chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.23
Sex: M
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Injection site urticaria, Needle issue, Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 month old male patient. The patient pertinent medical history was none and no known drug allergies. On 10-FEB-2015 the patient was received a partial dose of M-M-R II (dose and frequency were unspecified) (lot # K008625 and expiry date: 16-JUN-2016) subcutaneous in the left leg because the needle was not correctly attached to the syringe. Concomitant medications were none. On 10-FEB-2015, the patient subsequently developed hives at the injection site on the patient's thigh within 30 seconds of receiving the partial dose. The patient was immediately treated with BENADRYL. No lab tests were performed. The outcome of hives at the injection site was reported as recovering/resolving. The causality of hives was not reported. No product quality complaint (PQC) was reported for (M-M-R II). Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Information has been received from a physician and a healthcare worker referring to a 35 year old female patient with no pertinent medical history and no known allergies. On 06-FEB-2015 the patient was vaccinated dose 1 of M-M-R II (0.5 ml, subcutaneous, right upper arm, lot # reported as K008198 Exp 05-JUN-2016). There was no concomitant medication. The healthcare worker reported that patient took a urine pregnancy test, at home, on 09-FEB-2015, and it was positive for pregnancy. The LMP and EDD was not known. The pregnancy outcome was outcome pending. The outcome of vaccine exposure during pregnancy was unknown. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Anaphylactic reaction, Dyspnoea, Throat tightness, Urticaria
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 6 year old female patient with food allergies, atopic dermatitis and eczema. Approximately in 2013, the patient was vaccinated with a dose of M-M-R II (dose, frequency, route of administration, lot# and expiration date were not reported). There was no concomitant medication. Approximately in 2013 (reported as in the fall of 2013 after receiving M-M-R II, the patient experienced anaphylactic reaction. It was reported that the patient's throat closed up, she had shortness of breath and hives. There were no laboratory tests performed. No product quality complain (PQC) was involved. The outcome of the adverse event was not reported. Causality assessment was not provided. This is one of several reports received from the same reporter and referring to the same patient. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Localized redness and warmth - slight firmness. Started 2/10/15 -> no better 2/12/15 after TYLENOL/BENADRYL x2 days then oral prednisone started 2/12/15.
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient pertinent medical history was not reported. The pharmacist reported that a patient received an unspecified hepatitis B vaccine (manufacturer unknown) (unknown to the pharmacist to which hepatitis B vaccine the patient received so this being reported as Merck's RECOMBIVAX) when the patient was younger (unspecified of how many doses of Hepatitis B vaccine were administered to the patient and unspecified dates of administration) and the patient reported to the pharmacist that when she had a titer drawn on an unspecified date, the titer showed that she was below 10. No product quality complaint was reported. The causality of the event was not reported. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Rash, Skin irritation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 52-years-old male patient. Information about patient's medical history was not provided. On 28-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (refrigerated vial) (dose, frequency, route of administration and lot # were not reported). Concomitant medication was not reported. On an unknown date, the patient routinely experienced "breakouts" of rashes in an unspecified area, described as "uncomfortable and irritating". The pharmacist felt the presence of the rashes indicated recurrence of shingles and possibly vaccine failure, but this had not been confirmed by an official diagnosis. No treatment was given for adverse event. The patient did not seek medical attention. No product quality complaint (PQC) was involved. The outcome of "recurrence of shingles" and "possible vaccine failure" was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received KINRIX (batch number 99A7M, expiry date 3rd September 2016). On an unknown date, the patient received KINRIX .5 ml. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This case is one of the 2 cases reported by the same reporter for the same vaccine.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an approximately 3 year old male patient. The pertinent medical history was not reported. On 09-FEB-2015 (also reported as yesterday) the patient was vaccinated with improperly stored VARIVAX (Merck) dose 1, 0.5 ml, subcutaneously in the right thigh. No adverse effect was reported. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to her 23 month old daughter. On 23-JUL-2014, the patient was vaccinated with a first dose of VAQTA (0.5 ml, intramuscular in the left arm, lot# and expiration date were not reported). On 22-JAN-2015, the patient was vaccinated with a second dose of VAQTA (0.5 ml, intramuscular in the left arm, lot# and expiration date were not reported). The time between the first and the second vaccination was considered to be too short (also reported as one day shy of 6 months). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected, because a physician did not wish to be contacted.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy to vaccine, Drug hypersensitivity, Dyspnoea, Incomplete course of vaccination, Injection site pain
Clinical narrative: Information has been received from a field representative on 21-JAN-2015 concerning his daughter, an 11 year old female patient with allergy to BACTRIM. The patient's pertinent medical history included sports injuries. Concomitant therapies included unspecified nasal steroids. The patient received her first dose of GARDASIL injection (strength, dose and lot# were not reported) in NOV-2014 (reported as "two months ago") and she fainted. After the patient received her second GARDASIL dosage on 20-JAN-2015, she complained of injection site pain, and later experienced shortness of breath, nausea and facial splotchiness. The representative called and discussed the patient's symptoms with her physician, and the physician said to give ibuprofen as treatment. Since it appeared that the patient had an allergy to GARDASIL, she would probably not receive the third and final dosage. No lab diagnostics studies were performed. At the time of reporting, the patient still felt some nausea. The outcome of other events was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Rash macular
Clinical narrative: Information has been received from a field representative on 21-JAN-2015 concerning his daughter, an 11 year old female patient with allergy to BACTRIM. The patient's pertinent medical history included sports injuries. Concomitant therapies included unspecified nasal steroids. The patient received her first dose of GARDASIL injection (strength, dose and lot# were not reported) in NOV-2014 (reported as "two months ago") and she fainted. After the patient received her second GARDASIL dosage on 20-JAN-2015, she complained of injection site pain, and later experienced shortness of breath, nausea and facial splotchiness. The representative called and discussed the patient's symptoms with her physician, and the physician said to give ibuprofen as treatment. Since it appeared that the patient had an allergy to GARDASIL, she would probably not receive the third and final dosage. No lab diagnostics studies were performed. At the time of reporting, the patient still felt some nausea. The outcome of other events was unknown. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a physician refers to a 9 year old male patient (son the reporting physician). The patient's pertinent medical history was not reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB (dose, frequency and route were not reported). On an unknown date, the patient had adverse experiences. The outcome of experienced adverse experiences was unknown. The causality of adverse experiences was not reported. The physician reported that the patient had experienced adverse experiences on a number of unspecified vaccines and RECOMBIVAX HB cannot be ruled out. Additional information is not expected as the reporter details were not reported.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 56 year old female patient with no drug reactions/allergies. The patient's medical history included unspecified cancer. On 06-FEB-2015 the patient was vaccinated with ZOSTAVAX (0.65 ml, once, lot # K020801, expiration date: 31-JAN-2016) subcutaneously at the right arm. On 07-FEB-2015, the patient experienced swelling, redness and warmth at the injection site in her right arm. There was no treatment given for the adverse events. No lab diagnostics studies performed. The patient had sought medical attention by contacting the pharmacy. The outcome of the events was reported as not recovered. This is one of the several reports from the same reporter. Other patients' adverse events were captured in case # 1502USA004169, case #1502USA4635, case# 1502USA004628 and case # 1502USA004646. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, 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. The patients relevant medical history was not reported. On an unknown date, the patients were vaccinated with subcutaneously with VARIVAX (Merck) (dose, lot# and expiration date were not reported) which had been improperly stored. Information about co-suspect and concomitant medication was not reported. No adverse effect was reported. No PWC (product quality complaint) was involved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 57 year old female patient. The pertinent medical history was not reported. On an unknown date the physician vaccinated the patient with PROQUAD (Merck) (dose and route unspecified) in error. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. Patient's concurrent conditions and relevant medical history was no reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. On an unknown date, the patient was determined to be pregnant following vaccination. The patient was in her first trimester of pregnancy. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. The pregnancy outcome was outcome pending. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with VARIVAX (Merck) was not reported. Product quality issue was not involved. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative and refers to a 16 year old male patient. Patient's medical history and current conditions were not provided. On an unknown date the 16 year old male patient was vaccinated with a dose of GARDASIL (lot #, expiration date, dose and route were not reported). No concomitant medications were reported. No adverse effects were being reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant (C.M.A.) (also reported as nurse) refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of M-M-R II dose number, lot# and expiration date was not reported, which underwent a supported temperature excursion. No adverse effects reported. Follow-up information has been received. On 04-FEB-2015 several telephone attempts were placed to the certified medical assistant however she was unavailable at the time of calls. This one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that on an unknown dates an unspecified number of patients received doses of VAQTA (route, dose, frequency and lot # not reported) that were improperly stored. No adverse experiences reported. No further information provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that on an unknown dates an unspecified number of patients received doses of PNEUMOVAX (route. dose, frequency and lot # not reported) that were improperly stored. No adverse experiences reported. No further information provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that on an unknown dates an unspecified number of patients received doses of RECOMBIVAX (route, dose, frequency and lot # not reported) that were improperly stored. No adverse experiences reported. No further information provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that on an unknown dates an unspecified number of patients received doses of GARDASIL (route, dose, frequency and lot # not reported) that were improperly stored. No adverse experiences reported. No further information provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On an unspecified date, the patient was inadvertently administered 2 doses of VARIVAX (Merck) (lot#, dose and route not provided). No adverse effect was reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a 18 year old male patient. Physician reported that "years ago" patient received complete VARIVAX (Merck) (dose, strength not reported) series. On an unknown date, patient developed a rash. The patient's parents told physician that "it looked like shingles". The reporter had not assessed this patient for shingles at time of call. The outcome of the event was unknown. The relatedness between event and VARIVAX (Merck) was not reported. No product quality complaint (PQC) reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a 46 year old female patient. There were no known pertinent medical history and drug reactions or allergies for the patient. On 02-FEB-2015 the patient was vaccinated with ZOSTAVAX (lot # K020801, expiration date 31-JAN-2016, 0.65 ml) subcutaneous in the unspecified arm. No other concomitant medication included for the patient. On 03-FEB-2015, the patient experienced injection site swelling, injection site warmth and injection site redness. The patient sought medical attention via office visit. No treatment was given for the events and no lab diagnostics studies were performed. The outcome of injection site swelling, injection site warmth and injection site redness was unknown. The causality of the events was unknown. No PQC involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Accidental overdose
Clinical narrative: This case was received from a other health professional and described the occurrence of accidental overdose in a 18-year-old male patient who received ENGERIX B adult. In December 2014, the patient received ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.
Age: 0.3
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received KINRIX (batch number 5412R, expiry date 23rd July 2016). Previously administered products included DTAAP vaccine (dose 1). On an unknown date, the patient received KINRIX .5 ml, On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information received: 4 month old was accidentally given KINRIX as the 2nd DTAP dose.
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a pharmacist and described the occurrence of drug dose administration interval too long in a 51-year-old female patient who received TWINRIX. Co-suspect products included TWINRIX. Previously administered products included TWINRIX (dose 1). On 25th September 2014, the patient received the 2nd dose of TWINRIX 1 ml. On 10th December 2014, the patient received the 3rd dose of TWINRIX. On an unknown date, an unknown time after receiving TWINRIX and TWINRIX, the patient experienced drug dose administration interval too long and drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too short were unknown. Additional information received: TWINRIX was administered on 5/2013 and then on Sept 25, 2014 and then on 12/10/2014. The dose 2 was delayed and dose 3 was given too early. No specific reason for this.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (lot #, strength, dosage, route unspecified). No adverse effects were reported. Additional information is not expected because the physician did not want to be contacted.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac murmur, Dizziness, Malaise
Clinical narrative: Patient reported not feeling well a couple of days after immunization - said lightheaded. He had a visit with cardiologist for "heart murmur" and they found his BP to be elevated to 200 and sent him to ER on 2/11/15. He came in to pharmacy to fill Rx for carvedilol and stated it was from a reaction to the immunization on 2/6/15.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a 4-year-old male patient who received KINRIX (batch number unknown, expiry date 23rd November 2014). On 4th December 2014, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Local area of redness and itching, slightly raised.
Age: 1.17
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Minutes after receiving vaccines developed a red, flat rash on extremities and trunk. No respiratory distress or symptoms. Gave 3cc of BENADRYL. Rash started to resolve before giving BENADRYL and was completely resolved soon after.
Age: 1.14
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Croup infectious, Generalised tonic-clonic seizure, Influenza virus test negative, Pyrexia, Streptococcus test negative
Clinical narrative: Patient had vaccines (below) on 1/22/15. On 2/10/15 developed grand mal seizure < 5 minutes and fever up to 102 F. Also diagnosed with croup on 2/11/15- given oral steroids.
Age: 1.14
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urine analysis normal
Clinical narrative: Patient had vaccines (below) on 1/22/15. On 2/10/15 developed grand mal seizure < 5 minutes and fever up to 102 F. Also diagnosed with croup on 2/11/15- given oral steroids.
Age: 1.84
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Entire deltoid area of left arm is red, swollen, firm and warm to touch. Also very painful. Pt. told to use warm compresses and take BENADRYL.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Odynophagia, Oropharyngeal pain
Clinical narrative: C/o pain in throat, just below adam's apple, shortly after receiving vaccines. Pain persisted with swallowing. Denied SOB, resp distress. Swelling of lips or tongue. No rash. Contacted primary provider-advised to proceed to ER if sx progressed. Follow up phone call on 2-11-15: patient went to ER. Was given a dose of steroid and discharged sx gradually resolved.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a healthcare student, concerning a 51 year old male patient with diabetes. In January 2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare student reported that in January 2015 (reported as a month ago), a patient who received ZOSTAVAX experienced a shingle-like rash on his unspecified thigh, buttock and torso region, about 4 days after being vaccinated. In approximately 2015, the patient recovered of the "shingles-like rash". The healthcare student reported that the patient seek medical attention at the physician office and was treated with acyclovir. Additional information is not expected, due the healthcare student do not wish to be contacted regarding this adverse event report and declined to provide physician's information.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Pt received PNEUMOVAX 23 on 2-4-15. She states within 24 hours her arm became very sore at inj. site. It was Seep cranberry red in color. Was swollen out from arm 3 1/2" and was 4-6 in across. She then developed a fever and felt foggy. On 2-6-15 she spiked a fever of 106.0 (per pt). Today 2-12-15 arm is till sore, not as red and has starting itching.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pt received PNEUMOVAX 23 on 2-4-15. She states within 24 hours her arm became very sore at inj. site. It was Seep cranberry red in color. Was swollen out from arm 3 1/2" and was 4-6 in across. She then developed a fever and felt foggy. On 2-6-15 she spiked a fever of 106.0 (per pt). Today 2-12-15 arm is till sore, not as red and has starting itching.
Age: 65.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2011US010118, is an initial spontaneous report received from a nurse on 21 Nov 2011 and a follow up received on 17 Dec 2013. This report refers to 65-year-old female patient. Her medical history and concomitant medications were not reported. She had no history of vaccination. She inadvertently received MENVEO (batch number X11022) at a dose of 0.5 ml intramuscularly into the left deltoid on 15 Nov 2011. No adverse event occurred following this administration. Follow-up was received from the nurse on 17 Dec 2013: Updated vaccination history, batch number, site and route of MENVEO.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Swelling and redness of entire left upper arm extending onto the chest.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report was received from a consumer concerning a relative of hers, a 12 year old male patient. The patient's pertinent medical history and concurrent conditions were not provided. On an unspecified year, described as probably sometime between 2002 and 2006, the patient was vaccinated with a dose of M-M-R II (dose, route and lot# not provided). On an unknown date the patient experienced a mild case of autism and had autism symptoms described as hand slapping and other typical autism behaviors since he acted differently. The consumer reported that she was certain it was from the M-M-R II. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information is not expected because there are no contact details.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2012US023399 is an initial spontaneous report received from a nurse on 27 Nov 2012 with a follow-up received on 03 Apr 2013: This report refers to a 12-year-old female child. Her vaccination status was up to date with exception of MENVEO. She was given only MenCYW lyophilized conjugate component of MENVEO (batch number: X11050) intramuscularly in to the right deltoid on 14 Nov 2012. No adverse event was reported following this administration error. Follow-up received from the nurse on 03 Apr 2013: Updated demographics, vaccination history and site of vaccination.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HEP, MMR, MNQ, PNC13, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2013US003551 is an initial spontaneous report received from a nurse on 07 Feb 2013, with a follow up received on 05 Mar 2013. This report refers to a 25-months-old male patient. His medical history was not reported and his concomitant medication included MMR vaccine, PEDIARIX, PCV 13 and VCV and Hepatitis B vaccine. It was reported that he was administered a dose of MENVEO (batch number: A11051) intramuscularly to upper right vastus lateralis, but was supposed to receive a dose of HIB (manufacturer and batch number: not reported hence conservatively taken as VAXEMHIB INN) on 18 Jan 2013. No adverse reactions were reported. Follow up received on 05 Mar 2013: Updated the concomitant medications, time, site of application, height and weight of the patient.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US003889 is an initial spontaneous report received from a nurse on 11 Feb 2013 with a follow-up received on 08 Mar 2013: This report refers to a 12-years-old male patient. His concomitant vaccination included administration of BOOSTRIX (other manufacturer, batch number: ACSB102BA) intramuscularly at 0.5 ml on 08 Feb 2013. It was reported that he received only MenCYW-135 liquid component of MENVEO (batch number: 11081) intramuscularly on 11 Feb 2013 and did not receive MenA lyophilized conjugate. No adverse events were reported following the inadvertent administration. Follow-up received from the nurse on 08 Feb 2013: Updated concomitant vaccination and date of vaccination.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site vesicles
Clinical narrative: Case number PHEH2013US017662 is an initial spontaneous report from the nurse received on 16 Aug 2013. This report refers to a 12-year-old female patient. She was vaccinated with MENVEO (batch number: M12129) via intramuscular route on 07 Aug 2013. On an unknown date, "a little while" after vaccination the patient experienced blisters that broke out around the injection site. The outcome of the event was not known at the time of reporting. The seriousness and causality of the event were not reported. No other information was available.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Peripheral swelling, Urticaria
Clinical narrative: Case number PHEH2013US018411 is an initial spontaneous report received from a nurse on 28 Aug 2013. This report refers to a 13-years-old male patient. His medical history and concomitant medications were not reported. His vaccination history included administration of Tdap (other manufacturer, batch number: not reported) following which he had redness at the injection site (TDAP reaction was not severe). He was vaccinated with MENVEO (batch number: not reported) on 14 Jun 2013 at 11:30 am. It was reported that later that afternoon he went for swimming and noticed redness and swelling at the vaccination site. His mother gave him an unspecified antihistamine. Two days later, the vaccination site swelling became progressively worse and it turned to a whelp and was swollen below the elbow. Whelp was hot, red and painful. He was taken to the emergency room and was treated with high dose antibiotics for suspected cellulitis. He had to have the dose of antibiotics reduced and the events eventually improved and symptoms subsided. His physician referred him to an allergist. Upon research, the allergist determined that the reaction was probably not cellulitis, but rather a "diphtheria-toxoid reaction". The outcome of the event was reported as complete recovery. The seriousness and causality were not reported.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Vaccination complication, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Case number PHEH2013US018411 is an initial spontaneous report received from a nurse on 28 Aug 2013. This report refers to a 13-years-old male patient. His medical history and concomitant medications were not reported. His vaccination history included administration of Tdap (other manufacturer, batch number: not reported) following which he had redness at the injection site (TDAP reaction was not severe). He was vaccinated with MENVEO (batch number: not reported) on 14 Jun 2013 at 11:30 am. It was reported that later that afternoon he went for swimming and noticed redness and swelling at the vaccination site. His mother gave him an unspecified antihistamine. Two days later, the vaccination site swelling became progressively worse and it turned to a whelp and was swollen below the elbow. Whelp was hot, red and painful. He was taken to the emergency room and was treated with high dose antibiotics for suspected cellulitis. He had to have the dose of antibiotics reduced and the events eventually improved and symptoms subsided. His physician referred him to an allergist. Upon research, the allergist determined that the reaction was probably not cellulitis, but rather a "diphtheria-toxoid reaction". The outcome of the event was reported as complete recovery. The seriousness and causality were not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Case number PHEH2013US003979 is an initial spontaneous report from the health care professional received on 13 Feb 2013, with a follow-up received from a physician on 30 Apr 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M12013) at a dose of 0.5 ml intramuscularly into left arm on 12 Feb 2013. On the same day, few hours after vaccination, he experienced a large swollen area on his left upper arm. On 13 Feb 2013, he consulted the physician and noticed swelling and redness of the left arm with size 164/6 cm. It was reported that swollen area was warm to touch and approximately 50mm across was painful. He received treatment with ATARAX and prednisone for the events. On 14 Feb 2013, the swelling and redness were barely visible. The final outcome of the events was reported as recovered. The seriousness and causality of the events were not reported. Follow-up was received on 30 Apr 2013: Patient demographics, vaccine information (batch number, vaccination dose, site of vaccination, events (swelling/ redness of left arm), treatment medication and outcome of the events were updated.
Age: 12.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: Case number PHEH2013US017053 is an initial spontaneous report received from a nurse on 08 Aug 2013: This report refers to a 12-year-old male patient. He was vaccinated with MENVEO (batch number: M12123) intramuscularly in to the right arm at 0.5ml and with Dtap (other manufacturer, batch number: unknown) in to the left arm on an undetermined date. On an unspecified date after vaccinations, he experienced a circle around the shot that felt hard and was warm to touch. No further information about seriousness, outcome and causality was reported.
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2012US018900 is an initial spontaneous report received from a medical assistant on 18 Sep 2012: This report refers to a 24-year-old female patient. She was vaccinated with MENVEO, (batch number: unknown) intramuscularly in the previous week before the date pf reporting. On 18 Sep 2012 she notified the facility that she was 15-weeks pregnant. No adverse event was reported since administration of the vaccine. Follow up information received on 13 Aug 2013: Multiple attempts were made to obtain outcome of event without success. This case is considered lost to follow up.
Age: 43.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Case number PHEH2013US017159 is an initial spontaneous report from pharmacist on 09 Aug 2013. This report refers to 43 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: X11041) intramuscular on 02 Aug 2013. On 08 Aug 2013, the patient noticed a red, itchy rash in the area where the vaccine was administered. Outcome of the events was ongoing. Seriousness an causality assessment was not reported.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHEH2013US009125, is an initial spontaneous report received from a medical assistant on 19 Apr 2013. This report refers to a 12-years-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: M120127 and expiry date: Dec 2014) at dose of 0.5 ml intramuscularly on 18 Apr 2013. On the same day after vaccination, he experienced redness and swelling at the injection site on left arm. These symptoms were subsided on the next day. The outcome of the events was reported as completely recovered. The seriousness and causality of the events was not reported.
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Case number PHEH2013US009362 is an initial spontaneous report received from a consumer on 18 Apr 2013. This report refers to a female patient of an unknown age. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO, (batch number: unknown) on 12 Apr 2013 (Friday). On an unspecified date, injection site became red and was itchy. The outcome of the events was not reported. No other information was provided.
Age: 28.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2013US011178 is an initial spontaneous report received from a consumer on 17 May 2013. This case refers to a 28-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: not reported) intramuscularly in his right arm on 14 May 2013. On the same day in the evening, he developed injection site swelling, lightheadedness and dizziness. In the morning of 15 May 2013, the injection site was sore, had a knot at the site, and was red and swollen. The final outcome was reported as unknown. No other information was available at the time of this report.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Peripheral swelling
Clinical narrative: Case number PHEH2013US012001 is an initial spontaneous report from a nurse via sales representative on 30 May 2013, and a follow up received from the nurse on 20 Jun 2013. This report refers to a 15-year-old female patient. She had no medical history and her concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M11042) at a dose of 0.5 ml intramuscularly in her left deltoid on 02 Aug 2012. She developed swelling of left arm and went to emergency room in 03 Aug 2012. The nurse did not visualize the arm when the event occurred. The patient had recovered completely on an unspecified date. The seriousness and causality was not reported. No other information was provided. Follow up information received from the nurse on 20 Jun 2013: Update site and dose of vaccination, and outcome of event.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2013US014616 is an initial spontaneous report from the physician received on 05 Jul 2013. This report refers to a 11-year-old male patient. He was vaccinated with MENVEO (batch number: M12125) via intramuscular route on 01 Jul 2013. On 02 Jul 2013, his injection site was warm to touch and swollen. His MD (reporter) saw the patient and treated him with an antibiotic. The outcome of the events was reported as decreased, but not completely resolved at the time of reporting. The seriousness and causality of the events were not reported.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Injection site pain
Clinical narrative: Case number PHEH2013US014818 is an initial spontaneous report received from a nurse on 09 Jul 2013: This report refers to an adolescent female patient. She was vaccinated with MENVEO (batch number: M12123) intramuscularly on 08 Jul 2013 and began experiencing severe pain in the upper arm at injection site, and dizziness throughout the evening. Outcome of the events was reported as ongoing. No further information about causality and seriousness was reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHEH2013US014822 is an initial spontaneous report received from a physician on 10 Jul 2013, with a follow-up received on 30 Jul 2013: This report refers to an 11-year-old male patient. His medical history included cutis marmorata diagnosed in new born and had complete resolution. He was previously vaccinated with MENVEO (batch number: unknown) on an unspecified date and was well tolerated. He was further vaccinated with MENVEO (batch number: M12097, expiry date: 20 Aug 2014) at a dose of 0.5 ml intramuscularly in to right arm on 08 Jul 2013 (at 2.00 pm). On the same day after vaccination, he experienced pain and lack of mobility in the arm. On 09 Jul 2013, he had swelling and could not raise the right arm. Patient went to a comp on 09 Jul 2013 but the physician did not know what he did there. His mother placed ice on the arm. He consulted his physician on 10 Jul 2013. Seriousness and causality of the events were not reported. Following an internal review of the data received on 10 Jul 2013, it was observed that verbatim swelling of the arm was erroneously coded to swelling. Therefore, it was correctly captured as extensive swelling of vaccinated limb, in the case. Follow-up was received on 30 Jul 2013: Patient demographics, medical history, previous vaccination information, vaccination dose and site were updated.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling
Clinical narrative: Case number PHEH2013US014898 is an initial spontaneous report from the medical assistant on 11 Jul 2013, with a follow up received from the medical assistant on 05 Aug 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M10133) at a dose of 0.5 ml in the left arm on 09 May 2013 at 11:00 AM. On the same date, he underwent TB test in the right arm. next day morning (10 May 2013, after vaccination his left deltoid was very swollen, about 3 cm long at the injection site. It was reported that when the patient came back for follow up of the TB test, he had a very swollen deltoid. His physician (MD) advised to apply compresses on the arm. The outcome, seriousness and causality of the event were not reported. Follow up received from the  medical assistant on 05 Aug 2013: Updated patient demographics, MENVEO batch number, dose and vaccination date and time.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Case number PHEH2013US015594 is an initial spontaneous report received from a nurse on 18 Jul 2013 with a follow up information received on 24 Jul 2013. This report reefers to an 11-years and 2-months old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO, (batch number: M11032, expiry date: not available) at a dose of 0.5 ml intramuscularly on 15 Jun 2013. His parent reported on 16 Jun 2013 that on unknown date he experienced itchiness, redness and swelling around the vaccination site. The outcome of the event was not reported. No further information was provided. Follow up information received on 24 Jul 2013: Batch number of the vaccine updated.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Case number PHEH2013US015772, is an initial spontaneous report received from a nurse on 18 Jul 2013. This report refers to an 11-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO, (batch number: A12011, expiry date: Feb 2014) at dose of 0.5 ml intramuscularly on 12 Jul 2013. On 15 Jul 2013, her parent called and reported that, she experienced injection site of MENVEO was red and hot (exact date of onset of reaction was not known). The outcome, seriousness and causality of the events were not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Case number PHEH2013US015777, is an initial spontaneous report received from a nurse on 18 Jul 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: A12011, expiry date: Feb 2014) at dose of 0.5 ml intramuscularly on 17 Jul 2013. On 18 Jul 2013, his parent called and reported that, he experienced redness, heat and swelling at MENVEO injection site, low grade fever and headache (onset exact date of reactions was not known). The outcome, seriousness and causality of the events were not reported. Following an internal review received on 06 Aug 2013, the case number PHEH2013US016372 was identified to be a duplicate of PHEH2013US015777 and hence all the information from PHEH2013US016372 was merged into PHEH2013US015777 and the case PHEH2013US016372 would be deactivated.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema
Clinical narrative: Case number PHEH2013US016332, is an initial spontaneous report received from a medical assistant on 30 Jul 2013. This report refers to 11 year 3 months old male child. He was vaccinated with MENVEO (batch number: unknown) at a dose of 0.5 ml intramuscularly on 17 Jul 2013. On 18 Jul 2013, he experienced localized red reaction at injection site. Outcome, seriousness and causality assessment of the event was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Injection site erythema, Peripheral swelling
Clinical narrative: Case number PHEH2013US016334 is an initial spontaneous report received from a medical assistant on 30 Jul 2013 and a follow up report from the medical assistant received on 20 Aug 2013. This report refers to an 11-year-old male child. He was vaccinated with MENVEO, (batch number: unknown) at a dose of 0.5 ml intramuscularly in the arm on 17 Jul 2013 (at 9:15 am). On the same date, after vaccination he experienced localized red reaction at injection site, which later became as red swollen arm. On 20 Jul 2013, he recovered from the event. The event was reported as non serious. The causality assessment of the event was not reported. Follow up report from the medical assistant received on 20 Aug 2013: The vaccination site and date, event (red swollen arm), start date and outcome of the event and seriousness of the event were updated.