chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JAN-2017, the patient was vaccinated with the improperly stored dose of VARIVAX, subcutaneously (dose was not reported) (lot # M036292, expiration date 17-AUG-2017) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion greater than 5 degrees Fahrenheit and less than 14 degrees Fahrenheit (6.1 degrees Fahrenheit) for 41 hours and 20 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1702USA004122: US-009507513-1702USA004127: US-009507513-1702USA004124: US-009507513-1702USA004125: US-009507513-1702USA004126: US-009507513-1702USA004121: US-009507513-1702USA001032: US-009507513-1702USA004176:
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No adverse event, Seroconversion test negative
Clinical narrative: This spontaneous report was received from a Certified Nurse Practitioner and refers to a 20 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant)(manufacturer unknown), (strength, dose, dose number, route, anatomical location, lot number and expiration date were not reported), for prophylaxis. No other suspect or concomitant therapies were reported. On 14-JAN-2017, a blood titer's test was performed to the patient and the patient "failed to seroconvert" (hepatitis b surface antibody negative).  No adverse events were reported. Product quality complain was not involved. At the time of reporting, the outcome of hepatitis b surface antibody negative was unknown. and, the reporter did not assess the causal relationship between hepatitis b surface antibody negative and the therapy with Hepatitis B Vaccine (Recombinant)(manufacturer unknown). This is one of several reports from the same patient. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005672: US-009507513-1701USA013594:
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Seroconversion test negative, Varicella virus test negative
Clinical narrative: This spontaneous report was received from a Certified Nurse Practitioner and refers to a 20 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated varicella virus vaccine live (oka/merck)(manufacturer unknown), (strength, dose, dose number, route, anatomical location, lot number and expiration date were jot reported), for prophylaxis. No other suspect or concomitant therapies were reported. On 14-JAN-2017,  a blood titer's test was performed to the patient and the patient "failed to seroconvert" (varicella virus test negative).  No adverse events were reported. Product quality complain was not involved. At the time of reporting, the outcome of varicella virus test negative was unknown, and the reporter did not assess the causal relationship between the  varicella virus test negative and the therapy with varicella virus vaccine live (Oka/Merck)(manufacturer unknown). This is one of several reports from the same patient.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA013594: US-009507513-1702USA005671:
Sex: F
Vaccine: ANTH
Symptoms: Autoimmune disorder, Bedridden, Impaired work ability, Malaise
Clinical narrative: A spontaneous report was received via email from a consumer on 31JAN2017. A husband reported that his wife, went from a healthy vibrant person to sick patient that spends most of her time seeing doctors who can't tell what is wrong exactly. He reports that she started showing signs of autoimmune disease following her anthrax vaccine administered. The husband stated that his wife went from being a fitness leader to being bedridden at 35 years old. She was medically discharged after serving 16 years. Additional information has been requested.
Age: 1.58
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: Mom reports fever of 102 since 2/4/17.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swollen Arm on the inside at her elbow.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Constipation, Intussusception, Laparoscopic surgery, Vomiting
Clinical narrative: Vomiting x5, no stooling for 12 hours as of 2:26 PM on 01/03/2017 when seen by doctor.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Cough, Dry eye, Feeling abnormal
Clinical narrative: Sore throat-felt like there was a lump in the back of my throat when swallowing. 7 PM yucky feeling. 8PM Dry eyes. 8:30 PM chills, achy muscles, phlegmy cough and by 10 PM wave of nausea midnight achy muscles & joints
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Productive cough, Sensation of foreign body
Clinical narrative: Sore throat-felt like there was a lump in the back of my throat when swallowing. 7 PM yucky feeling. 8PM Dry eyes. 8:30 PM chills, achy muscles, phlegmy cough and by 10 PM wave of nausea midnight achy muscles & joints
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: After administration of the Influenza vaccine. Stood and walked to the checkout station then passed out standing. Another nurse grabbed the patient and laid the patient down on the gurney. Patient was temporary passed out then came to shortly after by laid down with feet up.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: PAIN IN SHOULDER OF THE ARM VACCINATION WAS GIVEN. PATIENT STATED OVER PHONE CONVERSATION HE CAN NO LONGER ELEVATE ARM ABOVE HEAD.
Age: 35.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: I awoke at 3:30 AM unable to move my neck side to side or up and down. I was in extreme pain in my neck and shoulders extending into my arms.
Age: 35.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: I awoke at 3:30 AM unable to move my neck side to side or up and down. I was in extreme pain in my neck and shoulders extending into my arms.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: She had redness, over upperarm from shoulder to elbow.  It was painful, itchy, and swollen.  She took ibuprofen for the pain.  The area had increased in size from bedtime to morning.  She reported it to me 2/7/17 in the morning and I told her to take oral Benadryl and to watch if the size of the area kept increasing.  She reported back on 2/8/17 that symptoms were improving and report if any relapse.  I haven't heard from her.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Platelet count decreased
Clinical narrative: Possible cause: In a subsequent physical exam on the above date, platelet count was very low, 48.  I have scheduled an appointment with a hematologist on Feb 23 to determine treatment.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site induration, Injection site pain
Clinical narrative: 48 hours after Tdap-large 8x10 cm area of induration at site-tender.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Ache joints, stiff neck, feverish, chills. Raised, warm red area at inj site 6" x 2.5".
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: Ache joints, stiff neck, feverish, chills. Raised, warm red area at inj site 6" x 2.5".
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Influenza, Pain, Pyrexia, Scab
Clinical narrative: Patient received flu shot on right deltoid muscle on 1/20/17. Approximately 1 week later, he came down with flu symptoms (fever, body aches). The flu resolved, but he continues to have pain, soreness and tenderness in his Right arm (underneath the shoulder) and radiates to his right upper back. He has also noticed a scan on his right upper back. Recommended TYELNOL or ADVIL for the pain and if it doesn't resolve in 3-5 days, he should follow up with his primary care provider.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Patient received flu shot on right deltoid muscle on 1/20/17. Approximately 1 week later, he came down with flu symptoms (fever, body aches). The flu resolved, but he continues to have pain, soreness and tenderness in his Right arm (underneath the shoulder) and radiates to his right upper back. He has also noticed a scan on his right upper back. Recommended TYELNOL or ADVIL for the pain and if it doesn't resolve in 3-5 days, he should follow up with his primary care provider.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Blood lactic acid, Chills, Full blood count
Clinical narrative: 1 hour after 3rd dose of TRUMEMBA vaccine patient developed uncontrollable shivering. Prednisone 60 mg oral given.
Age: 51.0
Sex: F
Vaccine: HEPA
Symptoms: Injected limb mobility decreased, Injection site swelling, Injection site warmth
Clinical narrative: Patient received vaccine on Saturday 1/28. Patient called pharmacy on Monday 1/30 to report that the site of injection was swollen and hot to the touch and she couldn't raise her arm.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MENB
Symptoms: Abdominal pain lower, Chills, Crying, Hypoaesthesia, Pain in extremity
Clinical narrative: Concerns with reaction to vaccine. Aunt called, patient received vaccines today and Aunt stated she was crying in pain from vaccines and saying her lower abdomen hurt and fingers on both hands felt numb. The left arm where she received the flu vaccine and MenB vaccine was hurting the worst and patient was complaining that she was having the chills and could not stop shaking. Aunt gave child ibuprofen around 4:00pm, asked Aunt how much Ibuprofen was given - she stated child took two prescription 800mg. Talked with doctor about vaccine concerns and reaction, also discussed amount of ibuprofen patient. Doctor recommended that I tell Aunt to call poison control, which she did, and she called us back to let us know that poison control said the abdominal pain could come from the amount of ibuprofen she took but the other symptoms needed to be mentioned to a physician. Advised Aunt to place cold compress on tender arm and offer clear liquids. I told her I would follow up with them prior to leaving clinic this evening. Time of Call: 02/13/2017 05:13 PM. Aunt called back around 5:20pm, the patient started with a fever of 104 and was shaking on and off. Aunt stated patient was shaking so bad she was rubbing the skin on the inside of her feet raw. I advised Aunt to take patient to one of the hospitals if she felt calm enough to drive her, if not - ok to take her to different hospital or call ambulance for transportation to E/D. Aunt was ok to take her to hospital, which ever one she could get to first. If patient started with seizure like activity, vomiting, syncope, or chest pain prior to leaving for the hospital, call ambulance. Aunt agreed with plan. Response from Doctor: Acknowledged. We need to fill out a VAERS report. Please follow up with patient tomorrow.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MENB
Symptoms: Pyrexia, Tremor
Clinical narrative: Concerns with reaction to vaccine. Aunt called, patient received vaccines today and Aunt stated she was crying in pain from vaccines and saying her lower abdomen hurt and fingers on both hands felt numb. The left arm where she received the flu vaccine and MenB vaccine was hurting the worst and patient was complaining that she was having the chills and could not stop shaking. Aunt gave child ibuprofen around 4:00pm, asked Aunt how much Ibuprofen was given - she stated child took two prescription 800mg. Talked with doctor about vaccine concerns and reaction, also discussed amount of ibuprofen patient. Doctor recommended that I tell Aunt to call poison control, which she did, and she called us back to let us know that poison control said the abdominal pain could come from the amount of ibuprofen she took but the other symptoms needed to be mentioned to a physician. Advised Aunt to place cold compress on tender arm and offer clear liquids. I told her I would follow up with them prior to leaving clinic this evening. Time of Call: 02/13/2017 05:13 PM. Aunt called back around 5:20pm, the patient started with a fever of 104 and was shaking on and off. Aunt stated patient was shaking so bad she was rubbing the skin on the inside of her feet raw. I advised Aunt to take patient to one of the hospitals if she felt calm enough to drive her, if not - ok to take her to different hospital or call ambulance for transportation to E/D. Aunt was ok to take her to hospital, which ever one she could get to first. If patient started with seizure like activity, vomiting, syncope, or chest pain prior to leaving for the hospital, call ambulance. Aunt agreed with plan. Response from Doctor: Acknowledged. We need to fill out a VAERS report. Please follow up with patient tomorrow.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: One month old full term infant received hep B vaccination 2/11/17. On 2/12/17 left leg, anterior thigh is mildly swollen, not red, slightly tender, slightly warm.
Age: 9.0
Sex: M
Vaccine: DTAP, FLU4, IPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 year old male patient. No medical history, concomitant therapies, drug reactions and allergies or concurrent conditions were reported. 02-NOV-2016 at 15:15 hours, the patient was vaccinated with a dose of M-M-R II (lot # M015931 expiry date not reported, dose 1 administered on left deltoid, dose and injection route and site were not reported). Other suspect therapies included diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid and influenza virus vaccine (unspecified). Data logger was involved. On an unknown date, the vaccine was stored at temperature of 11.5F (also reported as 12 F), time frame was reported as 18 days and 19 hours. There were no previous temperature excursions. No adverse events were reported and he did not have illness at the time of vaccination. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA004027.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist 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 26-JAN-2017, the patient was vaccinated with a expired dose of ZOSTAVAX lot # L035504 with an expiration date 16-DEC-2016 for prophylaxis (dose, route of administration and anatomical location were not reported). No adverse effects were reported. Product quality complaint (PQC) was not reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Arm pain (severe) with radiation up to neck/shoulder occurring 48 hrs after vaccine. 10/10 severe pain.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Arm pain (severe) with radiation up to neck/shoulder occurring 48 hrs after vaccine. 10/10 severe pain.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abnormal behaviour, Activities of daily living impaired, Anger, Asthenia, Back pain
Clinical narrative: Initial unsolicited report received from a consumer from on 17-Jan-2017. This case involves a 80-year-old male patient, who was vaccinated with FLUZONE HD (lot number, expiry date, route and site of administration not reported) in right arm on 07-Dec-2016. Patient previously vaccinated with unspecified vaccines without any adverse event. Patient also received flu vaccine for 45 years without any adverse event. Patient's concomitant medication was not reported. On an unknown date of Dec-2016, after the vaccination, patient experienced intense pain in right arm, which was increasing and was suffering from injury and debilitation so much that patient cannot lift the bed covers off among other normal activities one dose with the right arm. It was also reported that patient had pain and weakness in right arm. Patient had a doctor visit on 06-Jan-2017. Patient's lab data and corrective treatment was not reported. The patient was not yet recovered from the events (Still had pain and weakness in right arm after 41 days). List of the documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bone scan, Chills, Condition aggravated, Crying, Decreased appetite
Clinical narrative: Initial unsolicited report received from a consumer from on 17-Jan-2017. This case involves a 80-year-old male patient, who was vaccinated with FLUZONE HD (lot number, expiry date, route and site of administration not reported) in right arm on 07-Dec-2016. Patient previously vaccinated with unspecified vaccines without any adverse event. Patient also received flu vaccine for 45 years without any adverse event. Patient's concomitant medication was not reported. On an unknown date of Dec-2016, after the vaccination, patient experienced intense pain in right arm, which was increasing and was suffering from injury and debilitation so much that patient cannot lift the bed covers off among other normal activities one dose with the right arm. It was also reported that patient had pain and weakness in right arm. Patient had a doctor visit on 06-Jan-2017. Patient's lab data and corrective treatment was not reported. The patient was not yet recovered from the events (Still had pain and weakness in right arm after 41 days). List of the documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Dysphagia, Dyspnoea, Dysstasia, Eye pruritus
Clinical narrative: Initial unsolicited report received from a consumer from on 17-Jan-2017. This case involves a 80-year-old male patient, who was vaccinated with FLUZONE HD (lot number, expiry date, route and site of administration not reported) in right arm on 07-Dec-2016. Patient previously vaccinated with unspecified vaccines without any adverse event. Patient also received flu vaccine for 45 years without any adverse event. Patient's concomitant medication was not reported. On an unknown date of Dec-2016, after the vaccination, patient experienced intense pain in right arm, which was increasing and was suffering from injury and debilitation so much that patient cannot lift the bed covers off among other normal activities one dose with the right arm. It was also reported that patient had pain and weakness in right arm. Patient had a doctor visit on 06-Jan-2017. Patient's lab data and corrective treatment was not reported. The patient was not yet recovered from the events (Still had pain and weakness in right arm after 41 days). List of the documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling cold, Flushing, Gait disturbance, Hypertension, Impatience
Clinical narrative: Initial unsolicited report received from a consumer from on 17-Jan-2017. This case involves a 80-year-old male patient, who was vaccinated with FLUZONE HD (lot number, expiry date, route and site of administration not reported) in right arm on 07-Dec-2016. Patient previously vaccinated with unspecified vaccines without any adverse event. Patient also received flu vaccine for 45 years without any adverse event. Patient's concomitant medication was not reported. On an unknown date of Dec-2016, after the vaccination, patient experienced intense pain in right arm, which was increasing and was suffering from injury and debilitation so much that patient cannot lift the bed covers off among other normal activities one dose with the right arm. It was also reported that patient had pain and weakness in right arm. Patient had a doctor visit on 06-Jan-2017. Patient's lab data and corrective treatment was not reported. The patient was not yet recovered from the events (Still had pain and weakness in right arm after 41 days). List of the documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site joint pain, Injection site pain, Injury, Insomnia, Irritability
Clinical narrative: Initial unsolicited report received from a consumer from on 17-Jan-2017. This case involves a 80-year-old male patient, who was vaccinated with FLUZONE HD (lot number, expiry date, route and site of administration not reported) in right arm on 07-Dec-2016. Patient previously vaccinated with unspecified vaccines without any adverse event. Patient also received flu vaccine for 45 years without any adverse event. Patient's concomitant medication was not reported. On an unknown date of Dec-2016, after the vaccination, patient experienced intense pain in right arm, which was increasing and was suffering from injury and debilitation so much that patient cannot lift the bed covers off among other normal activities one dose with the right arm. It was also reported that patient had pain and weakness in right arm. Patient had a doctor visit on 06-Jan-2017. Patient's lab data and corrective treatment was not reported. The patient was not yet recovered from the events (Still had pain and weakness in right arm after 41 days). List of the documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint swelling, Mobility decreased, Mood swings, Muscle spasms, Muscular weakness
Clinical narrative: Initial unsolicited report received from a consumer from on 17-Jan-2017. This case involves a 80-year-old male patient, who was vaccinated with FLUZONE HD (lot number, expiry date, route and site of administration not reported) in right arm on 07-Dec-2016. Patient previously vaccinated with unspecified vaccines without any adverse event. Patient also received flu vaccine for 45 years without any adverse event. Patient's concomitant medication was not reported. On an unknown date of Dec-2016, after the vaccination, patient experienced intense pain in right arm, which was increasing and was suffering from injury and debilitation so much that patient cannot lift the bed covers off among other normal activities one dose with the right arm. It was also reported that patient had pain and weakness in right arm. Patient had a doctor visit on 06-Jan-2017. Patient's lab data and corrective treatment was not reported. The patient was not yet recovered from the events (Still had pain and weakness in right arm after 41 days). List of the documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal stiffness, Nausea, Nocturia, Nuclear magnetic resonance imaging, Obsessive-compulsive disorder
Clinical narrative: Initial unsolicited report received from a consumer from on 17-Jan-2017. This case involves a 80-year-old male patient, who was vaccinated with FLUZONE HD (lot number, expiry date, route and site of administration not reported) in right arm on 07-Dec-2016. Patient previously vaccinated with unspecified vaccines without any adverse event. Patient also received flu vaccine for 45 years without any adverse event. Patient's concomitant medication was not reported. On an unknown date of Dec-2016, after the vaccination, patient experienced intense pain in right arm, which was increasing and was suffering from injury and debilitation so much that patient cannot lift the bed covers off among other normal activities one dose with the right arm. It was also reported that patient had pain and weakness in right arm. Patient had a doctor visit on 06-Jan-2017. Patient's lab data and corrective treatment was not reported. The patient was not yet recovered from the events (Still had pain and weakness in right arm after 41 days). List of the documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Peripheral coldness, Screaming, Spinal pain, Urinary retention
Clinical narrative: Initial unsolicited report received from a consumer from on 17-Jan-2017. This case involves a 80-year-old male patient, who was vaccinated with FLUZONE HD (lot number, expiry date, route and site of administration not reported) in right arm on 07-Dec-2016. Patient previously vaccinated with unspecified vaccines without any adverse event. Patient also received flu vaccine for 45 years without any adverse event. Patient's concomitant medication was not reported. On an unknown date of Dec-2016, after the vaccination, patient experienced intense pain in right arm, which was increasing and was suffering from injury and debilitation so much that patient cannot lift the bed covers off among other normal activities one dose with the right arm. It was also reported that patient had pain and weakness in right arm. Patient had a doctor visit on 06-Jan-2017. Patient's lab data and corrective treatment was not reported. The patient was not yet recovered from the events (Still had pain and weakness in right arm after 41 days). List of the documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vision blurred, Weight decreased, Wheezing, Yawning
Clinical narrative: Initial unsolicited report received from a consumer from on 17-Jan-2017. This case involves a 80-year-old male patient, who was vaccinated with FLUZONE HD (lot number, expiry date, route and site of administration not reported) in right arm on 07-Dec-2016. Patient previously vaccinated with unspecified vaccines without any adverse event. Patient also received flu vaccine for 45 years without any adverse event. Patient's concomitant medication was not reported. On an unknown date of Dec-2016, after the vaccination, patient experienced intense pain in right arm, which was increasing and was suffering from injury and debilitation so much that patient cannot lift the bed covers off among other normal activities one dose with the right arm. It was also reported that patient had pain and weakness in right arm. Patient had a doctor visit on 06-Jan-2017. Patient's lab data and corrective treatment was not reported. The patient was not yet recovered from the events (Still had pain and weakness in right arm after 41 days). List of the documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Asthenia, Injury, Muscular weakness, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer from on 17-Jan-2017. This case involves a 80-year-old male patient, who was vaccinated with FLUZONE HD (lot number, expiry date, route and site of administration not reported) in right arm on 07-Dec-2016. Patient previously vaccinated with unspecified vaccines without any adverse event. Patient also received flu vaccine for 45 years without any adverse event. Patient's concomitant medication was not reported. On an unknown date of Dec-2016, after the vaccination, patient experienced intense pain in right arm, which was increasing and was suffering from injury and debilitation so much that patient cannot lift the bed covers off among other normal activities one dose with the right arm. It was also reported that patient had pain and weakness in right arm. Patient had a doctor visit on 06-Jan-2017. Patient's lab data and corrective treatment was not reported. The patient was not yet recovered from the events (Still had pain and weakness in right arm after 41 days). List of the documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Chest X-ray, Dyspnoea, Eructation, Erythema
Clinical narrative: 12/24/16 BELCHING, RUNNY NOSE, DIFFICULTY BREATHING, RASH, REDNESS NECK AND CHEST AREA. 12/31/16 SENSITIVE TO COLD, TINGLING OF HANDS, FEET, ARMS, CRAWLING SENSATION BACK AND SCALP, FATIGUE. SEEN GP 4 TIMES AND NEUROLOGIST 2 TIMES. AS OF 2/10/17 NECK PAIN, TINGLING SENSATION ARMS AND LEGS WORSEN, WITH NEW SYMPTOMS OF BURNING SENSATION. PAIN IN HANDS, FEET, AND MUSCLE ACHES AND GENERALIZED FATIGUE.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Formication, Myalgia, Neck pain, Pain in extremity
Clinical narrative: 12/24/16 BELCHING, RUNNY NOSE, DIFFICULTY BREATHING, RASH, REDNESS NECK AND CHEST AREA. 12/31/16 SENSITIVE TO COLD, TINGLING OF HANDS, FEET, ARMS, CRAWLING SENSATION BACK AND SCALP, FATIGUE. SEEN GP 4 TIMES AND NEUROLOGIST 2 TIMES. AS OF 2/10/17 NECK PAIN, TINGLING SENSATION ARMS AND LEGS WORSEN, WITH NEW SYMPTOMS OF BURNING SENSATION. PAIN IN HANDS, FEET, AND MUSCLE ACHES AND GENERALIZED FATIGUE.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Rash, Rhinorrhoea, Spinal X-ray, Temperature intolerance
Clinical narrative: 12/24/16 BELCHING, RUNNY NOSE, DIFFICULTY BREATHING, RASH, REDNESS NECK AND CHEST AREA. 12/31/16 SENSITIVE TO COLD, TINGLING OF HANDS, FEET, ARMS, CRAWLING SENSATION BACK AND SCALP, FATIGUE. SEEN GP 4 TIMES AND NEUROLOGIST 2 TIMES. AS OF 2/10/17 NECK PAIN, TINGLING SENSATION ARMS AND LEGS WORSEN, WITH NEW SYMPTOMS OF BURNING SENSATION. PAIN IN HANDS, FEET, AND MUSCLE ACHES AND GENERALIZED FATIGUE.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: X-ray limb
Clinical narrative: 12/24/16 BELCHING, RUNNY NOSE, DIFFICULTY BREATHING, RASH, REDNESS NECK AND CHEST AREA. 12/31/16 SENSITIVE TO COLD, TINGLING OF HANDS, FEET, ARMS, CRAWLING SENSATION BACK AND SCALP, FATIGUE. SEEN GP 4 TIMES AND NEUROLOGIST 2 TIMES. AS OF 2/10/17 NECK PAIN, TINGLING SENSATION ARMS AND LEGS WORSEN, WITH NEW SYMPTOMS OF BURNING SENSATION. PAIN IN HANDS, FEET, AND MUSCLE ACHES AND GENERALIZED FATIGUE.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unspecified date, in 2015, the patient was vaccinated with the first dose in the series of GARDASIL (dose, route of administrations, Lot # and expiration date were not reported) for prophylaxis. The healthcare worker reported that the patient was in the office, on 16-JAN-2017, to receive the second dose in the series of GARDASIL, which was longer than recommended, but she did not receive the dose as the Center was closed and she was unable to call them to ask if GARDASIL 9 could be used as the second dose. No adverse effects were reported. There was no product quality complaint 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 referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses (5 doses) of PROQUAD lot number L032761, expiration date: 24-FEB-2017 (dose and route of administration were not provided) for prophylaxis. There were no adverse effects reported. Administered doses of PROQUAD were exposed to a temperature excursion of >5°F but <14°F for 2 hours 20 minutes and >14°F but <46°F for 50 minutes. Data logger was involved. There were previous temperature excursions of >14°F but <46°F for 6 hours 10 minutes. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA006035.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. On an unknown date the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # M036728, expiration date 20-MAY-2018, 0 .5 ml (strength, frequency, route of administration were not provided) for prophylaxis. The reporter stated that the temperature range of the vaccine was >46 Fahrenheit degrees (F) but <77  Fahrenheit degrees (F) and the time frame was 2 hours and 40 minutes. There was not previous temperature excursion, this information was registered in a digital data logger. No symptoms were reported nor product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unspecified date in 2014, the patient was vaccinated with GARDASIL 9, then on an unspecified date in 2016, the patient was vaccinated with 2 doses of GARDASIL (interchange of vaccine products) (dose, route, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 31-JAN-2017, the patient was vaccinated with an expired dose of VAQTA, injection (unspecified strength, dose and frequency) (Lot number: L027735; expiration date: 12-JAN-2017) for prophylaxis. No adverse effects were reported. 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 as received from a registered nurse referring 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 was vaccinated with an improperly stored dose of GARDASIL 9 lot # M009378, expiration date 23-APR-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of : >46 degrees Fahrenheit but < 77 degrees Fahrenheit for 2 hours 36 minutes according to the data logger. There were no previous excursions reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Keratitis
Clinical narrative: This spontaneous report was received from a healthcare professional via an article published online by unknown source, which was brought to the attention of global safety by a sales representative. It concerns an unspecified number of adult patients of unknown age and gender; whose concurrent conditions, medical history or concomitant medications were unknown. On an unknown date, the patients were vaccinated with zoster vaccine live (manufacturer unknown) as shingles vaccine or with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) as chickenpox vaccine (dose, route of administration, lot number and expiration date were not reported). On an unknown date, within 24 days after of vaccination, the patients developed symptoms of keratitis. At the reporting time, the outcome of keratitis was unknown. The causality between ZOSTAVAX and keratitis was not reported. Upon internal review, the keratitis was considered a medically significant event. There was no product quality complaint involved. This is one of two reports received from the same source. Additional information is not expected as no consent was given to contact the reporter. Sender's Comments: US-009507513-1702USA002429.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Keratitis
Clinical narrative: This spontaneous report was received from a healthcare professional via an article published online by unknown source, which was brought to the attention of global safety by a sales representative. It concerns an unspecified number of child patients of unknown age and gender; whose concurrent conditions, medical history or concomitant medications were unknown. On an unknown date, the patients were vaccinated with zoster vaccine live (manufacturer unknown) as shingles vaccine or with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) as chickenpox vaccine (dose, route of administration, lot number and expiration date were not reported) (dose, route of administration, Lot # and expiration date were not reported) for prophylaxis. On an unknown date, within 14 days after of vaccination, the children developed symptoms of keratitis (also reported as after receive a chickenpox or shingles vaccine). At the reporting time, the outcome of keratitis was unknown. The causality between the vaccines and keratitis was not reported. Upon internal review, the keratitis was considered a medically significant event. There was no product quality complaint involved. This is one of two reports received from the same source. Additional information is not expected as we can not contact the physician. Sender's Comments: US-009507513-1702USA002427.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent condition, drug reactions/allergies and concomitant medication were not reported. On 01-FEB-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection (lot # M009378; expiry date: 23-APR-2018) (dosing details were not reported) for prophylaxis. Nurse reported that the vaccine was exposed at >46 F but <77 F for 2 hours 36 minutes. There were no previous temperature excursions. Data Logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 08-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot number M006102, expiration date 01-AUG-2017, (dose, route and anatomical location were not reported), for prophylaxis. The temperature was greater than -10 Celsius degrees but less than 8 Celsius degrees for a time frame of 40 hours. The vaccines did not experience any previous temperature excursion and digital data logger was not involved. The outcome was reported as "Supported". No product quality complain was involved. No other suspect or concomitant therapies were reported. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA005705.
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from the patient's father concerning his 16 year old son with allergy to red dye 40 and no pertinent medical history. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (dose and lot # not reported) intramuscularly. There was no concomitant medication.       On an unknown date, the patient experienced hives. The patient spent an unspecified amount of time at urgent care and received an unspecified treatment. There were no Lab/diagnosis or studies performed. The patient would see his physician on 10-FEB-2017 for a follow up. At the time of the report, the patient had not recovered.  Additional information is not expected as the reporter does not want to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 08-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot number M006102, expiration date 01-AUG-2017, (dose, route and anatomical location were not reported), for prophylaxis. The temperature was greater than -10 Celsius degrees but less than 8 Celsius degrees for a time frame of 40 hours. The vaccines did not experienced any previous temperature excursion, and, digital data logger was not involved. The outcome was reported as "Supported". No adverse effects were reported. No product quality complain was involved. No other suspect or concomitant therapies were reported. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005613:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients received 1 improperly stored dose of VARIVAX lot number L025207, expiration date: 07-JUL-2017 (dose and route of administration were not provided) for prophylaxis. There were no adverse effects reported. Administered doses of VARIVAX were exposed to a temperature excursion of >5°F but <14°F for 2 hours 20 minutes and >14°F but <46°F for 50 minutes. Data logger was involved.  There were previous temperature excursions of >14°F but <46°F for 6 hours 10 minutes. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000275:
Sex: F
Vaccine: TTOX
Symptoms: Herpes zoster
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) via other company, Pfizer (Reference number- 2016211870) on 30-Jan-2017. This case involves a female patient (age was not reported) who was vaccinated with TETANUS TOXOID (Tetanus shot) (lot number, expiration date, route of administration, site of administration, dose and dose in series were not reported) on an unspecified day. The medical history and the concomitant medications were not reported. On an unknown day of 2016 (reported as summer 2016), following the vaccination, the patient developed shingles on her arm. The laboratory test and the corrective treatment was not reported. On an unknown day, the outcome of the event was recovered (reported as event for a while). List of the documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site mass
Clinical narrative: Initial unsolicited pregnancy report received from a patienton 31-JAN-2017. This case involves a female patient (onset age unknown) who was vaccinated with a first dose injection of ADACEL (batch number: UI568AA, expiry date: UI568AA 16-JUN-2018, dose were not reported) in the unknown route (reported as subcutaneous or intramuscular) in right deltoid on 17-JAN-2017 while she was pregnant. The patient had reported her last menstrual period on an unknown date of JUN-2016 and estimated conception period was not reported. The patient also reported expected delivery date on 27-MAR-2017. The patient's medical history was reported as Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify): Patient denied and comment regarding the mother's health during pregnancy, specific risk factors (e.g.: alcohol, tobacco drugs) was not reported. The patient had not reported any concomitant medications. Any other vaccinations within four weeks of vaccinations were also not reported. On 18-JAN-2017, one day following the vaccination, the patient had developed a lump in the injection site. It was a case of vaccine exposure during pregnancy. The corrective treatment was reported as the patient had self-medicated with Tylenol. The outcome if the event was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Epicondylitis
Clinical narrative: Initial unsolicited report received from a consumer via nurse on 31-Jan-2017. This case involves a female patient (age not reported), who was vaccinated with a dose of DIPHTHERIA AND TETANUS (batch number, expiry date, dose, route and dose in series not reported) on an unknown date. Patient had a medical history of multiple sclerosis for which patient was taking AUBAGIO orally since 29-Dec-2016 as concomitant medication. On an unspecified date after the vaccination, patient had developed cellulitis on left side and tennis elbow on right side. Lab test was not reported. Corrective treatment included ten day course of antibiotics which was completed by patient. Outcome of the events was reported as unknown. Upon internal review the case was considered as serious because of important medical events: cellulitis on left side and tennis elbow on right side. Documents held by sender: none. Sender's Comments: This case concerns an unknown age female with history of multiple sclerosis (MS) was on AUBAGIO, who received DIPHTHERIA AND TETANUS TOXOIDS and experienced cellulitis on left side and tennis elbow on right side. Time to onset is unknown. However details regarding relevant medical history, prior vaccination history and its tolerance, patient demographics, diameter of the cellulitis are needed for complete assessment of the case.
Age: 43.0
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2014051489) on 31-Jan-2017. This case involves a female patient (onset age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination the patient experienced Allergic to Tetanus Shot (Allergy to vaccine). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer, Manufacturer report number: 20166568559) on 31 January 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, dose, site and route of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient was allergic to tetanus toxoid. Lab data and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient had redness, itchy, and hot around injection site that appeared 6 days after injection.