chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR, MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. No information provided regarding concurrent conditions and medical history. On an unknown date the patient was vaccinated with MMR II (dose, route, lot# not reported). No concomitant medications were reported. It was reported that the MMR II was exposed to 20.5 degree Celsius for 2.5 hours and may have been administered to patients and no adverse effects reported. PQC was not involved. This is one of the 3 report reported by the same reporter (1405USA009701, 1405USA009072). Additional information has been requested.
Sex: U
Vaccine: HIBV, HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. No information provided regarding concurrent conditions and medical history. On an unknown date the patient was vaccinated with LIQUID PEDVAXHIB (dose, route, lot# not reported). No concomitant medications were reported. It was reported that the LIQUID PEDVAXHIB was exposed to 20.5 degree Celsius for 2.5 hours and may have been administered to patients and no adverse effects reported. PQC was not involved. This is one of the 3 report reported by the same reporter (1405USA009701, 1405USA008829). 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 nurse practitioner refers to a patient of unknown age and gender. No information provided regarding concurrent conditions and medical history. On an unknown date the patient was vaccinated with GARDASIL (dose, route, lot # not reported). No concomitant medications were reported. It was reported that the vaccine GARDASIL was exposed to 20.5 degree Celsius for 2.5 hours and may have been administered to patients and no adverse effects reported. PQC was not involved. This is one of the 3 report reported by the same reporter (1405USA009701, 1405USA009702). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age. The patients medical history was not reported. On 13-MAY-2014, the patient was vaccinated with 1 dose of VAQTA (lot # J011385, Expiry date : 10-MAR-2015) that were stored outside of the recommended storage temperature. The concomitant medications were not reported. No adverse effects were reported. The outcome of vaccinated with above temperature excursions and no adverse effects reported was unknown. This case is linked to case # 1405USA009669. 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 refers to a unspecified number of patients of unknown age. The patients medical history was not reported. On 12-MAY-2014, the patients were vaccinated with 3 doses of GARDASIL (lot # J010668, Expiry date: 29-APR-2016) that were stored outside of recommended storage temperature. The concomitant medications were not reported. No adverse effects were reported. The outcome of vaccinated with above temperature excursion and no adverse effects reported was unknown. This case is linked to Case # 1405USA007228. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Mental status changes, Poor peripheral circulation, Pyrexia, Shock, Tachycardia
Clinical narrative: Developed fever, several episodes of possible seizure activity. Presented to Emergency Dept with shock-like symptoms (tachycardia, poor perusion, mental status changes).
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR
Symptoms: Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia
Clinical narrative: Thrompocytopenia requiring hospitalization, intravenous gamma globulin.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a 4 year old patient. On an unspecified date, the patient was vaccinated with the 2nd dose of VARIVAX (Merck) (strength, dose and lot # not reported). On 02-MAY-2014 the patient was vaccinated with the 2nd dose of VARIVAX (Merck) (lot # J009166, expiration date: 24-JUL-2015, strength and dose not reported) which was improperly stored at -11 Celsius degree for an unspecified number of hours. No adverse effects reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster
Clinical narrative: This spontaneous report as received from a approximately 88 year old male patient with penicillin allergy. The patient currently had a implant pacemaker. Approximately in May 2010 (reported as 3-4 years ago) the patient was vaccinated with ZOSTAVAX injection. Concomitant therapies included warfarin (manufacturer unknown) 1 milligram (mg) 2 1/2 tablets a day, bisoprolol Fum (manufacturer unknown) tablets 5 mg 1/2 tablet a day, CARTIA 180 mg takes 1 capsule, torsemide (manufacturer unknown) 20 mg and potassium (manufacturer unknown) 10 mg. Approximately in March 2014 (reported as 2 months ago) the patient came down with shingles 2 months ago which lasted a couple of weeks, since then shingles have gone away. On 13-MAY-2014, the blood test was conducted to determine for blood thinner. The outcome of came down with shingles 2 months ago which lasted a couple of weeks was reported as recovered/resolved (reported as gone away). The causality was not reported. It was reported as the patient sought the medical attention. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Lip swelling, Metabolic function test normal, Rash, Red blood cell count decreased
Clinical narrative: Pt had 9:30 AM appt, reports during sleep that night after 12:00 AM woke up with swollen upper lip and rash around jaw line. Denies any tongue, throat, or orbital edema. H/o seasonal allergies. Mom reports provided BENADRYL and symptoms resolved w/o sequelae. Pt. lives in shelter system. PPD administered same day, left forearm.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, Herpes zoster, Secondary transmission
Clinical narrative: This spontaneous prospective pregnancy report as received from a pharmacist refers to herself an approximately 31 year old female patient. None pertinent medical history, drug reactions or allergies were reported. On unknown dates, the patient administered multiple ZOSTAVAX subcutaneous injections to anonymous patients. The patient did not take concomitant medication. The patient became pregnant with LMP of 18-FEB-2014 and EDD of 25-NOV-2014. In May 2014, after administering multiple ZOSTAVAX injection, the patient developed a mild case of shingles. The patient stated that she had not received ZOSTAVAX. The patient was 12 weeks pregnant. Treatment was not given for the adverse events. None lab studies were performed. The patient sought medical attention. The outcome of after administering multiple ZOSTAVAX injections to patients she developed a mild case of shingles was reported as recovering. The pregnancy outcome was pending. Causality was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Blood pressure systolic increased, Cough, Crying, Diarrhoea
Clinical narrative: Case number PHHY2014US057494 is an initial literature report received on 10 May 2014. The authors discuss about an algorithm which was developed using the Brighton collaboration case definitions was more efficient for determining diagnostic certainty. This report refers to 12 months old male patient. He had history of atopic dermatitis, egg allergy (prick +) and reports of hives after eating carrots. On an unknown date, he visited the allergist's office to receive his 1st influenza vaccine. Due to the patient's history of egg allergy, he received seasonal influenza vaccine (manufacturer and batch number unknown) was administered per 2-part protocol to right quadriceps. First dose of vaccine was given at a dose of 0.05 cc intramuscularly. He was noted to have full strength, which was monitored for 30 minutes. No other adverse reaction was noted. Second dose of vaccine was given at a dose of 0.02 cc intramuscularly. Within 30 minutes of the second dose, he experienced urticaria of neck, anterior torso and both arms. He also became fussy and started crying. He had increased work of breathing, coughing, stridor, retractions, mild erythema and angioedema of uvula. The following lab values were noted after second vaccination: respiratory rate was 42 bpm, O2 saturation was 93%, pulse rate was 137 bpm and systolic blood pressure was 176. The patient was treated with epinephrine intramuscularly along with cetirizine, prednisolone and albuterol. He went home and the night after the clinic visit, he experienced diarrhea, mild wheezing and a blotchy rash. He was treated in the clinic with albuterol and BENADRYL. The family reports that the child had not eaten any eggs, nuts or carrots and there were no changes in the home. The authors concluded based on the algorithm developed from the Brighton collaboration case definition for anaphylaxis this case met the Brighton level 1 criteria.
Age: 1.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Irritability, Palatal oedema, Pharyngeal erythema, Rash macular
Clinical narrative: Case number PHHY2014US057494 is an initial literature report received on 10 May 2014. The authors discuss about an algorithm which was developed using the Brighton collaboration case definitions was more efficient for determining diagnostic certainty. This report refers to 12 months old male patient. He had history of atopic dermatitis, egg allergy (prick +) and reports of hives after eating carrots. On an unknown date, he visited the allergist's office to receive his 1st influenza vaccine. Due to the patient's history of egg allergy, he received seasonal influenza vaccine (manufacturer and batch number unknown) was administered per 2-part protocol to right quadriceps. First dose of vaccine was given at a dose of 0.05 cc intramuscularly. He was noted to have full strength, which was monitored for 30 minutes. No other adverse reaction was noted. Second dose of vaccine was given at a dose of 0.02 cc intramuscularly. Within 30 minutes of the second dose, he experienced urticaria of neck, anterior torso and both arms. He also became fussy and started crying. He had increased work of breathing, coughing, stridor, retractions, mild erythema and angioedema of uvula. The following lab values were noted after second vaccination: respiratory rate was 42 bpm, O2 saturation was 93%, pulse rate was 137 bpm and systolic blood pressure was 176. The patient was treated with epinephrine intramuscularly along with cetirizine, prednisolone and albuterol. He went home and the night after the clinic visit, he experienced diarrhea, mild wheezing and a blotchy rash. He was treated in the clinic with albuterol and BENADRYL. The family reports that the child had not eaten any eggs, nuts or carrots and there were no changes in the home. The authors concluded based on the algorithm developed from the Brighton collaboration case definition for anaphylaxis this case met the Brighton level 1 criteria.
Age: 1.0
Sex: M
Vaccine: FLUX
Symptoms: Stridor, Urticaria, Use of accessory respiratory muscles, Wheezing
Clinical narrative: Case number PHHY2014US057494 is an initial literature report received on 10 May 2014. The authors discuss about an algorithm which was developed using the Brighton collaboration case definitions was more efficient for determining diagnostic certainty. This report refers to 12 months old male patient. He had history of atopic dermatitis, egg allergy (prick +) and reports of hives after eating carrots. On an unknown date, he visited the allergist's office to receive his 1st influenza vaccine. Due to the patient's history of egg allergy, he received seasonal influenza vaccine (manufacturer and batch number unknown) was administered per 2-part protocol to right quadriceps. First dose of vaccine was given at a dose of 0.05 cc intramuscularly. He was noted to have full strength, which was monitored for 30 minutes. No other adverse reaction was noted. Second dose of vaccine was given at a dose of 0.02 cc intramuscularly. Within 30 minutes of the second dose, he experienced urticaria of neck, anterior torso and both arms. He also became fussy and started crying. He had increased work of breathing, coughing, stridor, retractions, mild erythema and angioedema of uvula. The following lab values were noted after second vaccination: respiratory rate was 42 bpm, O2 saturation was 93%, pulse rate was 137 bpm and systolic blood pressure was 176. The patient was treated with epinephrine intramuscularly along with cetirizine, prednisolone and albuterol. He went home and the night after the clinic visit, he experienced diarrhea, mild wheezing and a blotchy rash. He was treated in the clinic with albuterol and BENADRYL. The family reports that the child had not eaten any eggs, nuts or carrots and there were no changes in the home. The authors concluded based on the algorithm developed from the Brighton collaboration case definition for anaphylaxis this case met the Brighton level 1 criteria.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Infection, Pain in extremity
Clinical narrative: Unknown exact start dates of adverse effect. Patient states his arm hurt and got red and the he developed an infection and went to his PCP who gave him a prescription for antibiotics.
Age: 1.11
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient developed hives on torso area and scalp. In no apparent distress. Benadryl 0.3 ml administered.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Woke up with severe soreness in left upper arm, redness and swelling in area of vaccination that involved about a golf ball sized area of the arm.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: The incorrect vaccine given to the patient was discovered while the patient was still at the medical office. Instructions given to the patient's mother regarding potential signs and symptoms to watch for. Patient left facility without presenting adverse symptoms.
Age: 1.59
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Body temperature increased, Injection site erythema, Lethargy
Clinical narrative: TEMP 103.4, LETHARGIC, RED SPOT 1/2 INCH DIAMETER ON LEFT LATERAL THIGH.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Joint stiffness, Local swelling, Pyrexia
Clinical narrative: Arm became swollen from elbow to shoulder and redness the size of a dime at the injection site. He is running a fever up to 103.6 and is complaining of stiffness all over in all joints.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Rash pruritic
Clinical narrative: Pt went to the ER 10 days post vaccination with ACAM2000. Has local itchy rash, non-pustular. Pt was given Benadryl, Zofran, and Zantac and discharged to home.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Anaemia, Coagulation test abnormal, Coagulopathy, Confusional state, Culture negative
Clinical narrative: Fever up to 104 degrees Fahrenheit; Headache; Watery diarrhea for two days; Mental confusion on day 3 of illness; Admitted to hospital on day 3 and treated with antibiotics and ICU monitoring.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Diarrhoea, Full blood count abnormal, Haemoglobin decreased, Headache, Intensive care
Clinical narrative: Fever up to 104 degrees Fahrenheit; Headache; Watery diarrhea for two days; Mental confusion on day 3 of illness; Admitted to hospital on day 3 and treated with antibiotics and ICU monitoring.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Leukopenia, Platelet count decreased, Polymerase chain reaction, Pyrexia, Renal disorder
Clinical narrative: Fever up to 104 degrees Fahrenheit; Headache; Watery diarrhea for two days; Mental confusion on day 3 of illness; Admitted to hospital on day 3 and treated with antibiotics and ICU monitoring.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Renal impairment, Serology negative, Shift to the left, Thrombocytopenia, Transaminases increased
Clinical narrative: Fever up to 104 degrees Fahrenheit; Headache; Watery diarrhea for two days; Mental confusion on day 3 of illness; Admitted to hospital on day 3 and treated with antibiotics and ICU monitoring.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: White blood cell count decreased
Clinical narrative: Fever up to 104 degrees Fahrenheit; Headache; Watery diarrhea for two days; Mental confusion on day 3 of illness; Admitted to hospital on day 3 and treated with antibiotics and ICU monitoring.
Age: 0.11
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Small amount of blood in stool.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Local swelling
Clinical narrative: Arm started swelling and redness.
Age: 49.0
Sex: F
Vaccine: DTAP
Symptoms: Axillary mass, Erythema, Swelling
Clinical narrative: Red and swollen about 3 inches in diameter with a raised lump, used ice to reduce swelling. Down to dime size on 05.18.14. As of 05.20.14 lump still exists under skin to touch.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Diarrhoea, Headache, Induration, Local swelling
Clinical narrative: SEVERE HEADACHE, LOCAL SWELLING AND INDURATION, NAUSEA WITH VOMITING, DIARRHEA, WEAKNESS, FEVER.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: SEVERE HEADACHE, LOCAL SWELLING AND INDURATION, NAUSEA WITH VOMITING, DIARRHEA, WEAKNESS, FEVER.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Computerised tomogram, Pharyngeal oedema, Sensation of foreign body, X-ray
Clinical narrative: Found golf ball size lump in middle of sons throat.  Called PCP.  Told if he was ok and breathing to keep an eye on it.  Throat was so swollen by 5:30AM next morning we rushed to the ER.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Swollen Thigh (injection site) down to knee and swollen knee.  Significant Leg Pain.
Sex: U
Vaccine: VARCEL
Symptoms: Dizziness, Loss of consciousness, Tremor
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. In 2009, the patient was vaccinated with the 2nd dose of VARIVAX (Merck) (strength, dose and lot# not reported). In 2009, the patient developed dizziness, blacked out and shaking shortly after receiving the scheduled second dose of VARIVAX (Merck). The outcome of dizziness, blacked out and shaking was unknown. Upon internal review, black out was considered to be medically significant. This is one of the several reports from the same source. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Rash pruritic
Clinical narrative: Pt came by clinic 5/17/14 to report event she received her 1st Hep A vaccine, developed a mild pruritic rash on chest and low face. Today some slight spread of rash upper face. No known unusual exposures. Denied SOB/wheezing. Instructed take ZYRTEC, monitor sym - ER if worsens. 5/20/14 Talked to pt today, had no further rxn, rash subsiding.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Chills, Erythema, Inflammation, Leukocytosis, Oedema
Clinical narrative: This literature marketed report as received from a other health professional refers to a 43 year old female patient with asthma. This is case 4 of 5 reports. Patient's medical history was not reported. On an unknown date the patient was vaccinated with PCV (manufacturer unknown) (dose and frequency unknown) in the arm. Other suspect therapy included influenza virus vaccine (manufacturer unknown). Both the vaccination were received in the same arm. The patient was also vaccinated with Tdap. The patient received an additional injection Tdap vaccine in the opposite arm. On an unknown date the patient experienced large local inflammatory reactions (erythema, oedema and warmth), rigors, fever, leucocytosis and presumed cellulitis. The patient's laboratory results included WBC 22K/microliter, and Maximum temperature 102.8 degree F. It was reported that the patient was not hospitalised. The patient sought care within 2-3 d of vaccination. Within 5-7 days, the patient experienced improvement in the skin findings and resolution of the systemic symptoms. In one patient, the local swelling and erythema at the injection site lasted about 2 weeks. No patients included in this series have received any subsequent vaccines. The outcome of large local inflammatory reactions (erythema, oedema and warmth) and presumed cellulitis was reported as recovering/resolving. The outcome of fever, leucocytosis and rigors was reported as recovered/resolved. The reporter considered the events to be not related to Influenza Virus Vaccine (manufacturer unknown). The reporter considered the events to be related to PCV (manufacturer unknown). The author stated that "the 5 patients in this series all had leukocytosis, fever and large local inflammatory reactions following influenza vaccine (manufacturer unknown) and PCV (manufacturer unknown). Based on the known side effects of PCV (manufacturer unknown), the lack of similar findings in patients who receive the influenza vaccine (manufacturer unknown) and another patient's lack of influenza vaccine (manufacturer unknown associated local symptoms we believe these reactions were due to PCV (manufacturer unknown)". This case is linked to case # 1405USA008574, 1405USA007995, 1405USA008573 and 1405USA008576 (same reporter link). Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Pyrexia, Skin warm, White blood cell count increased
Clinical narrative: This literature marketed report as received from a other health professional refers to a 43 year old female patient with asthma. This is case 4 of 5 reports. Patient's medical history was not reported. On an unknown date the patient was vaccinated with PCV (manufacturer unknown) (dose and frequency unknown) in the arm. Other suspect therapy included influenza virus vaccine (manufacturer unknown). Both the vaccination were received in the same arm. The patient was also vaccinated with Tdap. The patient received an additional injection Tdap vaccine in the opposite arm. On an unknown date the patient experienced large local inflammatory reactions (erythema, oedema and warmth), rigors, fever, leucocytosis and presumed cellulitis. The patient's laboratory results included WBC 22K/microliter, and Maximum temperature 102.8 degree F. It was reported that the patient was not hospitalised. The patient sought care within 2-3 d of vaccination. Within 5-7 days, the patient experienced improvement in the skin findings and resolution of the systemic symptoms. In one patient, the local swelling and erythema at the injection site lasted about 2 weeks. No patients included in this series have received any subsequent vaccines. The outcome of large local inflammatory reactions (erythema, oedema and warmth) and presumed cellulitis was reported as recovering/resolving. The outcome of fever, leucocytosis and rigors was reported as recovered/resolved. The reporter considered the events to be not related to Influenza Virus Vaccine (manufacturer unknown). The reporter considered the events to be related to PCV (manufacturer unknown). The author stated that "the 5 patients in this series all had leukocytosis, fever and large local inflammatory reactions following influenza vaccine (manufacturer unknown) and PCV (manufacturer unknown). Based on the known side effects of PCV (manufacturer unknown), the lack of similar findings in patients who receive the influenza vaccine (manufacturer unknown) and another patient's lack of influenza vaccine (manufacturer unknown associated local symptoms we believe these reactions were due to PCV (manufacturer unknown)". This case is linked to case # 1405USA008574, 1405USA007995, 1405USA008573 and 1405USA008576 (same reporter link). Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Nausea, Oropharyngeal pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 48 year old female patient with high blood pressure and allergies. The patient had drug reactions/allergies to CELEBREX, ULTRAM, NEMBUTAL (reactions unspecified). On 13-MAY-2014 the patient was vaccinated with PNEUMOVAX 23 (lot #J004332, expiration date 26-SEP-2014, reported as 25-SEP-2014) (strength, dose and frequency were not provided) intramuscularly. Concomitant therapies included SINGULAIR, PRILOSEC, TOPAMAX and verapamil. On 14-MAY-2014, the patient experienced extreme nausea, cough and sore throat which worsened by 15-MAY-2014. The patient called the pharmacist for medical attention and didn't receive any treatment for the adverse event. Lab diagnostics studies performed were reported as none. At the time of report, the outcome of the adverse events was reported as not recovered/not resolved. The relationship between the PNEUMOVAX 23 and the adverse events was not provided. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Maternal exposure before pregnancy, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative, Rubella in pregnancy
Clinical narrative: This spontaneous report as received from a healthcare student refers to unspecified number of female patients of unknown ages. The patients pertinent medical history was unspecified. On an unknown date unspecified number of patients were vaccinated with M-M-R II. The concomitant medications were unspecified. The unspecified number of patients received M-M-R II on unspecified dates approximately 3 years before becoming pregnant and had no immunity to measles, mumps or rubella during pregnancy. It was reported that the lab diagnostic tests conducted were unspecified. The outcome of no immunity to measles, mumps or rubella during pregnancy was unknown. The causality was not reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Malaise, Throat irritation, Tongue coated
Clinical narrative: Malaise, headache, itchy throat, coating on tongue.
Age: 9.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Diarrhea, fever, vomiting.
Age: 18.0
Sex: M
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Rash on stomach
Sex: U
Vaccine: VARZOS
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 12-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # J001698, expiration date 08-MAY-2014, 0.65 ml, subcutaneous. On 12-MAY-2014, the patient received an expired dose of ZOSTAVAX. No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Convulsion, Dizziness, Loss of consciousness, Pallor
Clinical narrative: Prior to giving Tdap, pt was totally alert/oriented. Vaccine screening completed per protocol. After confirming pt information, administered Tdap IM (L) delt. Pt then became faint, discolored (pale), and slowly lost consciousness. Pt took a few minutes and started to "seize", yet breathing. Administered ammonia via nasal x2 pt then slowly regained consciousness.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac disorder, Pruritus
Clinical narrative: A few hours after flu shot, I felt like some electrical things going on with my heart and the next morning it happened again but not after that. I don't know if I'm allergic to latex or rubber. I itch when I take my tube socks off. I've been getting the flu shot for over 50 years without side effects.
Age: 55.0
Sex: M
Vaccine: IPV, TDAP, TYP, YF
Symptoms: Urticaria
Clinical narrative: 9:30am 5/1/14 - pt reports hives in mid section (ribs, belt line) and legs that started 4/30/14. I advised pt to use BENADRYL. I checked back with him at 6pm 5/1/14. He said symptoms are improved and clear.
Age: 13.0
Sex: M
Vaccine: HPV4, YF
Symptoms: Chest pain, Dyspnoea, Pruritus, Urticaria
Clinical narrative: Within 5 minutes post vaccination patient c/o SOB, mid chest pain, no radiation, itchy skin, hives presented on (R) face, (R) back. VSS BP 110/70, HR 80, RR 18. Transported via medic to emergency room.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Dyskinesia, Feeling hot, Malaise, Neuropathy peripheral
Clinical narrative: 1 wk bed after FLUZONE HIGH DOSE, got violently ill, jerking and shaking out of control, freezing feet turned blue to ankles. Alone. Couldn't call at time. Put body in warm water to warm up - Dr on call. Neuropathy feet, hands and body. Feet hot and hands since flu shot. Wrong diagnosis finally. Neuropathy from flu shot.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral coldness, Tremor
Clinical narrative: 1 wk bed after FLUZONE HIGH DOSE, got violently ill, jerking and shaking out of control, freezing feet turned blue to ankles. Alone. Couldn't call at time. Put body in warm water to warm up - Dr on call. Neuropathy feet, hands and body. Feet hot and hands since flu shot. Wrong diagnosis finally. Neuropathy from flu shot.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt received flu injection on 11/25/13 and ever since has had pain at the site, decreased range of motion. Pt reports decrease use of deltoid. Pt has tried NSAIDs - ice - heat - massage little relief.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Patient said she had a reaction around mid-section including raised red areas.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Rash
Clinical narrative: 12.5 cm x 12 cm area of erythema, induration and warmth at injection site. Patient's mother gave BENADRYL and ibuprofen prn and used warm compress to area. Rash occurred within 24 hrs of receiving vaccine.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Injection site rash, Rash, Rash erythematous, Skin warm
Clinical narrative: Rash at injection site developed a couple days later -> rash traveled down the arm to the fore arm. The rash red, warm, uncomfortable. Pt reported to MD 4-5 days later. Pt state MD gave oral antibiotic and BENADRYL OTC.
Age: 16.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16 year old patient of unknown gender. Medical history and current conditions not reported. On an unknown date the patient was inadvertently vaccinated with 1 ml (overdose) of VAQTA dose 2 (reported as a booster dose), intramuscular (strength, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
Sex: M
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 male patient of unknown age. On 22-JAN-2011, the patient was vaccinated with a dose of GARDASIL (dose, route and frequency were not reported) and on 01-MAR-2012, the patient received the second dose of GARDASIL (dose, route and frequency were not reported). No adverse effects were reported. At the time of the report, the patient's outcome was unknown. 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 registered nurse refers to unspecified number of patients. On an unknown date, the patients were vaccinated with some improperly stored doses of GARDASIL (dose, route and lot # not reported). No adverse effects were reported. This is one of several reports received 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 was received from a registered nurse refers to a patient of unknown age. On 09-MAY-2014, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscular, Exp date 09-MAR-2014. On 09-MAY-2014, the patient was administered expired PNEUMOVAX 23. No adverse effects reported. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema multiforme, Pruritus, Rash, Urticaria
Clinical narrative: Skin rash, rash, erythema multiforme and urticaria pruritus. Loratadine 10 mg AM.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients. On an unknown date, the patients were vaccinated with some improperly stored doses of COMVAX (dose, route and lot # not reported). No adverse effects were reported. This is one of several reports received 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 healthcare worker refers to unknown number of patients of unknown age and gender. On an unknown date, the patients might have been vaccinated with GARDASIL (dose not reported) that was exposed to temperatures below 36 degrees F for an unknown amount of time. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pallor, Rash erythematous
Clinical narrative: On 9 May 2014, patient received Hepatitis B #4 (received Hepatitis B #3 at approximately 4.5 months)/PENTACEL #3/ROTATEQ #3/PREVNAR #3 and within five minutes of the injection, it was noticed patient had a blanching/non-whelpy/red round rash on the bottom of both of his feet. He was completely non-toxic, happy, and his lungs were clear. We kept him in the office to watch him and within 20 minutes, he had a similar rash as the above in the genital region. Again, the lungs were clear - he was given BENADRYL (approximately 5mg/kg) and within 30 minutes of the administration of the BENADRYL, the rash was faded, if not gone entirely on the genital area and had faded considerably on his feet. He was discharged to the care of his parents with strict instructions on when to seek emergency care. I called his parents later on in the evening and no new rash had developed. Mom called on the morning of 10 May and reported she gave one dose of BENADRYL during the night and the rash was gone in the morning.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 16-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J001698, exp. 08-MAY-2014, 0.65 ml, subcutaneous. No adverse effects reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Patient received an expired vaccine administered 5/16/14, expiration 5/8/14. No adverse reactions reported. Our clinic will revaccinate 28 days from first vaccine on June 13, 2014. Contacted manufacturer 5/19/14 spoke with personnel. Personnel advised that normally there is 28 day time period between vaccines, but in this particular case, this (same vaccine) with lot # J001698 had some extended potency, but no specific parameters could be given. Personnel stated it is up to medical provider to.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The certified medical assistant (CMA) reported that the following improperly stored doses of vaccines were administered to unspecified patients on unspecified dates: 3 doses of ROTATEQ (reported as "ROTATEQ suspension 2") (dose, route, lot# not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients. On an unknown date, the patients were vaccinated with some improperly stored doses of PNEUMOVAX 23 (dose, route and lot # not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients. On an unknown date, the patients were vaccinated with some improperly stored doses of ROTATEQ (doses, route and lot # not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age and gender. On an unknown date, the patients might have been vaccinated with RECOMBIVAX HB that was exposed to temperatures below 36 degrees F for an unknown amount of time. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (C.M.A.) refers to an unspecified number of unspecified patients of unknown gender and age. On an unknown date, an unspecified number of patients were vaccinated with doses of RECOMBIVAX HB injection (lot#, dose, frequency and route not provided) that were exposed to temperatures that were outside of the recommended temperature range. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Injected on 1/20/14 and diagnosed with shingles on 4/30/14.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Convulsion, Dyskinesia, Loss of consciousness, Pallor, Syncope
Clinical narrative: As reported by nurse practitioner: Convulsive syncope 1-2 minutes post first HPV (GARDASIL) vaccination. Brief LOC (2-3 seconds). Parent states pt. was "jerky" for a few seconds during syncopal incident. No prior history of seizure. Pt. pale immed. after episode - color returned within 1 min. O2 sat 98%, BP 110/58 after incident, HR 59. Gave crackers, juice and instructed to lay down for 15 additional minutes.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: Shaking, chills, fever >100 degrees, site of injection red and sore, some c/o N/V (6 days after administration of Tdap).
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Tremor, Vomiting
Clinical narrative: Shaking, chills, fever >100 degrees, site of injection red and sore, some c/o N/V (6 days after administration of Tdap).
Age: 26.0
Sex: M
Vaccine: HEPAB
Symptoms: Convulsion, Immediate post-injection reaction
Clinical narrative: Seizure after shot.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Fall, Grand mal convulsion, Laceration, Lip injury, Syncope
Clinical narrative: A few minutes after Tdap vaccine, patient had abrupt syncope and generalized tonic clonic seizure that lasted for < 30 sec. IV started and bolus given. Patient transported by EMS to ER. Pt lacerated chin, broke upper front teeth and lacerated lip in fall.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Tooth fracture
Clinical narrative: A few minutes after Tdap vaccine, patient had abrupt syncope and generalized tonic clonic seizure that lasted for < 30 sec. IV started and bolus given. Patient transported by EMS to ER. Pt lacerated chin, broke upper front teeth and lacerated lip in fall.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Anuria, Decreased appetite, Haematochezia, Irritability
Clinical narrative: Mo states child became fussy. Denies fever - only taking a few oz of formula at a time 2-3 oz every several hrs. Had taken maybe 9-10 oz in 24 hrs after vaccine. Mo states no urination since vaccine given 5/12. 5/13 PM Mo noticed slight blood tinge in diaper x2. Referred to ER ASAP.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Urticarial rash over face, torso and extremities within. Seen by Dr. when rash became pronounced.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Pruritus, Rash, Swelling face
Clinical narrative: Pt received BOOSTRIX on 5/12/14. Called on 5/14/14 with complaints of swelling of face/hands, itching and rash. Rec pt take BENADRYL and contact PCP.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Swelling, redness: rash at injection site - BENADRYL given and cold compress.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Full-body aches, chills, slight fever (99.55 degrees F).
Age: 16.0
Sex: F
Vaccine: HPV4, MMR, MNQ, VARCEL
Symptoms: Face injury, Fall, Head injury, Immediate post-injection reaction, Pain
Clinical narrative: Vasovagal syncope immediately after vaccine administration. Patient fell forward, hitting her nose and forehead on chair in exam room. Appropriate mental status and blood pressure. Patient was given some juice and a dose of MOTRIN for pain after which she felt well enough to walk to the car.
Age: 16.0
Sex: F
Vaccine: HPV4, MMR, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Vasovagal syncope immediately after vaccine administration. Patient fell forward, hitting her nose and forehead on chair in exam room. Appropriate mental status and blood pressure. Patient was given some juice and a dose of MOTRIN for pain after which she felt well enough to walk to the car.
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Mom reports that approximately one and a half hours after receiving vaccines patient began to cry and cried for 7 hours inconsolably.
Age: 0.98
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Pyrexia
Clinical narrative: 5/15/14 objective fever 101.2 degrees F tympanic. 5/16-5/18/14 subjective fever.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Nodule
Clinical narrative: Red bump, knot - local reaction that improved and has resolved.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and painful to touch at site of injection. 11 1/2 cm x 5 cm. Treated with prednisone 20mg, 2 daily for 5 days.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: 1.5 days later patient developed a localized red raised itchy area approximately 2 inches across.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 1.5 days later patient developed a localized red raised itchy area approximately 2 inches across.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizziness, fatigue.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper arm redness, warmth, tenderness and swelling - tx'd w/ ZYRTEC and MEDROL dose pak.
Age: 6.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site redness in a 6, possibly 7-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included varicella virus vaccine (non-gsk); non-GSK manufacturer; subcutaneous; back of right arm given on 12 November 2013. On 12 November 2013 the subject received 5th dose of INFANRIX (.5 ml, intramuscular, right deltoid). In November 2013, within two days of vaccination with INFANRIX, the subject experienced injection site redness, swelling injection site and injection site pruritus. The nurse reported the subject was brought in for medical attention due to redness, swelling and some itching on the arm where vaccines were given; it was four inches below the INFANRIX injection site. VARIVAX was administered subcutaneously on the back of the right arm. The subject had no fever. At the time of reporting the outcome of the injection site redness, swelling injection site and injection site pruritus was unspecified. The nurse stated this would also be reported to VAERS.
Age: 0.18
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Diarrhoea, Faecal volume increased
Clinical narrative: MY CHILD BEGAN HAVING DIARRHEA. THE DIARRHEA HAS NOT IMPROVED AND IT HAS BEEN 2 WEEKS SINCE HE RECEIVED THE ROTAVIRUS (ROTATEQ) VACCINE.
Age: 0.18
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Diarrhoea
Clinical narrative: MY CHILD BEGAN HAVING DIARRHEA. THE DIARRHEA HAS NOT IMPROVED AND IT HAS BEEN 2 WEEKS SINCE HE RECEIVED THE ROTAVIRUS (ROTATEQ) VACCINE.
Age: 3.0
Sex: M
Vaccine: MENHIB
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Irritability
Clinical narrative: Fussy, low fever, pain when moving or touching his leg, hard lump at injecton site accompanied by redness around area.
Age: 3.0
Sex: M
Vaccine: MENHIB
Symptoms: Pain, Pyrexia
Clinical narrative: Fussy, low fever, pain when moving or touching his leg, hard lump at injecton site accompanied by redness around area.
Age: 32.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, aching joints, sore throat, headache.
Age: 57.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Low grade fever, itchy, 2 spots on hand.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Diarrhoea, Malaise, Pruritus, Rash
Clinical narrative: 5/13/14 father in to clinic stating his son had "shots yesterday". Father stated his son felt fine yesterday and upon arising the next day his son ate a bowl of tomato soup at around 640am.  He stated his son c/o not feeling well.  But wanted to go to school. Father stated he was called from the school around 750am.  That his son had projectile vomiting. After he got home father stated his son had "loose stools with abdominal cramping.  Stated he "looked funny". He noticed a rash to his face, neck, and back, as well as both arms on inside.  He stated it went away quickly and he did c/o itching the the right arm.  The father stated he checked the date on the can of soup and it had expired on June 2012.  The father stated his son is home resting and after a nap stated felt better.  Father requested info if this could be related to vaccines the child received or from the 2 year old expired soup the child consumed. Frequent adverse reactions were discussed with the father and informed the father to follow up with child's PCP if vomiting persists or for further evaluation. Father verbalized understanding.