chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: MMR
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. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored M-M-R II. Strength, dose, route and lot number were not provided. M-M-R II was exposed to a temperature between 46.5F and highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004215 and 1405USA004216). 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 nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB. Strength, dose, route and lot number were not provided. RECOMBIVAX HB was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014; Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range from 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004216 and 1405USA002823). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: On an unknown date the patients were vaccinated with improperly stored ROTATEQ. Strength, dose, route and lot number were not provided. ROTATEQ was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004215 and 1405USA002823). Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Dizziness, Headache, Influenza like illness, Injected limb mobility decreased
Clinical narrative: (L) arm soreness and decreased ROM, pain and mild redness to injection sites. Flu-like sx, temp 100.5-101, nausea, headache and mild dizziness. Pt managing at home w/MOTRIN, heat, rest, fluids.
Age: 29.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Nausea, Pain in extremity
Clinical narrative: (L) arm soreness and decreased ROM, pain and mild redness to injection sites. Flu-like sx, temp 100.5-101, nausea, headache and mild dizziness. Pt managing at home w/MOTRIN, heat, rest, fluids.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 18 year old female patient. On 24-APR-2014 the patient was vaccinated with GARDASIL injection, dose 3 (dose and route unspecified). Other suspect therapies included VAQTA dose 3 (dose and route unspecified). No concomitant medication was reported. On an unknown date medication error was reported that the patient was in the office today on 24-APR-2014 to receive her third dose of GARDASIL and her booster dose of VAQTA later than the recommended dosing schedule. Patient was given her first dose of GARDASIL (0.5mL dose) on 03-NOV-2009 and second dose of GARDASIL on 30-JUL-2010; Patient was given her first dose of hepatitis a vaccine, inactivated (0.5 ml (milliliters) dose) on 30-JUL-2010. No adverse effects reported. 1 Nurse called to inquire if a patient is late in getting their scheduled third dose of GARDASIL and booster dose of VAQTA, would vaccination series need to be restarted or could proceeding dose be given. There was no product quality complaint involved. The outcome of the medication error was unknown. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: FLUX
Symptoms: Cardiac arrest
Clinical narrative: Flu vacin I contract stop heart to relative, do 501C Merck STD.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Chest discomfort, Dyspnoea, Throat tightness
Clinical narrative: Shortness of breath, throat tightness, mild chest tightness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling, redness kept expanding. Treatment: Triamcinolone 0.1% cream, Famotidine 20 mg Prednisone 20 7 day course.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Generalised erythema, Injection site pruritus, Pruritus generalised
Clinical narrative: Pt. started c/o face, body and leg itching also she had some red patches on face and body. Notified NP and ordered BENADRYL 7.5 mL PO given pt. Wait 30 minute to be reevaluated by NP. Pt was reevaluated and d/c by NP. Pt. went home in stable condition.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that after the patient was vaccinated with 1st shot of GARDASIL intramuscular, the patient developed rash which lasted for weeks. it was also reported that after the patient received the 2nd shot of GARDASIL the patient developed rash that lasted for months. The reporter mentioned that patient started the series approximately on an unknown date in 2008 (reported as about 6 years ago) and the patient never received the 3rd shot of GARDASIL. The outcome of the event reported is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-APR-2014 the patient was vaccinated with an expired dose of M-M-R II (dose and strength not reported, lot # 02878AE is an invalid lot number for M-M-R II, expiry date 01-FEB-2014). The reporter stated the M-M-R II has had no previous temperature excursions. The reporter did not state what dose this was in the M-M-R II series. No adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: HPV4, MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous report as received from a consumer regarding his wife, refers to a female patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. On an unknown date the patient was vaccinated with M-M-R II, GARDASIL and (Oka/Merck) VARIVAX route reported as injection. The reporter stated that on an unknown date the patient just found she was pregnant. The pregnancy outcome was outcome pending. the outcome of event reported is unknown. The patient had not sought medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history included pacemaker. Patient had none of drug reactions/allergies. On 01-MAY-2014, the patient was vaccinated with ZOSTAVAX, (lot # and expiry date unspecified) 0.65 ml once, subcutaneously for his wife had shingles and he didn't want to go through the same pain that she did. Concomitant medication was unspecified. On 01-MAY-2014 (also reported as immediately after administration of vaccine), patient developed a "red welt the size of a dime in diameter" at the injection site. The pharmacist instructed the patient to put ice on the reaction and take TYLENOL when he got home (it was unknown whether patient took prescribed medicine). Lab diagnostics studies were not performed. There was no product quality complaint. Action taken with the ZOSTAVAX was not applicable. Patient did not recover from the reported event. Causality of the reported event was unspecified for ZOSTAVAX. Additional information is not expected.
Age: 47.0
Sex: F
Vaccine: HEPAB, MMR, TDAP, VARCEL
Symptoms: Rash generalised, Rash vesicular, Vaccination site reaction
Clinical narrative: Vesiculated rash that started at vaccine site (left arm) and has spread to neck, abdomen, legs, face and scalp.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Numbness to right side of face and right arm which is the arm that vaccination was placed.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Redness of injection site.
Age: 19.0
Sex: F
Vaccine: FLU4, HEPA, PPV
Symptoms: Axillary pain, Injection site pain
Clinical narrative: Pain at Right armpit and R shoulder not controlled with 400 MG advil x 1 dose. Pain began in the evening and had continued the next day. Pain rated 6 on a 1-10 scale on 5-7-14 at 10:45 AM.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Throat tightness
Clinical narrative: Rash, throat fullness.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Erythema, Local swelling
Clinical narrative: SWELLING AND REDNESS OF ARM.
Age: 73.0
Sex: M
Vaccine: HEPA, PPV, TDAP, VARZOS
Symptoms: Blood pressure decreased, Body temperature decreased, Erythema, Eye swelling, Influenza like illness
Clinical narrative: Sister in law who is a RN states this patient's symptoms started with "flu-like" symptoms and his face was "swollen and glowing red.His cheeks, eyes, fingers, knuckles, ankles, all were swollen". She further stated that he had no difficulty breathing and that he was always alert and oriented.She did not take his temperature until after tylenol had been given and then she reports a temperature of 91 degrees F. She states she believes he may have had a fever of as high as 104 degrees F, but did not take his temperature to varify that. She stated that his normal blood pressure is 104/60 and that his blood pressure during this time when he had these symptoms was 84/44. She reports having pushed fluids to hydrate him. Her husband is a physician and they monitored him throughout the night and his symptoms decreased. Today, 5-8-14 at 2:45 pm when she phoned to report these symptoms, she reports that he is doing much better, his blood pressure is within normal limits and all of the swelling has subsided.
Age: 73.0
Sex: M
Vaccine: HEPA, PPV, TDAP, VARZOS
Symptoms: Joint swelling, Local swelling, Pyrexia, Swelling face
Clinical narrative: Sister in law who is a RN states this patient's symptoms started with "flu-like" symptoms and his face was "swollen and glowing red.His cheeks, eyes, fingers, knuckles, ankles, all were swollen". She further stated that he had no difficulty breathing and that he was always alert and oriented.She did not take his temperature until after tylenol had been given and then she reports a temperature of 91 degrees F. She states she believes he may have had a fever of as high as 104 degrees F, but did not take his temperature to varify that. She stated that his normal blood pressure is 104/60 and that his blood pressure during this time when he had these symptoms was 84/44. She reports having pushed fluids to hydrate him. Her husband is a physician and they monitored him throughout the night and his symptoms decreased. Today, 5-8-14 at 2:45 pm when she phoned to report these symptoms, she reports that he is doing much better, his blood pressure is within normal limits and all of the swelling has subsided.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Inflammation, Pain, Pruritus
Clinical narrative: ITCHY REDNESS INFLAMATION PAIN
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: erythema, induration, warmth to L deltoid: DTaP administered at site 2days prior
Age: 58.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Diarrhoea, Dysstasia, Vomiting
Clinical narrative: Vomitting and diarrhea, weakness, can't stand for to long
Age: 12.0
Sex: F
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Angioedema, Blister, Blood test, Depression, Diarrhoea
Clinical narrative: Woke up with what seemed to be a mild outbreak of Chicken Pox, red, blistery pustules on hands and feet and trunk area. Developed, severe, chronic hives in June 2013 and continues to worsen over time, with no help from any doctors.  She has now developed Angioedema, whole face swells, develops severe respiratory distress, gastrointestinal problems, including vomiting and diarrhea, severe headaches, depression, shaking, allergies.  She basically is a different child with numerous health problems with no explanation and no cure.  My daughter has 2 epi pens kept near her at all times, one with her and one is kept at school.  Have spent so much money and numerous specialists to try to find answers to no avail.
Age: 12.0
Sex: F
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Erythema, Gastrointestinal disorder, Headache, Hypersensitivity, Rash pustular
Clinical narrative: Woke up with what seemed to be a mild outbreak of Chicken Pox, red, blistery pustules on hands and feet and trunk area. Developed, severe, chronic hives in June 2013 and continues to worsen over time, with no help from any doctors.  She has now developed Angioedema, whole face swells, develops severe respiratory distress, gastrointestinal problems, including vomiting and diarrhea, severe headaches, depression, shaking, allergies.  She basically is a different child with numerous health problems with no explanation and no cure.  My daughter has 2 epi pens kept near her at all times, one with her and one is kept at school.  Have spent so much money and numerous specialists to try to find answers to no avail.
Age: 12.0
Sex: F
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Respiratory distress, Swelling face, Tremor, Urticaria, Varicella post vaccine
Clinical narrative: Woke up with what seemed to be a mild outbreak of Chicken Pox, red, blistery pustules on hands and feet and trunk area. Developed, severe, chronic hives in June 2013 and continues to worsen over time, with no help from any doctors.  She has now developed Angioedema, whole face swells, develops severe respiratory distress, gastrointestinal problems, including vomiting and diarrhea, severe headaches, depression, shaking, allergies.  She basically is a different child with numerous health problems with no explanation and no cure.  My daughter has 2 epi pens kept near her at all times, one with her and one is kept at school.  Have spent so much money and numerous specialists to try to find answers to no avail.
Age: 12.0
Sex: F
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Vomiting
Clinical narrative: Woke up with what seemed to be a mild outbreak of Chicken Pox, red, blistery pustules on hands and feet and trunk area. Developed, severe, chronic hives in June 2013 and continues to worsen over time, with no help from any doctors.  She has now developed Angioedema, whole face swells, develops severe respiratory distress, gastrointestinal problems, including vomiting and diarrhea, severe headaches, depression, shaking, allergies.  She basically is a different child with numerous health problems with no explanation and no cure.  My daughter has 2 epi pens kept near her at all times, one with her and one is kept at school.  Have spent so much money and numerous specialists to try to find answers to no avail.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Fainted, experienced seizure-like activity a few minutes after receiving the vaccination.
Age: 1.16
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 13 month old patient (gender unknown). On 28-APR-2014, the patient was vaccinated with M-M-R II 0.5 ml once, subcutaneous (lot 007155; exp date on 20-JUN-2015) Albumin Status was HSA, subcutaneous. Other suspect therapies included VARIVAX (Merck) (lot J010252; exp date on 02-AUG-2015) (dose, route not provided). It was reported that the patient detected (at unspecified time) to have a porcine type allergy. At the time of the report, the outcome of porcine type allergy was unknown. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: DTAP, HPV4, IPV, MNQ, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an elderly male patient. On 24-APR-2014 the patient was vaccinated with expired ZOSTAVAX lot # H016762 (expiration date 11-DEC-2013) (unknown dose), route not reported. No adverse events were reported. 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 register nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 07-JAN-2014, the patient was vaccinated with GARDASIL intramuscular (dose, strength, lot number and expiration date were not reported). Secondary and concomitant therapies were not reported. Nurse reported that a patient was administered dose two of GARDASIL on 10-NOV-2013 and dose three of GARDASIL on 07-JAN-2014, which was only six weeks interval. No adverse effects reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: This spontaneous report as received from an office manager, refers to a 73 year old female patient with penicillin allergy. In November 2007, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not reported) (Lot # and expiration date were not reported). On an unspecified date, the patient also received a dose of PNEUMOVAX 23 (dose, route and frequency were not reported) (Lot # and expiration date were not reported). On 24-APR-2014 the patient developed prickling feeling on scalp and forehead. On 25-APR-2014, the patient was seen in physician's office and diagnosis of shingles was confirmed. As treatment, physician ordered GABAPENTIN, acyclovir and BENADRYL. The office manager reported that as the patient's condition advanced, physician ordered GABAPENTIN. Patient's condition has not involved patient's eyes. No lab diagnostic studies were performed. At the time of the report, the patient's outcome of shingles was unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Paraesthesia, Skin lesion
Clinical narrative: This spontaneous report as received from an office manager, refers to a 73 year old female patient with penicillin allergy. In November 2007, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not reported) (Lot # and expiration date were not reported). On an unspecified date, the patient also received a dose of PNEUMOVAX 23 (dose, route and frequency were not reported) (Lot # and expiration date were not reported). On 24-APR-2014 the patient developed prickling feeling on scalp and forehead. On 25-APR-2014, the patient was seen in physician's office and diagnosis of shingles was confirmed. As treatment, physician ordered GABAPENTIN, acyclovir and BENADRYL. The office manager reported that as the patient's condition advanced, physician ordered GABAPENTIN. Patient's condition has not involved patient's eyes. No lab diagnostic studies were performed. At the time of the report, the patient's outcome of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: This spontaneous report as received from a physician refers to "a full of clients" of unknown genders and ages. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, route and lot # not reported). The physician reported that on an unknown date, the patients experiencing feeling tired post vaccination with GARDSAIL. The patients did not receive treatment for the adverse event. At the time of the report, the patients' outcomes were unknown. 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 certified medical assistant refers to a patient of unknown age and gender. Medical history was not reported. On 22-APR-2014 the patient was vaccinated with ZOSTAVAX, (lot # not reported) 0.65 ml, subcutaneous. Concomitant therapy was not reported. The reporter informed that ZOSTAVAX underwent two temperature excursions. On 11-APR-2014 was the first excursion, the ZOSTAVAX, was on 9.5 F for 2 hours. The second excursion was 11F for 2 hours on 22-APR-2014. The patient received ZOSTAVAX, on 22-APR-2014, prior to second excursion. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.65
Sex: M
Vaccine: DTAPIPVHIB, IPV, PNC13, RV5
Symptoms: Unevaluable event
Clinical narrative: None noted.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: 1101AM BP 77/45 1105AM BP 89/58. Patient received immunizations and was sitting in the chair talking with this nurse. She looked at this nurse funny and put her head between her legs. She told me she felt dizzy. I had her sit up in the chair. Became diaphoretic. Was given water, sucker, and fan. Drank a couple glasses of water and ate a sucker. Educated patient and mom to drink plenty of fluids and eat lunch when they get home, follow up with primary doctor if they felt they needed to.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Erythematous, slightly warm, and tender area at site of MCV injection on right posterior upper arm. Measuring 3.5 cm in diameter.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Hypersensitivity, Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Erythematous, slightly warm, and tender area at site of MCV injection on right posterior upper arm. Measuring 3.5 cm in diameter.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site warmth
Clinical narrative: Erythematous, slightly warm, and tender area at site of MCV injection on right posterior upper arm. Measuring 3.5 cm in diameter.
Age: 46.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Red, warm to touch, mildly painful area of induration 25 mm diameter at site of VARIVAX vaccination, (L) upper arm SQ.
Age: 23.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Pain in extremity, Pruritus, Pyrexia, Rash
Clinical narrative: Fever, arm with rash, pain, itching, (L) arm Depo Medrol 80mg IM given.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Eye swelling, Fatigue, Feeling abnormal, Injection site erythema, Injection site swelling
Clinical narrative: Approximately 2 hours after receiving vaccine, (L) shoulder/arm became warm, swollen, and red. Became nauseous, tired, "in a fog". She was sent home, napped for 3 1/2 hours, woke up with swollen eyes, (+) tactile fever, malaise. Went to ED. Given Naproxen, Diagnosed with "Drug Rxn" due to vaccine, and sent home.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Injection site warmth, Malaise, Nausea, Pyrexia, Vaccination complication
Clinical narrative: Approximately 2 hours after receiving vaccine, (L) shoulder/arm became warm, swollen, and red. Became nauseous, tired, "in a fog". She was sent home, napped for 3 1/2 hours, woke up with swollen eyes, (+) tactile fever, malaise. Went to ED. Given Naproxen, Diagnosed with "Drug Rxn" due to vaccine, and sent home.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient's husband noticed rash on patient's arm 2 days after vaccine was given. The rash was at injection site, about 2 inches in diameter and red. No treatment needed at this time.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm w/warm/red/swollen 3 x 3 cm patch, tender to touch. Tx: KEFLEX 250 mg/5ml 1 tsp 3x/d x 7 D, re-eval in 4 d.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Erythematous raised skin 4 x 3 cm around injection site ((R) deltoid) fever 101-102 degrees F.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness
Clinical narrative: Lightheaded, faint feeling approx 2 hours after receiving tetanus. No treatment was seeked.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient reports red itchy area around vaccination site.
Age: 0.31
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Cellulitis, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Noted red swelling rt thigh the evening of the immunization on 4/22. Documented given PCV 13. On exam skin rt ant thigh streak erythematous and slightly raised, no area of fluctuance. DX. cellulitis. Rx clindamycin.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Autopsy, Death
Clinical narrative: This spontaneous report as received from a physician via Medical Representative refers to a 8 week old male patient. The patient did not have any pertinent medical history. On 12-MAR-2014, the patient was vaccinated with ROTATEQ (oral, injection on thigh, Lot # J009772), PEDVAXHIB (dose unspecified, injection on thigh, invalid Lot# reported as J011983), PREVNAR (dose unspecified, injection on thigh, Lot# reported as H39262) and PEDIARIX (dose unspecified, injection on thigh, Lot# reported as CA22J73). On 12-MAR-2014, the patient experienced suffocation. The physician reported that the medical examiner would call it SIDS (Sudden Infant Death Syndrome) but with co-sleeping arrangement in the home the reason was called suffocation. On 13-MAR-2014, the patient died (also reported as between 12-MAR-2014 and 13-MAR-2014). The cause of death was reported as suffocation. There was no details provided about treatment or hospitalization. Causality assessment was not provided. Upon internal review the event of suffocation was considered as medically significant. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: This spontaneous report as received from a physician via Medical Representative refers to a 8 week old male patient. The patient did not have any pertinent medical history. On 12-MAR-2014, the patient was vaccinated with ROTATEQ (oral, injection on thigh, Lot # J009772), PEDVAXHIB (dose unspecified, injection on thigh, invalid Lot# reported as J011983), PREVNAR (dose unspecified, injection on thigh, Lot# reported as H39262) and PEDIARIX (dose unspecified, injection on thigh, Lot# reported as CA22J73). On 12-MAR-2014, the patient experienced suffocation. The physician reported that the medical examiner would call it SIDS (Sudden Infant Death Syndrome) but with co-sleeping arrangement in the home the reason was called suffocation. On 13-MAR-2014, the patient died (also reported as between 12-MAR-2014 and 13-MAR-2014). The cause of death was reported as suffocation. There was no details provided about treatment or hospitalization. Causality assessment was not provided. Upon internal review the event of suffocation was considered as medically significant. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Asphyxia, Bed sharing, Death
Clinical narrative: This spontaneous report as received from a physician via Medical Representative refers to a 8 week old male patient. The patient did not have any pertinent medical history. On 12-MAR-2014, the patient was vaccinated with ROTATEQ (oral, injection on thigh, Lot # J009772), PEDVAXHIB (dose unspecified, injection on thigh, invalid Lot# reported as J011983), PREVNAR (dose unspecified, injection on thigh, Lot# reported as H39262) and PEDIARIX (dose unspecified, injection on thigh, Lot# reported as CA22J73). On 12-MAR-2014, the patient experienced suffocation. The physician reported that the medical examiner would call it SIDS (Sudden Infant Death Syndrome) but with co-sleeping arrangement in the home the reason was called suffocation. On 13-MAR-2014, the patient died (also reported as between 12-MAR-2014 and 13-MAR-2014). The cause of death was reported as suffocation. There was no details provided about treatment or hospitalization. Causality assessment was not provided. Upon internal review the event of suffocation was considered as medically significant. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Blood culture negative, Chest X-ray normal, Computerised tomogram head normal, Cyanosis, Full blood count normal
Clinical narrative: This spontaneous report as received from a consumer (mother of the patient) refers to a male patient at the age of 2 years and 1 month. There was no pertinent medical history. On 23-APR-2014 the patient was vaccinated with M-M-R II (lot# and expiration date were unspecified) first dose in the series. The patient was also administered an unspecified HIB vaccine (manufacturer unknown) on 23-APR-2014. Customer stated that, on 24-APR-2014, her son had tested positive for a streptococcus infection. He was prescribed amoxicillin (manufacturer unknown) for the strep infection. On 30-APR-2014 the patient developed a fever which continued through 02-MAY-2014. On the morning of 02-MAY-2014 at 9:40 AM, the patient had a tonic-clonic seizure that lasted "a couple of minutes" with cyanosis. The patient was taken on an unknown date in May 2014 to an unspecified emergency room and computerized axial tomography (CAT) scan, chest x-ray, spinal tap and blood cultures were performed. According the consumer "all the tests came back clear". While in the emergency room the patient received ROCEPHIN for the strep infection diagnosed on 24-APR-2014. His temperature in the emergency room was 104 F and climbing prior treatment of ROCEPHIN. The patient was not admitted to the unspecified hospital. The patient's unspecified sister had also tested positive for a strep infection on 23-APR-2014 and was prescribed amoxicillin (manufacturer unknown) which did not treat the streptococcus infection and she had to be prescribed AUGMENTIN on an unspecified date. The outcome of the tonic-clonic seizure was recovered (with recovered date estimate as 02-MAY-2014 it was reported that seizure lasted a couple of minutes). The outcome of the rest events was unknown. The relatedness between the events and M-M-R II was unknown. Upon internal review the tonic-clonic seizure was considered to be medically significant. This case is linked with case MARRS # 1405USA003823 (same reporter link). Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Grand mal convulsion, Lumbar puncture normal, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer (mother of the patient) refers to a male patient at the age of 2 years and 1 month. There was no pertinent medical history. On 23-APR-2014 the patient was vaccinated with M-M-R II (lot# and expiration date were unspecified) first dose in the series. The patient was also administered an unspecified HIB vaccine (manufacturer unknown) on 23-APR-2014. Customer stated that, on 24-APR-2014, her son had tested positive for a streptococcus infection. He was prescribed amoxicillin (manufacturer unknown) for the strep infection. On 30-APR-2014 the patient developed a fever which continued through 02-MAY-2014. On the morning of 02-MAY-2014 at 9:40 AM, the patient had a tonic-clonic seizure that lasted "a couple of minutes" with cyanosis. The patient was taken on an unknown date in May 2014 to an unspecified emergency room and computerized axial tomography (CAT) scan, chest x-ray, spinal tap and blood cultures were performed. According the consumer "all the tests came back clear". While in the emergency room the patient received ROCEPHIN for the strep infection diagnosed on 24-APR-2014. His temperature in the emergency room was 104 F and climbing prior treatment of ROCEPHIN. The patient was not admitted to the unspecified hospital. The patient's unspecified sister had also tested positive for a strep infection on 23-APR-2014 and was prescribed amoxicillin (manufacturer unknown) which did not treat the streptococcus infection and she had to be prescribed AUGMENTIN on an unspecified date. The outcome of the tonic-clonic seizure was recovered (with recovered date estimate as 02-MAY-2014 it was reported that seizure lasted a couple of minutes). The outcome of the rest events was unknown. The relatedness between the events and M-M-R II was unknown. Upon internal review the tonic-clonic seizure was considered to be medically significant. This case is linked with case MARRS # 1405USA003823 (same reporter link). Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Blood culture negative, Chest X-ray normal, Computerised tomogram normal, Cyanosis, Grand mal convulsion
Clinical narrative: This spontaneous report as received from a consumer (mother of the patient) refers to a male patient at the age of 2 years and 1 month. There was no pertinent medical history. On 23-APR-2014 the patient was vaccinated with M-M-R II (lot# and expiration date were unspecified) first dose in the series. The patient was also administered an unspecified HIB vaccine (manufacturer unknown) on 23-APR-2014. Customer stated that, on 24-APR-2014, her son had tested positive for a streptococcus infection. He was prescribed amoxicillin (manufacturer unknown) for the strep infection. On 30-APR-2014 the patient developed a fever which continued through 02-MAY-2014. On the morning of 02-MAY-2014 at 9:40 AM, the patient had a tonic-clonic seizure that lasted "a couple of minutes" with cyanosis. The patient was taken on an unknown date in May 2014 to an unspecified emergency room and computerized axial tomography (CAT) scan, chest x-ray, spinal tap and blood cultures were performed. According the consumer "all the tests came back clear". While in the emergency room the patient received ROCEPHIN for the strep infection diagnosed on 24-APR-2014. His temperature in the emergency room was 104 F and climbing prior treatment of ROCEPHIN. The patient was not admitted to the unspecified hospital. The patient's unspecified sister had also tested positive for a strep infection on 23-APR-2014 and was prescribed amoxicillin (manufacturer unknown) which did not treat the streptococcus infection and she had to be prescribed AUGMENTIN on an unspecified date. The outcome of the tonic-clonic seizure was recovered (with recovered date estimate as 02-MAY-2014 it was reported that seizure lasted a couple of minutes). The outcome of the rest events was unknown. The relatedness between the events and M-M-R II was unknown. Upon internal review the tonic-clonic seizure was considered to be medically significant. This case is linked with case MARRS # 1405USA003823 (same reporter link). Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Lumbar puncture normal, Pyrexia, Streptococcal infection, Streptococcus test positive
Clinical narrative: This spontaneous report as received from a consumer (mother of the patient) refers to a male patient at the age of 2 years and 1 month. There was no pertinent medical history. On 23-APR-2014 the patient was vaccinated with M-M-R II (lot# and expiration date were unspecified) first dose in the series. The patient was also administered an unspecified HIB vaccine (manufacturer unknown) on 23-APR-2014. Customer stated that, on 24-APR-2014, her son had tested positive for a streptococcus infection. He was prescribed amoxicillin (manufacturer unknown) for the strep infection. On 30-APR-2014 the patient developed a fever which continued through 02-MAY-2014. On the morning of 02-MAY-2014 at 9:40 AM, the patient had a tonic-clonic seizure that lasted "a couple of minutes" with cyanosis. The patient was taken on an unknown date in May 2014 to an unspecified emergency room and computerized axial tomography (CAT) scan, chest x-ray, spinal tap and blood cultures were performed. According the consumer "all the tests came back clear". While in the emergency room the patient received ROCEPHIN for the strep infection diagnosed on 24-APR-2014. His temperature in the emergency room was 104 F and climbing prior treatment of ROCEPHIN. The patient was not admitted to the unspecified hospital. The patient's unspecified sister had also tested positive for a strep infection on 23-APR-2014 and was prescribed amoxicillin (manufacturer unknown) which did not treat the streptococcus infection and she had to be prescribed AUGMENTIN on an unspecified date. The outcome of the tonic-clonic seizure was recovered (with recovered date estimate as 02-MAY-2014 it was reported that seizure lasted a couple of minutes). The outcome of the rest events was unknown. The relatedness between the events and M-M-R II was unknown. Upon internal review the tonic-clonic seizure was considered to be medically significant. This case is linked with case MARRS # 1405USA003823 (same reporter link). Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: This medically confirmed report received from a pharmacist via a field employee (initial receipt 29-Apr-2014) concerns a 60 year old male patient. On an unspecified date, four months ago, the patient received flu shot (manufacturer and batch number not reported) and ZOSTAVAX (batch number not reported). On an unspecified date, after vaccination, the patient developed Bell's palsy. It was reported that the patient was not hospitalised. The outcome was not reported.
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Dyspnoea, Rash generalised
Clinical narrative: This spontaneous report as received from a female pharmacist of unknown age referring to herself with AUGMENTIN allergy. On an unknown date in 1999 (also reported as about 15 years ago), the patient was vaccinated with VARIVAX (merck) dose 1, route not reported. No concomitant medication reported. On an unknown date, the patient experienced difficulty breathing and rash all over her body. In addition, on an unknown date in 1999 (also reported as the same day of the VARIVAX (merck) vaccination), pharmacist states she also may have inhaled some aerosolization of VARIVAX (merck) when she opened the vial, before she reconstituted the vaccine to administer to a patient. Pharmacist also stated that she went to the emergency room and was treated with albuterol, Epinephrine, prednisone, and was released. Pharmacist was not hospitalized. Pharmacist never received the second dose of VARIVAX (merck) (vaccination). Pharmacist had recovered from difficulty breathing and rash all over her body. Causality between VARIVAX (merck) (vaccination) and the events difficulty breathing and rash all over her body was not reported. The events of difficulty breathing and rash all over her body was reported as life threatening. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer (patient's sister) refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with M-M-R II. The customer stated that the patient had a fever and a seizure on an unspecified date after receiving her first dose of M-M-R II. The action taken was not reported. The outcome of seizure and fever was unknown. The relatedness between events and the therapy with M-M-R II was unknown. Upon internal review the seizure was considered to be medically significant. This case is linked with case MARRS # 1405USA003634 (same reporter link). Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old female patient (first client). The patient's pertinent medical history was not reported. On 24-APR-2014 the patient was inadvertently vaccinated with Dtap (unspecified), tetanus toxoid (manufacturer unknown) instead of GARDASIL. Reported as staff error only. Nurse states they are unsure which client the vaccine error occurred. For First client, this should had been the client's second dose of GARDASIL. For second client it should have been her first dose of GARDASIL. Both clients were vaccinated on the same day of 24-APR-2014. Nurse stated unsure which client got the Dtap (unspecified), tetanus toxoid (manufacturer unknown) instead of GARDASIL. No adverse effects reported. The outcome of inadvertently vaccinated with Dtap (unspecified), tetanus toxoid (manufacturer unknown) instead of GARDASIL and no adverse effects reported was unknown. This case is linked to case # 1405USA004069. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old female patient (second client). The patient's pertinent medical history was not reported. On 24-APR-2014 the patient was inadvertently vaccinated with Dtap (unspecified), tetanus toxoid (manufacturer unknown) instead of GARDASIL. Reported as staff error only. Nurse states they are unsure which client the vaccine error occurred. For First client, this should had been the client's second dose of GARDASIL. For second client it should have been her first dose of GARDASIL. Both clients were vaccinated on the same day of 24-APR-2014. Nurse stated unsure which client got the Dtap (unspecified), tetanus toxoid (manufacturer unknown) instead of GARDASIL. No adverse effects reported. The outcome of inadvertently vaccinated with Dtap (unspecified), tetanus toxoid (manufacturer unknown) instead of GARDASIL and no adverse effects reported was unknown. This case is linked to 1405USA004705. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Paraesthesia
Clinical narrative: This spontaneous report as received fro a female consumer of unknown age refers to herself. On 22-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported). The patient reported that on 24-APR-2014, she experienced the same tingling sensation and the injection site got really red, after she received ZOSTAVAX. The patient explained the tingling sensation was brief and the redness and tingling resolved on an unspecified date. No treatment was given for adverse event. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown gender and unknown age. On 29-APR-2014 (reported as yesterday), the patient was vaccinated with a dose of expired PROQUAD (Merck) lot # H019439, expiry date: 25-APR-2014, 0.5 ml, subcutaneous in the left arm. No adverse effects were reported. Additional information is not expected.
Sex: U
Vaccine: MMRV, VARCEL, VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date, the patient was vaccinated with VARIVAX (Merck). Other suspect therapies included PROQUAD (Merck) and ZOSTAVAX. On an unknown date, temperature excursion to ZOSTAVAX, VARIVAX (Merck) and PROQUAD (Merck) which was supported and no product was administered. However, the healthcare worker then stated that the freezer has had episodes of cycling after which the practice had administered all three products. ZOSTAVAX, VARIVAX (Merck) and PROQUAD (Merck) all supported post cycling events described. The healthcare worker had no knowledge of adverse effects note by any patient post administration. The outcome of temperature excursion and ZOSTAVAX, VARIVAX and PROQUAD all supported post cycling events described were unknown. This case is case 2 of 3. This case is related to case 1405USA001785 and 1405USA004771 (same reporter link). Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via Company Representative refers to a 54 year old female patient with no drug reactions or allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX (injection, dose not reported). On 28-APR-2014, the patient experienced injection site reactions, described as following: injection site was warm to the touch, injection site was red, with swelling and it had a lump. The patient had no fever (date unspecified) and had not previously had reactions to other injections. The patient's outcome was unknown. Causality assessment was not provided. 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 pharmacy technician refers to an unspecified group of patients (demographic data not provided). The patients were vaccinated with VARIVAX (Merck) on an unknown date, after "some" vaccines were exposed to 43.1 for 29 hours on 03-MAR-2014. No adverse event was reported. This report is linked with case MARRS # 1405USA002815 (the same reporter link). Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to a 33 year old female patient. Relevant medical history and concomitant medication were not provided. On an unknown date, reported as a child, the patient was vaccinated with M-M-R II two dose series. On an unknown date the patient's rubella titers were drawn and found to be equivocal. The nurse asked if the patient could received the third dose. The outcome of rubella titer equivocal was unknown. The reporter causality was not provided. Additional information has been requested.