chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-MAY-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # L000450, expiration date 09-MAR-2016, exact dose and route of administration were not reported). No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding multiple unspecified patients of unknown age. There was no information about concurrent conditions and historical medication. On an unknown date the patients were vaccinated with (Oka-Merck) PROQUAD, lot # L023114, expiration date -24-DEC-2016, lot # L033698, expiration date- 28-FEB-2017, lot # L021601, expiration date- 10-DEC-2016 and lot # L034931, expiration date- 03-MAR-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature was -3 degree Celsius, Time frame was 6 hours and it was back in range. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Influenza like illness, Injection site pain, Pain
Clinical narrative: Pt rc'd the vaccine into the right deltoid on 4/28/16, complains of soreness to site within 1-2 hours of injection. Applied ice/heat. Reports fever of 100.1, body aches, chills, pain, fatigue (flu like sx) x 24 hours. Now just mild soreness at site remains.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pt rc'd the vaccine into the right deltoid on 4/28/16, complains of soreness to site within 1-2 hours of injection. Applied ice/heat. Reports fever of 100.1, body aches, chills, pain, fatigue (flu like sx) x 24 hours. Now just mild soreness at site remains.
Age: 63.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Inflammation, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt called on 10/16/15 regarding red, swollen, warm 2-3" diameter at injection site (L) upper arm. Flu admin left deltoid 10/13/15 site itchy. Stated 16th area decreased in size from day prior. Phone call 4/14/16 pt reported saw private provider 10/16/15 started on ciprofloxacin 500mg q 12 hours x 28 days. Inflammation resolved, no further problems. Medical director notified.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Dysphonia, Dyspnoea, Gastrooesophageal reflux disease, Haemoptysis
Clinical narrative: I woke up with difficulty breathing and hoarseness; spat out clumps of dark flesh, sinus membranes and blood from behind uvula, then bright red blood. I immediately requested to see health care, by the time I did an hour later, the symptoms subsided. I still went over to health care to report this but was subverted by being differentially diagnosed with acid reflux, a condition I hadn't had since my cholecystectomy in 2006. All was clear by the time I was seen by health care.
Age: 39.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Tiny bumps and redness with possible swelling and swarming of gnats sometimes.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Infection, Pain in extremity, Peripheral swelling
Clinical narrative: 4/24/16 Patient noticed that her upper arm that she received a PREVNAR vaccination on 4/18/2016 was red and had pain when she lifted her arm. She reported mild swelling of upper arm. No itching, no fever. She visited her physician, he suspected an infection and placed patient on oral antibiotic treatment.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Injection site reaction - pt describes as hard, swollen and red. Improving.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding multiple unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with VARIVAX, lot # L028278, expiration date- 28-JUL-2017, lot no. L002121, expiration date- 10-JUN-2017 and lot #L019126, expiration date- 27-MAY-2017(incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature -3 degree Celsius, Time frame was 6 hours and it was back in range. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HIBV, RVX
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: Based on additional information received on 07 March 2016, this case became medically confirmed. Initial unsolicited report received from a consumer (Parent) on 06 January 2016. This case involves a 06 months old female patient who was vaccinated with a dose of Daptacel (Batch number, dose, dose in series and route were not reported) in the right thigh on 05 January 2016 and dose of Rotavirus (Batch number, dose, dose in series and manufacturer name were not reported) via oral route on 05 January 2016 and dose of (HIB) (Batch number, dose, dose in series, route and site of administration were not reported manufacturer name: Unknown) on 08 December 2015. At time of vaccination the patient had runny nose without fever. Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as not none. On 06 January 2016, one day following the vaccination, the patient had developed 9 millimeter area of redness and swelling at the injection site (right thigh) and a low grade temperature of 99 Farad. No any other laboratory test was done. Corrective treatments were not reported. The patient was not recovered from the event. List of documents held by sender: none. Follow up information received from a physician on 07 March 2016. Patient had received 0.5 ml dose of Pentacel (batch number H7599, expiry date 07 May 2017) intramuscularly, received 2 ml of Rotavirus (batch number 1020861, expiry date 25 January 2017) and also received a 0.5 ml dose of Acthib (batch number UI346AA, expiry date 03 February 2017) intramuscularly in left thigh. On 05 January 2016, same day following the vaccination, the patient developed red and raised spot at injection site, patient's leg was almost 2 inch in diameter bigger than left (right 11 inch and left 10.25 inch) temperature was 99.4 degree Celsius. Patient needed no treatment. Outcome of event was not recovered.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Anxiety, Chills, Confusional state, Depression, Dizziness
Clinical narrative: Depression, anxiety, weight gain, chills, confusion, dizziness. No treatment.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Weight increased
Clinical narrative: Depression, anxiety, weight gain, chills, confusion, dizziness. No treatment.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling 1 1/2 inches in diameter after receiving vaccines.
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Lethargy, Pyrexia, Urticaria
Clinical narrative: Urticaria, high fever, lethargy.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Pain in extremity, Soft tissue swelling
Clinical narrative: Soft tissue swelling, redness and induration w/UE pain within 24 hr. of immunization.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Employee was given MMR vaccine on 04/11/16; 3 days later had temp. 99 degrees then had a few red, raised areas appear on neck, shoulder area; itching. Rash spreading - no other symptoms. Sent to Dr. for evaluation.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 5 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: Upper arm is swollen, red, tender, and is a little itchy. No systemic symptoms. Local reaction only. Swelling down to his elbow.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 20-FEB-2016, the patient was vaccinated with first dose of RECOMBIVAX HB therapy type, lot, dosing details unknown. Concomitant medications were not reported. On an unknown date in April 2016 (also reported as now), It was reported that the patient was likely to get the second dose (inappropriate schedule of drug administration). No adverse symptoms were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an 18 month old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not reported. On 28-OCT-2015, the patient was vaccinated with first does of VAQTA (lot # L028666, expiry date 04-NOV-2016) dosing details unknown. Concomitant medications were not reported. On 26-APR-2016, the patient was vaccinated with second dose of VAQTA (Lot # L023232, expiry date 25-FEB-2017) which was less than recommended 6 month interval (inappropriate schedule of vaccine administrated). No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored M-M-R II, lot #L005291, expiration date 17-FEB-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature/Time: 9.5C for 2 hours and 30 minutes, Data Logger: Yes, yes it was administered. There was a previous temperature excursion 1.5 C for 1 hour, 10.5C for 1 hour and 30 minutes. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Headache, chills, skin hurts to touch, muscle aches especially across shoulders and traveling up neck, joint pain almost everywhere, nausea.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Pain of skin
Clinical narrative: Headache, chills, skin hurts to touch, muscle aches especially across shoulders and traveling up neck, joint pain almost everywhere, nausea.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site joint pain, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, redness at injection site.  Joint pain worse in limb (left) where vaccine was given.
Age: 1.53
Sex: F
Vaccine: HEPA
Symptoms: Injection site rash, Rash erythematous, Rash generalised, Rash macular, Rash pruritic
Clinical narrative: 11-18-15 = phone call for 3 blotches on stomach. 11-20-15 = phone call for continued rash, dad wanted seen. 11-27-15 = dad reported rash for 10 days. 11-29-15 = urgent care visit. 11-30-15 - derm. visit. 11/30/2015 Patient is an 18-month-old female toddler who presents at the request of Dr. for evaluation of a rash that is red and flat. She has had this for 2 weeks. It changes shapes and itches (intermittent, mild to moderate severity). It is all over her body. She is using BENADRYL 5mg every 6 hours partially effective. She had a Hepatitis A injection on the 17th and then she broke out that evening with the rash around the injection site and then it spread. 11/29/2015 11/17/15 had shots had hives that night gradual increase, was seen by Dr, have given BENADRYL x 7 days crying at night. 12 days ago, had shots. Occurred that evening after shots. Has not seemed itchy. First noticed around area of injection (L) thigh. The noticed on abd. Now noticed face, legs, abd. About 1 week into this, skipped a day of BENADRYL, and then seemed to worsen again. Noted temp scan temp of 99.7, one day. Change in appetite since shot, nonspecific. Noticed diarrhea last week, now better. No URI symptoms. Mom thinks might be teething. No ibuprofen given. PFSH: Hep A vaccine was only thing given. 11/20/2015 Patient is in today with her father regarding a rash started on her stomach as red blotches on 11/18. It has spread. Dad isn't noticing her scratching. She received her HepA vaccine on 11/17. No other exposures that dad can think of. No runny nose, cough, wheezing, difficulty breathing, fever, diarrhea or vomiting. Eating and drinking well. Sleeping well. PGF has allergy to sulfa.
Sex: F
Vaccine: MMR
Symptoms: Loss of consciousness
Clinical narrative: This study report as received from a consumer, as part of a marketing research study, refers to a female patient of unknown age enrolled in an market research. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with M-M-R II, subcutaneous. On an unknown date, she had a reaction to MMR vaccine when she was small. She just passed out. At the time of this report, outcome of event loss of consciousness was unknown. The reporter did not assess causality of event loss of consciousness with MMR. Upon internal review, event loss of consciousness was determined to be medically significant. Additional information has been requested.
Age: 0.58
Sex: M
Vaccine: DTAP, IPV, RV5
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives on both legs and right arm 2 hours after administration of vaccines on 05/09/16, po Benadryl 4 ml given by parent and hives subsided within 1 hour. Recurred again at 4 a.m. 05/10/16 - Benadryl given and then recurred at 8 a.m.
Age: 28.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Pain, Viral titre
Clinical narrative: 1 week after receiving vaccine, pt reports approximately 2 x 4 in area of red, hard itching to back of right arm where she received the vaccine. Pt  also reported arm pain with movement. These symptoms lasted 2 weeks and resolved on their own. Pt did not seek medical attention.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Myalgia
Clinical narrative: Pt states 2 days after the vaccine was given she experienced pain in her deltoid muscle of which has affected her shoulders as well and she has been seeing a chiropractor.
Age: 1.24
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash in the Rt arm site area of V-VAX given 04/27/16.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored ROTATEQ, lot # K014826, expiration date- 28-MAY-2016 and lot # K011948, expiration date- 07-JUN-2016 (incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature was -3 degree Celsius, Time frame was 6 hours and it was back in range. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored VAQTA, lot # L022259, expiration date- 06-APR-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature/Time: 9.5C for 2 hours and 30 minutes. Data Logger: Yes, yes it was administered. There was a previous temperature excursion 1.5 C for 1 hour, 10.5C for 1 hour and 30 minutes. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a female patient around 65 years old. The patients medical history and concurrent conditions included diabetes mellitus, wheelchair user, disability, allergy to TYLENOL, sulfonamide and cephalosporin. On 22-APR-2016, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose number, route, lot number and expiration date were not provided). Concomitant therapies were not provided. The patient stated that in April 2016, her unspecified arm was swollen and she had unspecified injection site pain. Additionally the patient experienced, injection site swelling, injection site erythema and injection site irritation. No treatment was given for the adverse events, the case did not involve cancer or overdose. The outcome of injection site pain, injection site swelling, injection site erythema, injection site irritation and peripheral swelling was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 98.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Local swelling, Rash vesicular
Clinical narrative: Pt. has been vaccinated on 05/05/2016 on right arm. ZOSTAVAX and MMR. Has developed rash on left and hump. Look like milk shingles. Pt will check with MD today.
Age: 20.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: After injection she got dizzy and had a very brief 2 second syncope possibly vaso-vagal. Treatment Dr. monitored patient room for 15 minutes and patient laid down and drank water.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fall, Joint injury
Clinical narrative: Patient was fine after vaccine, walked to front of store then fell. Said she felt dizzy, but never lost consciousness. Called ambulance since she hit her knee on boxes.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Dyspnoea, Nausea, Pain in extremity, Skin burning sensation
Clinical narrative: About 30 minutes after administration of HPV vaccine, pt. c/o skin burning all over, nausea, trouble getting a deep breath. B.P. 118/68. Accu-check 76. Rested, H2O, snack. No rash, no noted injection site irritation. Feeling some better but skin burning and arm pain. Instructed could take MOTRIN per M.D. here. She will do that at home. To ER if worsens.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red area at site 50 cent piece area, hot to touch. Advised cold compresses, MOTRIN. Patient mother to bring her in to be checked if symptoms persist/worsen. Phone call in 2 days. Mother not returned call.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Product reconstitution issue
Clinical narrative: Both components of vaccine were not administered. Patient needed MCV and the office stocks MENVEO and only the Liquid portion of the vaccine was given. Liquid portion was not mixed with powder.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient reports about 12 hours after receiving PREVNAR vaccine she had local reaction. The area of the shot swelled up to the size of an apple, it was red and warm to the touch. She took a BENADRYL and placed cool compresses on her arm. The area is now pink and only swollen to the size of a walnut.
Age: 72.0
Sex: F
Vaccine: PNC
Symptoms: Dizziness, Fatigue, Muscle spasms
Clinical narrative: Fatigue,leg cramps, and dizziness.
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Headache
Clinical narrative: Symptoms started night of 1st pill with severe, hacking cough. Symptoms became worse with each pill intake and included fever (100.0 degrees F - 102.8 degrees F), chills, shortness of breath, sweating, and severe fatigue, and severe headaches. Patient still had one more pill to take before vaccine completed.
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Symptoms started night of 1st pill with severe, hacking cough. Symptoms became worse with each pill intake and included fever (100.0 degrees F - 102.8 degrees F), chills, shortness of breath, sweating, and severe fatigue, and severe headaches. Patient still had one more pill to take before vaccine completed.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Pt called 5/5/2016 to report that she noted redness and swelling at the site of the vaccination - swelling tracked down her arm as did the erythema. She took a picture of it and it was quite impressive. It took until 5/10/16 for it to nearly resolve. She treated with ice and at our advice, ibuprofen. This was helpful.
Age: 51.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient stated she started having high fevers around 0200 (10May2016). Also stated chills, body aches and soreness on left arm.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Left arm slight redness no edema noted, pt has slight edema at the medial epicondyle, good rom of the arm, slight warmth, good grip rom of all left upper joints.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Hypoaesthesia, Neck pain, Pain in extremity, Throat tightness
Clinical narrative: Severe pain and numbness to left arm (arm injection given in), head ache, neck ache, tight throat.
Age: 1.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Clumsiness, Decreased appetite, Diarrhoea, Fall, Gait disturbance
Clinical narrative: Within 2 hours of the shot, he became clumsy and began falling frequently. By the next day, he began taking less weight on his left leg and demonstrating a significant limp. The limp became progressively worse over the next two weeks. He was taking almost no weight on that leg and the leg was also observed to buckle if he did put weight on that leg, up to 8-10 times per hour, resulting in falls. After 1 week of symptoms, I took him back to the pediatrician, and bilateral hip, knee, and ankle xrays were ordered, but no abnormality was found. There was also no redness or swelling or obvious pain to palpation. I am his mother and a pediatric occupational therapist, and I can tell you from my professional perspective that there appeared to be peripheral nerve/sensory involvement. It was as if he could not feel or move his leg when ambulating. I called Pfizer, who stated that his symptoms are consistent with the known adverse event of "limitation of limb movement". It is slowly resolving, but it is not yet fully resolved. In addition to his limping, he also had a severely reduced appetite and diarrhea for 14 days.
Age: 1.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site hypoaesthesia, Injection site movement impairment, Injection site reaction, Weight bearing difficulty, X-ray limb normal
Clinical narrative: Within 2 hours of the shot, he became clumsy and began falling frequently. By the next day, he began taking less weight on his left leg and demonstrating a significant limp. The limp became progressively worse over the next two weeks. He was taking almost no weight on that leg and the leg was also observed to buckle if he did put weight on that leg, up to 8-10 times per hour, resulting in falls. After 1 week of symptoms, I took him back to the pediatrician, and bilateral hip, knee, and ankle xrays were ordered, but no abnormality was found. There was also no redness or swelling or obvious pain to palpation. I am his mother and a pediatric occupational therapist, and I can tell you from my professional perspective that there appeared to be peripheral nerve/sensory involvement. It was as if he could not feel or move his leg when ambulating. I called Pfizer, who stated that his symptoms are consistent with the known adverse event of "limitation of limb movement". It is slowly resolving, but it is not yet fully resolved. In addition to his limping, he also had a severely reduced appetite and diarrhea for 14 days.
Age: 1.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: X-ray of pelvis and hip normal
Clinical narrative: Within 2 hours of the shot, he became clumsy and began falling frequently. By the next day, he began taking less weight on his left leg and demonstrating a significant limp. The limp became progressively worse over the next two weeks. He was taking almost no weight on that leg and the leg was also observed to buckle if he did put weight on that leg, up to 8-10 times per hour, resulting in falls. After 1 week of symptoms, I took him back to the pediatrician, and bilateral hip, knee, and ankle xrays were ordered, but no abnormality was found. There was also no redness or swelling or obvious pain to palpation. I am his mother and a pediatric occupational therapist, and I can tell you from my professional perspective that there appeared to be peripheral nerve/sensory involvement. It was as if he could not feel or move his leg when ambulating. I called Pfizer, who stated that his symptoms are consistent with the known adverse event of "limitation of limb movement". It is slowly resolving, but it is not yet fully resolved. In addition to his limping, he also had a severely reduced appetite and diarrhea for 14 days.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and redness from injection site on Left deltoid past elbow into upper forearm. Limited range of motion of elbow. Became increasingly hotter and harder for 4 days. No treatment until night 4 when person took ADVIL and began alternating ice packs and warm, moist compresses on arm. Swelling decreased, ROM increased by Day 5 when began taking ZYRTEC and continued warm, moist compresses. Day 6 continued ZYRTEC but stopped when swelling much decreased, full ROM occurred. Injection site began itching. Day 7 went to doctor.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: Swelling and redness from injection site on Left deltoid past elbow into upper forearm. Limited range of motion of elbow. Became increasingly hotter and harder for 4 days. No treatment until night 4 when person took ADVIL and began alternating ice packs and warm, moist compresses on arm. Swelling decreased, ROM increased by Day 5 when began taking ZYRTEC and continued warm, moist compresses. Day 6 continued ZYRTEC but stopped when swelling much decreased, full ROM occurred. Injection site began itching. Day 7 went to doctor.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Burning sensation, Crying, Erythema, Fatigue, Inflammation
Clinical narrative: Injection sight on right arm swollen, puncture hole visible, redness and extreme pain to touch. Burning throbbing in entire extremity. Patient in tears, warmth and redness extended from injection site upward to right side of neck and into upper shoulder blade.  Patient has since had an increase in over all inflammation of body and tiredness.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Injection sight on right arm swollen, puncture hole visible, redness and extreme pain to touch. Burning throbbing in entire extremity. Patient in tears, warmth and redness extended from injection site upward to right side of neck and into upper shoulder blade.  Patient has since had an increase in over all inflammation of body and tiredness.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Skin warm
Clinical narrative: Injection sight on right arm swollen, puncture hole visible, redness and extreme pain to touch. Burning throbbing in entire extremity. Patient in tears, warmth and redness extended from injection site upward to right side of neck and into upper shoulder blade.  Patient has since had an increase in over all inflammation of body and tiredness.
Age: 48.0
Sex: F
Vaccine: FLUR3
Symptoms: Balance disorder, Dizziness, Headache, Nausea, Neck pain
Clinical narrative: Sudden onset of nausea, dry heaves, headache, neck pain.  Was seen by primary care physician and referred to neurologist. Symptoms of dizziness, unsteadiness, dry heaves, H/a continued. Had vestibular evaluation performed 5 days after onset of symptoms with positive head shaking nystagmus test using video frenzel lenses with unilateral beating nystagmus. was treated with meclizine, vestibular habituation exercises. symptoms gradually improved but were provoked by visual stimulation and motion such as riding in car. Had multiple dry heaves whenever in car until 12-22-15 was first day I drove to work without dry heaves. Symptoms continued to improve but were greatly provoked when driving in car if it was raining/snowing and if needed to use windshield wipers. By 1-10-16 symptoms seemed to significantly improve.
Age: 48.0
Sex: F
Vaccine: FLUR3
Symptoms: Opticokinetic nystagmus tests abnormal, Retching
Clinical narrative: Sudden onset of nausea, dry heaves, headache, neck pain.  Was seen by primary care physician and referred to neurologist. Symptoms of dizziness, unsteadiness, dry heaves, H/a continued. Had vestibular evaluation performed 5 days after onset of symptoms with positive head shaking nystagmus test using video frenzel lenses with unilateral beating nystagmus. was treated with meclizine, vestibular habituation exercises. symptoms gradually improved but were provoked by visual stimulation and motion such as riding in car. Had multiple dry heaves whenever in car until 12-22-15 was first day I drove to work without dry heaves. Symptoms continued to improve but were greatly provoked when driving in car if it was raining/snowing and if needed to use windshield wipers. By 1-10-16 symptoms seemed to significantly improve.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Diplopia, Facial paralysis, Guillain-Barre syndrome
Clinical narrative: 10/30 Tingling in hands and feet. 11/2 While brushing teeth in morning, had sudden left facial drooping. Went to ED, dx w/Bell's Palsy, tx Valtrex and Prednisone. 11/3 Saw neurologist, suspected GBS, but no symptoms. 11/4 Facial drooping began on right side, paresthesia bilaterally in hands and feet, blurred and double vision, mild headache. Dx Guillain-Barre Syndrome. Tx Claritin, Privigen, Potassium.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Nuclear magnetic resonance imaging, Paraesthesia, Vision blurred
Clinical narrative: 10/30 Tingling in hands and feet. 11/2 While brushing teeth in morning, had sudden left facial drooping. Went to ED, dx w/Bell's Palsy, tx Valtrex and Prednisone. 11/3 Saw neurologist, suspected GBS, but no symptoms. 11/4 Facial drooping began on right side, paresthesia bilaterally in hands and feet, blurred and double vision, mild headache. Dx Guillain-Barre Syndrome. Tx Claritin, Privigen, Potassium.
Age: 1.26
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Child woke with a widespread rash covering her whole body and fever. Rash and fever worsened and persisted for 7 days.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR
Symptoms: Blood test normal, Crying, Decreased appetite, Diarrhoea, Dyskinesia
Clinical narrative: Patient Started with head jerking and staring into space. Not really responsive for 3 weeks. Also had unsteady gait and was falling all of the time from 02/20/16 - 04/10/2016. On April 10th patient had uncontrollable crying and on set of diarrhea this continued until May 4th. During this time she also had an unexplainable rash head to toe and the mouth rash just cleared up o May 7th, 2016. The loose stool is still on and off but finally subsiding. Patient also had lose of appetite and lost weight at the time of all this. Symptoms kept popping up over a two month time periods. After speaking with Dr today on May 10th she agrees a possible reaction has taken place. The parents believe that is it all related to either the MMR and/or Hep A Vaccine .
Age: 1.01
Sex: F
Vaccine: HEPA, MMR
Symptoms: Fall, Gait disturbance, Rash generalised, Staring, Unresponsive to stimuli
Clinical narrative: Patient Started with head jerking and staring into space. Not really responsive for 3 weeks. Also had unsteady gait and was falling all of the time from 02/20/16 - 04/10/2016. On April 10th patient had uncontrollable crying and on set of diarrhea this continued until May 4th. During this time she also had an unexplainable rash head to toe and the mouth rash just cleared up o May 7th, 2016. The loose stool is still on and off but finally subsiding. Patient also had lose of appetite and lost weight at the time of all this. Symptoms kept popping up over a two month time periods. After speaking with Dr today on May 10th she agrees a possible reaction has taken place. The parents believe that is it all related to either the MMR and/or Hep A Vaccine .
Age: 1.01
Sex: F
Vaccine: HEPA, MMR
Symptoms: Weight decreased
Clinical narrative: Patient Started with head jerking and staring into space. Not really responsive for 3 weeks. Also had unsteady gait and was falling all of the time from 02/20/16 - 04/10/2016. On April 10th patient had uncontrollable crying and on set of diarrhea this continued until May 4th. During this time she also had an unexplainable rash head to toe and the mouth rash just cleared up o May 7th, 2016. The loose stool is still on and off but finally subsiding. Patient also had lose of appetite and lost weight at the time of all this. Symptoms kept popping up over a two month time periods. After speaking with Dr today on May 10th she agrees a possible reaction has taken place. The parents believe that is it all related to either the MMR and/or Hep A Vaccine .
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Gastrointestinal pain, Headache, Injection site discolouration, Injection site reaction
Clinical narrative: Initial symptoms were severe stomach/intestinal cramping which progressed to constant nausea and low grade headache. A lesion appeared at the injection site approximately 24 hours after administration measuring 1 inch x 3 inches. The lesion is scaly and started as pink progressing to purple/blue in appearance. An antibiotic was prescribed on 5/10/2016 for possible injection site infection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Skin exfoliation, Skin lesion
Clinical narrative: Initial symptoms were severe stomach/intestinal cramping which progressed to constant nausea and low grade headache. A lesion appeared at the injection site approximately 24 hours after administration measuring 1 inch x 3 inches. The lesion is scaly and started as pink progressing to purple/blue in appearance. An antibiotic was prescribed on 5/10/2016 for possible injection site infection.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Nerve conduction studies, Neuropathy peripheral, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Started having tingling in hands and slightly in feet. A few weeks later developed blisters across my back. Neuropathy has been getting worse. Never had any tingling or Neuropathy until the shingles vaccine.
Age: 54.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Dermatomyositis, Dysphagia, Dyspnoea, Fatigue, Muscular weakness
Clinical narrative: Hard to swallow. Shortness of breath. Swelling edema. Rash over body and shoulders. Muscle weakness. Exhaustion. Extreme fatigue. Medication for symptoms.
Age: 54.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Oedema, Pathology test, Rash generalised, Swelling
Clinical narrative: Hard to swallow. Shortness of breath. Swelling edema. Rash over body and shoulders. Muscle weakness. Exhaustion. Extreme fatigue. Medication for symptoms.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 25-year-old female subject was enrolled in an open label study. The subject received BOOSTRIX (intramuscular) on 12th May 2015. Concomitant products included Prenatal Vitamins. The subject's estimated date of delivery was 5th January 2016. The subject received BOOSTRIX at week 6 of the pregnancy and during the first trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX, the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided as follows: No other events reported. The nurse administering the vaccine is the reporter. Follow-up information received on 16 June 2015 from nurse: The subject's last menstrual period was on 1st April 2015. The subject's ethnic origin was provided. (Pregnancy Notes) On 20 March 2016, this case was considered lost to follow-up. Follow up information received on 5th April 2016 from nurse via call centre representative: This case was upgraded to serious due to GSK medically significant term miscarriage. The patient had a normal conception. The patient did not have any previous pregnancy. The patient was allergic to penicillin, amoxicillin and doxycycline. The patient's husband was a social drinker and was not a smoker and did not have any daily medications or allergies. In 1st week of June 2015, at 8 to 10 weeks of gestation (approximately 2 weeks after vaccination), the patient had a miscarriage. The VAERS details were updated.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Polymyalgia rheumatica
Clinical narrative: Case number PHEH2016US010864, is an initial spontaneous report received from a nurse on 29 Apr 2016. This report refers to a 66 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514701) at a dose of 0.5 ml intramuscularly on 21 Oct 2015. On 02 Dec 2015, the patient was diagnosed with polymyalgia rheumatica. It was reported as the symptoms (unspecified) started in the week of Thanksgiving. The outcome of the event was reported as unknown. The seriousness and causality of the event was not reported. Seriousness assessment of the event polymyalgia rheumatica was upgraded based on Novartis Important Medical Events list. The reporter declined follow up be sent as she did not have any more information to provide in regards to the events reported, hence considered as lost to follow up.
Age: 0.6
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Acute disseminated encephalomyelitis, Anti-NMDA antibody positive, Decreased activity, Encephalitis autoimmune, Eye movement disorder
Clinical narrative: Case number PHHY2016US059733 is an initial literature report received on 28 Apr 2016. The author described about a case of antibody-verified anti-N-methyl-D-aspartate (anti-NMDA) receptor encephalitis in a neonate following influenza vaccination. This report refers to a 7 month old female patient. She was previously healthy. She was vaccinated with a booster dose of influenza vaccine (manufacturer and batch number: not reported) during her first influenza season (vaccination date was not reported). Within 48 hours of vaccination, she presented with acute onset of altered mental status, decreased activity, roving eye movements and opisthotonic posturing. She was initially diagnosed with acute demyelinating encephalomyelitis (ADEM) and treated with a short burst of corticosteroids followed by a taper. Symptoms subjectively improved during steroid therapy, but did not persist, prompting further diagnostic evaluations. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid antibody titer 68 days after onset of symptoms. Treatment was then undertaken with serial courses of intravenous immunoglobulin (IVIG) and rituximab. The patient's hospital course was protracted and she required utilization of intensive care unit resources due to aspiration risk, surgical placement of nutritional and vascular access devices and paroxysmal autonomic hyperactivity (PAH). Minimal improvement in her neurologic exam was observed at time of hospital discharge and might be due to delayed start of treatment as well as the cumulative effect of unrecognized seizures early in her illness course. The author stated that this case described the youngest patient with ant-NMDA receptor encephalitis yet reported and the first to suggest correlation with recent influenza vaccination. The author concluded the article stating that as higher likelihood of neurologic recovery was associated with early initiation of treatment, providers were encouraged to consider autoimmune neurologic disorders like anti-NMDA receptor encephalitis when mental status abnormalities and developmental regression persist, regardless of patient's age.
Age: 0.6
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immunoglobulin therapy, Intensive care, Mental status changes, Opisthotonus, Posturing
Clinical narrative: Case number PHHY2016US059733 is an initial literature report received on 28 Apr 2016. The author described about a case of antibody-verified anti-N-methyl-D-aspartate (anti-NMDA) receptor encephalitis in a neonate following influenza vaccination. This report refers to a 7 month old female patient. She was previously healthy. She was vaccinated with a booster dose of influenza vaccine (manufacturer and batch number: not reported) during her first influenza season (vaccination date was not reported). Within 48 hours of vaccination, she presented with acute onset of altered mental status, decreased activity, roving eye movements and opisthotonic posturing. She was initially diagnosed with acute demyelinating encephalomyelitis (ADEM) and treated with a short burst of corticosteroids followed by a taper. Symptoms subjectively improved during steroid therapy, but did not persist, prompting further diagnostic evaluations. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid antibody titer 68 days after onset of symptoms. Treatment was then undertaken with serial courses of intravenous immunoglobulin (IVIG) and rituximab. The patient's hospital course was protracted and she required utilization of intensive care unit resources due to aspiration risk, surgical placement of nutritional and vascular access devices and paroxysmal autonomic hyperactivity (PAH). Minimal improvement in her neurologic exam was observed at time of hospital discharge and might be due to delayed start of treatment as well as the cumulative effect of unrecognized seizures early in her illness course. The author stated that this case described the youngest patient with ant-NMDA receptor encephalitis yet reported and the first to suggest correlation with recent influenza vaccination. The author concluded the article stating that as higher likelihood of neurologic recovery was associated with early initiation of treatment, providers were encouraged to consider autoimmune neurologic disorders like anti-NMDA receptor encephalitis when mental status abnormalities and developmental regression persist, regardless of patient's age.
Age: 0.6
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Psychomotor hyperactivity
Clinical narrative: Case number PHHY2016US059733 is an initial literature report received on 28 Apr 2016. The author described about a case of antibody-verified anti-N-methyl-D-aspartate (anti-NMDA) receptor encephalitis in a neonate following influenza vaccination. This report refers to a 7 month old female patient. She was previously healthy. She was vaccinated with a booster dose of influenza vaccine (manufacturer and batch number: not reported) during her first influenza season (vaccination date was not reported). Within 48 hours of vaccination, she presented with acute onset of altered mental status, decreased activity, roving eye movements and opisthotonic posturing. She was initially diagnosed with acute demyelinating encephalomyelitis (ADEM) and treated with a short burst of corticosteroids followed by a taper. Symptoms subjectively improved during steroid therapy, but did not persist, prompting further diagnostic evaluations. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid antibody titer 68 days after onset of symptoms. Treatment was then undertaken with serial courses of intravenous immunoglobulin (IVIG) and rituximab. The patient's hospital course was protracted and she required utilization of intensive care unit resources due to aspiration risk, surgical placement of nutritional and vascular access devices and paroxysmal autonomic hyperactivity (PAH). Minimal improvement in her neurologic exam was observed at time of hospital discharge and might be due to delayed start of treatment as well as the cumulative effect of unrecognized seizures early in her illness course. The author stated that this case described the youngest patient with ant-NMDA receptor encephalitis yet reported and the first to suggest correlation with recent influenza vaccination. The author concluded the article stating that as higher likelihood of neurologic recovery was associated with early initiation of treatment, providers were encouraged to consider autoimmune neurologic disorders like anti-NMDA receptor encephalitis when mental status abnormalities and developmental regression persist, regardless of patient's age.