chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Headache, Postural orthostatic tachycardia syndrome, Pyrexia, Serum ferritin decreased, Tremor
Clinical narrative: Extreme joint pain, Dysautonomia-POTS, chronic fatigue, daily debilitating headaches, constant shaking, chills, fever. Has not gotten better-still has all symptoms.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Vitamin D decreased
Clinical narrative: Extreme joint pain, Dysautonomia-POTS, chronic fatigue, daily debilitating headaches, constant shaking, chills, fever. Has not gotten better-still has all symptoms.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Antinuclear antibody positive, Arthralgia, Asthenia, Autonomic nervous system imbalance, Chills
Clinical narrative: Extreme joint pain, Dysautonomia-POTS, chronic fatigue, daily debilitating headaches, constant shaking, chills, fever. Has not gotten better-still has all symptoms.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Fatigue, Headache, Postural orthostatic tachycardia syndrome, Pyrexia, Serum ferritin decreased
Clinical narrative: Extreme joint pain, Dysautonomia-POTS, chronic fatigue, daily debilitating headaches, constant shaking, chills, fever. Has not gotten better-still has all symptoms.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Tremor, Vitamin D decreased
Clinical narrative: Extreme joint pain, Dysautonomia-POTS, chronic fatigue, daily debilitating headaches, constant shaking, chills, fever. Has not gotten better-still has all symptoms.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Patient called pharmacy complaining of severe arm stiffness and shoulder pain that started day after vaccine given and has continued for 2 months.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt. mom notified this nurse on 1/18/17 at 16:30 that pt. arm that received injection was "swollen from shoulder down to elbow, warm to touch, and c/o itching." Mom states no fever, states pt denies pain or discomfort. 1/19/17 mom states "hasn't gotten worse but isn't better."
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain
Clinical narrative: 11-30-16 ZOSTAVAX given "Sq" Lt arm. Patient states soreness after injection which continues. No redness noted. 07-15-10 Patient diagnosed with Herpes Zoster.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: No adverse effects observed.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Migraine, Pyrexia
Clinical narrative: Fever, migraine, lump at injection site (golf ball size), pain lasted 5 days. Started the day after the shot.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Circumstance or information capable of leading to medication error, Injection site erythema, Injection site warmth
Clinical narrative: Pt. pulled arm away during administration of injection of KINRIX. Mother reports pt. had large red circle around area of injection approx. 3 inches in diameter, red, hot touch for 2 days.
Age: 66.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Back pain, Blood test abnormal, Headache, Limb injury, Muscular weakness
Clinical narrative: Sirva and neuropathy - ongoing - from Dec. 2015 - until current - Jan, 2017 - ongoing pain in arm and shoulder. Fever for 4 weeks; itching; pain in back reoccurring; headaches off and on from beginning 2015 - 2017; weakness in left hand arm and shoulder; pain and burn; tingling in arms, hands, shoulder and back - ongoing. Occupational therapy in Aug, 2016. Headaches and ringing in ears on and off.
Age: 66.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Neuropathy peripheral, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Sirva and neuropathy - ongoing - from Dec. 2015 - until current - Jan, 2017 - ongoing pain in arm and shoulder. Fever for 4 weeks; itching; pain in back reoccurring; headaches off and on from beginning 2015 - 2017; weakness in left hand arm and shoulder; pain and burn; tingling in arms, hands, shoulder and back - ongoing. Occupational therapy in Aug, 2016. Headaches and ringing in ears on and off.
Age: 66.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pruritus, Pyrexia, Tinnitus
Clinical narrative: Sirva and neuropathy - ongoing - from Dec. 2015 - until current - Jan, 2017 - ongoing pain in arm and shoulder. Fever for 4 weeks; itching; pain in back reoccurring; headaches off and on from beginning 2015 - 2017; weakness in left hand arm and shoulder; pain and burn; tingling in arms, hands, shoulder and back - ongoing. Occupational therapy in Aug, 2016. Headaches and ringing in ears on and off.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Presented with 2 day history right axilla lymph node swelling and tenderness. Treat with heat and ibuprofen.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Patient received flu shot 1/8/17 - on Monday 1/9/17 patient noticed itching on back. Tuesday 1/10/17 patient saw red rash on chest and back-with raised red bumps. Area of involvement is being treated with steroid cream.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: Day after vaccine given, red and swollen, hot to touch - low grade fever - redness spreading on (R) leg.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Patient presented to ER with red swollen upper left arm. ? Discomfort as she is non verbal. Suspect cellulitis from recent immunizations. Script for BACTRIM.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Pyrexia, Speech disorder
Clinical narrative: Per moms report, 103 fever and speech regression. mom states both have recovered. MD office not notified of symptoms until 1-9-17.
Age: 64.0
Sex: F
Vaccine: FLU4, HEPA, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Flu vaccine, TDaP, and Hep A given 10 min, 2 min apart. Pt passed out after Hep A vaccine. EPI given. Pt regained consciousness. Sent to ER.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site rash
Clinical narrative: Pt inform she had a rash extending from the vaccination site to the elbow. This happened two days after receiving the vaccine. At the time of reporting it, pt didn't seek treatment.
Age: 83.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt received vaccine on 10/4/16 and got a sore arm, as of 1/5/17 it is still sore and he has trouble lifting arm. Pain never went away.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Abdominal pain upper, Dyspnoea, Wheezing
Clinical narrative: 15-20 min after vaccines- as leaving the building she had trouble breathing and stomach hurt-came back and was wheezing. EPI PEN, Jr. given. BENADRYL and Albuterol neb/O2 given. Pulse Ox was 90%-911 called and to ER.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal discomfort, Chills, Discomfort, Injection site pain, Pyrexia
Clinical narrative: 12/29/2016 Received Pneumococcal (PPSV23) vaccine. Within 6 hours developed extreme soreness in left shoulder (where vaccine given) plus chills, fever, stomach distress and overall body discomfort. As of 1/9/17 still some shoulder soreness.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Somnolence, Vomiting, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Developed vomiting and sleepiness within 1st 24 hr of vaccines - continued with vomiting x 7 days. Slept a lot 1st 24hr. Mom would wake for feedings. Note: 1-9-17 - received PEDIARIX, PEDVAXHIB, PREVNAR 1-6-17 and did fine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left arm warm, red just MOTRIN, TYLENOL, cold compress.
Age: 1.83
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Erythema, Induration, Lethargy, Pyrexia
Clinical narrative: Fever of up to 104 degree Fahrenheit. Redness, swelling, hardness, heat-at the area on the leg-thigh. Lethargic, loss of appetite. Treated with BENADRYL and TYELNOL.
Age: 1.83
Sex: M
Vaccine: DTAP
Symptoms: Skin warm, Swelling
Clinical narrative: Fever of up to 104 degree Fahrenheit. Redness, swelling, hardness, heat-at the area on the leg-thigh. Lethargic, loss of appetite. Treated with BENADRYL and TYELNOL.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Confusional state, Disorientation, Dyspnoea, Heart rate decreased
Clinical narrative: Shot given on 10/4, developed fever before going home. Following symptoms developed and progressed during the next few days: low pulse rate, pain and weakness in muscles (esp back and legs), confusion and disorientation, difficulty breathing, trembling.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Myalgia, Nuclear magnetic resonance imaging, Pyrexia, Tremor
Clinical narrative: Shot given on 10/4, developed fever before going home. Following symptoms developed and progressed during the next few days: low pulse rate, pain and weakness in muscles (esp back and legs), confusion and disorientation, difficulty breathing, trembling.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Abdominal pain, Antinuclear antibody negative, C-reactive protein normal, Full blood count normal, Helicobacter test
Clinical narrative: Within a day of receiving 1st HPV vaccine, he began to have symptoms of gnawing abdominal pain with nausea and vomiting. This has become more frequent since 2nd HPV dose (10/26/2016). CBC, CMP, H. Pylori have been negative. Have tried ZANTAC to diet modification without help.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Metabolic function test normal, Nausea, Red blood cell sedimentation rate normal, Vomiting
Clinical narrative: Within a day of receiving 1st HPV vaccine, he began to have symptoms of gnawing abdominal pain with nausea and vomiting. This has become more frequent since 2nd HPV dose (10/26/2016). CBC, CMP, H. Pylori have been negative. Have tried ZANTAC to diet modification without help.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Abdominal pain, Antinuclear antibody negative, C-reactive protein normal, Full blood count normal, Helicobacter test negative
Clinical narrative: Within a day of receiving 1st HPV vaccine, he began to have symptoms of gnawing abdominal pain with nausea and vomiting. This has become more frequent since 2nd HPV dose (10/26/2016). CBC, CMP, H. Pylori have been negative. Have tried ZANTAC to diet modification without help.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling hot, Rash
Clinical narrative: Extreme rash (down to elbow), warmth day after vaccination by lessen. Rash continued by until 1-19-17.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Heart rate increased, Immediate post-injection reaction, Nausea
Clinical narrative: Immediate flushing to face and head, rapid pulse, nausea, dizziness following the administration of FLUZONE HIGH DOSE 2016-17; Vaccine as administered on 11/7/2016 at store.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: Unknown.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Fatigue, Hot flush, Hyperhidrosis
Clinical narrative: Patient started w/chills and hot flashes, sweats on 1/19/17 at 3:00 pm. Patient in our office 1/20/17 2:00 pm, still complains of fatigue, lightheaded, painful at vaccination site (L) deltoid. Temp. 98.6 degrees F.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site pain
Clinical narrative: Patient started w/chills and hot flashes, sweats on 1/19/17 at 3:00 pm. Patient in our office 1/20/17 2:00 pm, still complains of fatigue, lightheaded, painful at vaccination site (L) deltoid. Temp. 98.6 degrees F.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Laboratory test, Pruritus generalised, Swelling face
Clinical narrative: Father reported that at approx 4:30-4:40 pm on 1-18-17 after receiving the vaccines, client experienced swelling of the face as well as a general feeling of "itchiness" all over his body. Father reported that client had no breathing issues or wheezing.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 2 day history of erythema, swelling and discomfort and itching involving entire right upper arm (right deltoid to elbow). Treated with cephalexin, cool compress and BENADRYL and allergy referral.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash generalised, Urticaria
Clinical narrative: Rash/hives (starting from lower extremities spread all over body).
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Influenza, Rash generalised, Vaccination failure
Clinical narrative: Rash/hives (starting from lower extremities spread all over body).
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Confirmed cellulitis after injection.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Diplegia, Myelitis transverse, Paralysis
Clinical narrative: 11/12/16 while traveling sudden onset (L) and (R) UE paralysis. W/U at Med Ctr c/w Transverse myelitis w/1 mo. R/O of other causes (MS, infec, NMO, Autoimmunity, etc) 1-mo rehab w/partial paralysis.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site. Treatment advised to use ibuprofen and ice for pain. Also advised to follow up if swelling hasn't resolved in one week from today.
Age: 33.0
Sex: U
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient is experiencing pain and limited movement in right shoulder 2+ weeks after immunization. Recommended NSAIDS, ice,  and referred to MD.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029300, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 33 years old female patient. Past medical history and concomitant medications were not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent at 52F for 1 hour occurred on 16 Oct 2016. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly on 20 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error (incorrect product storage).
Age: 52.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pain
Clinical narrative: 1/9/17 Reported continued soreness after receiving Tdap vaccine on 12/14/16.
Age: 18.0
Sex: F
Vaccine: DTPIHI
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Diarrhea, nausea, headache, fatigue, sore throat.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Pharmacist gave me the shingles vaccine in my left arm. However he did not give it in my deltoid. He gave it on the back of my arm about 2" above my elbow - perhaps in a tendon? I have a large painful lump which is hot to touch. I'm also worried that if he didn't hit a large muscle, the $250 shot I paid for may not be effective. Additionally, he never gave me a VIS. He told me AFTER the shot that it was a live virus and could give me flu-like symptoms.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Acne, Erythema, Induration
Clinical narrative: Mom noticed patient has a raised pimple with white head on left leg with redness about 1/2 inch around it, hard, not painful to touch, not itchy, no streaking.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Left arm swollen and warm to the touch, Pt advised to apply ice to area and take antihistamine and anti-inflammatory such as BENADRYL and ibuprofen.
Age: 55.0
Sex: M
Vaccine: PNC13
Symptoms: Bursitis
Clinical narrative: Bilateral hip bursitis, right greater than left, exacerbated by flexion and extension of hip, pain controlled easily with ibuprofen 200 gm po, acute onset and lasted approximately 18 hours with slow improvement.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose, Fall, Head injury, Loss of consciousness
Clinical narrative: Patient passed out 2 minutes after receiving flu shot. She fell hit her head on the counter. EMT's were called. They checked her blood pressure and blood sugar. No allergic reaction to the shot was determined. They believe she had a drop in blood pressure resulting from the stress of the shot.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Blood immunoglobulin G decreased, Blood immunoglobulin M increased, Crying, Decreased appetite, Discomfort
Clinical narrative: Mom noticed baby's right face looked "chubby" and had a hard lump under his right chin on 01/15/2017. He was fussy and not eating well. He had a low-grade fever of 99.7 that evening. Mom brought him into the office on 01/16/17. His temperature was 97.7 via temporal artery thermometer. He had significant swelling to his right outer cheek and chin. He had internal swelling of the right buccal mucosa. He was uncomfortable and crying. Due to the unilateral presentation, he was worked up for mumps via: CBCD, EBV acute antibodies, Mumps IGM and IGM, mumps viral culture, respiratory viral panel via nasopharyngeal swab, mycoplasma pneumonia culture via nasopharyngeal swab. He was treated for anterior cervical lymphangitis with Amoxicillin 600mg -Clavulanate 42.9/5 ml with 3 ml every 12 hours x 10 days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Epstein-Barr virus antibody negative, Haemoglobin normal, Induration, Irritability, Lymphangitis
Clinical narrative: Mom noticed baby's right face looked "chubby" and had a hard lump under his right chin on 01/15/2017. He was fussy and not eating well. He had a low-grade fever of 99.7 that evening. Mom brought him into the office on 01/16/17. His temperature was 97.7 via temporal artery thermometer. He had significant swelling to his right outer cheek and chin. He had internal swelling of the right buccal mucosa. He was uncomfortable and crying. Due to the unilateral presentation, he was worked up for mumps via: CBCD, EBV acute antibodies, Mumps IGM and IGM, mumps viral culture, respiratory viral panel via nasopharyngeal swab, mycoplasma pneumonia culture via nasopharyngeal swab. He was treated for anterior cervical lymphangitis with Amoxicillin 600mg -Clavulanate 42.9/5 ml with 3 ml every 12 hours x 10 days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Mass, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Mean cell volume decreased, Monocyte count increased
Clinical narrative: Mom noticed baby's right face looked "chubby" and had a hard lump under his right chin on 01/15/2017. He was fussy and not eating well. He had a low-grade fever of 99.7 that evening. Mom brought him into the office on 01/16/17. His temperature was 97.7 via temporal artery thermometer. He had significant swelling to his right outer cheek and chin. He had internal swelling of the right buccal mucosa. He was uncomfortable and crying. Due to the unilateral presentation, he was worked up for mumps via: CBCD, EBV acute antibodies, Mumps IGM and IGM, mumps viral culture, respiratory viral panel via nasopharyngeal swab, mycoplasma pneumonia culture via nasopharyngeal swab. He was treated for anterior cervical lymphangitis with Amoxicillin 600mg -Clavulanate 42.9/5 ml with 3 ml every 12 hours x 10 days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Mumps antibody test negative, Mycoplasma test, Neutrophil count normal, Oedema mucosal, Pyrexia
Clinical narrative: Mom noticed baby's right face looked "chubby" and had a hard lump under his right chin on 01/15/2017. He was fussy and not eating well. He had a low-grade fever of 99.7 that evening. Mom brought him into the office on 01/16/17. His temperature was 97.7 via temporal artery thermometer. He had significant swelling to his right outer cheek and chin. He had internal swelling of the right buccal mucosa. He was uncomfortable and crying. Due to the unilateral presentation, he was worked up for mumps via: CBCD, EBV acute antibodies, Mumps IGM and IGM, mumps viral culture, respiratory viral panel via nasopharyngeal swab, mycoplasma pneumonia culture via nasopharyngeal swab. He was treated for anterior cervical lymphangitis with Amoxicillin 600mg -Clavulanate 42.9/5 ml with 3 ml every 12 hours x 10 days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Red cell distribution width increased, Respiratory viral panel, Swelling face, White blood cell count normal
Clinical narrative: Mom noticed baby's right face looked "chubby" and had a hard lump under his right chin on 01/15/2017. He was fussy and not eating well. He had a low-grade fever of 99.7 that evening. Mom brought him into the office on 01/16/17. His temperature was 97.7 via temporal artery thermometer. He had significant swelling to his right outer cheek and chin. He had internal swelling of the right buccal mucosa. He was uncomfortable and crying. Due to the unilateral presentation, he was worked up for mumps via: CBCD, EBV acute antibodies, Mumps IGM and IGM, mumps viral culture, respiratory viral panel via nasopharyngeal swab, mycoplasma pneumonia culture via nasopharyngeal swab. He was treated for anterior cervical lymphangitis with Amoxicillin 600mg -Clavulanate 42.9/5 ml with 3 ml every 12 hours x 10 days.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site movement impairment, Injection site swelling, Musculoskeletal disorder, Musculoskeletal pain, Pain
Clinical narrative: My upper shoulder where the injection site was administered is swollen and movement is at 25%. Feels like my Bursa is inflamed due to pain and lack of ability to use left arm. I wake with shoulder pain every morning. I went to my Physician and was told if pain continues then schedule MRI.
Age: 76.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Cold sweat, Dizziness, Insomnia, Nausea
Clinical narrative: High fever, chills, cold sweat, light headedness, loss of sleep during the night; daytime, nausea, body aches, mild fever. 1/20/2017 night sweats, body aches; loss of sleep. 1/21/2017 Nausea, body aches, ongoing today. Treating with Excedrin, extra fluid intake.
Age: 76.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Night sweats, Pain, Pyrexia
Clinical narrative: High fever, chills, cold sweat, light headedness, loss of sleep during the night; daytime, nausea, body aches, mild fever. 1/20/2017 night sweats, body aches; loss of sleep. 1/21/2017 Nausea, body aches, ongoing today. Treating with Excedrin, extra fluid intake.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Some minor soreness and stiffness in shoulder which has not gone away after four months.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Cough, Night sweats
Clinical narrative: Mom called Sat 1-21 early afternoon. He had temp of 102 and chills and hot sweats only at night since Wed. He has regular temp during day. Mom giving him alternating ibuprofen & TYLENOL, coughing Friday nite gave him cough syrup.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Fatigue, Malaise, Pain, Rash, Rash pruritic
Clinical narrative: She felt ill for 4 days (tiredness, achy, etc) then she developed an itchy rash on her face.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Blood glucose increased, Pain, Pyrexia
Clinical narrative: Pain, fever 99.4, and blood glucose around 200.
Age: 43.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Hypersensitivity, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Baseball size knot where injection given, red, swollen, hot to touch, chills, body aches. Patient went to hospital on 1/20/17 since physician could not see her. Patient was told having an allergic reaction to the vaccine and was told had pneumonia. Was given a MEDROL Dosepak, Oxycodone and LEVAQUIN by hospital doctor.
Age: 43.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site warmth, Pain, Pneumonia
Clinical narrative: Baseball size knot where injection given, red, swollen, hot to touch, chills, body aches. Patient went to hospital on 1/20/17 since physician could not see her. Patient was told having an allergic reaction to the vaccine and was told had pneumonia. Was given a MEDROL Dosepak, Oxycodone and LEVAQUIN by hospital doctor.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Altered state of consciousness, Asthenia, Fatigue, Gait disturbance, Hypoaesthesia
Clinical narrative: Total arm pain/numbness and tingling in right arm (side of injection), very tired and fatigue that still has not gone away. Nauseous that still has not gone away. General weakness, cannot walk down the hall without needing to stop and rest and feeling like she's going to pass out. Still has not gotten better. Very, very pale.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Nausea, Pain in extremity, Pallor, Tinea capitis
Clinical narrative: Total arm pain/numbness and tingling in right arm (side of injection), very tired and fatigue that still has not gone away. Nauseous that still has not gone away. General weakness, cannot walk down the hall without needing to stop and rest and feeling like she's going to pass out. Still has not gotten better. Very, very pale.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Oropharyngeal pain, Pain, Productive cough, Secretion discharge
Clinical narrative: Total arm pain/numbness and tingling in right arm (side of injection), very tired and fatigue that still has not gone away. Nauseous that still has not gone away. General weakness, cannot walk down the hall without needing to stop and rest and feeling like she's going to pass out. Still has not gotten better. Very, very pale.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Nausea, Pain in extremity, Pallor, Paraesthesia, Tinea capitis
Clinical narrative: Total arm pain/numbness and tingling in right arm (side of injection), very tired and fatigue that still has not gone away. Nauseous that still has not gone away. General weakness, cannot walk down the hall without needing to stop and rest and feeling like she's going to pass out. Still has not gotten better. Very, very pale.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: 101.3 degree fever; administered 5 mL Tylenol.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Computerised tomogram, Full blood count, Immune thrombocytopenic purpura, Immunoglobulin therapy, Mouth haemorrhage
Clinical narrative: Dx Idiopathic Thrombocytopenia Purpura. Platelets fell below 10,000. Had to have IVIG, platelets, prednisone. Petechia, mucosal bleeding in mouth and tongue blisters.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Petechiae, Platelet count decreased, Platelet transfusion, Tongue blistering
Clinical narrative: Dx Idiopathic Thrombocytopenia Purpura. Platelets fell below 10,000. Had to have IVIG, platelets, prednisone. Petechia, mucosal bleeding in mouth and tongue blisters.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Immune thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Dx Idiopathic Thrombocytopenia Purpura. Platelets fell below 10,000. Had to have IVIG, platelets, prednisone. Petechia, mucosal bleeding in mouth and tongue blisters.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Injection site erythema, Injection site pruritus
Clinical narrative: Red itchy area about 1.5 inches long, 1/2 inch wide at site of injection. Not sure when it started- patient reported it to us 2 days after vaccination. No other symptoms. She also told us she was allergic to Band-Aids and a Band-Aid was used. We were not aware of this at the time of vaccination. Not sure if reaction is due to ZOSTAVAX or Band-Aid.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Blood test, Electrocardiogram, Nuclear magnetic resonance imaging, Tinnitus
Clinical narrative: Loud ringing in the ears followed by room spinning very fast, vomiting, no equilibrium. Spent six hours in emergency room and diagnosed with severe vertigo.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Vertigo
Clinical narrative: Loud ringing in the ears followed by room spinning very fast, vomiting, no equilibrium. Spent six hours in emergency room and diagnosed with severe vertigo.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash erythematous, Rash pruritic, Scab
Clinical narrative: On 12-15-16 received ZOSTAVAX vaccine. I wanted to report the Shingles vaccine reaction I suffered. On 12-19- a bump (about 1 cm diameter) appeared in the middle of my chest (between both breasts) Although itched a lot, it hurt when touched. On 12-20 another bump showed up on the right side of my body (at the level of the bra elastic).  A day later, a smaller rash below the breast (on right side).  A few days later another big bump in the in the middle of my back.  All of the bumps or rashes itched but when touched hurt.  An irradiating pain showed up (around 12-19) on the same side as the bumps (right side of my body).  At some point the bumps turned bright red, and on 12-30-15 they were getting older and colored a darker red and appeared crusty -as if finally healing but these  still hurt at touch and continued to itc).  The one in the back turning bright red but did not evolve as the other bumps did (was not crusty).  Occasionally rashes appeared on my leg and other parts of my body but generally only on my right side (the shot was administered  on the left side).  By today 01-15-17, the pain is gone but I still have occasional rashes showing up randomly.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: On 12-15-16 received ZOSTAVAX vaccine. I wanted to report the Shingles vaccine reaction I suffered. On 12-19- a bump (about 1 cm diameter) appeared in the middle of my chest (between both breasts) Although itched a lot, it hurt when touched. On 12-20 another bump showed up on the right side of my body (at the level of the bra elastic).  A day later, a smaller rash below the breast (on right side).  A few days later another big bump in the in the middle of my back.  All of the bumps or rashes itched but when touched hurt.  An irradiating pain showed up (around 12-19) on the same side as the bumps (right side of my body).  At some point the bumps turned bright red, and on 12-30-15 they were getting older and colored a darker red and appeared crusty -as if finally healing but these  still hurt at touch and continued to itc).  The one in the back turning bright red but did not evolve as the other bumps did (was not crusty).  Occasionally rashes appeared on my leg and other parts of my body but generally only on my right side (the shot was administered  on the left side).  By today 01-15-17, the pain is gone but I still have occasional rashes showing up randomly.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt stated that she started getting red, pain, and swelling in the arm of the IMZ. She stated that it went from the site of injection (upper arm), down about 3/4 of the way to the elbow.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Abnormal sensation in eye, Facial paralysis, Mastication disorder, Paraesthesia, Paraesthesia oral
Clinical narrative: Eye felt dry, tingling in tongue and face, could not chew, could not move left part of face.
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, X-ray
Clinical narrative: Arm continued to hurt, thought it was just from injection but as days passed pain went up to my shoulder and within a week I couldn't raise my arm without causing severe pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Sight of injection was red, hot and itchy.  Continued to spread down the arm toward elbow.
Age: 0.17
Sex: M
Vaccine: DTAP, FLU3, HIBV, IPV, RV1
Symptoms: Autism, Disturbance in social behaviour, Eating disorder, Frustration tolerance decreased, Speech disorder developmental
Clinical narrative: LACKING SOCIAL INTERACTION, DELAYED SPEECH, PICKY EATER, FRUSTRATION.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Tremor
Clinical narrative: Pt stated that a few hours after vaccination he started to shake and BP skyrocketed. Went to ER, was kept overnight for observation.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling and itching.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient's arm turned red from injections site to elbow. Felt warm. Patient is icing it and said it is better.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Erythema, Injection site bruising, Skin warm, Tremor
Clinical narrative: Red, warm area about 4 in below injection site. Bruising at inj. site. Slight shakiness, weakness overall fully recovered by 10/7/2016.
Age: 51.0
Sex: F
Vaccine: DTAP, FLU3, PNC13, VARZOS
Symptoms: Dizziness, Limb mass, Pain, Rash
Clinical narrative: Case number PHHY2015US166729, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596093) website on 14 Dec 2015. This report refers to a 51-year-old female patient. Medical history was not reported. Past medication included BENADRYL and it was not helping. Concomitant medication was not reported. The patient was vaccinated with of FLUVIRIN (batch number: 157022), into left arm, INFANRIX (batch number: D93LR) into right arm, PREVNAR 13 (batch number: J67648) into left arm intramuscularly and ZOSTAVAX (batch number: L012477) into left arm subcutaneously on 15 Sep 2015. On 17 Sep 2015 the patient developed softball sized rash and lump on patient's arm below the injection site that spread to her forearm. She states that it is painful and she started to get dizzy. The outcome of the events were unknown and seriousness was reported as non-serious and causality was not reported. Following an internal review for the data received on 14 Dec 2015, significant case correction was performed: Coding of the events changed vaccination site rash, vaccination site pain and Vaccination site mass.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Mobility decreased, Pyrexia, Swelling, Vomiting
Clinical narrative: Case number PHHY2015US166723, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596142) website on 14 Dec 2015. This report refers to a 40-year-old male patient. Medical history was not reported. Concomitant medication included, JANUVIA, metformin (manufacturer unknown), LANTUS, trazodone (manufacturer unknown), citalopram (manufacturer unknown), lisinopril (manufacturer unknown), ZETIA, ibuprofen (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: 15734P) into left arm and PNEUMOVAX (batch number: L022262) into right arm intramuscularly on 16 Sept 2015. On 18 Sep 2015 the patient experienced showed redness, swelling, inability to move arm, fever, vomiting. The patient visited to emergency room. The outcome of the events was unknown and seriousness was reported as non serious and causality was not reported.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Injection site swelling
Clinical narrative: Case number PHHY2015US167751, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596231) 14 Dec 2015. This report refers to a 57-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with fourth dose of FLUVIRIN (batch number 1514801) into left arm intramuscularly on 19 Sep 2015. On the same day after vaccination the patient experienced swelling at injection site about the size of a quarter, there was no itching and discomfort was reported. The patient blood pressure was 135/84. The outcome of the events was unknown and seriousness was reported as non serious and causality was not reported.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Case number PHHY2015US167080, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 596539) website on 14 Dec 2015. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 157604, expiry: not reported) and PNEUMOVAX (other manufacturer) (batch number: K007262, expiry: not reported); both intramuscularly into the left arm on 20 Sep 2015. On 21 Sep 2015, the patient experienced swelling between shoulder and neck describing it as a big ball. He agreed to seek medical attention. The outcome of the event swelling was unknown. The seriousness and causality of the event were not reported.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2015US167152, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 596555) website on 14 Dec 2015. This report refers to a 53 year old female patient. Past history of the patient included hepatitis C and codeine allergy. Concomitant medications included omeprazole (manufacturer unknown), sucralfate (manufacturer unknown), PHENARGAN, phentermine (manufacturer unknown), Hydroxyzine (manufacturer unknown) and ammonium lactate (manufacturer unknown) 12% lotion. She was vaccinated with FLUVIRIN (batch number: 15755P), PNEUMOVAX (other manufacturer) (batch number: K021881) both into the right arm and ADACEL (other manufacturer, batch number: C4774AA); into the left arm intramuscularly on 14 Sep 2015. On 15 Sep 2015, her right arm became swollen and hurt, and she went to the emergency room. She was given BENADRYL there and then discharged. The outcome of the events was reported as complete recovery on an unknown date. These events were assessed as non serious. The causality of the events was not reported.
Age: 72.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Case number PHHY2015US166255, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 596600) website on 14 Dec 2015. This report refers to a 72-year-old female patient. Current conditions included Type 2 diabetes and slight latex allergy. Concomitant medications included simvastatin, lisinopril, vitamins, minerals, herbal supplements and metformin. The patient was vaccinated with FLUVIRIN (batch number: 66521-0118-02) intramuscularly into the left arm along with BOOSTRIX (batch number: 58160-0842-52) intramuscularly into the left arm on 19 Sep 2015. On 20 Sep 2015, the patient experienced extreme muscle weakness in arm and high level of pain radiating down the arm. The events prompted the patient to visit emergency room. Final outcome of the events was not recovered. Events were reported as non-serious. Causality was not reported.
Age: 57.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Case number PHHY2015US167076, is an initial spontaneous report received from a physician and from a nurse via sales representative via Vaccine Adverse Event Reporting System (VAERS reference number: 596985) website on 14 Dec 2015. This report refers to a 57-year-old female patient. Past medical history was not reported. Current condition included chronic obstructive pulmonary disease. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1411401, expiry date: 05 Jan 2015) into left deltoid and PREVNAR 13 (batch number: J49849 and expiry date: 02 Jan 2016) into right deltoid, both on 05 Dec 2014. On 06 Dec 2014 after vaccination, the patient experienced swelling, redness and pain. The outcome of the event was reported as complete recovery. Seriousness of the event was reported as non serious and causality not reported.
Age: 35.0
Sex: U
Vaccine: FLU3
Symptoms: Muscle spasms, Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2015US173015 is an initial spontaneous report received via Adverse Events Reporting System (VAERS reference number: 597065) on 14 Dec 2015. This report refers to a 35 year old patient whose identifies were not reported. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1575101) intramuscularly on an unknown date. Approximately 1 hour after the flu vaccination, the patient reported severe cramping and stabbing pain from shoulder to finger tips. The events outcome was reported as unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: Case number, PHHY2015US167125 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 597187) website on 14 Dec 2015. This report refers to an 11 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157605, needle lot: 3198468, expiry: Jul 2018) intramuscularly in the left arm) on 18 Sep 2015. It was reported that, the syringe plunger did not depress, so pulled the shot back and bit and it still did not depress. The syringe was discarded and gave another one from the same lot and it worked just fine. Seriousness of the event was reported as non serious. Outcome and causality of the event was not reported. Non significant follow up information received from Quality Assurance (QA) department on 05 Feb 2016: QA reference number (1011844) was added in the case.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal distension, Rash
Clinical narrative: Case number PHHY2015US166449, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 597405) website on 14 Dec 2015. This report refers to a 43-year-old female patient. Historical conditions included heart disease, lung disease and anemia. Concomitant medication included: potassium chloride (manufacturer unknown), lorazepam (manufacturer unknown), Oxycodone/Acetaminophen, VENTOLIN, prochlorperazine (manufacturer unknown), gabapentin (manufacturer unknown), cetirizine (manufacturer unknown), furosemide (manufacturer unknown), ibuprofen (manufacturer unknown), butalbital and acetaminophen (manufacturer unknown). PREMARIN, Lisinopril/Hidroclorotiazide, ADVAIR DISKUS, nortriptyline (manufacturer unknown), cephalexin (manufacturer unknown), CARTIA XT. Current condition included asthma. The patient was vaccinated with FLUVIRIN (batch number: 15753P) and PNEUMOVAX (batch number: L024129) in left arm and right arm intramuscularly respectively on 24 Sep 2015. On the same day of vaccination the patient complained of a swollen arm in arm injection was given, and a rash in that arm. The patient was instructed to apply a cold compress and took BENADRYL for allergy. The outcome of the events was reported as unknown and seriousness was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Injection site vesicles, Myalgia
Clinical narrative: Case number PHHY2015US167172 is an initial spontaneous report received via Vaccine Adverse Events Reporting (VAERS reference number: 597636) on 14 Dec 2015. This report refers to a 27 year old female patient. She had no medical history or current conditions. Her concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 15754P) intramuscularly in the left arm on 24 Sep 2015. On the same day after vaccination, she had circular reaction around the injection site which was further described as blisters in a circular formation. There was no redness and the reaction looked similar to ring worm. She had no fever, but had muscle soreness. She went to emergency room. Muscle soreness resolved on 25 Sep 2015. The outcome of the blister around injection site was unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Hypoaesthesia
Clinical narrative: Case number PHHY2015US167992, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 597653) 14 Dec 2015. This report refers to an 18-year-old pregnant female patient. Medical history was not reported. Past vaccination history included Influenza vaccine. Concomitant medication Prenatal. The patient was vaccinated with dose of FLUVIRIN (batch number: 15753P) into left arm intramuscularly on 28 Sep 2015. On the same day after vaccination the patient experienced numbness in left upper arm. The patient was 5 months pregnant (exposure during pregnancy). The outcome of the event vaccination site hypoaesthesia was complete recovery. Seriousness was reported as non-serious and causality was not reported. This case was lot to follow up at initial. Significant case correction was performed for the MRD 14 Dec 2015. Updated lost to follow up information in patient tab.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Case number PHHY2015US167105, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 597705) website on 14 Dec 2015. This report refers to a 59-year-old female patient. Current illness were none. Concomitant medication was not reported. The patient received FLUVIRIN (batch number: 1514501) intramuscularly on 26 Sep 2015. On the same day after vaccination the patient experienced injection site swelling and bleeding. Ice was applied and swelling started to go down. The patient was checked later in afternoon and the patient was doing fine and also the bleeding stopped. Final outcome of the events was recovered. Events were reported as non-serious. Causality was not reported.
Age: 52.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site warmth, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2015US168476, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 598524) website on 14 Dec 2015. This report refers to a 52 years old female patient. Historical condition included auto accident in Feb 2015 and recovering. Concomitant medication was not reported. The patient vaccinated with FLUVIRIN (batch number: 157901) intramuscular into right arm along with ZOSTAVAX (other manufacture, batch number: L021610) subcutaneously on 26 Sep 2015. On 27 Sep 2015, the patient developed redness around injection site, heat around injection area, swelling in entire arm, pain and numbness and tingling in entire arm. The outcome of the events was unknown. The seriousness was reported as non serious and causality of the events was not reported.