chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients (unknown age and gender). On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX (dose, lot number and route of administration were not reported). On an unknown date, the patient experienced injection site reactions. The outcome of injection site reactions was unknown. The relatedness between the events and (Oka/Merck) VARIVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). Pertinent medical history, drug reactions or allergies were not reported. On 05-APR-2014 the patient was vaccinated with improperly stored dose of ZOSTAVAX, LOT number: J011548, expiration date: 19-DEC-2014, (dose, route not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients (unknown age and gender). On an unknown date in 2013 (reported as past year), the patients were vaccinated with ZOSTAVAX (dose, lot number and route of administration were not reported). On an unknown date in 2013 (reported as past year), the patients experienced injection site reactions. The outcome of injection site reactions was unknown. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). Pertinent medical history, drug reactions or allergies were not reported. On 03-APR-2014, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot number: J011548, expiration date: 19-DEC-2014, (dose, route not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 19 year old female patient who was not pregnant. The medical assistant reported that the patient received two doses of (Oka/Merck) VARIVAX (lot#, dose, route not reported) as a child on unspecified dates. Concomitant therapy was not reported. The patient had titer for varicella drawn on an unspecified date and the titers for varicella was "low". The patient was adminsitered a third dose of (Oka/Merck) VARIVAX on an unspecified date. It's also reported that "No adverse effect reported". Outcome of the event was not reported. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Eye swelling, Rash, Rash generalised, Throat tightness
Clinical narrative: Rash all over body, swelling eyes, throat felt tight.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Patient administered PPSV-23 instead of Prevnar-13.
Age: 63.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain upper, Blood glucose increased, Dizziness, Dyspnoea, Liver function test normal
Clinical narrative: Has been having stomach pain since she received the 3rd her rabies vaccine 7/24/14, severe pain, bilateral upper quadrants. The second to the last shot was given Monday 7/28/14 and last shot will be next Monday 8/4/14. Woke up at midnight with trouble breathing and pain in her upper quadrants, character: feels like knots, associated with mild nausea, some dizziness, hurts more when she eats, treatment: milk of magnesia.  c/o nausea.  Denies : vomiting. fever. blood in stool. heartburn. diarrhea loose stools. bowel pattern loose bowels, last episode this AM.
Age: 63.0
Sex: F
Vaccine: RAB
Symptoms: Metabolic function test normal, Nausea, Renal function test normal
Clinical narrative: Has been having stomach pain since she received the 3rd her rabies vaccine 7/24/14, severe pain, bilateral upper quadrants. The second to the last shot was given Monday 7/28/14 and last shot will be next Monday 8/4/14. Woke up at midnight with trouble breathing and pain in her upper quadrants, character: feels like knots, associated with mild nausea, some dizziness, hurts more when she eats, treatment: milk of magnesia.  c/o nausea.  Denies : vomiting. fever. blood in stool. heartburn. diarrhea loose stools. bowel pattern loose bowels, last episode this AM.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dyspnoea, Erythema, Immediate post-injection reaction, Infection, Nodule
Clinical narrative: On 8/5/14, patient received Gardasil (left arm) and Menactra (right arm).  He immediately developed erythematous papules.  Over the next two days he developed, papules, hives, and periorbital edema.  The papules turned into nodules and become secondarily infected after he scratched.  The hives did not improve with Benadryl.  He was seen at urgent care on 8/7/14 at 4:30 AM and he recieved Benadryl and Prednsione.  2 hours later he had no improvement and stated that he had shortness of breath (no tachypnea, hypoxia, or wheezes on examination).  He was given an EpiPen and had improvement of all of his symptoms.  He was observed for 6 hours and continued to improve and was discharged home.  Pediatric allergy was consulted over the phone, and could not determine if this was an allergy to Gardasil but recommended no further doses and reporting to VAERS.  The patient had no other known reason for hives, periorbital edema, shortness of breath, or nodules.  He had no viral symptoms, bug bites, or new medications/drugs.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Papule, Periorbital oedema, Pruritus, Urticaria
Clinical narrative: On 8/5/14, patient received Gardasil (left arm) and Menactra (right arm).  He immediately developed erythematous papules.  Over the next two days he developed, papules, hives, and periorbital edema.  The papules turned into nodules and become secondarily infected after he scratched.  The hives did not improve with Benadryl.  He was seen at urgent care on 8/7/14 at 4:30 AM and he recieved Benadryl and Prednsione.  2 hours later he had no improvement and stated that he had shortness of breath (no tachypnea, hypoxia, or wheezes on examination).  He was given an EpiPen and had improvement of all of his symptoms.  He was observed for 6 hours and continued to improve and was discharged home.  Pediatric allergy was consulted over the phone, and could not determine if this was an allergy to Gardasil but recommended no further doses and reporting to VAERS.  The patient had no other known reason for hives, periorbital edema, shortness of breath, or nodules.  He had no viral symptoms, bug bites, or new medications/drugs.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 67 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 10-JUL-2014 the patient was vaccinated with ZOSTAVAX, (lot # K000995, expiration date 16-MAR-2015, dose, route and frequency were not reported). Concomitant therapies included metformin. Approximately 9 days later, on approximately 19-JUL-2014, the patient developed a rash all over her legs and arms and the pharmacy technician mentioned that most of the rash was from the patient's waist down. The patient had sought for medical attention by contacting the pharmacy technician. Treatment given for the adverse event included VISTARIL, NORCO, prednisone (manufacturer unknown). No lab diagnostics studies performed. VZVIP packet was faxed. The outcome of the event was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. The nurse reported that since June 2014, on unspecified dates of 2014, unknown dose of (Oka/Merck) VARIVAX (lot#, dose, route and frequency were not provided) were administered after being improperly stored to unknown number of patients. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, one single short, subcutaneous, (lot# and dose unspecified) for treatment of shingles. On an unknown date the patient presented with flu like symptoms: fever, chills, and body aches. The patient did not seek medical attention and no treatment was given for the events. No lab diagnostics studies performed. The outcome of the events was unknown. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified the patients of unkonwn age. No information about medical history, drug reactions and allergies was specified. On unspecified dates the patients were vaccinated with doses of VARIVAX (Merck) (lot#, dose, route not reported) that were exposed to a temperature excursion (temperatures of 6 Fahrenheit (F) for 20 minutes) on 15-JUL-2041, that was supported, have been administered to unspecified patients. No concomitant medications were reported. No adverse effects have been observed or reported. This is one of the two reports received from the same reporter (same reporter case 1408USA003916). Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Apparent death, Guillain-Barre syndrome, Muscular weakness, Paralysis, Plasmapheresis
Clinical narrative: Muscle weakness in limbs, Guillain-Barre Syndrome-diagnosed. Treated by Plasmapheresis, 5 times. About 80% recovered weakness ongoing in legs. Was completely paralyzed at peak of condition and near death.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chronic inflammatory demyelinating polyradiculoneuropathy, Fall, Fatigue, Hypoaesthesia
Clinical narrative: The afternoon and next day of shot I had soreness in arm. Over next several months, fatigue, numbness in both hands, loss of lower body muscle strength, numbness in both feet, until unable to lift feet, finally collapsing due to leg weakness; at which time, I went to ER. Diagnosed on 4/24/14 as having CIDP / treatment has been prednisone and IVIG infusion therapy.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: The afternoon and next day of shot I had soreness in arm. Over next several months, fatigue, numbness in both hands, loss of lower body muscle strength, numbness in both feet, until unable to lift feet, finally collapsing due to leg weakness; at which time, I went to ER. Diagnosed on 4/24/14 as having CIDP / treatment has been prednisone and IVIG infusion therapy.
Age: 63.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain in extremity, Rash
Clinical narrative: Rash on arm, pain from shoulder to hand
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: ERYTHEMA TO UPPER LEFT DELTOID MEASURES 2 INCHES LENGTH AND 2 1/2 WIDTH WITH WARM TO TOUCH, HARD. MOTHER STATED PT HAD FEVER 100.3 AND REDUCED WHEN GAVE MOTRIN.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Rash, Rash erythematous
Clinical narrative: Red spots appeared on his face and arms. The area where the injections was, was all clear. We are treating him with 25mg of Benadryl every 6 hours until symptoms go away.
Age: 25.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Hyperhidrosis, Hyperventilation, Laboratory test, Loss of consciousness, Pallor
Clinical narrative: Pt became unconscious and quickly recovered w/ pale, sweaty symptoms. Pt also started to hyperventilate for a minute before catching his breath. A medical team responded and provided oxygen/labwork. No epi required. Pt fully recovered.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Torticollis
Clinical narrative: 5 min after administrat developed torticollis.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B core antigen positive, Hepatitis B surface antigen positive
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of Hepatitis B surface antigen positive and Hepatitis B core antigen positive in an adult female subject who was vaccinated with Hepatitis B vaccine recombinant (manufacturer unspecified). The subject's last menstrual period and expected date of delivery were unknown. The authors reported that the subject did not have Hepatitis C or any major medical illness. No further information was provided on the subject's medical history, concurrent medical history or concomitant medications. The subject reported having received an undetermined number of doses of unspecified Hepatitis B vaccine on unspecified dates (doses, routes and injection sites unknown; batch numbers not specified). On an unknown date, at an unspecified time after vaccination with Hepatitis B vaccines, the subject was tested positive for Hepatitis B surface Antigen and total Hepatitis B core Antigen. It was not possible to determine if exposure occurred during pregnancy or within the 3-month period prior to conception with the information provided. This case was assessed as medically serious by GSK due to possible vaccination failure. Treatment was unknown. The outcome of the events and of the pregnancy was unspecified. The authors did not comment on any causal relationship between the event and the unspecified hepatitis B vaccine. The authors' conclusion stated that "although the majority of discrepant HBsAg reactive screening results from this retrospective analysis of pregnant women were false positives, true positives occurred. Total anti-HBc was the most useful single test to resolve HBsAg discrepancies. Validation of a testing algorithm for resolving discrepant results will require prospective studies". This case is 1 of the 2 valid cases reported in the same literature article (see case B1020364A).
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. No information about medical history, drug reactions and allergies was specified. On unspecified dates the patients were vaccinated with doses of PROQUAD (Merck) (lot#, dose, route not reported) that were exposed to a temperature excursion (temperatures of 6 Fahrenheit (F) for 20 minutes) on 15-JUL-2014, that was supported, have been administered to unspecified patients. No concomitant medications were reported. No adverse effects have been observed or reported. This is one of the two reports received from the same reporter (same reporter case 1408USA002172). Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old male patient with no pertinent medical history. On 11-JUL-2014 the patient was vaccinated with GARDASIL, injection (lot# and expiration date not provided) (1 single shot), intramuscularly. On 11-JUL-2014, after receiving GARDASIL the patient stood up, became dizzy and went to the bathroom to throw up. No diagnostic tests were reported. The patient did not seek medical attention. There was none treatment given for the all events. The outcome of "stood up, became dizzy and went to the bathroom to throw up" was reported as recovered/resolved, on 11-JUL-2014. The relatedness between the events and GARDASIL was not reported. Additional information is not expected, because there was no permission to contact the doctor.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. Since 25-JUL-2014, the patients were vaccinated with ROTATEQ (lot#, expiration date, route, frequency and dose were unknown) which had been improperly stored. No adverse effects were reported. This one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. The nurse reported that the patient vaccinated with the first dose of GARDASIL (injection) (dose, frequency, lot number not reported) on an unspecified date in December 2010, then vaccinated with the second dose of GARDASIL (injection) (dose, frequency, lot number not reported) on 07-MAR-2011 and vaccinated with the third dose of GARDASIL (injection) (dose, frequency, lot number not reported) on 04-AUG-2014. No adverse event was reported. Action taken was not applicable. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse (L.V.N.) refers to two patients of unknown age and gender. On 24-JUL-2014 the patients were vaccinated with a dose of ZOSTAVAX that were improperly stored for (dosage and route not reported). Lot # J011829, expiry date 26-DEC-2014. No adverse events were reported. The outcome of event was not reported. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Headache
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 83 year old male patient. The patient's medical history included chicknepox. Patient had no drug reactions/allergies. On 23-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route were unknown). No concomitant medication was reported. On 24-JUL-2014, the patient sought medical attention by calling pharmacy and reported headache, warmth of head, face and an unspecified part of his body and redness. No treatment was given for the events. No lab diagnostics studies performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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 of unknown age and gender. Since 23-MAY-2014 (approximately in 2014, exact date was not reported) unspecified number of patients were vaccinated with unspecified number of doses of VARIVAX (Merck) (lot#H015136, expiration date: 09-AUG-2014) (dose not reported) that were exposed to temperatures outside of range on 23-MAY-2014. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant (also reported as healthcare worker) refers to a patient of unknown demographics. The patient's medical history and current condition are not reported. On 04-AUG-2014 the patient was vaccinated with MMR II of unknown strength, frequency and route of administration (lot # K000255 and expiry date 08-JAN-2016 (also reported as 20-JAN-2016). It was reported that improperly stored MMR II was administered to an unspecified patient. No adverse effect reported. Product quality complaint was not involved. The outcome of the event is unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 03-AUG-2012 the patient was vaccinated with the first dose of GARDASIL (dose reported as 0.5 ml, intramuscularly, lot # unknown). On 13-SEP-2013 the patient was vaccinated with the second dose of GARDASIL (dose reported as 0.5 ml, intramuscularly, lot # unknown). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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 of unknown age and gender. Since 23-MAY-2014 (approximately in 2014, exact date was not reported) unspecified number of patients were vaccinated with unspecified number of doses of VARIVAX (Merck) (lot#J012378, expiration date: 03-OCT-2015) (dose not reported) that were exposed to temperatures outside of range on 23-MAY-2014. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Flushing
Clinical narrative: Baby developed flushing to face and arms and legs within 3 minutes of vaccines. Cool compress was done and flushing resolved, fading to face. Re-examination done and normal except flushed cheeks.
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a certified medical assistant, via a company representative, refers to a male patient of unknown age. No information on his medical history, concurrent conditions or concomitant drugs was provided. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 dose, site and route of injection, lot# and expiration date not reported. On an unknown date, after receiving PNEUMOVAX 23, the patient developed a high fever. The patient sought medical attention and visited an unspecified Emergency Room for treatment, but it was unspecified whether was admitted or not. The outcome of the adverse was unknown. Relatedness between use of PNEUMOVAX 23 and the high fever was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant. On 23-JUN-2014, the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX, 0.5 ml, subcutaneously, Lot # J005726 and expiration date verified as 08-MAY-2014 (reported as 08-APR-2014) that underwent a temperature excursion. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected, because all pertinent information has been received.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a physician via field representative refers to an approximately 41 years old female patient. On 29-NOV-2012, the patient was vaccinated with PNEUMOVAX 23 lot # H011780, expiry date 16-FEB-2014, standard dose/one injection, injection, for the prevention of the pneumococcal virus. On an unknown date in November 2012 (also reported as within twenty-four hours of receiving the injection), patient had developed pain in the arm that had received PNEUMOVAX 23 vaccine. Onset time of the reaction was within twenty-four hours of receiving the injection. On an unknown date in December 2012 (also reported as four to five days after receiving the injection), the patient had recovered from the pain. Action taken with respect to PNEUMOVAX 23 was not applicable. Causality was not provided. No product quality complaint (PQC) reported. No further adverse event information provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a patient of unknown age and gender. No information received regarding medical history and concurrent conditions. On an unknown date the unspecified patients were vaccinated with PROQUAD (merck) (dose, lot#, not reported). No concomitant medications reported. The nurse reported that since 01-JUL-2014, unspecified patients may have been administered with PROQUAD (merck), that were not stored properly. No adverse effects reported. This is one of the several report received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age. On an unknown date, unspecified number of patients were vaccinated with improperly stored PROQUAD (Merck) (dose, frequency, route and indication were not provided). No concomitants were reported. No adverse symptoms reported. No further information provided. Outcome of events was unknown. No product quality complaint (PQC) reported. 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 medical assistant refers to a male patient of unknown age. On 01-AUG-2014 the patient was vaccinated with a dose of GARDASIL, (0.5 ml, intramuscular) and inadvertently, he was administered another dose of GARDASIL on 05-AUG-2014. Pertinent medical history and concomitant medications were unspecified by the reporter. No adverse effects reported. The outcome of the events was unknown. No further information provided. Additional information has been requested.
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Headache, Hypoaesthesia oral, Swollen tongue
Clinical narrative: Case number PHEH2014US015199 is an initial spontaneous report received from a consumer (patient) on 28 Jul 2014. This report refers to a female patient of unknown age. Her medical history and concomitant medication were not reported. She was vaccinated with the first dose of RABAVERT (batch number: not reported) via intramuscular route on 23 Jul 2014. She was also taking sulfamethoxazole and trimethoprim (unknown manufacturer) via unknown route at unknown dose for bacterial infection from an unknown date. She stated that soon after receiving the vaccine, she began to feel lightheaded and experienced a headache. She also experienced a numb sensation on the tongue and swelling of the tongue around this time. The patient recovered from headache and lightheadedness within a day. Outcome for numb sensation on the tongue and swelling of the tongue was reported as condition improving. The reporter was not sure whether RABAVERT or the antibacterial drugs have contributed to the events. The seriousness was not reported.
Age: 20.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives w/o respiratory/throat probs.
Age: 74.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased, Nausea, Pain
Clinical narrative: Nausea, low-grade fever, Redness and swelling at injection site, body ache and inability to lift arm. Pt informed us on 8/6/14 when she was about to get 2nd dose.
Age: 74.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Pyrexia
Clinical narrative: Nausea, low-grade fever, Redness and swelling at injection site, body ache and inability to lift arm. Pt informed us on 8/6/14 when she was about to get 2nd dose.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Coxsackie viral infection, Culture throat negative, Cyanosis, Electrocardiogram, Febrile convulsion
Clinical narrative: Febrile seizure with cyanosis 8/5/14 see at hospital ER 8/5/14. See at primary care and oral ulcers and rash c/w Coxsackie.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Mouth ulceration, Rash, Streptococcus test negative
Clinical narrative: Febrile seizure with cyanosis 8/5/14 see at hospital ER 8/5/14. See at primary care and oral ulcers and rash c/w Coxsackie.
Age: 1.05
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Erythematous papules macular rash started two days after vaccine started on face moved to back of neck, then legs. Not itchy. No wheezing, fever. No treatment.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Convulsion, Dizziness, Syncope
Clinical narrative: GARDASIL and Hep A-VAQTA pediatric was administered and approximately within 1 minute post vaccine patient stated that he felt lightheaded as he was still sitting in the same position as I went to lay him down he had a syncopal episode and went right into seizure activity which lasted 30 seconds or so before he opened his eyes.
Age: 1.12
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Rash generalised
Clinical narrative: Child had onset rash over body with temperature of 100 taken per ear. Was seen by doctor for evaluation.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Resuscitation, Syncope
Clinical narrative: Pt fainted twice in our office after the shot. He did routine resuscitation per protocol. Recovered in 3 min BP went down to 60/20.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Broke out in hives. Mom unsure if rash started on Sunday 7/20 or after vaccine 7/22. Mom had documented picture of hives. No respiratory distress.
Sex: U
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: Case number PHEH2014US014988 is an initial spontaneous report received from a pharmaceutical company (Merck) on 25 Jul 2014. This report refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: not reported) on an unspecified date. The patient passed out after receiving vaccination on unspecified date. The outcome, seriousness and causality of the event were not reported.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Malaise, Pain, Skin warm
Clinical narrative: Iduration has persisted and started turning warm and red in the last 2 days, malaise and local pain.  induration is a bit bigger.
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a registered nurser refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ROTATEQ, orally (dose and lot# not reported). It was reported that patient threw up everything in her stomach during administration of ROTATEQ. The outcome of the event was unknown. The relationship between the ROTATEQ and the event was unknown. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt shows about 2 in. in diameter red circle around injection site reports itching and warm temp. in the area. Pt taken BENADRYL for itching.
Age: 2.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow-up information has been received from the registered nurse who provided patient details. This report refers to a 2 year old infant patient of unknown gender. On 11-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot # J015437, expiration date: 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). Pertinent medical history, drug reactions or allergies were not reported. On 19-JUL-2014 the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot number: J011548, expiration date: 19-DEC-2014, (dose, route not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). Pertinent medical history, drug reactions or allergies were not reported. On 28-MAY-2014 the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot number: J011548, expiration date: 19-DEC-2014, (dose, route not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 8/6 pt noticed injection site of ZOSTAVAX was swollen, red, warm to touch. The area measures 2.5 x 3" swelling and redness 2 x 3". Pt had shot administered on 8/5 at 4pm. Pt is currently self treating w/ BENADRYL at home.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 01-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 injection, lot # J004747, Exp date 20-JUL-2014, (dose and route unspecified). No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Dizziness, Facial pain, Headache, Musculoskeletal pain, Pyrexia
Clinical narrative: Dizzy, fever 102-103 c/o face/head/shoulders hurting, headache.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Developed severe headache, dizziness, fatigue at 7pm.
Age: 49.0
Sex: F
Vaccine: MNQ
Symptoms: Balance disorder, Fall
Clinical narrative: Pt received MENACTRA vaccine while sitting no events. Pt waited for approx 5 min pt decided to stand up and leave pt was responsive and cheerful but quickly lost balance and fell.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: About 40 minutes after the immunizations DTaP, IPV, MMR, Varicella, the mom called stating the child had developed hives on torso and face. No breathing problems. Child was given 1/2 tsp BENADRYL. Hives were better - no other problems.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Mass, Pain, Swelling
Clinical narrative: Redness about 4 inches in diameter, Swelling, Lump, Pain in area, Flu like Symtoms Stated 08/07/2014 8:30 AM
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Haemolytic uraemic syndrome, Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: First noted petechaie on the morning of the 5th, it got worse the next day.  Diagnosed with ITP, platelets of 11.  Now diagnosed with aquired aHUS 6/28/14.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cardiac failure, Lethargy, Myocarditis, Pyrexia, Troponin T increased
Clinical narrative: Fever, lethargy. Later developed vomiting and went into heart failure. Preliminary diagnosis of Acute myocarditis.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Fever, lethargy. Later developed vomiting and went into heart failure. Preliminary diagnosis of Acute myocarditis.
Age: 13.0
Sex: M
Vaccine: HEPA, HIBV, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Pt was given a HIB vaccine instead of a Mennigitis (Menactra) vaccine.
Age: 18.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Syncope 10 minutes following vaccination.  While waiting in waiting room following vaccine, patient was observed to begin leaning sideways in chair.  Staff rushed to side. Within a minute patient "came to".  Stated she  "blacked out".   Cold washcloth applied to forehead and patient was then instructed to wait for another half hour before leaving. After 5-10 minutes of waiting patient stated she felt fine and waited approx. 20 minutes longer before leaving facility.  Patient was called approx. 1/2 hr after leaving and stated she felt fine.
Age: 54.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Local swelling, Pain, Rash generalised
Clinical narrative: Pt got a rash all over her body and face.  Pt c/o swollen area behind her right ear that was painful.  Symptoms lasted 3-4 days.
Age: 65.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Convulsion, Hyperhidrosis, Loss of consciousness, Tremor
Clinical narrative: shaking, profuse sweating, seizures.-pt did not seek medical treatment but stated she briefly lost consciousness with her family.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dyspnoea, Irritability, Local swelling, Respiratory disorder
Clinical narrative: Pt called in to Nurse and told her that she got shot earlier that day and she woke up from her nap very fussy states gasping for air Respiration were irregular her legs/feet and genital area were swollen
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash maculo-papular
Clinical narrative: Patient developed maculopapular rash on the the stomach
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site reaction
Clinical narrative: injection site reaction / cellulitis tx medrol dose pak and bactrim ds
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Had limb swelling, redness and pain in the limb where DTaP vaccine was administered
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient reported continued pain on touch at injection site 2 weeks post vaccination. Patient was notified could make nursing appt for eval. Never made. And no further complaints as of 3 months out.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Eye discharge, Faeces discoloured, Lacrimation increased, Mucous stools, Scab
Clinical narrative: Green stool with mucous began on 07/30/2014 and continued through 08/06/2014.  Watery, teary eyes (both right and left eyes), crusting into green eye discharge began on 08/01/2014 and lasted through 08/05/2014.  As of 08/07/2014, watery eyes continue but no longer green.  Discussed symptoms with doctor's office nurse; no treatment required.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Per mom "his arm is red and hot", monitoring and ice packs.
Age: 1.04
Sex: F
Vaccine: MM, PPV
Symptoms: Irritability, Rash morbilliform
Clinical narrative: Measles like bumps for 3 days. She was fussy. She was given infant Advil.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: FEVER,redness, pain, swelling to left arm where vaccines where administred.
Age: 14.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cardiac monitoring, Dizziness, Fatigue, Head discomfort, Headache
Clinical narrative: Fatigue, sharp pains in my head, headaches, not walking, fainting, heavy head, tingling in my feet.
Age: 14.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Paraesthesia, Syncope
Clinical narrative: Fatigue, sharp pains in my head, headaches, not walking, fainting, heavy head, tingling in my feet.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. On an unknown date the patients were inadvertently vaccinated with ROTATEQ which had been improperly stored (lot#, expiration date, frequency, dose and route were unknown). And no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a patient of unknown age (gender unspecified). On unknown dates in approximately 2008, "six years ago", the patient was vaccinated with dose one and two of GARDASIL. Lot# and administration route were not provided. On 04-AUG-2014 the patient might be vaccinated with the dose three of GARDASIL. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from the patient's neighbor referred to a male patient of unknown age. The reporter advised the patient received by mistake, two doses of ZOSTAVAX (Lot# unspecified) about a year apart (dose, frequency, route and indication unspecified). Patient had a "full blown case of shingles." The reporter advised it was "not mild by any means." Outcome of the events were unknown. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On 29-JUL-2014 the patient was vaccinated with 0.5ml expired dose of PNEUMOVAX 23 (lot # H021941, expiration date 11-JUL-2014) intramuscularly. No adverse effect was reported. Additional information has been requested.
Age: 1.03
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 1 year old patient of unknown gender. Concomitant medication and pertinent medical history were not provided. On 29-JUL-2014 the patient was vaccinated with an expired dose of M-M-R II (rHA) (injection, batch # J008882, lot# 0293AA, expiration date 27-JUL-2014, dose, route and frequency were not provided). No adverse effect has been observed or reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEPAB, HPV4
Symptoms: Immediate post-injection reaction, Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: (R) arm - lot itchier and red bump. (L) arm just itched and not as much. Itching started approx 24 hours later itching stopped 8/7/14 - though has little bump. Hurt immediately and for 1 day - both arms, but more on (R) arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: About a day after shots, Mom feel hard area on patient's left upper arm. It is red and hard to the touch - 4" in diameter. Patient not c/o pain, has full mobility.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Patient developed local rash. Said it got worse 2 days following vaccine. No fever/pain associated with rash.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Patient developed local rash. Said it got worse 2 days following vaccine. No fever/pain associated with rash.
Age: 8.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP
Symptoms: Pyrexia, Urticaria
Clinical narrative: 08/04/2014 Severe. Other. Severe urticaria/hives. 08/05/2014, Moderate. Other Fever to 102 degrees.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Unevaluable event
Clinical narrative: None stated.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Abdominal pain, Dehydration, Intestinal obstruction, Rectal haemorrhage, Urine output decreased
Clinical narrative: Couldn't keep any formula down. Diapers stayed dry...slept constantly. Took him to hospital late that evening and they thought it was colic. They said he was dehydrated so they gave him fluids through an IV and to take home because he thought he had colic. Early the next morning I took him to the medical center because he was getting worse. He passed blood in his diaper while we were there and thought he had a blockage in his intestines and would have to send him to another facility because they weren't equipped to treat him.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Couldn't keep any formula down. Diapers stayed dry...slept constantly. Took him to hospital late that evening and they thought it was colic. They said he was dehydrated so they gave him fluids through an IV and to take home because he thought he had colic. Early the next morning I took him to the medical center because he was getting worse. He passed blood in his diaper while we were there and thought he had a blockage in his intestines and would have to send him to another facility because they weren't equipped to treat him.
Age: 5.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a consumer refers to his 5 year old male son with food allergy to cinnamon. On 30-JUL-2014 the patient was vaccinated with a dose of GARDASIL (dose, strength, lot number, expiration date and route were not reported). Concomitant therapies included poliovirus vaccine inactivated (unspecified) and varicella virus vaccine live (manufacturer unknown). The parent stated his son was seen today (30-JUL-2014) in the physician's office and was accidentally given the GARDASIL vaccine by a Nurse Practitioner (anonymous male) instead of a vaccine. The patient experienced "injection site pain" and had "trouble with his legs while walking to the car". The patient was not observed for the fifteen minutes after receiving the injection as stated in the prescribing information. Instead, the patient walked to his car about five minutes after receiving the injection. While in the office, the patient also received a vaccine injection to prevent chicken pox, varicella virus vaccine live (manufacturer unknown). At the time of the report the outcome was unknown. Patient did not received medical attention or treatment for the adverse event. No lab diagnostics studies were performed. Additional information has been requested.