chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Local swelling, Mobility decreased, Neck pain, Pain, Pyrexia
Clinical narrative: I received both the flu and pneumonia shots on my left arm a couple inches apart. After a few hours I had a very sore shot sight and very sore neck pain. Later that night I had flu like symptoms such as; headache, body aches, chills, fever, fatigue that lasted for two days. I was also very dehydrated and my urine was a dark brown color. I also had a swollen arm/shoulder and could not move my arm. The swelling moved down my arm about three inches. It was painful to touch and very warm. It is now 8 days later and I still have a sore bump where the injection sight is. I called the clinic and they suggested I go to the ER where I could possibly get an IV for the dehydration. At the ER they released me with the diagnoses of cellulitis of the arm and an allergic reaction. I went home with pain killers and an antibiotic. On 10/22/2014 I woke up with a terrible headache and neck pain. I was seen at the ER because I thought it was because of the shot. I was diagnosed with a tension headache caused from all the stress my body was under.
Age: 30.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Skin warm, Tenderness, Tension headache
Clinical narrative: I received both the flu and pneumonia shots on my left arm a couple inches apart. After a few hours I had a very sore shot sight and very sore neck pain. Later that night I had flu like symptoms such as; headache, body aches, chills, fever, fatigue that lasted for two days. I was also very dehydrated and my urine was a dark brown color. I also had a swollen arm/shoulder and could not move my arm. The swelling moved down my arm about three inches. It was painful to touch and very warm. It is now 8 days later and I still have a sore bump where the injection sight is. I called the clinic and they suggested I go to the ER where I could possibly get an IV for the dehydration. At the ER they released me with the diagnoses of cellulitis of the arm and an allergic reaction. I went home with pain killers and an antibiotic. On 10/22/2014 I woke up with a terrible headache and neck pain. I was seen at the ER because I thought it was because of the shot. I was diagnosed with a tension headache caused from all the stress my body was under.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site haematoma, Oedema, Pain in extremity
Clinical narrative: Left arm pain and redness. Edema.  Diagnosed with injection site hematoma.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Arthralgia, Drug administered at inappropriate site, Musculoskeletal pain, Pain
Clinical narrative: Pain in right shoulder.  Hurts to lift arm over head.  Hurts to lift arm out to the side.  Tried to throw a ball for my dog and couldn't throw very far at all.  Painful shoulder joint.  Injection site of influenza immunization is very high up on my right arm just below my shoulder joint.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Headache, Pruritus
Clinical narrative: 2hrs after the injection the pt developed a headache, itching, and a swollen eye. Pt took aleve with some relief. Pt is now back to normal.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Right arm pain and swelling.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: At the time of the needle stick (prior to the serum being injected) I stated to the nurse that she must have hit a nerve.  She asked if I was in pain and I said, "Not pain, but there is an achey feeling from my shoulder to my fingertips."  She continued with the injection and withdrew the needle and at that time asked if it was still hurting.  I stated no, not at the time.  Later that evening, the left shoulder and arm was in severe pain and I was not even able to lift my arm away from my body.  I treated myself with over the counter Tylenol and was still in severe pain the next day so I sought treatment from the Occupational Health doctor on 10/7/2014.  DX was Left deltoid pain after annual flu vaccination.  I was told to ice as I could for 15 minutes at a time and to take Aleve as directed on the bottle.  I returned on 10/9/14 for the scheduled follow up and was feeling better and range of motion was improving as I was using Aleve and ice to treat.  I was told to follow up as needed.  I never improved beyond that point and the following week the pain began to get worse.  I called to see Dr. again on 10/21/14 and was told the next available appointment was on 10/23/14.  I again saw Dr. that afternoon and was given the same instructions and was recommended therapy, which was denied by Workers Compensation.  As of 10/29/14 I am still experiencing pain in my left shoulder and upper arm.  I am scheduled to follow up on 11/6/14 if allowed by workers compensation.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Injection site reaction, Joint crepitation
Clinical narrative: Shoulder pain and loss of range of motion in the arm (left) that received vaccination. Tingling in the forearm and hand. Also have clicking in the shoulder. It feels like it wants to come out of joint. It is worthy to note that the vaccine administer was standing (as I was seated) on my right side and reached over me and with one hand and gave me the injection near the top of my left shoulder.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Shoulder pain and loss of range of motion in the arm (left) that received vaccination. Tingling in the forearm and hand. Also have clicking in the shoulder. It feels like it wants to come out of joint. It is worthy to note that the vaccine administer was standing (as I was seated) on my right side and reached over me and with one hand and gave me the injection near the top of my left shoulder.
Age: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: Dysgeusia, Parosmia, Rhinorrhoea
Clinical narrative: Rotten egg smell and taste. Runny nose.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Disturbance in attention, Hallucination, auditory
Clinical narrative: After school, on the day that patient received the flu shot at school, he experienced a 20 min episode during which he heard voices "like in a crowded restaurant." Later that night, he experienced a similar episode lasting 10-15 seconds.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Feeling cold, Headache, Injection site erythema
Clinical narrative: PATIENT STARTED EXPERIENCING SYMPTOMS AT 1930 THE SAME DAY VACCINE WAS ADMINISTERED. SYMPTOMS INCLUDED BLURRY VISION, OCULAR HYPEREMIA, SEVERE HEADACHE, REDNESS AND HEAD AT INJECTION SITE, MALAISE, FEELING OF COLD, DYSPNEA. CLIENT WENT TO BED AND FELT BETTER THE NEXT DAY. CLIENT CONTINUES TO FEEL A LITTLE TIRED BUT BETTER.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Malaise, Ocular hyperaemia, Vision blurred
Clinical narrative: PATIENT STARTED EXPERIENCING SYMPTOMS AT 1930 THE SAME DAY VACCINE WAS ADMINISTERED. SYMPTOMS INCLUDED BLURRY VISION, OCULAR HYPEREMIA, SEVERE HEADACHE, REDNESS AND HEAD AT INJECTION SITE, MALAISE, FEELING OF COLD, DYSPNEA. CLIENT WENT TO BED AND FELT BETTER THE NEXT DAY. CLIENT CONTINUES TO FEEL A LITTLE TIRED BUT BETTER.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Nausea, Pruritus, Swelling face
Clinical narrative: Pt shortly after vaccine administration she went home to prepare breakfast.  She stated she became nauseated and later noticed swelling and itching on face and arm. She reported to the ER for treatment.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Local swelling, Pain in extremity, Pyrexia
Clinical narrative: Patient reported headache, feeling feverish, and chills for 3 days following the vaccine. She also reported that her upper arm swelled and became very painful and that also lasted for 3 days.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Blood glucose increased, Burning sensation, Headache, Malaise
Clinical narrative: "...felt like truck ran over me." At 4 AM on 10/17"...felt my upper body on fire with pressure inside head and face. BS 322, took meds. At 7AM BS 176, felt "horrible." At 1300 woke up, shaky and weak BS 140. At 1800 felt normal."
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: "...felt like truck ran over me." At 4 AM on 10/17"...felt my upper body on fire with pressure inside head and face. BS 322, took meds. At 7AM BS 176, felt "horrible." At 1300 woke up, shaky and weak BS 140. At 1800 felt normal."
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Full blood count, Henoch-Schonlein purpura, Metabolic function test, Renal function test, Urine analysis
Clinical narrative: Diagnosed with HSP 13 days after receiving Flumist.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Hemiparesis, Neurological symptom, VIIth nerve paralysis
Clinical narrative: Case number PHEH2014US021350, is an initial spontaneous report from a nurse received on 21 Oct 2014. This report refers to a 56-year-old male patient. His medical history included  neurological issues and left side weakness. Concomitant medications were not reported. He was vaccinated with intramuscular dose of FLUVIRIN (batch number: unknown) on an unknown date. Post vaccination, since 09 Oct 2014, the patient experienced left side of his face drooping for one week and visited nurse. The nurse treated the patient as if he had Bell's palsy. The outcome, seriousness and causality assessment of the event was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Rash macular, Swelling face
Clinical narrative: Case number PHEH2014US021315, is an initial spontaneous report from a health care professional received on 20 Oct 2014. This report refers to female patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1412501) intramuscularly on 17 Oct 2014. Lab technician reported that she experienced a full body rash and a swollen face after vaccination on the same day. She self-treated with BENADRYL and still had splotchy skin on day 3 after the vaccination. Her face swelling had subsided and rash was slowly resolving. Seriousness and causality assessment was not reported. Seriousness assessment of swelling face was upgraded based on information available in the source documents.
Age: 45.0
Sex: F
Vaccine: FLUC3
Symptoms: Activities of daily living impaired, Hypoaesthesia, Impaired driving ability, Impaired work ability, Injection site anaesthesia
Clinical narrative: Case number PHEH2014US021025, is an initial spontaneous report from a consumer (patient's spouse) received on 19 Oct 2014. This report refers to a 45-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of FLUCELVAX, (batch number: 161211) into deltoid on 13 October 2014 at 12:15 hours. On the same day, post vaccination, she experienced vertigo at 12:45 hours and injection site whole arm numbness at 14:00 hours. It was reported that she could not go to work or drive from 13 Oct 2014 at 23:45 hours till 15 Oct 2014 at 07:15 hours. On 14 Oct 2014, she experienced malaise at 6:00 hours. Event of numbness was resolved on 13 Oct 2014 at 17:30 hours, malaise on 15 Oct 2014 at 5:45 hours and vertigo on 19 Oct 2014 at 12:00 hours. The reporter assessed the events as serious (significant disability). Causality assessment of the events was not reported.
Age: 45.0
Sex: F
Vaccine: FLUC3
Symptoms: Malaise, Vertigo
Clinical narrative: Case number PHEH2014US021025, is an initial spontaneous report from a consumer (patient's spouse) received on 19 Oct 2014. This report refers to a 45-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of FLUCELVAX, (batch number: 161211) into deltoid on 13 October 2014 at 12:15 hours. On the same day, post vaccination, she experienced vertigo at 12:45 hours and injection site whole arm numbness at 14:00 hours. It was reported that she could not go to work or drive from 13 Oct 2014 at 23:45 hours till 15 Oct 2014 at 07:15 hours. On 14 Oct 2014, she experienced malaise at 6:00 hours. Event of numbness was resolved on 13 Oct 2014 at 17:30 hours, malaise on 15 Oct 2014 at 5:45 hours and vertigo on 19 Oct 2014 at 12:00 hours. The reporter assessed the events as serious (significant disability). Causality assessment of the events was not reported.
Age: 1.85
Sex: M
Vaccine: FLU3
Symptoms: Febrile convulsion, Grand mal convulsion, Middle insomnia, Otitis media, Pyrexia
Clinical narrative: Per mom, that evening developed fever. Mom had been using antipyretics, mom heard him wake in middle of nite, when mom went to get him he developed gen'l T/C seizure lasting less than a minute. Felt warm. Called 911. To ER via amb. Diagnosed with OM. Fever 104.7 Dx: febrile seizure. Improved on antipyretics. Seen 10/23 @ENT-ears nl.
Age: 1.85
Sex: M
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Per mom, that evening developed fever. Mom had been using antipyretics, mom heard him wake in middle of nite, when mom went to get him he developed gen'l T/C seizure lasting less than a minute. Felt warm. Called 911. To ER via amb. Diagnosed with OM. Fever 104.7 Dx: febrile seizure. Improved on antipyretics. Seen 10/23 @ENT-ears nl.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Pyrexia
Clinical narrative: Two hours following vaccinations, mother noticed redness and a knot at injection site. L thigh, fever started 10/15/14 during the night.  Patient is still moving around like normal and has no change in behavior per mother.  Mother says she does not favor right leg over left leg. Patient in clinic for assessment of L leg which remains red and puffy at injection site with 4 cm in diameter area noted.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Injection site bruising, Injection site pain, Pruritus
Clinical narrative: Fatigue, bruising and soreness at injection site, itchy hives on arm, hand and stomach, headache.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Fatigue, bruising and soreness at injection site, itchy hives on arm, hand and stomach, headache.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Dysphonia, Eye pain, Eye pruritus
Clinical narrative: Large swelling, heat pain @ injection site and soreness same side shoulder; treated with elevation and active ROM; 18 hours post injection had large hives below the waist which decreased to smaller hive over the next 8 days; day five got sore, itchy eyes, hoarseness, mild headache and as the hives decreased they were replaced by general itching and fatigue; after day 8 I had a mild cough for two days; all Sx appeared resolved by day 10; NEVER had body swelling nor breathing difficulties, which is why I did not call my MD; unclear if I had faster heartbeat one night about day 3, or not; late term dizziness last days #8, 9.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large swelling, heat pain @ injection site and soreness same side shoulder; treated with elevation and active ROM; 18 hours post injection had large hives below the waist which decreased to smaller hive over the next 8 days; day five got sore, itchy eyes, hoarseness, mild headache and as the hives decreased they were replaced by general itching and fatigue; after day 8 I had a mild cough for two days; all Sx appeared resolved by day 10; NEVER had body swelling nor breathing difficulties, which is why I did not call my MD; unclear if I had faster heartbeat one night about day 3, or not; late term dizziness last days #8, 9.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Large swelling, heat pain @ injection site and soreness same side shoulder; treated with elevation and active ROM; 18 hours post injection had large hives below the waist which decreased to smaller hive over the next 8 days; day five got sore, itchy eyes, hoarseness, mild headache and as the hives decreased they were replaced by general itching and fatigue; after day 8 I had a mild cough for two days; all Sx appeared resolved by day 10; NEVER had body swelling nor breathing difficulties, which is why I did not call my MD; unclear if I had faster heartbeat one night about day 3, or not; late term dizziness last days #8, 9.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Paraesthesia oral, Pyrexia, Swelling face, Urticaria
Clinical narrative: Patient reported tingling in lower lip and tongue starting at 2:00 pm with subjective fever and joint pain in both knees.  When he got home later in the day patient reported that his wife thought his face looked a little swollen.  Woke up on 10/24/14 with hives on his back and scalp, but fever, tingling and swelling had resolved.  Still has some pain in his knees.  Patient then called Health Services to report his symptoms on 10/24/2014 at approx. 1:30 pm.  Patient was referred to his private physician who treated him with Zyrtec with good effect.  Hives completely resolved by 10/25/2014.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: PATIENT RETURNED TO PHARMACY ON 10/29 REPORTING THAT HE HAD A RASH. HE STATED HE HAS HAD A RASH LIKE THIS BEFORE BUT WANTED TO KNOW IF THE FLU SHOT COULD HAVE CAUSED IT. I TOLD HIM YES AND THAT HE SHOULD CALL HIS DOCTOR TO MAKE THEM AWARE AND THAT BENADRYL SHOULD HELP.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Patient appeared to have an injection site reaction. It was sore, inflammed and slightly red.
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Breaking out in red itchy hives under each arm and along left flank.  Also some hives in groin area near lymph nodes.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pharyngeal oedema, Throat tightness
Clinical narrative: Swollen tight painful throat. Given 50mg Benadryl and 150mg Zantac symptoms improved over 20-30 minutes.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Vomiting
Clinical narrative: Dizziness, anorexia, x24 hrs, vomited x1, diarrhea x4.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Impaired work ability, Nodule, Pain, Tendon injury
Clinical narrative: Patient states that pharmacist gave her the shot ~1-1.5 " posteriolateral of shoulder blade & asked if that was too high.  She states that vaccine administrator said no.  She had no immediate pain & only complained of 'normal soreness' the evening of the shot.  However, her pain increased daily to the point of affecting her ADLs & ability to perform her job & states it hurts to turn her steering wheel left.  She visited her PCP on 10-21-14 who states her tendon was pierced, however NO imaging has been done.  He prescribed exercises for her & told her to apply heat regularly.  She called me 10-22-14 & visited me 10-24-14 to come give the detailed account.  She said it feels similar to 'bursitis'.  No bruising, no swelling, just pain.  No marks on the skin of any kind, but she says she & dr can palpate a 'knot'.  Dr. also referred her to physical therapist, therapy to begin Nov 4th but states she will call us to let us know if she actually starts.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: ARM INITAILLY SORE, PATIENT CALLED PHARMACY 3 DAYS LATER COMPLAINED 3INX3IN RED HOT SORE ARM IN INJECTION AREA NO OTHER COMPLAINTS.
Age: 65.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Chills, Dyspnoea, Musculoskeletal stiffness
Clinical narrative: Chills, muscle stiffness, shortenss of breath.
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site pain, Middle insomnia, Pain
Clinical narrative: Experienced marked soreness in left deltoid when lifting arm forward or sideways .... woke up at night with pain after anti-inflammatory medicine wore off.  Continues until today although slowly improving.  Utilizing 800 - 1600 mg / day of Ibuprofen to control pain
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Hyperhidrosis, Swollen tongue
Clinical narrative: SOB, sweating and tongue swelling.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pyrexia
Clinical narrative: Localized swelling and erythema, low grade fevers.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Attention-seeking behaviour, Urticaria
Clinical narrative: Possible hives, given Benadryl 50mg IM.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Coma, Pupillary reflex impaired, Unresponsive to stimuli
Clinical narrative: Comatose for approximately 16-18 hours; unresponsive to physical stimulation and verbal stimulation, eyes unresponsive to light when eyelids lifted.
Age: 13.0
Sex: M
Vaccine: FLU4, VARCEL
Symptoms: Acne, Pruritus
Clinical narrative: "PIMPLE LOOKING" ROUND AREAS ON FACE, TRUNK AREA WITH ITCHING.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Delirium, Mobility decreased, Musculoskeletal pain, Pyrexia
Clinical narrative: Left shoulder pain, unable to lift arm then developed low grade fever, delirium and admission to hosptial for observation.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Pain at injection site; fever.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Joint range of motion decreased, Paraesthesia
Clinical narrative: PAIN IN RIGHT UPPER ARM, NUMBNESS AND TINGLING IN 4TH AND 5TH FINGERS OF RIGHT ARM. CONTINOUS PAIN AND LIMITED RANGE OF MOTION IN RIGHT ARM. TAKING IBUPROFEN FOR PAIN.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster, Hyperaesthesia, Rash
Clinical narrative: Began with sensitivity on the left side (same side vaccine was given) just below breast to the bottom of rib cage. By 10/24/2014, rash began to develop only in the area of sensitivity. Called doctor and began valacyclovir for shingles on 10/25/14. Symptoms persist at time of this report.
Age: 62.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of drug administration, Nasopharyngitis
Clinical narrative: Vaccine was administred intramuscularly rather than subcutaneously and reported cold like symptoms on 10/29/2014.
Age: 73.0
Sex: F
Vaccine: YF
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Stiffening and pain in all major muscles including neck, shoulders, legs, upper arms. Began ADVIL, 2000 mg per day, muscle relaxers. After 2 months placed on prednisone for short course while on my trip.  Finally symptoms gone October 1/2, 2014.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urticaria
Clinical narrative: Hives - Called Emergency Room - advised to take Benadryl.  Followed advice.  Hives went away but returned AM 10/29/2014.  Called hospital advised to take Benadryl for 2 days.  Outcome not known at this time.  Had never had a reaction before after many years of getting the flu shot.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pruritus, Rash erythematous
Clinical narrative: Large, hard, red, 6X3 inch rash. Itchy.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Culture wound, Injection site bruising, Injection site nodule, Injection site swelling
Clinical narrative: Pt given Flu Vaccine 5 days after B12 Injection in the right arm, within one week of flu vaccine, pt developed nodules under the skin at site of both injections with bruising and swelling. Pt was given next B12 Injection on 10/1/2014 in the left arm with same symptoms.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Pain, Rash
Clinical narrative: RASH; THAT NIGHT EXPERIENCED HA, CHILLS, BODY ACHES, COUGH, TIGHTNESS TO THROAT. TOOK ADVIL, TYLENOL. WAS SEEN IN THE ED ON 10/26/14; RECEIVED EXAM, ADVICE; NO TEST ORDERED.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: RASH; THAT NIGHT EXPERIENCED HA, CHILLS, BODY ACHES, COUGH, TIGHTNESS TO THROAT. TOOK ADVIL, TYLENOL. WAS SEEN IN THE ED ON 10/26/14; RECEIVED EXAM, ADVICE; NO TEST ORDERED.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Neck pain, Nodule
Clinical narrative: About 7 hours after her injection she noticed a knot developed and pain at the base of her neck.  It was the same side as the injection.  She described the pain and knot as the same as she was feeling in her shoulder from the shot.  Today she says the pain is resolved, however the knot is still mildly present.  She did not seek medical treatment.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Dyspnoea, Throat irritation, Throat tightness
Clinical narrative: Client stated that she was having some discomfort and a tickle in the back of her throat.  She was told to wait another 10 minutes.  Approximately 5 minutes later she stated that she felt like the back of her throat was closing and the nurse noticed that while she was talking she seemed short of breath. Epinephrine was administered and 911 was called.  The hospital was directly next door to the facility, so they were there quickly, and gave patient IV Benadryl and took her to hospital.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Eye discharge, Eye pruritus, Nausea, Swelling face
Clinical narrative: Nausea, itchy eyes, face felt swollen, labored breathing, eyes mattered shut next day.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Cough, fever, throwing up, wheezing, chest tightness, runny nose.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Cough, fever, throwing up, wheezing, chest tightness, runny nose.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Posture abnormal
Clinical narrative: Patient was sitting in a chair in our vaccine office, moved to his hands and knees to compose himself, then was on his back. He revived within ten seconds.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Fatigue, Incorrect dose administered, Injection site pain
Clinical narrative: Pt. received an Afluria 2014-2015 vaccine instead of a Tdap vaccine. Patient then received the Tdap vaccine in the other arm as well. The patient had received a flu vaccine in late August and this was a second dose of the flu vaccine for 2014-2015 this year. The manufacturer was contacted and they had no information about receiving 2 flu shots. They think the patient may experience more of the injection side effect. Talked to the Patient the next day and she was fine just felt tired and was sore at the injection site.
Age: 52.0
Sex: M
Vaccine: FLUC3
Symptoms: Swelling face
Clinical narrative: Left sided facial swelling, and feeling of fluid under his face.  No breathing issues, or itching, or rash.  Took Tylenol and Benadryl.  Symptoms began to resolve the next day.  Did not miss any work time.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash on trunk of body, on back and chest. No fever.  Rash lasted longer than 24 hours.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity, Swelling
Clinical narrative: Pt had Flu vaccinaction 1 month, and 6 days ago. Pt still has arm soreness and muscle pain. There is slight swelling.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Soreness in area of injection Right upper arm which persisted for months and worsened. I sought treatment in December and was treated with steroid injections, Medrol dose packs, Toradol-and one session of physical therapy which exacerbated symtoms so I did not seek further therapy until 2014. I saw pain specialist Dr. who tried one steroid injection and then referred me to another physical therapy department which I have continued to receive treatments 3 times per week to regain functionality of right arm.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PPV, RVX
Symptoms: Convulsion, Drooling, Musculoskeletal stiffness, Tremor
Clinical narrative: Seizure activity < 1 min: stiffening, shaking, drooling.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Pain, Pruritus
Clinical narrative: L ARM REDNESS; ITCHING; ACHE; CIRCULAR ERYTHEMA APRX 4 CM; LOCALIZED INFLAMMATION; PT ADVISED TO RETURN TO CLINIC TO GO TO ER IF CONDITION WORSENS.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Excoriation, Pain in extremity, Rash erythematous, Vaccination site reaction
Clinical narrative: Patient reported to the pharmacy 2 days after vaccination stating her arm was turning red and became painful and warm to the touch about 1 day after vaccination.  Patient showed back of arm where vaccination was given and there had devoloped a red rash on skin that was warm to the touch.  Rash was about 8 inches x 3 inches in size.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site warmth
Clinical narrative: Patient reported to the pharmacy 2 days after vaccination stating her arm was turning red and became painful and warm to the touch about 1 day after vaccination.  Patient showed back of arm where vaccination was given and there had devoloped a red rash on skin that was warm to the touch.  Rash was about 8 inches x 3 inches in size.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Erythema, Headache, Pyrexia, Swelling
Clinical narrative: Swelling, redness, feverish, diarrhea, headache.
Age: 47.0
Sex: M
Vaccine: DTAP
Symptoms: Incorrect route of drug administration, Medication error, No adverse event
Clinical narrative: When administering medications, wrong syringe was grabbed and Tdap was given IV instead of IM. No adverse reaction noted up to an hour and a half later.   Doctor notified and patient notified.
Age: 6.0
Sex: F
Vaccine: DT
Symptoms: Fatigue, Headache, Lethargy, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Headache for 8 days; stiff leg unable to support her weight for 3 days; fever for 8 days (highest temperature was 104.8 for 2 hours; otherwise temperature was 100-103); extremely lethargic for 3 days, then continued fatigue for 5 more days.
Age: 6.0
Sex: F
Vaccine: DT
Symptoms: Weight bearing difficulty
Clinical narrative: Headache for 8 days; stiff leg unable to support her weight for 3 days; fever for 8 days (highest temperature was 104.8 for 2 hours; otherwise temperature was 100-103); extremely lethargic for 3 days, then continued fatigue for 5 more days.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Guillain-Barre syndrome
Clinical narrative: AFTER FLU SHOT, PATIENT FELT TIRED,WEAK. IT WAS GETTING WORSE, HE DID NOT HAVE ENERGY TO HOLD THINGS. HE WAITED FOR 3-4 DAYS THEN SAW DOCTOR, INFORMED BY MD THAT HE GOT GBS. NOW HE IS RECOVERING.
Age: 31.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Arthralgia, Chest discomfort, Chills, Cough, Dizziness
Clinical narrative: Difficulty breathing, wheezing, tightness in chest, erratic heartbeat, dizziness, slight swelling of tongue and throat, chills, achy joints, redness of eyes, thirst, fatigue. Patient took Benadryl, albuterol inhaler, inhaled steam, and relaxed. Worst symptoms resolved within 2-3 hours with some residual cough, chills, and soreness.  Patient fatigued through the next 24 hours.
Age: 31.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Dyspnoea, Fatigue, Heart rate increased, Ocular hyperaemia, Pain
Clinical narrative: Difficulty breathing, wheezing, tightness in chest, erratic heartbeat, dizziness, slight swelling of tongue and throat, chills, achy joints, redness of eyes, thirst, fatigue. Patient took Benadryl, albuterol inhaler, inhaled steam, and relaxed. Worst symptoms resolved within 2-3 hours with some residual cough, chills, and soreness.  Patient fatigued through the next 24 hours.
Age: 31.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Pharyngeal oedema, Swollen tongue, Thirst, Wheezing
Clinical narrative: Difficulty breathing, wheezing, tightness in chest, erratic heartbeat, dizziness, slight swelling of tongue and throat, chills, achy joints, redness of eyes, thirst, fatigue. Patient took Benadryl, albuterol inhaler, inhaled steam, and relaxed. Worst symptoms resolved within 2-3 hours with some residual cough, chills, and soreness.  Patient fatigued through the next 24 hours.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pt developed a stiffness and pain in the shoulder and neck of the left arm (the arm were the vaccine was delivered) with no explainable other reason.  The pain has continued for the last 6 days and according to the patient has not gotten better.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dehydration, Pain, Tremor
Clinical narrative: Shivering uncontrollably described as very tremor like.  Vomiting, severe dehydration, weak and sore.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Shivering uncontrollably described as very tremor like.  Vomiting, severe dehydration, weak and sore.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Headache, Hot flush, Nausea
Clinical narrative: Patient indicating that she experienced: chest tightness, fever, chills, hot flashes, nausea, vomiting, headache and a thick white crust on her tongue and around her mouth.  Today, however she is feeling fine and only has the headache that she admitted might be due to lack of caffeine.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Scab, Tongue coated, Tongue discolouration, Vomiting
Clinical narrative: Patient indicating that she experienced: chest tightness, fever, chills, hot flashes, nausea, vomiting, headache and a thick white crust on her tongue and around her mouth.  Today, however she is feeling fine and only has the headache that she admitted might be due to lack of caffeine.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Periarthritis, Rotator cuff syndrome
Clinical narrative: Dull shoulder pain at onset - intensified overnight limiting mobility in shoulder - severe shoulder pain by following morning and very limited mobility - pain intensity lessened over the following month, but mobility remained restricted.  Doctor diagnosis was rotator cuff injury and adhesive capsulitis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Entire right leg has swollen up and is very red.  Child complains frequently that it hurts.  The leg is very hot to the touch.  Bruising appears around the injection site.  Child has been given ice packs to reduce swelling and burning sensation and Tylenol for the pain.
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: Soreness in shoulder.
Age: 1.88
Sex: F
Vaccine: FLU3
Symptoms: Culture wound, Injection site abscess, Tenderness, Wound secretion
Clinical narrative: Development of abscess at injection site starting 72-96 hours after infection; no fever; mild tenderness; prescribed Keflex PO and culture done of wound drainage.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Blood pressure increased, Blood test normal, Chest pain, Chills
Clinical narrative: Tired/chills/weakness beginning at 9PM on day of shot - next day increased chills/fatigue - numbness and tingling of limbs, swelling of Tongue & Throat and Difficulty breathing with chest pain -was seen in ER - given Benadryl which relieved swelling symptoms - had low fever as well.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Fatigue, Hypoaesthesia, Paraesthesia, Pharyngeal oedema
Clinical narrative: Tired/chills/weakness beginning at 9PM on day of shot - next day increased chills/fatigue - numbness and tingling of limbs, swelling of Tongue & Throat and Difficulty breathing with chest pain -was seen in ER - given Benadryl which relieved swelling symptoms - had low fever as well.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Swollen tongue
Clinical narrative: Tired/chills/weakness beginning at 9PM on day of shot - next day increased chills/fatigue - numbness and tingling of limbs, swelling of Tongue & Throat and Difficulty breathing with chest pain -was seen in ER - given Benadryl which relieved swelling symptoms - had low fever as well.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Dizziness, Eye movement disorder, Loss of consciousness, Musculoskeletal stiffness, Syncope
Clinical narrative: Syncopal episode:  Patient had her Tdap and Menactra today.  She was a little anxious when they were administered, but seemed fine afterward.  She went out into the waiting room w/ her mother and while there she felt light headed and blacked out.  Mother states patient's eyes rolled back, she stiffened and went down into a chair.  No loss of bowel/bladder control, no jerking movement of extremities or head/neck.  When I came out the waiting room patient was slumped in a chair.  She was alert, but appeared anxious.  She was able to stand and I walked her back to the exam room.  She sat down and was a little shakey (mild tremulousness).  She was responsive to verbal stimuli. She drank a small cup of water.  She said she could hear her mother when she blacked out, but could not see her.  VS were stable and her blood sugar was 103.  I kept her in the office for another 15-20 min and she felt much better.  She was able to walk out of the office on her own.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Tremor
Clinical narrative: Syncopal episode:  Patient had her Tdap and Menactra today.  She was a little anxious when they were administered, but seemed fine afterward.  She went out into the waiting room w/ her mother and while there she felt light headed and blacked out.  Mother states patient's eyes rolled back, she stiffened and went down into a chair.  No loss of bowel/bladder control, no jerking movement of extremities or head/neck.  When I came out the waiting room patient was slumped in a chair.  She was alert, but appeared anxious.  She was able to stand and I walked her back to the exam room.  She sat down and was a little shakey (mild tremulousness).  She was responsive to verbal stimuli. She drank a small cup of water.  She said she could hear her mother when she blacked out, but could not see her.  VS were stable and her blood sugar was 103.  I kept her in the office for another 15-20 min and she felt much better.  She was able to walk out of the office on her own.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blood bilirubin increased, Infection, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a physician and refers to an approximately 66 year old female patient. Current condition included hypertension. No drug allergies reported. On 22-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (dose unknown) (lot # K009105; expiry: 21-JAN-2016 (also reported as December 2016) in the right arm (route not specified). Other suspect therapies included influenza virus vaccine (unspecified) (manufacturer unknown) administered the same day in the left arm. Concomitant therapies included aspirin (manufacturer unknown), simvastatin (manufacturer unknown), metoprolol and EXFORGE. Approximately on an unknown date in October 2014, 4 hours after getting the vaccination the patient was presented to the emergency with a fever of 103 Fahrenheit (F) (Hospitalization), nausea (Hospitalization), body aches (Hospitalization), erythema (Hospitalization), swelling and extreme warmth at the site of PNEUMOVAX 23 injection (Hospitalization). The physician stated that the patient experienced heart rate was 110 (units unknown), white blood cell (WBC) count 20,000 (units unknown) and bilirubin 2.7 (units unknown) when the patient arrived to the hospital. The patient's most recent WBC count was 14000 (units unknown). The patient was treated with unspecified antibiotics for presumed infection fluids and unspecified topical steroid for localized reaction. Physician reported that she no longer has a fever and expressed no other complaints other than continued swelling in the arm (reported as recovering). Physician reports that the patient is still hospitalized at this time. The outcome of a fever of 103 F was reported as recovered as she no longer had fever approximately on an unknown date in October 2014. The outcome nausea, extreme warmth at PNEUMOVAX 23 injection site, body aches, erythema and was reported as resolved approximately on an unknown date in October 2014. The causality for the events was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Local reaction, Local swelling, Nausea, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a physician and refers to an approximately 66 year old female patient. Current condition included hypertension. No drug allergies reported. On 22-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (dose unknown) (lot # K009105; expiry: 21-JAN-2016 (also reported as December 2016) in the right arm (route not specified). Other suspect therapies included influenza virus vaccine (unspecified) (manufacturer unknown) administered the same day in the left arm. Concomitant therapies included aspirin (manufacturer unknown), simvastatin (manufacturer unknown), metoprolol and EXFORGE. Approximately on an unknown date in October 2014, 4 hours after getting the vaccination the patient was presented to the emergency with a fever of 103 Fahrenheit (F) (Hospitalization), nausea (Hospitalization), body aches (Hospitalization), erythema (Hospitalization), swelling and extreme warmth at the site of PNEUMOVAX 23 injection (Hospitalization). The physician stated that the patient experienced heart rate was 110 (units unknown), white blood cell (WBC) count 20,000 (units unknown) and bilirubin 2.7 (units unknown) when the patient arrived to the hospital. The patient's most recent WBC count was 14000 (units unknown). The patient was treated with unspecified antibiotics for presumed infection fluids and unspecified topical steroid for localized reaction. Physician reported that she no longer has a fever and expressed no other complaints other than continued swelling in the arm (reported as recovering). Physician reports that the patient is still hospitalized at this time. The outcome of a fever of 103 F was reported as recovered as she no longer had fever approximately on an unknown date in October 2014. The outcome nausea, extreme warmth at PNEUMOVAX 23 injection site, body aches, erythema and was reported as resolved approximately on an unknown date in October 2014. The causality for the events was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: White blood cell count increased
Clinical narrative: This spontaneous report was received from a physician and refers to an approximately 66 year old female patient. Current condition included hypertension. No drug allergies reported. On 22-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (dose unknown) (lot # K009105; expiry: 21-JAN-2016 (also reported as December 2016) in the right arm (route not specified). Other suspect therapies included influenza virus vaccine (unspecified) (manufacturer unknown) administered the same day in the left arm. Concomitant therapies included aspirin (manufacturer unknown), simvastatin (manufacturer unknown), metoprolol and EXFORGE. Approximately on an unknown date in October 2014, 4 hours after getting the vaccination the patient was presented to the emergency with a fever of 103 Fahrenheit (F) (Hospitalization), nausea (Hospitalization), body aches (Hospitalization), erythema (Hospitalization), swelling and extreme warmth at the site of PNEUMOVAX 23 injection (Hospitalization). The physician stated that the patient experienced heart rate was 110 (units unknown), white blood cell (WBC) count 20,000 (units unknown) and bilirubin 2.7 (units unknown) when the patient arrived to the hospital. The patient's most recent WBC count was 14000 (units unknown). The patient was treated with unspecified antibiotics for presumed infection fluids and unspecified topical steroid for localized reaction. Physician reported that she no longer has a fever and expressed no other complaints other than continued swelling in the arm (reported as recovering). Physician reports that the patient is still hospitalized at this time. The outcome of a fever of 103 F was reported as recovered as she no longer had fever approximately on an unknown date in October 2014. The outcome nausea, extreme warmth at PNEUMOVAX 23 injection site, body aches, erythema and was reported as resolved approximately on an unknown date in October 2014. The causality for the events was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 31-year-old female subject was enrolled in a study during pregnancy or within 28 days preceding conception. On an unknown date, the subject received Flu QIV. The subject's estimated date of delivery was 19th January 2015. On an unknown date, an unknown time after receiving Flu QIV the subject developed exposure during pregnancy (Non-serious). The outcome of exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the exposure during pregnancy to be related to Flu QIV. Given that this was from a consumer, this report was completed only as a precaution. Additional details: A patient who was currently 6 months pregnant reported wanting to get the FLUARIX QUADRIVALENT and wondered if GSK has any information about its use during pregnancy. No administration had occurred.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 36-year-old female subject was enrolled in a study. On 15th October 2014, the subject received Flu Seasonal QIV Dresden (intramuscular) .5 ml. The subject's last menstrual period was on 18th April 2014 and estimated date of delivery was 23rd January 2015. The subject received Flu Seasonal QIV Dresden at week 26 of the pregnancy and during the second trimester of pregnancy. On an unknown date, an unknown time after receiving Flu Seasonal QIV Dresden the subject developed exposure during pregnancy (Non-serious). The outcome of exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the exposure during pregnancy to be related to Flu Seasonal QIV Dresden. Additional details: The dosage given was 0.5cc. She stated she is 26 weeks gestation. Reporter called to register in pregnancy registry.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown gender and age. It was reported that the office did not monitor the freezer temperature for the past two months (from August 2014), and it was not known if the freezer had been maintaining the correct temperature. The freezer stored VARIVAX (Merck) and unspecified number of patients were vaccinated (in approximately 2014) with VARIVAX (Merck) injection (dose, dose number, lot/batch number, expiration date and route of administration were not reported). No symptoms were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: (L) shoulder/upper arm pain since flu shot.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Radiating pain from injection site starting 3-4 hours post injection. Intense pain x 3 days. Pain has gotten better over time, but still has significant pain (27 days post injection).