chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 41 year old female patient. The patient had no drug allergy. Pertinent medical history included Crohn's disease. On 30-SEP-2015 the patient was vaccinated with a dose of PNEUMOVAX23 lot # L08664 with expiration date of 03-NOV-2015, 0.5 ml, intramuscular) in the deltoid of the left arm. Concomitant therapies included budesonide and vedolizumab. About 2 hours later after the patient received PNEUMOVAX23, the patient's left shoulder was swollen and hot. It was hard for the patient to lift her arm. On 01-OCT-2015 the patient emailed the hospital and reported the events. On the same day, the patient was seen at the emergency room because "her left upper arm had then become red, warm, and painful". In the Emergency Room the patient had a complete blood count (CBC) performed which showed "her while blood cell count was 15,000 (unit not provided) which was elevated. An unspecified physician at the hospital diagnosed the patient with cellulitis. The patient was given ANCEF (manufacturer unspecified) as treatment while in the Emergency Room. The patient was also given a  prescription for CEFALEX (manufacturer unspecified). The patient was not admitted to the hospital and left "later in the day" on 01-OCT-2014. ON 02-OCT-2015 the patient was seen by her unspecified primary care provider ad it was reported that the redness had spread and the patient wasn't getting better. The patient was then prescribed BACTRIM (manufacturer  unspecified). The outcome of the events was unknown. IT was also unknown if the patient was taking all of the above mentioned treatments (ANCEF, CEFALEX, and BACTRIM) at the same time. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, White blood cell count increased
Clinical narrative: Information has been received from a pharmacist referring to a 41 year old female patient. The patient had no drug allergy. Pertinent medical history included Crohn's disease. On 30-SEP-2015 the patient was vaccinated with a dose of PNEUMOVAX23 lot # L08664 with expiration date of 03-NOV-2015, 0.5 ml, intramuscular) in the deltoid of the left arm. Concomitant therapies included budesonide and vedolizumab. About 2 hours later after the patient received PNEUMOVAX23, the patient's left shoulder was swollen and hot. It was hard for the patient to lift her arm. On 01-OCT-2015 the patient emailed the hospital and reported the events. On the same day, the patient was seen at the emergency room because "her left upper arm had then become red, warm, and painful". In the Emergency Room the patient had a complete blood count (CBC) performed which showed "her while blood cell count was 15,000 (unit not provided) which was elevated. An unspecified physician at the hospital diagnosed the patient with cellulitis. The patient was given ANCEF (manufacturer unspecified) as treatment while in the Emergency Room. The patient was also given a  prescription for CEFALEX (manufacturer unspecified). The patient was not admitted to the hospital and left "later in the day" on 01-OCT-2014. ON 02-OCT-2015 the patient was seen by her unspecified primary care provider ad it was reported that the redness had spread and the patient wasn't getting better. The patient was then prescribed BACTRIM (manufacturer  unspecified). The outcome of the events was unknown. IT was also unknown if the patient was taking all of the above mentioned treatments (ANCEF, CEFALEX, and BACTRIM) at the same time. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patient of unknown age and gender. On an unknown dates, the patients were vaccinated with doses of (Oka/Merck) VARIVAX lot # L009203, expiration date 17-MAR-2017, lot # L013827, expiration date 21-APR-2017 and lot # reported as L024250, expiration date 30-JUN-2017 which were exposed to temperatures outside of the recommended range. No adverse experienced has been reported This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. The patient was vaccinated with GARDASIL (dose, route, lot # and expiration date were not reported) on 21-JUL-2015 and GARDASIL 9 (dose, route, lot # and expiration date were not reported) on 22-SEP-2015. (interchange of vaccine products) Concomitant drug was not reported. No adverse symptoms were reported. Outcome of the events and the causality were not reported. Additional information has been requested.
Age: 1.03
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and a healthcare worker who was the administrator, concerning to a 1 year old patient of unknown gender. The patient's current conditions and medical history were not provided. On 06-OCT-2014, the patient was vaccinated with an VARIVAX (dose and frequency were unknown) subcutaneous, lot # L016125, exp. 06-JUN-2017, which had been exposed to temperatures outside of the recommended range. No adverse effects were reported. There was not a product complain involved. This is one of several reports received from the same source.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt received PNEUMOVAX and she developed (L) arm soreness radiating down (L) arm into thumb; arm is warm to touch, red, swollen.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: RA-redness, no swelling, sore right arm. No reaction on left arm where flu shot was given.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a male patient who was 60 to 70 years old. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On approximately 15-SEP-2015 (reported as about 4 weeks ago), the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. In approximately 2015 (reported as few days ago), the patient came to the pharmacy complaining of a sporadic rash on his arm (rash) and several other parts of his body (rash generalized). At the time of the report, the outcome of the complaining of a sporadic rash on his arm and several other parts of his body was reported as not recovered.  The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. On 27-OCT-2015 the patient was vaccinated with dose of improperly stored PNEUMOVAX23 (lot # K010465 with expiration date: 23-MAR-2016, 0.5 ml, intramuscularly). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information bout patient's concomitant medications and pertinent medical history reported. On 22-OCT-2015, and expired dose of PNEUMOVAX23) lot # K006681, expiry date 21-OCT-2015 (dose, route and site of administration were not reported) was inadvertently administered to an unspecified patient. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant medications were not reported. ON 26-OCT-2015,, the patient was vaccinated with an expired dose of PNEUMOVAX23 (dose and route of administration were not reported; lot # K006681 and expiration date on 21-OCT-2015). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: This spontaneous report was received from a 43 year old male consumer, as part of a marketing research program conducted by MSW Research, referring to himself. Information about the patient's medical history and concurrent conditions was not reported. On an unknown date the patient was vaccinated with pneumococcal vaccine (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided). Concomitant medications was not reported. It is reported that the patient had the vaccine once and got the disease (pneumococcal infection). At the time of reporting, the outcome of pneumococcal infection was unknown. The reporter did not assess the relatedness between pneumococcal infection and pneumococcal vaccine (manufacturer unknown). Additional information is not expected as no reporter details were provided.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Depressed level of consciousness
Clinical narrative: Pt almost passed out after giving Tdap vaccine. For about 1 min. I kept talking to her and put her feet up. Washed her face with water.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: (Lt) arm cellulitis. (Resolved).
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dermatitis diaper, Diarrhoea
Clinical narrative: Diarrhea for 6 or more days and diaper rash.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Differential white blood cell count, Full blood count, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 3 inch x 2 1/2 induration (L) thigh. Redness and warm to the touch.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Ultrasound scan, Vaccination complication
Clinical narrative: 3 inch x 2 1/2 induration (L) thigh. Redness and warm to the touch.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician assistant via field representative referring to a 67 year old female patient. The patient's medical history or concurrent condition were not reported. On 31-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (1 single shot, strength, formulation, lot#, exact dose, route were unspecified). On an unknown date in October 2015, "last week", the patient developed shingles. The patient had sought unspecified medical attention. The outcome of the event was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Joint swelling, Musculoskeletal pain
Clinical narrative: Constant ongoing pain at injection site and shoulder (pain and swelling). Patient complain about shoulder pain while driving her car (when she steer her car's steering wheel).
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning fifteen patients of unknown ages and genders. The patients concurrent conditions and medical histories were not reported. On an unknown dates, fifteen patients were vaccinated with improperly stored doses of VAQTA, lot # K005323, expiration date: 10-FEB-2017 (frequencies, doses, strengths, routes and expiration dates were not reported). Co-suspect therapies or concomitant medications were not  provided. No adverse symptoms reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning nine patients of unknown ages and genders. The patients concurrent conditions and medical histories were not reported. On an unknown dates, nine patients were vaccinated with improperly stored doses of ROTATEQ, oral, lot # K017576, expiration date: 12-JUN-2016, (frequencies, does and strengths were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse symptoms reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning eleven patients of unknown age and genders. The patients concurrent conditions and medical histories were not reported. On an unknown dates, eleven patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # K024552, expiration date 22-OCT-2016, (frequencies, doses, strengths and routes were not reported). Co-suspect therapies or concomitant medications were not provided. The pharmacist reported. No adverse symptoms reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a male patient of unknown age. Concurrent condition and medical history were not reported. On an unspecified date in January 2014, the patient was vaccinated with one dose of GARDASIL (lot#, expiration date, dose and route were unknown). On 23-OCT-2015, the patient was vaccinated with the second dose of GARDASIL (lot#, expiration date, dose and route were unknown). No adverse effects were reported. Additional information is not expected as the pharmacist did not wish to be contacted further.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 30-OCT-2013, the patient was vaccinated with the first dose of PNEUMOVAX23 (lot #, expiration date, dose and strength unknown). On 21-OCT-2015 the patient was vaccinated with the second dose of PNEUMOVAX23 (lot # L013428 with expiration date of 03-FEB-2017, dose and strength unknown). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 21-OCT-2015 the patient was vaccinated with one improperly stored dose of ZOSTAVAX (lot # was reported as L0274322, expiration date 21-OCT-2016, dose and route unspecified). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse reporting that an unspecified amount of patients were administered on unspecified dates, improperly stored doses of (Oka/Merck) VARIVAX, from these possible lot #'s: (L013064, expiry date: 14-APR-2017), (L018001, expiry date, 19-MAY-2017), (L021215, expiry date, 10-JUN-2017), (L026410, expiry date, 15-FEB-2017), (L011083, expiry date, 01-APR-2017), and (L001335, expiry date, 13-JAN-2017). No adverse effects were reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Adverse event following immunisation, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a reporter who works in a physician's office, via company representative, concerning a 58 year old male patient. The patient's concurrent conditions included uncontrolled diabetes. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 22-APR-2015, the patient was vaccinated with PNEUMOVAX23, 1 vial, intramuscular (dose number, anatomical location, lot number and expiration date were unspecified). On 22-APR-2015 or 23-APR-2015, the patient called the physician's office and stated that he experienced pain, swelling and redness at the injection site and claimed that he had fever. In addition, the patient said "that injection you gave me knocked me to the floor" (adverse event following immunization). No treatment was given for the adverse events. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 27 year old female patient. The patient's concurrent conditions, medical history or allergy/drug reactions were reported as none. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9, (strength, dose, frequency, route, lot no. and expiration date were unspecified). Thera was no concomitant medication described. On an unknown date, the patient experienced a significant rash that appeared down side her torso from her nipple line down to her abdomen, 24 hours after the administration of the vaccine. It was also described that the rash was on the same side as the site of the injection and lasted about a week. No treatment was given. There was not a product quality complain involved. There was not laboratory testes performed. At the time of this report, the outcome of the above mentioned event was reported as recovered on an unspecified date. Additional information has been requested.
Age: 0.7
Sex: U
Vaccine: DTAP, HEP, PPV, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 7 month old patient, of unknown gender. Concurrent or medical conditions were not reported. On 21-OCT-2015, the patient inadvertently was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular in the deltoid, lot # reported as K020800, expiration date 05-JUN-2016. Concomitant therapies included ROTATEQ, hepatitis b vaccine (recombinant) (manufacturer unknown), hib conj vaccine (unspecified carrier) and poliovirus vaccine inactivated. The patient was younger that indicated age for PNEUMOVAX23. Presently no adverse effects being reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Per NP note on 12./20/2011: PNEUMOVAX 0.5 ml to (R) deltoid 12/16/2011 followed by gradual onset. Redness/tenderness at site of injection which subsequently spread down right arm anteriorly over bicep and above elbow joint. (R) deltoid warm tender to palp., erythema over (R) deltoid spreading down anteriorly over bicep and disipating at the level of the elbow. Bicep circumference 38 cm bilat, without edema. Arm and shoulder strength equal bilat with no loss in ROM including overhead reach.
Age: 13.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to five patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with an improperly stored GARDASIL, lot # L010596 with expiration date 06-APR-2017 (dose and route of administration were not reported). No adverse effects were reported. On 19-OCT-2015 a phone call was placed to the registered nurse who was unable to provide information. Follow up information has been received on 20-OCT-2015. Patient identifiers was given. This case refers to a 13 year old patient. On 31-AUG-2015, the patient was vaccinated with the improperly stored GARDASIL. This is one of several cases from the same reporter. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Mobility decreased, Pain in extremity
Clinical narrative: None stated.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain
Clinical narrative: None stated.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort
Clinical narrative: PATIENT SAID HE EXPERIENCD BLOOD PRESSURE INCREASE AND  PULSE RATE INCREASE. LASTING APPROXIMATELY 1 HOURS.  THEN  GOT BETTER AND BEEN GOOD EVERY SINCE.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: PATIENT SAID HE EXPERIENCD BLOOD PRESSURE INCREASE AND  PULSE RATE INCREASE. LASTING APPROXIMATELY 1 HOURS.  THEN  GOT BETTER AND BEEN GOOD EVERY SINCE.
Age: 2.0
Sex: M
Vaccine: FLUX, MMR, VARCEL, FLU3, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: Cardiac arrest, Death, Resuscitation
Clinical narrative: Patient received vaccines and checked out of doctors office at 1240. The doors were locked for lunch. At approximately 1245, patient's mother was banging on office door because patient was unresponsive. Dr. performed CPR until EMS arrival. Patient was transported to the hospital.
Age: 2.0
Sex: M
Vaccine: FLUX, MMR, VARCEL, FLU3, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: Patient received vaccines and checked out of doctors office at 1240. The doors were locked for lunch. At approximately 1245, patient's mother was banging on office door because patient was unresponsive. Dr. performed CPR until EMS arrival. Patient was transported to the hospital.
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 50-year-old female patient who received FLUARIX QUADRIVALENT (Batch number A9SY5, expiry date 30th May 2016). In 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site itching, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site itching, injection site warmth and injection site swelling were unknown. It was unknown if the reporter considered the injection site itching, injection site warmth and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: In 2015, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced itching, warmness and swollen arm ar the injection site (unknown arm). No further information was available regarding the event.
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 50-year-old female patient who received FLUARIX QUADRIVALENT (Batch number A9SY5, expiry date 30th May 2016). In 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site itching, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site itching, injection site warmth and injection site swelling were unknown. It was unknown if the reporter considered the injection site itching, injection site warmth and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: In 2015, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced itching, warmness and swollen arm ar the injection site (unknown arm). No further information was available regarding the event.
Age: 38.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Ear swelling, Eye swelling, Eyelids pruritus, Mouth swelling, Nasal inflammation
Clinical narrative: Case number PHEH2015US021101 is an initial spontaneous report received from a nurse on 16 Oct 2015. This report refers to a 38 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1518101 or 1514701) intramuscularly at a dose of 0.5 ml on 07 Oct 2015. On 09 Oct 2015, the patient had ocular syndrome (OCS) issue after receiving FLUVIRIN. He had closed, red and itchy eyes with upper respiratory issues started on 09 Oct 2015. The events were worse on 11 Oct 2015. The physician prescribed him BENADRYL eye drops and FLONASE. The events outcome was reported as complete recovery. The event ocular syndrome was reported as non-serious, but the event was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 38.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Ocular hyperaemia, Oculorespiratory syndrome, Pruritus, Respiration abnormal, Swollen tongue
Clinical narrative: Case number PHEH2015US021101 is an initial spontaneous report received from a nurse on 16 Oct 2015. This report refers to a 38 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1518101 or 1514701) intramuscularly at a dose of 0.5 ml on 07 Oct 2015. On 09 Oct 2015, the patient had ocular syndrome (OCS) issue after receiving FLUVIRIN. He had closed, red and itchy eyes with upper respiratory issues started on 09 Oct 2015. The events were worse on 11 Oct 2015. The physician prescribed him BENADRYL eye drops and FLONASE. The events outcome was reported as complete recovery. The event ocular syndrome was reported as non-serious, but the event was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 38.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Eye disorder, Eye pruritus, Ocular hyperaemia, Respiratory disorder
Clinical narrative: Case number PHEH2015US021101 is an initial spontaneous report received from a nurse on 16 Oct 2015. This report refers to a 38 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1518101 or 1514701) intramuscularly at a dose of 0.5 ml on 07 Oct 2015. On 09 Oct 2015, the patient had ocular syndrome (OCS) issue after receiving FLUVIRIN. He had closed, red and itchy eyes with upper respiratory issues started on 09 Oct 2015. The events were worse on 11 Oct 2015. The physician prescribed him BENADRYL eye drops and FLONASE. The events outcome was reported as complete recovery. The event ocular syndrome was reported as non-serious, but the event was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 13.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Lethargy, Pyrexia
Clinical narrative: Increased fever within an hr of administration per patient - 102.8 TYLENOL adm. by parents. Approximate dose. I just want to make sure is just a fever and that the MENVEO does not have any additives like pertussis - I also want a note for school for today and tomorrow so he cant stay at home. The patient is a 13 year, 0 month old male who presents with fever. Maximum temperature taken tympanically was 102.9 (taken at home). Symptoms do not include sore throat, ear pain, cough, rhinorrhea, skin swelling, rash, headache, poor oral intake, vomiting, diarrhea, abdominal pain or dysuria. Onset was sudden hour(s) ago (after MENVEO injection was given-approximately-about and hr after getting shot). Onset following none (MENVEO injection given this morning). This is described as improving (TYLENOL was given by dad). Associated symptoms include fatigue, while associated symptoms do not include wheezing. Current treatment includes acetaminophen (adequate dose).
Age: 13.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Activities of daily living impaired, Fatigue, Pyrexia
Clinical narrative: Increased fever within an hr of administration per patient - 102.8 TYLENOL adm. by parents. Approximate dose. I just want to make sure is just a fever and that the MENVEO does not have any additives like pertussis - I also want a note for school for today and tomorrow so he cant stay at home. The patient is a 13 year, 0 month old male who presents with fever. Maximum temperature taken tympanically was 102.9 (taken at home). Symptoms do not include sore throat, ear pain, cough, rhinorrhea, skin swelling, rash, headache, poor oral intake, vomiting, diarrhea, abdominal pain or dysuria. Onset was sudden hour(s) ago (after MENVEO injection was given-approximately-about and hr after getting shot). Onset following none (MENVEO injection given this morning). This is described as improving (TYLENOL was given by dad). Associated symptoms include fatigue, while associated symptoms do not include wheezing. Current treatment includes acetaminophen (adequate dose).
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, X-ray limb normal
Clinical narrative: I was given the vaccine in my left shoulder while at work. A few hours into my shift, I noticed that my shoulder began to hurt, more then the other times I received the vaccine. Everyday after, the pain became more intense until it was unbearable. I can not move my shoulder without sharp shooting pain. I went to the Dr. at Occupational health, at my work, on Oct 21, 2015. The Dr prescribed naproxen and tramadol. I was told to return in a week. I returned on Oct 27th. I saw a different Dr this time. He ordered a shoulder Xray, which he said was negative. He said to continue taking the anti-inflammatories, showed me some exercises to do and said to return in 10 days. He also stated that if my shoulder wasn't better then, I could do physical therapy. My shoulder is still in a lot of pain. I am not able to use my arm because of the pain.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Injection site warmth, Local reaction
Clinical narrative: LOCAL REACTION AT INJECTION SITE WITH ERYTHEMA, INDURATION, WARMTH AND MILD VESICULAR REACTION.  MILD SYSTEMIC REACTION WITH MYALGIA.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: LOCAL REACTION AT INJECTION SITE WITH ERYTHEMA, INDURATION, WARMTH AND MILD VESICULAR REACTION.  MILD SYSTEMIC REACTION WITH MYALGIA.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Swelling
Clinical narrative: Swelling, soreness, bump, arm pain.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Chills, Headache, Neck pain, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient reported a sore throat and neck, a headache, and she had a fever (100 degrees) and chills (shaking). We treated with ibuprofen. On 10/29 her symptoms had mostly resolved.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus generalised, Pyrexia, Rash generalised, Urticaria
Clinical narrative: Head to Toe in severe hives & rash. His rash on the back of thighs and buttock had fever. Low grade fever of 99. His was itching all over.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Blood test, Chills, Decreased appetite
Clinical narrative: Fever, Chills, Sweats, Weakness, Muscle ache, Joint ache, loss of appetite, poor sleep, Bad headache.  This was from a Flu Vaccine.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Hyperhidrosis, Myalgia, Poor quality sleep, Pyrexia
Clinical narrative: Fever, Chills, Sweats, Weakness, Muscle ache, Joint ache, loss of appetite, poor sleep, Bad headache.  This was from a Flu Vaccine.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Borrelia test negative, CSF immunoglobulin G index, CSF oligoclonal band absent, Computerised tomogram normal, Diplopia
Clinical narrative: The night of the flu vaccine the patient stated that she felt symptoms of what she described as a "sinus headache." The next morning she awoke with the headache and intermittent diplopia. This continued on and off for several days leading to admission on 10/14/15. MD review resulted in diagnosis of partial 6th nerve palsy with question of relation to influenza vaccine.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Sinus headache, VIth nerve paralysis
Clinical narrative: The night of the flu vaccine the patient stated that she felt symptoms of what she described as a "sinus headache." The next morning she awoke with the headache and intermittent diplopia. This continued on and off for several days leading to admission on 10/14/15. MD review resulted in diagnosis of partial 6th nerve palsy with question of relation to influenza vaccine.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Discomfort, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test normal
Clinical narrative: EE, a FT CT technician, reports to OIM with a CC of "lower extremities numbness and tingling." EE reports that symptoms started after he had his flu shot on Sunday the 4th of October. On Wednesday the 7th of October, he "woke up with numbness and tingling sensation in his calves." As the day progressed, the numbness and tingling moved to his thigh and pelvic area. On 10-08-2015,  the numbness and tingling was "more intense," and the sensation had moved up to his abdomen. On the 10-09-2015, the symptoms had intensified so much so that he could not lay down or sleep. On the 10-10-2015, he reports that he felt "pressure in his belly and spine," that was unbearable, and felt like "the two had collapsed on each other." He presented to the ED that same day. Per eemr notes, he did receive extensive testing all of which was negative. Last note by neurologist indicates a differential diagnosis of Guillain Barre vs transverse myelitis. He was discharged on Monday, 10-12-2015. He reports that the symptoms continued Monday night and he felt as though his right leg was going to callapse. He called the neurologist, who advised him to come back to the ER. However, patient decided not to at the time and his symptoms resolved. He reports that the symptoms continue to occur, but are not as intense as they were over the weekend. He continues to have numbness and tingling constantly, but numbness and tingling is more intense certain times of the day and can last for 2-3 hours. Her takes tramadol to help with the "pain," but he is not sure if the tramadol helps or the symptoms subside over time. He does have a f/u with the neurologist on 10-19-2015. Formally diagnosed with "paresthesias or lower extremities."
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Limb discomfort, Myelitis transverse, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Pain
Clinical narrative: EE, a FT CT technician, reports to OIM with a CC of "lower extremities numbness and tingling." EE reports that symptoms started after he had his flu shot on Sunday the 4th of October. On Wednesday the 7th of October, he "woke up with numbness and tingling sensation in his calves." As the day progressed, the numbness and tingling moved to his thigh and pelvic area. On 10-08-2015,  the numbness and tingling was "more intense," and the sensation had moved up to his abdomen. On the 10-09-2015, the symptoms had intensified so much so that he could not lay down or sleep. On the 10-10-2015, he reports that he felt "pressure in his belly and spine," that was unbearable, and felt like "the two had collapsed on each other." He presented to the ED that same day. Per eemr notes, he did receive extensive testing all of which was negative. Last note by neurologist indicates a differential diagnosis of Guillain Barre vs transverse myelitis. He was discharged on Monday, 10-12-2015. He reports that the symptoms continued Monday night and he felt as though his right leg was going to callapse. He called the neurologist, who advised him to come back to the ER. However, patient decided not to at the time and his symptoms resolved. He reports that the symptoms continue to occur, but are not as intense as they were over the weekend. He continues to have numbness and tingling constantly, but numbness and tingling is more intense certain times of the day and can last for 2-3 hours. Her takes tramadol to help with the "pain," but he is not sure if the tramadol helps or the symptoms subside over time. He does have a f/u with the neurologist on 10-19-2015. Formally diagnosed with "paresthesias or lower extremities."
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Sleep disorder
Clinical narrative: EE, a FT CT technician, reports to OIM with a CC of "lower extremities numbness and tingling." EE reports that symptoms started after he had his flu shot on Sunday the 4th of October. On Wednesday the 7th of October, he "woke up with numbness and tingling sensation in his calves." As the day progressed, the numbness and tingling moved to his thigh and pelvic area. On 10-08-2015,  the numbness and tingling was "more intense," and the sensation had moved up to his abdomen. On the 10-09-2015, the symptoms had intensified so much so that he could not lay down or sleep. On the 10-10-2015, he reports that he felt "pressure in his belly and spine," that was unbearable, and felt like "the two had collapsed on each other." He presented to the ED that same day. Per eemr notes, he did receive extensive testing all of which was negative. Last note by neurologist indicates a differential diagnosis of Guillain Barre vs transverse myelitis. He was discharged on Monday, 10-12-2015. He reports that the symptoms continued Monday night and he felt as though his right leg was going to callapse. He called the neurologist, who advised him to come back to the ER. However, patient decided not to at the time and his symptoms resolved. He reports that the symptoms continue to occur, but are not as intense as they were over the weekend. He continues to have numbness and tingling constantly, but numbness and tingling is more intense certain times of the day and can last for 2-3 hours. Her takes tramadol to help with the "pain," but he is not sure if the tramadol helps or the symptoms subside over time. He does have a f/u with the neurologist on 10-19-2015. Formally diagnosed with "paresthesias or lower extremities."
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain in (R) shoulder that started after getting flu shot. Initially felt this was usual soreness but now unable to lift (R) arm above shoulder height or across upper body without experiencing increased pain. No obvious redness or swelling noted and arm cool to touch.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chest discomfort, Loss of consciousness, Urticaria
Clinical narrative: 2:30pm - complained about stomach pain, tightness in chest. 3:30-4pm - hives. 4:30pm - passed out, called 911, went to hospital. EPIPEN given at hospital.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient given adult dose of Hep A vaccine instead of pediatric/adolescent dose of Hep A.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Injection site swelling, Local swelling, Myalgia, Peripheral swelling
Clinical narrative: 2 hours after receiving vaccine, muscle aches, headache, swelling at shot site, next day, arm swollen to armpit area and chest.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Chills, low grade fever, general malaise.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Cough, Pyrexia, Vomiting
Clinical narrative: Chills, fever of 100.9, cough, one event of copious vomiting. Not allowed to use Tylenol or NSAIDs because of cirrhosis. Cool cloth to head, blankets, a little bit of coca-cola after vomiting.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient complained of intense itching and whelps on arm that was vaccinated.  She said it lasted 24 hours and got better the next day.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Asthenia, Injection site pain, Nausea, Pain
Clinical narrative: Vomiting, nausea, stomach ache, pain where shot was given, body aches, weakness. Vomiting lasted throughout the night. Weakness, nausea, pain in arm continued throughout all next day (10/29).
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Vomiting, nausea, stomach ache, pain where shot was given, body aches, weakness. Vomiting lasted throughout the night. Weakness, nausea, pain in arm continued throughout all next day (10/29).
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Acoustic stimulation tests normal, Aggression, Aphasia, Autism, Electroencephalogram abnormal
Clinical narrative: My 13-year-old son has autism and was also diagnosed with Landau-Kleffner Syndrome. He received the MMR and varicella vaccines on 09/04/03, a day after his first birthday. Soon after receiving these vaccines, the life went out of him. He stopped talking, became aggressive, head banging, screaming, staying up all night, and tearing the house apart. His hearing was tested and came back normal. He was screened by psychiatry and speech who soon diagnosed him with autism. He was tested by neurologist, who performed a 24-hour EEG that showed seizure activity when asleep affecting patient's speech as well. Patient was put on valium for seizures and focalin for his behavior.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Head banging, Insomnia, Neurological examination, Psychiatric evaluation, Screaming
Clinical narrative: My 13-year-old son has autism and was also diagnosed with Landau-Kleffner Syndrome. He received the MMR and varicella vaccines on 09/04/03, a day after his first birthday. Soon after receiving these vaccines, the life went out of him. He stopped talking, became aggressive, head banging, screaming, staying up all night, and tearing the house apart. His hearing was tested and came back normal. He was screened by psychiatry and speech who soon diagnosed him with autism. He was tested by neurologist, who performed a 24-hour EEG that showed seizure activity when asleep affecting patient's speech as well. Patient was put on valium for seizures and focalin for his behavior.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Seizure
Clinical narrative: My 13-year-old son has autism and was also diagnosed with Landau-Kleffner Syndrome. He received the MMR and varicella vaccines on 09/04/03, a day after his first birthday. Soon after receiving these vaccines, the life went out of him. He stopped talking, became aggressive, head banging, screaming, staying up all night, and tearing the house apart. His hearing was tested and came back normal. He was screened by psychiatry and speech who soon diagnosed him with autism. He was tested by neurologist, who performed a 24-hour EEG that showed seizure activity when asleep affecting patient's speech as well. Patient was put on valium for seizures and focalin for his behavior.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Feeling hot
Clinical narrative: Face became hot and red, erythema and heat right cheek, nose and left cheek.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Antinuclear antibody negative, Blood glucose normal, Blood homocysteine normal, Borrelia test negative, Double stranded DNA antibody
Clinical narrative: Numbness in thighs, then spread to entire legs and feet and up to waist by that night.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Glycosylated haemoglobin normal, Hypoaesthesia, Immunology test normal, Laboratory test, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: Numbness in thighs, then spread to entire legs and feet and up to waist by that night.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid factor negative, Vitamin B12 normal
Clinical narrative: Numbness in thighs, then spread to entire legs and feet and up to waist by that night.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Type III Hypersensitivity Reaction.
Age: 31.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Blindness unilateral
Clinical narrative: After leaving clinic patient went home took a nap, upon awakening, he was unable to see out of right eye.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Rash, Skin warm
Clinical narrative: RASH THAT IS WARM TO THE TOUCH, LUMP AT INJECTION SITE. PATIENT STATES THE AREA IS PAINFUL. PATIENT IS SEEING DR 10/29/15 FOR UNRELATED REASON AND WILL INQUIRE CONCERNING INJECTION SITE.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Injection site pain
Clinical narrative: Awaken with light headedness; low grade fever (98.2); soreness at inj site; site tenderness to touch; tire and weak; loss of appetite.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Awaken with light headedness; low grade fever (98.2); soreness at inj site; site tenderness to touch; tire and weak; loss of appetite.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Swelling
Clinical narrative: Left arm with area of redness and swelling 20cm below the injection site.  Area of redness 10cm above and 10cm on the left and right of the injection site.  Area is painful when touched.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swollen, warm to touch 3 X 3 Painful.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Flushing, Hyperhidrosis, Musculoskeletal discomfort, Paraesthesia oral
Clinical narrative: Congestion, diaphoresis, flushing, tongue tingling, joint discomfort, dyspnea.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Congestion, diaphoresis, flushing, tongue tingling, joint discomfort, dyspnea.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Pain on injection and persistent pain since injection, soreness at injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe shoulder and arm pain within hours after immunization; call to PCP to report pain on Friday.  Was told to use ibuprofen over the weekend.  Patient saw provider on Monday and was prescribed a course of prednisone taper.  Patient still reports discomfort, although not as painful as 17 months ago.  Vaccine was administered high on deltoid muscle, close to top of deltoid muscle.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Itching, followed by Rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: SHINGLES VACCINE: Shot in left arm...cannot move my arm away from ribs...feels like the shot settled in my shoulder socket...today is day 3 and still in severe pain.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Itching Follow weals and redness, Took Zyrtec, Hydrocortisone Cream, prednisone.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: While vaccine injected, felt like a glob of glue was injected.  Immediate injection site pain.  Pain continues in injection site.  Cannot lift arm over head to dress, comb hair.  Pain wakes me up while sleeping at night.