chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 12-MAR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis. A digital data logger was used. No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014153: US-009507513-1706USA001720: Original Case: 1706USA001714: US-009507513-1706USA001721: Original Case: 1706USA001714: US-009507513-1706USA001722: Original Case: 1706USA001714: US-009507513-1706USA001723: Original Case: 1706USA001714: US-009507513-1706USA001719: Original Case: 1706USA001714: US-009507513-1706USA001724: Original Case: 1706USA001714: US-009507513-1706USA001725: Original Case: 1706USA001714: US-009507513-1706USA001714: Original Case: 1706USA001714: US-009507513-1706USA001727: Original Case: 1706USA001714: US-009507513-1706USA001728: Original Case: 1706USA001714: US-009507513-1706USA001729: Original Case: 1706USA001714.
Age: 26.0
Sex: M
Vaccine: HIBV, MEN, PPV
Symptoms: Dizziness, Dyspnoea, Erythema, Fatigue, Headache
Clinical narrative: Swollen lymph nodes, swelling, and readness, shortness of breath, fatigue, body aches, dizziness, light headedness, headache, fever, elevated white cell count.
Age: 26.0
Sex: M
Vaccine: HIBV, MEN, PPV
Symptoms: Lymphadenopathy, Pain, Pyrexia, Swelling, White blood cell count increased
Clinical narrative: Swollen lymph nodes, swelling, and readness, shortness of breath, fatigue, body aches, dizziness, light headedness, headache, fever, elevated white cell count.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Bone pain, Chills, Decreased appetite, Dizziness
Clinical narrative: Swollen red injection site, goose egg size knot developed within 12 hours; high fever; body aches; nausea; pain in bones and joints; muscle pain; numbness in fingers; fatigue; loss of appetite; headache; dizziness; fainting spell; chills.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Hypoaesthesia, Injection site erythema, Injection site nodule
Clinical narrative: Swollen red injection site, goose egg size knot developed within 12 hours; high fever; body aches; nausea; pain in bones and joints; muscle pain; numbness in fingers; fatigue; loss of appetite; headache; dizziness; fainting spell; chills.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Swollen red injection site, goose egg size knot developed within 12 hours; high fever; body aches; nausea; pain in bones and joints; muscle pain; numbness in fingers; fatigue; loss of appetite; headache; dizziness; fainting spell; chills.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Syncope
Clinical narrative: Swollen red injection site, goose egg size knot developed within 12 hours; high fever; body aches; nausea; pain in bones and joints; muscle pain; numbness in fingers; fatigue; loss of appetite; headache; dizziness; fainting spell; chills.
Age: 51.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Injection site mass, Pain in extremity
Clinical narrative: On 06/01/17 patient received 2 vaccinations. BOOSTRIX (NDC 58160-0842-52) in his right arm (upper IM) and HAVRIX (NDC 58160-0826-52) in his right arm (lower IM). Patient wanted both shots in one arm as he was also getting an allergy shot after the vaccines. All shots were given under the IMZ standing order physician. Patient came in on 06/04/17 complaining of soreness and a lump in his right arm. Pharmacist spoke to patient and advised him to continue taking Tylenol as there is no evidence of an allergic reaction and the lump was 6 to 8 inches below the injection site which is most likely not due to the injection.
Age: 1.42
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Aphasia, Asthenia, Decreased eye contact, Disability, Mobility decreased
Clinical narrative: Projectile Vomiting, Fever, Rash all over body measles like rash. Lasted Two days weak could not even move. Then, lost all eye contact skills learned and lost all speech he had all 250 words. Now non verbal and disabled.
Age: 1.42
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash morbilliform, Vomiting projectile
Clinical narrative: Projectile Vomiting, Fever, Rash all over body measles like rash. Lasted Two days weak could not even move. Then, lost all eye contact skills learned and lost all speech he had all 250 words. Now non verbal and disabled.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Dyspnoea, Erythema, Skin warm
Clinical narrative: Patient's face started to get red and hot and then she found it harder to breathe. Her granddaughter convinced her to go to the emergency room on Friday morning (5/26/17) where they gave her cetirizine 10mg daily for 7 days, as well as did chest xrays and drew blood as well as monitored her BP. Patient states that this is the same reaction she had to a liquid calcium supplement, which they determined to be an allergy to beeswax.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Nausea, Soft tissue disorder, Vomiting
Clinical narrative: Patient with nausea and vomiting for 48 hours after receiving influenza vaccine 2 years in a row, as well as significant soft tissue reaction, 3cm in diameter area of induration and erythema as last year. Recommend no future IM influenza vaccines.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Skin lesion
Clinical narrative: Reports rash / lesions after influenza vaccination few weeks ago. States was not the first episode.
Age: 10.0
Sex: M
Vaccine: HEP, HEPA, TD, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient got Td and Varicella on the right arm yesterday. At the location of Varicella (not Td) today he developed redness and mild swelling No fever. No headache. No med was given. On the red arm at the location of pervious varicella immunization there is swelling and redness about 4 cm. Not fluctuant. No discharge. Normal distal pulses on the right arm and normal sensation and motor function. No sign of neurovascular compromise.
Age: 61.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Back pain, Biopsy muscle, Blood pressure increased, Blood test, Computerised tomogram
Clinical narrative: Sensation of exaggerated cold sensitivity in fingers on 11/22/2016. On 12/5/2016 noted numbness and tingling in fingers spreading to feet, tongue, lips and face. On 12/6/2016 experienced severe back pain. On 12/12/2016 had elevated blood pressure. All movement was limited and legs very weak. Symptoms started to improve 2/17/2017.
Age: 61.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Lumbar puncture, Mobility decreased, Muscular weakness
Clinical narrative: Sensation of exaggerated cold sensitivity in fingers on 11/22/2016. On 12/5/2016 noted numbness and tingling in fingers spreading to feet, tongue, lips and face. On 12/6/2016 experienced severe back pain. On 12/12/2016 had elevated blood pressure. All movement was limited and legs very weak. Symptoms started to improve 2/17/2017.
Age: 61.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Neuropathy peripheral, Paraesthesia, Paraesthesia oral, X-ray
Clinical narrative: Sensation of exaggerated cold sensitivity in fingers on 11/22/2016. On 12/5/2016 noted numbness and tingling in fingers spreading to feet, tongue, lips and face. On 12/6/2016 experienced severe back pain. On 12/12/2016 had elevated blood pressure. All movement was limited and legs very weak. Symptoms started to improve 2/17/2017.
Age: 71.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Feeling cold, Lymph node pain, Malaise, Salivary gland pain
Clinical narrative: Pain, tenderness right parotid gland, right submandibular gland, right posterior pharynx. Fatigue, sleeping, general malaise. no fever or rash. feels cold.
Age: 71.0
Sex: F
Vaccine: MMR
Symptoms: Somnolence
Clinical narrative: Pain, tenderness right parotid gland, right submandibular gland, right posterior pharynx. Fatigue, sleeping, general malaise. no fever or rash. feels cold.
Age: 27.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Dizziness, Pallor, Syncope, Visual impairment
Clinical narrative: SYNCOPE: FAINTING, DIZZINESS, PALENESS, VISUAL DISTURBANCES.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, hot, pain at injection site.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Enema administration, Intussusception
Clinical narrative: Intussusception.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Haematochezia, Intussusception
Clinical narrative: Intussusception.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash macular, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Swelling of the (L) thigh around vaccine site. Splotchy rash over the area.
Age: 26.0
Sex: F
Vaccine: MMR, TYP
Symptoms: Nonspecific reaction
Clinical narrative: 4 days after vaccine administration, patient had a episode at home.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: At injection site-sup to 5", red, hot and hard bump also mild joint pain for 10 days after injection.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Expired product administered, Immunisation
Clinical narrative: Patient inadvertently given expired TDaP vaccine. Per CDC and manufacturer, patient was re-vaccinated with fresh vaccine.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site rash
Clinical narrative: Local induration and rash at Left arm site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelling, redness and pain.
Age: 0.67
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Dehydration, Influenza virus test negative, Urine analysis normal, Vomiting
Clinical narrative: 6-2-17 4:00 P rectal temp to 103.4 vomited x 1. 6-3-17 5:00 am rectal temp to 104.6 vomited TYLENOL. Sent to ED and had neg work up for flu, neg U/A. Traveling and got MMR 5-26-17.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Eye swelling, Peripheral swelling, Urticaria
Clinical narrative: Hives on Abdomen. Swelling around eyes and bilateral hands and feet.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Disorientation, Immediate post-injection reaction, Musculoskeletal stiffness, Syncope, Vomiting
Clinical narrative: As soon as the shot was given, the patient fainted. I then lifted her feet onto a chair. Then, she became disoriented, stiff. Patient's mother was holding her, holding cold water to her forehead/face. After becoming alert, she sat up and vomited. After taking a nap at home, pt. fully recovered.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain
Clinical narrative: Pt rec'd '5 year' shots in office on 6/02/17. Seen 6/03/17 in office for 4 1/2 x 3 cm area of redness (RT) arm. Reports increased redness and pain at site and temp at 100 F. Tx= Ice packs to site. If itching occurs - HC cream or BENADRYL. (ER if pain).
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu like symptoms. Headache, muscle aches, fever 100.6. Weakness. Using TYLENOL per MD instruction.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Chills, Influenza like illness, Laboratory test, Pain
Clinical narrative: Flu-like sx, fever, chills, aches. ER to hospital admission. Sepsis.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Sepsis
Clinical narrative: Flu-like sx, fever, chills, aches. ER to hospital admission. Sepsis.
Sex: U
Vaccine: FLU4
Symptoms: Neuropathy peripheral
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of neuropathy in a 15-year-old patient who received FLUARIX TETRA. On an unknown date, the patient received FLUARIX TETRA at an unknown dose. On an unknown date, unknown after receiving FLUARIX TETRA, the patient experienced neuropathy. On an unknown date, the outcome of the neuropathy was unknown. It was unknown if the reporter considered the neuropathy to be related to FLUARIX TETRA. Additional details were provided as follows: The age at vaccination was not reported. The physician refused to provide further details.
Sex: F
Vaccine: MEN, MNQ
Symptoms: Antibody test abnormal, Drug administered to patient of inappropriate age, Laboratory test, Therapeutic response decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of therapeutic response decreased in a adult female patient who received Meningococcal ACWY Vaccine (potential MENVEO). Co-suspect products included Meningococcal B vaccine. On an unknown date, the patient received Meningococcal ACWY Vaccine (potential MENVEO) at an unknown dose and Meningococcal B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Meningococcal ACWY Vaccine (potential MENVEO) and Meningococcal B vaccine, the patient experienced therapeutic response decreased and inappropriate age at vaccine administration. On an unknown date, the outcome of the therapeutic response decreased and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Meningococcal ACWY Vaccine (potential MENVEO) and Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient was not sure what brand she received, but BEXSERO sounded familiar to her. The patient had received multiple doses of the multiple serogroup vaccine, and had received two different brands. The first vaccine was appropriate for patient's age group, but she had low titers afterwards, which led the patient to have a low titers. The patient then received the one which was approved for a younger age group than the patient's age, which led to inappropriate age at vaccine administration. This vaccine worked well for the patient and her titers were good. It was reported that, every two weeks the patient received infusions of a medication that leaves her at high risk for developing a meningococcal infection, so it was important for her to maintain good titer levels. This was why the patient had received multiple injections with the multiple serogroup vaccine. The patient wants to make sure her titers for serotype B are still high, but cannot find a place which could do the titer.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and raised at injection site and redness wrapped around arm 6 inches. Tried BENADRYL and ice then went to UC and was rx'ed KEFLEX and started getting better right away.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itchy. Swelling. Pink/reddish area 1-2" x 3-4". Today - smaller pink area.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Red/welt at site of immunization (PROQUAD) (+) pain. Dx. with cellulitis. Rx: AUGMENTIN ES 600.
Age: 93.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Swelling
Clinical narrative: Patient given vaccine in left deltoid on 5/8/17. Returned to office on 5/9/17 with a hypersensitivity reaction. Large area of redness and swelling near site of PNEUMOVAX vaccination. Patient advised cool compress, hydrocortisone and BENADRYL.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received PNEUMOVAX 23 to right deltoid on 5/24/17. Reported pain, redness, swelling in same area on 5/25/17. Seen in office, site red and hot to touch. Treatment OTC BENADRYL and ibuprofen.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Patient received PNEUMOVAX 23 to (R) deltoid on 5/22/17. Returned to office with significant swelling redness below injection site. Rx'd cephalexin 500 mg Q12 x 5 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site dermatitis
Clinical narrative: Received KINRIX and PROQUAD on 5/31/17. Developed dermatitis on (R) and (L) shoulders (Rx).
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: She returned to store with swollen, red severe pain at injection site.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Swelling, redness, with induration.
Age: 58.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: 36-48 hours post administration-red, warm swollen lump under injection site for ZOSTAVAX.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Haemoglobin normal, Lymphocyte percentage decreased, Monocyte percentage, Mouth haemorrhage, Neutrophil percentage increased
Clinical narrative: Patient developed mouth pain with petechiae of hard palate and decreased platelet count (61) 2 days after vaccine admin.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Oral pain, Platelet count decreased, Streptococcus test negative, White blood cell count normal
Clinical narrative: Patient developed mouth pain with petechiae of hard palate and decreased platelet count (61) 2 days after vaccine admin.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Swelling, redness, pain to right upper arm. Subjective fevers reported. Pain described as superficial not deep - much "like a sunburn".
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site reaction. Redness, swelling and itching about the size of a golf ball at injection site.
Age: 1.92
Sex: M
Vaccine: HIBV, MMRV, PNC, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Patient was seen for follow up visit. MMR and VARIVAX were ordered by provider. MMRV combo was drawn up and given. Patient is to young for (discovered on/report 6/2/17 Agency reported) MMRV.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, HIBV
Symptoms: Cafe au lait spots, Idiopathic urticaria, Injection site mass, Injection site nodule, Injection site pain
Clinical narrative: Reaction onset 6-7 months after 7/1/2014 Hep A vac (lt. thigh) and 11 months after 3/6/2014 Hib and DTaP (left thigh) vaccines. 2/2/2015 Mom reports lump to left thigh x 1 month, noticed while applying lotion to skin, site itchy but lotion helps. Exam: dimple to right chest, "small less than pea size" nodule on left anterior thigh, no erythema or tenderness exam. 9/1/2015 Peds Surg f/u: 1 yr Hx intermittent swelling/itching over left ant thigh, child c/o sore thigh and itchy last night. HCP documented a normal exam no mass palpable. Referred to peds/allergy as may be chronic fluctuating response from a prior vaccination. 2017 reaction resolved and being monitored, has café au lait spots to area w/diagnosis of dermatographic urticaria by dermatologist. Mom's concerns about possible "glass in vaccine" as the reason for her daughters persistent itching and scratching with nodule at the vaccine site. Mom advised lots of specialty visits and symptoms have resolved as of 2017 (waxed and waned for 2 years). She questions "glass" in vaccine based on reporters article.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, HIBV
Symptoms: Injection site pruritus, Injection site swelling, Mechanical urticaria, Ultrasound Doppler abnormal
Clinical narrative: Reaction onset 6-7 months after 7/1/2014 Hep A vac (lt. thigh) and 11 months after 3/6/2014 Hib and DTaP (left thigh) vaccines. 2/2/2015 Mom reports lump to left thigh x 1 month, noticed while applying lotion to skin, site itchy but lotion helps. Exam: dimple to right chest, "small less than pea size" nodule on left anterior thigh, no erythema or tenderness exam. 9/1/2015 Peds Surg f/u: 1 yr Hx intermittent swelling/itching over left ant thigh, child c/o sore thigh and itchy last night. HCP documented a normal exam no mass palpable. Referred to peds/allergy as may be chronic fluctuating response from a prior vaccination. 2017 reaction resolved and being monitored, has café au lait spots to area w/diagnosis of dermatographic urticaria by dermatologist. Mom's concerns about possible "glass in vaccine" as the reason for her daughters persistent itching and scratching with nodule at the vaccine site. Mom advised lots of specialty visits and symptoms have resolved as of 2017 (waxed and waned for 2 years). She questions "glass" in vaccine based on reporters article.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, HIBV
Symptoms: Cyst, Injection site mass, Injection site pruritus, Limb mass, Product quality issue
Clinical narrative: Reaction onset 6-7 months after 7/1/2014 Hep A vac (lt. thigh) and 11 months after 3/6/2014 Hib and DTaP (left thigh) vaccines. 2/2/2015 Mom reports lump to left thigh x 1 month, noticed while applying lotion to skin, site itchy but lotion helps. Exam: dimple to right chest, "small less than pea size" nodule on left anterior thigh, no erythema or tenderness exam. 9/1/2015 Peds Surg f/u: 1 yr Hx intermittent swelling/itching over left ant thigh, child c/o sore thigh and itchy last night. HCP documented a normal exam no mass palpable. Referred to peds/allergy as may be chronic fluctuating response from a prior vaccination. 2017 reaction resolved and being monitored, has café au lait spots to area w/diagnosis of dermatographic urticaria by dermatologist. Mom's concerns about possible "glass in vaccine" as the reason for her daughters persistent itching and scratching with nodule at the vaccine site. Mom advised lots of specialty visits and symptoms have resolved as of 2017 (waxed and waned for 2 years). She questions "glass" in vaccine based on reporters article.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, HIBV
Symptoms: Rash, Urticaria
Clinical narrative: Reaction onset 6-7 months after 7/1/2014 Hep A vac (lt. thigh) and 11 months after 3/6/2014 Hib and DTaP (left thigh) vaccines. 2/2/2015 Mom reports lump to left thigh x 1 month, noticed while applying lotion to skin, site itchy but lotion helps. Exam: dimple to right chest, "small less than pea size" nodule on left anterior thigh, no erythema or tenderness exam. 9/1/2015 Peds Surg f/u: 1 yr Hx intermittent swelling/itching over left ant thigh, child c/o sore thigh and itchy last night. HCP documented a normal exam no mass palpable. Referred to peds/allergy as may be chronic fluctuating response from a prior vaccination. 2017 reaction resolved and being monitored, has café au lait spots to area w/diagnosis of dermatographic urticaria by dermatologist. Mom's concerns about possible "glass in vaccine" as the reason for her daughters persistent itching and scratching with nodule at the vaccine site. Mom advised lots of specialty visits and symptoms have resolved as of 2017 (waxed and waned for 2 years). She questions "glass" in vaccine based on reporters article.
Age: 0.92
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Diarrhoea, Ear infection, Pyrexia, Viral infection, Vomiting
Clinical narrative: Per Father, child started day care 2-3 weeks prior to shots. Client was sick that first week with runny nose, sneezing and fevers. Client seemed to recover and came for the child's first set of shots on May 25. Evening of May 25, child was vomiting and had diarrhea with fevers up to 102 degrees. Child to ER on May 26th or 27th, diagnosed with ear infection. Symptoms continued for 8 days. Returned to ER on May 31, diagnosed with virus. Still having symptoms - of a June 5.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Peripheral swelling
Clinical narrative: Day after vaccine noted leg swelling down to knee. Resolved by 5-16-17 and no cellulitis noted.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was inappropriately given the shingles vaccine by pharm on 05/26/2017. It was discovered on 5/27/17. Pt uses different pharmacy and did not have his history. Pt unable to tell you what he takes.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: No adverse event
Clinical narrative: Patient was inappropriately given the shingles vaccine by pharm on 05/26/2017. It was discovered on 5/27/17. Pt uses different pharmacy and did not have his history. Pt unable to tell you what he takes.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Patient was inappropriately given the shingles vaccine by pharm on 05/26/2017. It was discovered on 5/27/17. Pt uses different pharmacy and did not have his history. Pt unable to tell you what he takes.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received via medical records from a licensed practical nurse and refers to a 10 year old female patient (one of 3 siblings). Information on the patient's concurrent conditions or concomitant therapy was not reported. The patient's historical drugs included PEDIARIX, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), pneumococcal vaccine (unspecified), Hib conj vaccine (unspecified carrier), varicella virus vaccine live (Oka/Merck) (manufacturer unknown), PENTACEL, KINRIX, Hepatitis B Vaccine (Recombinant) (manufacturer unknown), TWINRIX, HPV vaccine (unspecified) (manufacturer unknown), influenza virus vaccine (unspecified), poliovirus vaccine inactivated (unspecified), M-M-R II, meningococcal conj vaccine (unspecified), PNEUMOVAX23, rotavirus vaccine (unspecified) (manufacturer unknown), VARIVAX and ZOSTAVAX (captured in MARRS# 1706USA002211). On 20-JUL-2016, the patient was vaccinated with a first dose of VAQTA (intramuscularly, dose, lot# and expiration date were not provided). On 31-AUG-2016, the patient was vaccinated with a second dose of VAQTA (lot # L043209, expiration date 17-SEP-2017, intramuscularly in the right leg), which was stored improperly. The data logger was involved, prior temperature excursion reported: in July 2016 (1 Celsius degree for 69 hours 30 minutes) and in March 2017 (10 Celsius degree for 77 hours 41 minutes). No adverse effects were reported. This is one of 3 reports concerning 1 of 3 siblings. Additional information is not expected as all follow-up information has been received. All available medical records will be provided upon request.; Sender's Comments: US-009507513-1704USA001524: US-009507513-1705USA009103: US-009507513-1706USA002211:
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Chills, Insomnia, Joint range of motion decreased, Musculoskeletal discomfort, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 66-year-old female patient received PREVNAR 13 (Lot# R49358), via an unspecified route of administration, on 29Mar2017 at 09:00 AM, at 0.5 ml single, for immunisation. The patient was vaccinated at physician office. Medical history included ongoing type 2 diabetes mellitus, tachycardia, thyroid disorder, herpes virus infection, blood cholesterol abnormal, weight decreased (50 some pounds), seasonal allergy, parosmia, ongoing knee issue. Concomitant medication included metformin (unspecified trade name) from 2000 and ongoing for type 2 diabetes mellitus, simvastatin (unspecified trade name) from 2000 and ongoing for cholesterol, metoprolol (unspecified trade name) for tachycardia, levothyroxine (unspecified trade name) for thyroid disorder, valacyclovir hydrochloride (unspecified trade name) for herpes virus infection, ibuprofen  (unspecified trade name) from an unspecified date and ongoing for knee issue, TYLENOL (Lot# JJA021, Exp date Jan2020) from an unspecified date and ongoing for knee issue, methylprednisolone (unspecified trade name) from 06Apr2017 to an unspecified date for muscle relaxant. The patient previously took methylprednisolone (unspecified trade name) with good results. The patient experienced immobility in left arm on 30Mar2017 with outcome of recovering, flu like symptoms  on 29Mar2017 with outcome of recovered on 29Mar2017, the room was spinning on 29Mar2017 with outcome of recovered on 29Mar2017, diarrhea on 29Mar2017 with outcome of recovered in Apr2017 (2 weeks), chills on 29Mar2017 with outcome of recovered on 29Mar2017, burning in arm and shoulder on 29Mar2017 with outcome of recovering, tingling in her fingers on 28May2017 with outcome of recovered on 28May2017, she couldn't even raise her arm or couldn't pull it away on an unspecified date with outcome of unknown, hadn't been able to drive on an unspecified date with outcome of unknown, the pain was terrible on an unspecified date with outcome of unknown, nerve damage on an unspecified date with outcome of unknown. She went back to doctor's office and was seen by the PA on 05Apr2017. She has had 8 sessions of physical therapy. The patient underwent lab tests and procedures which included blood test: everything is good on 29Mar2017, laboratory test on 29Mar2017. The patient attributed diarrhea to too much medication, TYLENOL and Ibuprofen, that caused her to go to the bathroom since it was making her stomach burn.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Nausea, Neuralgia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 66-year-old female patient received PREVNAR 13 (Lot# R49358), via an unspecified route of administration, on 29Mar2017 at 09:00 AM, at 0.5 ml single, for immunisation. The patient was vaccinated at physician office. Medical history included ongoing type 2 diabetes mellitus, tachycardia, thyroid disorder, herpes virus infection, blood cholesterol abnormal, weight decreased (50 some pounds), seasonal allergy, parosmia, ongoing knee issue. Concomitant medication included metformin (unspecified trade name) from 2000 and ongoing for type 2 diabetes mellitus, simvastatin (unspecified trade name) from 2000 and ongoing for cholesterol, metoprolol (unspecified trade name) for tachycardia, levothyroxine (unspecified trade name) for thyroid disorder, valacyclovir hydrochloride (unspecified trade name) for herpes virus infection, ibuprofen  (unspecified trade name) from an unspecified date and ongoing for knee issue, TYLENOL (Lot# JJA021, Exp date Jan2020) from an unspecified date and ongoing for knee issue, methylprednisolone (unspecified trade name) from 06Apr2017 to an unspecified date for muscle relaxant. The patient previously took methylprednisolone (unspecified trade name) with good results. The patient experienced immobility in left arm on 30Mar2017 with outcome of recovering, flu like symptoms  on 29Mar2017 with outcome of recovered on 29Mar2017, the room was spinning on 29Mar2017 with outcome of recovered on 29Mar2017, diarrhea on 29Mar2017 with outcome of recovered in Apr2017 (2 weeks), chills on 29Mar2017 with outcome of recovered on 29Mar2017, burning in arm and shoulder on 29Mar2017 with outcome of recovering, tingling in her fingers on 28May2017 with outcome of recovered on 28May2017, she couldn't even raise her arm or couldn't pull it away on an unspecified date with outcome of unknown, hadn't been able to drive on an unspecified date with outcome of unknown, the pain was terrible on an unspecified date with outcome of unknown, nerve damage on an unspecified date with outcome of unknown. She went back to doctor's office and was seen by the PA on 05Apr2017. She has had 8 sessions of physical therapy. The patient underwent lab tests and procedures which included blood test: everything is good on 29Mar2017, laboratory test on 29Mar2017. The patient attributed diarrhea to too much medication, TYLENOL and Ibuprofen, that caused her to go to the bathroom since it was making her stomach burn.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood test normal, Burning sensation, Chills, Diarrhoea, Dyspepsia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 66-year-old female patient received PREVNAR 13 (Lot# R49358), via an unspecified route of administration, on 29Mar2017 at 09:00 AM, at 0.5 ml single, for immunisation. The patient was vaccinated at physician office. Medical history included ongoing type 2 diabetes mellitus, tachycardia, thyroid disorder, herpes virus infection, blood cholesterol abnormal, weight decreased (50 some pounds), seasonal allergy, parosmia, ongoing knee issue. Concomitant medication included metformin (unspecified trade name) from 2000 and ongoing for type 2 diabetes mellitus, simvastatin (unspecified trade name) from 2000 and ongoing for cholesterol, metoprolol (unspecified trade name) for tachycardia, levothyroxine (unspecified trade name) for thyroid disorder, valacyclovir hydrochloride (unspecified trade name) for herpes virus infection, ibuprofen  (unspecified trade name) from an unspecified date and ongoing for knee issue, TYLENOL (Lot# JJA021, Exp date Jan2020) from an unspecified date and ongoing for knee issue, methylprednisolone (unspecified trade name) from 06Apr2017 to an unspecified date for muscle relaxant. The patient previously took methylprednisolone (unspecified trade name) with good results. The patient experienced immobility in left arm on 30Mar2017 with outcome of recovering, flu like symptoms  on 29Mar2017 with outcome of recovered on 29Mar2017, the room was spinning on 29Mar2017 with outcome of recovered on 29Mar2017, diarrhea on 29Mar2017 with outcome of recovered in Apr2017 (2 weeks), chills on 29Mar2017 with outcome of recovered on 29Mar2017, burning in arm and shoulder on 29Mar2017 with outcome of recovering, tingling in her fingers on 28May2017 with outcome of recovered on 28May2017, she couldn't even raise her arm or couldn't pull it away on an unspecified date with outcome of unknown, hadn't been able to drive on an unspecified date with outcome of unknown, the pain was terrible on an unspecified date with outcome of unknown, nerve damage on an unspecified date with outcome of unknown. She went back to doctor's office and was seen by the PA on 05Apr2017. She has had 8 sessions of physical therapy. The patient underwent lab tests and procedures which included blood test: everything is good on 29Mar2017, laboratory test on 29Mar2017. The patient attributed diarrhea to too much medication, TYLENOL and Ibuprofen, that caused her to go to the bathroom since it was making her stomach burn.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Impaired driving ability, Influenza like illness, Injected limb mobility decreased, Laboratory test, Nerve injury
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 66-year-old female patient received PREVNAR 13 (Lot# R49358), via an unspecified route of administration, on 29Mar2017 at 09:00 AM, at 0.5 ml single, for immunisation. The patient was vaccinated at physician office. Medical history included ongoing type 2 diabetes mellitus, tachycardia, thyroid disorder, herpes virus infection, blood cholesterol abnormal, weight decreased (50 some pounds), seasonal allergy, parosmia, ongoing knee issue. Concomitant medication included metformin (unspecified trade name) from 2000 and ongoing for type 2 diabetes mellitus, simvastatin (unspecified trade name) from 2000 and ongoing for cholesterol, metoprolol (unspecified trade name) for tachycardia, levothyroxine (unspecified trade name) for thyroid disorder, valacyclovir hydrochloride (unspecified trade name) for herpes virus infection, ibuprofen  (unspecified trade name) from an unspecified date and ongoing for knee issue, TYLENOL (Lot# JJA021, Exp date Jan2020) from an unspecified date and ongoing for knee issue, methylprednisolone (unspecified trade name) from 06Apr2017 to an unspecified date for muscle relaxant. The patient previously took methylprednisolone (unspecified trade name) with good results. The patient experienced immobility in left arm on 30Mar2017 with outcome of recovering, flu like symptoms  on 29Mar2017 with outcome of recovered on 29Mar2017, the room was spinning on 29Mar2017 with outcome of recovered on 29Mar2017, diarrhea on 29Mar2017 with outcome of recovered in Apr2017 (2 weeks), chills on 29Mar2017 with outcome of recovered on 29Mar2017, burning in arm and shoulder on 29Mar2017 with outcome of recovering, tingling in her fingers on 28May2017 with outcome of recovered on 28May2017, she couldn't even raise her arm or couldn't pull it away on an unspecified date with outcome of unknown, hadn't been able to drive on an unspecified date with outcome of unknown, the pain was terrible on an unspecified date with outcome of unknown, nerve damage on an unspecified date with outcome of unknown. She went back to doctor's office and was seen by the PA on 05Apr2017. She has had 8 sessions of physical therapy. The patient underwent lab tests and procedures which included blood test: everything is good on 29Mar2017, laboratory test on 29Mar2017. The patient attributed diarrhea to too much medication, TYLENOL and Ibuprofen, that caused her to go to the bathroom since it was making her stomach burn.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pain, Paraesthesia, Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 66-year-old female patient received PREVNAR 13 (Lot# R49358), via an unspecified route of administration, on 29Mar2017 at 09:00 AM, at 0.5 ml single, for immunisation. The patient was vaccinated at physician office. Medical history included ongoing type 2 diabetes mellitus, tachycardia, thyroid disorder, herpes virus infection, blood cholesterol abnormal, weight decreased (50 some pounds), seasonal allergy, parosmia, ongoing knee issue. Concomitant medication included metformin (unspecified trade name) from 2000 and ongoing for type 2 diabetes mellitus, simvastatin (unspecified trade name) from 2000 and ongoing for cholesterol, metoprolol (unspecified trade name) for tachycardia, levothyroxine (unspecified trade name) for thyroid disorder, valacyclovir hydrochloride (unspecified trade name) for herpes virus infection, ibuprofen  (unspecified trade name) from an unspecified date and ongoing for knee issue, TYLENOL (Lot# JJA021, Exp date Jan2020) from an unspecified date and ongoing for knee issue, methylprednisolone (unspecified trade name) from 06Apr2017 to an unspecified date for muscle relaxant. The patient previously took methylprednisolone (unspecified trade name) with good results. The patient experienced immobility in left arm on 30Mar2017 with outcome of recovering, flu like symptoms  on 29Mar2017 with outcome of recovered on 29Mar2017, the room was spinning on 29Mar2017 with outcome of recovered on 29Mar2017, diarrhea on 29Mar2017 with outcome of recovered in Apr2017 (2 weeks), chills on 29Mar2017 with outcome of recovered on 29Mar2017, burning in arm and shoulder on 29Mar2017 with outcome of recovering, tingling in her fingers on 28May2017 with outcome of recovered on 28May2017, she couldn't even raise her arm or couldn't pull it away on an unspecified date with outcome of unknown, hadn't been able to drive on an unspecified date with outcome of unknown, the pain was terrible on an unspecified date with outcome of unknown, nerve damage on an unspecified date with outcome of unknown. She went back to doctor's office and was seen by the PA on 05Apr2017. She has had 8 sessions of physical therapy. The patient underwent lab tests and procedures which included blood test: everything is good on 29Mar2017, laboratory test on 29Mar2017. The patient attributed diarrhea to too much medication, TYLENOL and Ibuprofen, that caused her to go to the bathroom since it was making her stomach burn.
Age: 37.0
Sex: F
Vaccine: IPV, MNQ, IPV, MNQ
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 37-year-old female patient who received MENVEO (batch number M15144, expiry date 31st July 2017). Concomitant products included Polio vaccine. On 12th May 2017, the patient received MENVEO .5 ml. On 15th May 2017, 3 days after receiving MENVEO, the patient experienced fatigue and nausea. On an unknown date, the outcome of the fatigue and nausea were unknown. It was unknown if the reporter considered the fatigue and nausea to be related to MENVEO. Additional details were provided as follows: Concomitant medication included oral contraceptives and polio vaccine (non GSK, batch number: N1A461M) which was received in right arm. The patient received a dose of MENVEO on right arm.
Age: 37.0
Sex: F
Vaccine: IPV, MNQ, IPV, MNQ
Symptoms: Fatigue, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 37-year-old female patient who received MENVEO (batch number M15144, expiry date 31st July 2017). Concomitant products included Polio vaccine. On 12th May 2017, the patient received MENVEO .5 ml. On 15th May 2017, 3 days after receiving MENVEO, the patient experienced fatigue and nausea. On an unknown date, the outcome of the fatigue and nausea were unknown. It was unknown if the reporter considered the fatigue and nausea to be related to MENVEO. Additional details were provided as follows: Concomitant medication included oral contraceptives and polio vaccine (non GSK, batch number: N1A461M) which was received in right arm. The patient received a dose of MENVEO on right arm.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Crying, Eczema, Rash generalised, Rash pruritic
Clinical narrative: Constant crying, itchy rash covering body/eczema. Months seeing dermatologist and allergist.
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: Blood glucose, Dizziness, Electrocardiogram, Pallor
Clinical narrative: After receiving the vaccine shortly after the patient felt dizzy and became pale. We called 911 and in the meantime I kept talking to the patient and gave him water. He didn't show signs/symptoms of anaphylaxis. EMS arrived and took over the scene. They did an EKG, took his blood pressure and did a glucose test. Patient refused to go to the hospital and said his wife will take him if he feels worse.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Febrile convulsion, Seizure
Clinical narrative: Febrile Seizure X 3 (10:35am, 3:55pm, 8:30pm). Seizure again 5/29 3:30pm without fever. Seizures continued 6/1 twice daily since. Currently in diagnosis process for seizures.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with a dose of PROQUAD injection (albumin status: recombinant human albumin (rHA), lot# M015699, expiry date 26-SEP-2017; exact dose and route of administration were not reported) and with a dose of M-M-R II injection (albumin status rHA, lot# M008589 and expiration date 16-FEB-2018 ; exact dose and and route of administration were not reported) at the same time. Doses were reconstituted with sterile diluent. No adverse affects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a pharmacist referring to an unspecified patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 21-DEC-2016, patient  was vaccinated with the first dose of RECOMBIVAX HB for prophylaxis and received second dose in May 2017 (dose, route of administration, lot number and expiration date were not reported). No adeverse effects reported. Additional information is not expected because there was no consent to contact pharmacist.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker 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 an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). Concomitant therapies included sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions of: -14 to -10 degrees Celsius for 3 hours and 45 minutes; -9 to 8 degrees Celsius for 3 hours and 30 minutes. There were no previous excursions reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001241: US-009507513-1706USA001242: US-009507513-1706USA001243: US-009507513-1706USA001244: US-009507513-1706USA001245: US-009507513-1706USA001246: US-009507513-1706USA001247: US-009507513-1706USA001248: US-009507513-1706USA001249: US-009507513-1706USA001250: US-009507513-1706USA001251: US-009507513-1706USA001252: US-009507513-1706USA001253: US-009507513-1706USA001254: US-009507513-1706USA001255: US-009507513-1706USA001256: US-009507513-1706USA001257: US-009507513-1706USA001258: US-009507513-1706USA001259: US-009507513-1706USA001260: US-009507513-1706USA001261: US-009507513-1706USA001262: US-009507513-1706USA001263: US-009507513-1706USA001264: US-009507513-1706USA001265: US-009507513-1706USA001266: US-009507513-1706USA001267: US-009507513-1706USA001268: US-009507513-1706USA001269: US-009507513-1706USA001270: US-009507513-1706USA001271: US-009507513-1706USA001272: US-009507513-1706USA001273: US-009507513-1706USA001274: US-009507513-1706USA001275: US-009507513-1706USA001276: US-009507513-1706USA001277: US-009507513-1706USA001278: US-009507513-1706USA001234: US-009507513-1706USA001235: US-009507513-1706USA001236: US-009507513-1706USA001237: US-009507513-1706USA001238: US-009507513-1706USA001239: US-009507513-1706USA001240:
Age: 4.0
Sex: F
Vaccine: DTAP, HPV9, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 4 year old patient of unknown gender.  No information regarding the patient's medical history, concurrent conditions and concomitant therapies was reported. On 17-MAY-2017, the patient was vaccinated with GARDASIL 9 (dose, route and frequency were not provided) lot # M041990, expiration date 28-JUN-2019 for prophylaxis. On 17-MAY-2017, the four year old patient was inadvertently administered a dose of GARDASIL 9 (drug administered to patient of inappropriate age).  No adverse effects were reported. A Product Quality Complaint was not involved. Additional information has been requested.