chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, once, lot # L03343, expiration date: 13-SEP-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursions of 30 degrees Fahrenheit for 73 hours and 49 degrees Fahrenheit for 25 hours, respectively, that were captured using digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Myelitis, Nuclear magnetic resonance imaging
Clinical narrative: Myelitis Cervical Spine.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Rash generalised
Clinical narrative: Rash all over body.
Age: 0.04
Sex: M
Vaccine: HEP
Symptoms: Apnoea, Blood culture negative, Bradycardia, CSF culture negative, Continuous positive airway pressure
Clinical narrative: Per charting "0525 - Called to room by mother for frank red blood that was coming from the mouth and nose of the baby. Dad had used the bulb syringe to extract some and discharged it into the toilet. There was a large amount of bright red blood noted in the toilet bowl, and blood continuing to come from the baby. The baby and family were immediately taken to the NICU for evaluation." Following reports per MD note " Was rooming in with parents. They noted that he was more fussy than normal. He was then found with blood in his mouth and nose. He was taken into the unit and was found to have apnea. nCPAP was started and I took him off several hours later to exam him. He did well and I had nursing take him off and place in mom's arms. He became apneic and bradycardic in mom's arms. CPAP was restarted and he continued to have apneic events. He was intubated by the NNP." Antibiotics and acyclovir were initiated (8/18-8/20 d/c with cultures neg). Multiple days of NPO and TPN required do to destaturations for copious secretions. Patient was extubated on 8/20, TPN d/c and diet restarted on 8/23, ready for transition home from 8/23-8/24. Of note no other changes in this patients medical treatment from a medication standpoint or otherwise were made near the event.
Age: 0.04
Sex: M
Vaccine: HEP
Symptoms: Culture urine negative, Drug screen negative, Endotracheal intubation, Enterovirus test negative, Epistaxis
Clinical narrative: Per charting "0525 - Called to room by mother for frank red blood that was coming from the mouth and nose of the baby. Dad had used the bulb syringe to extract some and discharged it into the toilet. There was a large amount of bright red blood noted in the toilet bowl, and blood continuing to come from the baby. The baby and family were immediately taken to the NICU for evaluation." Following reports per MD note " Was rooming in with parents. They noted that he was more fussy than normal. He was then found with blood in his mouth and nose. He was taken into the unit and was found to have apnea. nCPAP was started and I took him off several hours later to exam him. He did well and I had nursing take him off and place in mom's arms. He became apneic and bradycardic in mom's arms. CPAP was restarted and he continued to have apneic events. He was intubated by the NNP." Antibiotics and acyclovir were initiated (8/18-8/20 d/c with cultures neg). Multiple days of NPO and TPN required do to destaturations for copious secretions. Patient was extubated on 8/20, TPN d/c and diet restarted on 8/23, ready for transition home from 8/23-8/24. Of note no other changes in this patients medical treatment from a medication standpoint or otherwise were made near the event.
Age: 0.04
Sex: M
Vaccine: HEP
Symptoms: Intensive care, Irritability, Laboratory test normal, Mouth haemorrhage, Parenteral nutrition
Clinical narrative: Per charting "0525 - Called to room by mother for frank red blood that was coming from the mouth and nose of the baby. Dad had used the bulb syringe to extract some and discharged it into the toilet. There was a large amount of bright red blood noted in the toilet bowl, and blood continuing to come from the baby. The baby and family were immediately taken to the NICU for evaluation." Following reports per MD note " Was rooming in with parents. They noted that he was more fussy than normal. He was then found with blood in his mouth and nose. He was taken into the unit and was found to have apnea. nCPAP was started and I took him off several hours later to exam him. He did well and I had nursing take him off and place in mom's arms. He became apneic and bradycardic in mom's arms. CPAP was restarted and he continued to have apneic events. He was intubated by the NNP." Antibiotics and acyclovir were initiated (8/18-8/20 d/c with cultures neg). Multiple days of NPO and TPN required do to destaturations for copious secretions. Patient was extubated on 8/20, TPN d/c and diet restarted on 8/23, ready for transition home from 8/23-8/24. Of note no other changes in this patients medical treatment from a medication standpoint or otherwise were made near the event.
Age: 0.04
Sex: M
Vaccine: HEP
Symptoms: Respiratory viral panel
Clinical narrative: Per charting "0525 - Called to room by mother for frank red blood that was coming from the mouth and nose of the baby. Dad had used the bulb syringe to extract some and discharged it into the toilet. There was a large amount of bright red blood noted in the toilet bowl, and blood continuing to come from the baby. The baby and family were immediately taken to the NICU for evaluation." Following reports per MD note " Was rooming in with parents. They noted that he was more fussy than normal. He was then found with blood in his mouth and nose. He was taken into the unit and was found to have apnea. nCPAP was started and I took him off several hours later to exam him. He did well and I had nursing take him off and place in mom's arms. He became apneic and bradycardic in mom's arms. CPAP was restarted and he continued to have apneic events. He was intubated by the NNP." Antibiotics and acyclovir were initiated (8/18-8/20 d/c with cultures neg). Multiple days of NPO and TPN required do to destaturations for copious secretions. Patient was extubated on 8/20, TPN d/c and diet restarted on 8/23, ready for transition home from 8/23-8/24. Of note no other changes in this patients medical treatment from a medication standpoint or otherwise were made near the event.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Fainted; nurse put her on a bed and gave her juice when she came to.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Dizziness, Feeling abnormal, Malaise
Clinical narrative: Patient awoke the next morning not feeling well, dizzy, fever and chills, felt so bad by 1pm her son took her to the ER.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient awoke the next morning not feeling well, dizzy, fever and chills, felt so bad by 1pm her son took her to the ER.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Malaise, Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: Red circular rash around area vaccination site.  Rash was hot to the touch. Feeling ill.  This was the varicella vaccination.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS SWELLING AND PAIN ON INJECTION SITE.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Severe fever, shaking, chills, aching, headache, pain in arm. Fever lasted 3 days on and off with Ibuprofen and cool towels to help. Aching body lasted one week. Headaches lasted 2 weeks.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: Severe fever, shaking, chills, aching, headache, pain in arm. Fever lasted 3 days on and off with Ibuprofen and cool towels to help. Aching body lasted one week. Headaches lasted 2 weeks.
Age: 70.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Rash developed around injection site later the day of administration of ZOSTAVAX vaccine. Patient states that is painful and itches. It is a red, irregular, spotty rash.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Injection site swelling
Clinical narrative: SWELLING IN ARM AT SITE BUMP.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Hypoaesthesia, Injection site erythema, Pain in extremity, Paraesthesia
Clinical narrative: Fever up to 101 for 3 days, redness at injection site;  Then on 8/22/16 fever resolved and headache & left facial numbness/tingling extending into left arm developed and has persisted although somewhat improved.  Left arm feels sore although somewhat improved.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever up to 101 for 3 days, redness at injection site;  Then on 8/22/16 fever resolved and headache & left facial numbness/tingling extending into left arm developed and has persisted although somewhat improved.  Left arm feels sore although somewhat improved.
Age: 18.0
Sex: M
Vaccine: HPVX, MENB
Symptoms: Body temperature increased, Chills, Dizziness, Fatigue, Injection site pain
Clinical narrative: Violent chills, Nausea, Fatigue, Dizziness. At physician's recommendation, drank orange juice and had some food. Around 2:20 PM, temperature rose to 102.1 degrees. Gradually, temperature came down slightly. Around 11:00 PM, temperature rose to 102.6 degrees. It dropped to 98.5 by 1:30 AM. By 8:45 AM the next morning (8/11/16), temperature rose to 101.2. By 1:15 PM on 8/11/16, temperature dropped to 96.9. Although his temperature was low, the patient felt fine. Patient noticed that his temperature dropped after eating. Around 9:30 PM on 8/11/16, patient developed what looked like heat rash on his torso, neck and face. These symptoms gradually went away when he applied a cool, damp towel to those areas.
Age: 18.0
Sex: M
Vaccine: HPVX, MENB
Symptoms: Miliaria, Nausea
Clinical narrative: Violent chills, Nausea, Fatigue, Dizziness. At physician's recommendation, drank orange juice and had some food. Around 2:20 PM, temperature rose to 102.1 degrees. Gradually, temperature came down slightly. Around 11:00 PM, temperature rose to 102.6 degrees. It dropped to 98.5 by 1:30 AM. By 8:45 AM the next morning (8/11/16), temperature rose to 101.2. By 1:15 PM on 8/11/16, temperature dropped to 96.9. Although his temperature was low, the patient felt fine. Patient noticed that his temperature dropped after eating. Around 9:30 PM on 8/11/16, patient developed what looked like heat rash on his torso, neck and face. These symptoms gradually went away when he applied a cool, damp towel to those areas.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Anxiety, Injection site pain, Loss of consciousness, Posture abnormal
Clinical narrative: HPV9 ADMINISTERED TO PT'S LEFT DELTOID AT 1PM. PT VERBALIZED IT WAS PAINFUL. 30 SECONDS LATER. PT DROPPED HER HEAD. TRYING TO WAKE UP PATIENT AND GOT EPINEPHRINE INJECTION FROM THE CABINATE. PT WAKE UP ANXIOUS. ASKING" WHAT HAPPENED?" BENADRYL 1TSP GIVEN. MONITORED PT FOR 15 MINUUTES. PT WAS ALERT AWAKE ORIENTED PLEASANT AMBULATING OUT OF THE CLINIC AT 115PM.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Breast pain, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Phone call from patient 8/24/16: Had a shingles vaccine on Monday in her left arm. It was the only vaccine she had at the time. Now has a rash at the injection is about 4 inches and is slight itchy and red and hot.   Under her arm and to the side of her breast is achy, and is also sore to press on. Pain is worse under her armpit.  States it almost feels like when she had shingles in the past. It feels better if she keeps her arm down.  No visible rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Tenderness
Clinical narrative: Phone call from patient 8/24/16: Had a shingles vaccine on Monday in her left arm. It was the only vaccine she had at the time. Now has a rash at the injection is about 4 inches and is slight itchy and red and hot.   Under her arm and to the side of her breast is achy, and is also sore to press on. Pain is worse under her armpit.  States it almost feels like when she had shingles in the past. It feels better if she keeps her arm down.  No visible rash.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Staphylococcal infection
Clinical narrative: Patient describes the injection site was raised, warm, and red. Her doctor prescribed clindamycin for MRSA.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse drug reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth around injection site.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Incorrect route of drug administration
Clinical narrative: Case number PHEH2016US021227, is an initial spontaneous report received from a pharmacist on 12 Aug 2016. This report refers to a male patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient received Influenza Virus Vaccine Seasonal (manufacturer unknown, batch number not reported) subcutaneously (Inappropriate route of vaccination) on unknown date in 1982 at unknown dose. The patient developed Guillain Barre Syndrome. Seriousness, outcome and causality of the event was not reported. Seriousness of the event Guillain Barre Syndrome was upgraded based on the Novartis Important medical event list.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Blood test, Computerised tomogram, Gait disturbance
Clinical narrative: Hands and feet numb and tingling, back pain from my back all the way down my left leg, tremors in my body, weakness, difficulty walking - medicine by mouth, and all of the things in box 12.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Lumbar puncture, Nerve block, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: Hands and feet numb and tingling, back pain from my back all the way down my left leg, tremors in my body, weakness, difficulty walking - medicine by mouth, and all of the things in box 12.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia, Tremor
Clinical narrative: Hands and feet numb and tingling, back pain from my back all the way down my left leg, tremors in my body, weakness, difficulty walking - medicine by mouth, and all of the things in box 12.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored dose of VARIVAX (lot# reported as M009766, expiry date 23-FEB-2018). No adverse symptoms reported. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. In August 2016, reported as dates starting on or after 04-AUG-2016, the patients were vaccinated with improperly stored doses of VAQTA lot # M021124, expiry date 02-FEB-2018 (strength, dose, route and site of administration were not reported). No adverse effect was reported. Administered doses of vaccines experienced the temperature excursion of 35 degrees Fahrenheit for 6 hours and 25 minutes and 47 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous temperature excursions reported. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored dose of PROQUAD (lot # M017337, expiry date 05-OCT-2017) (dose and route were not reported). No adverse symptoms reported. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 25-JUL-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was unknown, lot # M004883, expiration date on 02-OCT-2017), oral, which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. No previous temperature excursion was reported. Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown ages and genders. The patients' medical history, concurrent condition and concomitant medication were unknown. On multiple unknown dates, the patients were vaccinated with improperly stored PROQUAD (dose and frequency unknown, lot # M009745, expiration date: 23-AUG-2017, albumin status: rHA; lot # M015700, expiration date: 26-SEP-2017, albumin status: rHA). The vaccines were stored under 11.0 Fahrenheit degree for 30 minutes. There was no previous temperature excursion. The call was due to a "data logger". No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 2 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose and route of administration were not reported). The reporter was unsure which lot numbers were administered so she provided two lot numbers that were possibly involved: L006385 with expiration date 25-FEB-2017 and L025207 with expiration date 27-JUL-2017. There was no symptoms reported. Administered doses of vaccine experienced a temperature excursion of 6 degrees Fahrenheit for 40 hours. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patients pertinent medical history, drug reactions and allergies were not reported. On an unknown date the patients received unspecified doses of improperly stored GARDASIL 9 (lot # L044475, expiry date 12-MAY-2017) concentration, dose, route of administration were not provided. It was reported that the temperature excursion was for cumulative 95 hours 24 minutes at -1.1C, according to the data logger. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Paraesthesia, Pruritus
Clinical narrative: Information has been received from a consumer referring to a 64 year old female patient. The patient had drug reactions/allergies to penicillin and codeine. Pertinent medical history was not provided. On 04-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX, (lot#, expiration date, dose, and strength were unknown), subcutaneously. Concomitant medication included unspecified thyroid medication. On an unknown date in August 2016 (reported as " a couple of days ago"), the patient began to experience tingles in her face, and then pain in her stomach and straight through to her back. The patient also experienced itchy feet. She also stated that she had no rash anywhere on her. No treatment was given for the events. No lab diagnostics studies was performed. The outcome of all the events was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ which had lot # L004456, expiry date: 07-AUG-2017, (strength, dose and route not reported). No adverse effects reported. No product quality complaint (PQC) involved. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date, the patients was vaccinated with zoster vaccine live (manufacturer unknown) in error 5 days post its expiration date, (dose, strength, lot number, expiration date and administration route were not provided). No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored PROQUAD lot# reported as M007963 with expiration date: 09-OCT-2017 (dose, route of administration and injection site were not reported). Administered doses of PROQUAD underwent temperature excursions at 12 Fahrenheit degrees, for 720 minutes. Previous temperature excursions was at 32 Fahrenheit degrees, for 750 minutes. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a consumer(patient's mother) regarding a 23 year old female patient. The patient was not pregnant. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. The patient received her first vaccination of VARIVAX (by subcutaneous route, exact dose and frequency not reported) on 20-JAN-1999 and then a second booster of VARIVAX (by subcutaneous route, exact dose and frequency not reported) on 26-NOV-2008. On an unknown date, the patient experienced an adverse event with VARIVAX.  During a recent (exact date unknown) pre-employment physical her prospective employer asked if she needed to be re-immunized with VARIVAX due to undetected titers(antibody test negative). The patient did not sought medical attention. She did not receive any treatment for the events. The consumer asked how often re-immunization is necessary. The outcome of the events were considered to be unknown. Causality assessment was not provided. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 6-year-old male patient who received KINRIX. On 10th August 2016, the patient received KINRIX. On 10th August 2016, less than a week after receiving KINRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site warmth to be related to KINRIX. Additional details were provided as follows: The patient had no prior allergy to vaccine. Initially it was reported that, the patient's left arm was swollen, hot when touch and very, very red after vaccination. Later it was reported that, immediately after vaccination with KINRIX the patient experienced injection site pain. Few hours later the patient experienced injection site redness. Less than a week after vaccination the patient experienced swelling, redness and warm to touch in the left arm (10 into 5 cm). The patient had pain at injection site with movement. The patient was treated with ice. The patient did not have fever.  The patient's father was cardiologist.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 4-year-old male patient who received KINRIX (batch number GM7X3, expiry date 13th November 2017). Concomitant products included MMRV. On 11th August 2016, the patient received KINRIX .5 ml. On 12th August 2016, 1 days after receiving KINRIX, the patient experienced fever (serious criteria other: serious as per reporter), injection site rash and injection site soreness. On an unknown date, the outcome of the fever, injection site rash and injection site redness were unknown. The reporter considered the fever, injection site rash and injection site redness to be almost certainly related to KINRIX. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by an administrator. The patient received KINRIX vaccine in his left thigh. On the same day, the patient received MMRV vaccine concomitantly. The patient experienced fever (102 degrees) with rash and redness at the injection site after receiving KINRIX vaccination. This case has been linked to case US2016117314, reported by the same reporter.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Extensive swelling of vaccinated limb, Headache, Immediate post-injection reaction, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 11-year-old male patient who received MENVEO (batch number A15125, expiry date May 2017). On 11th August 2016, the patient received MENVEO. On 11th August 2016, immediately after receiving MENVEO, the patient experienced nausea and headache. On 12th August 2016, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, nausea, headache, injection site erythema and injection site warmth were unknown. the reporter considered the extensive swelling of vaccinated limb, nausea, headache and injection site warmth to be probably related to MENVEO. It was unknown if the reporter considered the injection site erythema to be related to MENVEO. Additional details were provided as follows: This case was not previously reported to anyone. the patient felt nauseated and had headache immediately after receiving MENVEO vaccine in left deltoid. He was given some juice and asked to lie down. the next morning, he developed a 6 by 7 inch red area that was swollen and hot to the touch.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 11-year-old male patient who received MENVEO (batch number A15125, expiry date May 2017). On 11th August 2016, the patient received MENVEO. On 11th August 2016, immediately after receiving MENVEO, the patient experienced nausea and headache. On 12th August 2016, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, nausea, headache, injection site erythema and injection site warmth were unknown. the reporter considered the extensive swelling of vaccinated limb, nausea, headache and injection site warmth to be probably related to MENVEO. It was unknown if the reporter considered the injection site erythema to be related to MENVEO. Additional details were provided as follows: This case was not previously reported to anyone. the patient felt nauseated and had headache immediately after receiving MENVEO vaccine in left deltoid. He was given some juice and asked to lie down. the next morning, he developed a 6 by 7 inch red area that was swollen and hot to the touch.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Headache, Injection site pain, Injection site warmth, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 19-year-old male patient who received BEXSERO (batch number 154101A, expiry date unknown). On 10th August 2016, the patient received the 1st dose of BEXSERO (intramuscular). On 10th August 2016, 30 min after receiving BEXSERO, the patient experienced injection site pain and injection site warmth. On 11th August 2016, the patient experienced nausea, headache and joint pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, injection site warmth, headache and joint pain were not recovered/not resolved and the outcome of the nausea was recovered/resolved. The reporter considered the injection site pain, injection site warmth, nausea and headache to be related to BEXSERO. It was unknown if the reporter considered the joint pain to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, the patient received BEXSERO at 16:00. Within few hours after vaccination the patient experienced warmness at injection site. By the next morning the patient was slightly nauseated, had headache and the patient was experiencing pain in his joints, specifically hips and knees. The patient was treated with 800 mg ibuprofen last night.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The medical assistant reported that an expired dose of properly stored (wistar ra 27-3) M-M-R II lot # K008815 with expiration date 19-JUN-2106 was administered to an unspecified patient on 29-JUL-2106. No adverse reaction reported. No product quality complain twas involved. No further information was provided. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Borrelia test negative, Borrelia test positive
Clinical narrative: Pt seen 6/6 for PE, given HPV-9 valent (dose #3) prior two HPV were quadrivalent 6/3/15 and 8/6/15. Had vaccine approximately 1030 AM, then approximately 6 PM had sudden onset fever, abd. pain, HA, myalgia, then later that PM had facial swelling, tongue tingling, no hives -> in ER 6/6 PM. Family gave history of previous tick removal in recent wks (lg ticks). Had had braces put on 6 days prior. ER (-) mono, (-) RS. Told he had a rash (not present at PE). Started on BENADRYL, steroids, doxy. 6/7 developed stiff neck, HA, lg temp. 6/8 pt seen in office - (-) rash alert, in NAD, (-) facial swelling, felt better. (+) neck soreness, (+) enlarged sm nodes, mild upper abd soreness. Weaned off steroids 6/9 continued doxy added labs to blood drawn in ER Lyme, RMSF, EBV. EBV ord infections (past)/(-) Lyme/RMSF (-). 6/13 seen again in ER for continued HA, neck stiffness. No LP done. Had nl WBC, CMP. 6/14 seen in office. Still with neck soreness, not rigidity, Lg HA, afebrile. States he felt a little weak. Nl strength on exam, good. Completed 14 days doxy for ? tick borne illness although felt to be HPV reaction. Was to RTC in a week. 7/24 I called mom as pt did not RTC symptoms had all resolved by 7/1/16.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Epstein-Barr virus test negative, Headache, Interchange of vaccine products, Laboratory test normal, Lymphadenopathy
Clinical narrative: Pt seen 6/6 for PE, given HPV-9 valent (dose #3) prior two HPV were quadrivalent 6/3/15 and 8/6/15. Had vaccine approximately 1030 AM, then approximately 6 PM had sudden onset fever, abd. pain, HA, myalgia, then later that PM had facial swelling, tongue tingling, no hives -> in ER 6/6 PM. Family gave history of previous tick removal in recent wks (lg ticks). Had had braces put on 6 days prior. ER (-) mono, (-) RS. Told he had a rash (not present at PE). Started on BENADRYL, steroids, doxy. 6/7 developed stiff neck, HA, lg temp. 6/8 pt seen in office - (-) rash alert, in NAD, (-) facial swelling, felt better. (+) neck soreness, (+) enlarged sm nodes, mild upper abd soreness. Weaned off steroids 6/9 continued doxy added labs to blood drawn in ER Lyme, RMSF, EBV. EBV ord infections (past)/(-) Lyme/RMSF (-). 6/13 seen again in ER for continued HA, neck stiffness. No LP done. Had nl WBC, CMP. 6/14 seen in office. Still with neck soreness, not rigidity, Lg HA, afebrile. States he felt a little weak. Nl strength on exam, good. Completed 14 days doxy for ? tick borne illness although felt to be HPV reaction. Was to RTC in a week. 7/24 I called mom as pt did not RTC symptoms had all resolved by 7/1/16.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Metabolic function test normal, Mononucleosis heterophile test negative, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: Pt seen 6/6 for PE, given HPV-9 valent (dose #3) prior two HPV were quadrivalent 6/3/15 and 8/6/15. Had vaccine approximately 1030 AM, then approximately 6 PM had sudden onset fever, abd. pain, HA, myalgia, then later that PM had facial swelling, tongue tingling, no hives -> in ER 6/6 PM. Family gave history of previous tick removal in recent wks (lg ticks). Had had braces put on 6 days prior. ER (-) mono, (-) RS. Told he had a rash (not present at PE). Started on BENADRYL, steroids, doxy. 6/7 developed stiff neck, HA, lg temp. 6/8 pt seen in office - (-) rash alert, in NAD, (-) facial swelling, felt better. (+) neck soreness, (+) enlarged sm nodes, mild upper abd soreness. Weaned off steroids 6/9 continued doxy added labs to blood drawn in ER Lyme, RMSF, EBV. EBV ord infections (past)/(-) Lyme/RMSF (-). 6/13 seen again in ER for continued HA, neck stiffness. No LP done. Had nl WBC, CMP. 6/14 seen in office. Still with neck soreness, not rigidity, Lg HA, afebrile. States he felt a little weak. Nl strength on exam, good. Completed 14 days doxy for ? tick borne illness although felt to be HPV reaction. Was to RTC in a week. 7/24 I called mom as pt did not RTC symptoms had all resolved by 7/1/16.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Paraesthesia oral, Pyrexia, Rash, Respiratory syncytial virus test negative, Swelling face
Clinical narrative: Pt seen 6/6 for PE, given HPV-9 valent (dose #3) prior two HPV were quadrivalent 6/3/15 and 8/6/15. Had vaccine approximately 1030 AM, then approximately 6 PM had sudden onset fever, abd. pain, HA, myalgia, then later that PM had facial swelling, tongue tingling, no hives -> in ER 6/6 PM. Family gave history of previous tick removal in recent wks (lg ticks). Had had braces put on 6 days prior. ER (-) mono, (-) RS. Told he had a rash (not present at PE). Started on BENADRYL, steroids, doxy. 6/7 developed stiff neck, HA, lg temp. 6/8 pt seen in office - (-) rash alert, in NAD, (-) facial swelling, felt better. (+) neck soreness, (+) enlarged sm nodes, mild upper abd soreness. Weaned off steroids 6/9 continued doxy added labs to blood drawn in ER Lyme, RMSF, EBV. EBV ord infections (past)/(-) Lyme/RMSF (-). 6/13 seen again in ER for continued HA, neck stiffness. No LP done. Had nl WBC, CMP. 6/14 seen in office. Still with neck soreness, not rigidity, Lg HA, afebrile. States he felt a little weak. Nl strength on exam, good. Completed 14 days doxy for ? tick borne illness although felt to be HPV reaction. Was to RTC in a week. 7/24 I called mom as pt did not RTC symptoms had all resolved by 7/1/16.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: White blood cell count normal
Clinical narrative: Pt seen 6/6 for PE, given HPV-9 valent (dose #3) prior two HPV were quadrivalent 6/3/15 and 8/6/15. Had vaccine approximately 1030 AM, then approximately 6 PM had sudden onset fever, abd. pain, HA, myalgia, then later that PM had facial swelling, tongue tingling, no hives -> in ER 6/6 PM. Family gave history of previous tick removal in recent wks (lg ticks). Had had braces put on 6 days prior. ER (-) mono, (-) RS. Told he had a rash (not present at PE). Started on BENADRYL, steroids, doxy. 6/7 developed stiff neck, HA, lg temp. 6/8 pt seen in office - (-) rash alert, in NAD, (-) facial swelling, felt better. (+) neck soreness, (+) enlarged sm nodes, mild upper abd soreness. Weaned off steroids 6/9 continued doxy added labs to blood drawn in ER Lyme, RMSF, EBV. EBV ord infections (past)/(-) Lyme/RMSF (-). 6/13 seen again in ER for continued HA, neck stiffness. No LP done. Had nl WBC, CMP. 6/14 seen in office. Still with neck soreness, not rigidity, Lg HA, afebrile. States he felt a little weak. Nl strength on exam, good. Completed 14 days doxy for ? tick borne illness although felt to be HPV reaction. Was to RTC in a week. 7/24 I called mom as pt did not RTC symptoms had all resolved by 7/1/16.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or concurrent conditions were reported. the pharmacist reported that multiple unknown patients were vaccinated on multiple unknown dates with improperly stored PROQUAD (rHA) lot number M014304, expiration date 22-SEP-2017, lot number M014302, expiration date 22-SEP-2017 and lot number M007965, expiration date 15-AUG-2017, (dose, route and frequency not reported). No adverse effects were reported. the pharmacist reported that the temperature of the excursion was -14.4 C, and that the time frame was 12 hours and 15 minutes. There were no previous temperature excursions and the report was because of a data logger. No product quality complaint was reported. Lot numbers M014304, M014302, and M007965 have been verified to be valid lot numbers for PROQUAD (rHA). This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 20-JUN-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017 (strength, dose number, anatomical location and route of administration were not reported). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner regarding a patient of unknown age. There was no information about concurrent condition and historical medication. On 15-AUG-2016, 16-AUG-2016, 17-AUG-2016, 18-AUG-2016, and 19-AUG-2016, the patient was vaccinated with improperly stored PROQUAD, lot# M004891, expiration date-25-JUL-2017, lot# I040414, expiration date- 13-APR-2017, lot no. I040960, expiration date- 16-OCT-2016 and lot# M004891, expiration date- 25-JUL-2017. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was developed. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Injection site urticaria, Rash
Clinical narrative: The night after injection, patient got rash and hives around the injection site. Improvement with BENADRYL po but now in emergency room for further evaluation. Skin rash. Diphenhydramine 50mg QID.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner regarding a patient of unknown age. There was no information about concurrent condition and historical medication. On 15-AUG-2016, 16-AUG-2016, 17-AUG-2016, 18-AUG-2016, and 19-AUG-2016, the patient was vaccinated with improperly stored VARIVAX, lot# L048464, expiration date - 02-DEC-2016, lot# L035129, expiration date - 14-SEP-2017, lot no. M040181, expiration date - 01-MAR-2018 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was developed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On 15-AAUG-2106, 16-AUG-2016, 17-AUG-2016, 18-AUG-2016 and 19-AUG-2016, the patients were vaccinated with improperly stored (wistar ra 27-3) M-M-R II (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was developed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. the patient's pertinent medical history and drug reactions or allergies were not reported. On 20-JUN-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017 (strength, dose number, anatomical location and route of administration were not reported). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Incorrect route of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was been received from a Nurse Practitioner refers to a patient of unknown age and gender. The patient's medical history, concomitant medications and concurrent conditions were not reported. On an unspecified dates, the patient was vaccinated with the first two doses of GARDASIL (strength, dose, administration route, lot number and expiration date were not provided). On an unspecified date, the patient received a dose of GARDASIL 9 (strength, dose, administration route, lot number and expiration date were not provided), and on 10-AUG-2016, the patient was vaccinated with the second dose (the fourth dose in the series of vaccination) of GARDASIL 9 (strength, and dose were not provided, lot number reported as M007764) subcutaneously. The nurse practitioner state it's not know when the patient received the previous doses of GARDASIL and GARDASIL 9. Additionally, no adverse effects were reported. Lot number M007764 in an invalid number for HPV. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a Physician via a company representative referring to a female patient of unknown age. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX. (Lot #, expiration date, strength, dose and route were not provided). On an unknown date, approximately one week after receiving the vaccine, the patient experienced herpes zoster. The patient  received an unspecified treatment and recovered from the shingles. The reporter did not assess causality between the event and the use of the medication. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 22-JUN-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017 (strength, dose number, anatomical location and route of administration were not reported). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 28-JUN-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017) (strength, dose number, anatomical location and route of administration were not reported). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.