chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: Client received vaccine just prior to noon on 1/21/15. TC to HD at 1650 with c/o swollen itchy eyes, raspy voice, swelling in throat and chest tightness. Advised to take BENADRYL 50mg and if experiencing prob. breathing to go to ER. 1/22/15 TC to HD at 8:10 AM. States had T-101.5 at 7:30PM. Took ALEVE, went to bed, slept well in NOC. States feels fine this AM and is afebrile.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: This case was reported by a other health professional and described the occurrence of hives in a 52-year-old female patient who received Influenza vaccine (batch number 3E532, expiry date June 2015). On 28th October 2014, the patient received Influenza vaccine. On 28th October 2014, an unknown time after receiving Influenza vaccine, the patient experienced hives, erythema and swelling. On 2nd November 2014, the outcome of the hives, erythema and swelling were recovered/resolved. The reporter considered the hives, erythema and swelling to be probably related to Influenza vaccine. Additional information: Injection given at agency by physician (company hired to administer flu vaccine); hive, redness, swelling on her extremities and trunk. This is the 1st time she ever received.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received FLUARIX. On an unknown date, the patient received FLUARIX QIV at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: 30 expired doses of FLUARIX QIV were shipped from VFC and 14 doses were administered to patients. Nurse does not have any patient level information.
Age: 0.3
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of wrong vaccine administered in a 4-month-old female patient who received FLUARIX (batch number LM55C, expiry date 23rd June 2015). On an unknown date, the patient received FLUARIX. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information: FLUARIX was inadvertently administered to a 4 month old instead of PEDIARIX.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 63 years old female patient. The pertinent medical history was unspecified. On 08-FEB-2015, the patient was vaccinated with ZOSTAVAX, (lot # K016326, Expiry: December 2015) 0.65 ml, subcutaneous. Concomitant therapies included amlodipine. On an unknown date in February 2015 the patient's injection site was itchy and had a knot. The patient sought medical attention by calling the pharmacist on phone on 10-FEB-2015. The pharmacist reported that there was no description of a rash provided by the patient and the pharmacist had not assessed the inejction site in person. No lab tests were performd and no treatment was rendered for the event. Packet was offered however the pharmacist was adamant about not receiving it. The outcome of the event was not recovered/not resolved. The causality was not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 63 years old female patient. The pertinent medical history was unspecified. On 08-FEB-2015, the patient was vaccinated with ZOSTAVAX, (lot # K016326, Expiry: December 2015) 0.65 ml, subcutaneous. Concomitant therapies included amlodipine. On an unknown date in February 2015 the patient's injection site was itchy and had a knot. The patient sought medical attention by calling the pharmacist on phone on 10-FEB-2015. The pharmacist reported that there was no description of a rash provided by the patient and the pharmacist had not assessed the inejction site in person. No lab tests were performd and no treatment was rendered for the event. Packet was offered however the pharmacist was adamant about not receiving it. The outcome of the event was not recovered/not resolved. The causality was not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site nodule, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 63 years old female patient. The pertinent medical history was unspecified. On 08-FEB-2015, the patient was vaccinated with ZOSTAVAX, (lot # K016326, Expiry: December 2015) 0.65 ml, subcutaneous. Concomitant therapies included amlodipine. On an unknown date in February 2015 the patient's injection site was itchy and had a knot. The patient sought medical attention by calling the pharmacist on phone on 10-FEB-2015. The pharmacist reported that there was no description of a rash provided by the patient and the pharmacist had not assessed the inejction site in person. No lab tests were performd and no treatment was rendered for the event. Packet was offered however the pharmacist was adamant about not receiving it. The outcome of the event was not recovered/not resolved. The causality was not reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US016905 is an initial spontaneous report received from a health care professional on 23 Jul 2013. This report refers to an 18-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an expired dose of MENVEO (batch number: A10047, expiry date: Dec 2012) on 19 Jul 2013. It was reported that he was immediately revaccinated with a non-expired dose of MENVEO (batch number: A12009, expiry date: Feb 2014) after the expired dose. No adverse events reactions were reported following the maladministration.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 29 patients of unknown age and gender. Concomitant therapy, pertinent medical history or drug reactions/allergies were not reported. On an unknown date the patients were vaccinated with GARDASIL (0.5 ml, intramuscularly) that underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US017772 is an initial spontaneous report received from a nurse on 19 Aug 2013. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. It was reported that the patient was possibly vaccinated only with an intramuscular dose of MenCYW-135 liquid component of MENVEO (batch number: not reported) without being reconstituted with Men A lyophilized conjugate on 15 Aug 2013. It was reported that the nurse could not confirm this as she had two different lot numbers (lot number A12026 for the MenA vial she had in her hand and batch number 10133 in documentation) and she was unsure who the patient was. No adverse reactions were reported following the maladministration.
Sex: U
Vaccine: HPV4
Symptoms: Depressed level of consciousness, Eye movement disorder, Syncope
Clinical narrative: Information has been received from a vaccine administrator (unspecified HCP) via a company representative referring to multiple unspecified patients of unknown age and gender. The reporter reported that more times than not, when he/she administered GARDASIL (lot#, dose, route not reported) to these patients, on a daily basis, the patients not only experienced syncope, but their eyes also 'rolled back' and they nearly passed out on unspecified dates. The reporter asked the patients to sit for longer than 15 minutes observation after receiving GARDASIL. Outcome of the events was not reported. The causality was not provided. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Patient's current condition or medical history was not reported. On 09-FEB-2015 the patient was vaccinated with a dose of RECOMBIVAX HB (lot#, dose not reported, intramuscularly) which underwent a non supported temperature excursion. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US018713, is an initial spontaneous report received from a nurse on 04 SEP 2013. This case refers to a male patient of unspecified age. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: A11032) at dose of 0.5 ml intramuscularly on 30 JUL 2013, MENVEO had experienced a one time temperature excursion of 9.0-9.5 C for maximum time of 18 minutes. No adverse event was reported following this administration error.
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH203US018749, is an initial spontaneous report received from a healthcare professional on 04 SEP 2013. This report refers to a female patient of unspecified age. She received only MEN C Y W-135 liquid conjugate component of MENVEO (batch number: not reported), without being reconstituted with MEN A lyophilized conjugate vaccine component on an unspecified date. No adverse event was reported following this administration error.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report has been received from a pharmacist refers to a 52 year old female patient. The patient's medical history included brain tumor. No drug reactions/allergies. On 23-JAN-2015 the patient was vaccinated with ZOSTAVAX (lot# reported as K020801, exp 31-JAN-2016), 0.65 ml, once, subcutaneous in the right arm. Concomitant medication was other unspecified medications. On 24-JAN-2015, swelling, redness, and warmth at the injection site in her right arm after received ZOSTAVAX. No treatment and no lab given to the events. The patient had sought medical attention by contacted pharmacy. The outcome of the events was reported as recovered/resolved on an unknown date in 2015. No PQC involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US018762 is an initial spontaneous report received from a pharmacist on 04 Sep 2013. This report refers to a 63-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A11082) intramuscularly on 01 Sep 2013. No adverse events were reported following the maladministration.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a nurse who reported that an unspecified number of patients (of unknown age and gender) were administered improperly stored doses of M-M-R II on unspecified dates. No adverse events were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The pertinent medical history and concomitant medications were not reported. On 09-FEB-2015 the patient was vaccinated with a dose of PEDVAXHIB, intramuscular which underwent a supported temperature excursion. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US019082, is an initial spontaneous report received from a medical assistant on 10 Sep 2013. This report refers to an 11 years old male patient. He was vaccinated with MENVEO, batch number: M12093 and expiry date: Aug 2014), at dose of 0.5 ml intramuscularly on 28 Aug 2013. MENVEO vaccine was reached 33 to 51 F overnight and vaccine did not freeze. No adverse event was reported following this administration error.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to some patients of unknown age and gender. On unknown dates the patients were vaccinated with (Oka/Merck) VARIVAX (lot number, dose and route were unknown) which exposed to 8F. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US019084, is an initial spontaneous report received from a medical assistant on 10 Sep 2013. This report refers to an 11 years old male patient. He was vaccinated with MENVEO (batch number: M12093 and expiry date: Aug 2014), at dose of 0.5 ml intramuscularly on 05 Sep 2013. MENVEO vaccine was reached 33 to 51 F overnight and vaccine did not freeze. No adverse event was reported following this administration error.
Age: 1.28
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Croup infectious, Nasal congestion, Pyrexia
Clinical narrative: Patient presented with croup cough, fever, and nasal congestion. Another patient presented with similar symptoms following varicella vaccine.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US019085, is an initial spontaneous report received from a medical assistant on 10 Sep 2013. This report refers to a 16 years old male patient. He was vaccinated with MENVEO, batch number: M12093 and expiry date: Aug 2014), at dose of 0.5 ml intramuscularly on 06 Sep 2013. MENVEO vaccine was reached 33 to 51 F overnight and vaccine did not freeze. No adverse event was reported following this administration error.
Age: 1.07
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Influenza virus test negative, Pyrexia, Rash generalised, Streptococcus test negative
Clinical narrative: This spontaneous report as received from the patient's mother refers to a 1 year old female patient with no known allergies. The patient had none medical history. On 03-FEB-2015, the patient was vaccinated with a dose of M-M-R II (albumin status was not reported) and a dose of VARIVAX (Merck) (dose, lot#, expiration date, site and route of administration were not reported for both). There was no concomitant medication. On 03-FEB-2015, in the evening, the patient developed fever (highest reading was 104.3 F). The event was ongoing despite use of MOTRIN. On 06-FEB-2015, the patient developed rash on her face. The patient was seen by her physician on 06-FEB-2015. Strep test and flu evaluate were negative. In February 2015 (reported as over the weekend), the rash progressed to generalised all over child's body. The outcome of events was reported as not recovered/not resolved. The relatedness between the events and M-M-R II and VARIVAX (Merck) was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender who on 08-FEB-2015 was vaccinated with a dose of ZOSTAVAX lot # J012679 that had expired on 21-JAN-2015. No adverse events were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: MNQ, VARZOS
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US020428, is an initial spontaneous report received from a pharmacist on 27 Sep 2013 and a follow up report from the pharmacist received on 19 Nov 2013. This report refers to a 62-years-old female patient. Her concomitant vaccine included ZOSTAVAX (batch number: J003360, other manufacturer) on 26 Sep 2013. Accidentally she received only Men C, Y, W-135 liquid component of MENVEO (batch number: X12097), intramuscularly in the deltoid without being reconstituted with Men A lyophilized conjugate vaccine component on 26 Sep 2013. No adverse event was reported following this administration error. Follow up report from the pharmacist received on 19 Nov 2013: Concomitant vaccine was added. The site of MENVEO vaccination was updated.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Case number PHEH2013US020639, is an initial spontaneous report received from a nurse on 30 Sep 2013. This report refers to an unspecified age and gender patient. The patient received only MEN C, Y, W-135 liquid conjugate component of MENVEO, batch number: not reported), without being reconstituted with Men A lyophilized conjugate vaccine component on an unspecified date. Reporter stated that, she believes administration error occurred around the end of August. No more information was available.
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a currently 57 year old male patient. On an unknown date (reported as a child), the patient was vaccinated with MMR (manufacturer unknown) (dose, units, route of administration, anatomical location, lot number were not reported). On an unknown date, the patient needed proof of MMR (measles, mumps and rubella) immunity due to his occupation, had titers drawn which resulted negative. The outcome of the event was not reported. The relatedness between the event and MMR (manufacturer unknown) was not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021738 is an initial spontaneous report received from a health care professional on 16 Oct 2013. This report refers to an 11-year-old male patient. He was vaccinated with an initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in to left deltoid on 28 May 2013 (at 15:00). It was reported that the patient received vaccine which was compromised due to refrigeration malfunction (temperature error). No adverse event was reported following the medication error. He was revaccinated on 26 Jul 2013.
Sex: F
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a female patient of unknown age. Information regarding drug reactions or allergies and medical history was not reported. On 04-FEB-2015 the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot#, expiration date were not reported). Concomitant therapies were not reported. In approximately February 2015 (reported as: "now") the patient was experiencing severe sinus infection. There was treatment with MEDROL dose pack given for the event. The outcome of severe sinus infection was reported as not recovered/not resolved. The patient sought medical attention by seeing a doctor. The relatedness between the therapy with ZOSTAVAX and the event was not reported. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US02537 is an initial spontaneous report received from a nurse on 05 Dec 2013: This report refers to a patient of unknown age and gender. This patient was given only MenCYW liquid component of MENVEO (batch number: M12131) intramuscularly on an undetermined date. No adverse event was reported following this administration error.
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Accidental exposure to product, Exposure via direct contact, No adverse event
Clinical narrative: Case number of PHEH2013US022972 is an initial spontaneous report from the nurse received on 30 Oct 2013. This report refers to a 25-year-old female nurse. On 30 Oct 2013, during reconstitution of the vaccine MENVEO (batch number: X11081), the needle got detached from the syringe and the vaccine just squirted up straight from the syringe into the eyes of the nurse. No adverse event reported. The vaccine was discarded and no patient was involved. No other information was available.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Since 19-JAN-2015 the patients were vaccinated with VAQTA (dose: 0.5 ml, administered intramuscularly) which were improperly stored. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date (couple of weeks ago), the patient was vaccianted with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not provided). On an unknown date, after receiving ZOSTAVAX, the patient broke out in what was referred to as 'chickenpox onn the arm and forearm'. It was not specified which arm. Patient sought medical attention, she called physician. Acyclovir and VALTREX were given for the treatment. The outcome of the event was reproted as not recovered/not resolved. Relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Immunisation, No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US023219 is an initial spontaneous report received from the medical assistant on 05 NOV 2013 with a follow up information received from the medical assistant on 03 DEC 2013. This report refers to a 12-year-old female patient. She had no medical history and her concomitant medications were not reported. Her vaccination status was up to date and it was unknown whether MENVEO was tolerated in the past. She needed only Men A lyophilized conjugate component of Menveo (batch number: A12095), reconstituted with sterile water instead of MenCYW-135 liquid component intramuscularly at a dose of 0.5 ml in the right deltoid on 04 NOV 2013. No adverse reaction reported following the administration error. She was revaccinated with a proper dose on 11 NOV 2013. No further information was provided.  Follow up information received from the medical assistant on 03 DEC 2013. Patient demographics (weight), site of vaccination, re-vaccination details updated.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US023931 is an initial spontaneous report received from a health care professional on 13 NOV 2013. This case refers to a 16 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A11076 and expiry date: APR 2014) at a dose of 0.5 ml intramuscular on 07 NOV 2013, which was reached 0 C for about 1.5 hours on 06 NOV 2013. No adverse event was reported following this administration error.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL (dose, route of administration, anatomical location, lot# and exp. date were not reported). No adverse effects were reported. The outcome of the event was unknown. This is one of the two reports received from the same source. Additional information has been requested.
Age: 1.92
Sex: M
Vaccine: MNQ
Symptoms: Immunisation, No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2014US000616 is an initial spontaneous report from the physician received on 03 JAN 2014 and a follow up report from the physician received on 12 FEB 2014. This report refers to a 23-months old male patient. His medical history was not reported. On an unknown date, the patient was accidentally vaccinated with only 0.5 nl of Men A lyophilized conjugate of MENVEO (batch number: M11071) mixed with normal saline instead of Men CYW 135 liquid component. It was reported that the patient did not experience any adverse event after the mal-administration. The patient was re-vaccinated with both the components of MENVEO on an unknown date. NO other information was available.   Follow up report from the physician received on 12 FEB 2014. The patient's age and information related to revaccination was updated.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Pain
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 73 year old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was subcutaneously vaccinated with ZOSTAVAX, 1 dose once (exact dose, anatomical location, lot # and expiration date were not reported) for prevention shingles. There was none concomitant medication reported. On an unknown date (reported as a couple of days ago), after receiving ZOSTAVAX, the patient experienced headache, gastrointestinal distress and body ache. There was no treatment given for adverse events. The outcome of the events was unknown. The relatedness between the events and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2014US000714 is an initial spontaneous report received from a consumer (wholesale distributor) on 06 JAN 2014. This report refers to a patient of unknown age and gender. This patient was given only MenCYW liquid component of MENVEO (batch number unknown) without being reconstituted with MenA, intramuscularly on an undetermined date. No adverse event was reported following this administration error (inappropriate preparation of medication).
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2014US001212 is an initial spontaneous report received from a medical assistant on 13 JAN 2014. This report refers to a 12-year-old female patient. Her medical history and concomitant medications was not reported She received only Men A lyophilized conjugale component of MENVEO (batch number: A12094) reconstituted with a sterile diluent instead of MenCYW-135 liquid  component intramuscularly on 09 DEC 2013. No adverse reaction reported following this administration error.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 10-FEB-2015, the patient who was in the office to receive (Oka/Merck) ZOSTAVAX was inadvertently vaccinated with (Oka/Merck) VARIVAX, (lot number unspecified) 0.5 ml, subcutaneous. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014JUS001214 is an initial spontaneous report received from a nurse on 13 JAN 2014 with a follow up information received from a nurse on 13 FEB 2014 and a follow up received on 17 FEB 2014. This report refers to a 17-years-old female patient. Past medical history and concomitant medications was not reported. Her vaccination history included administration of MENVEO (batch number: not reported) on 03 APR 2009 which was  well tolerated. She was vaccinated with MENVEO (batch number: A12099) at a dose of 0.5 ml subcutaneously in the left upper arm on 10 JAN 2014 at 16:21 PM. No adverse reaction reported following this administration error.  Follow up information received from a nurse on 13 FEB 2014. Patient demographics (initials, age, date of birth, gender, height and weight) vaccination history, batch number of MENVEO, vaccination date, dose and site of suspect vaccine administration updated.   Follow up information received from a nurse on 17 FEB 2014. Updated vaccination history.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US019893 is an initial spontaneous report received from a nurse on 20 SEP 2013. This report refers to an unspecified age and gender patient. The patient received only Men A lyophilized conjugate component of MENVEO (batch number: M12097) reconstituted with sterile water intramuscularly on an unspecified date. The patient did not receive the Men C Y W-135 liquid conjugate component of MENVEO vaccine. No adverse reaction was reported following this administration error.
Age: 31.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from 31 year old female patient with no medical history, drug reactions allergies or concurrent conditions. On 06-FEB-2015 the patient was vaccinated with an unspecified varicella virus vaccine live (manufacturer unknown) (dose, frequency, indication, lot number and expiration date were not reported). The consumer reported that she received a dose of an unspecified varicella virus vaccine (manufacturer unknown) and subsequently, she discovered that she was 6 weeks pregnant. She took a pregnancy test and the results were positive. The patient last menstrual period (LMP) was approximately on 29-DEC-2014, the estimated date od conception and estimated date of delivery were 12-JAN-2015 and 12-JAN-2015 respectively. The patient contacted her physician and made an appointment. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Tuberculin test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from 31 year old female patient with no medical history, drug reactions allergies or concurrent conditions. On 06-FEB-2015 the patient was vaccinated with an unspecified varicella virus vaccine live (manufacturer unknown) (dose, frequency, indication, lot number and expiration date were not reported). The consumer reported that she received a dose of an unspecified varicella virus vaccine (manufacturer unknown) and subsequently, she discovered that she was 6 weeks pregnant. She took a pregnancy test and the results were positive. The patient last menstrual period (LMP) was approximately on 29-DEC-2014, the estimated date od conception and estimated date of delivery were 12-JAN-2015 and 12-JAN-2015 respectively. The patient contacted her physician and made an appointment. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Abortion induced, Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy test positive, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from 31 year old female patient with no medical history, drug reactions allergies or concurrent conditions. On 06-FEB-2015 the patient was vaccinated with an unspecified varicella virus vaccine live (manufacturer unknown) (dose, frequency, indication, lot number and expiration date were not reported). The consumer reported that she received a dose of an unspecified varicella virus vaccine (manufacturer unknown) and subsequently, she discovered that she was 6 weeks pregnant. She took a pregnancy test and the results were positive. The patient last menstrual period (LMP) was approximately on 29-DEC-2014, the estimated date od conception and estimated date of delivery were 12-JAN-2015 and 12-JAN-2015 respectively. The patient contacted her physician and made an appointment. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Ultrasound antenatal screen, Varicella virus test negative
Clinical narrative: This spontaneous prospective pregnancy report was received from 31 year old female patient with no medical history, drug reactions allergies or concurrent conditions. On 06-FEB-2015 the patient was vaccinated with an unspecified varicella virus vaccine live (manufacturer unknown) (dose, frequency, indication, lot number and expiration date were not reported). The consumer reported that she received a dose of an unspecified varicella virus vaccine (manufacturer unknown) and subsequently, she discovered that she was 6 weeks pregnant. She took a pregnancy test and the results were positive. The patient last menstrual period (LMP) was approximately on 29-DEC-2014, the estimated date od conception and estimated date of delivery were 12-JAN-2015 and 12-JAN-2015 respectively. The patient contacted her physician and made an appointment. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash to injection site. Flat, red, marked borders. Mom to monitor call if: raised site, give BENADRYL and call office. Go to ED with SOB, swelling.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Impaired driving ability, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Unbearable pain in both arms, 3 hours later after vaccine was administered. Constant pain in right arm. Limitation in right arm due to pain. Unable to perform dressing, bathing and home making act. Unable to drive due to pain occupational therapy prescribed by doctor.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 1/29 (R) Lateral shoulder greater than or equal to softball size, indurated, tender and warm to touch. No GI/resp/cardiac symptoms. IM-Diphenhydramine 50mg and dexamethasone 6mg 1/30 improvement in skin reaction.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Induration, Nausea, Pain, Pyrexia
Clinical narrative: Nausea. Fever, chills, body aches. 24 hr duration.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient in office 2/8/15 with rash, redness and swelling 5.5 x 7.5 cm upper (L) arm larger circumference that previous day. Temp high 101.3 on 2/7/15. Exam = (L) deltoid 6x8 cm erythema with induration up to 1cm of edge of erythema, hot centrally, in injection at sup. center, fain erythema inferior and lateral non and edema. Increased pain with elbow flex, minimal with lifting upper deltoid and shoulder clear. Tx = ice, ibuprofen 2/11/15 arm less Increased.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pain, Pyrexia
Clinical narrative: Patient in office 2/8/15 with rash, redness and swelling 5.5 x 7.5 cm upper (L) arm larger circumference that previous day. Temp high 101.3 on 2/7/15. Exam = (L) deltoid 6x8 cm erythema with induration up to 1cm of edge of erythema, hot centrally, in injection at sup. center, fain erythema inferior and lateral non and edema. Increased pain with elbow flex, minimal with lifting upper deltoid and shoulder clear. Tx = ice, ibuprofen 2/11/15 arm less Increased.
Sex: M
Vaccine: MMR
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a consumer refers to her second brother as a male patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with MMR II (dose, route, lot # were not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced bad reaction after a dose of MMR II. The reporter was unspecified what type of reactions. The reporter states she was a young child when this occurred. The reporter also stated that her mother told her the rest of the MMR II was not administered to her brother. Action taken was not applicable. The outcome of event was unknown. Causality was not assessed by the reporter. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a health professional (registered nurse) refers to a patient of unknown demographics. On 10-FEB-2015 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J005068, expiration date: 18-JAN-2015) .5 ml, intramuscular. No symptoms were reporter. No product quality complaint (PQC) was involved. Outcome of the event was unknown. Reporter considered the event to be not related to PNEUMOVAX 23. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema of eyelid, Eye discharge, Eyelid irritation, Eyelid rash, Eyelids pruritus
Clinical narrative: This spontaneous report as received from a nurse refers to a 65 years old female patient with hypothyroidism, hypertension, deep vein thrombosis (DVT), arthritis and reactions/allergies to CRESTOR, ZITHROMAX and CEFZIL. On 26-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles (dose, lot number and expiration date were not reported). In approximately January 2015, within 24 to 48 hours after vaccination, the patient experienced burning, itching, redness, purulent drainage and both eyes and bumps on the lower eyelid. The patient was given gentamicin eye drops for the treatment of the events. The patient was seen by physician on 04-FEB-2015. The patient had no improvement and was back to see physician on 10-FEB-2015. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. Relatedness between the events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Purulent discharge
Clinical narrative: This spontaneous report as received from a nurse refers to a 65 years old female patient with hypothyroidism, hypertension, deep vein thrombosis (DVT), arthritis and reactions/allergies to CRESTOR, ZITHROMAX and CEFZIL. On 26-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles (dose, lot number and expiration date were not reported). In approximately January 2015, within 24 to 48 hours after vaccination, the patient experienced burning, itching, redness, purulent drainage and both eyes and bumps on the lower eyelid. The patient was given gentamicin eye drops for the treatment of the events. The patient was seen by physician on 04-FEB-2015. The patient had no improvement and was back to see physician on 10-FEB-2015. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. Relatedness between the events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from a health care professional on 09 January 2014. A 4-month-old female patient, whose medical history and concomitant medications were not reported., received first dose of PENTACEL (lot number: C4555AB, intramuscular in the left thigh) on 7 January 2014 the patient had also received PREVNAR (manufacturer not reported, dose number, route and site of vaccination and dose number was not reported) on an unspecified date.  IT was reported that the patient had experienced injection site tenderness, redness and swelling about a size of a silver dollar. Illness at the time of vaccination and pre-existing physician diagnosed allergies and birth defect was unknown. Laboratory details and corrective treatment was not reported. At the time of this report the patient was not recovered from adverse event. Documents held by sender: none
Sex: M
Vaccine: MMR
Symptoms: Adverse reaction, Incomplete course of vaccination
Clinical narrative: This spontaneous report was received from a consumer refers to her first brother as a male patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with M-M-R II (dose, route, lot # were not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced bad reaction after a dose of M-M-R II. The reporter was unspecified what type of reactions. The reporter states she was a young child when this occurred. The reporter also states that her mother told her the rest of the M-M-R II series was not administered to her brother. Action taken was not applicable. The outcome of event was unknown. Causality was not assessed by the reporter. This is one of the several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Adverse event, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a consumer refers to her first brother as a male patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with MMR II (dose, route, lot # were not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced bad reaction after a dose of MMR II. The reporter was unspecified what type of reactions. The reporter states she was a young child when this occurred. The reporter also stated that her mother told her the rest of the MMR II was not administered to her brother. Action taken was not applicable. The outcome of event was unknown. Causality was not assessed by the reporter. This is one of the several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a consumer refers to her third brother as a male patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with MMR II (dose, route, lot # were not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced bad reaction after a dose of MMR II. The reporter was unspecified what type of reactions. The reporter states she was a young child when this occurred. The reporter also states that her mother told her the rest of the MMR II was not administered to her brother. Action taken was not applicable. The outcome of event was unknown. Causality was not assessed by the reporter. This is one of the several reports from the same source. Additional information has been requested.
Age: 1.29
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Pyrexia, Rash, Staring
Clinical narrative: Had fever 24 hours after MMR and on and off for 5 days after that. Also had rash on cheek with some swelling of face and neck. Reported staring episodes and acting "loopy" and out of it on and off.
Sex: U
Vaccine: DTAPHEPBIP, HEP, HEPA
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received HAVRIX. Co-suspect products included PEDIARIX and ENGERIX B. On an unknown date, the patient received HAVRIX at an unknown dose, PEDIARIX at an unknown dose and ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX, PEDIARIX and ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Up to 45 patients may have been vaccinated with vaccine stored outside data limits.
Age: 0.2
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of expired vaccine used in a 3-month-old female patient who received ENGERIX B (batch number AHBVC103AA, expiry date 30th May 2014). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expirenced expirenced vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: HCP stated that 7 doses of expired ENGERIX-B were administered to patients. She said that her office does not pay attention to expiration dates very well. All patients received a dose from the same lot number and expiration date from above on form. This case is one of the 7 case reported by the same reporter for the same vaccine.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Accidental overdose, 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 5-year-old female patient who received HAVRIX adult (batch number 59D74, expiry date 5th February 2016). On 15th May 2014, the patient received HAVRIX adult. On an unknown date, an unknown time after receiving HAVRIX adult, the patient experienced inappropriate age at vaccine administration and accidental overdose. On an unknown date, the outcome of the inappropriate age at vaccine administration and accidental overdose were unknown.
Age: 0.3
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of expired vaccine used in a 3-month-old male patient who received ENGERIX B (batch number AHBVC103AA, expiry date 30th May 2014). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: HCP stated that 7 doses of expired ENGERIX-B were administered to patients. She said that her office does not pay attention to expiration dates very well. All patients received a dose from the same lot number and expiration date. This case is one of the 7 cases reported by the same reporter for the same vaccine.
Age: 1.33
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia, Rash generalised, Rash maculo-papular
Clinical narrative: Pt received vaccines on 02/16/15, developed fever of 101.7 max on 02/08/15 with diarrhea but no URI symptoms which resolved spont. On 2/11/15 developed generalized maculo-papular rash, no fever/URI symptoms.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 13 February 2014. A 4-month-old patient (gender was not reported) had received a dose of PENTACEL and a dose of ActHIB on the same day. No adverse event was reported. Documents held by sender: none.