chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Initial unsolicited report received from a pharmacist on 25-Aug-2017. This case involves 71 year old female patient who was vaccinated with a first dose (also reported as previous dose 0) of ADACEL batch number- U5654AA, expiry date - 27-APR-2019 in right deltoid and PNEUMOVAX left deltoid (Dose, route were not reported for both the vaccines) on 21-Aug-2017. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) not provided. Illness at the time of vaccination was none. Any other vaccinations within four weeks of vaccinations were also not reported. On 25-Aug-2017, four day following the vaccination, the patient had redness and swelling on her left arm that was larger than 2 inches with itching. It was reported that during the discussion it was noticed that the PNEUMOVAX was given on the Left arm and the ADACEL on the Right the pt confirmed it is her left arm that she is having the reaction will call Merck to report the VAERS but, advised patient that will also complete the report since it was mostly complete. Also advised her prior to this discovery that the pt should be advised to see her primary provider for evaluation. Patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were none. Patient was not recovered from the event. List of documents held by sender: none.
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Injection site erythema
Clinical narrative: Initial unsolicited report received from a pharmacist on 25-Aug-2017. This case involves 71 year old female patient who was vaccinated with a first dose (also reported as previous dose 0) of ADACEL batch number- U5654AA, expiry date - 27-APR-2019 in right deltoid and PNEUMOVAX left deltoid (Dose, route were not reported for both the vaccines) on 21-Aug-2017. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) not provided. Illness at the time of vaccination was none. Any other vaccinations within four weeks of vaccinations were also not reported. On 25-Aug-2017, four day following the vaccination, the patient had redness and swelling on her left arm that was larger than 2 inches with itching. It was reported that during the discussion it was noticed that the PNEUMOVAX was given on the Left arm and the ADACEL on the Right the pt confirmed it is her left arm that she is having the reaction will call Merck to report the VAERS but, advised patient that will also complete the report since it was mostly complete. Also advised her prior to this discovery that the pt should be advised to see her primary provider for evaluation. Patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were none. Patient was not recovered from the event. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pyrexia
Clinical narrative: My daughter developed a fever of 103 F and had severe muscle aches, chills, red eyes the evening after receiving the flu vaccine.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MMR, MNQ, TDAP
Symptoms: Contusion, Injection site bruising, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Patient received vaccines on 8/29/17, and patient called to report muscle aching pain during movement and swollen at the injection site on 8/31/17. Patient was advised to apply cold compression at the injection area and return to see primary care provider if symptom worsen or not improved. Patient then was being seen at PCP office on 9/6/17 because patient complaining of her arm has been hurting since last week when she received her vaccines. Patient states her arm was swollen, bruised, and a bump. Per patient, her left arm is still painful and her right arm is not painful anymore. General inspection on 9/6/17: Right deltoid - 1cm bruise, Left deltoid mild tender to palpation, no cellulitis on both arm. Patient was recommended to try MOTRIN if desired and was reassured symptom should continue to improve.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MMR, MNQ, TDAP
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received vaccines on 8/29/17, and patient called to report muscle aching pain during movement and swollen at the injection site on 8/31/17. Patient was advised to apply cold compression at the injection area and return to see primary care provider if symptom worsen or not improved. Patient then was being seen at PCP office on 9/6/17 because patient complaining of her arm has been hurting since last week when she received her vaccines. Patient states her arm was swollen, bruised, and a bump. Per patient, her left arm is still painful and her right arm is not painful anymore. General inspection on 9/6/17: Right deltoid - 1cm bruise, Left deltoid mild tender to palpation, no cellulitis on both arm. Patient was recommended to try MOTRIN if desired and was reassured symptom should continue to improve.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Nasopharyngitis, Urticaria
Clinical narrative: My son was given a flu shot 9/1/2017. He has cold symptoms and he is breaking out in hives all over his face, arms, and chest.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX lot # M039453 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # M028546 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age. On 2017 the patients were vaccinated with VARIVAX lot # M010482 (expiration date: 01-MAR-2018), M027347 (expiration date: 01-JUN-2018), M048200 (expiration date: 04-DEC-2018), N007930 (expiration date: 08-MAR-2019) for prophylaxis. Concomitant therapies included sterile diluent. On 08-AUG-2017 was reported incorrect product storage. No adverse event reported. The outcome of incorrect product storage was unknown. The reporter considered incorrect product storage to be not related to VARIVAX. Sender's Comments: US-009507513-1709USA001426.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 01-SEP-2017, the patient was inadvertently vaccinated with one dose of expired ZOSTAVAX lot # M041510, expiration date 27-JUL-2017, for prophylaxis. Concomitant therapies included sterile diluent lot # K023008, expiration date 25-SEP-2017. No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age. On 2017 the patients were vaccinated with ZOSTAVAX lot # M042850 (expiration date: 18-JAN-2018), N016185 (expiration date: 31-JUL-2018) for prophylaxis. Concomitant therapies included sterile diluent. On 08-AUG-2017 was reported incorrect product storage. No adverse event reported. The outcome of incorrect product storage was unknown. The reporter considered incorrect product storage to be not related to ZOSTAVAX. Sender's Comments: US-009507513-1709USA000913.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Lot number M045400 is an invalid lot number for VARIVAX. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 month old patient. On 31-AUG-2017 the patient was vaccinated with PROQUAD lot # N008826 for prophylaxis. Other suspect therapies included VARIVAX. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). On 31-AUG-2017, 1 day after onset of therapy the patient experienced overdose. On an unknown date the patient experienced no adverse event. The outcome of overdose and no adverse event is unknown. The reporter considered overdose to be not related to PROQUAD and VARIVAX. The reporter considered no adverse event to be not related to VARIVAX and PROQUAD. {Additional information has been requested. / Additional information is not expected.}
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Overnight right arm began to be sl warm and this AM was swollen, tender and indurated. No particular abnml over actual injection site, but 5x8cm swath along right deltoid is red. Sl tactile temp and sl tired but not toxic appearing, playing with brother and went to school today.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Overnight right arm began to be sl warm and this AM was swollen, tender and indurated. No particular abnml over actual injection site, but 5x8cm swath along right deltoid is red. Sl tactile temp and sl tired but not toxic appearing, playing with brother and went to school today.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Decerebrate posture, Eye movement disorder, Fall, Feeling abnormal
Clinical narrative: Patient had only the PEDIARIX shot today. Approximately 5 minutes after she had the injection, while she was playing and waiting for her other siblings to get their shot. She was standing and talking with her Mother on the opposite side of my desk when she just fell backwards onto the floor. She began to stiffen, her eyes rolled up into her head and were only partially visable. She began exhibit Decerebrate posturing. Her Mother started calling out her name with no response from the patient. Her Mom then began to gently shake her shoulders, and when I came around the desk and started assessing her, she came to. She started to cry, hug her Mom and said "I don't feel good". The whole episode lasted 15 to 20 seconds. Patient was very pale, but no labored breathing and heart rate was normal. I called her physician, and Dr. requested to see her right away.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Musculoskeletal stiffness, Pallor, Unresponsive to stimuli
Clinical narrative: Patient had only the PEDIARIX shot today. Approximately 5 minutes after she had the injection, while she was playing and waiting for her other siblings to get their shot. She was standing and talking with her Mother on the opposite side of my desk when she just fell backwards onto the floor. She began to stiffen, her eyes rolled up into her head and were only partially visable. She began exhibit Decerebrate posturing. Her Mother started calling out her name with no response from the patient. Her Mom then began to gently shake her shoulders, and when I came around the desk and started assessing her, she came to. She started to cry, hug her Mom and said "I don't feel good". The whole episode lasted 15 to 20 seconds. Patient was very pale, but no labored breathing and heart rate was normal. I called her physician, and Dr. requested to see her right away.
Age: 40.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Aphasia, Computerised tomogram normal, Discomfort, Laboratory test normal, Malaise
Clinical narrative: Reported not feeling well and had aches in shoulders and neck. Discomfort increased 7/28/17 drove self to ER that afternoon because of severe swelling in the neck and throat, unable to talk be 5:00pm. ER gave injection, thinks maybe steroid which helped her breathing and talking. Remained in ER until 12:00 am for observation and then released home.
Age: 40.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Musculoskeletal pain, Neck pain, Pharyngeal oedema, Swelling, X-ray normal
Clinical narrative: Reported not feeling well and had aches in shoulders and neck. Discomfort increased 7/28/17 drove self to ER that afternoon because of severe swelling in the neck and throat, unable to talk be 5:00pm. ER gave injection, thinks maybe steroid which helped her breathing and talking. Remained in ER until 12:00 am for observation and then released home.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Red macular lesion on right upper thigh.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Dizziness, Nausea, Vomiting
Clinical narrative: Patient complained about feeling dizzy a little while after receiving the vaccine. Around 11:30am she vomited. After leaving work she continued to vomit and began having diarrhea. The events began to happen more frequently and resulted in the patient being taken to the ER via ambulance. She received fluids and nausea medication and responded to the treatment.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient experienced soreness the following morning (Wednesday the 6th) after the vaccine was given in the left deltoid. That same night, he noticed the swelling, redness and slight warmth to touch in the vaccine site. It was elliptical in shape and was 50 by 100 mm in length. He reported to the Health department in person on the morning of Thursday the 7th.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number patients of unknown age and gender. On an unknown date, the patients were vaccinated with an unspecified number of doses of PROQUAD lot # n008825 with expiration date 12-SEP-2018 (therapy type: rHA) and lot # n002336 with expiration date 19-JUL-2018 (therapy type: rHA), reconstituted with sterile diluent. There were no adverse effects reported. Administered doses of vaccine experienced the temperature excursion from 6 to 14 degrees Fahrenheit for 4 hours. There were previous excursions reported, from 6 to 14 degrees Fahrenheit for 6 hours. Data logger was involved. Sterile diluent used for reconstitution did not undergo a temperature excursion. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA011062:
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a male patient of unknown age who was reporting on himself. In August 2017 (reported as "last week"), the patient was vaccinated with ZOSTAVAX for prophylaxis. In August 2017, the patient experienced expired product administered. No adverse symptoms reported. The outcome of expired product administered was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a multiple unknown patients of unknown age and gender. The multiple patients' pertinent medical history, Drug Reactions/Allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M037014 and expiry date: 22-NOV-2017) for prophylaxis along with properly stored doses of sterile diluent (lot and expiration date unknown by the reporter). The vaccine was exposed to temperature excursion of 6 Degrees Fahrenheit (°F) to 14° F for 5 hours. There were no previous temperature excursion reported. The call was not due to data logger. No adverse effects were reported. No product quality complaint was filed. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1708USA013329: US-009507513-1709USA001928.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a multiple unknown patients of unknown age and gender. The multiple patients' pertinent medical history, Drug Reactions/Allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M041080 with expiry date:06-OCT-2018, lot#M039317 with expiry date:20-SEP-2018, lot# M028552 with expiry date:07-JUN-2018 and lot#M024702 with expiry date:18-MAY-2018) for prophylaxis along with properly stored doses of sterile diluent (lot and expiration date unknown by the reporter). The vaccine was exposed to temperature excursion of 6 Degrees Fahrenheit (°F) to 14 °F for 5 hours. There were no previous temperature excursion reported. The call was not due to data logger. No adverse effects were reported. No product quality complaint was filed. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1709USA001926: US-009507513-1708USA013329.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On NOV-2015 the patient was vaccinated with GARDASIL dose 1, 1 DF for prophylaxis. Other suspect therapies included GARDASIL 9. On 05-SEP-2017 the patient experienced inappropriate schedule of drug administration and interchange of vaccine products. The outcome of inappropriate schedule of drug administration and interchange of vaccine products is unknown. The reporter considered inappropriate schedule of drug administration and interchange of vaccine products to be not related to GARDASIL 9 and GARDASIL. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ lot# M045544 with expiry date: 23-JUN-2018 (dosing details, anatomical location were unknown) (route defaulted to oral) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 31F or colder (31.2F) for 2 hours and 32F to 35F for 356.5 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1709USA002053: US-009507513-1709USA000595.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to 2 patients of unknown age. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # reported as N012890. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 31 degrees Fahrenheit or colder for 12 hours but number of cold cycles were unknown.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 24 year old patient.    On an unknown date the patient was vaccinated with GARDASIL 9 dose 3, 1 DF for prophylaxis. On an unknown date the patient experienced inappropriate schedule of drug administration and no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to GARDASIL 9.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 06-SEP-2017 the patient was vaccinated with GARDASIL 9 lot # N003703 for prophylaxis.    Concomitant therapies included sterile diluent (STERILE DILUENT). On 06-SEP-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown.; Sender's Comments: US-009507513-1709USA003214:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age and gender. On 02-JUN-2017, 05-JUN-2017 and 06-JUN-2017, the patient were vaccinated with an improperly stored dose of GARDASIL 9 lot # M041212, 1 DF for prophylaxis.  No averse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dysphagia, Ear pain, Facial paralysis, Herpes zoster
Clinical narrative: Information was received on 05-SEP-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 18-FEB-2011 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain condition of herpes zoster and post herpetic neuralgia. On or about 31-MAY-2016, the patient was treated by a physician's assistant and a physician, for a blistering vesicular outbreak and stabbing pain in her ears which was then diagnosed as severe herpes zoster, or shingles. On or about 08-JUN-2016, the patient has worsening and uncontrolled symptoms, and called her medical team for treatment of severe pain. On or about 15-JUN-2016, the patient was treated by a physician for new and worsening symptoms of shingles, accompanied by facial drooping and difficulty talking and swallowing. The patient was then diagnosed with Bell's Palsy, secondary to zoster infections. On or about 29-JUN-2016, the patient was treated by another physician for worsening neurological symptoms of herpes zoster and Bell's Palsy. On or about 08-AUG-2016, the patient received subsequent treatment from a physician for continued complications of facial paralysis. On or about 28-OCT-2016, the patient was treated by a physician, who then diagnosed her with post-herpetic neuralgia, a chronic condition of nerve pain and permanent damage secondary to shingles outbreaks. The patient continues to seek treatment from a neurology team for treatment of her worsening Bell's Palsy condition. For management of her outbreaks and complications, the patient has been prescribed VALTREX, gabapentin (manufacturer unknown), prednisone (manufacturer unknown), pramoxine (manufacturer unknown), tretinoin (manufacturer unknown), ciclopirox (manufacturer unknown), PRAMOSONE, ZONALONE, doxepin (manufacturer unknown), HYTONE 2.5% and TEMOVATE, at increased dosages, in attempts to curb her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, Bell's Palsy was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Neurological symptom, Pain, Post herpetic neuralgia, Rash vesicular, Speech disorder
Clinical narrative: Information was received on 05-SEP-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 18-FEB-2011 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain condition of herpes zoster and post herpetic neuralgia. On or about 31-MAY-2016, the patient was treated by a physician's assistant and a physician, for a blistering vesicular outbreak and stabbing pain in her ears which was then diagnosed as severe herpes zoster, or shingles. On or about 08-JUN-2016, the patient has worsening and uncontrolled symptoms, and called her medical team for treatment of severe pain. On or about 15-JUN-2016, the patient was treated by a physician for new and worsening symptoms of shingles, accompanied by facial drooping and difficulty talking and swallowing. The patient was then diagnosed with Bell's Palsy, secondary to zoster infections. On or about 29-JUN-2016, the patient was treated by another physician for worsening neurological symptoms of herpes zoster and Bell's Palsy. On or about 08-AUG-2016, the patient received subsequent treatment from a physician for continued complications of facial paralysis. On or about 28-OCT-2016, the patient was treated by a physician, who then diagnosed her with post-herpetic neuralgia, a chronic condition of nerve pain and permanent damage secondary to shingles outbreaks. The patient continues to seek treatment from a neurology team for treatment of her worsening Bell's Palsy condition. For management of her outbreaks and complications, the patient has been prescribed VALTREX, gabapentin (manufacturer unknown), prednisone (manufacturer unknown), pramoxine (manufacturer unknown), tretinoin (manufacturer unknown), ciclopirox (manufacturer unknown), PRAMOSONE, ZONALONE, doxepin (manufacturer unknown), HYTONE 2.5% and TEMOVATE, at increased dosages, in attempts to curb her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, Bell's Palsy was considered medically significant. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 06-SEP-2017 the patient was vaccinated with M-M-R II lot # M045392 for prophylaxis. Other suspect therapies included VARIVAX. Concomitant therapies included sterile diluent. On 06-SEP-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. Sender's Comments: US-009507513-1709USA003131.
Sex: M
Vaccine: TDAP
Symptoms: Cough, Culture positive, Pertussis, Vaccination failure
Clinical narrative: SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from consumer on 30-Aug-2017. This case involves 16-year-old male patient who was vaccinated with first dose of ADACEL (Batch number: U4384AA, expiration date: 30 Nov 2014, dose and site of administration was not reported) via intramuscular route on 19 Oct 2012. The patient had a medical history of paralyzed vocal cord and prematurity. Illness at time of vaccination were reported as none. Patient had NKA (no known allergies). Concomitant medications was not reported. On 09 Aug 2017, 4 years 9 months 21 days (1755 days) following the vaccination, the patient experienced cough and was formally diagnosed with Whooping Cough on 23 Aug 2017 based on cultures. Patient was formally diagnosed and was continuing to cough and the parent had consulted with the Pediatrician over the phone and they advised that the cough will continue but to return if he has any concerning symptoms. It was reported that, the patient required emergency room visit. This was also a case of vaccination failure. Lab data were not reported. Patient received Z-PAK as corrective treatment. The patient had not recovered from events. Upon internal review, the company decided to consider the event serious because of important medical event whooping cough, cough and vaccination failure. List of documents held by sender: none. Sender's Comments: In this case Whooping Cough was reported approx. 4 years 10 month after vaccination with ADACEL vaccine. Whooping Cough was diagnosed based on culture however report was not provided. Considering that patient was fully vaccinated as a child he should be protected against pertussis, this case is therefore a suspected vaccination failure. More information regarding patient's medical history, immune status, vaccination schedule and PCR report (positive for pertussis) and investigation reports are needed for complete assessment of the case.
Sex: F
Vaccine: FLU4, HEP
Symptoms: Immune thrombocytopenic purpura, Incorrect product storage
Clinical narrative: SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from a pharmacist (patient herself) on 29-Aug-2017. This case is linked to case Id 2017SA165455 (Same patient). This case involves a 59-year-old female patient, who was vaccinated with second dose of FLUZONE QUADRIVALENT (batch number, expiry date, dose, route not reported) on fall 2016. Patient's medical history and concomitant medication was not reported. Patient's previous medication includes vaccination with first dose of FLUZONE (batch number, expiry date, dose, route not reported) on an unknown date which had been stored incorrectly. On an unknown date of 2016, after the vaccination, patient experienced idiopathic thrombocytopenic purpura (ITP). Lab test was not reported. Patient was treated with corrective treatment (unspecified). On Oct-2016, patient got recovered from the event. Upon internal review the case was considered as serious because of all important medical event: idiopathic thrombocytopenic purpura (ITP). Documents held by sender: none. Sender's Comments: Patient vaccinated with FLUZONE QUADRIVALENT and HEPATITIS B VACCINE. Patient was diagnosed with Immune thrombocytopenia which is unlisted following FLUZONE QUADRIVALENT. Time to onset is compatible with vaccine. Immune thrombocytopenia can cause by autoimmune disease, antibody against platelet, any viral infection which could be triggering factor and sometime it is idiopathic. Patient medical history, medication history and any congenital disorder like antiphospholipid syndrome, von Willebrand factor or any recent viral infection is unknown and, as two vaccines were administered concomitantly, the role of each component cannot be assessed separately.
Sex: M
Vaccine: DTAP
Symptoms: Pertussis
Clinical narrative: Seriousness criteria: Important Medical Event. Initial unsolicited report received from a consumer on 30-Aug-2017. This case involves a male patient of unknown age who was vaccinated with a booster dose of DTAP (batch number, expiry date, route and site of administration was not reported), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed whooping cough. The patient's laboratory data and corrective treatment were not reported. The event outcome was not reported. Upon internal review the case was considered as serious because of important medical event: whooping cough. List of documents held by sender: none. Sender's Comments: The patient experienced whooping cough post vaccination with DTAP (MFR UNK). Time to onset was not reported. No information regarding patient's medical condition at the time of vaccination or medical history was reported. No PCR test results were provided to confirm the diagnosis. Additional information regarding the same and vaccine manufacturer and latency would be required to assess the case. Based upon reported information the role of the vaccine cannot be assessed.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Pt came to pharmacy the day after the vaccine was administered. Pt presents with fever, joint pain, itch at injection site, hot to touch. Applied hydrocortisone cream to affected area.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Papule, Pruritus, Swelling
Clinical narrative: Few scattered papules. Treatment - Diphenhydramine HCL for itching/swelling.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Cold sweat, Diarrhoea, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Fever, nausea, vomiting diarrhaea, swelling at injection site, extreme piain at injection site. Inability to move arm due to pain, cold sweats.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fever, nausea, vomiting diarrhaea, swelling at injection site, extreme piain at injection site. Inability to move arm due to pain, cold sweats.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Crying, Injection site pruritus, Injection site rash, Scratch
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a child female patient who received KINRIX. The patient's past medical history included anaphylaxis and allergy. Concurrent medical conditions included milk allergy, egg allergy and peanut allergy. In June 2017, the patient received the 2nd dose of KINRIX .5 ml. In June 2017, 1 day after receiving KINRIX, the patient experienced rash, itchy legs, crying and scratch. On an unknown date, the outcome of the rash, itchy legs, crying and scratch were recovered/resolved. The reporter considered the rash to be possibly related to KINRIX. It was unknown if the reporter considered the itchy legs, crying and scratch to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient no longer had a milk allergy, however, 24 hours after receiving the KINRIX vaccine, the patient's mother said that the patient's legs itched so bad and the patient was crying and scratching her thighs. The patient's mother noticed that on both thighs the patient had a rash that was itchy so she washed her legs and she gave her some BENADRYL and the rash resolved. The reporter described the rash like tiny hives. When the patient received the KINRIX vaccine, they were not aware that it was not her final DTaP and Polio vaccine so she might need another vaccine.
Age: 11.0
Sex: F
Vaccine: HPV2
Symptoms: Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of rash in a 11-year-old female patient who received CERVARIX. In November 2016, the patient received the 1st dose of CERVARIX. In December 2016, 30 days after receiving CERVARIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to CERVARIX. Additional details were provided as follows: The patient got a CERVARIX vaccine. Approximately 1 month later, the patient developed rash. The patient was still having this symptom as it was able to see in her last medical appointment. The patient was being treated.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test normal, Borrelia test negative, Brain scan normal, Dizziness, Fatigue
Clinical narrative: Extreme nauseau, Extreme headaches, extreme fatigue, dizziness, extreme lethargy.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Lethargy, Mononucleosis heterophile test negative, Nausea, Neurological examination normal
Clinical narrative: Extreme nauseau, Extreme headaches, extreme fatigue, dizziness, extreme lethargy.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Scan with contrast normal, Streptococcus test negative
Clinical narrative: Extreme nauseau, Extreme headaches, extreme fatigue, dizziness, extreme lethargy.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Patient complaint of fever, headache, leg pain, nausea, fatigue since 9/5/17 evening.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Patient was seen in the ER 4 days after flu vaccine given. C/O numbness in feet. 6 days after flu vaccine numbness progressed to waist. 8 days after patient back in ER.
Sex: F
Vaccine: HPV9
Symptoms: Injection site abscess, Injection site pain, Vaccination site movement impairment
Clinical narrative: This spontaneous report as received from a nurse prescriber and refers to a female patient of unknown age. The patient's concurrent conditions included hypersensitivity. On 07-AUG-2017 the patient was vaccinated with GARDASIL 9 lot # N007931 in the right arm for prophylaxis. Concomitant therapies included fluticasone propionate(FLONASE) and cough, cold, and flu therapies (unspecified)(COUGH, COLD, AND FLU THERAPIES (UNSPECIFIED)). On 21-AUG-2017, 15 days after onset of therapy the patient experienced injection site abscess, vaccination site movement impairment and injection site pain. The outcome of injection site abscess, vaccination site movement impairment and injection site pain was reported as not recovered/not resolved.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 19 year old female patient. On 02-APR-2015 the patient was vaccinated with GARDASIL lot # L001442 dose 1 for prophylaxis. Other suspect therapies included GARDASIL 9. On an unknown date the patient experienced interchange of vaccine products, no adverse event and inappropriate schedule of drug administration. The outcome of interchange of vaccine products, no adverse event and inappropriate schedule of drug administration is unknown. The reporter considered interchange of vaccine products to be not related to GARDASIL 9 and GARDASIL. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to GARDASIL and GARDASIL 9.
Sex: M
Vaccine: VARZOS
Symptoms: Abasia, Anxiety, Emotional distress, Injury, Myelitis transverse
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On 21-NOV-2015, the patient received ZOSTAVAX (lot number dosage and route of administration unknown) from his primary care physician, during an annual physical for the prevention of shingles. It was reported that less than five months after receiving the vaccine, the patient woke up and discovered he was unable to walk. The patient was hospitalized and subsequently diagnosed with acute transverse myelitis. As a direct and proximate result of the defective ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of, his condition. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review, acute transverse myelitis was considered medically significant. The lawyer considered acute transverse myelitis to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Physical disability, Quality of life decreased
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On 21-NOV-2015, the patient received ZOSTAVAX (lot number dosage and route of administration unknown) from his primary care physician, during an annual physical for the prevention of shingles. It was reported that less than five months after receiving the vaccine, the patient woke up and discovered he was unable to walk. The patient was hospitalized and subsequently diagnosed with acute transverse myelitis. As a direct and proximate result of the defective ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of, his condition. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review, acute transverse myelitis was considered medically significant. The lawyer considered acute transverse myelitis to be disabling. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a 22 year old patient.  On 23-JAN-2017, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis. On 22-AUG-2017, 7 months after onset of therapy, the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration is unknown. Therapy with GARDASIL 9 was restarted and no adverse event did not recur. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to GARDASIL 9.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional referring to an unspecified number of patients of unknown age. On 06-SEP-2017, the patients were vaccinated with ROTATEQ orally for prophylaxis. On 06-SEP-2017, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA003179: US-009507513-1709USA003178.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional referring to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with ROTATEQ for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA003158: US-009507513-1709USA003178.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a other health professional referring to an unspecified number of patients of unknown age. On 06-SEP-2017, the patients were vaccinated with VAQTA for prophylaxis. On 06-SEP-2017, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. This is one of two reports received from the same reporter. Lot number N002922 is an invalid lot number for [generic name of hepatitis a vaccine, inactivated]. Sender's Comments: US-009507513-1709USA003158: US-009507513-1709USA003178.
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Decreased immune responsiveness, Emotional distress, Herpes zoster, Injury
Clinical narrative: Information was received 06-SEP-2017 from a lawyer regarding a case in litigation concerning a female plaintiff of unspecified age. It was claimed the plaintiff was inoculated with ZOSTAVAX on or about 07-SEP-2007, administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused her to contract a persistent strain of herpes zoster. On or about 20-JUN-2012, the plaintiff was treated by a different physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. It was claimed that as a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. It was claimed that as a direct result of the vaccine, the plaintiff suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition. The plaintiff suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events of caused her to contract a persistent strain of herpes zoster / severe vesicular eruption accompanied by weakened immune symptoms diagnosed as severe herpes zoster, or shingles were considered disabling. Additional information was requested.