chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Headache, Pain, Pyrexia
Clinical narrative: Severe body aches, especially back pain, headaches and fever for 5 days so far.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Injection site erythema, Nausea, Pain
Clinical narrative: Complaint of intermittent sharp pain to entire left side pain level 5/10, nausea, redness at injection site and on lower left anterior arm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Platelet count decreased, Thrombocytopenia
Clinical narrative: Routine blood work 5 days after injection showed thrombocytopenia. Platelets were at 22,000.  Hospitalized 2 days for observation & began prednisone therapy. Prednisone seemed to help the situation. Weekly Hematologist appointments along with weekly blood tests to assess platelet count. 7 weeks later still weaning off of prednisone with next appointments for blood work & doctor scheduled after in 4 weeks.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen at injection site and traveled down the arm towards in side of the arm. The swelling was not warm to the touch and was about 6 inches in diameter. It had a little redness around the area.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Left upper arm and left shoulder became extremely painful with slightest movement and to touch. Body became chilled and energy level dropped dramatically for about 36 hours.  The movement of left arm was painful to the point of not able to use left arm or being able to touch upper left arm especially injection site.
Age: 48.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Feeding disorder, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Husband states patient has been experiencing fever, chills, a rash spreading throughout the body, nausea to which she hasn't been able to eat, and swollen arm at inject site as well as redness.
Age: 48.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Husband states patient has been experiencing fever, chills, a rash spreading throughout the body, nausea to which she hasn't been able to eat, and swollen arm at inject site as well as redness.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Erythema, induration, and pain 10 cm radius of injection site as evaluated approximately 36 hours after placement. No systemic symptoms.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling
Clinical narrative: Swelling of lips, ongoing as of 12/16/2017 AM.
Age: 21.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: Cellulitis on upper left arm, redness, pain, began 12/15, began antibiotics 12/16.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash generalised
Clinical narrative: Skin rash all over body. Comes and goes. Seems to worsen after showering. Itching /reddening.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Feeling abnormal, Immediate post-injection reaction, Pruritus generalised, Throat tightness
Clinical narrative: Felt out of it immediately after vaccination. Difficulty breathing, throat clogging, shortness of breath started about 1.5 hours after vaccine. Full body itchiness started after about 3 hours.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Injected limb mobility decreased, Injection site discolouration, Pain, Pain in extremity
Clinical narrative: Extreme right arm pain still occurring three days later, inability to lift arm over 45°. Shirt material touching arm is painful. White oval area at site of injection still remaining to date. Fever- like symptoms for 2 days following injection, body aches, medicine head feeling.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Tenderness
Clinical narrative: Extreme right arm pain still occurring three days later, inability to lift arm over 45°. Shirt material touching arm is painful. White oval area at site of injection still remaining to date. Fever- like symptoms for 2 days following injection, body aches, medicine head feeling.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Approximately 20 minutes after the shot he reported feeling lightheaded/dizzy and as if he was going to faint. He had to sit down for a few minutes and then reported he began to feel fine again.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen and red from shoulder to mid forearm.
Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Alveolitis allergic, Biopsy lung, Borrelia test positive, Fatigue, Headache
Clinical narrative: Flu like symptoms, sore throat, sinus pain, head pain, ached all over, tired, joints swollen, hypersensitivity pneumonitis, migraines, vertigo, vocal cord dysfunction and developed allergies to mold. It has progressively worsened over the last 17 years and no treatment thus far has helped.
Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Influenza like illness, Joint swelling, Migraine, Mycotic allergy, Oropharyngeal pain
Clinical narrative: Flu like symptoms, sore throat, sinus pain, head pain, ached all over, tired, joints swollen, hypersensitivity pneumonitis, migraines, vertigo, vocal cord dysfunction and developed allergies to mold. It has progressively worsened over the last 17 years and no treatment thus far has helped.
Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Pain, Pulmonary function test, Sinus pain, Urine analysis abnormal, Vertigo
Clinical narrative: Flu like symptoms, sore throat, sinus pain, head pain, ached all over, tired, joints swollen, hypersensitivity pneumonitis, migraines, vertigo, vocal cord dysfunction and developed allergies to mold. It has progressively worsened over the last 17 years and no treatment thus far has helped.
Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Vocal cord dysfunction
Clinical narrative: Flu like symptoms, sore throat, sinus pain, head pain, ached all over, tired, joints swollen, hypersensitivity pneumonitis, migraines, vertigo, vocal cord dysfunction and developed allergies to mold. It has progressively worsened over the last 17 years and no treatment thus far has helped.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Arthritis, Laboratory test, Pain, Vaccination complication
Clinical narrative: I got a flu shot at work October 5th as I usually do. By Sunday night I had become sore and achy all across my body. I went to an emergency room on Monday as I knew something was very wrong. Unfortunately the doctor who saw me ignored most of my symptoms and diagnosed me with arthritis in the knee. Later that week I saw Dr and he diagnosed a bad reaction to the flu vaccine. He referred me to a rheumatologist  as the vaccine seems to have triggered arthritis.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Insomnia, Pain, Pain in extremity
Clinical narrative: I received the flu shot 10/05/2017 then that night about 10:00 PM my arm started hurting that night and still today my arm won't let me sleep at night my arm just aches I work in apparel and hang up clothes put returns away fix racks and fold clothes on tables and my arm just aches it is keeping me from sleeping and doing my job.
Age: 68.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient is a nurse. About 6pm the evening of the injection I.M. to the Left Arm Deltoid Muscle she noticed a slight feeling of pain and associated slight stiffness. Especially when lifting arm vertically (above her head). The positive of the bandage that covered the puncture site was noticeably high on the left appendage, almost at, where the Deltoid Muscle connects to the Clavicle. The patient suspected if the injection was at this height, it may have missed the Deltoid and the vaccine may have been deposited in the sub deltoid bursa. She reports that as of date of this report (12/15/2017), that there is still tenderness and soreness at the site and that vertical lifting of the arm is still impaired. It is showing improvement. But advised by other medical personnel whom she works with to mention the adverse event when next time at the Pharmacy. There was no redness or swelling or discoloration at the site at time of injection or afterwards. Pt is not physically impaired by the noticeable soreness when arm is lifted or moved at this time but discomfort upon movement as described continues to be present. Her thoughts are that healing is still ongoing and prognosis is good for full recovery at this time.
Age: 57.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient says after he received PNEUMOVAX-23, the next day, the area was red, swollen, extremely sore, painful, couldn't pick up arm for 3-4 days. There was a redness circle that spread around arm and shoulder. This subsided in one week. This occurred in left arm.
Age: 43.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Muscular weakness, Musculoskeletal pain, Pain in extremity
Clinical narrative: This initial serious spontaneous case, was received on 06-Dec-2017, from a nurse, concerning a 43-year-old adult female patient. The patient's current conditions included, high blood pressure and hypothyroidism. The patient's concomitant medications included, SYNTHROID and hydrochlorothiazide for unknown indications. On 10-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195219, expiry date: 30-Apr-2018). On 15-Oct-2017, after 6 days of vaccination, the patient developed pain and weakness in her left shoulder and arm. It was reported that, the patient had a questionable reaction of Parsonage-Turner Syndrome. The patient consulted physician and was advised with physical therapy. There was no improvement with physical therapy. At the time of the report, the patient had not recovered from the event. The reporter assessed the events as related to the vaccine.
Age: 43.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: This initial serious spontaneous case, was received on 06-Dec-2017, from a nurse, concerning a 43-year-old adult female patient. The patient's current conditions included, high blood pressure and hypothyroidism. The patient's concomitant medications included, SYNTHROID and hydrochlorothiazide for unknown indications. On 10-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195219, expiry date: 30-Apr-2018). On 15-Oct-2017, after 6 days of vaccination, the patient developed pain and weakness in her left shoulder and arm. It was reported that, the patient had a questionable reaction of Parsonage-Turner Syndrome. The patient consulted physician and was advised with physical therapy. There was no improvement with physical therapy. At the time of the report, the patient had not recovered from the event. The reporter assessed the events as related to the vaccine.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Mobility decreased, Pain in extremity
Clinical narrative: As of 12/16/2017 still experiencing soreness in area where vaccine was given on 11/13/2017. Unable to raise arm over head, restricted range of motion, and constant pain daily.
Age: 0.58
Sex: F
Vaccine: DTAP
Symptoms: Bacterial test negative, CSF cell count normal, CSF culture negative, CSF glucose normal, CSF protein normal
Clinical narrative: About three weeks after vaccination: Bulging fontanelle, change in cry, low fever (100.4) possibly associated with cold not vaccine reaction. Spinal Tap performed at Hospital to rule out bacterial, viral, or fungal infection of central nervous system; no infection found after blood, urine, and spinal fluid samples tested. The multiple physicians told us it was "just her normal range of fluid".
Age: 0.58
Sex: F
Vaccine: DTAP
Symptoms: CSF virus no organisms observed, Crying, Differential white blood cell count normal, Enterovirus test negative, Fontanelle bulging
Clinical narrative: About three weeks after vaccination: Bulging fontanelle, change in cry, low fever (100.4) possibly associated with cold not vaccine reaction. Spinal Tap performed at Hospital to rule out bacterial, viral, or fungal infection of central nervous system; no infection found after blood, urine, and spinal fluid samples tested. The multiple physicians told us it was "just her normal range of fluid".
Age: 0.58
Sex: F
Vaccine: DTAP
Symptoms: Full blood count normal, Fungal test negative, Metabolic function test normal, Polymerase chain reaction, Pyrexia
Clinical narrative: About three weeks after vaccination: Bulging fontanelle, change in cry, low fever (100.4) possibly associated with cold not vaccine reaction. Spinal Tap performed at Hospital to rule out bacterial, viral, or fungal infection of central nervous system; no infection found after blood, urine, and spinal fluid samples tested. The multiple physicians told us it was "just her normal range of fluid".
Age: 0.58
Sex: F
Vaccine: DTAP
Symptoms: Urine analysis normal
Clinical narrative: About three weeks after vaccination: Bulging fontanelle, change in cry, low fever (100.4) possibly associated with cold not vaccine reaction. Spinal Tap performed at Hospital to rule out bacterial, viral, or fungal infection of central nervous system; no infection found after blood, urine, and spinal fluid samples tested. The multiple physicians told us it was "just her normal range of fluid".
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy, Blood test, Diarrhoea, Discomfort, Lip swelling
Clinical narrative: Swollen Face - a few days. Lip Swelling - a few days. Hives from onset until present (they appear and disappear all over my body and in crevices). Diarrhea from onset until the end of September. Severe Itching and discomfort from onset until mid October.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: Swollen Face - a few days. Lip Swelling - a few days. Hives from onset until present (they appear and disappear all over my body and in crevices). Diarrhea from onset until the end of September. Severe Itching and discomfort from onset until mid October.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Muscle soreness in shoulder/upper arm where vaccine was given. Can only lift arm halfway up. It goes away for a little while during the day if patient works out but will be very sore in the morning after sleeping all night.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient is experiencing worsening pain in her shoulder that radiates to her elbow. Has difficulty lifting her right arm and has trouble dressing herself.
Age: 55.0
Sex: M
Vaccine: FLUR3
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Tinnitus
Clinical narrative: Within 5 minutes the patient experienced diaphoresis, weakness, lightheadedness, and 1 hour later got tinnitus in bilateral ears which has occurred intermittently on an ongoing basis since the vaccine administration, and which had NEVER occurred prior to receiving the vaccine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient presented to the pharmacy 5 days after the immunization was administered. She states that on day post immunization, she noticed redness and swelling  in the arm. When this didn't improve, she went to Convenient Care where she was given topical OTC lidocaine and told the swelling should improve. Two days later, she still hadn't noticed any improvement, so she went to the ER where she was given famotidine and benadryl and was told to contacted her allergist if there was still no improvement
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Blood test normal, Electroencephalogram, Febrile convulsion, Nuclear magnetic resonance imaging, Urine analysis normal
Clinical narrative: Febrile seizure, hospitalized, outpatient EEG and MRI pending.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenopathy, Nerve injury
Clinical narrative: Nerve damage to left arm and swollen  axillary lymph node.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Muscular weakness, Sensation of foreign body, Tremor
Clinical narrative: DIZZYNESS, SHAKING, LUMP IN THROAT, SHORTNESS OF BREATH, FEELING FAINT, LEG WEAKNESS.
Age: 40.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: CSF test, Ejaculation failure, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Patient is 40 Years Old Male. Pt. stayed in hospital for a few days recently with the Dx of myelitis, poss. due to TDaP vaccine. On 10/5/2017, pt had flu shot and Tdap vaccine here for preventive care as routine as well indicated as a construction worker. A few days later pt had dull headache moderate, and pt felt very tired. Gradually pt felt numbness below the lower back level. Then pt's headache became worse not responded to OTC pain med. On 10/13, pt C/O intolerable headache, pt RTC and NAPROSYN was given, pt's Sx is still not responded at all. Next day on 10/14, pt went to ER, and admitted as myelitis, pt stayed there for a few days, had CSF/ brain MRI and other test. Pt was given IV steroids for 3 days, his headache resolved, and his numbness is subsiding. However pt C/O he had been unable to ejaculate. Up to today, pt's numbness resolved, and his ejaculation problem has improved, but not resolved yet. Pt is going to repeat brain MRI on 11/22/2017 and F/U with neurologist.
Age: 40.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Laboratory test, Myelitis, Nuclear magnetic resonance imaging brain
Clinical narrative: Patient is 40 Years Old Male. Pt. stayed in hospital for a few days recently with the Dx of myelitis, poss. due to TDaP vaccine. On 10/5/2017, pt had flu shot and Tdap vaccine here for preventive care as routine as well indicated as a construction worker. A few days later pt had dull headache moderate, and pt felt very tired. Gradually pt felt numbness below the lower back level. Then pt's headache became worse not responded to OTC pain med. On 10/13, pt C/O intolerable headache, pt RTC and NAPROSYN was given, pt's Sx is still not responded at all. Next day on 10/14, pt went to ER, and admitted as myelitis, pt stayed there for a few days, had CSF/ brain MRI and other test. Pt was given IV steroids for 3 days, his headache resolved, and his numbness is subsiding. However pt C/O he had been unable to ejaculate. Up to today, pt's numbness resolved, and his ejaculation problem has improved, but not resolved yet. Pt is going to repeat brain MRI on 11/22/2017 and F/U with neurologist.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: CANNOT RAISE ARM.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient started feeling itching and warm at injectin site. Redness spread about 6 to 7 inches from injection site. Pt applied hydrocortisone cream otc. Patient was told by pharmD to take Benadryl and then later decided to go to emergency room to get checked. ER prescriber gave her a prescription for prednisone to take along with zantac. She also recommended zyrtec.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Tinnitus
Clinical narrative: This initial serious spontaneous case, was received from other non-health professional (consumer) on 16-Nov-2017, concerns a 61-year-old female patient. The patient's medical history included seasonal allergies and concomitant medications included CLARITIN for allergies. On 30-Oct-2017, the patient was administered with FLUCELVAX QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 195233 and expiry date: May-2018). On the same day, few hours post vaccination, the patient developed severe ringing in ears, which continued. The patient consulted ENT. She was prescribed with lipoflavonoid plus and was advised to see an audiologist in the following week for hearing test. On an unknown date, the audiologist identified a mild hearing loss in right ear, but not in left ear. The patient continued vitamins (lipoflavonoids) recommended by the physician. At the time of this report, the patient had not yet recovered from the events. Follow-up report received on 05-Dec-2017: Added event hearing loss unilateral, case was upgraded to serious (medically significant), added reporter's comment. Accordingly updated narrative.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Pain at injection site next day leading to pins/needles shooting down arm and numbness to thumb/pointer finger.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Inflammation, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Patient had an injection site reaction (redness and swelling) as well as fever, muscle ache, and chills. She is currently taking ibuprofen to reduce inflammation from the reaction.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient had an injection site reaction (redness and swelling) as well as fever, muscle ache, and chills. She is currently taking ibuprofen to reduce inflammation from the reaction.
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a health care professional via Pfizer (MFR control# 2017327286) regarding a female patient of unknown age. Her concurrent conditions included polycystic ovaries, essential hypertension and insulin resistance. Her medical history and concomitant mediations were not reported. The patient did not have any adverse events (AEs) prior to the vaccination. On an unknown date in 2017 at 08:45, the patient was vaccinated with GARDASIL 9 second dose (dose, units not reported) (lot # N001533, expiration: 16-OCT-2019), via intramuscular route in the left deltoid with MENACTRA second dose (0.5 cc each, one time) (lot # 45415AA, expiration: 16-NOV-2017 (also reported as 16-OCT-2017)) via intramuscular route at right deltoid and TRUMENBA (0.5 cc each, one time) (lot # R450077, expiration: 31-JUL-2018) via intramuscular route at right arm for starting college (prophylaxis). The patient was vaccinated at the physician's office. On 16-JUL-2017, the patient experienced local reaction causing cellulitis). The patient had cellulitis of right upper arm (also reported as cellulitis of left upper arm). The patient was not hospitalized. The patient did not require emergency room admission but had a visit to the physician office. It was noted that there were no disposing factors for the development of cellulitis. No cultures were performed. On 21-JUL-2017, the patient was treated with cephalexin (500 mg every 12 hrs by mouth for 7 days) and MEDROL (as per directions) for the event. The outcome of cellulitis of upper arm was reported as recovered/resolved on an unknown date in 2017. The reporter did not provide the causality of cellulitis with HPV GARDASIL 9 and MENACTRA. The reporter assessed the causality of cellulitis with TRUMENBA as related. Upon internal review, the cellulitis was determined to be medically significant.
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Injection site cellulitis, Local reaction
Clinical narrative: This spontaneous report was received from a health care professional via Pfizer (MFR control# 2017327286) regarding a female patient of unknown age. Her concurrent conditions included polycystic ovaries, essential hypertension and insulin resistance. Her medical history and concomitant mediations were not reported. The patient did not have any adverse events (AEs) prior to the vaccination. On an unknown date in 2017 at 08:45, the patient was vaccinated with GARDASIL 9 second dose (dose, units not reported) (lot # N001533, expiration: 16-OCT-2019), via intramuscular route in the left deltoid with MENACTRA second dose (0.5 cc each, one time) (lot # 45415AA, expiration: 16-NOV-2017 (also reported as 16-OCT-2017)) via intramuscular route at right deltoid and TRUMENBA (0.5 cc each, one time) (lot # R450077, expiration: 31-JUL-2018) via intramuscular route at right arm for starting college (prophylaxis). The patient was vaccinated at the physician's office. On 16-JUL-2017, the patient experienced local reaction causing cellulitis). The patient had cellulitis of right upper arm (also reported as cellulitis of left upper arm). The patient was not hospitalized. The patient did not require emergency room admission but had a visit to the physician office. It was noted that there were no disposing factors for the development of cellulitis. No cultures were performed. On 21-JUL-2017, the patient was treated with cephalexin (500 mg every 12 hrs by mouth for 7 days) and MEDROL (as per directions) for the event. The outcome of cellulitis of upper arm was reported as recovered/resolved on an unknown date in 2017. The reporter did not provide the causality of cellulitis with HPV GARDASIL 9 and MENACTRA. The reporter assessed the causality of cellulitis with TRUMENBA as related. Upon internal review, the cellulitis was determined to be medically significant.
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a health care professional via Pfizer (MFR control# 2017327286) regarding a female patient of unknown age. Her concurrent conditions included polycystic ovaries, essential hypertension and insulin resistance. Her medical history and concomitant mediations were not reported. The patient did not have any adverse events (AEs) prior to the vaccination. On an unknown date in 2017 at 08:45, the patient was vaccinated with GARDASIL 9 second dose (dose, units not reported) (lot # N001533, expiration: 16-OCT-2019), via intramuscular route in the left deltoid with MENACTRA second dose (0.5 cc each, one time) (lot # 45415AA, expiration: 16-NOV-2017 (also reported as 16-OCT-2017)) via intramuscular route at right deltoid and TRUMENBA (0.5 cc each, one time) (lot # R450077, expiration: 31-JUL-2018) via intramuscular route at right arm for starting college (prophylaxis). The patient was vaccinated at the physician's office. On 16-JUL-2017, the patient experienced local reaction causing cellulitis). The patient had cellulitis of right upper arm (also reported as cellulitis of left upper arm). The patient was not hospitalized. The patient did not require emergency room admission but had a visit to the physician office. It was noted that there were no disposing factors for the development of cellulitis. No cultures were performed. On 21-JUL-2017, the patient was treated with cephalexin (500 mg every 12 hrs by mouth for 7 days) and MEDROL (as per directions) for the event. The outcome of cellulitis of upper arm was reported as recovered/resolved on an unknown date in 2017. The reporter did not provide the causality of cellulitis with HPV GARDASIL 9 and MENACTRA. The reporter assessed the causality of cellulitis with TRUMENBA as related. Upon internal review, the cellulitis was determined to be medically significant.
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Cellulitis, Local reaction
Clinical narrative: This spontaneous report was received from a health care professional via Pfizer (MFR control# 2017327286) regarding a female patient of unknown age. Her concurrent conditions included polycystic ovaries, essential hypertension and insulin resistance. Her medical history and concomitant mediations were not reported. The patient did not have any adverse events (AEs) prior to the vaccination. On an unknown date in 2017 at 08:45, the patient was vaccinated with GARDASIL 9 second dose (dose, units not reported) (lot # N001533, expiration: 16-OCT-2019), via intramuscular route in the left deltoid with MENACTRA second dose (0.5 cc each, one time) (lot # 45415AA, expiration: 16-NOV-2017 (also reported as 16-OCT-2017)) via intramuscular route at right deltoid and TRUMENBA (0.5 cc each, one time) (lot # R450077, expiration: 31-JUL-2018) via intramuscular route at right arm for starting college (prophylaxis). The patient was vaccinated at the physician's office. On 16-JUL-2017, the patient experienced local reaction causing cellulitis). The patient had cellulitis of right upper arm (also reported as cellulitis of left upper arm). The patient was not hospitalized. The patient did not require emergency room admission but had a visit to the physician office. It was noted that there were no disposing factors for the development of cellulitis. No cultures were performed. On 21-JUL-2017, the patient was treated with cephalexin (500 mg every 12 hrs by mouth for 7 days) and MEDROL (as per directions) for the event. The outcome of cellulitis of upper arm was reported as recovered/resolved on an unknown date in 2017. The reporter did not provide the causality of cellulitis with HPV GARDASIL 9 and MENACTRA. The reporter assessed the causality of cellulitis with TRUMENBA as related. Upon internal review, the cellulitis was determined to be medically significant.
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Eye swelling, Pyrexia, Rash generalised
Clinical narrative: Initial unsolicited report received from other health care professional on 04-Dec-2017 and additional information received on 05 Dec 2017. This case involves 31 month old (reported as two year old) female patient who was vaccinated with 0.25 ml third dose of FLUZONE QIV (frequency: once, Batch number, expiration date, dose and site of administration was not reported) via intramuscular route on 20 Sep 2017. The patient's medical history includes seasonal allergies and reflux. Corrective treatment includes Zyrtec and Zantac for seasonal allergies and reflux. On 20 Sep 2017 in the afternoon, same day following the vaccination, the patient experienced allergic reaction i.e. rash with hives. After treatment, the patient transported to an urgent care as she did not improve and now had a low-grade temperature of 100.2F (started on an unspecified date post vaccination). In the early am of 22 Sep 2017, two days post vaccination, the parents reached out to the office to say they felt the child's face was swelling she was transported to hospital emergency room. They evaluated the child they did not find an increase in allergy symptoms and instructed the parents to continue the same treatments already prescribed. Lab data was not reported. The patient received corrective treatment with Benadryl orally along with Prednisone. The patient improved gradually with treatment. On an unspecified date, the patient was recovered from the events. This case was considered as serious due to medically significant events. List of documents held by sender: none. Sender's Comments: The patient experienced allergic reaction post vaccination with FLUZONE QIV. Time to onset was compatible. Since the patient was already on treatment for seasonal allergies and reflux. It might as well be possible that the response underliying allergic condition. Based temporal relationship the role of the vaccine cannot be excluded.
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Body temperature increased, Hypersensitivity, Rash, Swelling face, Urticaria
Clinical narrative: Initial unsolicited report received from other health care professional on 04-Dec-2017 and additional information received on 05 Dec 2017. This case involves 31 month old (reported as two year old) female patient who was vaccinated with 0.25 ml third dose of FLUZONE QIV (frequency: once, Batch number, expiration date, dose and site of administration was not reported) via intramuscular route on 20 Sep 2017. The patient's medical history includes seasonal allergies and reflux. Corrective treatment includes Zyrtec and Zantac for seasonal allergies and reflux. On 20 Sep 2017 in the afternoon, same day following the vaccination, the patient experienced allergic reaction i.e. rash with hives. After treatment, the patient transported to an urgent care as she did not improve and now had a low-grade temperature of 100.2F (started on an unspecified date post vaccination). In the early am of 22 Sep 2017, two days post vaccination, the parents reached out to the office to say they felt the child's face was swelling she was transported to hospital emergency room. They evaluated the child they did not find an increase in allergy symptoms and instructed the parents to continue the same treatments already prescribed. Lab data was not reported. The patient received corrective treatment with Benadryl orally along with Prednisone. The patient improved gradually with treatment. On an unspecified date, the patient was recovered from the events. This case was considered as serious due to medically significant events. List of documents held by sender: none. Sender's Comments: The patient experienced allergic reaction post vaccination with FLUZONE QIV. Time to onset was compatible. Since the patient was already on treatment for seasonal allergies and reflux. It might as well be possible that the response underliying allergic condition. Based temporal relationship the role of the vaccine cannot be excluded.
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypersensitivity, Pharyngeal erythema, Urticaria
Clinical narrative: Mild perioral hives same day after vaccine resolved without sequelae after BENADRYL.
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Urticaria
Clinical narrative: Mild perioral hives same day after vaccine resolved without sequelae after BENADRYL.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia, Hypoaesthesia, Loss of personal independence in daily activities
Clinical narrative: I had every side effect that the shot had! About 2 week after I took the shot all my joints hurt. The first 2 weeks I hurt so bad I couldn't sleep in my bed I had to sit in a chair-2nd week I lost all fellings in the bath tub. My wife had to help me out of it and also fainted in my living room. My fingers on my left hand has hurt me ever since this shot I don't have any control of my fingers on either hand some of my muscles in my arm and shoulder are still sore. I had to learn how to walk again. I'm beginning to tie my shoes again I can't still button my pants and have no control of my hands. This shot has really ruined my body as well as my life. I've been hurting since Oct. I took this shot 2 years ago no problem when the guy give me the shot my arm bleed.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Gait disturbance, Insomnia, Loss of personal independence in daily activities, Musculoskeletal stiffness
Clinical narrative: I had every side effect that the shot had! About 2 week after I took the shot all my joints hurt. The first 2 weeks I hurt so bad I couldn't sleep in my bed I had to sit in a chair-2nd week I lost all fellings in the bath tub. My wife had to help me out of it and also fainted in my living room. My fingers on my left hand has hurt me ever since this shot I don't have any control of my fingers on either hand some of my muscles in my arm and shoulder are still sore. I had to learn how to walk again. I'm beginning to tie my shoes again I can't still button my pants and have no control of my hands. This shot has really ruined my body as well as my life. I've been hurting since Oct. I took this shot 2 years ago no problem when the guy give me the shot my arm bleed.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Myalgia, Pain in extremity, Sensory loss, Syncope
Clinical narrative: I had every side effect that the shot had! About 2 week after I took the shot all my joints hurt. The first 2 weeks I hurt so bad I couldn't sleep in my bed I had to sit in a chair-2nd week I lost all fellings in the bath tub. My wife had to help me out of it and also fainted in my living room. My fingers on my left hand has hurt me ever since this shot I don't have any control of my fingers on either hand some of my muscles in my arm and shoulder are still sore. I had to learn how to walk again. I'm beginning to tie my shoes again I can't still button my pants and have no control of my hands. This shot has really ruined my body as well as my life. I've been hurting since Oct. I took this shot 2 years ago no problem when the guy give me the shot my arm bleed.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Syringe issue
Clinical narrative: Medical assistant was administering a High Dose Flu shot. While administering the injection, a piece of plastic came off the syringe, creating a hole. The liquid went down the patient's arm. Without full knowledge of exactly what happen the patient left. After inspecting the syringe, the medical assistant noticed the hole and searched the room and found the piece that had broke off.
Age: 33.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Cellulitis, Injection site abscess, Injection site rash, Rash
Clinical narrative: Small rash (~.5 in) came on late evening on Dec 9 on the left arm, about 1.5 inches from the injection site. The next morning had spread to about 3 inches. By that evening it covered most of the upper arm and was noticeably warm to the touch. I went to the doctor the next afternoon and was diagnosed with cellulitis and prescribed Doxycycline, which I took for seven days. After a day of Doxy the heat was gone and rash had faded, by two days it was gone.
Age: 26.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Firmness and swelling to the left deloid.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain, Pain in extremity
Clinical narrative: Very sore left arm starting on the morning after inoculation. I have severe pain when raising my left arm to take off and put on clothes, and reach out to do anything at all like wash or style my hair, routine housework, put on or take off a coat. It has been 6 1/2 weeks now, with some small decrease in pain in just the last few days. I had pain 2 years ago from a flu shot, but it only lasted about 5 days. I will not get another flu shot until my research determines that you have fixed this problem. It is bad medicine to inflict pain for ADL's on aging people in the name of health care. I would rather have the full use of my arm. I will be watching and reaching out to others about this issue, and plan to not have another "treatment" which is so debilitating.
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 20 year old male patient. The patient's medical history, drug reactions/allergies and concomitant medications were not provided. On 13-NOV-2017, the patient was vaccinated with the first dose of VARIVAX subcutaneously, in the right deltoid, for prophylaxis (lot# L049532, expiration date: 08-DEC-2017) in the physician's office. On 16-NOV-2017, the patient went back to the office for a laboratory appointment, the staff read wrong the provider note, and he received a second dose of VARIVAX subcutaneously, in the left deltoid, for prophylaxis (lot# L049532, expiration date: 08-DEC-2017). Both doses were reconstituted with sterile diluent (manufacturer unknown). The patient was vaccinated at a Private doctor's office with private founds. The reporter described that the event was related to human error and was not a result of product confusion. The patient did not complain for any side effects, no adverse effects were reported and no product quality complaint was involved. No prescription drug treatment for the experience was required. The vaccines did not undergo temperature excursion.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injected limb mobility decreased, Nausea
Clinical narrative: This spontaneous report as received from a physician refers to a 66 year old female patient via Medical Records. The patient's concomitant medication included chronic kidney disease stage 3 with a glomerular filtration rate (GFR) mildly low, astigmatism, onychomycosis and spinal osteoarthritis. The patient's medical history included intervertebral disc space narrowing. The patient's historical drug included PREVNAR, terbinafine and celecoxib (CELEBREX). The patient did not have allergies. On 14-NOV-2017 at 17:15,  the patient was vaccinated with PNEUMOVAX 23 lot number N019348, expiration date 08-FEB-2017 (dose, route and anatomical site were not reported) for prophylaxis. Concomitant therapies included acetaminophen, diphenhydramine hydrochloride (TYLENOL PM) and acay berry extract. On 15-NOV-2017 at 02:30, the patient woke up and "could not lift the arm which was vaccinated, and whole side was throbbing". The patient also experienced "nausea, headache and chills". It was reported that she took nabumetone 500mg, but the physician did not prescribe treatment for the events. Afterwards, she recovered throughout the day. The causal relationship between the events and PNEUMOVAX 23 was not reported. All available medical records will be provided upon request.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacy technician who referred to a 65 years old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unspecified date in 2017 (reported as 31-OCT-2017 or 15-NOV-2017), the patient was vaccinated with PNEUMOVAX 23 injection, intramuscularly, lot # N013521, expiration date 23-JAN-2019 (dose was not reported) for prophylaxis. On 17-NOV-2017, the patient came to the pharmacist in pharmacy and reported that he experienced "redness and swelling down the unspecified arm that he received the PNEUMOVAX 23 in". No treatment was given for the adverse events. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. The reporter requested a lot check for lot N013521 of PNEUMOVAX 23. Sender's Comments: US-009507513-1711USA007973.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacy technician who referred to a 65 years old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unspecified date in 2017 (reported as 31-OCT-2017 or 15-NOV-2017), the patient was vaccinated with PNEUMOVAX 23 injection, intramuscularly, lot # N013521, expiration date 23-JAN-2019 (dose was not reported) for prophylaxis. On 17-NOV-2017, the patient came to the pharmacist in pharmacy and reported that she experienced "redness and swelling down the unspecified arm that she received the PNEUMOVAX 23 in". No treatment was given for the adverse events. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. The reporter requested a lot check for lot# N013521 of PNEUMOVAX 23.; Sender's Comments:  US-009507513-1711USA007967:
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to 18 years old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions, and allergies were not reported. On 19-FEB-2017, the patient was vaccinated with the first dose of GARDASIL intramuscularly for prophylaxis. (Dosage schedule, strength, lot number, and expiration date were not reported). On 11-AUG-2017 and 13-NOV-2017, the patient was vaccinated with the second and third dose of GARDASIL 9 respectively, intramuscularly in the left deltoid, for prophylaxis (Lot numbers: N004799 and N017833 expiration dates: 15-NOV-2019 and 16-NOV-2019; however the dosage schedule and strength were not reported). By the time of the report, the patient did not experience any adverse events.
Sex: U
Vaccine: HIBV, HPV9, MMR, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, concerning multiple unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant medications were not reported. The nurse informed that on an unspecified date, multiple patients were vaccinated with improperly stored doses of M-M-R II lot #N001531, Expiration date 13-ENE-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis which was reconstituted with a properly stored sterile diluent( MERCK STERILE DILUENT); GARDASIL 9 lot #N015089, expiration date 20-OCT-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis; LIQUID PEDVAXHIB lot #N000238 and N007750 respectively, expiration dates 25-OCT-2019 and 29-NOV-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis; and with PNEUMOVAX 23 lot #N020501, expiration date 03-MAR-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse reactions were reported. The temperature of excursion was reported as 47°F to 77°F (47.8°F) during a time frame of 1 hour and 5 minutes. There was no previous temperature excursion reported. There was a digital data logger involved.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner who refers to a an approximately16 years old patient of unknown gender. No information regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies was reported. In December 2014 , at the age of 14 years, the patient was vaccinated with a first dose of GARDASIL injection (lot #, expiration date, dose and route of administration were not provided) for prophylaxis. On 25-JUL-2017, the patient was vaccinated with second dose of GARDASIL injection (lot #, expiration date, dose and route of administration were not provided) for prophylaxis. The patient did not experience any adverse event.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 21-NOV-2017, the patient inadvertently received both VARIVAX 0.5 ml subcutaneously (frequency, anatomical location were unknown) with lot # M015731 and expiration date 30-MAR-2018 and PROQUAD (route, dose, frequency, anatomical location were unknown) with lot # N002336 and expiration date 19-JUL-2018 for prophylaxis, both reconstituted with sterile diluent (MERCK STERILE DILUENT) with lot # L019488 and expiration date 11-FEB-2018.