chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Loss of consciousness, Pain in extremity, Vertigo
Clinical narrative: Adverse events for patient 10/13/2017 Reported to me by husband at 5 PM. Pt. was administered FLUZONE HD on Saturday, 10/07/2017. Monday pt. had stomach pain and husband took to Urgent Care where they said reflux and treated with PRILOSEC. Thursday morning pt. passed out at home and husband took to Hospital - EKG, CBC, blood pressure, blood sugar all checked and normal sent home with meclizine for vertigo (which she has had in past) but also said could be residual from flu vaccine to report it. Thursday evening pt. complained of feet hurting to husband and he used Epsom. Friday morning pt. ankles swollen. Pt. called cardiologist and was told since checked at E.R. that he was not concerned at this time, but to report flu vaccine adverse event to us. Friday evening husband reports to me and said she now has bruising on right breast and outside of both ankles and scratch on bottom of one foot. He had already talked to cardiologist. Doctor and myself think bruising related to fall. Sent an email to protocol doctor at 5:45 PM to notify. Husband is to keep updating us.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient reported swelling in shoulder that moved down to elbow and lasted 5 days. On followup (10-6-17) patient reported symptoms resolved and full recovery.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Feeling cold
Clinical narrative: About an hour after receiving vaccine pt got chills and 8 hours later 1 bout of diarrhea. Diarrhea resolved but chills less after 6 days. Still had mild chills 9/26/17. Still mild chills 9/26/17. Pt ok now 10/12/17.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Joint range of motion decreased, Pain in extremity
Clinical narrative: Left arm soreness, numbness, and decreased range of motion for 3 months following vaccine.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient complained of pain in hand and wrist after injection.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Fatigue, Headache, Rhinorrhoea
Clinical narrative: Runny nose. Bad cough. Headache. Tired. For 2-3 days.
Age: 73.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Erythema, Eye swelling, Feeding disorder, Injection site swelling, Insomnia
Clinical narrative: Arm very sore, swole from site, down to elbow which was very large to midway down arm. Bright red in color Lots of pain. Swole in cheek and eye on same side. 103 fever for 2 days. Didn't itch until swelling went down on the 7th day. Could not eat (nauseated). Didn't feel well, sleep. (I only weigh 74lbs).
Age: 73.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Malaise, Nausea, Pain, Pain in extremity, Pruritus
Clinical narrative: Arm very sore, swole from site, down to elbow which was very large to midway down arm. Bright red in color Lots of pain. Swole in cheek and eye on same side. 103 fever for 2 days. Didn't itch until swelling went down on the 7th day. Could not eat (nauseated). Didn't feel well, sleep. (I only weigh 74lbs).
Age: 73.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Swelling face
Clinical narrative: Arm very sore, swole from site, down to elbow which was very large to midway down arm. Bright red in color Lots of pain. Swole in cheek and eye on same side. 103 fever for 2 days. Didn't itch until swelling went down on the 7th day. Could not eat (nauseated). Didn't feel well, sleep. (I only weigh 74lbs).
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Fatigue, Headache, Pyrexia, Rhinorrhoea
Clinical narrative: Fever at 99 F. Runny nose, bad cough, headache, tired for 2-3 days.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) upper arm swelling/redness around injection site.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pt reports swelling, redness, pain, rash in left arm where shot was given. This happened within a day of her vaccination. She was advised by a physician to take a pain reliever which she said offered no relief.
Age: 36.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Malaise
Clinical narrative: Patient said when he received his flu shot (FLUARIX QUAD) and his PNEUMOVAX 23 he got sick. Went to his doctor and was diagnosed with cellulitis and was on two courses of antibiotics. Shots were given on 9-22-17.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient called to pharmacy stating on 10/7/17 that he was experiencing bruising and pain in arm at site of injection. Iced w/cold pack.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Nervousness, Pain
Clinical narrative: Patient was given PNEUMOVAX 23 and within 10-15 mins started feeling shaky, pain all over, chest pain. Patient sat for about 30 mins. and ambulance was eventually called.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Headache, Peripheral swelling, Rash
Clinical narrative: Dizziness - headache - rash - swelling in the arm - tachycardia - elevated high arterial pressure 158/88 mmHg, HR: 109 pm - no history of HTN - after 25 min
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia
Clinical narrative: Dizziness - headache - rash - swelling in the arm - tachycardia - elevated high arterial pressure 158/88 mmHg, HR: 109 pm - no history of HTN - after 25 min
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Nausea, Pharyngeal oedema, Swollen tongue
Clinical narrative: Burning feeling in arm on administration, nausea, swelling of tongue/throat, redness of skin.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Neck pain, Pain in extremity
Clinical narrative: Bruising, Pinching pain radiating from forearm to neck.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Body temperature increased, Erythema, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: Patient received PNEUMOVAX immunization in right arm on 09/26/17. Patient came by store 09/28/17 in the evening with patch of redness extending from site of injection to under the arm. Patient said area was warm and she had a temp of 100 degrees earlier. Patient taking TYLENOL and will see her Dr. on Friday. Dr. said it was a normal immune response and no need for any treatments.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Dizziness, Syncope
Clinical narrative: Lightheaded, dizzy, fainted, possible seizure. Paramedic arrived and checked blood pressure and sugar. Blood pressure dropped when patient stood up and patient became dizzy again. Patient was taken to emergency room.
Age: 73.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Neck pain
Clinical narrative: Feeling of warmth near injection site, pain, swelling and tenderness towards the elbow and pain around the neck.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Flu vaccine administered at 11:40 AM, 1 (one) hour later patient started feeling a tightness in her throat and difficulty breathing. Respiratory treatment given to patient in emergency room.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Local site, redness, swelling and itchiness. No treatment at this time.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Injection site reaction. Redness, swelling, bruise.
Age: 75.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Inflammation, Musculoskeletal pain, Myalgia, Skin warm
Clinical narrative: Sore shoulder and muscular pain, red, hot inflamed shoulder that lasted for 4 days.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received flu vaccination approx 4:30pm on Sun. 10/1. By Mon. am 10/2 had chills and aching. In afternoon fever to 100 degrees. On Tues. 10/3 at 0400am fever spiked to 101.5. 10/5 Seen in Employee health service. Injection site had slight bruise in appropriate area for injection but upper arm swollen, red and warm to touch. Sent to Urgent Care to be seen. 10/13 reports was given antibiotics and is improving.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Received flu vaccination approx 4:30pm on Sun. 10/1. By Mon. am 10/2 had chills and aching. In afternoon fever to 100 degrees. On Tues. 10/3 at 0400am fever spiked to 101.5. 10/5 Seen in Employee health service. Injection site had slight bruise in appropriate area for injection but upper arm swollen, red and warm to touch. Sent to Urgent Care to be seen. 10/13 reports was given antibiotics and is improving.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood creatine phosphokinase, Full blood count, Injected limb mobility decreased, Injection site pain, Metabolic function test
Clinical narrative: Pain of muscles surrounding (L) shoulder including biceps/trapezius, supraspinatus; levator SCAP,  SCM, latissimus on (L) pain inhibiting mobility of shoulder on exam normal rom passive.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Pain of muscles surrounding (L) shoulder including biceps/trapezius, supraspinatus; levator SCAP,  SCM, latissimus on (L) pain inhibiting mobility of shoulder on exam normal rom passive.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Aggression, Incoherent, Pyrexia, Rhinorrhoea, Screaming
Clinical narrative: Mom called and said on 10/7/17 pt had low grade fever talking out of her head for couple of hours. On 10/8/17 pt was screaming, hitting and punching people for 1 hour. On 10/9/17 pt screamed, yelled and kicked for 1 hour and had runny nose. On 10/10/17 pt was better but still had low grade fever. On 10/12/17 mom states pt is fine. Mom called to let us known this on 10/12/17.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Decreased appetite, Fatigue, Pain, Pyrexia
Clinical narrative: Injection on 10-11-17. 10-12-17 - Aches, fever. 10-14-17 - Fatigue, weakness, vomited once, loss of appetite. Has not missed any work but states may go to MD.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Injection on 10-11-17. 10-12-17 - Aches, fever. 10-14-17 - Fatigue, weakness, vomited once, loss of appetite. Has not missed any work but states may go to MD.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient received ZOSTAVAX and came back in with red and inflamed at site of injection about 2 inches in diameter.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: Injection of AFLURIA in right arm. Leaving large area of redness, feeling tender, exhaustion, nausea and low grade fever.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Influenza, Injection site pain, Oropharyngeal pain
Clinical narrative: I am reporting on the FLUZONE HIGH-DOSE 2017-18 0.5ml syr, qty. 0.5. I have the following allergies: iodides, DEMEROL 100mg tablets, bees. Several hours after my annual flu shot, I got all the symptoms of flu. It started with a sore throat, then aches, loss of appetite, weakness, and soreness at the injection site. This has happened for the last two years. My doctor said that I am receiving a higher dose of the flu virus since I turned 65. I am reporting these symptoms because the drug information leaflet says that I should not expect flu symptoms. The symptoms subsided after about 30 hours and with treating the symptoms.
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: I am reporting on the FLUZONE HIGH-DOSE 2017-18 0.5ml syr, qty. 0.5. I have the following allergies: iodides, DEMEROL 100mg tablets, bees. Several hours after my annual flu shot, I got all the symptoms of flu. It started with a sore throat, then aches, loss of appetite, weakness, and soreness at the injection site. This has happened for the last two years. My doctor said that I am receiving a higher dose of the flu virus since I turned 65. I am reporting these symptoms because the drug information leaflet says that I should not expect flu symptoms. The symptoms subsided after about 30 hours and with treating the symptoms.
Age: 9.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient is on a catch up schedule was given DTaP instead of TDaP. No adverse reaction to vaccine.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site pain, Skin warm, Urticaria
Clinical narrative: Baseball sized red hot welt on (L) arm. Tenderness at injection site.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Erythema, Pain, Rash, Swelling
Clinical narrative: Erythema, swelling, pain, rash that is localized. Treated with cool pack/ice, TYLENOL. Cont to monitor closely with follow up in 1 week.
Age: 9.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Arm had a little bulge, had grouping of welts, also arm was painful ice to reduce swelling, compression if able, acetaminophen if painful.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Inflamed, red, swollen left upper arm, given ORAPRED and ZITHROMAX prescriptions at urgent care to treat cellulitis/reaction.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Dermatitis, Erythema, Pain, Skin infection
Clinical narrative: Cellulitis - An acute, infectious inflammation of the skin - Warmth - differs from an injection site reaction - pain, tenderness to touch, redness, swelling.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Cellulitis - An acute, infectious inflammation of the skin - Warmth - differs from an injection site reaction - pain, tenderness to touch, redness, swelling.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site swelling, Loss of consciousness, Pain in extremity, Peripheral swelling
Clinical narrative: Patient fainted and blacked out. Patient was seen in ER. Left arm was swollen from shoulder to forearm and warm and red. Patient says extremely painful and tender. ED doctor advised to take Diphenhydramine.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Skin warm, Syncope, Tenderness
Clinical narrative: Patient fainted and blacked out. Patient was seen in ER. Left arm was swollen from shoulder to forearm and warm and red. Patient says extremely painful and tender. ED doctor advised to take Diphenhydramine.
Age: 5.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Body temperature increased, Headache, Streptococcus test negative, Vomiting
Clinical narrative: Acute vomiting started approx 11 hours after vaccine. Vomited hourly x 7. Temp 102, headache, ZOFRAN prescribed.
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Pt. states that after she had a lot of pain in her (L) arm later that day. Then the swelling started along with redness.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Dizziness, Headache, Nausea
Clinical narrative: Burning sensation in neck, dizziness, nausea, headache.
Sex: M
Vaccine: HPV4
Symptoms: Death, Myocarditis
Clinical narrative: This social media spontaneous report as received from a social media, referring to a 14 year old male patient. The patient had no medical history, concurrent conditions and concomitant therapy (reported as healthy). On an unknown date, the patient was vaccinated with GARDASIL (dosage details and lot number were unknown) for prophylaxis. The next day after vaccination (on an unspecified date), the patient experienced myocarditis. It was reported that  the boy died next day after receiving GARDASIL. It was unknown whether an autopsy was performed. The reporter considered the patient's death to be related with GARDASIL. However, the relationship between GARDASIL and the event myocarditis was not provided. Upon internal review, the patient's death and myocarditis were considered to be medically significant.; Reported Cause(s) of Death: unspecified cause of death.
Age: 1.0
Sex: M
Vaccine: MMR, MMR, PNC13
Symptoms: Facial paralysis
Clinical narrative: Shortly after patient came down with bilateral mastoiditis and developed right sided Bell's Palsy. The infectious disease consult MD mentioned that Bell's Palsy could be an autoimmune mediated response and was possibly related to recent vaccinations although it is only documented with varicella immunization which he did not have prior to the hospitalization.
Age: 1.0
Sex: M
Vaccine: MMR, MMR, PNC13
Symptoms: Facial paralysis, Mastoiditis
Clinical narrative: Shortly after patient came down with bilateral mastoiditis and developed right sided Bell's Palsy. The infectious disease consult MD mentioned that Bell's Palsy could be an autoimmune mediated response and was possibly related to recent vaccinations although it is only documented with varicella immunization which he did not have prior to the hospitalization.
Age: 1.0
Sex: M
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Urticaria
Clinical narrative: Temp of 103.6 from Thursday til Sunday night, followed by hives (rash) Tuesday all over his body.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Skin warm
Clinical narrative: PT DESCRIBES NOTICING LEFT UPPER ARM WAS RED AFTER HE SHOWERED ON 10/13/2017. HE SAID THE ARM WAS WARM TO THE TOUCH. IT DIDN'T HURT. IT WASN'T ITCHY. HE DIDN'T HAVE ANY FEVER. HE HAD AN APPOINTMENT TO SEE HIS MD THE NEXT DAY, SO HE WAITED IT OUT. HE ASKED HIS MD ABOUT IT ON 10/14/17. THE MD SUSPECTED CELLULITIS AND PRESCRIBED CEPHALEXIN, BUT TOLD THE PATIENT NOT TO TAKE THE MEDICATION UNLESS HIS ARM GETS WORSE. THE UPPER ARM WAS NOT AS RED ON 10/16/2017, BUT HE NOTICED THAT THE REDNESS HAD SPREAD TO HIS FOREARM. HE DECIDED TO FILL THE CEPHALEXIN AT OUR PHARMACY. THIS WAS ALSO THE TIME THAT THE WIFE NOTIFIED US OF THE REACTION. WE CALLED THE MD TO LET HIM KNOW THAT THE PATIENT IS FILLING THE RX AS THE REDNESS HAD.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: PT DESCRIBES NOTICING LEFT UPPER ARM WAS RED AFTER HE SHOWERED ON 10/13/2017. HE SAID THE ARM WAS WARM TO THE TOUCH. IT DIDN'T HURT. IT WASN'T ITCHY. HE DIDN'T HAVE ANY FEVER. HE HAD AN APPOINTMENT TO SEE HIS MD THE NEXT DAY, SO HE WAITED IT OUT. HE ASKED HIS MD ABOUT IT ON 10/14/17. THE MD SUSPECTED CELLULITIS AND PRESCRIBED CEPHALEXIN, BUT TOLD THE PATIENT NOT TO TAKE THE MEDICATION UNLESS HIS ARM GETS WORSE. THE UPPER ARM WAS NOT AS RED ON 10/16/2017, BUT HE NOTICED THAT THE REDNESS HAD SPREAD TO HIS FOREARM. HE DECIDED TO FILL THE CEPHALEXIN AT OUR PHARMACY. THIS WAS ALSO THE TIME THAT THE WIFE NOTIFIED US OF THE REACTION. WE CALLED THE MD TO LET HIM KNOW THAT THE PATIENT IS FILLING THE RX AS THE REDNESS HAD.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Low-grade fever 99.9, headache, fatigue (resolved when I saw patient today). Site reaction - 11 x 7.5 cm erythema/mild swelling with mild tenderness.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Low-grade fever 99.9, headache, fatigue (resolved when I saw patient today). Site reaction - 11 x 7.5 cm erythema/mild swelling with mild tenderness.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on face. Itching. I took one Benadryl at about 1pm and the itching stopped after about 1/2 hour.  Itching started again about 5 hours later so I took two Benadryls. The next morning the hives were gone and no more itching.
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Insomnia, Nausea
Clinical narrative: Nausea, dizziness, sleeplessness.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Dizziness, Nausea, Pain
Clinical narrative: Aching pain. Bruise about 2 inches down from top of shoulder. From the aching pain, I feel faint and nauseated.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt was given the vaccine around noon local time, and did not notice any reaction until later that night after he got off shift. His right shoulder had localized swelling around the injection point with a diameter of about 6 cm in diameter. There was some redness at the injection site with a diameter of 2 mm. Pt described it as slightly itchy, and denied any further symptoms. Pt was given anti-itch cream and told to follow up as needed.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Lymph node pain, Lymphadenopathy, Neck pain, Pain in jaw
Clinical narrative: Within 30-45 minutes of receiving vaccine, patient developed a sharp pain  in L side of neck extending to jaw then noted tender swelling of tonsillar lymph node region - within 2 hours - pain had subsided but mild swelling persisted.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Muscular weakness
Clinical narrative: 89 year old male experienced two weeks of crippling weakness in  the lower extremities. Inability to get out of bed. Required assistance from family member living outside the home. He reported his symptoms after they had already resolved, approximately 2 weeks after vaccination.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Ill-defined disorder, Malaise, Muscular weakness
Clinical narrative: Patient states that after the influenza vaccination she experienced prolonged illness, fatigue, malaise, fevers, chills, muscle weakness, inability to get out of bed. This lasted approximately 4 weeks. Patient states that she has been getting flu shots for 30 years and has never had a reaction .
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient states that after the influenza vaccination she experienced prolonged illness, fatigue, malaise, fevers, chills, muscle weakness, inability to get out of bed. This lasted approximately 4 weeks. Patient states that she has been getting flu shots for 30 years and has never had a reaction .
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Eyelid function disorder, Facial paralysis, Facial paresis
Clinical narrative: Bell's palsy started Monday morning at 710. Right sided facial weakness, inability to close right eye, right sided facial drooping.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site haemorrhage, Injection site pain, Pain in extremity
Clinical narrative: Bleeding at injection site followed by muscle pain for 2 days. Then severe pain and inability to move right arm in an upward motion, with muscle failure began on Tuesday morning 10/17/2017. It has not improved. I have limited mobility in my right arm and constant pain. I have placed a call in to my doctor today and await a response.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swollen, red itchy area approximately 1 inch from the injection site. Appeared < 24 hours after injection. Started at ~1 inch in diameter. 48 hours after injection it is 2-3 inches in diameter.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Eye swelling, Headache, Peripheral swelling, Pruritus
Clinical narrative: Received vaccine at approximately 11:00 AM on 10/11/17. At approximately 2:00 PM noted left hand was swollen, red and itchy. Just after 2:00 PM noted headache behind left eye, headache lasted 1-1.5 hours. After work noted that the left eye was swollen. Left eye remained noticeably swollen on 10/12/17. Symptoms cleared over 72 hours.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 28 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-SEP-2017, the patient was vaccinated with a ZOSTAVAX 19400 PFU, lot # N013278, expiry date 26-JUL-2018 (dose and routed of administration were not provided) reconstituted with sterile diluent (MERCK STERILE DILUENT). The reporter stated that administration was due to human error (also reported as given instead of VARIVAX). No adverse effect was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Immunisation, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 23-SEP-2017, the pharmacist was preparing to administer an unspecified influenza vaccine and ZOSTAVAX (exact dose was not specified; lot # N012492 with the expiration date of 17-MAR-2018) reconstituted with sterile diluent (lot # M047667 with the expiration date of 20-JUL-2019) to the patient. The pharmacist got distracted and inadvertently administered ZOSTAVAX intramuscularly (instead of the unspecified influenza vaccine). When he realized the error, the pharmacist immediately administered a second dose of ZOSTAVAX subcutaneously, as he thought that the dose administered intramuscularly would not be valid. No adverse effects were reported. Lot information apply to both doses of ZOSTAVAX and sterile diluent administered.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Peripheral swelling, Soft tissue swelling
Clinical narrative: This spontaneous report was received from a physician via a field representative, concerning a 12 year old female patient. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. Her concomitant medications included loratadine (CLARITIN), magnesium oxide, montelukast sodium (SINGULAIR), naproxen, mometasone furoate (NASONEX), and albuterol (VENTOLIN). On an unspecified date, the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, strength, dose, route of administration, and anatomical location were not provided), for prophylaxis. On 24-AUG-2017, the patient received her second dose of GARDASIL 9 with lot # N017697 and expiration date on 21-JAN-2020 (strength, dose, and route of administration were not provided), administered in her left deltoid for prophylaxis. The vaccine did not have temperature excursions during its storage. On the same date, the patient also received an unspecified allergy shot. The patient had no any illness at the time of vaccination. On 10-SEP-2017, approximately two weeks after vaccination, she experienced pain and swelling of her left arm (Pain in extremity/Peripheral swelling). She developed a lump on her arm vaccination site which continued to grow and became painful (Vaccination site mass). An X-ray was performed and showed soft tissue swelling; but the discomfort and lump persisted. An ultrasound and a magnetic resonance imaging (MRI) revealed linear tract hyperemia of the area as well as intense inflammation. Subsequently, the patient was treated with amoxicillin (+) clavulanate potassium (AUGMENTIN) later switch to cefdinir. No product quality complaint (PQC) was involved. At the time of this report, the patient was recovering from the pain in extremity, peripheral swelling and intense inflammation, vaccination site mass, soft tissue swelling, discomfort, and hyperemia. The causal relationship between the events and with GARDASIL 9 was not provided.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Ultrasound scan abnormal, Vaccination site discomfort, Vaccination site inflammation, Vaccination site mass, Vaccination site pain
Clinical narrative: This spontaneous report was received from a physician via a field representative, concerning a 12 year old female patient. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. Her concomitant medications included loratadine (CLARITIN), magnesium oxide, montelukast sodium (SINGULAIR), naproxen, mometasone furoate (NASONEX), and albuterol (VENTOLIN). On an unspecified date, the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, strength, dose, route of administration, and anatomical location were not provided), for prophylaxis. On 24-AUG-2017, the patient received her second dose of GARDASIL 9 with lot # N017697 and expiration date on 21-JAN-2020 (strength, dose, and route of administration were not provided), administered in her left deltoid for prophylaxis. The vaccine did not have temperature excursions during its storage. On the same date, the patient also received an unspecified allergy shot. The patient had no any illness at the time of vaccination. On 10-SEP-2017, approximately two weeks after vaccination, she experienced pain and swelling of her left arm (Pain in extremity/Peripheral swelling). She developed a lump on her arm vaccination site which continued to grow and became painful (Vaccination site mass). An X-ray was performed and showed soft tissue swelling; but the discomfort and lump persisted. An ultrasound and a magnetic resonance imaging (MRI) revealed linear tract hyperemia of the area as well as intense inflammation. Subsequently, the patient was treated with amoxicillin (+) clavulanate potassium (AUGMENTIN) later switch to cefdinir. No product quality complaint (PQC) was involved. At the time of this report, the patient was recovering from the pain in extremity, peripheral swelling and intense inflammation, vaccination site mass, soft tissue swelling, discomfort, and hyperemia. The causal relationship between the events and with GARDASIL 9 was not provided.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: X-ray abnormal
Clinical narrative: This spontaneous report was received from a physician via a field representative, concerning a 12 year old female patient. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. Her concomitant medications included loratadine (CLARITIN), magnesium oxide, montelukast sodium (SINGULAIR), naproxen, mometasone furoate (NASONEX), and albuterol (VENTOLIN). On an unspecified date, the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, strength, dose, route of administration, and anatomical location were not provided), for prophylaxis. On 24-AUG-2017, the patient received her second dose of GARDASIL 9 with lot # N017697 and expiration date on 21-JAN-2020 (strength, dose, and route of administration were not provided), administered in her left deltoid for prophylaxis. The vaccine did not have temperature excursions during its storage. On the same date, the patient also received an unspecified allergy shot. The patient had no any illness at the time of vaccination. On 10-SEP-2017, approximately two weeks after vaccination, she experienced pain and swelling of her left arm (Pain in extremity/Peripheral swelling). She developed a lump on her arm vaccination site which continued to grow and became painful (Vaccination site mass). An X-ray was performed and showed soft tissue swelling; but the discomfort and lump persisted. An ultrasound and a magnetic resonance imaging (MRI) revealed linear tract hyperemia of the area as well as intense inflammation. Subsequently, the patient was treated with amoxicillin (+) clavulanate potassium (AUGMENTIN) later switch to cefdinir. No product quality complaint (PQC) was involved. At the time of this report, the patient was recovering from the pain in extremity, peripheral swelling and intense inflammation, vaccination site mass, soft tissue swelling, discomfort, and hyperemia. The causal relationship between the events and with GARDASIL 9 was not provided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Lip swelling, Pain
Clinical narrative: This spontaneous report was received from a pharmacist, regarding to a female patient of unknown age. The patient's concurrent conditions included allergy to lisinopril (manufacturer unknown) (captured on MARRS # 1710USA008694), allergy to ciprofloxacin (CIPRO) and pseudoephedrine hydrochloride (SUDAFED). Her pertinent medical history was not mentioned. On 01-SEP-2017, the patient was vaccinated with ZOSTAVAX lot # N014018 for prophylaxis. Other suspect therapies included sterile diluent(STERILE DILUENT). Concomitant therapies included hydrochlorothiazide (HYDROCHLOROTHIAZIDE), cephalexin(KEFLEX), hydralazine(HYDRALAZINE), bupropion hydrochloride and yellow fever virus vaccine. On an unknown date the patient experienced lip swelling, pain, injection site erythema and dizziness. The patient received treatment with Prednisone (manufacturer unknown). The outcome of lip swelling, pain, injection site erythema and dizziness was reported as recovered/resolved. The relatedness between vaccination with ZOSTAVAX and the events was not provided. This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1710USA008679: US-009507513-1710USA008694:
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Rash
Clinical narrative: This spontaneous report was received from a 62 year old male patient referring to himself. The patient was a retired paramedic. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. The patient reported that on an unspecified date, a fewdays ago, he was vaccinated at the clinic with one dose of ZOSTAVAX, subcutaneously, for prophylaxis (strength, dose, lot number or expiration date were not reported). On an unknown date the patient developed localized swelling at the injection site with about 2.5 inches of diameter. The patient also reported that the affected area was warm to the touch. On an unspecified date, the patient also developed rash.  The patient did not seek medical attention and he had not taken any medication for the events at the time of this report. The outcome of injection site swelling, injection site warmth and rash was reported as not resolved. Causality assessment was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 4 years old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M003435 and expiration date on 19-JUL-2017, lot # M038229 and expiration date on 06-MAR-2018 or lot M044020 with expiration date on 01-MAY-2018 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses of PROQUAD were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments:  US-009507513-1710USA008686: Linked Report: US-009507513-1710USA008688: US-009507513-1710USA008690: US-009507513-1710USA008691: US-009507513-1710USA008692: US-009507513-1710USA008693: US-009507513-1710USA008685: US-009507513-1710USA008684:  US-009507513-1710USA008689:
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not provided. The patient's concurrent conditions included immunosuppression, because he was taking adalimumab (HUMIRA). On 10-AUG-2017, the patient was immunosuppressed and was administered 1 dose of ZOSTAVAX 19400 plaque-forming units (PFU) vial, lot # M042851 with expiration date on 18-JAN-2018, subcutaneously (dose was not reported), for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's medical history, concomitant medications or concurrent conditions was provided. On 10-OCT-2017, the patient was vaccinated with an expired dose of VARIVAX (lot # L029466 with no expiration date in 06-AUG-2017), for prophylaxis (dose, frequency and route were not provided). Other suspect therapies included sterile diluent (STERILE DILUENT). No adverse effects were reported. No product quality complaint (PQC) was involved. Lot Number N000808 has been verified to be NOT valid for STERILE DILUENT.
Sex: U
Vaccine: DTAP, HIBV, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-OCT-2017, the patient was vaccinated with one dose of improperly stored LIQUID PEDVAXHIB lot# N007749, expiration date 29-NOV-2019 or lot # N000238, expiration date 25-OCT-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 9 and 25 degrees Celsius for 1 hour and 12 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA008878: US-009507513-1710USA008877: US-009507513-1710USA008876: US-009507513-1710USA008879: US-009507513-1710USA008875:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 4 years old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M003435 and expiration date on 19-JUL-2017, lot # M038229 and expiration date on 06-MAR-2018 or lot M044020 with expiration date on 01-MAY-2018 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses PROQUAD were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments:  US-009507513-1710USA008686: US-009507513-1710USA008693: US-009507513-1710USA008688: US-009507513-1710USA008689: US-009507513-1710USA008690: US-009507513-1710USA008691: US-009507513-1710USA008692: US-009507513-1710USA008685: US-009507513-1710USA001141: US-009507513-1710USA008687:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 4 years old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M023384 and expiration date on 20-JUL-2018 of lot # M033906 with expiration date on 06-JUN-2019 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses of VARIVAX were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1710USA008686: US-009507513-1710USA008693: US-009507513-1710USA008688: US-009507513-1710USA008689: US-009507513-1710USA008690: US-009507513-1710USA008691: US-009507513-1710USA008692: US-009507513-1710USA001141: US-009507513-1710USA008684: US-009507513-1710USA008687:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 18 months old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M023384 and expiration date on 20-JUL-2018 of lot # M033906 with expiration date on 06-JUN-2019 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses VARIVAX were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1710USA001141: US-009507513-1710USA008693: US-009507513-1710USA008688: US-009507513-1710USA008689: US-009507513-1710USA008690: US-009507513-1710USA008691: US-009507513-1710USA008692: US-009507513-1710USA008685: US-009507513-1710USA008684: US-009507513-1710USA008687:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 16 months old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M023384 and expiration date on 20-JUL-2018 of lot # M033906 with expiration date on 06-JUN-2019 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses of VARIVAX were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1710USA008686: US-009507513-1710USA008693: US-009507513-1710USA008688: US-009507513-1710USA008689: US-009507513-1710USA008690: US-009507513-1710USA008691: US-009507513-1710USA008692: US-009507513-1710USA008685: US-009507513-1710USA008684: US-009507513-1710USA001141:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 17 months old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M023384 and expiration date on 20-JUL-2018 of lot # M033906 with expiration date on 06-JUN-2019 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses of VARIVAX were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1710USA008686: US-009507513-1710USA008693: US-009507513-1710USA001141: US-009507513-1710USA008689: US-009507513-1710USA008690: US-009507513-1710USA008691: US-009507513-1710USA008692: US-009507513-1710USA008685: US-009507513-1710USA008684: US-009507513-1710USA008687:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 17 months old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M023384 and expiration date on 20-JUL-2018 of lot # M033906 with expiration date on 06-JUN-2019 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses of VARIVAX were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1710USA008686: US-009507513-1710USA008693: US-009507513-1710USA008688: US-009507513-1710USA001141: US-009507513-1710USA008690: US-009507513-1710USA008691: US-009507513-1710USA008692: US-009507513-1710USA008685: US-009507513-1710USA008684: US-009507513-1710USA008687:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 5 years old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M023384 and expiration date on 20-JUL-2018 of lot # M033906 with expiration date on 06-JUN-2019 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses of VARIVAX were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1710USA008686: US-009507513-1710USA008693: US-009507513-1710USA008688: US-009507513-1710USA008689: US-009507513-1710USA001141: US-009507513-1710USA008691: US-009507513-1710USA008692: US-009507513-1710USA008685: US-009507513-1710USA008684: US-009507513-1710USA008687: