chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). No concomitant therapy was reported. The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Borrelia test, C-reactive protein, Laboratory test, Musculoskeletal stiffness, Myalgia
Clinical narrative: Severe diffuse muscle pain and stiffness same vaccine without prior c/o these SX. NSAIDs and physical therapy.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Severe diffuse muscle pain and stiffness same vaccine without prior c/o these SX. NSAIDs and physical therapy.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 that had been left out in the open for 30 to 40 minutes. It was not specified which outside clinic the patient went to receive the vaccine. No adverse effect was reported. The outcome of the event was unknown. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a other health professional referring to a male patient of unknown age. No medical history, concurrent conditions or concomitant therapies were reported. An unspecified date in 2009, the patient was vaccinated with ZOSTAVAX, 19400 DF (Dose, lot number, expiration date and administration route were not provided). On an unspecified date, reported as "recently", the patient experienced shingles lasting an unspecified duration of time. At the time of reporting, the outcome of shingles was unknown. The causal relationship between therapy with ZOSTAVAX and the shingles was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 03-AUG-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L043213, expiration date 28-AUG-2017 (dose number, route and anatomical location were unspecified. No adverse effects reported. The reporter stated that this was supported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored adult dose of VAQTA 50/1.0 U/ml injection (lot # L004745 with expiry date; 28-APR-2017; exact dose, route and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. Data logger was involved. No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 08-MAR-2016"), the patient was vaccinated with an improperly stored adult dose of VAQTA 50/1.0 U/ml injection (lot # L004745 with expiry date: 28-APR-2017; exact dose, route and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. Data logger was involved. No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Gait disturbance, Herpes zoster, Injection site rash, Rash
Clinical narrative: Suspected herpes zoster in a 2-dose varicella vaccine recipient. Painful rash on left thigh and left lower back. Clustered patches. He was limping. No antivirals prescribed. Lasted about a week. No history of varicella. Medical record does not differentiate between varicella and herpes zoster, but based on pain and rash location, I am reporting it as a suspected case of herpes zoster. Visited facility on 7/1/2016.
Age: 92.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Very sore arm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, unspecified patients were vaccinated with improperly stored VARIVAX lot # M009764, expiration date: 23-FEB-2018. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site administration were unspecified). No concomitant therapy was reported. The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever. headache, muscle ache, fatigue, generalized abdominal pain - all symptoms began 1 hour after receiving MC4 vaccination.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Furuncle, Pain, Product use issue
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 66 year old female patient. No pertinent medical history, concurrent conditions and concomitant therapies were reported. On 10-AUG-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # M020521, expiration date: 17-NOV-2017), 0.5 ml, intramuscularly in an unspecified arm for boil on skin. Dose number was not provided. After vaccination, and within 24 hours, the patient noticed a boil on the opposite side of the same arm of the injection furthermore described as with size of a silver dollar, painful and raised with no redness or head associated with the area. The patient called the pharmacist but no treatment was given for the event. It was not a product quality complaint involved. The outcome of furuncle was reported as not recovered. The causality assessment between the event and the suspect therapy was not reported.
Age: 28.0
Sex: F
Vaccine: HEPA, MEN, TDAP
Symptoms: Antinuclear antibody negative, C-reactive protein normal, Inflammatory marker test, Laboratory test normal, Lymphadenopathy
Clinical narrative: 29-year-old female with a history of breast augmentation who experienced bilateral axillary lymphadenopathy, lethargy, malaise, myalgia and transient tenderness to injection site. On set of symptoms occurred at least one week following receipt of meningococcal, hepatitis A, and TDaP vaccines. Pt. reported she had an episode of localized unexplained edema to her left lower extremity, upper portions 6 days prior to vaccine receipt; etiology not explained. Patient evaluated by her primary care provider, who ordered an ultrasound that was done on 31 May 2016. Results of ultrasound revealed enlarged lymph nodes on the left, largest 18X10 cm with several other nodes, but all normal appearing. Repeat breast U/S June 24 2016 demonstrated improvement with size 1.6x0.49x.0.84; a R node (axillary) measured at 1.04x1.23x0.41. She was scheduled for biopsy, but the lymphadenopathy resolved. A lab workup for inflammatory and rheumatic markers ESR, CRP, RA, nuclear Ab, SLE profile and celiac disease were all normal. Lymphadenopathy is an expected adverse effect of immunization.
Age: 28.0
Sex: F
Vaccine: HEPA, MEN, TDAP
Symptoms: Oedema peripheral, Red blood cell sedimentation rate normal, Ultrasound scan abnormal
Clinical narrative: 29-year-old female with a history of breast augmentation who experienced bilateral axillary lymphadenopathy, lethargy, malaise, myalgia and transient tenderness to injection site. On set of symptoms occurred at least one week following receipt of meningococcal, hepatitis A, and TDaP vaccines. Pt. reported she had an episode of localized unexplained edema to her left lower extremity, upper portions 6 days prior to vaccine receipt; etiology not explained. Patient evaluated by her primary care provider, who ordered an ultrasound that was done on 31 May 2016. Results of ultrasound revealed enlarged lymph nodes on the left, largest 18X10 cm with several other nodes, but all normal appearing. Repeat breast U/S June 24 2016 demonstrated improvement with size 1.6x0.49x.0.84; a R node (axillary) measured at 1.04x1.23x0.41. She was scheduled for biopsy, but the lymphadenopathy resolved. A lab workup for inflammatory and rheumatic markers ESR, CRP, RA, nuclear Ab, SLE profile and celiac disease were all normal. Lymphadenopathy is an expected adverse effect of immunization.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician, via company representative refers to a currently 26 years old female. The patient's medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 (dose, lot# and expiry date were not reported), intramuscularly. The physician were reporting that the second shot of GARDASIL 9 was given "not even a month" after the first shot was given. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope, Tinnitus
Clinical narrative: Fainting and ringing in ears after 1 day per pt dad. Referred to otolaryngology for eval and treatment.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt received adult dose hepatitis A vaccine instead of pediatric dose. No adverse reaction noted or reported. Pt's mother is aware.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Arm became red, itchy, painful, hot and hard to the touch (red form shoulder to elbow and almost all the way around the arm) at 9pm. Less painful/easier to move on day 2.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pyrexia, Skin warm
Clinical narrative: Red, warm, fever of 105 degrees, put on steroids, (entire upper arm). Turned to Cellulitis and is on Antibiotics now.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Severe erythema, swelling at injection site - Hot to touch.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Confusional state, Immediate post-injection reaction, Seizure
Clinical narrative: Immediately after vaccine administrations HPV9, MCV4, Tdap consecutively. Pt stated seizing for approx. 5-8 secs. Held pt, told dad to go get Dr., Dr. arrive on the scene pt already stopped seizing, but a little confused. No vomiting or irritation noticed. Pt layed down in bed on applied cold compress to the head.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Impetigo, Polymerase chain reaction, Rash vesicular, Staphylococcal infection, Varicella virus test negative
Clinical narrative: Patient developed a generalized, vesicular rash about 10 days after vaccination, on 6/29. Rash worsened, and patient developed secondary skin infection, impetigo (diagnosed as staph infection). Vesicular fluid was collected for VZV-PCR and VZV Viral Culture on 7/14 (two weeks after onset), no VZV detected. Patient's rash improved after receiving a prescription cream for impetigo, is now resolved. No secondary varicella cases reported among contacts, no VZV exposure prior to illness identified.
Age: 12.0
Sex: U
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Immediate post-injection reaction, Local reaction, Rash
Clinical narrative: Patient came in for a "well child check", she received immunizations during the visit. The HPV and MCV4 was administered to the left deltoid. Immediately pt had local reaction (rash, redness) BENADRYL given 11:02 am. Epi Pen given 11:22 a. EMT came. Pt stable lungs clear.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacy technician referring to a 74 year old male patient. The patient's medical history included prostate cancer and hernia repair in past. The patient's concomitant medication and concurrent conditions were not provided. On 18-SEP-2012, the patient was vaccinated with ZOSTAVAX (strength, dose, lot number, expiration date and administration route were not provided). On 2015, the patient experienced a mild case of shingles. The outcome of herpes zoster was reported as recovered/resolved on an unspecified date. No product quality complaint (PQC) was involved. Additional information is not expected because the reported refused additional contact.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse concerning a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reaction and concomitant medications were reported. The nurse reported that the patient was prescribed to receive VARIVAX but on 09-AUG-2016, the patient was inadvertently vaccinated with ZOSTAVAX (dosing details, lot#, expiry date were not reported). No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site movement impairment, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain, limited range of movement to Left upper arm at site of VARICELLA injection, antibiotics, steroids reported on 7/4/16
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Crying, Feeling hot, Hyperhidrosis, Influenza like illness
Clinical narrative: Patient reported (1) Flu-like symptoms (2) sharp pain radiating down limbs (3) Hot/sweaty (4) Chest pains and (5) Crying from pain.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient reported (1) Flu-like symptoms (2) sharp pain radiating down limbs (3) Hot/sweaty (4) Chest pains and (5) Crying from pain.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Vomiting
Clinical narrative: Stomach pain followed by watery diarrhea at 2:00 PM Vomiting and diarrhea at 3:00 AM, No other symptoms. No fever, felt fine in between occurances.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site infection
Clinical narrative: Cellulitis and infection at site of injection.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Full blood count normal, Pyrexia
Clinical narrative: FEVER, BLISTERS IN AREA.
Age: 61.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal
Clinical narrative: Fever, headache, body aches, joint pain petechial rash and erythematous macule that were slightly elevated mostly on the lower extremities.
Age: 61.0
Sex: M
Vaccine: TD
Symptoms: Blood calcium normal, Blood chloride normal, Blood fibrinogen normal, Blood glucose normal, Blood potassium normal
Clinical narrative: Fever, headache, body aches, joint pain petechial rash and erythematous macule that were slightly elevated mostly on the lower extremities.
Age: 61.0
Sex: M
Vaccine: TD
Symptoms: Blood sodium normal, Blood urea normal, C-reactive protein, Carbon dioxide increased, Eosinophil percentage
Clinical narrative: Fever, headache, body aches, joint pain petechial rash and erythematous macule that were slightly elevated mostly on the lower extremities.
Age: 61.0
Sex: M
Vaccine: TD
Symptoms: Haematocrit normal, Haemoglobin decreased, Headache, International normalised ratio normal, Lymphocyte percentage
Clinical narrative: Fever, headache, body aches, joint pain petechial rash and erythematous macule that were slightly elevated mostly on the lower extremities.
Age: 61.0
Sex: M
Vaccine: TD
Symptoms: Metabolic function test normal, Monocyte percentage increased, Mouth haemorrhage, Neutrophil percentage decreased, Pain
Clinical narrative: Fever, headache, body aches, joint pain petechial rash and erythematous macule that were slightly elevated mostly on the lower extremities.
Age: 61.0
Sex: M
Vaccine: TD
Symptoms: Petechiae, Platelet count normal, Protein total normal, Prothrombin time shortened, Pyrexia
Clinical narrative: Fever, headache, body aches, joint pain petechial rash and erythematous macule that were slightly elevated mostly on the lower extremities.
Age: 61.0
Sex: M
Vaccine: TD
Symptoms: Rash macular, Red blood cell sedimentation rate increased, White blood cell count normal
Clinical narrative: Fever, headache, body aches, joint pain petechial rash and erythematous macule that were slightly elevated mostly on the lower extremities.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives on body and face. Treated with Benadryl.
Age: 65.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Asthenia, Joint injury, Musculoskeletal pain, Rotator cuff syndrome
Clinical narrative: Shoulder injury due to Flu shot. Left should pain and weakness.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Rt leg redden, warm to touch, no fever, did not itch. BENADRYL allergy children liquid.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Skin reaction, Skin warm, Urticaria
Clinical narrative: Pt noted 2 small red spots on arm, spread, welt. Warm to touch on 7th day on 8/17/16. It took 1 week to happen per Pt. Dr. advised Pt. to use hydrocortisone cream OTC and CLARITIN and given info on allergic reaction: case instructions.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site rash
Clinical narrative: Bilateral localized rash on thighs where injections given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site rash, Vaccination complication
Clinical narrative: Bilateral localized rash on thighs where injections given.
Age: 68.0
Sex: M
Vaccine: MMR
Symptoms: Pain, Rash, Stomatitis
Clinical narrative: Two types of rashes, mouth sores, achiness lasting for 48-72 hours.
Age: 22.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Severe headache, nausea, vomiting, fever and body aches.
Age: 51.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Immediate post-injection reaction, Injection site pain, Muscle spasms
Clinical narrative: Pt describes immediately feeling muscle spasms upon receiving vaccine.  Pt also noted some tenderness to the area and a slight headache.  All of which the patient is still experiencing.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling on arm of injection, with pain. Swelling is the size of a half avocado, and has pain all around the swelling.
Age: 1.25
Sex: M
Vaccine: DTP, FLUX, IPV, PPV
Symptoms: Abnormal behaviour, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Started later in the evening after shots and lasted two whole days. Right leg was red, swollen, tight, warm to the touch, had fever, not himself.
Age: 1.25
Sex: M
Vaccine: DTP, FLUX, IPV, PPV
Symptoms: Pyrexia, Skin tightness
Clinical narrative: Started later in the evening after shots and lasted two whole days. Right leg was red, swollen, tight, warm to the touch, had fever, not himself.
Age: 0.43
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Seizure
Clinical narrative: Seizure lasting approx. 5 minutes per parent report.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Musculoskeletal chest pain
Clinical narrative: Awoke with blister on leg; began to hurt in lower left quadrent; pain got more under left rib; sharp pain under left rib cage (3rd day); at Dr. x-ray no visable signs of pain; day 4 began showing blisters on left side; Day 5 broke out laft abdomen around to spinal column; Day 7 Dr. gave anti-viral pills for 1 week; Day 8 blisters began leaking.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to left shoulder.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain and erythema distal to site of immunization.
Age: 39.0
Sex: M
Vaccine: RAB
Symptoms: Pain
Clinical narrative: Bruising and firm nodule noticed at previous injection site. No redness, not warm to touch, pt complained of soreness.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9, MEN, TDAP
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Musculoskeletal stiffness, Pallor
Clinical narrative: Lost consciousness for about 10 seconds immediately after injection and slid down in chair, extremities stiff Within 10 seconds, child became alert and was pale and diaphoretic. asking what had happened. Child eased to floor in lying position to recover, mother present. Drank some water and eager to leave. Walked out of clinic at 2:40 PM.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Abnormal behaviour, Affective disorder, Cataplexy, Fatigue, Hypersomnia
Clinical narrative: Hypersomnia, fatigue, weight gain, mood and behavior disturbances, cataplexy developing over months following two doses of Flumist Quadrivalent.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Narcolepsy, Weight increased
Clinical narrative: Hypersomnia, fatigue, weight gain, mood and behavior disturbances, cataplexy developing over months following two doses of Flumist Quadrivalent.
Age: 39.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Axillary pain, Bacterial infection, Erythema, Injection site erythema, Injection site pain
Clinical narrative: A couple of hours after receiving Tdap and PPSV23 in his right upper arm shoulder area developed pain around injection site. The next morning had increased pain, redness, swelling at injection site with redness, swelling and pain radiating out from the injection site to the arm pit and  chest area. Developed 102. 2 temp for most of the day even with use of Ibuprofen. Contacted pharmacist who administered vaccines who recommended for him to see his doctor. The client went to urgent care and was told he had a bacteria infection and was prescribed antibiotics. Instructed to return if the symptoms didn't get better. Today the fever has resolved with a reduction in redness, swelling chest area. However, the redness, pain and swelling in the upper arm shoulder area and arm pit has gotten worse. The client plans to return to the urgent care if not better by 4-5pm this afternoon. Client advised to go urgent care sooner if symptoms get worse. Call 911 if facial swelling, or difficulty in breathing occurs.
Age: 39.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site swelling, Local swelling, Pyrexia
Clinical narrative: A couple of hours after receiving Tdap and PPSV23 in his right upper arm shoulder area developed pain around injection site. The next morning had increased pain, redness, swelling at injection site with redness, swelling and pain radiating out from the injection site to the arm pit and  chest area. Developed 102. 2 temp for most of the day even with use of Ibuprofen. Contacted pharmacist who administered vaccines who recommended for him to see his doctor. The client went to urgent care and was told he had a bacteria infection and was prescribed antibiotics. Instructed to return if the symptoms didn't get better. Today the fever has resolved with a reduction in redness, swelling chest area. However, the redness, pain and swelling in the upper arm shoulder area and arm pit has gotten worse. The client plans to return to the urgent care if not better by 4-5pm this afternoon. Client advised to go urgent care sooner if symptoms get worse. Call 911 if facial swelling, or difficulty in breathing occurs.
Age: 27.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling at site of injection r upper arm. Area is mildly tender and itchy.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Gait disturbance, Pallor
Clinical narrative: Patient developed a pallor and ambulation became more difficult. Patient escorted to seating area and vitals were taken. Given water and crackers and symptoms resolved within 30 minutes.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: Over 2 week hx of significant "feels like knives are stabbing" in arm where vaccine given and to acromion region as well- still present currently.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Presyncope
Clinical narrative: Vasovagal reaction within 20 min of vaccination. Had never had previous reaction to vaccine or injection.
Age: 73.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash, Vomiting
Clinical narrative: PATIENT REPORTED RASH/VOMITING, WENT TO DOCTOR FOR APPT LATER THAT DAY, WAITING TO HEAR BACK FROM DOCTOR.
Age: 32.0
Sex: F
Vaccine: DTOX, HEPAB, TYP
Symptoms: Decreased appetite, Dizziness, Nausea
Clinical narrative: Dizzy, nauseous, loss of appetite.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt. arm was very sore about 3 or 4 hours after receiving the vaccine. She could not lift her arm for 3-4 days after that. As of 8/18/2016 Pt. states she still can not lift her arm up enough to put on her own shirt.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Musculoskeletal stiffness, Pain, Painful respiration
Clinical narrative: Lower back became very stiff and hurt when moved.  Could not take a full breath without pain in back.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Fatigue, Injection site urticaria, Pain, Pyrexia
Clinical narrative: Hives from left deltoid down left flank to waist, fever, body aches, fatigue.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: Left arm pain in deltoid, then significant increase in burning pain in whole upper arm with increased sensitivity to touch to whole upper arm. Left forearm/hand numbness/tingling. Right upper arm pain.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Hypersomnia, Injection site erythema, Injection site induration
Clinical narrative: Pt had hard knot at injection site slight fever and chills little headache on 1st night. 2nd day slept a lot red rash and swelling about 1 and 1/2 inches below injection site on inside of bicep and sore on days 2 and 3.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site nodule, Injection site pain, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Pt had hard knot at injection site slight fever and chills little headache on 1st night. 2nd day slept a lot red rash and swelling about 1 and 1/2 inches below injection site on inside of bicep and sore on days 2 and 3.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness unilateral, Nuclear magnetic resonance imaging normal, Sudden hearing loss
Clinical narrative: Received higher dose or 4 flu strain vaccine for over 65 on 10/3/2014. On 10/17/2014 had sudden hearing loss in left ear. MRI to rule out tumors which were none and received steroid injections and medication from ENT. Hearing could not be restored.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On  11-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapies or concurrent conditions were not reported. On 09-AUG-2016, the patient was vaccinated with ZOSTAVAX (dose, lot number, administration route and expiration date were not provided), "a few hours" after the vaccine was reconstituted (outside of the prescribing information recommendations). No adverse events were reported. Additional information is not expected as there was no consent to contact the physician.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions and allergies were not reported. On 18-JUL-2016 the patient received a first dose of ZOSTAVAX (0.65 ml) subcutaneously (concentration, lot # and expiry date were not reported). Then, on 31-JUL-2106, a second dose was given (0.65 ml) subcutaneously (concentration, lot # and expiry date were 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 Licensed Practical Nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L040178 and expiration date 31-AUG-2017, administered by an unspecified route reported as intramuscular/subcutaneous (unspecified strength and dose). The patient's concomitant medication was not provided. Additionally, no adverse effect were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Information has been received from an unknown reporter regarding a patient of unknown age and gender who had enrolled in a Market Research program. The patient's concurrent condition, medical history and concomitant medication were unknown. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency and route were not reported). 'In the last 3 months', the reporter had seen or heard the following about PNEUMOVAX 23: 'crappy poly sach-needs booster-how to use in era of PREVNAR 13' (PT: Adverse event NOS). Action taken with the suspect vaccine was unknown. The outcome of vaccination failure was unknown. The reporter did not provide any causal relation between the event and PNEUMOVAX 23. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: Patient received flu and shingle shot. At injection site for shingles shot developed red hot spot. patient put ice on it. Today also has spot further down arm. Patient started developing rash on torso around waist moving to breast area.
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Weight bearing difficulty
Clinical narrative: This spontaneous report was received from a pharmacist referring to an approximately 71 year-old female patient. Pertinent medical history, concurrent conditions and concomitant therapies were not provided. Approximately in 2014 (reported as "about 2 years ago"), the patient was vaccinated with ZOSTAVAX 19400 plaque forming units (PFU). Route, dose, dose number, lot # and anatomical location were not reported. The pharmacist stated that the patient experienced muscle weakness from her neck to her calves since administrations of ZOSTAVAX "about 2 years ago". The reporter also stated that the patient had difficulty bearing weight on her legs. The patient was evaluated by an unspecified physician in the office; however there was not diagnosis or treatment provided. It was not a product quality complaint involved. At the time of reporting the outcome of muscular weakness and weight bearing difficulty was reported as not recovered. The causality assessment between the events and the suspect therapy was not provided. Additional information is not expected due there is not consent of follow-up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Rash erythematous
Clinical narrative: Received call from patient's mother reporting she had obtained a rash on (R) arm yesterday after getting vaccine 8/16/16. Patient came in and this RN assessed. Has faint red, flat rash to right upper arm to antecub and left upper inner thigh. Denies itching. Rash pinpoint. States rash to arm appeared yesterday and to left thigh today. Denies any further issues. Instructed to monitor and call Dr or seek medical attention if S/S worsen.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Varicella post vaccine
Clinical narrative: Break through VARICELLA rash.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Eye burns, Eye irritation, Myalgia, Nausea
Clinical narrative: Vomiting, photophobia, eye burning, nausea, myalgia, dizziness. The day of the injection and persisting for 48 hours.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Photophobia, Vomiting
Clinical narrative: Vomiting, photophobia, eye burning, nausea, myalgia, dizziness. The day of the injection and persisting for 48 hours.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Vaccine administered 8/16/16 approximately 1 pm- that evening pt said she had pain and throbbing in her shoulder that went around neck. She said by next day her joint and hips hurt and she had restriction in movement. On 8/17 she said she took 2 ALEVE  and by 8/18 the joint pain was gone the neck pain was present but much less severed. No complaints of redness or swelling.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus
Clinical narrative: (L) arm localized redness and itching. NP instructed patient to take TYLENOL and BENADRYL and to return with worsening of symptoms.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Burning sensation, Hyperhidrosis, Injection site inflammation, Pain, Pyrexia
Clinical narrative: Left upper arm inflammation. Fever, sweating. Burning sensation to touch. Painful.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, Aches, Pain, Body Aches, Pain at injection site.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Pain and heat (l) upper arm form shoulder to just above elbow.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Ascites, Irritability, Oedema, Urticaria
Clinical narrative: Child has 4 y old immunizations - 20 minutes later had hives and edema on face, neck, eyelids- upper airway ascites  irritability- Did not improve with BENADRYL. Resolved with EPIPEN 0.15 after 15 minutes.
Age: 11.0
Sex: M
Vaccine: IPV, MNQ, PNC13
Symptoms: Injection site rash, Local reaction
Clinical narrative: Local rash reaction on right deltoid.
Age: 60.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Fatigue, Lethargy, Palpitations, Pyrexia
Clinical narrative: Pt reported palpitation had to go to ER, they cleared her stating it isn't from the vaccine. Pt reporting fever 100 degrees and also feel tired and lethargic.
Age: 60.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Palpitations, Pyrexia
Clinical narrative: Pt reported palpitation had to go to ER, they cleared her stating it isn't from the vaccine. Pt reporting fever 100 degrees and also feel tired and lethargic.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Day following Hep A vaccine, pt. with diffuse urticaria. No fever. No SOB. No increased WOB. No airway compromise. Giving BENADRYL Q6 hours.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash-arms, legs, feet. No resp distress. No itching.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Urticaria
Clinical narrative: Immediately after injection of varicella, MMR, HEPA, and PREVNAR, patient started getting red patches of hive all over his face and neck.
Age: 47.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Neurological symptom
Clinical narrative: Initial unsolicited report received from the literature on 10-AUG-2016. This case was linked to 2016SA148381, 2016SA148766, 2016SA148776, 2016SA148787 and 2016SA148885. (Same literature). The following is verbatim from the article: Abstract: Background: In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use. Objective: To assess adverse events (AEs) after HDCV reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods: We searched VAERS for reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barre syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using Med-DRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results: VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions: This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. This case involves a 47-year-old female patient who was vaccinated with a dose of RABIES (HDC) VACCINE (batch number, expiry date, dose, 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 Guillain-Barre Syndrome (GBS) and presented with neurological symptoms characterized mainly by increasing weakness, numbness, and/or tingling in extremities and difficulty walking. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. Upon internal review the case was considered as serious because of important medical event: Guillain-Barre Syndrome. Documents held by sender: none. Sender's Comments: This is poorly documented case as patient presented with multiple symptoms and diagnosed with Guillain Barre syndrome (GBS) following IMOVAX RABIES vaccine. Time to onset is unknown, as GBS is often preceded by an infection, the most frequent being Campylobacter jejuni, complementary medical history, concomitant medication history, results of investigations (cytoalbuminologic dissociation, EMG, NCS, MRI) and etiological work-up (infection) are needed to assess the case. Based on available information role of vaccine cannot be assessed.
Age: 47.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Paraesthesia
Clinical narrative: Initial unsolicited report received from the literature on 10-AUG-2016. This case was linked to 2016SA148381, 2016SA148766, 2016SA148776, 2016SA148787 and 2016SA148885. (Same literature). The following is verbatim from the article: Abstract: Background: In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use. Objective: To assess adverse events (AEs) after HDCV reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods: We searched VAERS for reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barre syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using Med-DRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results: VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions: This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. This case involves a 47-year-old female patient who was vaccinated with a dose of RABIES (HDC) VACCINE (batch number, expiry date, dose, 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 Guillain-Barre Syndrome (GBS) and presented with neurological symptoms characterized mainly by increasing weakness, numbness, and/or tingling in extremities and difficulty walking. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. Upon internal review the case was considered as serious because of important medical event: Guillain-Barre Syndrome. Documents held by sender: none. Sender's Comments: This is poorly documented case as patient presented with multiple symptoms and diagnosed with Guillain Barre syndrome (GBS) following IMOVAX RABIES vaccine. Time to onset is unknown, as GBS is often preceded by an infection, the most frequent being Campylobacter jejuni, complementary medical history, concomitant medication history, results of investigations (cytoalbuminologic dissociation, EMG, NCS, MRI) and etiological work-up (infection) are needed to assess the case. Based on available information role of vaccine cannot be assessed.