chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Dehydration, Rotavirus infection, Rotavirus test positive
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 16 month old male patient. Information regarding concomitant medications and drug reactions or allergies was not reported. On 21-AUG-2013 the patient was orally vaccinated with a first dose of ROTATEQ (oral solution, lot#: J004394, expiration date: 10-SEP-2014). On 23-OCT-2013 the patient was orally vaccinated with a second dose of ROTATEQ (oral solution, lot #: J00050 which is an invalid lot number for ROTATEQ). On 12-DEC-2013 the patient was orally vaccinated with a third dose of ROTATEQ (oral solution, lot#: J006197, expiration date not assigned and not reported). Concomitant medications were not reported. The physician reported to the company representative that "a patient experienced rotavirus after completing the ROTATEQ vaccination regimen". On 22-OCT-2014 the patient was admitted to Medical Center for 24-hour period (till approximately October 2014) with severe dehydration, where he tested positive for rotavirus ("stool specimen" testing). Two days prior to the hospitalization (in approximately 20-OCT-2014) the patient had been taken to the ER with dehydration but was sent home. There was treatment given with unspecified intravenous (IV) fluids for the events of rotavirus and dehydration. The outcome of rotavirus and dehydration was reported as recovered/resolved in approximately 2014, exact dates not reported. The outcome of rotavirus test positive was unknown. The relatedness between the therapy with ROTATEQ and the events was not reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Gait disturbance, Musculoskeletal stiffness, Myalgia
Clinical narrative: This spontaneous report as received from a patient (about herself) refers to a 72 year old female patient. The patient's concurrent condition included arthritis, high cholesterol, osteoporosis. On 01-AUG-2014 (reported as first Friday in August 2014), the patient was vaccinated with ZOSTAVAX. Concomitant therapies included simvastatin (manufacturer unknown). Patient reported a bad reaction to ZOSTAVAX shot. On 04-AUG-2014 (reported as Monday), she could hardly walk (considered as disability), stiff all over with pain everywhere in her body. Patient reported muscle and joint pain for the past three (3) months. Patient reported having constant pain especially in her back and right leg. The patient now has a walking problem, and has been using a leg brace or a cane (considered as disability). The patient was treated with Ibuprofen (800 mg). No lab diagnostic tests were performed. The outcome of the events was reported as not recovered/not resolved. The patient sought medical attention, and visited the physician. Causality was not reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Orthosis user, Pain, Pain in extremity, Walking aid user
Clinical narrative: This spontaneous report as received from a patient (about herself) refers to a 72 year old female patient. The patient's concurrent condition included arthritis, high cholesterol, osteoporosis. On 01-AUG-2014 (reported as first Friday in August 2014), the patient was vaccinated with ZOSTAVAX. Concomitant therapies included simvastatin (manufacturer unknown). Patient reported a bad reaction to ZOSTAVAX shot. On 04-AUG-2014 (reported as Monday), she could hardly walk (considered as disability), stiff all over with pain everywhere in her body. Patient reported muscle and joint pain for the past three (3) months. Patient reported having constant pain especially in her back and right leg. The patient now has a walking problem, and has been using a leg brace or a cane (considered as disability). The patient was treated with Ibuprofen (800 mg). No lab diagnostic tests were performed. The outcome of the events was reported as not recovered/not resolved. The patient sought medical attention, and visited the physician. Causality was not reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain
Clinical narrative: This spontaneous report as received from a female consumer of unknown age reporting on herself. On an unknown date, the patient started therapy with DULERA (dose and indication not reported). Other suspect therapies included ZOSTAVAX received in November 2014, "the early part of last week". The patient reported that approximately on 08-NOV-2014, "past weekend", she experienced chest pain and went to the hospital (duration unknown). At the time of the report, the action taken with DULERA and the patient's outcome were unknown. Additional information is not expected. There is no contact information.
Age: 0.12
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Screaming
Clinical narrative: Screamed non-stop for 3.5 hours.
Age: 6.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Joint swelling, Local swelling, Urticaria
Clinical narrative: Hives in multiple spots on body including in the nose where administered, swelling of joints, swelling of hands and feet, itchy. Patient is currently taking OTC Benadryl, Pepsid AC, and a perscription liquid oral steroid course for four days.
Age: 6.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Erythema, Local swelling, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Hives in multiple spots on body including in the nose where administered, swelling of joints, swelling of hands and feet, itchy. Patient is currently taking OTC Benadryl, Pepsid AC, and a perscription liquid oral steroid course for four days.
Age: 6.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Urticaria
Clinical narrative: Hives in multiple spots on body including in the nose where administered, swelling of joints, swelling of hands and feet, itchy. Patient is currently taking OTC Benadryl, Pepsid AC, and a perscription liquid oral steroid course for four days.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Itchy hives all over body (face, neck, torso, arms, hands, legs) after recieving Hepatitis A shot. Steroids (prednisone) and Benadryl given. Hives bumps shrunk after 12 hours. Bright, pink/red spots continued for at least three days.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Feeling cold, Feeling hot, Flushing
Clinical narrative: Initially chilled, then flushed with heat, shaky, dizzy, weak, nausea.  All hit very suddenly. Went to lie down. Had friend drive me home. Fullness in throat with continued symptoms but less severe. Home and to bed. NyQuil. Much better today, still a bit weak at 8:30 AM.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Nervousness, Pharyngeal oedema
Clinical narrative: Initially chilled, then flushed with heat, shaky, dizzy, weak, nausea.  All hit very suddenly. Went to lie down. Had friend drive me home. Fullness in throat with continued symptoms but less severe. Home and to bed. NyQuil. Much better today, still a bit weak at 8:30 AM.
Age: 1.6
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling redness radiating 2 inches from injection site. Treating with ibuprofen for pain/swelling as per doctor's instructions.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Dizziness, Musculoskeletal stiffness, Pruritus generalised
Clinical narrative: Started itching and my head felt woozy and swimmy.  I felt like I couldn't put words together.  I also started to itch all over my face, head and body.  My neck started to get stiff.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Local swelling, Pruritus, Skin lesion, Tenderness
Clinical narrative: Left arm with large red raised lesion measuring approximately 11 cm x 12 cm. Tender, itchy. Has tried Benadryl cream with relief, Tylenol for tenderness.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age with unspecified cancer "on the left side of patient's body". On 21-OCT-2014 the patient was vaccinated with PNEUMOVAX23 (dose, route and lot # was not reported) and influenza virus vaccine (manufacturer unknown) in the right arm. Concomitant therapies included Anastrozole. On 31-OCT-2014, the patient experienced a high fever and injection site reaction (redness, swelling) and went to unspecified Emergency Room. The outcome of injection site reaction (redness, swelling) and a high fever was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Myalgia, Pharyngeal oedema, Pyrexia
Clinical narrative: Bronchitis; Swelling of esophagus; fever, muscle aches.
Sex: U
Vaccine: PNC13
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician who reported for a patient through a Pfizer Sales Representative. This is third of the 4 reports from same reporter. A patient of unknown age and gender received PREVNAR 13 single dose on unknown date. The patient experienced cellulitis at injection site and fever.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Possible inaccurate injection site: pt states given too high in arm/shoulder in deltoid - complaint of lack of range of motion and shoulder pain.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Received flu vaccine 10-27-14. Awoke with pruritic rash 10-28-14. Concentrated in (L) axillae, antecubital fossa and under breast. Treated with topical antifungal and steroid without relief. Then antibiotics and oral steroid.
Sex: U
Vaccine: PNC13
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician who reported for a patient through a Pfizer Sales Representative. This is second of the 4 reports from same reporter. A patient of unknown age and gender received PREVNAR 13 single dose on unknown date. The patient experienced cellulitis at injection site and fever.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red swollen, painful area to upper right arm. Notice on 11/13/14. 6x4cm area overlying HPV injection site.
Sex: U
Vaccine: PNC13
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician who reported for a patient through a Pfizer Sales Representative. This is fourth of the 4 reports from same reporter. A patient of unknown age and gender received PREVNAR 13 single dose on unknown date. The patient experienced cellulitis at injection site and fever.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Local swelling, Muscular weakness, Myalgia
Clinical narrative: Patient given influenza Fluzone High Dose vaccine at 11:30 on 11-13-14. She reports that around 2:00 AM on 11-14-14 she awoke with swelling in hands, joint pain, muscle pain and muscle weakness, chills and fever.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient given influenza Fluzone High Dose vaccine at 11:30 on 11-13-14. She reports that around 2:00 AM on 11-14-14 she awoke with swelling in hands, joint pain, muscle pain and muscle weakness, chills and fever.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Eye pain, Headache
Clinical narrative: Headache, left side, behind left eye to back of the head on my left. Alternating between entire rear of head and aforementioned locations with little relief from OTC products. Norco seems to help.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site pain, Pyrexia, Vaccination site induration
Clinical narrative: Had a couple days of pain at injection site and developed fever to 102 last night and this morning had large, painful, indurated area at site of vaccines.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass
Clinical narrative: Round red lump around 2 inches in diameter. No other problems.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Laboratory test, Paraesthesia, Tremor
Clinical narrative: Onset of tremor right hand and arm for 20 minutes.  Recurrent until present in right arm, then developed tremor in left arm/hand and left leg.  No nausea, dizziness, headache.  No weakness, numbness. Did have some 'tingling' in right arm/hand.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Dyskinesia, Insomnia, Myoclonus
Clinical narrative: Patient had difficulty going to sleep due to "jerking" movements that persisted for several hours, even during brief periods of sleep. Evaluated in two separate ERs - first on night of symptom onset, then on second night - diagnosed with myoclonic jerks. Symptoms continue to occur nightly and during naps. Evaluated by pediatrician 14 Nov and diagnosed with sleep myoclonus.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Dizziness, Dry mouth, Malaise
Clinical narrative: Chills, nausea, dizzy. I felt ill for two full days. Loss of appetite, nausea, chills, dry mouth.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Chills, nausea, dizzy. I felt ill for two full days. Loss of appetite, nausea, chills, dry mouth.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Site became red, swollen, and tender. Redness area became larger over the following days and site became hardened and red.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Persistent pain in upper left arm since injection.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV4, MNQ
Symptoms: Eye movement disorder, Musculoskeletal stiffness, Syncope, Unresponsive to stimuli
Clinical narrative: Received HPV #2, Flu shot, MCV, fainted 2mins after administration, became stiff, eyed rolled back, didn't respond to verbal questions. She was assisted to the floor, became responsive after two mins, stated she felt she was out for an hour.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Influenza like illness, Injection site pain, Injection site reaction
Clinical narrative: On 11/12/2014 I had extreme pain and swelling around injection site. The next day the pain was from my neck and shoulder all the way down to my elbow and the injection site had little red bumps surrounding the area. I had extreme fatigue and flu like symptoms including nausea, dizziness and fever which got up to 102.4 for 2 day following.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Nausea, Neck pain, Pyrexia, Rash erythematous
Clinical narrative: On 11/12/2014 I had extreme pain and swelling around injection site. The next day the pain was from my neck and shoulder all the way down to my elbow and the injection site had little red bumps surrounding the area. I had extreme fatigue and flu like symptoms including nausea, dizziness and fever which got up to 102.4 for 2 day following.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: Pt states she had extreme dizziness and nausea upon awakening. She has not lost consciousness.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Intense and prolonged pain at injection site, with resulting limited range of motion of left upper limb for almost 2 weeks.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Asthenia, Extraocular muscle paresis, Nuclear magnetic resonance imaging brain abnormal, Scan with contrast abnormal, VIIth nerve paralysis
Clinical narrative: Right sided mouth weakness and left eyelid weakness consistent with bilateral Bell's palsy.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Flushing, Headache, Immune system disorder, Nausea
Clinical narrative: 45 minutes after immunization Pt experienced headache, chills, nausea,. Pt woke up at 2:30 AM with total body shaking/tremors, aches, pain, continued headache, flushing. Pt fell back asleep and woke up at 6:30 AM with worsened symptoms. Went to urgent care and received Ondansetron and Ketorolac. All vitals were good! Per patient, MD thought it was an immunological response to the Fluzone HD.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Tremor
Clinical narrative: 45 minutes after immunization Pt experienced headache, chills, nausea,. Pt woke up at 2:30 AM with total body shaking/tremors, aches, pain, continued headache, flushing. Pt fell back asleep and woke up at 6:30 AM with worsened symptoms. Went to urgent care and received Ondansetron and Ketorolac. All vitals were good! Per patient, MD thought it was an immunological response to the Fluzone HD.
Age: 49.0
Sex: F
Vaccine: FLUR3
Symptoms: Excoriation, Fatigue, Local swelling, Ocular hyperaemia, Rash
Clinical narrative: Patient developed fatigue - generalized - 4 days after getting FLUBLOK, accompanied by itchy rash involving ears, neck, breast, neck swelling, red eyes and lower limb fatigue. She consulted PCP via phone and was managed with ammonium lactate 12% cream with symptom resolution. She was seen in OHS 12/20/13 with resolving papular rash and excoriation on right ear only.
Age: 49.0
Sex: F
Vaccine: FLUR3
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Patient developed fatigue - generalized - 4 days after getting FLUBLOK, accompanied by itchy rash involving ears, neck, breast, neck swelling, red eyes and lower limb fatigue. She consulted PCP via phone and was managed with ammonium lactate 12% cream with symptom resolution. She was seen in OHS 12/20/13 with resolving papular rash and excoriation on right ear only.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: 20 minutes after receiving flu vaccine patient reported rash to face.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Local swelling, Malaise, Pain in extremity
Clinical narrative: Swelling from elbow to top of arm. Area red, hard and painful. Felt ill!. 11/14/14 red but pt feels better.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from pharmacy student concerning a 60 year old female patient with allergy to clarithromycin (BIAXIN). On 01-NOV-2014 the patient was vaccinated with PNEUMOVAX23 (lot # J015868, expiration date 25-FEB-2015) 0.5 ml, intramuscular in the arm. Concomitant therapies included diclofenac, influenza vaccine (manufacturer unknown) administered on the same date of PNEUMOVAX23 in the opposite arm, allopurinol, metoprolol, AMBIEN and levothyroxine sodium (manufacturer unknown). On 02-NOV-2014, 2 days after onset of therapy the patient developed "big" bump that was about the size of a tennis ball at the injection site. She stated that the bump was red and itchy. She did not report any symptoms in the arm that the influenza virus vaccine was administered. No treatment was given. The patient sought medical attention called into the pharmacy on 04-NOV-2014. There were no laboratories diagnostic test performed. The outcome of red and itchy big bump at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: DTAP, FLU3, MMR, VARCEL
Symptoms: Injection site induration, Injection site pain
Clinical narrative: 7 x 7 cm area at induration, pain to right anterior thigh at varicella vaccine administration site - improving.
Age: 63.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Back pain, Injection site pain, Muscle spasms, Neck pain, Pain in extremity
Clinical narrative: Received flu vaccine in right deltoid on 10/24/14 at 10 AM. At 2 PM developed pain in right arm, up arm to neck, lower back and up left side of back, used hydrocodone for pain. Warm Epsom salt baths did not help. Pain and muscle spasm lasted until 11/12/14. Pain lasted until 10/28/14.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration
Clinical narrative: Immunizations given 6 mos too early for MMR and Varicella. KINRIX not indicated for under 4 yrs of age.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Altered state of consciousness, Dizziness, Dry eye, Feeling hot, Nausea
Clinical narrative: Pt was given shot he turned back on spinal cord stimulator walked up hallway. Felt like passing out, when white, nose sneezing, running, nausea, light head, very hot, eyes very dry. Lasted about 15 minutes.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Pallor, Rhinorrhoea, Sneezing
Clinical narrative: Pt was given shot he turned back on spinal cord stimulator walked up hallway. Felt like passing out, when white, nose sneezing, running, nausea, light head, very hot, eyes very dry. Lasted about 15 minutes.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Insomnia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain in left shoulder.  Pain has continued to worsen over the past two weeks.  Entire arm aches by the end of the day and I am having difficulty sleeping and performing many tasks needing use of my left arm.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Employee states he had severe pain at injection site in left deltoid and pain with raising his arm shortly after Flu shot administered.  He did not report s/s for 2 weeks at which time s/s improved but remained painful.  At 4 weeks Ee still complains of pain in deltoid and pain with raising arm.  No swelling, redness, hematoma seen or palpated.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, swelling and significant pain at injection site.
Age: 43.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Migraine, Paraesthesia, Rash
Clinical narrative: Rash, tingling throat this started about 30 to 45 mins later and 24 hrs later had a migraines.
Age: 0.88
Sex: F
Vaccine: FLU3, HEP
Symptoms: Cerebrovascular accident, Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: Seizure and stroke like activity.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, tenderness over Left upper arm of injection site with systemic chills, rigors, nausea, vomiting and weakness worse over 48 hrs.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Vomiting
Clinical narrative: Swelling, redness, tenderness over Left upper arm of injection site with systemic chills, rigors, nausea, vomiting and weakness worse over 48 hrs.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt. received vaccination in L deltoid. Never received flu vaccine before. Believed that immunization only made it to adipose tissue and not to muscle due to concentrated adipose tissue in upper arm. Pt. experience tingling and numbing in L arm due to reaction from adipose tissue.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Severe shoulder pain in area where flu shot was administered, limited range of motion, trouble sleeping (due to pain).  Attempted to treat with periodic ibruprofen until visit to primary care doctor one week later, followed by 2-week course of prescription NSAID.  Pain continues 6 weeks after vaccine administration.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Dizzy, blurred vision, throat swelling, fever, chills, aches.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Dizzy, blurred vision, throat swelling, fever, chills, aches.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Drug administered at inappropriate site, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Immediate sever pain in left shoulder/armpit region after receiving flu shot. (injection was given very high on my arm, about 1 inch toward my back from the top of my shoulder). Painful range of motion in shoulder. As of 11/13/14, pain has not subsided, there is still painful range of motion. Went to doctor on 11/12/14, and he prescribed a steroid and physical therapy type exercises/stretches to perform daily until healed. Instructed to not exercise using my left shoulder until healed.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Feeling hot, Headache, Middle insomnia
Clinical narrative: Started with headache, began shivering and put on multiple jackets. Had to go home and rest, woke up multiple times during the night.  Felt hot but didn't have a thermometer.  Took Advil and Tylenol.  Felt better today but returned to clinic and saw Nurse Practitioner.  Afebrile. Advised to rest, hydrate, use Advil if necessary.  Felt better today, 11/14.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Discomfort, Heart rate increased, Lethargy, Pain, Pyrexia
Clinical narrative: Uncomfortable progressed to febrile (103F) with extreme pain, lethargy/unresponsive and rapid HR.  Seen in ER on 11/8/2014.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Uncomfortable progressed to febrile (103F) with extreme pain, lethargy/unresponsive and rapid HR.  Seen in ER on 11/8/2014.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Local swelling
Clinical narrative: Left armpit/axillae swelling. No redness or warmth. Treatment: symptomatic.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram, Full blood count
Clinical narrative: Chest tightness, shortness of breath.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Lethargy, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, lethargy, sore throat.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling whole arm to hands and fingers.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Malaise, Musculoskeletal stiffness, Pain
Clinical narrative: Malaise, fatigue followed by neck and shoulder stiffness and pain the next 2 days requiring BR, NSAIDA and moist heat. Contacted Employee health, directed to see PCP, saw chiropractor with some relief -continue with current regime.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Dizziness, Feeling cold, Flushing
Clinical narrative: Patient was given vaccine with several people (8+) watching the administration. Patient had received vaccine in past without issue. Shortly after administration, patient left and returned complaining of lightheadedness, some chest tightness, and flushing. Patient was able to speak and swallow and was not in respiratory distress. Patient was given oral diphenhydramine 50 mg and closely monitored. After 5-10 minutes, patient reported feeling cold but better. Over 35-40 minutes, patient reported feeling better and was no longer flushed. She and S/O left. Later that evening, patient had chills, fevers, and vomiting. She was in hospital for 2 days. Patient feels much better.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient was given vaccine with several people (8+) watching the administration. Patient had received vaccine in past without issue. Shortly after administration, patient left and returned complaining of lightheadedness, some chest tightness, and flushing. Patient was able to speak and swallow and was not in respiratory distress. Patient was given oral diphenhydramine 50 mg and closely monitored. After 5-10 minutes, patient reported feeling cold but better. Over 35-40 minutes, patient reported feeling better and was no longer flushed. She and S/O left. Later that evening, patient had chills, fevers, and vomiting. She was in hospital for 2 days. Patient feels much better.
Age: 47.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Dizziness, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: Employee described severe diaphoresis, dizziness, shortness of breath, nausea and vomiting, chills and rigors.
Age: 47.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Employee described severe diaphoresis, dizziness, shortness of breath, nausea and vomiting, chills and rigors.
Age: 47.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Dyspnoea, Hyperhidrosis, Nausea, Vertigo
Clinical narrative: Employee described severe diaphoresis, dizziness, shortness of breath, nausea and vomiting, chills and rigors.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Cellulitis, Chills, Erythema, Feeling cold, Full blood count normal
Clinical narrative: The patient was seen 10/12/14 in Emergency Room with a swollen red painful left upper arm. He had a pneumonia shot and a tetanus shot in that arm on 10/10/14. That evening he began having shaking chills and malaise. His wife said that 10/11/14, he sat under a blanket all day because he was so cold. He had no fever. There is an area of cellulitis extending from 4 cm below the injection site under the arm and up to the top of the shoulder. The area is red and warm and tender. CBC was normal, Rocephin administered, also instructed to continue with Bactrim (taking for R hand infection-unrelated). Follow-up exam with PCP the 10/13/14 - no change in treatment.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Infection, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The patient was seen 10/12/14 in Emergency Room with a swollen red painful left upper arm. He had a pneumonia shot and a tetanus shot in that arm on 10/10/14. That evening he began having shaking chills and malaise. His wife said that 10/11/14, he sat under a blanket all day because he was so cold. He had no fever. There is an area of cellulitis extending from 4 cm below the injection site under the arm and up to the top of the shoulder. The area is red and warm and tender. CBC was normal, Rocephin administered, also instructed to continue with Bactrim (taking for R hand infection-unrelated). Follow-up exam with PCP the 10/13/14 - no change in treatment.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site warmth, Malaise, Skin warm, Tenderness, Tremor
Clinical narrative: The patient was seen 10/12/14 in Emergency Room with a swollen red painful left upper arm. He had a pneumonia shot and a tetanus shot in that arm on 10/10/14. That evening he began having shaking chills and malaise. His wife said that 10/11/14, he sat under a blanket all day because he was so cold. He had no fever. There is an area of cellulitis extending from 4 cm below the injection site under the arm and up to the top of the shoulder. The area is red and warm and tender. CBC was normal, Rocephin administered, also instructed to continue with Bactrim (taking for R hand infection-unrelated). Follow-up exam with PCP the 10/13/14 - no change in treatment.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Pt received flu shot on 11-11-14, noticed hives on Wed, 11-12-14 at approx 4:00pm.  Hive were located on her vaginal area, buttock, trunk of body.  Denies any on limps, neck, or face.
Age: 2.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Golf-ball size Red, hard bump on injection area. Found 11/09/2014 and took to a doctor on 11/12/2014. Doctor perscribed Amoxicillin & Clavulanate Potassium.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Flushing, Pruritus, Rash erythematous
Clinical narrative: Erythematous rash, flushing, warmth, and pruritis of cheeks that continued throughout following day. No exposure to new foods. Grandmother applied cortisone cream to cheeks 11/14/14 afternoon with no effect. Patient was seen in clinic on 11/14/14 evening. Prescribed Benadryl and instructed to call 911 if having signs/symptoms of anaphylaxis.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Pain in extremity, Skin warm
Clinical narrative: Patient had pneumonia vaccine on Wednesday afternoon in clinic, and that evening developed pain in the arm.  She was unable to move it at all without significant pain.  Dull, bore-like pain.  Like a nerve pain in a tooth. She had some Norco left over from a tooth procedure and required that for pain relief. Yesterday she developed redness and warmth of the area.  She has used a "temporal" thermometer on the area and it was reading 99, compared to her normal body temperature of 98. The pain has improved since Wednesday night and she is able to move her arm more without pain.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Eyelid oedema, Oedema mouth, Pharyngeal oedema, Rash
Clinical narrative: Began with swelling in throat, then had swollen/puffy eyes, then rash on chest, then more mouth swelling, then went to ER.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity
Clinical narrative: Allergic reaction at site of Pneumovax23 in left deltoid.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Joint crepitation, Mobility decreased, Pain in extremity
Clinical narrative: Per patient report - pain, difficulty lifting arm, clicking sound when using affected arm. Visited doctor 11/5, who prescribed pain medication and physical therapy.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Sort at the location of the injection and hot to the touch. I have a red welt that is about 3 inches round.  I have not had a reaction to flu shots in the past.
Age: 1.53
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Pyrexia
Clinical narrative: Mild fever in the afternoon.  Up to 102.6 at 7:00pm.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Neuralgia, Pain, Pain in extremity
Clinical narrative: Radiating pain down arm into hand. Throbbing nerve pain. Been going on for 1 1/2 weeks now. Severe pain.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Mobility decreased, Myalgia
Clinical narrative: INCREASING MUSCLE SORENESS, INCREASING PROGRESSIVELY FROM DAY TO DAY, FROM 10/20/2014 TO DATE OF REPORTING AT PHARMACY, UNABLE TO RAISE ARM FULLY ABOVE HEAD.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Retinal exudates, Vision blurred
Clinical narrative: Blurry vision in L eye, beginning one week after vaccination.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Over night started swelling and was really sore then started getting red and hot. The spot over a day started spreading across the shoulders area.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site vesicles
Clinical narrative: Cellulitis of left upper arm; reaction not around injection site; reaction lower than injection site; red with blisters present above and below injection site. Pt on AUGMENTIN and BENADRYL - started 11-14-14.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Chest pain, Cough, Wheezing
Clinical narrative: Pt received FLUMIST 11/13/14 at approx 9 AM on car ride home pt noted chest pain, coughing went to school and noted wheezing by school nurse; pt came back to office, started PROAIR inh for wheezing.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Headache, Inflammation, Pyrexia, Swelling face
Clinical narrative: Inflammation of the arm in which the pneumonia vaccine (left arm) was injected. Fever. Facial swelling, headache, shivering.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal disorder, Pain
Clinical narrative: Patient had pain upon admission of FLUZONE QUAD. A prefilled syringe was used with a 1" needle. Pain and loss of arm function was reported. Patient saw her physician, 8 days after administration. She was diagnosed with SIRVA. She was treated with oral steroids and physical therapy. Pain is slowly getting better but still continues.
Age: 36.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Staphylococcal infection
Clinical narrative: Patient was seen in ER and was reported to have a staph infection in her left arm at vaccination site (PNEUMOVAX 23).
Age: 6.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Antibody test abnormal, Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Pt developed local reaction. Redness, pain, fever at site of injection.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient with no drug reactions/allergies. On 08-NOV-2014 the patient was vaccinated with ZOSTAVAX 19400 PFU, lot # K009772, expiration date 09-OCT-2015, (dose, frequency and route not reported), to prevent shingles. No concomitant medication and pertinent medical history were reported. The pharmacist reported the patient developed a red rash at the injection site after receiving ZOSTAVAX on 08-NOV-2014. The pharmacist mentioned the rash was approximately 2 inches wide by 7 inches long. No treatment was given on the event. The outcome of the events was reported as recovering. The patient had sought medical attention by contacting pharmacist. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient with no drug reactions/allergies. On 08-NOV-2014 the patient was vaccinated with ZOSTAVAX 19400 PFU, lot # K009772, expiration date 09-OCT-2015, (dose, frequency and route not reported), to prevent shingles. No concomitant medication and pertinent medical history were reported. The pharmacist reported the patient developed a red rash at the injection site after receiving ZOSTAVAX on 08-NOV-2014. The pharmacist mentioned the rash was approximately 2 inches wide by 7 inches long. No treatment was given on the event. The outcome of the events was reported as recovering. The patient had sought medical attention by contacting pharmacist. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Staphylococcal infection
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. "About a month and a half ago", on approximately 27-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX (route not reported, dose: 1 injection). Concomitant medications were not provided. The pharmacist reported that the patient mentioned that, "about a month and a half ago", on approximately 27-SEP-2014 she developed a staph infection shortly after being administered the ZOSTAVAX vaccine. The patient was treated by her primary care physician. The patient had sought medical attention from her physician. Outcome of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unspecified age. On an unknown dates the patients were vaccinated with GARDASIL (lot number was not reported), which was improperly stored since 28-OCT-2014. No adverse effects were reported. Follow up information has been received from the nurse on 10-NOV-2014. The nurse reported that an additional excursion has affected the same doses of GARDASIL (lot# J009788, exp 17-MAR-2016) and of ROTATEQ (capture in MARRS # 1411USA003388), and multiple patients have been administered both products. No adverse effects reported. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 4 year old patient of unknown gender. On 08-OCT-2014 the patient was vaccinated with a dose of VARIVAX lot # K003420, exp. date unspecified, dose/frequency: 1 shot, therapy route: injection in the right thigh for vaccine. Patient received "ITV" at the same time. On 09-OCT-2014, the patient developed a varicella-like blister at injection site after receiving VARIVAX. No treatment was given for event. The outcome of the event was unknown. The causal relationship was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old male patient. Patient's concurrent conditions included unspecified heart condition, diabetes and pre-existing left shoulder condition. On 03-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX dose and route not reported, in right deltoid region (lot # K010648, expiration date: 30-OCT-2015). On an unspecified date in November 2014, after receiving ZOSTAVAX, the patient developed local injection site reaction with redness and tenderness. Additionally patient had nausea. On 04-NOV-2014 the patient received unspecified steroid injection in left shoulder to treat pre-existing unspecified shoulder condition. On 04-NOV-2014 the patient experienced episode of vomiting once. The patient did not seek medical attention. No treatment was given for the events. The outcome of nausea, local injection site reaction with redness and tenderness was reported as not recovered/not resolved. Relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old male patient. There was no relevant medical history. The patient's relevant past drug history was unknown. On 15-OCT-2014 the patient was vaccinated with a single dose of ZOSTAVAX lot # K007988, expiration date 03-SEP-2015, 0.65 ml, subcutaneously. Concomitant therapies included alprazolam, buspirone hydrochloride, carvedilol, isosorbide mononitrate, levothyroxine sodium (manufacturer unknown), sertraline hydrochloride and trazodone hydrochloride. (Also reported there was no relevant concomitant medications). On 16-OCT-2014, the patient experienced erythema, tenderness, warmth and swelling in his arm. There was no relevant lab data. The outcome of the events was reported as continued at the time of the report. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. Medical history was not reported. The medical assistant informed that on unknown dates the patients were vaccinated with improperly stored doses of GARDASIL injection (route, dosage and lot numbers were not reported). No symptoms reported. The outcome of the event was unknown. The health care professional contacted during telephone follow-up could not supply the following information: patients' names, dates of birth, dates of vaccination, dose numbers and lot numbers. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 55-65 years old female patient. On 01-NOV-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported, dose: 1 vaccination) intramuscularly for prevention of pneumonia. Concomitant medications were not provided. The pharmacist reported that the patient experienced "more than normal swelling" and an injection site reaction that was "warm to the touch" on 01-NOV-2014 after receiving a vaccination with PNEUMOVAX 23. Outcome of the events was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unkonwn age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# were not reported). On an unknown date the patient experienced rashes. The outcome of rashes was unknown. Causality was not reported. This is one of the reports from the same source. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old male patient. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# were not reported). On an unknown date the patient experienced rashes. The outcome of rashes was unknown. Causality was not reported. This is one of the reports from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Erythema, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: 10/10/14 Mother called stating son complaining of arm sore, red, and swollen, not feeling well and having diarrhea - this am I took ibuprofen and ice pack at school. 11/5/14 all symptoms resolved completely by 2 days after.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (other health professional) refers to a patients of unknown age and gender. On unspecified date in August 2014 the patients were vaccinated with 2 unsupported, improperly stored doses of GARDASIL lot # J010668, exp. date: 29-APR-2016; 0.5 ml, intramuscularly. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (other health professional) refers to a patients of unknown age and gender. On unspecified date in August 2014 the patient was vaccinated with one unsupported, improperly stored dose of GARDASIL lot # K001631, exp. date:06-NOV-2016; 0.5 ml, intramuscularly. No adverse effect was reported. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 1.06
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site cyst
Clinical narrative: 2 cm cystic lesion, mobile at injection site of MMR vaccine. Appeared 24 hours after injection. Treat with BENADRYL and NSAIDS.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 3 unspecified patients of unknown age and gender. Medical histories and current conditions were not reported. On an unknown date, the patients were vaccinated with incorrect storaged doses of ZOSTAVAX (lot number, expiration date and route of administration were not provided). No adverse events were reported. Concomitant medication was not reported. The outcome of patients vaccinated with incorrect storaged doses of ZOSTAVAX was unknown. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: IPV
Symptoms: Injection site induration, Injection site swelling, Injection site urticaria
Clinical narrative: I injected IPV sub q on (L) vast lateralis when I pulled needle out I noticed pt started developing a welt on her inj site, was hard and swollen.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 19 years old male patient. Medical history, current conditions and concomitant medication were not reported. On 19-SEP-2014, the patient was vaccinated with a pediatric dose of VAQTA (25/0.5) vial. (Lot number: K000707, expiration date was not reported) in error. The patient was indicated to receive an adult dose. The reporter does not have any record of this patient ever receiving a previous dose of hepatitis A vaccine. No adverse experience had been reported. The outcome of a patient received a pediatric dose of VAQTA in error was unknown. Additional information has been requested.