chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Rash, Swelling face
Clinical narrative: The mother of the patient called in and left a voicemail on a nurses phone here at the office at approximately 5:30 pm. I checked the voicemail and return the mothers call to see what was happening to the child. The mother stated that the child was having facial swelling in his temporal area on his face and a rash was developing. I told the mother that any possible reaction need to be seen by a healthcare provider and I recommended for her to take the child to the emergency room. Upon requesting the emergency room noted from the visit, the documentation from the ARNP who treated the child in the ER noted a rash on the child's face contributed to a possible allergic reaction to the Hepatitis A vaccine. The patient was treated with BENADRYL PO and given a prescription for oral steroids to take at home. The ER noted that the child was stable and discharged. I contacted the mother on 04/16/2018 to check on the child. The mother stated that he was fine and they did not fill his prescription for the oral steroids because his symptoms resided.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Arthralgia, Syncope
Clinical narrative: After MA left room after giving vaccine pt. fainted. Unwitnessed. Parent called office to notify of occurrance. Pt. at that time was at home. Per Mom pt. C/O pain in hip. Full ROM per Mom, but pt. would not left her look at it. Spoke with Mom the next day, no further issues or concerns.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Abnormal dreams, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Started w significant pain and swelling at injection site approx 1 hr after dose. Followed by fatigue, nausea, headache. Vomited x 1. Overnight, struggled to sleep and had vivid dreams and sensation of not being certain whether awake or asleep. Shaking chills during the night followed by sweats but has not had fever. Exam with erythema and induration 5 cm diameter at injection site, otherwise nonfocal. Advised Ibuprofen, cool compresses to injection site, fluids, supportive care and close monitoring.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Insomnia, Nausea
Clinical narrative: Started w significant pain and swelling at injection site approx 1 hr after dose. Followed by fatigue, nausea, headache. Vomited x 1. Overnight, struggled to sleep and had vivid dreams and sensation of not being certain whether awake or asleep. Shaking chills during the night followed by sweats but has not had fever. Exam with erythema and induration 5 cm diameter at injection site, otherwise nonfocal. Advised Ibuprofen, cool compresses to injection site, fluids, supportive care and close monitoring.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Night sweats, Tremor, Vomiting
Clinical narrative: Started w significant pain and swelling at injection site approx 1 hr after dose. Followed by fatigue, nausea, headache. Vomited x 1. Overnight, struggled to sleep and had vivid dreams and sensation of not being certain whether awake or asleep. Shaking chills during the night followed by sweats but has not had fever. Exam with erythema and induration 5 cm diameter at injection site, otherwise nonfocal. Advised Ibuprofen, cool compresses to injection site, fluids, supportive care and close monitoring.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site mass, Injection site pain, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 70-year-old female patient who received SHINGRIX. On 26th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On 26th March 2018, several hours after receiving SHINGRIX the patient experienced injection site lump, injection site rash and injection site pain. On 27th March 2018, 1 day after receiving SHINGRIX the patient experienced rash. In March 2018, the outcome of the injection site lump was recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site rash and injection site pain were recovering/resolving and the outcome of the injection site erythema and rash were unknown. The reporter considered the extensive swelling of vaccinated limb, injection site lump, injection site rash and injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the injection site erythema and rash to be related to SHINGRIX. Additional information received were as follows: The registered pharmacist reported that patient received SHINGRIX on Monday. On the same night of administration before going to bed, the patient experienced a lump at the site injection and it was hurt with a rash. The patient woke up in the next morning and the rash covering the upper part of her arm and it was still sore. The rash continued to cover the arm all day yesterday as well as today. The rash reduced in size and it was measuring approximately 6 inches in diameter today. The rash not found to be uniform and it was red and swollen on Monday night and on Tuesday. The rash described as being irregular in shape and in a strange pattern.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 70-year-old female patient who received SHINGRIX. On 26th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On 26th March 2018, several hours after receiving SHINGRIX the patient experienced injection site lump, injection site rash and injection site pain. On 27th March 2018, 1 day after receiving SHINGRIX the patient experienced rash. In March 2018, the outcome of the injection site lump was recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site rash and injection site pain were recovering/resolving and the outcome of the injection site erythema and rash were unknown. The reporter considered the extensive swelling of vaccinated limb, injection site lump, injection site rash and injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the injection site erythema and rash to be related to SHINGRIX. Additional information received were as follows: The registered pharmacist reported that patient received SHINGRIX on Monday. On the same night of administration before going to bed, the patient experienced a lump at the site injection and it was hurt with a rash. The patient woke up in the next morning and the rash covering the upper part of her arm and it was still sore. The rash continued to cover the arm all day yesterday as well as today. The rash reduced in size and it was measuring approximately 6 inches in diameter today. The rash not found to be uniform and it was red and swollen on Monday night and on Tuesday. The rash described as being irregular in shape and in a strange pattern.
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: Abnormal behaviour, Fatigue, Loss of consciousness, Vomiting
Clinical narrative: Loss of consciousness and possible seizure followed by vomiting and discombobulated behavior, exhaustion.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal dreams
Clinical narrative: Patient reported vivid dreams the night after receiving vaccine, possibly sexual in nature.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose normal, Chills, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Patient's arm started hurting immediately after injection but thought that was normal. As the night went on, it started hurting a lot more and she felt she was getting a fever. She went to bed and woke up around 3 am and her head was feeling like it was spinning and fuzzy and she was chilling and sweating. She took her blood sugar and it was fine. She went in to go to the bathroom and next thing she knew she was waking up on the floor and had passed out. She did not know how long she was out but had hit her head near her eye and had a bump. She stayed up for a little bit trying to figure out what had happened, but eventually went back to bed. She really felt it had something to do with getting the SHINGRIX vaccination. Other than a sore head from hitting it, she has had no other side effects and is feeling fine now.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Loss of consciousness, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Patient's arm started hurting immediately after injection but thought that was normal. As the night went on, it started hurting a lot more and she felt she was getting a fever. She went to bed and woke up around 3 am and her head was feeling like it was spinning and fuzzy and she was chilling and sweating. She took her blood sugar and it was fine. She went in to go to the bathroom and next thing she knew she was waking up on the floor and had passed out. She did not know how long she was out but had hit her head near her eye and had a bump. She stayed up for a little bit trying to figure out what had happened, but eventually went back to bed. She really felt it had something to do with getting the SHINGRIX vaccination. Other than a sore head from hitting it, she has had no other side effects and is feeling fine now.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Patient's arm started hurting immediately after injection but thought that was normal. As the night went on, it started hurting a lot more and she felt she was getting a fever. She went to bed and woke up around 3 am and her head was feeling like it was spinning and fuzzy and she was chilling and sweating. She took her blood sugar and it was fine. She went in to go to the bathroom and next thing she knew she was waking up on the floor and had passed out. She did not know how long she was out but had hit her head near her eye and had a bump. She stayed up for a little bit trying to figure out what had happened, but eventually went back to bed. She really felt it had something to do with getting the SHINGRIX vaccination. Other than a sore head from hitting it, she has had no other side effects and is feeling fine now.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 03-APR-2018, the patient was vaccinated with expired VARIVAX lot # M012992 with an expiration date 14-MAR-2018 for prophylaxis (dose, route of administration or anatomical location were not reported). Sterile diluent (MERCK) used for vaccination was not expired (lot# M041812 with an expiration date 17-MAY-2019). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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 15-NOV-2016, the patient was treated by a physician for a persistent vesicular rash, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient has been prescribed gabapentin, oxycodone and acyclovir for management of her painful symptoms and chronic pain. 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 15-FEB-2017, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), 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 12-MAY-2017, the patient was treated at physician office for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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, pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. During 2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), 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 31-MAY-2016, the patient was treated at physician office for a onset of severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient has been prescribed valacyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the 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, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of generalized urticaria in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 4 days after receiving SHINGRIX, the patient experienced generalized urticarial (serious criteria other: serious per reporter). On an unknown date, the outcome of the generalized urticaria was unknown. It was unknown if the reporter considered the generalized urticaria to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced serious generalized hives. This case has been linked with case US2018GSK064066, reported by the same reporter.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site reaction, Local reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 57-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) and (batch number ZX3YA, expiry date unknown). On 3rd April 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, the dose was an unknown dose. On 3rd April 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In April 2018, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional information was received as follows: The health care professional reported that SHINGRIX was inadvertently administered by subcutaneous route instead of intramuscular route which led to, inappropriate route of vaccine administration. The reporter reported that the patient experienced local injection site reactions at the site of the vaccine administration. No further information was provided. The reported batch number of SHINGRIX (ZX34A) did not exist in sales data and it was updated to ZX3YA.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Insomnia, Muscle spasms, Nausea, Pain in extremity
Clinical narrative: NAUSEA, VOMITING, FATIGUE, DID NOT SLEEP, CRAMPING AND SORENESS IN INJECTION ARM; FEET AND LEGS.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: NAUSEA, VOMITING, FATIGUE, DID NOT SLEEP, CRAMPING AND SORENESS IN INJECTION ARM; FEET AND LEGS.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Basophil count normal, Basophil percentage decreased
Clinical narrative: The day after the event about 24 hours there was increased pain and limiting range of motion in the arm of the vaccination. At about 30 hours after vaccination, patient had chills and felt unwell. Two days after vaccination patient had a fever of 102.4, chills, limited range of motion of the arm and erythema that was increasing around injection site. Erythema progressed down the arm distally and continued until 4 days after the injection and treatment of infection with clindamycin, vancomycin, and ceftriaxone at hospital.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased, Blood chloride normal, Blood creatinine normal
Clinical narrative: The day after the event about 24 hours there was increased pain and limiting range of motion in the arm of the vaccination. At about 30 hours after vaccination, patient had chills and felt unwell. Two days after vaccination patient had a fever of 102.4, chills, limited range of motion of the arm and erythema that was increasing around injection site. Erythema progressed down the arm distally and continued until 4 days after the injection and treatment of infection with clindamycin, vancomycin, and ceftriaxone at hospital.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture, Blood glucose normal, Blood lactic acid, Blood potassium normal, Blood sodium normal
Clinical narrative: The day after the event about 24 hours there was increased pain and limiting range of motion in the arm of the vaccination. At about 30 hours after vaccination, patient had chills and felt unwell. Two days after vaccination patient had a fever of 102.4, chills, limited range of motion of the arm and erythema that was increasing around injection site. Erythema progressed down the arm distally and continued until 4 days after the injection and treatment of infection with clindamycin, vancomycin, and ceftriaxone at hospital.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Blood urea normal, C-reactive protein increased, Carbon dioxide normal, Chills, Computerised tomogram
Clinical narrative: The day after the event about 24 hours there was increased pain and limiting range of motion in the arm of the vaccination. At about 30 hours after vaccination, patient had chills and felt unwell. Two days after vaccination patient had a fever of 102.4, chills, limited range of motion of the arm and erythema that was increasing around injection site. Erythema progressed down the arm distally and continued until 4 days after the injection and treatment of infection with clindamycin, vancomycin, and ceftriaxone at hospital.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Creatinine renal clearance normal, Culture wound, Drug trough level, Eosinophil count increased, Eosinophil percentage
Clinical narrative: The day after the event about 24 hours there was increased pain and limiting range of motion in the arm of the vaccination. At about 30 hours after vaccination, patient had chills and felt unwell. Two days after vaccination patient had a fever of 102.4, chills, limited range of motion of the arm and erythema that was increasing around injection site. Erythema progressed down the arm distally and continued until 4 days after the injection and treatment of infection with clindamycin, vancomycin, and ceftriaxone at hospital.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Glomerular filtration rate normal, Gram stain, Granulocyte count increased, Granulocyte percentage
Clinical narrative: The day after the event about 24 hours there was increased pain and limiting range of motion in the arm of the vaccination. At about 30 hours after vaccination, patient had chills and felt unwell. Two days after vaccination patient had a fever of 102.4, chills, limited range of motion of the arm and erythema that was increasing around injection site. Erythema progressed down the arm distally and continued until 4 days after the injection and treatment of infection with clindamycin, vancomycin, and ceftriaxone at hospital.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Haematocrit decreased, Haemoglobin decreased, Infection, Injected limb mobility decreased, Injection site erythema
Clinical narrative: The day after the event about 24 hours there was increased pain and limiting range of motion in the arm of the vaccination. At about 30 hours after vaccination, patient had chills and felt unwell. Two days after vaccination patient had a fever of 102.4, chills, limited range of motion of the arm and erythema that was increasing around injection site. Erythema progressed down the arm distally and continued until 4 days after the injection and treatment of infection with clindamycin, vancomycin, and ceftriaxone at hospital.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Lymphocyte count decreased, Lymphocyte percentage decreased, Malaise, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: The day after the event about 24 hours there was increased pain and limiting range of motion in the arm of the vaccination. At about 30 hours after vaccination, patient had chills and felt unwell. Two days after vaccination patient had a fever of 102.4, chills, limited range of motion of the arm and erythema that was increasing around injection site. Erythema progressed down the arm distally and continued until 4 days after the injection and treatment of infection with clindamycin, vancomycin, and ceftriaxone at hospital.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Mean cell volume normal, Mean platelet volume normal, Monocyte count decreased, Monocyte percentage increased, Neutrophil count increased
Clinical narrative: The day after the event about 24 hours there was increased pain and limiting range of motion in the arm of the vaccination. At about 30 hours after vaccination, patient had chills and felt unwell. Two days after vaccination patient had a fever of 102.4, chills, limited range of motion of the arm and erythema that was increasing around injection site. Erythema progressed down the arm distally and continued until 4 days after the injection and treatment of infection with clindamycin, vancomycin, and ceftriaxone at hospital.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Neutrophil percentage increased, Pain in extremity, Pathology test, Platelet count normal, Polymerase chain reaction
Clinical narrative: The day after the event about 24 hours there was increased pain and limiting range of motion in the arm of the vaccination. At about 30 hours after vaccination, patient had chills and felt unwell. Two days after vaccination patient had a fever of 102.4, chills, limited range of motion of the arm and erythema that was increasing around injection site. Erythema progressed down the arm distally and continued until 4 days after the injection and treatment of infection with clindamycin, vancomycin, and ceftriaxone at hospital.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Protein total normal, Pyrexia, Red blood cell count decreased, Red blood cell nucleated morphology, Red cell distribution width normal
Clinical narrative: The day after the event about 24 hours there was increased pain and limiting range of motion in the arm of the vaccination. At about 30 hours after vaccination, patient had chills and felt unwell. Two days after vaccination patient had a fever of 102.4, chills, limited range of motion of the arm and erythema that was increasing around injection site. Erythema progressed down the arm distally and continued until 4 days after the injection and treatment of infection with clindamycin, vancomycin, and ceftriaxone at hospital.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Staphylococcus test negative, White blood cell count increased
Clinical narrative: The day after the event about 24 hours there was increased pain and limiting range of motion in the arm of the vaccination. At about 30 hours after vaccination, patient had chills and felt unwell. Two days after vaccination patient had a fever of 102.4, chills, limited range of motion of the arm and erythema that was increasing around injection site. Erythema progressed down the arm distally and continued until 4 days after the injection and treatment of infection with clindamycin, vancomycin, and ceftriaxone at hospital.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site oedema, Injection site reaction, Injection site vesicles, Malaise
Clinical narrative: Vaccination administered on 3/19 @ 0911 AM. First mention of any issues in the MR was on 3/21 @ 1519 by hospitalist progress note: skin reaction noted to PNEUMOVAX, ID on board starting daptomycin 3/21 @ 0929 - infectious disease - fever, likely from cellulitis of the right shoulder, area of pneumoniac shot. Will DC levofloxacin and start daptomycin. 3/22 @ 1020 (Gen Med) - cellulistis and blister of the right shoulder, area of pneumonia shot, plan will cont. daptomycin. Pt. did not tolerate cold compresses 3/24 @ 1245 - (ID) continue current ATB's, consider kerlix and ace wrap of the right upper extremity. 3/25 @ 1041 - (ID) continue current ATB's, get ultrasound of the right shoulder/arm. 3/26 @ 1637 - (Gen Med) Us 1. no abscess formation at the area of abnormality in the proximal right upper extremity. 2. Diffuse subcutaneous edema and skin thickening is suggestive of cellulitis, continue on daptomycin per ID. Patient readmitted 4/11 from the infusion center getting levaquin and as she was not feeling well. Received dakins packing BID and ATB, improvement noted. 4/15 (ID)- -ready to discharge, continue dakins. FU in 2 weeks and augmentin therapy PO at home. Patient feeling better. 3/22 @ 1653 - (ID) okay with cold compress on the area of right shoulder.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Microbiology test normal, Pyrexia, Skin hypertrophy, Skin reaction, Ultrasound scan abnormal
Clinical narrative: Vaccination administered on 3/19 @ 0911 AM. First mention of any issues in the MR was on 3/21 @ 1519 by hospitalist progress note: skin reaction noted to PNEUMOVAX, ID on board starting daptomycin 3/21 @ 0929 - infectious disease - fever, likely from cellulitis of the right shoulder, area of pneumoniac shot. Will DC levofloxacin and start daptomycin. 3/22 @ 1020 (Gen Med) - cellulistis and blister of the right shoulder, area of pneumonia shot, plan will cont. daptomycin. Pt. did not tolerate cold compresses 3/24 @ 1245 - (ID) continue current ATB's, consider kerlix and ace wrap of the right upper extremity. 3/25 @ 1041 - (ID) continue current ATB's, get ultrasound of the right shoulder/arm. 3/26 @ 1637 - (Gen Med) Us 1. no abscess formation at the area of abnormality in the proximal right upper extremity. 2. Diffuse subcutaneous edema and skin thickening is suggestive of cellulitis, continue on daptomycin per ID. Patient readmitted 4/11 from the infusion center getting levaquin and as she was not feeling well. Received dakins packing BID and ATB, improvement noted. 4/15 (ID)- -ready to discharge, continue dakins. FU in 2 weeks and augmentin therapy PO at home. Patient feeling better. 3/22 @ 1653 - (ID) okay with cold compress on the area of right shoulder.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity, Screaming
Clinical narrative: The patient had worsening arm shoulder and neck pain that got so bad through the night that she "screamed out in pain anytime she moved". Movement was possible but did cause pain. Patient stayed in bed 24 hours and symptoms subsided.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Blood culture negative, Culture urine negative, Electrocardiogram normal, Lethargy, Pallor
Clinical narrative: Pallor, Lethargy, Tachycardia, Fever to 38.1 C, Poor Feeding.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Poor feeding infant, Pyrexia, Tachycardia, White blood cell count increased
Clinical narrative: Pallor, Lethargy, Tachycardia, Fever to 38.1 C, Poor Feeding.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site induration, Injection site reaction, Rash papular
Clinical narrative: Right thigh induration approx 5x5cm with raised papular rash over thigh, this happened with last vaccines too mom stated. She said both legs reacted last visit. Last visit patient had PEDIARIX and PCV, no Hib. Patient is happy and well, bearing weight on leg. No redness. No pain at sight.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenopia, Back pain, Bedridden, Dizziness, Eye pain
Clinical narrative: Severe low back pain. Both legs and feet hurt severly that left patient bed ridden. Severe dizziness which was helped by lying down. Splotchy vision both eyes. Headache. Tired. Throbbing heartbeat in ears. Faint. Patient couldn't stay awake. No pain at injection site. In bed 2.5 days. Stuffy nose. Symptoms began to subside on the 17th at time of this report except eyes are heavy and painful. Dr recommends water and ALEVE.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Headache, Nasal congestion, Pain in extremity, Palpitations
Clinical narrative: Severe low back pain. Both legs and feet hurt severly that left patient bed ridden. Severe dizziness which was helped by lying down. Splotchy vision both eyes. Headache. Tired. Throbbing heartbeat in ears. Faint. Patient couldn't stay awake. No pain at injection site. In bed 2.5 days. Stuffy nose. Symptoms began to subside on the 17th at time of this report except eyes are heavy and painful. Dr recommends water and ALEVE.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Somnolence, Syncope, Visual impairment
Clinical narrative: Severe low back pain. Both legs and feet hurt severly that left patient bed ridden. Severe dizziness which was helped by lying down. Splotchy vision both eyes. Headache. Tired. Throbbing heartbeat in ears. Faint. Patient couldn't stay awake. No pain at injection site. In bed 2.5 days. Stuffy nose. Symptoms began to subside on the 17th at time of this report except eyes are heavy and painful. Dr recommends water and ALEVE.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient got BOOSTRIX 4/10 and came in 4/11 to show his arm is red, swollen to the touch. Told him to ice it and take ibuprofen.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, erythema and tenderness at injection site which peaked on second day after administration of vaccine. One dose diphenhydramine was given.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pyrexia, Rash, Rash pruritic, Skin warm
Clinical narrative: Bilateral rash on both arms (wrist to elbow) and by ankle. Rash "feels warm", contains raised, small bumps that itch. Rash appears and disappears. Accompanied by joint aches and low grade fever (99.6 degrees F) (self-reported).
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Given vaccine Thursday afternoon and by Friday morning had swelling, redness, and heat at injection site. Patient had aches over entire body and a headaches for 3 days.
Age: 13.0
Sex: F
Vaccine: MMR
Symptoms: Wrong drug administered
Clinical narrative: Pt given extra MMR in error.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity, Rash erythematous, Rash generalised
Clinical narrative: Red spot in area of vaccine and arm very sore day of vaccination. Rash continued to spread. At time of reporting to RPh, patients husband said the whole body covered in red rash but no pain or itching.
Age: 72.0
Sex: F
Vaccine: CHOL, CHOL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Client had no adverse effects from this vaccine. However age indication for this vaccine is 18-64 and client is 72 years of age. Reason for VAERS report is simply due to the fact that client was outside recommended age for vaccine. No adverse effects were experienced by the recipient.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Dysphonia, Erythema, Joint range of motion decreased, Muscular weakness
Clinical narrative: 4/6/18 Hoarseness and a knot like obstruction on left side of throat, within about 15 to 20 minutes of receiving shot. Went back into the office took two BENADRYL and notified the nurses and Dr. Remained at office until BENADRYL took affect. The knot went down and hoarseness subsided. Dr. kept check on breathing, heart rate, and pulse. Took about 30 to 45 minutes.  Later in day arm began to stiffen, swell, and be warm. Ice made stiffness worse. Had very little range of motion. 4/7/18 Redness began along with more swelling. Swelling was to the point that had light bruising on arm when swelling went down.  Redness and swelling migrated down arm to elbow over the course of several days. Have photos of what the arm looked like. Still have issues with arm on 4/17/18. On set of weakness in muscle.  Tingling and pain if arm bent in use for prolonged periods. Must rest on pillow at times, even when driving or riding in a vehicle. Took series of Steroid over 7 days.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pain in extremity, Paraesthesia, Peripheral swelling, Pharyngeal oedema
Clinical narrative: 4/6/18 Hoarseness and a knot like obstruction on left side of throat, within about 15 to 20 minutes of receiving shot. Went back into the office took two BENADRYL and notified the nurses and Dr. Remained at office until BENADRYL took affect. The knot went down and hoarseness subsided. Dr. kept check on breathing, heart rate, and pulse. Took about 30 to 45 minutes.  Later in day arm began to stiffen, swell, and be warm. Ice made stiffness worse. Had very little range of motion. 4/7/18 Redness began along with more swelling. Swelling was to the point that had light bruising on arm when swelling went down.  Redness and swelling migrated down arm to elbow over the course of several days. Have photos of what the arm looked like. Still have issues with arm on 4/17/18. On set of weakness in muscle.  Tingling and pain if arm bent in use for prolonged periods. Must rest on pillow at times, even when driving or riding in a vehicle. Took series of Steroid over 7 days.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: 4/6/18 Hoarseness and a knot like obstruction on left side of throat, within about 15 to 20 minutes of receiving shot. Went back into the office took two BENADRYL and notified the nurses and Dr. Remained at office until BENADRYL took affect. The knot went down and hoarseness subsided. Dr. kept check on breathing, heart rate, and pulse. Took about 30 to 45 minutes.  Later in day arm began to stiffen, swell, and be warm. Ice made stiffness worse. Had very little range of motion. 4/7/18 Redness began along with more swelling. Swelling was to the point that had light bruising on arm when swelling went down.  Redness and swelling migrated down arm to elbow over the course of several days. Have photos of what the arm looked like. Still have issues with arm on 4/17/18. On set of weakness in muscle.  Tingling and pain if arm bent in use for prolonged periods. Must rest on pillow at times, even when driving or riding in a vehicle. Took series of Steroid over 7 days.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Blister, Injection site reaction, Polymerase chain reaction, Varicella virus test, Wound
Clinical narrative: 2 weeks after the vaccine patient developed a few scattered vesicles. Most went away, however the spot over the site of the immunization developed an open sore that has been present for 2 weeks.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Aphasia, Decreased eye contact, Neurological symptom, Pyrexia, Regressive behaviour
Clinical narrative: 104.5 fever for 4-5 days, uncontrollable screaming for 3 days, stopped babbling/talking/ making eye contact for about 6 weeks afterwards, noticeable neurological changes /regression.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Screaming
Clinical narrative: 104.5 fever for 4-5 days, uncontrollable screaming for 3 days, stopped babbling/talking/ making eye contact for about 6 weeks afterwards, noticeable neurological changes /regression.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Feeling cold, Loss of personal independence in daily activities
Clinical narrative: Arm tenderness right away that progressed through the day until I could not lift my arm. The stiffness and pain moved into my back and by 7 p.m. I had chills and immense fatigue and all over muscle aches, like the flu. No headache. I did not take my temp, but had a hard time getting warm for about 3 hours, despite a heating pad and down comforter. Today--24 hours later-- I feel better, but still with a very sore arm, backache, and exhaustion. I'm not up to normal activities.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal stiffness, Myalgia, Pain in extremity, Tenderness
Clinical narrative: Arm tenderness right away that progressed through the day until I could not lift my arm. The stiffness and pain moved into my back and by 7 p.m. I had chills and immense fatigue and all over muscle aches, like the flu. No headache. I did not take my temp, but had a hard time getting warm for about 3 hours, despite a heating pad and down comforter. Today--24 hours later-- I feel better, but still with a very sore arm, backache, and exhaustion. I'm not up to normal activities.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Body aches - moderate chills - moderate headache - very tired - several swollen, painful lymph nodes on left side of neck - swollen, pain pressure points behind right knee - pain/tenderness at injection site. Body aches, chills, headache and moderate tiredness lasted until about 36 hours post vaccine administration. Swollen, painful lymph nodes were ongoing until 2.5 days post vaccine then decreased gradually through day 4.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Body aches - moderate chills - moderate headache - very tired - several swollen, painful lymph nodes on left side of neck - swollen, pain pressure points behind right knee - pain/tenderness at injection site. Body aches, chills, headache and moderate tiredness lasted until about 36 hours post vaccine administration. Swollen, painful lymph nodes were ongoing until 2.5 days post vaccine then decreased gradually through day 4.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-MAR-2018, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 injection, lot # N025563, expiration date 08-APR-2019 (exact dose and route of administration were not reported). On an unknown date, the vaccine experienced a temperature excursion from 47 F to 77 F for 48 hours. There was no previous temperature excursion reported. The temperature excursion did not occur as a result of reading from digital data logger. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1804USA007262:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 22-FEB-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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 26-MAY-2016, the patient was treated at a medical center for a severe 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 13-APR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 23-AUG-2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, 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 condition of herpes zoster. On or about 19-MAR-2012, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acyclovir, XYLOCAINE and tramadol for management of her painful symptoms. As a direct and proximate result of the 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 01-MAY-2016, the patient was inoculated with ZOSTAVAX for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine was administered by a physician. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. During 2016, the patient was treated by the same physician for the onset of sever vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of 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: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-MAR-2018, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 injection, lot # N025563, expiration date 08-APR-2019 (exact dose and route of administration were not reported). On an unknown date, the vaccine experienced a temperature excursion from 47 F to 77 F for 48 hours. There was no previous temperature excursion reported. The temperature excursion did not occur as a result of reading from digital data logger. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1803USA011267.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself, enrolled in a Pfizer-sponsored program, (Pfizer RxPathways); this report regards an event part of the medical history of the patient. A currently 68-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at single dose for immunisation, ADVAIR, (lot 7DP5590, exp date Feb2019), on unspecified dates, at unknown dose and route, for an unspecified indication and SPIRIVA, via an unspecified route of administration from 2013 and ongoing at 1 breathing capsule in a handheld deal once daily every morning for longer bronchodilator. The patient medical history included ongoing COPD and emphysema. Concomitant medications were not reported. The patient previously received a pneumococcal vaccine on unknown date for immunization. The patient experienced pneumonia while taking tiotropium bromide and fluticasone propionate, salmeterol xinafoate on an unspecified date in 2015 or 2016 with outcome of recovered. The patient was hospitalized due to the event. The action taken for fluticasone propionate, salmeterol xinafoate was unknown, for tiotropium bromide was dose not changed. Information on the batch number has been requested. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.