chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: School nurse called Mother stating child's arm is red, swollen and warm to touch. Mom picked him up from school and brought to health department where injection was given. This nurse assessed area. Arm was swollen, red and warm to touch. Mom has not given child any medications today. Child states he did sleep on it but started hurting first thing the morning. AROM to right arm. Cap refill less than 3 sec. Child could squeeze my hand. Rated pain a 4/10. Instructed Mom about slight adverse reaction, apply ice a couple times a day for at least 30 minutes. Instructed Mom to alt between TYLENOL and ibuprofen. Dosage handout given to Mom. Instructed Mom, next year when he gets his flu shot, premedicate with antihistamine and do TYLENOL and ibuprofen alt 24 hours after injection. Mom verbalized understanding and has no further questions. Other children in the home did not have any reactions to their flu injection. Child denies any s/s anaphylaxis and if he does to tell Mom right away and go to nearest ER. Later that evening this nurse called to check on patient, Mom stated the child is doing very well.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Respiratory rate increased
Clinical narrative: Chest burning, shortness of breath, increased heart rate and respirations, couldn't get air exchange well for one hour.
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Dermatitis contact, Injection site scab, Insomnia, Musculoskeletal pain, Pain in extremity
Clinical narrative: After receiving the flu vaccine, patient had a reaction to the adhesive bandage. There is a permanent mark on her arm where the adhesive touched her skin. She states that her arm hurts, shoulder hurts, and she can't sleep on that side and that her shoulder/arm is swollen. She has an appointment to go to the doctor on Friday, October 19, 2018.
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Peripheral swelling
Clinical narrative: After receiving the flu vaccine, patient had a reaction to the adhesive bandage. There is a permanent mark on her arm where the adhesive touched her skin. She states that her arm hurts, shoulder hurts, and she can't sleep on that side and that her shoulder/arm is swollen. She has an appointment to go to the doctor on Friday, October 19, 2018.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Withing 10 minutes of vaccination experienced generalized pruritis and welting on back. Benadryl 50mg taken with relief from all symptoms within 30 minutes.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site movement impairment, Injection site pain, Injection site swelling
Clinical narrative: 5 yo male p/w arm pain, erythema, swelling and decreased ROM s/p receiving flu vaccine 2 days ago. Mom reports some initial difficulty moving his arm after receiving the vaccine. Yesterday afternoon, mom noticed that his entire upper arm appeared red, swollen and warm to the touch. Mom reports today he is moving his arm a little more though the redness and swelling seems slightly worse. Denies fever. Otherwise acting at baseline. Eating and drinking well. No treatments tried. No previous adverse reaction to vaccines per report. A: Cellulitis of left upper arm; adverse effect of influenza vaccine; P: - BENADRYL 12.5 mg/5 mL liquid 25 mg; Take 10 mLs (25 mg per dose) by mouth once given in office. - KEFLEX 250 mg/5 mL suspension; Take 5.3 mLs (265 mg per dose) by mouth 2 (two) times daily for 10 days. Dispense: 106 mL; Refill: 0 - F/u in 2 days.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: 5 yo male p/w arm pain, erythema, swelling and decreased ROM s/p receiving flu vaccine 2 days ago. Mom reports some initial difficulty moving his arm after receiving the vaccine. Yesterday afternoon, mom noticed that his entire upper arm appeared red, swollen and warm to the touch. Mom reports today he is moving his arm a little more though the redness and swelling seems slightly worse. Denies fever. Otherwise acting at baseline. Eating and drinking well. No treatments tried. No previous adverse reaction to vaccines per report. A: Cellulitis of left upper arm; adverse effect of influenza vaccine; P: - BENADRYL 12.5 mg/5 mL liquid 25 mg; Take 10 mLs (25 mg per dose) by mouth once given in office. - KEFLEX 250 mg/5 mL suspension; Take 5.3 mLs (265 mg per dose) by mouth 2 (two) times daily for 10 days. Dispense: 106 mL; Refill: 0 - F/u in 2 days.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema annulare, Flushing, Injection site reaction
Clinical narrative: SITE REACTION- ERYTHEMATOUS ANNULAR REACTION AT SITE (ONGOING) FLUSHING OF EARS AND FACE AND T MAX OF 99.0 FOR ABOUT 3 HOURS.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: Pt had a rash, fever, chills 24 hrs after the shot and it lasted 48 hrs.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPAB
Symptoms: Angioedema, Urticaria
Clinical narrative: A onetime episode of hives without angioedema or airway involvement that resolved with the administration of Benadryl and steroids. There is an automatic concern for anaphylaxis when hives occur, however anaphylaxis involves more than one body system. 2 ½ hours prior to the event he received his first influenza immunization (AFLURIA) and his second TWINRIX.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Upper left arm, in area of MCV4 vaccine, the arm is red, swollen, hot. The redness extends approx. 12 cm x 10 cm. The symptoms started several hours after the immunization was given. Patient has taken ibuprofen and BENADRYL. I have advised to continue as needed. And ice several times daily. Seek medical attention immediately if he has any difficulty breathing.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Injection site joint pain, Injection site pain
Clinical narrative: Severe pain in the joint area and at the back of the left arm along with trouble breathing approx. 15 hours after receiving the vaccine .
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 24-AUG-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot# R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis (product storage error). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 20-JAN-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 11-SEP-2017, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was treated with LYRICA for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX at physician's office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated at the same physician's office for a vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 27-AUG-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot # R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis. The sterile diluent (MERCK) (lot # and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 14-AUG-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot # R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Within 3 hours of injection, onset of chills, fever up to 101F, diffuse myalgias, intense fatigue/prostration lasting 24-30 hours before complete resolution. Symptoms were significant enough to disrupt my call duty that Saturday.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, redness, and induration in the area of injection.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Cardiac stress test, Dyspnoea, Feeling hot, Injection site pain
Clinical narrative: On July 14, 2018 at approximately 2:30 a.m. I got up to go to the bathroom and after standing up, I had a rush of warmth from my waist to my feet and for approximately 1 minute I was unable to pick my feet off the floor. My brain was telling my feet to move - but nothing. When I got into bed, I began to have pins and needles up and down my legs. This quasi-paralysis went on for 5-6 days. On July 23, 2018, I began experiencing sharp, jabbing pains behind my right shoulder (opposite side of vaccination). After 2-3 days I had to see an after-hours orthopedic surgeon. I was put on 10 days of prednisone. After finishing the steroid, the pain came back with a vengeance only this time in the left shoulder then moved to the center of the back. This went on for 2-3 days. I began experiencing extreme weakness in my once strong, muscular legs and became breathless, especially when climbing stairs. Initially, my arms were weak as well. Now, the weakness is primarily in my legs. I have seen a neurologist, my GP, an orthopedic surgeon, and a cardiac specialist (as one doctor thought the breathlessness and weakness could be my heart) and have had MRIs, Xrays, nerve and muscle conduction tests and stress tests. I have NEVER had an adverse reaction to any vaccinations before this. I am afraid I will not recover from this. (Note: question below offer me a choice to put unknown permanent damage so I must mark permanent).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Muscular weakness, Musculoskeletal pain, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: On July 14, 2018 at approximately 2:30 a.m. I got up to go to the bathroom and after standing up, I had a rush of warmth from my waist to my feet and for approximately 1 minute I was unable to pick my feet off the floor. My brain was telling my feet to move - but nothing. When I got into bed, I began to have pins and needles up and down my legs. This quasi-paralysis went on for 5-6 days. On July 23, 2018, I began experiencing sharp, jabbing pains behind my right shoulder (opposite side of vaccination). After 2-3 days I had to see an after-hours orthopedic surgeon. I was put on 10 days of prednisone. After finishing the steroid, the pain came back with a vengeance only this time in the left shoulder then moved to the center of the back. This went on for 2-3 days. I began experiencing extreme weakness in my once strong, muscular legs and became breathless, especially when climbing stairs. Initially, my arms were weak as well. Now, the weakness is primarily in my legs. I have seen a neurologist, my GP, an orthopedic surgeon, and a cardiac specialist (as one doctor thought the breathlessness and weakness could be my heart) and have had MRIs, Xrays, nerve and muscle conduction tests and stress tests. I have NEVER had an adverse reaction to any vaccinations before this. I am afraid I will not recover from this. (Note: question below offer me a choice to put unknown permanent damage so I must mark permanent).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Paralysis, X-ray
Clinical narrative: On July 14, 2018 at approximately 2:30 a.m. I got up to go to the bathroom and after standing up, I had a rush of warmth from my waist to my feet and for approximately 1 minute I was unable to pick my feet off the floor. My brain was telling my feet to move - but nothing. When I got into bed, I began to have pins and needles up and down my legs. This quasi-paralysis went on for 5-6 days. On July 23, 2018, I began experiencing sharp, jabbing pains behind my right shoulder (opposite side of vaccination). After 2-3 days I had to see an after-hours orthopedic surgeon. I was put on 10 days of prednisone. After finishing the steroid, the pain came back with a vengeance only this time in the left shoulder then moved to the center of the back. This went on for 2-3 days. I began experiencing extreme weakness in my once strong, muscular legs and became breathless, especially when climbing stairs. Initially, my arms were weak as well. Now, the weakness is primarily in my legs. I have seen a neurologist, my GP, an orthopedic surgeon, and a cardiac specialist (as one doctor thought the breathlessness and weakness could be my heart) and have had MRIs, Xrays, nerve and muscle conduction tests and stress tests. I have NEVER had an adverse reaction to any vaccinations before this. I am afraid I will not recover from this. (Note: question below offer me a choice to put unknown permanent damage so I must mark permanent).
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Injection site erythema, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Pt began to notice redness extending down her right arm from the site of the vaccination on 10/9/18 in the evening. The reaction covered the majority of her upper arm wrapping around to the interior part closest to her body. She had a slight fever, never over 100 degrees, and felt bad all day the day after her immunizations keeping her in bed most of the day. The arm remained red and slightly swollen through 10/14/18. Reaction was completely gone by 10/15/18. The arm was also very itchy during the whole reaction.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Neuralgia, Paraesthesia
Clinical narrative: Hit axillary nerve branch. Numbness, tingling and nerve pain from left ear all the way down to left fingers.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Oedema, Rash erythematous, Rash pruritic, Skin plaque
Clinical narrative: Rash started on 9/30/18. Rash is erythematous, edematous patches and plaques with lighter centers that are distributed to the face, neck, trunk, groin and proximal upper/lower extremities. Rash is pruritic. Was seen in our office on 10/1/18. ORAPRED was ordered for BID x 3 days. OTC antihistamines were discussed. Was diagnosed with sinusitis on 9/10/18 and placed on amoxicillin for 10 day course.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient is experiencing excruciating pain at injection site and palpitation unable to lift arm since receiving 2nd dose of SHINGRIX. No swelling or redness.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Periarthritis, Product administered at inappropriate site
Clinical narrative: Patient is experiencing excruciating pain at injection site and palpitation unable to lift arm since receiving 2nd dose of SHINGRIX. No swelling or redness.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rotator cuff syndrome
Clinical narrative: Patient is experiencing excruciating pain at injection site and palpitation unable to lift arm since receiving 2nd dose of SHINGRIX. No swelling or redness.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blood test normal, Chills, Dizziness, Headache
Clinical narrative: Pain redness rash at injection site, spent next two days (9-19 and 9-20) in bed with nausea, muscle pain, dizziness, shivers, headache, and approximately 36 hours after injection began sharp pain in right ribs that traveled into my right back. Went to my physician on September 26, 2018. They ordered blood test and ultrasound of my right quadrant stomach and gave prescription for acyclovir 800mg. Symptoms persisted for about 10 days. About 4 days after beginning medication I was able to resume some normal activities. Headache and dizziness persisted until about 3 days ago, October 14, 2018, and still have some back pain when lying down.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Pain redness rash at injection site, spent next two days (9-19 and 9-20) in bed with nausea, muscle pain, dizziness, shivers, headache, and approximately 36 hours after injection began sharp pain in right ribs that traveled into my right back. Went to my physician on September 26, 2018. They ordered blood test and ultrasound of my right quadrant stomach and gave prescription for acyclovir 800mg. Symptoms persisted for about 10 days. About 4 days after beginning medication I was able to resume some normal activities. Headache and dizziness persisted until about 3 days ago, October 14, 2018, and still have some back pain when lying down.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound abdomen normal
Clinical narrative: Pain redness rash at injection site, spent next two days (9-19 and 9-20) in bed with nausea, muscle pain, dizziness, shivers, headache, and approximately 36 hours after injection began sharp pain in right ribs that traveled into my right back. Went to my physician on September 26, 2018. They ordered blood test and ultrasound of my right quadrant stomach and gave prescription for acyclovir 800mg. Symptoms persisted for about 10 days. About 4 days after beginning medication I was able to resume some normal activities. Headache and dizziness persisted until about 3 days ago, October 14, 2018, and still have some back pain when lying down.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Beginning same day as vaccination pt had redness and swelling from site of injection to elbow. Middle of the night had chills. The next morning pt had severe headache and body aches with fever around 100 degrees Fahrenheit. Pt took ADVIL, which helped some with the symptoms. Headache lasted about 24 hours, body aches lasted about a week. Pt spoke with primary care physician who told her to take ADVIL and to just monitor. Pt states when pt is very warm the area of the arm gets red.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Beginning same day as vaccination pt had redness and swelling from site of injection to elbow. Middle of the night had chills. The next morning pt had severe headache and body aches with fever around 100 degrees Fahrenheit. Pt took ADVIL, which helped some with the symptoms. Headache lasted about 24 hours, body aches lasted about a week. Pt spoke with primary care physician who told her to take ADVIL and to just monitor. Pt states when pt is very warm the area of the arm gets red.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature decreased, Hyperhidrosis, Peripheral coldness, Rash, Rash maculo-papular
Clinical narrative: Was seen in ED on 9/4/18 for maculopapular rash and decreased temperature. Mother reported sweating through her clothes. She then noted babe was cold and re-dressed her. Babe again sweat through her clothes and as mom was undressing her again, checked her temperature (96.4 rectal) and noted a rash on her abdomen. Temperature was 97.3 degrees in ED. ED stated that this is consistent with viral illness.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Was seen in ED on 9/4/18 for maculopapular rash and decreased temperature. Mother reported sweating through her clothes. She then noted babe was cold and re-dressed her. Babe again sweat through her clothes and as mom was undressing her again, checked her temperature (96.4 rectal) and noted a rash on her abdomen. Temperature was 97.3 degrees in ED. ED stated that this is consistent with viral illness.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Allodynia, Headache, Injection site pain, Myalgia, Neck pain
Clinical narrative: The patient started feeling aches and pains the night after the vaccination. The next morning she reported headache, jaw pain, a sore neck, diffuse body aches, allodynia, fever, and injection site pain on the side of the SHINGRIX vaccination. The patient was counseled to take ibuprofen and acetaminophen to help with fever and muscle pain. Symptoms have not resolved at time of writing.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain, Pain in jaw, Pyrexia
Clinical narrative: The patient started feeling aches and pains the night after the vaccination. The next morning she reported headache, jaw pain, a sore neck, diffuse body aches, allodynia, fever, and injection site pain on the side of the SHINGRIX vaccination. The patient was counseled to take ibuprofen and acetaminophen to help with fever and muscle pain. Symptoms have not resolved at time of writing.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Injury associated with device
Clinical narrative: I was dropping the syringe into the sharps container after I finished the injection, and the needle landed on my middle knuckle on my right hand. It was a superficial puncture with no visible blood. I was able to see a small mark where it landed after I removed my glove.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 14-AUG-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot# R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis (product storage error). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 24-Aug-18, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot # R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis (product storage error). The sterile diluent (MERCK) (lot # and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 22-AUG-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot # R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis. The sterile diluent (MERCK) (lot # and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 03-AUG-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot# R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis (product storage error). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 10-AUG-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot# R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis (product storage error). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 04-SEP-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot# R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis (product storage error). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 07-SEP-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot# R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis (product storage error). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959.
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Pneumonia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bronchopneumonia in a female patient who received FLUARIX QUADRIVALENT for prophylaxis. Concurrent medical conditions included renal disease. On 27th September 2018, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced bronchopneumonia (serious criteria hospitalization and GSK medically significant), diarrhea (serious criteria hospitalization) and fever (serious criteria hospitalization). On an unknown date, the outcome of the bronchopneumonia, diarrhea and fever were unknown. It was unknown if the reporter considered the bronchopneumonia, diarrhea and fever to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The reporter was the patient who developed bronchiolar pneumonia and was hospitalized for 2 days. The patient also experienced fever and diarrhea. The reporter did not have phone or address for the pharmacy. The patient had denied permission to contact their physician.
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of hives in a infant male patient who received FLULAVAL QUADRIVALENT for prophylaxis. Co-suspect products included PEDIARIX for prophylaxis, PEDVAXHIB for prophylaxis, PREVNAR for prophylaxis and ROTATEQ for prophylaxis. On an unknown date, the patient received the 1st dose of FLULAVAL QUADRIVALENT, the 3rd dose of PEDIARIX, PEDVAXHIB at an unknown dose, PREVNAR at an unknown dose and ROTATEQ at an unknown dose. On an unknown date, 6 days after receiving FLULAVAL QUADRIVALENT, PEDIARIX and PEDVAXHIB, the patient experienced hives. The patient was treated with steroids NOS. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to FLULAVAL QUADRIVALENT and PEDIARIX. Additional details were provided as follows: The age at vaccination was not reported. The Healthcare professional (HCP) said that an patient received 6 month vaccines including PEDIARIX, PEDVAX HIB, ROATEQ and FLULAVAL QUADRIVALENT. A 6 days later patient experienced large hives to the face. The HCP planned to give steroid for the hives. It was unknown if the health care professional consider the event(s) to be life threatening. The patient did not admit to the hospital overnight or prolong an existing hospitalization. The event did not result in a congenital anomaly or birth defect. The patient did not patient die. It was unknown if the reporter considered the hives to be related to ROTATEQ and PREVNAR. No problem at second or fourth month visit receiving vaccines.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included cold sores lip (when exposed to shingles). Previously administered products included Shingles vaccine (received on an unknown date). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills and fatigue. On an unknown date, the outcome of the fever, chills and fatigue were unknown. It was unknown if the reporter considered the fever, chills and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was linked with US2018GSK186290, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Reactogenicity event
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of reactogenicity event in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (in the past). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced reactogenicity event (serious criteria hospitalization). On an unknown date, the outcome of the reactogenicity event was unknown. It was unknown if the reporter considered the reactogenicity event to be related to SHINGRIX. Additional details were reported as follows: At medical booth at event, the health care professional (HCP) asked about whether there were higher rates of reactogenicity when SHINGRIX was administered in someone having had ZOSTAVAX in the past. The reporter was seemed to be seeing this in her practice, including one patient hospitalized related to SHINGRIX reactogenicity. No additional details were provided. The reporter did not agree to follow up from GlaxoSmithKline(GSK). This case was linked with case US2018GSK188799, reported by the same reporter.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Body temperature increased, Injection site rash, Neuropathy peripheral, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of neuropathy in a 76-year-old male patient who received SHINGRIX (batch number 524S7, expiry date unknown) for prophylaxis. On 29th September 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 4 days after receiving SHINGRIX, the patient experienced neuropathy (serious criteria GSK medically significant), fever, injection site rash and back pain. On an unknown date, the outcome of the neuropathy, fever, injection site rash and back pain were unknown. It was unknown if the reporter considered the neuropathy, fever, injection site rash and back pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced fever and the body temperature was recorded over 40 degree. The patient experienced rash injection site, back pain and neuropathic in mouth. The reporter did not say there was a link with the vaccine.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Asthenia, Balance disorder, Chills, Decreased appetite
Clinical narrative: 10/13: Stomach Ache, Fever, Chills, Equilibrium Issues, Weakness; 10/14: Fever, Chills, Equilibrium Issues, Weakness, Aches  and Pains, No Appetite; 10/15: Fever Down Some, Equilibrium Improving, Less Weakness, Aches  and Pains Moderating, No Appetite; 10/16: Same Weakness, Still Some Aches and Pains, No Appetite, Constant Itching All Over; 10/17: Some Appetite, Still Itching but Not as Bad.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pruritus generalised, Pyrexia
Clinical narrative: 10/13: Stomach Ache, Fever, Chills, Equilibrium Issues, Weakness; 10/14: Fever, Chills, Equilibrium Issues, Weakness, Aches  and Pains, No Appetite; 10/15: Fever Down Some, Equilibrium Improving, Less Weakness, Aches  and Pains Moderating, No Appetite; 10/16: Same Weakness, Still Some Aches and Pains, No Appetite, Constant Itching All Over; 10/17: Some Appetite, Still Itching but Not as Bad.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Patient had aching in shoulder and neck. Was treated in emergency room. Treated with antibiotic (unknown).
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint injection, Pain, Shoulder injury related to vaccine administration
Clinical narrative: Severe pain and decrease range of motion in left shoulder. Evaluated in the Emergency Dept on 10/4/18 and was told I had SIRVA (shoulder injury related to vaccine administration) referred to orthopedic MD. Seen by Dr. on 10/4/18. Received cortisone injection in left shoulder and was given script for MRI w/o contrast of left shoulder. Awaiting authorization. The pain is returning as on 10/17/2018 (perhaps cortisone injection is wearing off)? Still having difficulty pain when taking off shirts, bras, movement of left shoulder.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: Hives, painful red rash, itching. Very sore arm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Erythema, swelling, itching on arm in area, fever, chills.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: When withdrawing needle from patient arm, she sprayed some blood out of the injection site for a second. Following this, the injection site started to bleed, and a bump appeared at the site of the reaction. Patient reported soreness in the muscle, similar to soreness that typically follows immunizations administered in the the deltoid muscle. Patient reported no itchiness or other tenderness or difficulty breathing. Patient was on the way to physician's office when she came to get her flu shot and she is going to report the reaction to the physician to be evaluated.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Blood test, Condition aggravated, Influenza like illness, Insomnia
Clinical narrative: Initially, flu-like symptoms, then vomiting and then HORRIBLE nervous system issues (anxiety and insomnia) that continue today.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nervous system disorder, Vomiting
Clinical narrative: Initially, flu-like symptoms, then vomiting and then HORRIBLE nervous system issues (anxiety and insomnia) that continue today.
Age: 9.0
Sex: M
Vaccine: FLUX, HPV9
Symptoms: Papilloma excision, Skin papilloma
Clinical narrative: This spontaneous report was received from a nurse and refers to a 10-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 02-OCT-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection, intramuscularly (exact dose was not reported), lot # N009173 with expiration date on 20-NOV-2019, concomitantly with influenza virus vaccine (manufacturer unknown) (exact dose, route of administration, lot# and expiration date were not reported). Both vaccines were administered in the left deltoid for prophylaxis. On 16-OCT-2017 (reported as '2 weeks later'), the patient developed viral warts on the right forearm. Patient returned to physician's office and was referred to the dermatologist. Patient was seen by the dermatologist on an unspecified date and had the warts burned off. The outcome of the event was reported as recovered on an unspecified date. The relatedness between the event and GARDASIL 9 and influenza virus vaccine (manufacturer unknown) was not reported.