinated in were swollen and red. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The relatedness for back of the arm and the armpit of the arm swollen and red was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Facial pain, Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a 66 year old female consumer reporting on herself, with irregular heartbeat, depression and no drug reactions or allergies. The patient was vaccinated in the right arm with a dose of ZOSTAVAX (lot #, dose and route not reported) on 23-JUL-2012, No other co-suspects were reported. Concomitant medications included TOPROL XL tablets, AMBIEN and LEXAPRO. The consumer reported that shortly after having the vaccine she noticed bumps on the right side of her face that went up into hairline and in the right ear on 03-AUG-2012. The right ear was where she experiencing pain down to her chin. The consumer was seen by her healthcare professional in 06-AUG-2012 and diagnosed with a case of shingles. The patient was given a prescription of antiviral medication as treatment. No lab diagnostic tests were performed. The outcome of shingles was unknown. The relatedness for shingles was not reported for ZOSTAVAX. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Anxiety, Blood test, Cardiac stress test, Chest X-ray, Chest discomfort
Clinical narrative: This spontaneous report as received from a consumer refers to a 19 years old male patient with allergies an no drug reactions. The patient was vaccinated intramuscularly with 0.5 ml dose 1 and 2 of GARDASIL (lot # not reported) on 17-MAY-2012 and 15-JUN-2012 respectively. No other co-suspects were reported. There was no concomitant medication. On MAY-2012 the patient experienced chest pain. Within days of receiving the first dose of the vaccine, the patient experienced chest pain. He got his second dose of the vaccine and saw his doctor on 26-JUN-2012. The patient had tightness and pressure in his chest, anxiety, confusion, and tingling in his back, neck and left arm. He had all sorts of tests done: Chest x-ray, two electrocardiograms (EKG), blood work, abdominal cat scan and stress test (results not provided), and nothing had been found. All of the above symptoms had not yet gone away at the time of the report. No treatment was given for the events. The dose series of GARDASIL was discontinued. The relatedness for the reported events was not provided for GARDASIL. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Chest pain, Computerised tomogram abdomen, Confusional state, Electrocardiogram, Paraesthesia
Clinical narrative: This spontaneous report as received from a consumer refers to a 19 years old male patient with allergies an no drug reactions. The patient was vaccinated intramuscularly with 0.5 ml dose 1 and 2 of GARDASIL (lot # not reported) on 17-MAY-2012 and 15-JUN-2012 respectively. No other co-suspects were reported. There was no concomitant medication. On MAY-2012 the patient experienced chest pain. Within days of receiving the first dose of the vaccine, the patient experienced chest pain. He got his second dose of the vaccine and saw his doctor on 26-JUN-2012. The patient had tightness and pressure in his chest, anxiety, confusion, and tingling in his back, neck and left arm. He had all sorts of tests done: Chest x-ray, two electrocardiograms (EKG), blood work, abdominal cat scan and stress test (results not provided), and nothing had been found. All of the above symptoms had not yet gone away at the time of the report. No treatment was given for the events. The dose series of GARDASIL was discontinued. The relatedness for the reported events was not provided for GARDASIL. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a male consumer of unknown age who on an unknown date was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that his arm still hurt at the injection site. No treatment information was reported. It was unspecified if the patient sought medical attention. The relatedness for arm still hurt at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site discolouration, Skin discolouration
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a 65 year old female patient with hypertension, who on 31-JUL-2012 was vaccinated with PNUEMOVAX 23, intramuscular, (lot number reported as 1947AA, expiration date 20-OCT-2013). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient experienced erythema and warmth from her neckline onto her chest and 3/4 the way down the arm that received the vaccination and the site got black. The nurse stated that on 03-AUG-2012, the patient was seen in the office and the patient was 75% better. The erythema was not as high up in the patient's arm anymore and there was a slight discoloration in the inner arm, but redness was disappearing. The patient was given BENADRYL and CLARITIN as treatment for the events. At the time of the report, the patient was recovering from the events. Additional information had been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age who in 2007 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL, in May 2012, was vaccinated with her second dose of GARDASIL and on 23-JUL-2012, received her third dose of GARDASIL (lot numbers not reported). No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Chest pain, Wheezing
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 18 years old female patient with no known medical history and previous illness on 23-APR-2012 was vaccinated IM with dose the first dose of GARDASIL (lot # 671994/1537AA) into the left arm. No other co-suspects were reported. Concomitant vaccines given on the same day included the first IM dose of HAVRIX (lot # AHAV550AA) into the left arm, the first IM dose of BOOSTRIX (lot # AC52B070BA) into the right arm and the first IM dose of MENACTRA (lot # U4025AA) into the right arm. On 23-APR-2012 the patient experienced wheezing and chest pain. It was reported that the mother gave albuterol for the treatment of the adverse events at home. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 458858. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood iron, Blood thyroid stimulating hormone, Full blood count, Metabolic function test, Paraesthesia
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 14 years old female patient with prolonged Q-T interval and no illness at the time the vaccine was administered. The patient was vaccinated intramuscularly in the left arm with lot # (0026AE) dose 2 of GARDASIL (dose not reported) on 04-MAY-2012. No other co-suspects were reported. Concomitant medications included SINGULAIR, atenolol, and FLOVENT. It was reported that the patient had been having a tingling sensation on her arms, heels and toes, since she received the vaccine on 04-MAY-2012. This had been happening intermittently and would last for 10-15 minutes each time. No treatment information was reported. The outcome of the event was unknown. The relatedness for the reported event was not provided for GARDASIL. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 455328. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Paraesthesia
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 14 years old female patient with prolonged Q-T interval and no illness at the time the vaccine was administered. The patient was vaccinated intramuscularly in the left arm with lot # (0026AE) dose 2 of GARDASIL (dose not reported) on 04-MAY-2012. No other co-suspects were reported. Concomitant medications included SINGULAIR, atenolol, and FLOVENT. It was reported that the patient had been having a tingling sensation on her arms, heels and toes, since she received the vaccine on 04-MAY-2012. This had been happening intermittently and would last for 10-15 minutes each time. No treatment information was reported. The outcome of the event was unknown. The relatedness for the reported event was not provided for GARDASIL. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 455328. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pallor, Rash erythematous, Rash generalised, Rash pruritic, Skin plaque
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 12 years old female patient with history of segmental neurofibromatosis and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the left arm with lot # (671994/1537AA) dose 1 of GARDASIL (dose not reported), on 09-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. On 10-MAY-2012, one day post vaccination, the patient initially noticed an itchy red rash on her back. During the day in 11-MAY-2012 at school the rash progressed to entire body. At 3:30pm on 11-MAY-2012 the patient had diffuse erythematous raised plaques, some with central pallor, all over trunk, bilateral extremities, palms, soles and face. No lab diagnostic tests were performed, the patient was given one dose of hydroxyzine 30mg and ZYRTEC 10mg. On an unspecified date the rash resolved. The outcome of diffuse erythematous raised plaques and central pallor was unknown. The relatedness for the reported events was not provided for GARDASIL. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 455792-1. No further information is available.
Age: 11.0
Sex: M
Vaccine: HPV4, MMR, MNQ, HPV4, MMR, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old male patient. The patient was vaccinated intramuscularly in the left arm with lot # (671463/1359AA) dose 1 GARDASIL (dose not reported) on 21-MAY-2012. Other suspect therapies included dose 3 of MMR II (lot # 1375AA) (dose not reported) applied subcutaneously in the left arm on 21-MAY-2012. Concomitant medications included: MENACTRA. On 22-MAY-2012 the patient developed red and swollen upper left arm with pain. No treatment information was reported. The outcome of the events was unknown. The relatedness for red and swollen upper left arm with pain was not provided for GARDASIL and MMR II. The original reporting source was not provided. The VAERS ID # is 456089. This report was considered non serious and no conditions by the agency. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female patient with Still's murmur and eyeglasses and no known drug allergies or any preexisting illness was vaccinated intramuscularly into the left arm with first dose of GARDASIL (lot # 672233/1561AA) on 21-MAY-2012 (at 1 yo physical). There were no concomitant medications. The patient experienced dizziness, headache, nausea, pyrexia and vomiting on 21-MAY-2012. Approximately 1 to 1.5 hours after vaccination, patient stated feeling lightheaded, nauseous, vomited, without temperature and went to ED (emergency department) seemed better. Next day patient experienced low grade temperature, nausea and headache. No laboratory studies performed. The listing indicated that one or more of the events required ER (emergency room) visit but were not serious. No further information is available. The original reporting source was not provided. The VAERS ID # is 456465-1.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: 8-8-12 TC fm mom, states child's arm swollen, hot, and red from elbow to shoulder, states "looks burned" - has a hard knot in it with a small red dot in center. Instructed mom to have child evaluated by pediatrician or ER. Mom took to ER 8-8-12 - Dx cellulitis vs. arthus reaction given antibiotics, steroid cream, & BENADRYL. 8-9-12 spoke with mom today states arm not any better. Informed may take 2-3 days to improve. Mom states will follow-up with phone call to report child's.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site warmth, Type III immune complex mediated reaction
Clinical narrative: 8-8-12 TC fm mom, states child's arm swollen, hot, and red from elbow to shoulder, states "looks burned" - has a hard knot in it with a small red dot in center. Instructed mom to have child evaluated by pediatrician or ER. Mom took to ER 8-8-12 - Dx cellulitis vs. arthus reaction given antibiotics, steroid cream, & BENADRYL. 8-9-12 spoke with mom today states arm not any better. Informed may take 2-3 days to improve. Mom states will follow-up with phone call to report child's.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: 8-8-12 TC fm mom, states child's arm swollen, hot, and red from elbow to shoulder, states "looks burned" - has a hard knot in it with a small red dot in center. Instructed mom to have child evaluated by pediatrician or ER. Mom took to ER 8-8-12 - Dx cellulitis vs. arthus reaction given antibiotics, steroid cream, & BENADRYL. 8-9-12 spoke with mom today states arm not any better. Informed may take 2-3 days to improve. Mom states will follow-up with phone call to report child's.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cough, Dysphonia, Dyspnoea, Feeling cold, Nasal congestion
Clinical narrative: Hoarse coughing, difficulty breathing, swollen nasal passages, sore throat, feeling cold.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: Hoarse coughing, difficulty breathing, swollen nasal passages, sore throat, feeling cold.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Cough, Fatigue, Increased upper airway secretion, Lower respiratory tract inflammation
Clinical narrative: Hoarse coughing, difficulty breathing, swollen nasal passages, sore throat, feeling cold.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nasal congestion, Secretion discharge
Clinical narrative: Hoarse coughing, difficulty breathing, swollen nasal passages, sore throat, feeling cold.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Pt. received 3 injections, when leaving clinic, pt. got light headed, pale and fainted. She came to very quickly, was given cold rag to forehead. Sat for 10 min and was fine.
Sex: U
Vaccine: MMR
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a patient of unknown age. The patient was vaccinated with MMR II (lot # not reported) on an unknown date. It was reported the patient had an anaphylactic reaction to MMR II but no more details could be provided. Whether the patients sought for medical attention was not reported. The outcome of anaphylactic reaction was unknown. Upon internal review, anaphylactic reaction to MMR II was considered to be an medically significant event. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a patient of unknown age. The patient was vaccinated with MMR II (lot # not reported) on an unknown date. It was reported the patient had an anaphylactic reaction to MMR II but no more details could be provided. Whether the patients sought for medical attention was not reported. The outcome of anaphylactic reaction was unknown. Upon internal review, anaphylactic reaction to MMR II was considered to be medically significant event. This is one of several reports received from the same source. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient had a syncopal event a few minutes after receiving 3rd GARDASIL injection. Lasted about 1 minute. Did fine with first 2 injections.
Age: 0.59
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Crying, Injection site erythema, Injection site papule, Injection site rash
Clinical narrative: Minutes after receiving vaccine, as mother was checking out, she noticed bumps on pt's legs.  Pt also was crying more than she did the first time, and after being re-roomed, it was noted that pt had small erythematous papules to both legs. Was given liquid Benadryl 12.5 mg and monitored for an additional 30 min, by which time rash had completely disappeared and infant was sleeping.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash erythematous, Urticaria
Clinical narrative: Red welps up and down neck area upper hands and left knees red bumps on left leg and hands and inner thighs, all spots itching so much I took Benadryl.. all sights still itich and red 5 days later.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Round red warm to touch 3cm slightly elevated "mark" around injection site both arms.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Culture negative, Erythema, Incisional drainage, Upper extremity mass
Clinical narrative: Rt arm with fluctuant erythematous mass - I/d --> (-) culture Clindamycin & ROCEPHIN.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Approximately 25 days after administration patient felt pain and stiffness at injection site. I could not locate a nodule or a raised area.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Headache, Injection site swelling, Pain
Clinical narrative: Swelling at injection site, headache, body aches.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: Left leg swollen and red. Cried for 4 hours. Unconsolable crying 4-5 hrs.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Lower rt arm - varicella adm. Swelling and redness and itch.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Back pain, Flank pain, Neck pain
Clinical narrative: Neck, back and side pains.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness, Malaise, Pallor
Clinical narrative: Pt. was in a sitting position approximately 10-15 min after MENACTRA vaccine administered when pt reported she didn't feel well. Pt appeared pale, pt then escorted by 2 nurses to exam table, when pt completely passed out, eased to the floor in a sitting position. Ammonia Inhalent used and pt came around within about 10-15 sec. Pt followed commands and advised to take slow deep breaths and made appropriate eye contact. Pt assisted to exam table and reclined with legs elevated. Cool cloth applied to forehead. BP 102/60 P=5-, pt denied any nausea/vomiting feeling. Pt continued to recline for approx 30 min, then assisted with ambulation without any apparent difficulty. Pt had reported after episode that she had not eaten this morning. Pt's color much improved after 30 min and reported feeling better. Pt left health department with mother without any further concerns. No other vaccines were placed ppd test placed to (L) forearm.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Pt developed a red rash at site of ZOSTAVAX given. Pt did not feel it and was not in pain. She recovered w/o cry & treatment.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Malaise, Musculoskeletal stiffness, Neck pain
Clinical narrative: Injection given at annual physical on 8/13/12 chills started on 8/13 evening. Temp 101.2 on 8/14/12 AM. Neck stiff and sore all over. Site OK, no itching. 8/14 Temp up to 102. 8/15 temp normal no joint pain & temp normal. Patient stated she thinks she got a little sick when she had shots to go overseas.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pyrexia, Vaccination site pain
Clinical narrative: Swollen (R) upper arm - painful warm, pink area 10 cm diameter surrounding vaccine site fever, fatigue.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Vaccination site warmth
Clinical narrative: Swollen (R) upper arm - painful warm, pink area 10 cm diameter surrounding vaccine site fever, fatigue.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Gaze palsy, Immediate post-injection reaction, Moaning, Musculoskeletal stiffness
Clinical narrative: Pt. was given GARDASIL #2. Immediately after giving vaccine and removing needle she stated, "I'm going to pass out." Laid her back on exam table, called for assistance. Pt. began moaning, eyes rolled back, arms and legs stiffened and she arched up from table. Within 30 seconds she relaxed, opened eyes. We rolled on side and when she was alert we elevated her legs.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Posture abnormal
Clinical narrative: Pt. was given GARDASIL #2. Immediately after giving vaccine and removing needle she stated, "I'm going to pass out." Laid her back on exam table, called for assistance. Pt. began moaning, eyes rolled back, arms and legs stiffened and she arched up from table. Within 30 seconds she relaxed, opened eyes. We rolled on side and when she was alert we elevated her legs.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Rash macular, Skin lesion
Clinical narrative: Within 2-3 minutes of receiving vaccines, the right thigh had a single indurated lesion at the injection site of 1x2cm with a large, blotchy erythematous flat lesion surrounding it. Varicella injection site. All 3 sites had erythema approx. 3-4 cm.
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Rash vesicular
Clinical narrative: Injection site erythema & varicella like rash.
Age: 10.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Blood glucose normal, Haemoglobin normal, Syncope
Clinical narrative: Syncopal episode. Vital signs, blood sugar, hemoglobin, pt. monitored.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Dizziness, Dyspnoea, Electrocardiogram, Nausea
Clinical narrative: 1-2 hours after vaccine eyes became red shortly thereafter patient felt nauseous/faint then had difficulty breathing. First went to urgent care where received ASA & steroid then to hospital & given MEDROL, Atenolol, & ASA rxs. Follow up w/cardiologist.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia
Clinical narrative: 1-2 hours after vaccine eyes became red shortly thereafter patient felt nauseous/faint then had difficulty breathing. First went to urgent care where received ASA & steroid then to hospital & given MEDROL, Atenolol, & ASA rxs. Follow up w/cardiologist.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Nausea, Syncope, Vomiting
Clinical narrative: PATIENT INDICATED THAT HE WAS NOT "GOOD " WITH INJECTIONS BUT SEEMED FINE UPON RECEIVING IMMUNIZATION. PATIENT FAINTED WITHIN MINUTE OR TWO OF RECEIVING IMMUNIZATION AND MAY HAVE HIT HEAD WHEN FALLING TO THE FLOOR. PATIENT BECAME COHERENT WITHIN SECONDS OF FAINTING. PATIENT SAT IN CHAIR AND DRANK SOME PROVIDED WATER.  REPORT WAS FILED ON THE FALL WITH MANAGER IN CHARGE OF GROCERY.  PATIENT LEFT THE STORE AFTER APPROXIMATELY 30 MINUTES. LATER THAT AFTERNOON RECEIVED CALL FROM GRANDMOTHER THAT PATIENT LEFT STORE AND GOT SOMETHING TO EAT, CAME HOME AND WAS SITTING IN CHAIR  AND BECAME NAUSEOUS AND VOMITED. SHE CALLED AS TO WHAT TO DO AND I ADVISED TO GO TO HOSPITAL TO GET CHECKED OUT.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and warmth at the site.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Dyskinesia, Fall, Headache, Moaning
Clinical narrative: Patient moaned, fell backwards onto exam table, her body and arms jerked severel times, she was incontinent of urine.  Then she opened her eyes. C/O dizziness and headache for the next 20 minutes. Tx - cold cloth.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Urinary incontinence
Clinical narrative: Patient moaned, fell backwards onto exam table, her body and arms jerked severel times, she was incontinent of urine.  Then she opened her eyes. C/O dizziness and headache for the next 20 minutes. Tx - cold cloth.
Age: 0.22
Sex: M
Vaccine: HIBV
Symptoms: CSF protein increased, Condition aggravated, Eczema, Gram stain, Gram stain negative
Clinical narrative: Per emergency room notes at 0530hrs on 14 Aug 2012: +fussy and fever Tmax 100.9 axillary; eczematous rash upper and lower extremities and abdomen.
Age: 0.22
Sex: M
Vaccine: HIBV
Symptoms: Haematocrit decreased, Irritability, Platelet count increased, Pyrexia, Rash
Clinical narrative: Per emergency room notes at 0530hrs on 14 Aug 2012: +fussy and fever Tmax 100.9 axillary; eczematous rash upper and lower extremities and abdomen.
Age: 0.22
Sex: M
Vaccine: HIBV
Symptoms: Red blood cell count decreased, White blood cell count increased
Clinical narrative: Per emergency room notes at 0530hrs on 14 Aug 2012: +fussy and fever Tmax 100.9 axillary; eczematous rash upper and lower extremities and abdomen.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Pt given HPV vaccine and left exam room to lobby with parent.  LOC at check out counter.  No injury noted.
Age: 12.0
Sex: M
Vaccine: HEPA, IPV, MEN, TDAP
Symptoms: Dyspnoea, Lip swelling, Oral herpes, Palatal oedema, Pharyngeal oedema
Clinical narrative: Swollen lips and throat and face.  Cold sore on lip.  Trouble breathing. Uvula swollen. Hep A, IPV, Tdap & MCV4 given yesterday.
Age: 12.0
Sex: M
Vaccine: HEPA, IPV, MEN, TDAP
Symptoms: Swelling face
Clinical narrative: Swollen lips and throat and face.  Cold sore on lip.  Trouble breathing. Uvula swollen. Hep A, IPV, Tdap & MCV4 given yesterday.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site mass, Injection site swelling, Maternal exposure during pregnancy, Premature rupture of membranes
Clinical narrative: Flu-like symptoms, swelling at shot location, and not sure if related but on July 29th, mucus plug was lost and on August 1st, membrane ruptured at 29 weeks, 4 days pregnant in an otherwise very uneventful pregnancy. At 3 weeks after shot was administered, there is still a lump under the tissue of my arm approximately the size of a grape. Have been on bedrest at the hospital since August 1st. This is an unusual situation as the TDAP is recommended for pregnant women and not sure if there was an allergic reaction or if it triggered an immune response that caused water to break.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site rash
Clinical narrative: RASH AND "LUMP" AT INJECTION SITE.  RED/PAINFUL.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Decreased appetite, Erythema, Fatigue, Mobility decreased
Clinical narrative: Pain in arm and slight swelling in arm started the evening the day dose given. The next by noon, had severe generalized aching and fatigue - had to leave work. The following day severe aching and fatigue continued but developed a fever and anorexia, arm had some swelling and hot to touch. Could not raise her arm above her shoulder. The third day same symptoms. The fourth day showed some improvement and the fifth day she was able to return to work. She remembered after the symptoms started that 10 years before, she had gotten a Td and her whole arm down to her fingertips had swollen, red, hot and painful. She said she called the clinic and reported it but did not see the doctor. She used Ibuprofen alternating with Acetaminophen for the aching and fever, Benadryl to try to decrease the reaction and ice pack to arm.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Pain in arm and slight swelling in arm started the evening the day dose given. The next by noon, had severe generalized aching and fatigue - had to leave work. The following day severe aching and fatigue continued but developed a fever and anorexia, arm had some swelling and hot to touch. Could not raise her arm above her shoulder. The third day same symptoms. The fourth day showed some improvement and the fifth day she was able to return to work. She remembered after the symptoms started that 10 years before, she had gotten a Td and her whole arm down to her fingertips had swollen, red, hot and painful. She said she called the clinic and reported it but did not see the doctor. She used Ibuprofen alternating with Acetaminophen for the aching and fever, Benadryl to try to decrease the reaction and ice pack to arm.
Age: 26.0
Sex: M
Vaccine: MEN
Symptoms: Chills, Dizziness, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu-like symptoms, tired, light-headed, fever, chills, headache.
Age: 26.0
Sex: M
Vaccine: MEN
Symptoms: Pyrexia
Clinical narrative: Flu-like symptoms, tired, light-headed, fever, chills, headache.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 1 hour after injection pain 4 hours after injection (+) swelling/warmth.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Woke up the following morning after receiving the vaccine with golf sized lump at injection site, pain, redness, warmth and developed a fever of 100.2-100.4 for 2 days (4/19/12-4/20/12).
Age: 1.49
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Urticaria
Clinical narrative: Mother called day after immunization given. Reported widespread hives on child's arms, legs and cheeks. Not making child itch much. Diminishing quickly. PHN suggested MOC contact physician if they reoccur.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Joint swelling, Rash
Clinical narrative: Bad rash, swollen joints...fingers, ankles, knees, face, elbows.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Discomfort, Gait disturbance, Joint swelling, Mobility decreased, Swelling
Clinical narrative: Bad rash, swollen joints...fingers, ankles, knees, face, elbows.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Swelling face, Urticaria
Clinical narrative: Bad rash, swollen joints...fingers, ankles, knees, face, elbows.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Fever & congestion.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness, soreness.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Dizziness, Nausea, Paraesthesia, Vaccination site pain
Clinical narrative: Pain at vaccination site, followed by dizziness, tingling in arm, and on 8/15/2012 diarrhea and nausea.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: MILD RED AND SWELLING AT LEFT SHOULDER AREA WITH SOME TENDERNESS.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Vaccination site cellulitis, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Significant erythema, swelling and development of cellulitis at vaccine site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: LEFT ARM SWELLING AND RED, NO OTHER SYMPTOM NOTED.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Severe full body hives from face down to feet starting at approximately 8:00 a.m. on Sunday, becoming more severe on Monday (8/13/12). Another doctor administered a steroid shot at approximately 9:00 a.m. on 8/13/12. Symptoms worsened by 11:30 a.m. and patient was taken to the ER. Patient was given and prescribed 1) Predisolone, 2) Famotadine, 3) Lortamide.  Currently on day 3 of hive breakouts, although not as severe as it was on 8/12 and 8/13.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: MILD SWELLING TO LEFT DELTOID AREA.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Red arm, swelling, slight temp.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site induration
Clinical narrative: 08/15/2012 pt had 10 X 15 duration in left deltoid. Pt taking Motrin and ice tid. Pt happy, playing and eating well.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain
Clinical narrative: Soreness around the shot area, even 6 months later I still have soreness in the area?
Age: 1.59
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Decreased appetite, Mood swings, Scab, Sleep disorder, Varicella post vaccine
Clinical narrative: One pox lesion appeared the morning of 8/7/12. Two more appeared with 24 hours, then there have consistently been 3-4 new lesions per day. Most scab over within 24 hours. Lesions do not appear to be causing discomfort or itching, but other symptoms have been observed. Patient has had severely disrupted sleep patterns compared to before the vaccination, mood swings more than typical for him, and loss of appetite.
Age: 21.0
Sex: F
Vaccine: IPV, PPV
Symptoms: Anion gap decreased, Bacterial test positive, Blood bicarbonate decreased, Blood calcium decreased, Blood chloride normal
Clinical narrative: Left arm - Pain at site of injection that spread down arm, macular red rash localized to left arm and fever (tmax103).
Age: 21.0
Sex: F
Vaccine: IPV, PPV
Symptoms: Blood creatine phosphokinase normal, Blood creatinine normal, Blood glucose normal, Blood potassium decreased, Blood sodium decreased
Clinical narrative: Left arm - Pain at site of injection that spread down arm, macular red rash localized to left arm and fever (tmax103).
Age: 21.0
Sex: F
Vaccine: IPV, PPV
Symptoms: Blood urea decreased, Blood urine present, Full blood count abnormal, Glomerular filtration rate, Glucose urine
Clinical narrative: Left arm - Pain at site of injection that spread down arm, macular red rash localized to left arm and fever (tmax103).
Age: 21.0
Sex: F
Vaccine: IPV, PPV
Symptoms: Haematocrit decreased, Haemoglobin, Injection site pain, Metabolic function test abnormal, Pain in extremity
Clinical narrative: Left arm - Pain at site of injection that spread down arm, macular red rash localized to left arm and fever (tmax103).
Age: 21.0
Sex: F
Vaccine: IPV, PPV
Symptoms: Platelet count decreased, Protein urine, Pyrexia, Rash macular, Red blood cells urine positive
Clinical narrative: Left arm - Pain at site of injection that spread down arm, macular red rash localized to left arm and fever (tmax103).
Age: 21.0
Sex: F
Vaccine: IPV, PPV
Symptoms: Urine ketone body present, White blood cell count increased, White blood cells urine positive
Clinical narrative: Left arm - Pain at site of injection that spread down arm, macular red rash localized to left arm and fever (tmax103).
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Back pain, Chest pain, Chills
Clinical narrative: Symptoms began at 11:00 pm with Extreme abdominal/stomach pain, Extreme back pain, Soreness at injection site (upper left arm), Extreme Nausea and Vomiting that lasted 7 hrs, moments of extreme body heat and sweating, and chills, Swollen lymph nodes, muscle soreness, Inability to sleep due to pain. Called the Doctors office at 8:00am on 08/14/2012 to ask what I needed to do. I was informed to not have any solid foods for at least 12 hrs and that if I got a high fever and pain in my right side to go to ER. Thankfully by that time the pain had decreased and I was able to eat soup and crackers to calm my stomach. Abdominal/chest and back pain persisted but was less extreme.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Hyperhidrosis, Injection site pain, Insomnia, Lymphadenopathy
Clinical narrative: Symptoms began at 11:00 pm with Extreme abdominal/stomach pain, Extreme back pain, Soreness at injection site (upper left arm), Extreme Nausea and Vomiting that lasted 7 hrs, moments of extreme body heat and sweating, and chills, Swollen lymph nodes, muscle soreness, Inability to sleep due to pain. Called the Doctors office at 8:00am on 08/14/2012 to ask what I needed to do. I was informed to not have any solid foods for at least 12 hrs and that if I got a high fever and pain in my right side to go to ER. Thankfully by that time the pain had decreased and I was able to eat soup and crackers to calm my stomach. Abdominal/chest and back pain persisted but was less extreme.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: Symptoms began at 11:00 pm with Extreme abdominal/stomach pain, Extreme back pain, Soreness at injection site (upper left arm), Extreme Nausea and Vomiting that lasted 7 hrs, moments of extreme body heat and sweating, and chills, Swollen lymph nodes, muscle soreness, Inability to sleep due to pain. Called the Doctors office at 8:00am on 08/14/2012 to ask what I needed to do. I was informed to not have any solid foods for at least 12 hrs and that if I got a high fever and pain in my right side to go to ER. Thankfully by that time the pain had decreased and I was able to eat soup and crackers to calm my stomach. Abdominal/chest and back pain persisted but was less extreme.
Age: 56.0
Sex: M
Vaccine: YF
Symptoms: Urticaria
Clinical narrative: Developed nickel size hive on forearms 5 days after YF shot. Denies any other symptoms. Taking Thuja Occidentalis from accupuncturist.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Musculoskeletal pain, Pain in extremity
Clinical narrative: Few hours after receiving vaccine patient started experiencing shoulder/arm pain. Got so bad he went to ER, came to office 8/14, had developed linear array of microvessicles & redness 2.5" long.
Age: 1.41
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Crying, Erythema, Oedema peripheral, Pain, Skin warm
Clinical narrative: Arm hot red & swollen (right arm) child crying c/o pain 8/12/12 - saw Dr. 8/13/12.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: (L) deltoid swollen & warm, non tender.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Blister, Erythema, Oedema peripheral, Skin warm
Clinical narrative: (L) deltoid & arm red warm with blisters - non tender swollen.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Headache, Injection site rash
Clinical narrative: Rash on injection site and headaches.
Age: 1.13
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Breath holding, Crying, Hypotonia, Nasal congestion
Clinical narrative: Patient was here for vaccinations. PREVNAR and varicella were administered in right thigh while patient was in arms of mother. Patient began to cry and held her breath for approximately five seconds. Patient began to breath again with stuffy nose. For approximately two seconds, patient became limp with eyes closed. Patient then opened her eyes, muscle tone returned and began to cry. Mother waited in office for fifteen minutes until child was calm, skin tone pink, and patient was alert. Advised to call doctor with any further symptoms.
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Feeling abnormal, Influenza like illness, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: Approximately 24 hours after administration site of injection inflamed to approximately 8 inches in diameter. Became hot to touch and mildly itchy. Patient counseled to take ibuprofen and/or BENADRYL. Also feels "bad" with flu-like symptoms.
Age: 0.78
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Eyelid oedema, Ocular hyperaemia, Swelling face
Clinical narrative: Approximately 30 min follow immunizations the mother of child reports she had bilateral mildly red eyes and bilateral moderately swollen eyelids & below eyes.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal sensation in eye, Dysphonia, Dyspnoea, Ear pain, Erythema
Clinical narrative: Difficulty breathing, hoarseness, wheezing, fast heartbeat, swelling/throat tightness, redness in face, feeling of pain/warmth in ears, sinus pain, headache, red/itchy eyes.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Headache, Heart rate increased, Ocular hyperaemia, Sinus headache
Clinical narrative: Difficulty breathing, hoarseness, wheezing, fast heartbeat, swelling/throat tightness, redness in face, feeling of pain/warmth in ears, sinus pain, headache, red/itchy eyes.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Throat tightness, Wheezing
Clinical narrative: Difficulty breathing, hoarseness, wheezing, fast heartbeat, swelling/throat tightness, redness in face, feeling of pain/warmth in ears, sinus pain, headache, red/itchy eyes.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: Two hours after Hep B vaccine patients temp was 101 (axillary) and he was feverish and cold. The next day (28 hrs) his temp was 102 (axillary). The following morning symptoms were resolved.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Feeling hot, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Received Hep A in left arm (HAVRIX) - immed felt tingling all the way down arm and arm felt "hot" no shortness of breath, no redness or swelling at site.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to a male patients of 16-18 age. The patient was vaccinated intramuscularly with 0.5 ml GARDASIL (lot# was unknown) on 08-AUG-2012 and passed out after vaccinated. The patient sought medical attention. The doctor doesn't believe that it was due to the vaccine, he believed it was because the patient were nervous about getting shot in general. The outcome of passed out was unknown. The doctor didn't want to be contacted regarding this AE. Upon internal review, the pass out was considered as medically significant. This is one of the same report received from the same source. Additional information is not expected.