chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of generalized urticaria in a adult female patient who received Seasonal Influenza vaccine. Previously administered products included Seasonal Influenza vaccine with an associated reaction of erythema (1st dose received on an unknown date, see case US2016GSK098540). On an unknown date, the patient received the 2nd dose of Seasonal Influenza vaccine. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced generalized urticaria. On an unknown date, the outcome of the generalized urticaria was recovered/resolved. It was unknown if the reporter considered the generalized urticaria to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient (receptionist in nurse practitioner office) told to sales representative that, she had reaction to flu vaccine (unknown if this was a GlaxoSmithKline vaccine)  for 2 consecutive years. On an unknown date, in the next year after receiving 1st dose, the patient received the 2nd dose and experienced hives all over her body. The patient said that, it was fine if GlaxoSmithKline wants to contact her directly. It was unknown if the event caused the patient to be hospitalized overnight or prolong an existing hospitalization. It was unknown if the reporting healthcare professional considered the event to be life threatening, to result in persistent or significant disability and incapacity as well as congenital anomaly or birth defect. The patient did not die due to the event. It was unknown if the event required surgical or medical intervention.
Age: 70.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had excessive injection site redness and swelling after injection of ADACEL in left arm.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to two patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot# K020189, expiration date 11-SEP-2016, exact doses and route of administration were not reported). It was reported that the vaccines had 2 temperature excursions. No adverse symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 31-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9 lot # L007560 (dose, route of administration and expiration date were not reported) that had experienced temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concomitant medications were not reported. On 13-JUL-2016, the patient was vaccinated orally with the first 2.0 ml dose of ROTATEQ (lot # L000433, expiry date 09-JUL-2016), which was expired. No adverse events were reported. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 14-SEP-2015, the patient was vaccinated with a dose of GARDASIL 9 lot # L007560 (dose, route of administration and expiration date were not reported) that had experienced temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. 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 medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 18-Jul-2016, the patient was vaccinated with improperly stored dose of VARIVAX lot # L011082, expiration date reported as 01-APR-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 7 degrees Fahrenheit for 5 hours 48 minutes. Data logger was involved. There were no previous excursion reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 15 year old no-pregnant female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On and unknown date, the patient was vaccinate with the dose of PROQUAD (dose, route of administration, lot # and expiration date were not reported). On 230JUN-2016, the patient was vaccinated with the dose of PROQUAD (lot # L031602; dose, route of administration and expiration were not reported) outside the recommended dose. The patient did not seek medical attention and no treatment was given for the adverse event. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 19-OCT-2015, the patient was vaccinated with a dose of GARDASIL 9 lot # L007560 (dose, route of administration and expiration date were not reported) that had experienced temperature excursion. No adverse reaction was reported. This is one several reports received from the same reporter. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Cough, Crying, Ear congestion, Ear infection, Ear pain
Clinical narrative: Hard and red around injections. High fever 103+4 crying for hours on and off. Concern about poor muscle. Holding her arms straight out behind her back when sitting or standing. Muscles twitching/body tremors. Sleep patterns disturbed. Ongoing floppy legs (loss of muscle tone). The next night - I noticed 15 minutes approx. res. onset of chronic respiratory problems/infections (seen by doc a month later for viral URI w/cough). Later, ear pain, infections/water always on ear etc. Screaming episodes lasting 15 to 30 minutes for 2-3 weeks after shots.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Hypotonia, Injection site erythema, Injection site induration, Muscle disorder, Muscle twitching
Clinical narrative: Hard and red around injections. High fever 103+4 crying for hours on and off. Concern about poor muscle. Holding her arms straight out behind her back when sitting or standing. Muscles twitching/body tremors. Sleep patterns disturbed. Ongoing floppy legs (loss of muscle tone). The next night - I noticed 15 minutes approx. res. onset of chronic respiratory problems/infections (seen by doc a month later for viral URI w/cough). Later, ear pain, infections/water always on ear etc. Screaming episodes lasting 15 to 30 minutes for 2-3 weeks after shots.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Respiratory disorder, Respiratory tract infection, Screaming, Sleep disorder
Clinical narrative: Hard and red around injections. High fever 103+4 crying for hours on and off. Concern about poor muscle. Holding her arms straight out behind her back when sitting or standing. Muscles twitching/body tremors. Sleep patterns disturbed. Ongoing floppy legs (loss of muscle tone). The next night - I noticed 15 minutes approx. res. onset of chronic respiratory problems/infections (seen by doc a month later for viral URI w/cough). Later, ear pain, infections/water always on ear etc. Screaming episodes lasting 15 to 30 minutes for 2-3 weeks after shots.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Tremor, Viral upper respiratory tract infection
Clinical narrative: Hard and red around injections. High fever 103+4 crying for hours on and off. Concern about poor muscle. Holding her arms straight out behind her back when sitting or standing. Muscles twitching/body tremors. Sleep patterns disturbed. Ongoing floppy legs (loss of muscle tone). The next night - I noticed 15 minutes approx. res. onset of chronic respiratory problems/infections (seen by doc a month later for viral URI w/cough). Later, ear pain, infections/water always on ear etc. Screaming episodes lasting 15 to 30 minutes for 2-3 weeks after shots.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified medical Assistant refers to a multiple unspecified patients of unknown ages and genders. The patient's medical history and concurrent conditions were not reported. On an unknown date between 01-JUL-2016 and 14-JUL-2016 the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number, expiration date, dose, route and frequency were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Urticaria
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of erythema in a adult female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received the 1st dose of Seasonal Influenza vaccine. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced erythema. On an unknown date, the outcome of the erythema was recovered/resolved. It was unknown if the reporter considered the erythema to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient (receptionist in nurse practitioner office) was told to sales representative that she had reaction to flu vaccine (unknown if this was a GlaxoSmithKline vaccine) for 2 consecutive years. On an unknown date, several years ago, the patient received 1st dose of flu vaccine and experienced redness down her arm. Then, in next year after receiving 2nd dose, she experienced hives all over her body (refer case US2016GSK087187). The patient said that is was fine if GlaxoSmithKline wants to contact her directly. It was unknown if the event caused the patient to be hospitalized overnight or prolong an existing hospitalization. It was unknown if the reporting healthcare professional considered the event to be life threatening, to result in persistent or significant disability and incapacity as well as congenital anomaly or birth defect. The patient did not die due to the event. It was unknown if the event required surgical or medical intervention.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2016, the patient was vaccinated with a dose of improperly stored PROQUAD, lot # L023114, expiry date 24-DEC-2016, (dose and frequency not reported). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information provided. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a female patient who received BEXSERO. On 6th July 2016, the patient received the 1st dose of BEXSERO. In July 2016, less than a week after receiving BEXSERO, the patient experienced injection site swelling and injection site tenderness. In July 2016, the outcome of the injection site swelling was recovered/resolved. On an unknown date, the outcome of the injection site tenderness was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling and injection site tenderness to be related to BEXSERO. Additional information was provided as follows: Age at vaccination was not reported. The nurse reported that the patient's swelling had gone down, but she was still having tenderness at the injection site. No further information was provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning 4 unspecified patients of unknown age and gender. The pertinent medical history and concurrent conditions were not reported. On an unknown date, 2 patients were vaccinated with ROTATEQ, orally, lot # L033545, expiration date: 31-MAY-2017 (strength and dose were not reported); and 2 patients were vaccinated with ROTATEQ, orally, lot # L038534, expiration date: 19-AUG-2017 (strength and dose were not reported); which were improperly stored. The lowest temperature excursion reported was 33.3 F for 2 hours and the highest temperature was 46.6 F for 30 minutes. The temperature excursion was detected by a digital data logger. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Activities of daily living impaired, Dizziness, Headache, Nausea
Clinical narrative: Headache, nausea, lightheaded, no syncope, no emesis. Self-limited but several hours after vaccine.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Altered state of consciousness
Clinical narrative: This spontaneous report was received from a nurse and refers to a 18 year old male patient without pertinent medical history, drug reactions or allergies. On 12-JUL-2016, the patient was vaccinated with GARDASIL 9 (strength, dose, route and lot number were not reported). Other suspect therapies included TRUMENBA intramuscularly (dose and lot number were not reported). There was no concomitant therapies. On 12-JUL-2016, after vaccination the patient "started to pass out, did not lose consciousness, rested and revived". On that same day, the patient recovered. The patient did not received treatment for the event and did not sought medical attention. No lab diagnostics studies were performed. The even did not required intervention to prevent serious criteria, did not produce significant disability or incapacity, did not required hospitalization and it was not life threatening for the patient. No product quality complain was reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Mobility decreased
Clinical narrative: Limited mobility in Right shoulder difficulty getting dressed, bathing, brushing teeth, doing hair shoulder pops. Prednisone, antibiotics, cortisone shots, pain and physical therapy.
Age: 1.63
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Cellulitis
Clinical narrative: Cellulitis on (L) arm.
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC13, RV5
Symptoms: Hypotonia
Clinical narrative: This spontaneous report as received from a physician assistant refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unspecified date in July-2015, the patient was vaccinated with COMVAX, intramuscularly (lot # C4761AA (reported as not valid), expiry date: 03-JUL-2017). On the same day, the patient was also vaccinated with ROTATEQ orally, PREVNAR 13, IPOL and two doses of DAPTACEL. On the same day, approximately fours hours following the administration of the multiple vaccinations, the patient became limp and was taken to emergency room on the same day (July-2015). The primary reporter stated that an examination of the patient was performed by unknown physician and it was determined that the patient's vital signs were within normal limits and the patient was developmentally normal. The primary reporter confirmed that the patient was discharged from the unknown emergency room on the same day in July 2015, and was not hospitalized. The outcome of the event was unknown. The causality of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, vaccination site, route unspecified). The reporter stated that, the patient had experienced rash after ZOSTAVAX vaccination. The outcome of rash was unknown. The reporter was interested in Varicella Zoster Virus (VZV) analysis by polymerase chain reaction (PCR) and wanted to send viral isolates. Product quality complaint (PQC) was not involved. Causality assessment was not provided. No further information was provided. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Blood glucose, Dizziness, Eye movement disorder, Musculoskeletal stiffness, Syncope
Clinical narrative: Fainting/possible seizure episode after receiving MCV4 #2. Patient was lightheaded with muscle stiffening and eyes rolled back after receiving MCV4 #2. With vaccines, no hx of seizures. Patient has not eaten today. Patient/client feels lightheaded. Stiffness in chair and slides down in chair. Assisted to floor and cool compress to head and neck by LVN. Call to 911. Pt has no hx of seizures, no hx of diabetes. Has not eaten today. Patient awake and breathing, laying on floor. 10:05am Fire Dept and EMS responded. BP: 110/80, HR-60, Resp-14. SPO2-95%. Blood glucose 106. RN 7/11/16 10:11am Patient feels lightheaded after blood glucose checked. Patient accepts EMS services to take ambulance to hospital. RN Additional note: Patient was given apple juice just before EMS arrived. RN
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a consumer (father), refers to a young female patient (daughter) of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. Reporter stated that his daughter received her second dose of VAQTA, intramuscularly, a full two weeks earlier (in 2014; exact date unknown) that the recommended six month timeframe by pediatrician. Reporter recently received a statement of 'non-compliance improper spacing' letter form the Health Department which stated that his daughter needs 'another' vaccine. Reporter was asking for guidance on this request asking if it was indeed necessary. The outcome of the event was unknown. No product quality complaint (PQC) was involved. No other adverse event information was given. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age. On 11-JUL-2016, the patient was inadvertently vaccinated with an expired dose of GARDASIL lot # K008335, 23-JUN-2016 intramuscular. No adverse effect was reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Drug ineffective, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter female with dysmenorrhea and no drug reactions or allergies who on 08-JUN-2007 (also reported as 18-JUN-2007), later in 2007 and on 08-JAN-2008 was vaccinated with the first, second and third dose of HPV vaccine (doses, routes and lot # were no reported), respectively. It was reported that about one week ago, in approximately 06-JAN-2012, the patient was tested positive for having human papillomavirus (HPV) strain 16 and 18 (determined by DNA test). It was noted that the consumer want to know why the vaccine did not work. It was reported that PAP smear was done by the physician and stated the result. The consumer mentioned that to saw the level and intensity of the strain, the physician did a colposcopy to investigate further and discover the severity (results not provided). Patient sought medical attention by visiting the physician's office. At the time of the report, the patient was recovering (also reported as AE did not improved). Follow up information has been received from the physician concerning a female patient who on 18-JUN-2007, was intramuscularly vaccinated with the first dose of dose of HPV vaccine (lot # 654535/0960F, dose not reported) in to left deltoid, on 17-AUG-2007, the patient was intramuscularly vaccinated with the second dose of HPV vaccine (lot # 658282/0929U, dose not reported) in to left deltoid and on 08-JAN-2008, the patient was vaccinated with the third dose of HPV vaccine (dose, route and lot number were not reported). Concomitant therapy included hepatitis a vaccine, VAQTA administered intramuscularly on 18-JUN-2007 (lot # 657305/0247U, dose was not reported), in to right deltoid and MENACTRA. The physician reported that no adverse event occurred with vaccine administration. Additional information has been requested. This is a corrected report. Hepatitis a vaccine, VAQTA was changed from a suspect to a concomitant product.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning 2 unspecified patients of unknown age and gender. The pertinent medical history and concurrent conditions were not reporter. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 injection, lot # L018503, expiration date: 15-MAR-2017 (dose, route and anatomical location of administration were not reported), which were improperly stored. The lowest temperature excursion reported was 33.3 F for 2 hours and the highest temperature was 46.6 F for 30 minutes. The temperature excursion was detected by a digital data logger. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient. The patient's pertinent medical history was unknown and drug allergies included penicillin. On 15-JUL-2016, the patient was vaccinated with ZOSTAVAX (lot # L044529 and expiry date: 09-FEB-2017). Concomitant medications included cholesterol and high blood pressure medicines (reporter did not provide names of medicines). Approximately in July 2016 (reported as after receiving vaccine), the patient experienced injection site reaction i.e., swelling (about size of fingertip) and redness around the injection site. The patient did not sought medical attention and no treatment was provided for the events. Patient visited the pharmacy on 19-JUL-2016 and the pharmacist reported that the swelling was gone little but injection site was still red. No causality was reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Sex: F
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Pruritus
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pruritus in a adult female patient who received MENVEO. Concurrent medical conditions included latex allergy (experienced allergic reaction in the form of rash). On an unknown date, the patient received MENVEO at an unknown dose. On an unknown date, immediately after receiving MENVEO, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was recovered/resolved. It was unknown if the reporter considered the pruritus to be related to MENVEO. Additional details were provided as follows: In the morning of the reporting date, the nurse passed out the purple MENVEO binder tags and received a Skype message from one of her pediatric staffs. The patient inquired the nurse whether the holder things of the MENVEO vaccine contain latex. It was reported that the patient started itching right away when she opened the MENVEO vaccine pack and touched them with her fingers. The itching lasted for 10 to 15 minutes only. The patient did not have further complaints and it was confirmed with the manufacturer for these vaccine that it does not contain latex.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-AUG-2014, the patient was vaccinated with the first dose of ZOSTAVAX (0.65 ml, subcutaneously; lot # and expiration date were not reported). In July 2016, the patient was vaccinated with the second dose of ZOSTAVAX (0.65 ml, subcutaneously; lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2016, the patient was vaccinated with a dose of improperly stored PROQUAD, lot # L023114, expiry date 24-DEC-2016, (dose and frequency not reported). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Expired product administered, Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse referring to a 12 month old patient. On 15-JUL-2016 the patient was inadvertently vaccinated with a dose of PROQUAD (Lot # L032761, exp date 24-FEB-2017) and a dose of expired VARIVAX (lot # K009758, expiration date 09-JUL-2016, route not reported) (accidental overdose). The nurse explained that the patient was actually in the office to receive a dose of VARIVAX and a dose of M-M-R II, however, the PROQUAD was inadvertently administered instead of the M-M-R II because the labels on both vials were very similar and the unknown health care worker only saw that the vial read Measles Mumps Rubella and did not see the label also stated Varicella on the vial of the PROQUAD until after the administration. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with improperly stored VAQTA (lot #, expiration date, dose and route were not reported). No adverse symptoms were reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a licensed practical nurse referring to an 18 year old male patient. The patient had no pertinent medical history or drug allergies. On 14-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9 (dose, route, lot # and expiration date were unknown) (product use in unapproved population). Other suspect therapies included VAQTA (dose and route were not reported) during the same office visit. Concomitant therapies included MENACTRA. The patient passed out for a half of a second after being vaccinated. No treatment was given to the event. No lab was performed. The outcome of the event was reported as recovered on 14-JUL-2016. The causality was not provided. Additional information had been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of an unknown age and gender. On 14-JUL-2016 the patient was vaccinated with the first dose of GARDASIL (route, lot # and expiration date were not reported). On 14-JUL-2016, the patient received the second dose of GARDASIL (route, lot # and expiration date were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were unspecified. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (dose: 0.5 ml, lot # L048468, expiry date: 15-SEP-2017) via intramuscular route. Medical assistant reported that the vaccine was stored at 14.4 degree Fahrenheit for 3 hours 18 minutes. No adverse effects were reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test positive, Rubulavirus test positive
Clinical narrative: This spontaneous report as received from a 46 year old female Medical Assistant reporting on herself. The patient had no pertinent medical history, drug reactions or concurrent conditions. On an unknown date, "during childhood", the patient was vaccinated with M-M-R II (albumin status HSA) subcutaneously. Dose, anatomical location, lot number and expiration date were not provided. No other suspect medications were reported and the patient did not have any concomitant medication. On an unknown date, in January 2014 the patient was performed a blood titer and showed that she was negative for mumps antibodies. Then, on an unknown date in March 2014, the patient was vaccinated with a second dose of M-M-R II subcutaneously. Dose, anatomical location, lot number and expiration date were not provided. And, on an unknown date, in April 2014, the patient was performed another blood titer and showed that she was positive for mumps antibodies. The outcome of the event was reported as recovered. The causality between the therapy with M-M-R II and the event was unknown. Additional information is not expected because there is no consent to contact the physician.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 13 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 14-SEP-2015, the patient was vaccinated with a dose of GARDASIL 9 lot # L007560 (dose, route of administration and expiration date were not reported) that had experienced temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. 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 medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 22-JUL-2016, the patient was vaccinated with improperly stored VARIVAX lot # L011082, expiration date reported as 01-APR-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose vaccine experienced the temperature excursion of 7 degrees Fahrenheit for 5 hours 48 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 (dosing details were not reported). On an unknown date, the patient was vaccinated with second dose of GARDASIL 9, intramuscularly six months after receiving her first dose. No adverse reactions were reported. No product quality complaint (PQC) was reported for GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning 32 unspecified patients of unknown age and gender. The pertinent medical history and concurrent conditions were not reported. On an unknown date, 1 patient was vaccinated with VAQTA injection, lot # L027735, expiration date: 12-JAN-2017 (dose, route and anatomical location of administration were not reported); 5 patients were vaccinated with VAQTA injection, lot # L045713, expiration date: 14-JAN-2017 (dose, route and anatomical location of administration were not reported); 22 patients were vaccinated with VAQTA injection, lot # M011116, expiration date: 17-JUN-2017 (dose, route and anatomical location of administration were not reported); and 4 patients were vaccinated with VAQTA injection, lot # M011839, expiration date: 13-SEP-2017 (dose, route and anatomical location of administration were not reported); which were improperly stored. The lowest temperature excursion reported was 33.3 F for 2 hours and the highest temperature was 46.6 F for 30 minutes. The temperature excursion was detected by a digital data logger. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This solicited report was received from a friend of the patient's mother (also reported as patient's mother), as part of a marketing research program and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the third dose of GARDASIL injection (route and site of administration, dose, lot number and expiration date were not reported). On an unknown date, after getting the third dose of GARDASIL, the patient passed out. The outcome of the event was unknown. The relatedness between the event and the vaccination with GARDASIL was not reported. Additional information is not expected as no consent for further contact was given.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning 11 unspecified patients of unknown age and gender. The pertinent medical history and concurrent conditions were not reported. On an unknown date, 4 patients were vaccinated with GARDASIL 9 injection, lot # L044475, expiration date: 12-MAY-2017 (dose, route and anatomical location of administration were not reported); and 7 patients were vaccinated with GARDASIL 9 injection, lot # M003659, expiration date: 20-SEP-2017 (dose, route and anatomical location of administration were not reported); which were improperly stored. The lowest temperature excursion reported was 33.3 F for 2 hours and the highest temperature was 46.6 F for 30 minutes. The temperature excursion was detected by a digital data logger. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning 15 unspecified patients of unknown age and gender. The pertinent medical history and concurrent conditions were not reported. On an unknown date, 2 patients were vaccinated with RECOMBIVAX HB injection, lot # M000442, expiration date: 31-MAR-2018 (dose, route and anatomical location of administration were not reported); and 13 patients were vaccinated with RECOMIBVAX HB injection, lot # L048236, expiration date: 31-MAR-2018 (dose, route and anatomical location of administration were not reported); which were improperly stored. The lowest temperature excursion reported was 33.3 F for 2 hours and the highest temperature was 46.6 F for 30 minutes. The temperature excursion was detected by a digital data logger. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
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. On 02-JUN-2016 the patient was vaccinated with improperly stored GARDASIL (lot # M014929, expiration date 27-MAY-2017, dose was not reported) intramuscularly. The lowest storage temperature of the vaccine was 29.3 Fahrenheit and the cumulative excursion time was 136 hours. Data logger had been involved. No adverse effects were reported. This is one of several reports received from same source. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Adult formulas given HepA.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Adult formula given (Hep A).
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a Registered nurse concerning to a pregnant female patient (age not reported). Medical history and concurrent conditions were not reported. On 07-JUL-2016, the patient was vaccinated with a dose of GARDASIL 9 (dose, site, route and lot number not reported). Concomitant medication was not reported. The last menstrual period and estimated delivery date was not reported. The pregnancy outcome was pending. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Axillary pain, Injection site pain, Injection site swelling, Lymph node pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a 17-year-old female patient who received BEXSERO. On 15th June 2016, the patient received BEXSERO. On 15th June 2016, less than a day after receiving BEXSERO, the patient experienced injection site swelling and injection site pain. On 16th June 2016, the patient experienced fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site swelling and fever were unknown and the outcome of injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site swelling, injection site pain and fever to be related to BEXSERO. Additional details were provided as follows: It was unknown if other vaccines given on the same date or within 4 weeks prior to suspect vaccine. This case was previously reported to a doctor. The reporter stated that, she was informed that the patient experienced swelling and achy at the site of injection after vaccination with BEXSERO (unknown arm). A full dose of BEXSERO was administered. Also, the ache extended to the arm pit and then towards the lymph node under the patient's arm pit. The night after the vaccination, the patient had a fever of 102 degree F which was treated with TYLENOL. The arm was still sore however it had improved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to an 84 year old female patient who was reporting on herself. No concurrent conditions, historical conditions or concomitant medications were reported. The patient had no previous drug reactions or allergies. On an unspecified date in 2009, the patient was vaccinated with ZOSTAVAX (dose, lot # and expiration date were not provided, route of administration was reported as injection ). On an unspecified day in approximately May 2016 (reported as "two months ago"), the patient experienced a case of shingles. An unspecified treatment was given for this adverse event. No laboratory diagnostic studies were performed. The patient did not seek medical attention. The outcome of the event was reported as not recovered/not resolved. The causality was not provided. Additional information is not expected as the reporting consumer did not wish to be contacted.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Back pain, Blood magnesium normal, Full blood count normal, Metabolic function test normal
Clinical narrative: Low back pain, left shoulder pain, left hip pain.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Red blood cell sedimentation rate normal
Clinical narrative: Low back pain, left shoulder pain, left hip pain.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Fainting 1 min. after injection.
Age: 1.03
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Patients mother called on-call nurse to report a rash (hives) after immunizations. Rash began on pt's (R) side, spread to chest, spread to back, spread to bilateral arms. Rash is now gone, no treatment.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling at injection, white at point of needed injection. Pain on touch.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Headache, Induration, Injection site pain
Clinical narrative: Pt had the injection on 7/20 at approx 2:15 pm. She woke up at 5:00 am with severe pain in her (L) Deltoid. Shoulder was painful and hot to touch. By 1 pm it was swollen w/purple discoloration and warm to touch. She got a headache and took fluids thinking she was dehydrated. 2:00 PM: Full body aches, By Friday: minor chills felt better but arm was still swollen, red, hard and painful. She took 400mg Ibuprofen Q 4 hours during that time. She is now taking 200mg Q 4hrs. She denied SOB, chest pain, dizziness.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pain, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: Pt had the injection on 7/20 at approx 2:15 pm. She woke up at 5:00 am with severe pain in her (L) Deltoid. Shoulder was painful and hot to touch. By 1 pm it was swollen w/purple discoloration and warm to touch. She got a headache and took fluids thinking she was dehydrated. 2:00 PM: Full body aches, By Friday: minor chills felt better but arm was still swollen, red, hard and painful. She took 400mg Ibuprofen Q 4 hours during that time. She is now taking 200mg Q 4hrs. She denied SOB, chest pain, dizziness.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Pt had the injection on 7/20 at approx 2:15 pm. She woke up at 5:00 am with severe pain in her (L) Deltoid. Shoulder was painful and hot to touch. By 1 pm it was swollen w/purple discoloration and warm to touch. She got a headache and took fluids thinking she was dehydrated. 2:00 PM: Full body aches, By Friday: minor chills felt better but arm was still swollen, red, hard and painful. She took 400mg Ibuprofen Q 4 hours during that time. She is now taking 200mg Q 4hrs. She denied SOB, chest pain, dizziness.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site induration, Injection site reaction, Injection site warmth, Pallor
Clinical narrative: 9 cm indurated warm local blanching area surrounding vaccine.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Nausea
Clinical narrative: Patient became lightheaded, dizziness, nausea within 3 minutes of injection. Side effects diminished within 15 minutes and patient was discharged.
Age: 1.04
Sex: F
Vaccine: MMR, PNC13
Symptoms: Erythema, Injection site warmth, Pyrexia
Clinical narrative: Some redness the night of 7/21/16. Low grade fevers, site warm to touch. On clindamycin oral.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Pallor
Clinical narrative: Given BEXSERO and MENACTRA. While giving urine sample 5 min later, developed pallor and dizziness. Improved with lying flat with feet elevated. Had not eat anything prior to visit.
Age: 24.0
Sex: U
Vaccine: TDAP
Symptoms: Adverse reaction
Clinical narrative: Patient is claiming adverse reaction to shot.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Pruritus
Clinical narrative: Pt describes itchy red lump, approximately size of a half-dollar. OTC treatment recommended but pt states will wait for it to subside (and not use any tx for adverse event).
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Blood glucose decreased, Electrocardiogram normal, Syncope
Clinical narrative: Syncope, 20 minutes after receiving vaccines.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Injection site erythema, Musculoskeletal stiffness, Nausea
Clinical narrative: Headache, dizziness, nausea, fever Temp 100.0 palpitations, redness at site of injection, swollen ringing in ears, neck stiffness.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Palpitations, Pyrexia, Swelling, Tinnitus
Clinical narrative: Headache, dizziness, nausea, fever Temp 100.0 palpitations, redness at site of injection, swollen ringing in ears, neck stiffness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Induration, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Around 7-21-16 pt. noticed hard red bumps on face (forehead area, nose, cheeks, around lips, inside ears) that itched & burned. On presentation today, looks as if scabs are healing. Has taken BENADRYL daily since 7-21-16.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: Around 7-21-16 pt. noticed hard red bumps on face (forehead area, nose, cheeks, around lips, inside ears) that itched & burned. On presentation today, looks as if scabs are healing. Has taken BENADRYL daily since 7-21-16.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient experienced high fever (101 degrees) starting at 4AM 7-23-16 and a severe headache. Injection site is swollen and red.
Age: 64.0
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: The patient was administered Hep B peds/adol dose instead of Hep B adult.