chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Contusion, Cough, Differential white blood cell count, Dyspnoea
Clinical narrative: Started swelling with mild swelling, by 6/22 am some rash had started on my arm and by 6-23 PM it had spread all of the way down to my wrist and had started on my other arm.  I had started having some mild wheezing and coughing issues.  I took Benadryl and applied Ice packs and went to the icc on 6-24 they gave me steroid shots and antibiotics and told me to continue with and inhaler and Benadryl and ice packs and follow up with a doctor on Monday. By Sunday night I could barely breathe and was un able to get out of bed. I went to the hospital on 6-27 with acute asthma and acute bronchitis.  Had 3 breathing treatments, steroid iv, Percocet for the pain in my chest and ribs from coughing so hard, cough meds, and they sent me home with prednisone, cough meds and doxycycline. I saw my doctor today 6-28-16 for a follow up and she said it was an anaphylactic reaction to the shot. I still have bruising all around my arm from the extreme swelling, itching, and am having trouble breathing.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Electrocardiogram, Full blood count, Metabolic function test, Mobility decreased, Musculoskeletal chest pain
Clinical narrative: Started swelling with mild swelling, by 6/22 am some rash had started on my arm and by 6-23 PM it had spread all of the way down to my wrist and had started on my other arm.  I had started having some mild wheezing and coughing issues.  I took Benadryl and applied Ice packs and went to the icc on 6-24 they gave me steroid shots and antibiotics and told me to continue with and inhaler and Benadryl and ice packs and follow up with a doctor on Monday. By Sunday night I could barely breathe and was un able to get out of bed. I went to the hospital on 6-27 with acute asthma and acute bronchitis.  Had 3 breathing treatments, steroid iv, Percocet for the pain in my chest and ribs from coughing so hard, cough meds, and they sent me home with prednisone, cough meds and doxycycline. I saw my doctor today 6-28-16 for a follow up and she said it was an anaphylactic reaction to the shot. I still have bruising all around my arm from the extreme swelling, itching, and am having trouble breathing.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash, Swelling, Troponin, Wheezing
Clinical narrative: Started swelling with mild swelling, by 6/22 am some rash had started on my arm and by 6-23 PM it had spread all of the way down to my wrist and had started on my other arm.  I had started having some mild wheezing and coughing issues.  I took Benadryl and applied Ice packs and went to the icc on 6-24 they gave me steroid shots and antibiotics and told me to continue with and inhaler and Benadryl and ice packs and follow up with a doctor on Monday. By Sunday night I could barely breathe and was un able to get out of bed. I went to the hospital on 6-27 with acute asthma and acute bronchitis.  Had 3 breathing treatments, steroid iv, Percocet for the pain in my chest and ribs from coughing so hard, cough meds, and they sent me home with prednisone, cough meds and doxycycline. I saw my doctor today 6-28-16 for a follow up and she said it was an anaphylactic reaction to the shot. I still have bruising all around my arm from the extreme swelling, itching, and am having trouble breathing.
Age: 17.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Activities of daily living impaired, Dizziness, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Extreme pain at injection site, headache, nausea, dizziness, low grade fever and sweating, unable to lift or use arm without significant pain. Injection site hot to the touch. Could not participate in football practice the day of the injection. Unable to sleep the night of the injection. Tried but was unable to work the day following injection. Treated with Tylenol every 6 hrs and ice compress the first day. Treated with 800 mg ibuprofen and ice the second day. Treatments have not relieved symptoms at all yet.
Age: 17.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Injection site warmth, Insomnia, Nausea, Pain, Pyrexia
Clinical narrative: Extreme pain at injection site, headache, nausea, dizziness, low grade fever and sweating, unable to lift or use arm without significant pain. Injection site hot to the touch. Could not participate in football practice the day of the injection. Unable to sleep the night of the injection. Tried but was unable to work the day following injection. Treated with Tylenol every 6 hrs and ice compress the first day. Treated with 800 mg ibuprofen and ice the second day. Treatments have not relieved symptoms at all yet.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Rash pustular
Clinical narrative: Three pustules on her back. She woke on 6/23/2016  with multiple pustules on her back.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Headache, Lymphadenopathy, Nausea
Clinical narrative: Patient went to the doctor with complaints of headache, nausea, abdominal pain, and swollen lymph nodes.  Doctor stated it was a rare side effect to vaccine.
Sex: U
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician concerning an unspecified patient. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot number was not reported). Following the administration of the vaccine, on an unknown date the patient experienced Guillain-Barre syndrome (GBS). The physician reported that the patient's GBS "cleared up" on unspecified date. Upon internal review, GBS was determined to be an other important event. Additional information is not expected because the physician is not allowed to be contacted.
Age: 51.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Back pain, Chills, Nausea, Pain, Pyrexia
Clinical narrative: Began with lower back pain, followed by nausea and fever. By the end of the day, had full body aches, mainly from the base of my skull to my lower back, fever and chills. Symptoms cleared up by Sunday, June 26th.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Papule, Rash
Clinical narrative: Rash developed on bilateral antecubital fossa. Red, raised papules. Scabbing over. More developed; One on the back, one on the R axilla, left knee, R forearm.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Pt fainted and fell off of the exam table  no additional injury noted.  Pt with no complaints of pain prior to leaving the office approximately 20 minutes after incident.
Age: 70.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Injection site warmth, Skin warm
Clinical narrative: Patient reported red welt warm to touch on back of arm where zoster vaccine was administered. She was instructed to ice the area and take ibuprofen to help with redness and swelling; told patient if worsened or did not improve within next day or two to see healthcare provider. Patient came to pharmacy on 6/28/16 and showed her arm. Back of arm where vaccine was administered was still very red and warm to the touch and had spread down to the forearm. Instructed patient to see her healthcare professional.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea, Eczema, Food allergy, Pyrexia, Rash vesicular
Clinical narrative: Upper respiratory infection, followed by severe diarrhea, projectile vomit, fever, herpes like rash spread over left side of back and upper buttocks, followed by rash covering entire lower extremities, arms and back. Followed by eczema on entire body and food allergies to foods he had been eating since 6 months old.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Upper respiratory tract infection, Vomiting projectile
Clinical narrative: Upper respiratory infection, followed by severe diarrhea, projectile vomit, fever, herpes like rash spread over left side of back and upper buttocks, followed by rash covering entire lower extremities, arms and back. Followed by eczema on entire body and food allergies to foods he had been eating since 6 months old.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, redness and swelling at site.
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pain, Skin discolouration, Skin irritation, Swelling
Clinical narrative: Swelling, Red ring of irritation, not which lasted 3 weeks and the not remains under core of the injection area. Stinging and soreness. Call doctors office twice and kept saying it will go away. I still have the not and cosmetic disturbing brown spot on my arm.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Joint crepitation, Joint range of motion decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Shoulder stiffness, pain, limited ROM. 11/17/15 doctors visit shoulder popping, numbness, pain, limited ROM. 12/4/16 doctors visit X-rays - normal. 12/22/16 drs visit same symptoms, referred to MRI. Partial full thickness tear versus impingement. 2-16 referral. 4/25/16 Surgery. Physical therapy current.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging abnormal, Periarthritis, Rotator cuff syndrome, Surgery, X-ray limb abnormal
Clinical narrative: Shoulder stiffness, pain, limited ROM. 11/17/15 doctors visit shoulder popping, numbness, pain, limited ROM. 12/4/16 doctors visit X-rays - normal. 12/22/16 drs visit same symptoms, referred to MRI. Partial full thickness tear versus impingement. 2-16 referral. 4/25/16 Surgery. Physical therapy current.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Injection site rash, Musculoskeletal pain, Paraesthesia
Clinical narrative: Sore left shoulder, tingling/numbness in left fingers, rash at injection site developed over several days.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Her arm was red and swollen. She said it itched a little bit.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test normal, Carpal tunnel syndrome, Hypoaesthesia, Mobility decreased, Nerve conduction studies
Clinical narrative: June 15, 2015 I went to clinic for annual physical. I was given the PCV 13 vaccine. Within a week of that date I woke up one morning unable to lift both of my arms and with numbness, and tingling in my hands and fingers. I did not have this problem before. July 8, 2015 I returned to the clinic because the pain in my arms, numbness, tingling in my hand and fingers had not stopped. I was told not to lift anything or exercise. The doctor gave me a prescription for Naproxen 375mg 1 tab twice per day. July 18, 2015 With no change in my condition I went to a local hospital clinic. I saw a doctor who increased the prescription of Naproxen to 500mg twice per day. The doctor said there could be a possibility of carpal tunnel problem. I was given wrist braces. August 4, 2015 Went to see a private primary doctor. I discussed my problems with him. He suggested a blood test to check for other illnesses which could be the cause my problems. All tests came back normal. He suggested to go to a Neurologist. Returned to my second home. October 21, 2015 Met with my primary doctor who referred me to a Neurologist. October 30, 2015 I met with the neurologist and set up nerve test. November 10, 2015 I had a full nerve test of both arms and hands. His report did not rule out the PCV 13 vaccine. He referred me to a hand surgeon. November 19, 2015 I saw the hand surgeon. We discussed carpal tunnel surgery. I decided to have the surgery in hope that it would bring some relief to my problems. The first surgery was December 17, 2015 and the second on April 21, 2016. After of all of this I have little or no relief.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity, Paraesthesia, Wrist surgery
Clinical narrative: June 15, 2015 I went to clinic for annual physical. I was given the PCV 13 vaccine. Within a week of that date I woke up one morning unable to lift both of my arms and with numbness, and tingling in my hands and fingers. I did not have this problem before. July 8, 2015 I returned to the clinic because the pain in my arms, numbness, tingling in my hand and fingers had not stopped. I was told not to lift anything or exercise. The doctor gave me a prescription for Naproxen 375mg 1 tab twice per day. July 18, 2015 With no change in my condition I went to a local hospital clinic. I saw a doctor who increased the prescription of Naproxen to 500mg twice per day. The doctor said there could be a possibility of carpal tunnel problem. I was given wrist braces. August 4, 2015 Went to see a private primary doctor. I discussed my problems with him. He suggested a blood test to check for other illnesses which could be the cause my problems. All tests came back normal. He suggested to go to a Neurologist. Returned to my second home. October 21, 2015 Met with my primary doctor who referred me to a Neurologist. October 30, 2015 I met with the neurologist and set up nerve test. November 10, 2015 I had a full nerve test of both arms and hands. His report did not rule out the PCV 13 vaccine. He referred me to a hand surgeon. November 19, 2015 I saw the hand surgeon. We discussed carpal tunnel surgery. I decided to have the surgery in hope that it would bring some relief to my problems. The first surgery was December 17, 2015 and the second on April 21, 2016. After of all of this I have little or no relief.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Slightly sour and ache after vaccinate, the symptoms continues all the time and the symptoms became gradually more serious, will feel painful if put for my strength on the left arm. Went to my family doctor on June 03 for treatment but so far the symptom continues.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Neck pain, Respiratory rate increased
Clinical narrative: Severe sudden onset of frontal headache, posterior neck pain and rapid breathing.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: Initially low grade fever turned quickly into skin rash beginning from the site of injection to all over the face, buttocks, hands and legs.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Dizziness, Fatigue, Injection site pain
Clinical narrative: x1 blood work attempted- failed then did shots, dizzy light headed, next day very fatigued, rt. arm hurt from injection site to shoulder.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Syncope post vaccine. Unconscious for few seconds.
Age: 1.72
Sex: M
Vaccine: HEPA
Symptoms: Abnormal behaviour, Fatigue, Vomiting
Clinical narrative: Pt began to act tired, vomited at home. mom took pt to ED because pt was "not acting right". Pt vomited twice in ED but was otherwise normal. Zofran given, pt discharged to home. pt vomited once in am on 6/24/16, tolerated pedialyte the rest of the day. As of 6/28/16 pt has totally recovered and is fine, per mom.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site reaction
Clinical narrative: Right upper arm 19cm circumference. Left upper arm 22.75cm circumference. 20cm X 16.5cm area of redness with underlying tauntness to the underlying tissue missing about 2 cm coverage to circumferentially affect upper left arm.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Patient said started getting larger at injection site and swelling the evening of the 27th and bothered her all night.  I suggested she take Benadryl for swelling and itching and to use a cold compress.  I also had her mark the edges with a pen so she can see if it is getting larger or smaller over the next 24 hours.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWOLLEN AND REDNESS AT INJECTION SITE.
Age: 1.03
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Abasia, Ataxia, Coordination abnormal, Drug screen negative, Dysstasia
Clinical narrative: After breakfast on Friday, 10/02/2015, our child began showing signs of ataxia and loss of coordination.  Normally, he was able to walk on his own without support.  As the morning progressed he could not walk, stand, or sit up on his own without falling over.  After arrival at the doctor's office that morning, he began vomiting.  He did not have a high temperature.  His condition slowly improved over the next 24-48 hours and was completely resolved by the end of the week.  However, on Monday, 10/05/2015, he developed a red rash on his upper left thigh, where his chicken pox vaccine was administered.  The rash eventually went away after about one week.
Age: 1.03
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site rash, Urine alcohol test negative, Vomiting
Clinical narrative: After breakfast on Friday, 10/02/2015, our child began showing signs of ataxia and loss of coordination.  Normally, he was able to walk on his own without support.  As the morning progressed he could not walk, stand, or sit up on his own without falling over.  After arrival at the doctor's office that morning, he began vomiting.  He did not have a high temperature.  His condition slowly improved over the next 24-48 hours and was completely resolved by the end of the week.  However, on Monday, 10/05/2015, he developed a red rash on his upper left thigh, where his chicken pox vaccine was administered.  The rash eventually went away after about one week.
Age: 1.02
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MNQ
Symptoms: Crying, Irritability, Pyrexia, Skin warm, Vomiting
Clinical narrative: Baby vomited after crying. Fever started. Baby was began to get fussy. At 2 AM baby was burning up. She had a 104 degree fever. Fever is still present at 101.5.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Significant pain and swelling of deltoid region which started hours after injection and lasted several days.
Age: 50.0
Sex: M
Vaccine: MNQ
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Pt reported severe pain on L arm, and swollen lymph nodes on neck, axillae, consulted PCP on weekend.
Age: 18.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Chills, Headache, Injection site pain, Muscle spasms, Nasopharyngitis
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tingling in a 18-year-old male patient who received BEXSERO. Concomitant products included HAVRIX. On 20th June 2016, the patient received the 2nd dose of BEXSERO .5 ml. On 20th June 2016, 2 hrs after receiving BEXSERO, the patient experienced tingling (serious criteria disability), muscle spasm (serious criteria disability), chills (serious criteria disability), vomiting (serious criteria disability), headache (serious criteria disability), pallor (serious criteria disability), cold (serious criteria disability) and injection site pain (serious criteria disability). On an unknown date, the outcome of the tingling was recovering/resolving and the outcome of the muscle spasm was recovered/resolved and the outcome of the chills, vomiting, headache, pallor, cold and injection site pain were unchanged. The reporter considered the tingling, muscle spasm, chills, vomiting, headache, pallor, cold and injection site pain to be related to BEXSERO. Additional details were received as follows: This case was reported by the patient's mother. The reporter did not have access to the lot number and expiration dates as she was not in the office. The reporter would call back to provide that information.
Age: 18.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Pallor, Paraesthesia, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tingling in a 18-year-old male patient who received BEXSERO. Concomitant products included HAVRIX. On 20th June 2016, the patient received the 2nd dose of BEXSERO .5 ml. On 20th June 2016, 2 hrs after receiving BEXSERO, the patient experienced tingling (serious criteria disability), muscle spasm (serious criteria disability), chills (serious criteria disability), vomiting (serious criteria disability), headache (serious criteria disability), pallor (serious criteria disability), cold (serious criteria disability) and injection site pain (serious criteria disability). On an unknown date, the outcome of the tingling was recovering/resolving and the outcome of the muscle spasm was recovered/resolved and the outcome of the chills, vomiting, headache, pallor, cold and injection site pain were unchanged. The reporter considered the tingling, muscle spasm, chills, vomiting, headache, pallor, cold and injection site pain to be related to BEXSERO. Additional details were received as follows: This case was reported by the patient's mother. The reporter did not have access to the lot number and expiration dates as she was not in the office. The reporter would call back to provide that information.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot #L048468 with expiration date 02-DEC-2017, lot # L050560 with expiration date 14-DEC-2017, lot # L048467 with expiration date 02-DEC-2017 and lot # M000760 with expiration date 06-JAN-2018; dose and route unspecified), which were exposed to temperatures 7 Celsius degree (C). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 75 year old patient of unknown gender. There was no concurrent condition, medical history or concomitant therapy reported. On 10-JUN-2016 the patient received an expired dose of PNEUMOVAX (lot # K008927 with expire date 17-MAR-2016, one injection, subcutaneous). No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Severe right shoulder and upper arm pain with mild rash of upper arm. KENALOG 40 mg IM given, TYLENOL #3 and Ibuprofen 800 mg tid.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist refers to a patient of unknown age. On 24-JUN-2016 the patient was vaccinated with the first dose of GARDASIL which was expired on August 2015, dose, route and frequency was not reported. There was no adverse event reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patients were vaccinated with PNEUMOVAX 23 injection, (lot #, expiry date, dose, frequency and route of administration not reported). On an unknown dates, patients developed "localized injection site reactions" following the administration of PNEUMOVAX 23. The outcome of the event was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. Reporter did not have any further details to provide. No further information provided. Additional information have been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Immunology test normal, No adverse event, Product name confusion, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient had lab work performed which showed negative immunity for chickenpox. Subsequently, the physician advised the patient to receive a dose of VARIVAX. On 06-JUN-2016, the patient went to an unspecified pharmacy and inadvertently requested to be vaccinated with ZOSTAVAX instead of VARIVAX. On the same day, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). The physician reported that the patient was coming into his office that day of the report as follow up to the patient receiving the wrong vaccine. No adverse effects were reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding an unspecified number of patients of unknown age and gender. Information on the concurrent conditions and medical history of the patients were not reported. On unspecified dates, the patients were vaccinated with improperly stored ZOSTAVAX lot# L021612, expiry date, 10-SEP-2016. Concomitant medication were not reported. No adverse event were reported. There were no Product Quality Complaint (PQC) involved. Temperature at which the vaccine was stored was 6.5 degree Centigrade, for a time frame of 3 hours. There were no previous temperature excursion. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Pruritus, Rash, Urine analysis
Clinical narrative: This spontaneous report as received from a 48 year old female patient regarding herself. No concurrent condition was reported. The patient's medical history included mono 3 years ago. There was no allergy/drug reaction. In April 2013, the patient was vaccinated with ZOSTAVAX injection (dosing details, lot#, expiry were not reported). The patient was on several unspecified concomitant medications. Approximately in 2013 (reported as 4 weeks later), the patient broke out with rash on her back and from her knees down that lasted 5 months. Approximately in 2013 (reported as after 5 months), the rash went away but itching below the knees never went away. Itching then started on her head and scalp. Approximately in June 2016 (reported as a week ago), blood and urine test done were done but the result was not reported. The outcome of 'rash her back and from her knees down' was reported as recovered/resolved. The outcome of 'Itching then started on her head and scalp' was unknown. The outcome of 'itching below the knees' was not recovered not/resolved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding an unspecified number of patients of unknown age and gender. Information on the concurrent conditions and medical history of the patient were not reported. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX, lot # L027287, expiry date 21-JUL-2017, lot # L018002, expiry date 19-MAY-2017, lot/batch # L021612, expiry date 10-SEP-2016. Concomitant medication were not reported. No adverse event were reported. There were no Product Quality Complaint (PQC) involved. Temperature at which the vaccine was stored was 6.5 degree Centigrade, for a time frame of 3 hours There were no previous temperature excursion. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse (also reported medical assistant) via company representative refers to a 65 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-JUN-2016, the patient was inadvertently vaccinated with a dose of VARIVAX (dose, route of administration, indication, lot # and expiration date were not reported) instead of ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding an unspecified number of patients of unknown age and gender. Information on the concurrent conditions and medical history of the patients were not reported. On unspecified dates, the patients were vaccinated with improperly stored PROQUAD lot #L034930, expiry date, 03-MAR-2017, Lot # L027634, expiry date 21-JAN-2017 (incorrect product storage). Concomitant medication were not reported. No adverse event were reported. There were no Product Quality Complaint (PQC) involved. Temperature at which the vaccine was stored was 6.5 degree Centigrade, for a time frame of 3 hours. There were no previous temperature excursion. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot# L042836 with expiration date 24-AUG-2018, lot# L051124 with expiration date 14-OCT-2018, lot # L042257 with expiration date 17-AUG-2018, lot# L051123 with expiration date 13-OCT-2018, intramuscular; dose unspecified), which were exposed to temperature excursion of 48.2 Fahrenheit degree (F) for 10 hours because of data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age. Concurrent condition and medical history of the patient were not reported. On an unknown date in 2012, the patient was vaccinated with the first dose of GARDASIL intramuscularly (lot #, expiration date, dose unspecified). However, the patient did not return for a second dose until 2016. The reporter did not known if the second dose was GARDASIL or GARDASIL 9. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent conditions were not provided. On 24-JUN-2016, the patient was vaccinated with expired dose of M-M-R II (status albumin not provided) lot # K008815, expiration date:19-JUN-2016 (dose, route of administration and anatomical location were not reported). There were no adverse effects reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (lot # M002053 with expiration date 11-JUL-2017, lot # L050910 with expiration date 14-JUN-2017, lot # M003436 with expiration date 19-JUL-2017 and lot # M001152 with expiration date 05-JUL-2017; dose and route not provided), which were exposed to temperatures of 7 Celsius degree (C) (incorrect product storage). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 27-JUN-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection, lot # K011239 and expiration date 11-JUN-2016 (dose and route of administration were not reported). No adverse effects reported. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a certified medical assistant referring to a female patient of unknown age. There was no medical history or drug reaction/allergies reported. On 21-JUN-2016, the patient was vaccinated with the first dose of ROTATEQ (oral, dose and lot# were unknown). No concomitant therapy was reported. After receiving the vaccine (unspecified date in June 2016), the patient vomited. The outcome of the event was unknown. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (route, site of administration and lot# not reported). Concomitant Medication included "unspecified steroids". On an unknown date, the patient developed "redness and itchiness" at the injection site, lasting for an unspecified duration of time. The pharmacist did not indicate the present status of the patient. Hence, the outcome of injection site erythema and injection site pruritus was unknown. No additional information was provided. Causality was not assessed by the reporter. Product quality complaint was not filed. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. No relevant medical history or concurrent conditions were reported. On an unknown date, the patient received only a partial dose for the third shot (dose and route not reported) in his HPV vaccine series because the syringe was leaking during administration (underdose, product quality issue). The nurse who administered the shot was able to give the patient "a little less than half" of the full dose amount due to the leakage. The reporter did not specify whether the leaking dose was Gardasil or Gardasil 9. However, the lot number was provided as L025737 with expiration date as 28-JUL-2017, which was valid for GARDASIL 9. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age gender. Medical history, concurrent conditions and concomitant medications were not reported. On 13-JUN-2016, the patient was vaccinated with expired dose of PNEUMOVAX23, lot # K024976, expiry date 09-JUN-2106. No adverse effect reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. 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 Licensed Practical Nurse, referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On an unspecified date in March 2016, unspecified number of PROQUAD vaccines were exposed to a temperatures ranged from -1.0 degree C to -14.8 degrees C. After that, on unspecified dates in 2016, the patients were vaccinated with lot numbers: L007230 (expiration date: 03-SEP-2016), and L002213 (expiration date 21-JUL-2016). No adverse events were reported. The licensed practical nurse, stated that the vaccines were not previous exposed to temperature excursion. Information was recorded from a data logger. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse via a company representative refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2016 (reported as "starting on or after 29-APR-2016"), the patients were vaccinated with improperly stored doses of PNEUMOVAX lot # M005287, expiration date: 08-OCT-2017 (exact dose, dose number and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9.26 degrees Celsius for 1 hour and 25 minutes and 21.04 degrees Celsius for 36 hours and 25 minutes. Data logger was involved. There were no previous excursions 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 registered nurse referring to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored PROQUAD (lot # L019995 with expiration date of 02-DEC-2016 and lot # L031600 with expiration date of 18-FEB-2017, dose and route unknown), which was exposed to the following condition: 8.8 Fahrenheit for 1 hour and 9 minutes with no previous temperature excursion, digital data logger was reported as yes. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored VARIVAX (lot # L034368 with expiration date of 08-SEP-2017, dose and route unknown), which was exposed to the following condition: 8.8 Fahrenheit for 1 hour and 9 minutes with no previous temperature excursion, digital data logger was reported as yes. No adverse symptoms were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse via a company representative refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2016 (reported as "starting on or after 29-APR-2016), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L033343, expiration date: 13-SEP-2017 (exact dose, dose number and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9.26 degrees Celsius for 1 hour and 25 minutes and 21.04 degrees Celsius for 26 hours and 25 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-JUN-2016, the patient was inadvertently vaccinated with a dose of M-M-R II intramuscularly instead of subcutaneously (lot # and expiration date were not reported). After the patient received the first dose incorrectly as an intramuscular injection, on an unknown date in June 2016, the patient was then given a second dose of M-M-R-II (lot # and expiration date were not reported) subcutaneously. No adverse effect was reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9, MNQ, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JUN-2016, the patient was vaccinated with one dose of improperly stored VARIVAX lot # L029472, expiration date 06-AUG-2017 (exact dose, route of administration and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: HEPA
Symptoms: Vertigo
Clinical narrative: Onset of vertigo 2 days after receiving 2nd dose of HAV vaccine.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Pt called the office stating she has three red spots on arm at site of vaccine that are painful. Denied fever, trouble breathing, N/V. Pt advised to apply ice to area, use TYLENOL for discomfort and report if not improving.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Neuralgia
Clinical narrative: Patient reported when Tdap was administered a "nerve shock" was felt in arm at time injection went into arm-moved up/down arm. Then intermittently continued based on arm position and putting elbow on arm rests. Patient stated this has continued since then-reports this in painful-more than sutures that were placed in finger.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngeal oedema, Urticaria
Clinical narrative: Hives on face, chest, back. Throat swelling.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 22-JUN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL (which had a lot # of L035105 and an expiration date of 14-MAY-2017; however, the dose, dosage number, route of administration and anatomical location were unknown). No concomitant medications were reported. The vaccine experienced a temperature excursion of 34 F for a time frame of 360 hours (also described as 15 days). No previous excursions had ever occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to approximately seven patients with unknown demographics. Their pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On unknown dates since April 2016, the patients were vaccinated, subcutaneously, with 0.65 ml doses of improperly stored ZOSTAVAX (which had a lot # of L044529 and an expiration date of 09-FEB-2017; however, the dosage numbers and anatomical locations were unknown. No concomitant therapies were reported. Despite being vaccinated with such an improperly stored vaccine, no adverse events were reported. Notably, the vaccine underwent a temperature excursion on 21 F for a time of 11 hours and 30 minutes on an unspecified date in April 2016. Following this, the vaccine experienced another temperature excursion of 6.8 F for a time frame of 11 hours and 20 minutes as well, on the night of 20-JUN-2016. However, following this recent improper storage, it had not been administered to any patient. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown ages and genders. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. Since the temperature excursion on 16-JUN-2016, the patients were vaccinated with improperly stored doses and not supported of PEDVAXHIB injection (subcutaneously, lot # L051123 with expiration date 13-OCT-2018; dose and anatomical location were not reported). The vaccines had a temperature excursion of 27 Fahrenheit for 11 hours. No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 5 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not provided. On an unknown date, the patient inadvertently received a dose of ZOSTAVAX (lot # L032184, expiration date 25-NOV-2016, dose and route were not reported) (inappropriate schedule of drug administration). The ZOSTAVAX was administered by an unspecified provider at an unspecified facility. No adverse effects were reported. Additional information is not expected since the physician does not want to be contacted.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a 73 year old female patient. The patient's medical history and concurrent conditions were not reported. On 09-JUN-2016, the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, dose and route of administration were not provided). No other suspect or concomitants therapies were reported. On the same date, the patient experienced soreness in arm and upset stomach. It was also reported that the patient sought medical attention in doctor's office at the time. Additionally, it was reported that no intervention to prevent a serious criteria was necessary, that pain in extremity and abdominal discomfort was no significant disability or incapacity or life threatening and that the patient was not hospitalized. No product quality complaint was involved. The outcome of soreness in arm and upset stomach were not provided. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. 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 healthcare worker (also reported as an office manager) refers to three patient of unknown ages and genders. Their pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (which had a lot # of L042265 with an expiration date of 26-JAN-2017; however, the dose, dosage number, route of administration and anatomical location were not reported). Information regarding their concomitant therapies was not provided. Despite being vaccinated with an improperly stored vaccine, no adverse events were reported. The vaccine experienced a temperature excursion of -1 F for an unknown time frame. It had previously experienced an excursion of 21 F for a time frame of 108 minutes. The excursion was not called out due to the data logger and the total number of doses administered were reportedly three. Additional information has been requested.