chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Rash
Clinical narrative: This spontaneous report was received on 03-OCT-2016 from a 69 year old male consumer regarding himself. In November 2015, the male was vaccinated with ZOSTAVAX subcutaneously. Medical history and concomitant medications were not provided (patient refused to provide as he felt they were not relevant or connected to his symptoms). He developed a rash a few days after the vaccination. He has also since been experiencing nerve pain throughout his body which has not dissipated. He had to go to the doctor each subsequent month since the vaccination. The outcome of the rash was unknown. The incurred as a result of the ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning 6 unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unspecified dates, the patients were vaccinated with unspecified improperly stored doses of PROQUAD (lot number L046510 with an expiration date of 19-MAY-2017 (strength, dosage schedule, route and anatomical location were not reported). No other suspect and concomitant medications were provided. There was no adverse effect reported. No product quality complaint was involved. This is one of the 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 medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. In May 2016, the patient was vaccinated with a dose of an improperly store ROTATEQ, orally, lot number K020181, expiration date 24-JUN-2016 (dose and frequency were not reported) before this lot of ROTATEQ expired. There was no concomitant medication reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown gender and age. The patient's concurrent conditions and medical history were not provided. On 03-OCT-2016, the patient was vaccinated with GARDASIL 9 (strength, lot and expiration date were not provided), intramuscular after the product had experienced a temperature excursion. There were no concomitant medications and adverse effects reported. No product complain was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager, refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of VAQTA (lot # L015460 and expiration date 20-JUL-2017) (lot # L023936 and expiration date 15-MAR-2017) (doses and administration route was not reported). The reporter stated that she was not aware of any adverse effects and no product quality complaint was involved. Temperature: 19.9 Fahrenheit degrees. Time Frame: unspecified at the time of his reporting. Temperature excursion (cumulative time): 255 hours. Was a data logger involved: Yes. This is one of several reports from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 64 year old female patient via a company representative referring to herself. The pertinent medical history and concomitant therapy of the patient were unspecified. On an unknown date, when the patient was 63 year old, she was vaccinated with a dose of ZOSTAVAX (lot # and expiration date unspecified), 0.65 ml, subcutaneously. An unspecified time after the vaccination, the patient developed shingles. The outcome of the event was reported as recovered/resolved on an unknown date. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Injected limb mobility decreased, Pain, Skin warm
Clinical narrative: Woke up two days after vaccine administration with 4 cm induration, erythema, increased localized heat, pain with decreased mobility to left arm.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Mom reports hives all over 5-6 hours after vaccines. She used BENADRYL and patient was improved the next morning. No other symptoms besides rash.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Warm at injection site and getting pinker, sore, tender to touch.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Received vaccine on 9/26/16 - started with redness at injection site - redness and warmth has increased daily - measuring 8 mm tall and 11 mm across on 9/29/16
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture, Culture stool, Decreased appetite, Diarrhoea, Frequent bowel movements
Clinical narrative: Decreased appetite after immunizations given went 11 hours between feedings. Diarrhea started about 18 hours later -stooling x6-8/day, cranky, afebrile, no vomiting.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Full blood count, Hepatitis viral test, Irritability, Metabolic function test, Rotavirus test
Clinical narrative: Decreased appetite after immunizations given went 11 hours between feedings. Diarrhea started about 18 hours later -stooling x6-8/day, cranky, afebrile, no vomiting.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Burning sensation, Injection site pain
Clinical narrative: Pain in upper right arm and shoulder 4 weeks after TDaP vaccine. Complaint of "burning, weakness, and muscle tear feeling with range of motion. Pt referred to PT.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Injection site erythema, Injection site warmth
Clinical narrative: Arm red at shot area, arm hot, welt on arm, dizzy, not hungry, diarrhea, stomach issues (upset).
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Hypotonia, Pyrexia, Unresponsive to stimuli
Clinical narrative: Patient was seen in office on 10-3-16 and given vaccines listed below around 9:46 am. When mother and pt returned home patient was limp and not responsive. Mom took pt to ER patient returned to normal behavior for the rest of the day. Patient was limp in her sleep mom felt on 10/3/16 but would wake patient to make sure she was okay. Patient had fever that night. Pt seems to be acting like herself today.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Diarrhoea, Rash
Clinical narrative: Parent called on 9-27-16 to report that on 9-23-16 patient started having diarrhea. He ran a low temp (101.0F) for the first two days, then a "small bumpy rash" appeared, starting on his head and face then descending to torso and linear. Rash was not itchy. Mom administered TYLENOL for the temp. The diarrhea continued throughout though he never vomited and was able to continue fluids. Mom took to ER for the diarrhea on 9-27-16. F/U call update from mom says ER Doc said rash not due to vaccines and as long as he was taking fluids to take him home. Symptoms disappeared by 9/29/2016.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Full blood count
Clinical narrative: 9/6/16 office visit for cellulitis, antibiotic. 9/6/16 ED for cellulitis, IV antibiotic given. 9/7/16 OV for follow up. 9/8/16 OV for follow up.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: PNEUMOVAX 23 admin. 8am 10/3/16 within 5 hrs pain worsening, swelling upper arm to below elbow, arm warm and reddened. Difficulty moving arm. Was improving with BENADRYL and ice by 9pm  Symptoms less today - some swelling, warmth and redness.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash
Clinical narrative: Rash over body zero on legs, no fever or site soreness. Hx of contact rash from new clothing. New food last night.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Patient had brief reported LOC (<30s) observed by mom. Mom assisted to floor - and no fever, no injuries BP 104/64, Pulse 70, D-stick 94, Tolerated PO, observed x 20m and fully recovered.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash, Swelling face
Clinical narrative: 9/27 -Vaccines received. 9/28 -mom noticed rash on face and facial swelling. Mom applied hydrocortisone cream. 9/29 -swelling resolved. Still some red rash on forehead and under eyes per mom. No physician visit during this time.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient received extra Hep B 10-3-16.
Age: 18.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: This is a Spontaneous report from a contactable physician.  A 18-year old male patient of unknown race received the first dose of TRUMENBA (Batch/Lot # and expiration date: M37314; Exp 30Apr2017) at 0.5 ml single dose, via intramuscular route on the left arm for immunization on 14Jun2016 11:20. The vaccine was administered at the physician office. On 11Jul2016 the patient experienced Grand mal seizure, the event require an emergency room but the patient was not hospitalized. The outcome was unknown. No known cause identified. Treated by neurologist. Currently on KEPPRA. No further seizures, including with second dose of vaccine received on 16Aug2016. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 18.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: This is a Spontaneous report from a contactable physician.  A 18-year old male patient of unknown race received the first dose of TRUMENBA (Batch/Lot # and expiration date: M37314; Exp 30Apr2017) at 0.5 ml single dose, via intramuscular route on the left arm for immunization on 14Jun2016 11:20. The vaccine was administered at the physician office. On 11Jul2016 the patient experienced Grand mal seizure, the event require an emergency room but the patient was not hospitalized. The outcome was unknown. No known cause identified. Treated by neurologist. Currently on KEPPRA. No further seizures, including with second dose of vaccine received on 16Aug2016. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Pt came to us on 9/23/16 and stated her arm has hurt and pain has radiated down to elbow since a couple of days after receiving vaccine. No treatment to date, not getting better. Advised pt to make a doctors appt. to have arm looked at.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Sleep disorder
Clinical narrative: Pt came to us on 9/23/16 and stated her arm has hurt and pain has radiated down to elbow since a couple of days after receiving vaccine. No treatment to date, not getting better. Advised pt to make a doctors appt. to have arm looked at.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pt came to us on 9/23/16 and stated her arm has hurt and pain has radiated down to elbow since a couple of days after receiving vaccine. No treatment to date, not getting better. Advised pt to make a doctors appt. to have arm looked at.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin, Herpes zoster, Pyrexia, Rash generalised, Rash pustular
Clinical narrative: Information has been received from a 65 years old female patient concerning herself. The patient's pertinent medical history included chickenpox when she was 9 years old. Concurrent conditions were not informed. The patient stated that she had not drug reactions or allergies. On 01-SEP-2016, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dosage and therapy route were not provided), one shot. Concomitant therapies included nortriptyline 50 mg and atorvastatin 20 mg. The patient reported that on 11-SEP-2016 she broke out in a "shingles like rash" on her left lower back that wrapped around to the right side of her abdomen and she had been feeling tired and experiencing headaches. Then on 15-SEP-2016, a "chickenpox like rash" appeared all over her body. The patient was concerned why she was this chickenpox like rash because she had it when she was 9 years old. Lab work was performed and on an unspecified date, the patient was sent to the dermatologist by her primary physician for a "needle biopsy" for the "shingles like rash", but the patient did not specified what "lab work" meant. Patient was advised to use calamine cream and triamcinolone. The outcome of shingles like rash, feeling tired, headaches and chickenpox like rash was reported as recovering at the time of the report since "the patient was still recovering from this ordeal"; the outcome was also reported as recovered. No product quality complaint (PQC) was involved. The causal relationship between ZOSTAVAX and chickenpox like rash was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a 65 years old female patient concerning herself. The patient's pertinent medical history included chickenpox when she was 9 years old. Concurrent conditions were not informed. The patient stated that she had not drug reactions or allergies. On 01-SEP-2016, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dosage and therapy route were not provided), one shot. Concomitant therapies included nortriptyline 50 mg and atorvastatin 20 mg. The patient reported that on 11-SEP-2016 she broke out in a "shingles like rash" on her left lower back that wrapped around to the right side of her abdomen and she had been feeling tired and experiencing headaches. Then on 15-SEP-2016, a "chickenpox like rash" appeared all over her body. The patient was concerned why she was this chickenpox like rash because she had it when she was 9 years old. Lab work was performed and on an unspecified date, the patient was sent to the dermatologist by her primary physician for a "needle biopsy" for the "shingles like rash", but the patient did not specified what "lab work" meant. Patient was advised to use calamine cream and triamcinolone. The outcome of shingles like rash, feeling tired, headaches and chickenpox like rash was reported as recovering at the time of the report since "the patient was still recovering from this ordeal"; the outcome was also reported as recovered. No product quality complaint (PQC) was involved. The causal relationship between ZOSTAVAX and chickenpox like rash was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diagnostic aspiration, Fatigue, Headache, Laboratory test, Rash generalised
Clinical narrative: Information has been received from a 65 years old female patient concerning herself. The patient's pertinent medical history included chickenpox when she was 9 years old. Concurrent conditions were not informed. The patient stated that she had not drug reactions or allergies. On 01-SEP-2016, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dosage and therapy route were not provided), one shot. Concomitant therapies included nortriptyline 50 mg and atorvastatin 20 mg. The patient reported that on 11-SEP-2016 she broke out in a "shingles like rash" on her left lower back that wrapped around to the right side of her abdomen and she had been feeling tired and experiencing headaches. Then on 15-SEP-2016, a "chickenpox like rash" appeared all over her body. The patient was concerned why she was this chickenpox like rash because she had it when she was 9 years old. Lab work was performed and on an unspecified date, the patient was sent to the dermatologist by her primary physician for a "needle biopsy" for the "shingles like rash", but the patient did not specified what "lab work" meant. Patient was advised to use calamine cream and triamcinolone. The outcome of shingles like rash, feeling tired, headaches and chickenpox like rash was reported as recovering at the time of the report since "the patient was still recovering from this ordeal"; the outcome was also reported as recovered. No product quality complaint (PQC) was involved. The causal relationship between ZOSTAVAX and chickenpox like rash was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a 65 years old female patient concerning herself. The patient's pertinent medical history included chickenpox when she was 9 years old. Concurrent conditions were not informed. The patient stated that she had not drug reactions or allergies. On 01-SEP-2016, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dosage and therapy route were not provided), one shot. Concomitant therapies included nortriptyline 50 mg and atorvastatin 20 mg. The patient reported that on 11-SEP-2016 she broke out in a "shingles like rash" on her left lower back that wrapped around to the right side of her abdomen and she had been feeling tired and experiencing headaches. Then on 15-SEP-2016, a "chickenpox like rash" appeared all over her body. The patient was concerned why she was this chickenpox like rash because she had it when she was 9 years old. Lab work was performed and on an unspecified date, the patient was sent to the dermatologist by her primary physician for a "needle biopsy" for the "shingles like rash", but the patient did not specified what "lab work" meant. Patient was advised to use calamine cream and triamcinolone. The outcome of shingles like rash, feeling tired, headaches and chickenpox like rash was reported as recovering at the time of the report since "the patient was still recovering from this ordeal"; the outcome was also reported as recovered. No product quality complaint (PQC) was involved. The causal relationship between ZOSTAVAX and chickenpox like rash was not reported. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Injection site induration, Injection site macule, Injection site vesicles, Rash macular, Tenderness
Clinical narrative: Initial unsolicited report received from a health care professional on 26-Sep-2016. This case involves a 27-year-old male patient, who was vaccinated with ADACEL via intramuscular route (batch number: U5477CA, expiry date: 29-Oct-2016, dose: unknown) in left deltoid and FLUARIX (manufacturer: GSK) (batch number: Y495S, expiry date and dose not reported) via intramuscular route in right deltoid on 24-Sep-2016. It was also reported that patient stated it was possible the patient received the vaccine more subcutaneous than intramuscular. Patient's had no Illness at time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions were also reported as none. On 24-Sep-2016, same day (evening) following the vaccination, patient had symptoms of stiffness and soreness in the left deltoid. On 25-Sep-2016, one day (next morning) after the vaccination patient had rash around the injection site, a macular, flat, brownish tone to dusky red, sized at 2cm x 6 cm with an irregular inferior boarder. 2cm superior to left deltoid injection site. Palpable induration 6x5 cm, and dense blistering 2cm in diameter around vaccination site. Patient required emergency room/doctor visit. Lab test was reported as none. Concomitant medication was not reported. Outcome of the events were reported as not recovered. Documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site macule, Injection site pain, Injection site rash
Clinical narrative: Initial unsolicited report received from a health care professional on 26-Sep-2016. This case involves a 27-year-old male patient, who was vaccinated with ADACEL via intramuscular route (batch number: U5477CA, expiry date: 29-Oct-2016, dose: unknown) in left deltoid and FLUARIX (manufacturer: GSK) (batch number: Y495S, expiry date and dose not reported) via intramuscular route in right deltoid on 24-Sep-2016. It was also reported that patient stated it was possible the patient received the vaccine more subcutaneous than intramuscular. Patient's had no Illness at time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions were also reported as none. On 24-Sep-2016, same day (evening) following the vaccination, patient had symptoms of stiffness and soreness in the left deltoid. On 25-Sep-2016, one day (next morning) after the vaccination patient had rash around the injection site, a macular, flat, brownish tone to dusky red, sized at 2cm x 6 cm with an irregular inferior boarder. 2cm superior to left deltoid injection site. Palpable induration 6x5 cm, and dense blistering 2cm in diameter around vaccination site. Patient required emergency room/doctor visit. Lab test was reported as none. Concomitant medication was not reported. Outcome of the events were reported as not recovered. Documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Injection site reaction, Injection site vesicles, Musculoskeletal stiffness, Vaccination site induration
Clinical narrative: Initial unsolicited report received from a health care professional on 26-Sep-2016. This case involves a 27-year-old male patient, who was vaccinated with ADACEL via intramuscular route (batch number: U5477CA, expiry date: 29-Oct-2016, dose: unknown) in left deltoid and FLUARIX (manufacturer: GSK) (batch number: Y495S, expiry date and dose not reported) via intramuscular route in right deltoid on 24-Sep-2016. It was also reported that patient stated it was possible the patient received the vaccine more subcutaneous than intramuscular. Patient's had no Illness at time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions were also reported as none. On 24-Sep-2016, same day (evening) following the vaccination, patient had symptoms of stiffness and soreness in the left deltoid. On 25-Sep-2016, one day (next morning) after the vaccination patient had rash around the injection site, a macular, flat, brownish tone to dusky red, sized at 2cm x 6 cm with an irregular inferior boarder. 2cm superior to left deltoid injection site. Palpable induration 6x5 cm, and dense blistering 2cm in diameter around vaccination site. Patient required emergency room/doctor visit. Lab test was reported as none. Concomitant medication was not reported. Outcome of the events were reported as not recovered. Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: FLU4, MMRV, DTAP, FLU4, MMRV
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Initial unsolicited report received from a physician on 16 September 2016. This case is linked with case 16-0315 (2016SA172908) (same reporter, same lot number). This case involves a four-year-old male patient who was vaccinated with a fifth dose of Daptacel (Batch number: C5101AA, expiry date: 26 November 2018, site was unknown) by intramuscular route, a dose of Fluarix and a dose of Proquad (Batch number, expiration date, dose, route and site of administration was not reported) on 15 September 2016. Patients Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects; medical conditions were reported as no known allergies. Concomitant medications were not reported. On 15 September 2016, immediately after vaccinations, patient vomited. Laboratory investigations and corrective treatment were not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Urticaria
Clinical narrative: 7:30pm shot; w/in 24 hrs - breathing trouble. Next evening 7-7:30 - breathing trouble; 8-8:30 - at hospital.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Laboratory test normal
Clinical narrative: 7:30pm shot; w/in 24 hrs - breathing trouble. Next evening 7-7:30 - breathing trouble; 8-8:30 - at hospital.
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site swelling, Musculoskeletal pain, Peripheral swelling
Clinical narrative: Left arm became hot swollen and sore. Within the next 2 hrs after receiving injection very sore to lift my arm. Woke up the next day left arm blew up 3 xs the size is hot swollen sore. Left under arm & lymph nodes enlarged underarm swollen huge. On Thurs 09/29/16 went to MD put me on antibiotics, on Mon 10/3/16 endocrinologist sent me for ultrasound to rule out blood clot & switched me to stronger antibiotic. As of today 10/05/16 I still have symptoms. Swelling warm swollen underarm lymphs still, prevalent!!!
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Lymphadenopathy, Oedema peripheral, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm became hot swollen and sore. Within the next 2 hrs after receiving injection very sore to lift my arm. Woke up the next day left arm blew up 3 xs the size is hot swollen sore. Left under arm & lymph nodes enlarged underarm swollen huge. On Thurs 09/29/16 went to MD put me on antibiotics, on Mon 10/3/16 endocrinologist sent me for ultrasound to rule out blood clot & switched me to stronger antibiotic. As of today 10/05/16 I still have symptoms. Swelling warm swollen underarm lymphs still, prevalent!!!
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Skin warm, Ultrasound scan
Clinical narrative: Left arm became hot swollen and sore. Within the next 2 hrs after receiving injection very sore to lift my arm. Woke up the next day left arm blew up 3 xs the size is hot swollen sore. Left under arm & lymph nodes enlarged underarm swollen huge. On Thurs 09/29/16 went to MD put me on antibiotics, on Mon 10/3/16 endocrinologist sent me for ultrasound to rule out blood clot & switched me to stronger antibiotic. As of today 10/05/16 I still have symptoms. Swelling warm swollen underarm lymphs still, prevalent!!!
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Inflammation, Injection site erythema, Local reaction, Peripheral swelling
Clinical narrative: Noticed on 9/30 at bedtime (7pm) that there was a lot of redness around injection site. Had a feeling same thing was going to happen that happened last year (did not report last year because doctor thought it was cellulitis). Anyway, my daughter woke up around 5:30 the next morning on 10/1 with a fever of 100.1, and half of her arm was bright red, hot to the touch, and swollen. Being that it was the weekend I took her to urgent care. The doctor there suspected that it was a localized reaction to the flu shot, and that her fever was due to the inflammation, but prescribed her antibiotic just in case it was an infection and also recommended OTC medicine to help with the itchiness and ibuprofen and cold compresses. By Saturday night, the redness had spread even more. It wasn't as bad this year only because I caught it earlier. She does NOT have any localized reactions to any other immunization she has ever received!!!! Only the flu shot the past two years! Last year they thought it was cellulitis but it happened again this year..... Please contact me if you would like pictures!!!!!!!  My other daughter who is three did not have this problem, she got her flu shot the same time.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Pyrexia, Skin warm
Clinical narrative: Noticed on 9/30 at bedtime (7pm) that there was a lot of redness around injection site. Had a feeling same thing was going to happen that happened last year (did not report last year because doctor thought it was cellulitis). Anyway, my daughter woke up around 5:30 the next morning on 10/1 with a fever of 100.1, and half of her arm was bright red, hot to the touch, and swollen. Being that it was the weekend I took her to urgent care. The doctor there suspected that it was a localized reaction to the flu shot, and that her fever was due to the inflammation, but prescribed her antibiotic just in case it was an infection and also recommended OTC medicine to help with the itchiness and ibuprofen and cold compresses. By Saturday night, the redness had spread even more. It wasn't as bad this year only because I caught it earlier. She does NOT have any localized reactions to any other immunization she has ever received!!!! Only the flu shot the past two years! Last year they thought it was cellulitis but it happened again this year..... Please contact me if you would like pictures!!!!!!!  My other daughter who is three did not have this problem, she got her flu shot the same time.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Local reaction, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Initial unsolicited report received from other non health care professional (Office Staff) on 16 September 2016. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE Vaccine (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, post vaccination, patient experienced increased local reactions, itchy, swollen arm and warm to the touch. Laboratory investigations and corrective treatment were not reported. The outcome of the events was not reported. List of documents held by sender: none.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Initial unsolicited report received from Physician on 23 September 2016. This case involves a 77- years-old female patient who was vaccinated with a dose of vaccine Fluzone HD (batch number-UI664AA, expiration date-06 April 2017, dose in series, dose and route were not reported) in "L" on 22 September 2016. Patient's Illness at time of vaccination was denied and pre-existing physician diagnosed allergies, birth defects, medical conditions were denied (any relevant pre-existing conditions). Concomitant medications were reported as none. On 23 September 2016, one day following the vaccination, the patient developed large erythematous patch measuring 4 cm diameter, itchiness (c/o), no warmth and no fever. Relevant laboratory data was not reported. Corrective treatment included Kenalog and Benadryl. On an unknown date outcome of event was reported as recovered. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Initial unsolicited report received from other health care professional (office staff) on 23-SEP-2016. This case involves a patient of unknown age and gender who was vaccinated with a dose of (FLUZONE HIGH DOSE (batch number: UI679AB, expiration date, dose and dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination the patient had vertigo. Lab data and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Initial unsolicited report received from a consumer on 23 September 2016. This case involves a 70-year-old female patient who was vaccinated with first dose Fluzone HD (batch number, expiration date, site of administration were not reported) intramuscularly on an unknown date in 2014. Any other vaccinations within 4 weeks of vaccinations was not reported. Patient illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions included no specific medication. Concomitant medications were not reported. On an unspecified date, within 15 minutes following the vaccination, the patient experienced full blown anaphylactic reaction. It was reported that patient was wheeled to the emergency room. Lab data was reported as none. The patient received corrective treatment with intravenous (IV) Benadryl steroids and breathing treatments. On an unspecified date after few hours after monitoring patient was fine and the outcome was reported as recovered. List of documents held by sender: none. Sender's Comments: This case concerns a 70 year old female patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and within fifteen minutes after vaccination developed full blown anaphylactic reaction. Time to onset of event was compatible. However details regarding medical history, concurrent conditions, patient immune status at the time of vaccination and other etiologies would be helpful to further assess this case.
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dysarthria, Somnolence
Clinical narrative: Initial unsolicited report received from a nurse on 28 Sep 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (Batch number: UI678AB, expiration date: 30 Jun 2017, dose, dose in series, route and site of administration were not reported) on 28 Sep 2016. Patient's medical history was reported that Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was gastric bypass and the patient had no known allergies. Illness at the time of vaccination was also reported as no illness as per reporter. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 28 Sep 2016, same day following the vaccination, the patient experienced weakness, slurring of speech and was feeling very sleepy. Laboratory investigations and corrective treatment were not reported. The outcome of events was reported as unknown. List of documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: States she broke out in hives later that evening after receiving her first flu vaccine.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Haemorrhage, Swelling
Clinical narrative: Gave patient flu shot on right arm. Patient bleed and then the area swell up. A ball swelling seemed to go down a bit. Swelling still there but pt have no other symptom.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site nodule
Clinical narrative: Parents noted two dime sized firm nodules on right thigh at the sites of vaccine administration approx. 10d previously.  Also there was a quarter sized area of erythema overtop the nodules.  She had Hep A and VZV given in this thigh right thigh.  This was non tender and resolved gradually over about 3-4 days.  She did have fever the two days prior to the 'lumps' being felt but on the day that parents noted the lumps the fever had self resolved.
Age: 0.86
Sex: F
Vaccine: FLU4
Symptoms: Electroencephalogram, Feeling abnormal, Laboratory test, Nuclear magnetic resonance imaging normal, Tremor
Clinical narrative: Mother stated child was dazed, eyes open and unresponsive however breathing. Left leg shaking which progressed to full leg shaking.
Age: 0.86
Sex: F
Vaccine: FLU4
Symptoms: Unresponsive to stimuli
Clinical narrative: Mother stated child was dazed, eyes open and unresponsive however breathing. Left leg shaking which progressed to full leg shaking.
Age: 11.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Chest discomfort, Cough, Food allergy, Milk allergy, Muscle spasms
Clinical narrative: COUGHING, SNEEZING, WHEEZING, TIGHTNESS IN CHEST, NAUSEA CRAMPING, HIVES CONTINUED TO PROGRESS, WAS GIVEN BENADRYL AND EPI PEN WAS ADMINISTERED.
Age: 11.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Nausea, Sneezing, Urticaria, Wheezing
Clinical narrative: COUGHING, SNEEZING, WHEEZING, TIGHTNESS IN CHEST, NAUSEA CRAMPING, HIVES CONTINUED TO PROGRESS, WAS GIVEN BENADRYL AND EPI PEN WAS ADMINISTERED.
Age: 11.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Chest discomfort, Cough, Muscle spasms, Nausea, Sneezing
Clinical narrative: COUGHING, SNEEZING, WHEEZING, TIGHTNESS IN CHEST, NAUSEA CRAMPING, HIVES CONTINUED TO PROGRESS, WAS GIVEN BENADRYL AND EPI PEN WAS ADMINISTERED.
Age: 11.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Urticaria, Wheezing
Clinical narrative: COUGHING, SNEEZING, WHEEZING, TIGHTNESS IN CHEST, NAUSEA CRAMPING, HIVES CONTINUED TO PROGRESS, WAS GIVEN BENADRYL AND EPI PEN WAS ADMINISTERED.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: PAIN, REDNESS, AND SWELLING TO LEFT ARM.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling surrounding vaccine site.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site joint pain, Nuclear magnetic resonance imaging
Clinical narrative: Immediate intense pain in shoulder joint.  Injection was very high up on shoulder.  Severe main and difficulty using affected arm was immediate.  Reported to PMD after one week.  MRI done 9/23/2016.  PT started 9/28/2016.  Pain and ROM limitation persist.
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Blood pressure decreased, Dyspnoea, Intensive care, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of anaphylactic reaction in a female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), hives, shortness of breath and wheezing. the patient was treated with epinephrine. On an unknown date, the outcome of the anaphylactic reaction, hives, shortness of breath and wheezing were unknown. It was unknown if the reporter considered the anaphylactic reaction, hives, shortness of breath and wheezing to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: the age at vaccination was not reported. the healthcare professional reported that the patient received a dose of FLUARIX QUADRIVALENT and then experienced an anaphylactic reaction, which was described as hives, shortness of breath, decreased blood pressure and wheezing. the patient was admitted to the ICU (Intensive Care Unit) and was given epinephrine. the healthcare professional had limited information for report.  the reporter refused to provide date of birth of the patient.
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of anaphylactic reaction in a female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), hives, shortness of breath and wheezing. the patient was treated with epinephrine. On an unknown date, the outcome of the anaphylactic reaction, hives, shortness of breath and wheezing were unknown. It was unknown if the reporter considered the anaphylactic reaction, hives, shortness of breath and wheezing to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: the age at vaccination was not reported. the healthcare professional reported that the patient received a dose of FLUARIX QUADRIVALENT and then experienced an anaphylactic reaction, which was described as hives, shortness of breath, decreased blood pressure and wheezing. the patient was admitted to the ICU (Intensive Care Unit) and was given epinephrine. the healthcare professional had limited information for report.  the reporter refused to provide date of birth of the patient.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Dyskinesia, Electroencephalogram normal, Metabolic function test normal
Clinical narrative: Approx 12-18 hrs after receiving Rotavirus. PEDIARIX, PREVNAR, flu vaccine patient had jerking movements at home. Taken to ER. Observed overnight. No fever, EEG normal.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 74-year-old female patient received a PREVNAR 13; (Lot Number: M60993, Expiration Date: 31Jul2017), intramuscular in the left arm on 19Sep2016 at 0.5 ml single dose for immunization. There was no medical history or concomitant medications. On 19Sep2016, the patient experienced redness and inflammation at the injection site. The area was not as big in the beginning but has gotten a little bigger and was now about 2 inches in diameter. There was no pain or itching. The patient went to her doctor to have labs done.  The doctor looked at the redness and inflammation and at that time was not concerned. The patient reported there was still redness and inflammation at the injection site. The clinical outcome of the events, redness and inflammation at the injection site, was not recovered.
Sex: F
Vaccine: PNC13
Symptoms: Adverse drug reaction, Biopsy skin abnormal, Dermatitis, Dermatitis contact, Eczema
Clinical narrative: This is a spontaneous report from a contactable female consumer reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at 0.5ml single on an unspecified date at the end of May for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced eczema in different part of her body, she got some of the benign growth called seborrheic keratosis on her back and different places. Consumer commented to have eczema and doctors have not been able to determine the cause of it, she received a shot of Prevnar 13 recently and that is why she suspects the eczema could be a systemic reaction to the vaccine. This eczema is like a rash and it was on different parts of the body and not limited to the administration site. The outcome of the events was unknown. She had bug bites (she believed that were bug bites) but she did not know if bug bites were due to Prevnar 13 shot. She had one of the spot biopsied, it came back that it said to contact dermatitis or drug reaction. She had a bunch of inflammatory skin conditions. Consumer mentioned that she was not sure if side effects she had were due to Prevnar 13 shot or not.
Sex: F
Vaccine: PNC13
Symptoms: Seborrhoeic keratosis
Clinical narrative: This is a spontaneous report from a contactable female consumer reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at 0.5ml single on an unspecified date at the end of May for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced eczema in different part of her body, she got some of the benign growth called seborrheic keratosis on her back and different places. Consumer commented to have eczema and doctors have not been able to determine the cause of it, she received a shot of Prevnar 13 recently and that is why she suspects the eczema could be a systemic reaction to the vaccine. This eczema is like a rash and it was on different parts of the body and not limited to the administration site. The outcome of the events was unknown. She had bug bites (she believed that were bug bites) but she did not know if bug bites were due to Prevnar 13 shot. She had one of the spot biopsied, it came back that it said to contact dermatitis or drug reaction. She had a bunch of inflammatory skin conditions. Consumer mentioned that she was not sure if side effects she had were due to Prevnar 13 shot or not.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age, ethnicity and gender received a PREVNAR 13, via an unspecified route of administration on an unknown date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced redness and swelling due to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The clinical outcome of the events, redness and swelling, was unknown.
Sex: F
Vaccine: MENB
Symptoms: Injection site inflammation
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A female patient of an unspecified age received a single dose of TRUMENBA; (lot M77282, Expiration Jun2017), via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced large inflammation at injection site with outcome of unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Headache, Hypersensitivity, Injection site pain
Clinical narrative: This is a spontaneous report by a contactable medical assistant calling on behalf of a physician. A male patient of unknown age and race received the first dose TRUMENBA at 0.5ml single dose for immunization on unknown date. Medical history and concomitant medication were not provided. The patient experienced the headache and pain at the injection site for 12 hours. The medical assistant described pain at injection site as hypersensitivity to the upper body for 12 hours. The outcome of the events was unknown.