chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV9, IPV, MNQ, TDAP
Symptoms: Analgesic drug level therapeutic, Blood alcohol normal, Delirium, Drug screen negative, Full blood count normal
Clinical narrative: Acute onset fever to 104, delirium, possible seizure with lip smacking, shaking and unresponsive.
Age: 13.0
Sex: F
Vaccine: HPV9, IPV, MNQ, TDAP
Symptoms: Human chorionic gonadotropin negative, Metabolic function test normal, Pyrexia, Tardive dyskinesia, Tremor
Clinical narrative: Acute onset fever to 104, delirium, possible seizure with lip smacking, shaking and unresponsive.
Age: 13.0
Sex: F
Vaccine: HPV9, IPV, MNQ, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Acute onset fever to 104, delirium, possible seizure with lip smacking, shaking and unresponsive.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient reported a red, sore, 2 inch rash at the injection site. It occurred two days after injection.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had a red circle around the injection site that seemed slightly raised and that was 3 to 4 inches in diameter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Patient received her immunization with ZOSTAVAX on 8/29/17. She reported having swelling, itchiness, and painful sensation at the site of vaccination a day later (8/30/17). Patient presented at the pharmacy on 8/31/17 with the presentation of a large erythematous rash at the site of immunization. The area appeared red, raised, and warm when palpitated. The diameter of her swollen rash was approximately 6 inches. Patient denied having symptoms of difficulty breathing, faintishness, or swelling of her throat. Patient's primary care provider was contacted about the incident through his case manager. The patient was provided with hydrocortisone cream 1 (CORTIZONE-10) and cetirizine 10 mg to resolve her symptoms. Patient was informed that she could visit her primary care provider's office but she declined from doing so since she is going on her trip on the same day. If her symptoms worsen, she was informed to contact Dr.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient received her immunization with ZOSTAVAX on 8/29/17. She reported having swelling, itchiness, and painful sensation at the site of vaccination a day later (8/30/17). Patient presented at the pharmacy on 8/31/17 with the presentation of a large erythematous rash at the site of immunization. The area appeared red, raised, and warm when palpitated. The diameter of her swollen rash was approximately 6 inches. Patient denied having symptoms of difficulty breathing, faintishness, or swelling of her throat. Patient's primary care provider was contacted about the incident through his case manager. The patient was provided with hydrocortisone cream 1 (CORTIZONE-10) and cetirizine 10 mg to resolve her symptoms. Patient was informed that she could visit her primary care provider's office but she declined from doing so since she is going on her trip on the same day. If her symptoms worsen, she was informed to contact Dr.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain upper
Clinical narrative: 1-2 days after injection, have experienced constant and irresolvable stomach pain. Seems to lessen with antacids, but does not resolve.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: Anaphylactic reaction pt had trouble breathing and went to primary care physician and was sent to Hospital from there.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, soreness at injection site and radiating down arm about 5 inches. Advised pt. to ice area every hour for 10-15 minutes and take TYLENOL as needed.
Age: 66.0
Sex: F
Vaccine: FLUC4, HEPA, TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient called next morning after vaccination, complaining of itchy hives on elbow, buttock, breast, leg and foot. Injection sites were clear and no other complaints. Follow up later that day had no change. Follow up with patient 8/21, pt reported 90% improvement in sites. Will call 8/22. Called pt 8/23, everything improved without problem.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling, numbness in arm/hand, no pain.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Haemorrhage, Injection site nodule, Injection site urticaria
Clinical narrative: Gave flu shot and patient was bleeding and there was a welt and knot at injection site. Followed-up patient and patient was fine - knot subsided and is okay.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: 8 yo male received 2017-2018 Flu vaccine in Left deltoid. 24 hours later his mother reports he developed a hive rash all over his entire L. arm. He was treated w/an ice pack and antihistamine. Symptoms have resolved.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Head lag, Hypotonia
Clinical narrative: Head lag and change in muscle tone (decreased tone) within 4 days of 2 month vaccines.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Within 1/2 hr swelling, warm to touch, just tender and hot to touch felt and looked swollen.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site rash, Injection site swelling, Rash
Clinical narrative: Rash all over arm, cheeks and leg. Swelling left deltoid.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypoaesthesia, Injection site mass, Injection site nerve damage, Injection site pain, Injection site paraesthesia
Clinical narrative: The patient experiences tingling and numbness along with sharp pains in upper left arm. She also experienced swelling at the site of the injection. She now has nerve damage in the area of the injection. The site of the shot is still sore and has lumps beneath the skin.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Limb injury
Clinical narrative: The patient experiences tingling and numbness along with sharp pains in upper left arm. She also experienced swelling at the site of the injection. She now has nerve damage in the area of the injection. The site of the shot is still sore and has lumps beneath the skin.
Age: 23.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Chills, Influenza like illness, Pain, Swelling
Clinical narrative: Pt returned next day, with swelling, extreme pain, he had chills, and flu-like symptoms night before -and chills down the spine. Feels better now.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: C/O itchiness at inj site. Redness and swelling at site.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Blood culture, Chest X-ray, Full blood count, Headache
Clinical narrative: Body aches, headache, vomiting. Patient was anxious at time of assessment.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Human chorionic gonadotropin negative, Metabolic function test, Pain, Urine analysis, Vomiting
Clinical narrative: Body aches, headache, vomiting. Patient was anxious at time of assessment.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site erythema, Injection site inflammation, Injection site warmth, Pain
Clinical narrative: Heat, redness, little bit inflamed around injxn. side. Boyfriend called and said it was red/purple and hurt to move. Told them to come in and let me see but if it gets worse to go see the doctor. Told them I had to report it, but wanted to see before reporting.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site/right deltoid.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Skin warm, Tenderness, Urticaria
Clinical narrative: Red welp at injection site (size of tennis ball). Painful to touch. Hot.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9, TD
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Pregnant client was seen in clinic for immunization updates. Client was assessed and health history was reviewed. Client was pregnant and therefore the second dose of Varicella was not given. Client was given HPV9, which is cautioned and not advised during pregnancy. This vaccine should have been withheld until after the duration of the pregnancy. No adverse symptoms or events at time of immunization. An alert added to clients record to advise to review event at clients next appointment.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Injection site reaction - Redness, tenderness, and soreness in Left upper deltoid.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Rash
Clinical narrative: Patient had rash on chest area and also large red, hard area near injection site of pneumonia vaccine. Has had FLUZONE in past with no issues.
Age: 82.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Cyanosis, Injection site bruising, Injection site reaction, Peripheral swelling
Clinical narrative: Pt received vaccine on 8/23, and the next day arm was swollen and whole upper left arm was bruised and blue.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received KINRIX on 08/29/17 to right thigh. Developed swelling and erythema 9 cm x 7 cm. Non tender but warm to touch.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt had reaction to PROQUAD on left thigh of 1.5 x 1.5 cm with red induration. Pt waited for 15 mins no reaction. VIS given.
Age: 81.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Swollen arm down to elbow. Red somewhat itchy not painful.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Rash and soreness developed on right shoulder. Vac. administered 1 inch apart.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling that started at site and spread down and to the inside of the arm.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Livedo reticularis
Clinical narrative: 2D after vaccine pt. developed approximately 6 in. diameter mottled erythematous rash at injection site. No fevers, no pain, no discharge, no signs of anaphylaxis. Supportive care w/return criteria established.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Erythema, Rash erythematous, Urticaria
Clinical narrative: Patients body had red welts on face, ears, chest, and neck. Red bumps on patients lets.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Skin reaction around injection site, red and painful for patient.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Pt. seen 8/28/17 in office for check up. Rec'd 5 yr immunizations. (*Declines Hep B #'s 2 and 3 and Hep A #2). Pt. seen again 8/29/17 for S/S=(Rt) arm with redness/edema/warmth to area app. 4-5" diameter pt denies pain; moving arm well. (Lt.) upper arm with 2-3 cm redness; no edema. Tx with PRN IB. and BENADRYL and ice.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 07-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012728 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 06-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012719 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Post vaccination autoinoculation
Clinical narrative: This unsolicited case was received on 21-AUG-2017 via a third party query tool search on the VAERS database, under reference number 692662. This case involves a 23-year-old female patient who was vaccinated with a dose ACAM2000 (batch number: VV0319, expiry date, dose, dose in series and route were not reported) in the left arm on 26-APR-2017. Patient did not have any medical history and current illnesses, and previous vaccinations were not reported. Concomitant medications were not reported. On 28-APR-2017, two days after vaccination, patient developed cross auto inoculation to left deltoid area. Lab tests and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Lymphadenitis
Clinical narrative: This unsolicited case was received on 21-Aug-2017 via a third party query tool search on the VAERS database, under reference number 693688. This case involves a 25 years old male patient who was vaccinated with dose of ACAM2000 (batch number: VV03-019-C, expiry date and route of administration were not reported) in left arm and dose of ANTHRAX VACCINE (ANTHRAX) (batch number: FAV487A and expiry date was not reported) intramuscularly in right Arm on 25 Feb 2017. The patient's medical history and concomitant medication were not reported. On 06 March 2017 (time reported as AM), 9 days following vaccination patient presented to ER with pain, redness, and swelling around smallpox injection site. On an unspecified date following vaccination patient had cellulitis and lymphadenitis and informed that symptoms are consistent with cellulitis lymphadenitis. Laboratory investigation was not reported. Patient was prescribed CEFALEXIN (cephalexin) antibiotics and SULFAMETHOXAZOLE/TRIMETHOPRIM (Septra DS) to treat infection, along with hydrocodone to manage pain. Patient was advised to follow up. On an unspecified date patient recovered from all of the events. Upon internal review the case was considered as serious because of important medical event: Cellulitis. List of documents held by sender: none.; Sender's Comments: The patient has experienced Injection site erythema, pain and swelling which are consistent with the diagnosis of cellulitis and lymphadenitis. Time to onset is compatible with the role of vaccine. Lymphadenitis is listed with the vaccine. Further information regarding immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Moreover, as two vaccines were administered concomitantly, the role of each component cannot be assessed separately.
Age: 1.08
Sex: M
Vaccine: MMR, HEPA, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a 13 month old male patient. On 05-JUL-2017 the patient was vaccinated with VARIVAX lot # L028277 in the right arm for prophylaxis. Other suspect therapies included VAQTA and M-M-R II. On 07-JUL-2017, 1 day 13 hrs 30 min after onset of therapy the patient experienced vomiting, constipation and pyrexia. The outcome of vomiting, constipation and pyrexia was reported as recovered/resolved. Sender's Comments: US-009507513-1707USA005250: Original Case: 1707USA005250.
Age: 1.08
Sex: M
Vaccine: MMR, HEPA, MMR, VARCEL
Symptoms: Constipation, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a other health professional refers to a 13 month old male patient. On 05-JUL-2017 the patient was vaccinated with VARIVAX lot # L028277 in the right arm for prophylaxis. Other suspect therapies included VAQTA and M-M-R II. On 07-JUL-2017, 1 day 13 hrs 30 min after onset of therapy the patient experienced vomiting, constipation and pyrexia. The outcome of vomiting, constipation and pyrexia was reported as recovered/resolved. Sender's Comments: US-009507513-1707USA005250: Original Case: 1707USA005250.
Age: 21.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: See additional page(s) for complete text.
Age: 21.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Unevaluable event
Clinical narrative: See additional page(s) for complete text.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a other health professional refers to a 4 year old male patient. On 29-AUG-2017, the patient was vaccinated with M-M-R II for prophylaxis. Other suspect therapies included VARIVAX, QUADRACEL and sterile diluent (manufacturer unknown). On 29-AUG-2017, the patient experienced urticaria. The outcome of urticaria was reported as recovered/resolved.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 17-OCT-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M019708 with expiry date: 25-OCT-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all the follow-up correspondence have been received. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report. Sender's Comments: US-009507513-1610USA014706.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 05-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012659 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 weeks old infant. The patient's concurrent conditions, medical history and drug allergies were not reported. On 16-NOV-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 02-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012687 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 14-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 15-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012708 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 8 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 16-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012709 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 16-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012710 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 16-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012711 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 16-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012712 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 19-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012713 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 19-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012714 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 06-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012720 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 06-DEC-2016, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ), oral, (dose not reported) from lot # M007311 (expiry date: unspecified)for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012721 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 06-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012722 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a 4-year-old patient of unknown gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 13-APR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M041083, expiration date 04-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint was involved. The reporter also stated that she had a printed report of the patients who received vaccines that had undergone the temperature excursion. The report included vaccine name, date given lot number and the name, gender and birth date of patient. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has already been received. This is an amended report, as corrected. This report was previously submitted with the incorrect Worldwide unique case identification number US-009507513-1705USA005093', and this new follow-up submission is to provide the correct identification number US-009507513-1706USA003935'. US-009507513-1705USA005093' is an existing case, therefore this safety report is not being nullified, just updated to reflect correct Worldwide Unique identification number. Sender's Comments: US-009507513-1705USA005086: US-009507513-1705USA005094: US-009507513-1705USA005093: US-009507513-1706USA003934: US-009507513-1705USA005093: US-009507513-1706USA003936: US-009507513-1706USA003937.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 60 year old female patient. On 29-JUN-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis lot# N009777 exp 04-MAR-2018. The vaccine had been stored improperly at temperature of 6° Fahrenheit to 14° Fahrenheit for 10 minutes and then 15° Fahrenheit to 46 F° Fahrenheit for 30 minutes. No previous temperature excursion. Call was due to data logger. There were no adverse events. Follow up information has been received from the pharmacist on 28-AUG-2017. The reporter stated that on an unknown date, the patient was vaccinated with ZOSTAVAX and was reconstituted with a sterile diluent (manufacturer unknown). The reporter stated that minor issue of freezer and no adverse events. The reporter has no further information to report.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product use issue
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced product use issue and no adverse event. The outcome of product use issue and no adverse event is unknown. The reporter considered product use issue and no adverse event to be not related to PNEUMOVAX 23. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PPV, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Muscle twitching, Vaccination site mass
Clinical narrative: This spontaneous report as received from a consumer refers to a 13 year old male patient with prophylaxis. On 29-DEC-2005 the patient was vaccinated with M-M-R II for prophylaxis. Other suspect therapies included DTaP, poliovirus vaccine inactivated (unspecified), PEDVAXHIB, VARIVAX and PNEUMOVAX 23. On 29-DEC-2005 the patient experienced vaccination site mass and drug administered to patient of inappropriate age. On an unknown date the patient experienced muscle twitching. The outcome of muscle twitching, drug administered to patient of inappropriate age and vaccination site mass is unknown. The reporter considered vaccination site mass to be related to PEDVAXHIB, VARIVAX, M-M-R II and PNEUMOVAX 23. The reporter considered muscle twitching to be related to M-M-R II, VARIVAX, PEDVAXHIB and PNEUMOVAX 23. The reporter considered drug administered to patient of inappropriate age to be related to M-M-R II, VARIVAX, PNEUMOVAX 23 and PEDVAXHIB. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: This spontaneous report as received from a registered nurse, concerning a 15 year old female patient with type 1 diabetes mellitus. On 01-JUN-2017 the patient was vaccinated with the first dose of GARDASIL 9 lot # M016193 for prophylaxis and on 02-AUG-2017, the patient received the second dose of GARDASIL 9 lot # N003703. Concomitant therapies included insulin and levothyroxine sodium(manufacturer unknown).  Approximately in June 2017 (reported as couple days later), the patient experienced nausea, abdominal pain and diarrhoea. On 03-AUG-2017 (reported as following day), the patient experienced nausea, abdominal pain and diarrhoea. The outcome of nausea, abdominal pain and diarrhoea was reported as recovered/resolved. The outcome of nausea, abdominal pain and diarrhoea was reported as not recovered/not resolved.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with ROTATEQ (lot numbers M038728 and M041184) oral for prophylaxis. On an unknown date, the vaccine was incorrectly storage. Sender's Comments: US-009507513-1708USA012512: US-009507513-1708USA012513.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown gender and age. The patients' concurrent condition, medical history and concomitant therapy were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored VARIVAX (dose, route, lot# and expiration date unknown) which was reconstituted with properly stored sterile diluent for prophylaxis. The vaccine was improperly stored at 15 to 46 degrees Fahrenheit for 1 hour and 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours 30 minutes. The vaccine also had a previous temperature excursion at 15 to 46 degrees Fahrenheit for 1 hour. No adverse effects were reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA010011: US-009507513-1708USA010012.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to several patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On unknown dates the unspecified number of patients were administered an unspecified number of doses of improperly stored VARIVAX (lot # M012990, expiry date-14-MAR-2018 and lot# M035687, expiry date 10-AUG-2018) as prophylaxis. It was reported that the vaccines underwent a temperature excursion of 4 degrees Fahrenheit to 14 degrees Fahrenheit for 50 minutes. The previous temperature excursion was for 6 degrees Fahrenheit to 14 degrees Fahrenheit for 7 hours and 40 minutes. It was reported that the sterile diluent {unknown lot, unknown expiration) used for reconstitution did not undergo a temperature excursion. A data logger was involved in recording of the temperature excursions. No adverse events were reported. No product quality complaint was filed. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA010501.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old female patient. On 22-AUG-2017, the patient was vaccinated with GARDASIL 9 intramuscularly (dose number, exact dose were not reported; lot # N004798 with the expiration date 31-OCT-2019), for prevention of Human papillomavirus (HPV). Upon sticking the patient with a needle, the patient jerked back and only a partial amount, "barely any", of the GARDASIL 9 was administered.