chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, Muscular weakness, Pain in extremity, Vaccination site injury
Clinical narrative: I was seated and nurse was standing.  Nurse had me role up shirt sleeve much higher than I've ever done for a shot (which I thought was odd but I count on them knowing what they are doing is correct).  I had initial soreness at injection site but an hour, or so, has not been uncommon with an injections in the past.  However, the soreness persisted and has led to arm strength weekness and pain pings.   On Sunday 11/01/2015, arm weakness and pain were so bad I called facility 24hr advice nurse to get recommendation on what to do and get a doctor appointment to have it looked at and discussed.  She suggested heat and to also try alternating with ice compress.  Doctor on 11/02 gave a stronger NSAID and suggested using rotator cuff exercises on printout.  He gave a referral for shoulder x-rays and said contact him in 2 weeks (i.e., at one month from onset) if pain continued for likely referral to ortho.  On my way out of facility, I stopped and talked with one of the two nurses handling flu vaccine intake and related my SIRVA to her and she was able to identify the nurse, who was actually there that day, and said she would convey the injury information (e.g., high shoulder stick results) to the vaccination nursing staff.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray limb
Clinical narrative: I was seated and nurse was standing.  Nurse had me role up shirt sleeve much higher than I've ever done for a shot (which I thought was odd but I count on them knowing what they are doing is correct).  I had initial soreness at injection site but an hour, or so, has not been uncommon with an injections in the past.  However, the soreness persisted and has led to arm strength weekness and pain pings.   On Sunday 11/01/2015, arm weakness and pain were so bad I called facility 24hr advice nurse to get recommendation on what to do and get a doctor appointment to have it looked at and discussed.  She suggested heat and to also try alternating with ice compress.  Doctor on 11/02 gave a stronger NSAID and suggested using rotator cuff exercises on printout.  He gave a referral for shoulder x-rays and said contact him in 2 weeks (i.e., at one month from onset) if pain continued for likely referral to ortho.  On my way out of facility, I stopped and talked with one of the two nurses handling flu vaccine intake and related my SIRVA to her and she was able to identify the nurse, who was actually there that day, and said she would convey the injury information (e.g., high shoulder stick results) to the vaccination nursing staff.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site vesicles, Musculoskeletal pain, Neck pain
Clinical narrative: Immediate area around injection site was sore "like any shot" per patient, beginning on the evening of administration.  States she woke up Sunday morning (11/01/2015), removed Band-Aid from site, and noticed a small blister at injection site. Upper arm, neck, and scapula on right side began to get achy and sore.  Blister increased in size, and pain got worse until 11/03/2015, when symptoms began to subside.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Immediate area around injection site was sore "like any shot" per patient, beginning on the evening of administration.  States she woke up Sunday morning (11/01/2015), removed Band-Aid from site, and noticed a small blister at injection site. Upper arm, neck, and scapula on right side began to get achy and sore.  Blister increased in size, and pain got worse until 11/03/2015, when symptoms began to subside.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria, Pharyngeal erythema, Pharyngeal oedema
Clinical narrative: Received flu shot at approximately 3PM - awoke 3AM with a swollen, red throat. Administered FIRAZYR to self to stop laryngeal attack. Also developed hives on upper left arm at and around shot site.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Arthropathy, Weight bearing difficulty
Clinical narrative: Shot given 10/20/15 first symptom - (R) knee joint on 10/21/15, (R) ankle joint. 10/23/15 (R) ankle joint. 10/24/15 both ankles no weight bearing - admitted to ER then hospital 10-24-15.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Mouth swelling
Clinical narrative: Left corner part of mouth and inside of cheek became swollen.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Blood test normal, Chest X-ray normal, Chest pain, Dizziness
Clinical narrative: Aching, nausea, dizziness evening after vaccine administered (afternoon) following morning, atypical chest pain, blood pressure increased, dizziness. Treated at emergency room.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram normal, Nausea, Pain
Clinical narrative: Aching, nausea, dizziness evening after vaccine administered (afternoon) following morning, atypical chest pain, blood pressure increased, dizziness. Treated at emergency room.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Full blood count, Irritability, Pyrexia, Tremor
Clinical narrative: Fever up to 104.0. Vomiting. Shakey tremors. Fussy. Not eating well. Onset the next day.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Vomiting
Clinical narrative: Fever up to 104.0. Vomiting. Shakey tremors. Fussy. Not eating well. Onset the next day.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives, began 1 day after vaccine administ lasting 2 weeks, seen in ER, given prednisone, BENADRYL.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Sore shoulder; stiff arm lasted three weeks.
Age: 48.0
Sex: U
Vaccine: FLU3
Symptoms: Abdominal pain upper, Laboratory test normal, Vomiting
Clinical narrative: Extreme upper stomach pain and vomiting.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site urticaria, Rash erythematous
Clinical narrative: Awoke 2:30 am w/burning, itching on left arm est over site of injection. Hives around injection site. Took BENADRYL, helped in 24 hrs, then had spread apart 3 red bumps on lateral upper arm, 2mm size ? bites, insect.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Feeling abnormal, Feeling cold, Headache
Clinical narrative: Pt reports chills, temp 101 degrees F, headache earlier but feeling better now except HA (approx 7:20 pm). Called pt 10/22/15 9:50 am - still feels bad but better, did not seek any medical attn.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave expired vaccine (4/15). No effects.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave expired vaccine (4/15) (no effects).
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Pt reports she started to notice bruising which worsened and became hot and red. The redness under bruised site began spreading down her arm so she was seen 2 days after vaccine administration at walk in where she was prescribed antibiotic and prednisone.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Erythema, Heart rate increased, Pain, Peripheral swelling
Clinical narrative: Fever, fast heartbeat, swelling, from shoulder down arm. Redness, extreme pain, weakness.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Fever, fast heartbeat, swelling, from shoulder down arm. Redness, extreme pain, weakness.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Soreness in arm and shoulder and pain ever since the immunization.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient presented to pharmacy with rash that starting on ankles and moved up the body to her trunk area.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chest X-ray, Dyspnoea, Hyperhidrosis, Peripheral swelling, Pneumonia
Clinical narrative: Left arm - swelling to size of softball, high fever. Shortness of breath, sweating. ER visit, got IV fluids. Diagnosed w/ pneumonia.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pyrexia
Clinical narrative: Left arm - swelling to size of softball, high fever. Shortness of breath, sweating. ER visit, got IV fluids. Diagnosed w/ pneumonia.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Malaise, Nausea, Pain
Clinical narrative: Received it before noon on 9/23/15 - by 6 pm - fever (next day was 103) chills, aches, nausea, dizziness, malaise. Sickest I have ever felt after flu shot.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Received it before noon on 9/23/15 - by 6 pm - fever (next day was 103) chills, aches, nausea, dizziness, malaise. Sickest I have ever felt after flu shot.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Got shot 11:00 AM 10/20. 11:00 PM 10/20 total body myalgia 10/21 called off work -> severe body myalgia. Took OTC ibuprofen. 10/22 felt little better. Still took off work. 10/23 felt better still and went to work. Now just has swelling at injection site.
Age: 35.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Nerve injury
Clinical narrative: 10/15/15 pt. reports doctor visit for nerve damage and possible shoulder impingement secondary to FLUVIRIN injection being given too low on the arm (left).
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: Pt received Flu v on 10/19/15 afternoon she went to her dance class. In 2-3 hrs complained severe headache. Next day fever of 102.6, more headache, "neck stiffness", dizziness. Pt was seen in office. Finally symptoms resolved in 2 days with Ibuprofen.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Periarthritis
Clinical narrative: Pt developed frozen shoulder one month after administration of vaccine.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Vaccine (Flu) IM received Monday 10/26 PM. Awoke with Left leg (Injection limb) twice the size, painful, and red. Hives began in early afternoon. Seen at facility and given Prednisone and BENADRYL.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Developed itch and rash. Went to doctor and was told he had hives. States he received a couple prescription meds and is better. Still has a few hives (rash) left. Has had flu shots in past years.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site urticaria, Injection site warmth, Myalgia, Pain in extremity
Clinical narrative: Very large hive on arm rt near injection site - hot - itchy - very sore arm and severe muscle aches for over 2 weeks.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Lymphadenopathy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient went for an MRI 3 days after receiving her influenza and PREVNAR 13 vaccinations both in her right arm. The MRI read enlarged lymph nodes under the arm on the right side.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site reaction, Local reaction
Clinical narrative: (R) lower deltoid localized rxn to flu shot. TX with ice and ibuprofen.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on arms and legs (Sunday 11/1/15) getting better Monday 11/2/15.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warm to the touch from injection site to elbow.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: PT called us on 11/8 stating that day after inj. site sl. temp became painful and red by Fri. (2) red, swollen up to shoulder and down to elbow - by the time she called area visible but not red, swollen or painful or fever refused appt on 10/15/15 - mild skin peeling at murging where inflammation had been.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Skin exfoliation
Clinical narrative: PT called us on 11/8 stating that day after inj. site sl. temp became painful and red by Fri. (2) red, swollen up to shoulder and down to elbow - by the time she called area visible but not red, swollen or painful or fever refused appt on 10/15/15 - mild skin peeling at murging where inflammation had been.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Pt rec'd ZOSTAVAX 10/30. Called to report 11/3 index-card sized raised, red, pruritic area that developed over the weekend. No other symptoms. Used home care/local therapy on the area. Improving today.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythema and tenderness at injection site.
Age: 28.0
Sex: F
Vaccine: FLUN4
Symptoms: Unevaluable event
Clinical narrative: None at this time.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to unspecified patient's of unknown age and gender. Patient's medical history and concurrent condition was reported. On unknown dates in July 2015 the patients were vaccinated with improperly stored oral, ROTATEQ lot # K017576, expiry date 12-JUN-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via field employee refers to multiple unspecified patients of unknown age and gender. Patient's medical history and concurrent condition was not reported. On an unknown dates, multiple patients were vaccinated with PNEUMOVAX23. (Dose, route, Lot number/Expiry date were unspecified). No information on concomitant medications was provided. On an unknown dates, these multiple unspecified patients experienced injection site swelling and injection site bruising. These events lasted for an unspecified amount of time. The action taken, outcome and causality was not reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to unspecified patient's of unknown age and gender. Patient's medical history and concurrent condition was not reported. On unknown dates in July 2015 the patients were vaccinated with improperly stored RECOMBIVAX HB lot # K024552, expiry date 22-OCT-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 30-JUL-2015 the patient was vaccinated with expired dose of M-M-R II, Lot # J006955, expiration date- 07-JUN-2015. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug allergies were not reported. On unknown dates, the patients received either one or tow doses of GARDASIL (dose, strength and route unknown). On unspecified dates, the patients were administered either one or two doses of GARDASIL 9 (dose, strength and route unknown) to complete their three-dose HPV vaccination series. These patients had an extended vaccination interval (more than 2 or 6 months, depending on which dose in the series for which they were due) between the administration of the two doses of GARDASIL or GARDASIL 9. No adverse effect reported. This is one of the two cases received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Mobility decreased, Pain, Paraesthesia
Clinical narrative: LOSS OF MOVEMENT FROM SHOULDER TO ELBOW WITHOUT PAIN. PAIN AND TINGLING/BURNING SENSATION WITHOUT MOVEMENT.
Age: 56.0
Sex: F
Vaccine: FLUC3
Symptoms: Diarrhoea, Headache, Heart rate increased, Injection site erythema, Injection site nodule
Clinical narrative: "I am employee and took the egg and perservative free vaccine on Tuesday 10/20/15. After about 2 hours I had a constant headache and racing pulse of 100 to 120 until on Sunday. Starting on Wednesday the injection site was red warm and had a knot on it. Starting on Thursday I got my first fever blister and have had green diarrhea since this time. I had no reaction at all last year."
Age: 56.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site warmth, Oral herpes
Clinical narrative: "I am employee and took the egg and perservative free vaccine on Tuesday 10/20/15. After about 2 hours I had a constant headache and racing pulse of 100 to 120 until on Sunday. Starting on Wednesday the injection site was red warm and had a knot on it. Starting on Thursday I got my first fever blister and have had green diarrhea since this time. I had no reaction at all last year."
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Patient states it hurt was red and swollen about 3x4 inches, began about 2 days after vaccine administered. She said it did get worse after 72 hours. Once told by pharmacist to use Benadryl and ice packs, the situation began to resolve and she is feeling much better. Dr. never returned her call.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Induration, Injected limb mobility decreased, Pain in extremity, Upper extremity mass
Clinical narrative: Left arm had hard lump and he was unable to move his arm.  Severe pain rated at 10/10.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Papule, Rash pruritic
Clinical narrative: Pt received flu shot on 10/10/2015 and developed a diffuse, pruritic rash w/ red papules.  Pt took Benadryl for 5 days without relieve.  Seen by primary care doctor on 10/15, and was given hydroxyzine, Allegra, and triamcinolone cream.
Age: 15.0
Sex: M
Vaccine: FLUN4, HEPA, HPV9
Symptoms: Urticaria
Clinical narrative: Symptoms started 24 to 36 hours after vaccine. He had an "urticarial reaction, with hives." It lasted 10 -14 days. Parent treated him with Claritin daily.
Age: 0.24
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Chest X-ray, Full blood count, Metabolic function test, Unresponsive to stimuli, Urine analysis
Clinical narrative: Patient was unresponsive at home and taken to ER, labs and x-rays done in the ER, patient was admitted to hospital for observation and discharged the following day.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: Patient had no adverse reaction as of 11/03/15 at 01:49 PM.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Pruritus, Urticaria
Clinical narrative: Itching/Hives/redness on hands and neck, dizziness.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood culture, Culture throat, Oropharyngeal pain, Pharyngeal oedema, Rash
Clinical narrative: Throat pain; swelling and burning; rash on throat.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Ultrasound scan
Clinical narrative: Throat pain; swelling and burning; rash on throat.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Pain in extremity
Clinical narrative: Shooting pain in back near right upper shoulder blade, radiating down arm to elbow.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Chest discomfort, Dyspnoea, Myalgia, Tinnitus
Clinical narrative: Shortly after getting flu shot patient complained of the following symptoms--ringing in ears, shortness of breath/chest tightness, lower body muscle aches. These were severe enough that the patient has missed 2 days of work thus far due to symptoms.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site reaction, Myalgia
Clinical narrative: Patient came back to pharmacy on 11/02/2015 to report that his arm was still very sore, and wondered if that was normal. Stated no redness, swelling, rash, or itching.  Only extreme soreness in the muscle. Also, stated that the injection itself "hurt really badly".  Was instructed to give it a few more days while taking OTC pain meds, and then maybe see primary care physician for further analysis.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: 10/28 arm very painful to move; 10/29 swollen; 10/30 less swollen but sore to touch; 10/31-11/1 pink but only slight soreness; 11/2 worse.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: High fever 101.9 tested after the first round of medication. 200 mg Advil and two White willow bark.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Infected skin ulcer, Injection site erythema, Injection site urticaria, Pyrexia, Rash erythematous
Clinical narrative: It started with swelling in the area of entry of the vaccine, which was hot to the touch. It was also red and hives began to develop. Red spots and infected-looking sores started to show up all over her body, including her private areas. She also has had a fever. I have pictures, excluding the private areas, that are available upon request. It looks like she has chicken pox, which she was supposed to be immunized against, but it seems it only gave her the virus. I have been giving her some over-the-counter children's generic allergy medicine, Tylenol, and been spraying the most painful areas with an aloe vera gel spray.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Rash vesicular, Vaccination site swelling, Vaccination site warmth, Varicella post vaccine
Clinical narrative: It started with swelling in the area of entry of the vaccine, which was hot to the touch. It was also red and hives began to develop. Red spots and infected-looking sores started to show up all over her body, including her private areas. She also has had a fever. I have pictures, excluding the private areas, that are available upon request. It looks like she has chicken pox, which she was supposed to be immunized against, but it seems it only gave her the virus. I have been giving her some over-the-counter children's generic allergy medicine, Tylenol, and been spraying the most painful areas with an aloe vera gel spray.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blepharospasm, Chest pain, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: FELT SICK, CHEST PAIN, EYE TWITCH, SWELLING AT INJECTION SITE, UPPER ARM SWOLLEN AND RED, BURNING, ITCHING, FEVER.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Pyrexia
Clinical narrative: FELT SICK, CHEST PAIN, EYE TWITCH, SWELLING AT INJECTION SITE, UPPER ARM SWOLLEN AND RED, BURNING, ITCHING, FEVER.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Patient began to notice a rash, heat, redness and soreness at site of injection the morning after the injection was administered.  Rash formed in approximately a 2 inch band around patient's arm over the next two days, then began to diminish.  Patient used ice on site and ibuprofen by mouth.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Soft tissue swelling
Clinical narrative: Soft tissue swelling as a reaction to the shot, which is now resolving, causes some nerve pain from the swelling.  Pt received steroids to help with swelling.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site nerve damage, Injection site pain, Pain, Pain in extremity
Clinical narrative: "During the flu line on Saturday morning, I received the flu shot in my left arm. It burned more than usual going in.  The pain in my left arm worsened over the next several days to the point of it feeling injured by someone yanking my arm out of place. I was on a cruise the week of 12 Oct and since I was unable to make contact with your office before departing (12th was Columbus Day), I decided to continue to monitor my arm for symptoms during my vacation in the hope it would resolve on its own.  For the first 2 weeks afterward, I hard time with basic arm motions (lifting, reaching, getting dressed) and at times it hurt to just move.  There were also several nights where I experienced pain when laying on my side, the most extreme pain occurring on the 18th. I went to my chiropractor on the 20th for a routine back adjustment and he said he sees this happen every year.  He suspects the shot went directly into a nerve in my upper arm.  He did some work on it yesterday and it feels better, although I'm still experiencing some symptoms.  He said it typically takes 4-6 weeks for everything to be back to normal when this happens."
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: "During the flu line on Saturday morning, I received the flu shot in my left arm. It burned more than usual going in.  The pain in my left arm worsened over the next several days to the point of it feeling injured by someone yanking my arm out of place. I was on a cruise the week of 12 Oct and since I was unable to make contact with your office before departing (12th was Columbus Day), I decided to continue to monitor my arm for symptoms during my vacation in the hope it would resolve on its own.  For the first 2 weeks afterward, I hard time with basic arm motions (lifting, reaching, getting dressed) and at times it hurt to just move.  There were also several nights where I experienced pain when laying on my side, the most extreme pain occurring on the 18th. I went to my chiropractor on the 20th for a routine back adjustment and he said he sees this happen every year.  He suspects the shot went directly into a nerve in my upper arm.  He did some work on it yesterday and it feels better, although I'm still experiencing some symptoms.  He said it typically takes 4-6 weeks for everything to be back to normal when this happens."
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Severe left arm pain for over 10 days now.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt is experiencing sore upper arm/shoulder since the injection.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt is experiencing continued soreness in the upper arm/shoulder.
Age: 1.84
Sex: M
Vaccine: FLUN4
Symptoms: Irritability, Malaise, Pain, Pyrexia, Rash generalised
Clinical narrative: Child began acting fussy and like he was hurting, began running a fever as well. He continued to act ill, then the next day developed a disseminated rash all over from head to toe.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or allergy/drug reactions were not reported. On 16-OCT-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K008078/exp. 03-SEP-2015) (dose, route and frequency were unspecified). Concomitant therapy was not reported. No adverse symptoms and no product quality complaint were informed. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # K002816, expiration date 26-FEB-2016, exact doses and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Follow-up information has been received from a nurse on 20-OCT-2015. On 27-AUG-2015, a patient of unknown age and gender received a dose of M-M-R II (lot # K002816, expiration date 26-FEB-2016), which was exposed to a maximum temperature 49F for a total of 11 days prior to administration. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested. Reporter , patient, suspect therapy, event and the narrative have been updated.
Age: 16.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 16 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 01-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not provided) at 16 years of age. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, refers to an unspecified number of patients, of unknown age and gender. Medical history and concurrent conditions were not reported. The medical assistant reported that on an unknown date, the patients were vaccinated with improperly stored doses of included COMVAX, lot#: J013884, expiration date: 19-AUG-2016. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, refers to an unspecified number of patients, of unknown age and gender. Medical history and concurrent conditions were not reported. The medical assistant reported that on an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL, lot#: K008931, expiration date: 04-MAR-2017 and Lot #K006960 expiration date: 19-FEB-2017 (strength, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This initial spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history or drug allergies/drug reactions described. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route, frequency and lot# were not provided). There was no concomitant medication reported. The pharmacist stated in approximately 2014 reported as "about one year ago", the patient developed redness at injection site. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. At the time of the report the outcome of the event was unknown. The relatedness between the event to ZOSTAVAX was not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This initial spontaneous report was received from a pharmacist referring to a 60 year old female patient. There was no pertinent medical history or drug allergies/drug reactions described. On 27-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous injection (lot # L011537 with expiration date 03-JUL-2016, 0.65 ml). There was no concomitant medication reported. The pharmacist stated on 29-OCT-2015, the patient reported to the physician that she developed redness (2 inches) at injection site. The physician recommended BENADRYL as treatment and when purchasing it at pharmacy, the reaction was reported to her/him. Lab test were not performed. Product quality complaint (PQC) was not involved. At the time of the report the outcome of the event was unknown. The relatedness between the event to ZOSTAVAX was not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, improperly stored doses of VARIVAX (Merck) lot # L016126 exp. 06-MAY-2017 (route of administration, dose were not reported) were administered to unspecified patients. There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Brain neoplasm, Headache
Clinical narrative: This initial spontaneous report was received from a physician via a company representative reporting that one of her patients told her of another patient of unknown age and gender whose pertinent medical history, concomitant medications or concurrent conditions were not described. The reporter stated that on an unknown date, the patient was vaccinated with a dose of an unspecified vaccine; GARDASIL or GARDASIL 9 injection (dose, route, lot# and expiration date were not provided). On an unknown date, the patient began getting headaches and sought medical attention at a Neurologist who told that the vaccine GARDASIL or GARDASIL 9 had also caused a brain tumor. Product quality complaint (PQC) was involved. At the time of the report, the outcome of the event was unknown. The reporter causality between the event to the suspect therapies was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, improperly stored doses of GARDASIL 9 lot # K026246 exp. 28-JAN-2017 (route of administration, dose were not reported) were administered to unspecified patients. There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, improperly stored doses of GARDASIL lot # K010215 exp. 05-MAY-2017 (route of administration, dose were not reported) were administered to unspecified patients. There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Scab, Skin irritation
Clinical narrative: Information has been received from a male patient of unknown age referring to himself. The patient had no drug allergies or reactions. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2012 (approximately three years ago), the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose, frequency and route were unknown). Concomitant therapies included pravastatin, benazepril hydrochloride, omeprazole (manufacturer unknown), WELCHOL and levothyroxine sodium (manufacturer unknown). Since receiving ZOSTAVAX, the patient had had an episode of shingles each year, currently for the third time. The episode was not bad, but it was always in the same place and the same size - about the size of a quarter. It got "pinchy and burny". His physician prescribed an unspecified dose of valacyclovir hydrochloride. The area then got crusty and went away. No lab diagnostics studies were performed. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Herpes zoster
Clinical narrative: This spontaneous report as received from an unspecified reporter via representative and other company representative, refers to a 53 year old female patient. The patient's medical history and concurrent conditions were not reported. On 12-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX lot # H020683, expiration date 15-FEB-2014 via subcutaneous route (dose was not reported). No concomitant medications were reported. On an unknown date (reported as shortly afterwards), the patient developed shingles with symptoms of redness under her temple (reported as under her hairline), in the corner of her eye (unspecified) and under her nose. The patient had also a dull headache. It was reported that the patient was treated with Acyclovir over a two day period (unspecified dates). The patient was also seen by an unspecified eye doctor on an unspecified date. At the time of the report, the outcome of herpes zoster was unknown. No product quality complaint was involved. Additional information is not expected as there is no reporter contact information.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (dose, route of administration, lot # and expiration dates were not reported) at intervals outside of the labeled dosing regimen of 0, 2 and 6 months. There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 22-JUL-2015 the patient was vaccinated with expired dose of M-M-R II, Lot # J006955, expiration date- 07-JUN-2015. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, an unspecified number of patients received an improperly stored dose of GARDASIL lot # K007264 exp. 02-MAR-2017 (dose, route of administration were not reported). There was no adverse effect reported. PQC was not involved. This is one from several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, an unspecified number of patients received an improperly stored dose of VAQTA lot# K012457 exp. 04-JUN-2017 (dose, route of administration were not reported). There was no adverse effect reported. PQC was not involved. This is one from several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, an unspecified number of patients received an improperly stored dose of ROTATEQ orally, lot # K016261 exp. 23-JUN-2016 (dose, was not reported). There was no adverse effect reported. PQC was not involved. This is one from several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a multiple patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, frequency and indication were not reported) lot # K005426 with expiration date 15-APR-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No pertinent or historical conditions were reported. On unspecified dates starting on or after 21-OCT-2015, the patients were administered an unspecified number of improperly stored doses of oral, ROTATEQ (lot L000571, expiration date 26-JUL-2016, lot L008054, expiration date 30-NOV-2016, lot L008578, expiration date 14-DEC-2016, strength and dose unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a multiple patients of unknown age and gender. On an unknown date, the patients were orally vaccinated with improperly stored doses of oral, ROTATEQ (dose, frequency and indication were not reported) lot # K023534 with expiration date 22-MAY-2016. No adverse effects are reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a physician regarding a 14 year old male patient. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with GARDASIL 9. No concomitant medication was reported. On an unknown date the patient experienced generalized rash all over his body which lasted for a while. The outcome of generalised rash was reported as resolved at the time of reporting. Causality between generalised rash and GARDASIL 9 was unknown. Additionl information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to unspecified patients of unknown age and gender. Patient's medical history and concurrent condition was not reported. On unknown dates in July 2015 the patients were vaccinated with improperly stored VAQTA lot # K005323, expiry date 10-FEB-2017. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of unspecified patients. On unspecified dates the patients were vaccinated with improperly stored GARDASIL 9 lot # L014415 (expiration date 25-JUL-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a plenty of unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with ZOSTAVAX (route, dose, frequency and lot # not reported). On an unknown date, the patients experienced pain, swelling and redness at the injection site. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 30-OCT-2015 the patient was inadvertently vaccinated with ZOSTAVAX (lot # K007989 with expiration date of 15-SEP-2015; strength, dosage, frequency and route unspecified) (expired product administered). No adverse effects were reported. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a multiple patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (dose, frequency, route of administration and indication were not reported) lot # K008931, with expiration date 04-MAR-2017 and lot # K011562, with expiration date 08-APR-2017. No adverse effects are reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, pain, itching at injection site.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Altered state of consciousness, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal, Muscle contractions involuntary
Clinical narrative: Approximately 2 minutes after administration of flu vaccine, patient had altered consciousness and tonic contraction of upper extremities concerning for seizure.  Lasted 10-30 seconds.  Resolved without treatment.  Returned to baseline quickly and is well now.