chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient called clinic, left word that she had a reaction to vaccine received 2 days prior. States she felt pain at time of flu injection, two days later arm became very painful, unable to raise arm, very red and swollen at injection site. She received flu and pneumonia vaccines in left deltoid but believed it was the flu she reacted to. (Received Tdap in right deltoid). Saw PCP 10/29/12, he prescribed Tylenol with Codeine for pain, ibuprofen for inflammation, promethazine for nausea.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Erythema, Feeling hot, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient called clinic, left word that she had a reaction to vaccine received 2 days prior. States she felt pain at time of flu injection, two days later arm became very painful, unable to raise arm, very red and swollen at injection site. She received flu and pneumonia vaccines in left deltoid but believed it was the flu she reacted to. (Received Tdap in right deltoid). Saw PCP 10/29/12, he prescribed Tylenol with Codeine for pain, ibuprofen for inflammation, promethazine for nausea.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Tenderness
Clinical narrative: Patient called clinic, left word that she had a reaction to vaccine received 2 days prior. States she felt pain at time of flu injection, two days later arm became very painful, unable to raise arm, very red and swollen at injection site. She received flu and pneumonia vaccines in left deltoid but believed it was the flu she reacted to. (Received Tdap in right deltoid). Saw PCP 10/29/12, he prescribed Tylenol with Codeine for pain, ibuprofen for inflammation, promethazine for nausea.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased, Nausea
Clinical narrative: 10/27/12 Throbbing at site (L) arm / 10/29/12 unable to lift arm over head - onset 2nd day after vaccine feels warm, redness into axilla, tender to touch, saw PCP -> prescribed TYL with Cod, Ibuprofen, Promethazine.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: 10/27/12 Throbbing at site (L) arm / 10/29/12 unable to lift arm over head - onset 2nd day after vaccine feels warm, redness into axilla, tender to touch, saw PCP -> prescribed TYL with Cod, Ibuprofen, Promethazine.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Erythema, Feeling hot, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: 10/27/12 Throbbing at site (L) arm / 10/29/12 unable to lift arm over head - onset 2nd day after vaccine feels warm, redness into axilla, tender to touch, saw PCP -> prescribed TYL with Cod, Ibuprofen, Promethazine.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Tenderness
Clinical narrative: 10/27/12 Throbbing at site (L) arm / 10/29/12 unable to lift arm over head - onset 2nd day after vaccine feels warm, redness into axilla, tender to touch, saw PCP -> prescribed TYL with Cod, Ibuprofen, Promethazine.
Age: 1.07
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Pt has swelling on his Left thigh.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Headache, Nausea, Pain, Pyrexia
Clinical narrative: 10/30: 2pm - Sinus congestion, headache, runny nose, body ache; 6pm - same as 2pm with fever. 10/31: 7am - sinus congestion, runny nose, cough, headache, body ache; 9am - same as 7am with nausea. Treated on 10/30 at 10pm with Acetaminophen (650mg), Chlorpheniramine maleate 4mg, Dextromethorphan HBr 20mg, Phenylephrine HCl 10mg. Treated on 10/31 at 8am and every 4 hours with Acetaminophen (650mg), Dextromethorphan HBr 20mg, Phenylephrine HCl 10mg.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea, Sinus congestion
Clinical narrative: 10/30: 2pm - Sinus congestion, headache, runny nose, body ache; 6pm - same as 2pm with fever. 10/31: 7am - sinus congestion, runny nose, cough, headache, body ache; 9am - same as 7am with nausea. Treated on 10/30 at 10pm with Acetaminophen (650mg), Chlorpheniramine maleate 4mg, Dextromethorphan HBr 20mg, Phenylephrine HCl 10mg. Treated on 10/31 at 8am and every 4 hours with Acetaminophen (650mg), Dextromethorphan HBr 20mg, Phenylephrine HCl 10mg.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MEN, MMR, TDAP, VARCEL
Symptoms: Pruritus generalised
Clinical narrative: PT DESCRIBED REACTION TO VACCINE AS ITCHY BREAKOUTS ALL OVER HER BODY WHICH LASTED FOR 3 WEEKS.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypoaesthesia oral, Wheezing
Clinical narrative: Symptoms of lips feeling numb and wheezing in chest. Felt a little short of breath.
Age: 12.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: Fever of 103, aches.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Mobility decreased, Muscle strain, Oedema peripheral
Clinical narrative: Redness, along injected area the muscle pulling, can not lift arm, headache.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Redness, along injected area the muscle pulling, can not lift arm, headache.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Abnormal behaviour, Chest pain, Dyspnoea, Oedema peripheral, Pyrexia
Clinical narrative: HIGH FEVER, TALKING OUT OF HEAD, ARM SWOLLEN, RASH, CHEST PAIN, SHORTNESS OF BREATH.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: HIGH FEVER, TALKING OUT OF HEAD, ARM SWOLLEN, RASH, CHEST PAIN, SHORTNESS OF BREATH.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: IPV vaccine was given 7 days after a previous IPV vaccine.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Erythema, Hypoaesthesia oral, Throat irritation
Clinical narrative: Lips became numb, throat began to tickle, chest became extremely tight, face and neck became beat red and at that point my throat began to close and I could not breathe.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Lips became numb, throat began to tickle, chest became extremely tight, face and neck became beat red and at that point my throat began to close and I could not breathe.
Age: 13.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Wrong vaccine given per patients age and patient received correct vaccine a year and a half prior.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Joint swelling, Oedema peripheral, Pruritus generalised, Urticaria
Clinical narrative: Itching hives around joint on entire body, swelling of joints, feet, and fingers. Lasted until 10/08/12 when seen by Allergist and given a high dose of Benadryl. Benadryl taken for the following 2 days. Still suffering from bone aching.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection became swollen, red, very tender (even to the touch of a shirt sleeve moving) and HOT.  This lasted until Sunday Evening.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Grand mal convulsion, Pyrexia, Respiratory distress, Stridor
Clinical narrative: Sudden onset fever, respiratory stridor and respiratory distress. Had tonic clonic seizure on 10/31/12 8am.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Redness and swelling in upper right arm; pain and burning sensation in upper right arm; pt unable to sleep for 2 days because of pain.  Pt took Excedrin and aspirin, but had no relief; also applied Tiger Balm patches.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Insomnia
Clinical narrative: Redness and swelling in upper right arm; pain and burning sensation in upper right arm; pt unable to sleep for 2 days because of pain.  Pt took Excedrin and aspirin, but had no relief; also applied Tiger Balm patches.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin abnormal, Erythema, Granuloma annulare, Induration, Rash
Clinical narrative: Rash involving the leg and trunk. On lower extremities, from ankle to the inferior thigh, she has pink plaques, well-circumscribed in some areas, confluent in others. They are firm but flat. The biopsy site on the posterior right calf is healing well without erythema or exudate.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin plaque
Clinical narrative: Rash involving the leg and trunk. On lower extremities, from ankle to the inferior thigh, she has pink plaques, well-circumscribed in some areas, confluent in others. They are firm but flat. The biopsy site on the posterior right calf is healing well without erythema or exudate.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Granuloma annulare, Laboratory test, Rash
Clinical narrative: Rash involving the leg and trunk. On lower extremities, from ankle to the inferior thigh, she has pink plaques, well-circumscribed in some areas, confluent in others. They are firm but flat. The biopsy site on the posterior right calf is healing well without erythema or exudate.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Seen in ED- Physician note "cellulitis". "Pt with swelling/erythema post-injection. Possible reaction from injection but more likely cellulitis based on duration of symptoms and timing of injection.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Rash generalised
Clinical narrative: RASH TO BODY x3 DAYS AFTER GETTING VACCINES. PRESCRIBED PRELONE, BENADRYL, AND HYDROCORTISONE CREAM.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dysphagia, Dyspnoea, Heart rate increased
Clinical narrative: Pt received flu then shingles vaccine, a few minutes later c/o increased HR. Sat at table started c/o difficulty swollowing and SOB. No  c/o chest pain. Nurse administered 0.4 mL epi into left deltoid. EMT called. Pt refused to go to ER, went home w husband.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Chills, Pyrexia
Clinical narrative: This spontaneous report as received from a health care worker refers to a female patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H013581; Exp date 03-MAR-2014) (dose and route not reported) a "couple of weeks ago" (approximately in 2012). No other co-suspects were reported. No concomitant medications were reported. The health care worker reported that the patient developed cellulitis, high fever and chills after receiving a dose of PNEUMOVAX 23. The patient was admitted into a hospital (unknown name and location) for 24 hours. The outcome of cellulitis, high fever and chills after receiving a dose of PNEUMOVAX 23 was reported as recovered on an unspecified date (in 2012). The relatedness for the reported events was not provided for PNEUMOVAX 23. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Pyrexia, Toxicity to various agents
Clinical narrative: This spontaneous report as received from a health care worker refers to a female patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H013581; Exp date 03-MAR-2014) (dose and route not reported) a "couple of weeks ago" (approximately in 2012). No other co-suspects were reported. No concomitant medications were reported. The health care worker reported that the patient developed cellulitis, high fever and chills after receiving a dose of PNEUMOVAX 23. The patient was admitted into a hospital (unknown name and location) for 24 hours. The outcome of cellulitis, high fever and chills after receiving a dose of PNEUMOVAX 23 was reported as recovered on an unspecified date (in 2012). The relatedness for the reported events was not provided for PNEUMOVAX 23. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Body temperature decreased, Dyspnoea, Haemorrhage subcutaneous, Injection site haematoma
Clinical narrative: Fainting, weakness, difficulty breathing, entire arm swollen to the point of dimpling flesh, rash around throat and chest, shocky low body temperature for 36 hours. Gradual decrease over >3 days. Massive bruise at administration site appeared after 24 hours, doubled in size each day for three days; evidence of fresh subcutaneous bleeding continues to develop more than one week later.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Oedema peripheral, Rash, Syncope
Clinical narrative: Fainting, weakness, difficulty breathing, entire arm swollen to the point of dimpling flesh, rash around throat and chest, shocky low body temperature for 36 hours. Gradual decrease over >3 days. Massive bruise at administration site appeared after 24 hours, doubled in size each day for three days; evidence of fresh subcutaneous bleeding continues to develop more than one week later.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Decreased appetite, Nausea, Pain, Pyrexia
Clinical narrative: Fever, aches, pains, nausea, chills, loss of appetite.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Ringing in ear over 2 hours on 9/30 at 3AM. Ringing in ear over 1 1/2 hours on 10/3 at 9:40pm. Ringing multiple times a day, lasting only seconds now.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Fatigue, Pain, Rash
Clinical narrative: Body/ joint aches, fatigue, rash on chest and groin area for 24 hours.  Rash on chest and groin persisted beyond 24 hours.   No treatment required.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness bilateral, Vertigo
Clinical narrative: Initial report was received from a consumer on 19 October 2012. A 64-year-old female patient had received an intramuscular injection of FLUZONE High-Dose, lot number U4497AA, in the right arm on 17 September 2012. Six hours later on 17 September 2012, the patient experienced hearing loss in her right ear. She was seen the next day and her ear was irrigated but the hearing loss continued. The patient was seen on 26 September 2012 for complaints of vertigo. The patient was seen by an ear nose and throat (ENT) doctor on 12 October 2012 and diagnosed with bilateral hearing loss with right greater than left. An MRI of brain was scheduled to rule out tumor. The patient had a "follow-up for asthma" at the time of vaccination. The patient had a history of asthma, deep vein thrombosis (DVT), hypertension, rheumatoid arthritis, rhinitis, osteoarthritis, endometriosis and bladder hypertonicity. The patient had allergies to sulfa and penicillin. The patient's outcome was not recovered. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Insomnia, Joint range of motion decreased, Musculoskeletal pain, Nerve injury
Clinical narrative: Sore shoulder with very limited range of motion. Very hard to perform daily activities (bathing, dressing, toileting). Pain very bad in bed and keeps me up throughout nights. Went to PCP on 10-11-12. Dr. said needle had hit nerve. Prescribed 20 tablets of Naproxen 500 mg. Still seeing no improvement 25 days after vaccine administered.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Sore shoulder with very limited range of motion. Very hard to perform daily activities (bathing, dressing, toileting). Pain very bad in bed and keeps me up throughout nights. Went to PCP on 10-11-12. Dr. said needle had hit nerve. Prescribed 20 tablets of Naproxen 500 mg. Still seeing no improvement 25 days after vaccine administered.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: Tenderness, redness, on the site of vaccine.
Age: 66.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Discomfort, Erythema, Insomnia, Pyrexia, Skin warm
Clinical narrative: Patient had fever, and large red spread out about 8 inches on the opposite side of injection, warm when touched. Patient felt very uncomfortable, unable to sleep. 10/19/12 got better, redness disappeared.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: On 10/25/12 pt developed a raised, red, itchy rash with hives which continues on 10/30. Pt taking BENADRYL & Hydrocortisone cream. Rash persists.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Oral mucosal exfoliation
Clinical narrative: 10-30-12 Notices mouth sloughing. Remembered had last year after flu vaccine too. Involves mucous tissue. No other symptoms at this time.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Rash
Clinical narrative: Rash - stated end of September - itchy red patches in right arm - area of vaccination.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Lip swelling, Rash
Clinical narrative: 30 to 40 min. after vaccine developed rash difficult breathing and puffy lips.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: 3 1/2 x 3 1/2 redness & soreness. Mild warmth occurred day after flu vaccine.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Sensation of heaviness, Tremor
Clinical narrative: Pt. never had a flu shot before. Only listed Novocaine as an allergy. Took PARLODEL > 17 yr. ago. Was temporarily on TEGRETOL for seizures from PARLODEL reaction. No longer having seizures or on TEGRETOL. 10 minutes after the shot she felt shaky hands, heavy feet. No breathing problems, but rapid heart beat. Called 911 - paramedics said she is OK. She left on her own.
Age: 42.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Both shots administered in (L) deltoid 9/28/12 pt. has pain, swelling, erythema at injection site "hard knot, hot to the touch" will try ice pack, BENADRYL / NSAIDS first. May seek further treatment. Pt went to urgent care and received antibiotic.
Age: 42.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site warmth
Clinical narrative: Both shots administered in (L) deltoid 9/28/12 pt. has pain, swelling, erythema at injection site "hard knot, hot to the touch" will try ice pack, BENADRYL / NSAIDS first. May seek further treatment. Pt went to urgent care and received antibiotic.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Hypoaesthesia, Paraesthesia, Tachycardia
Clinical narrative: Pt experienced tachycardia and tingling and numbness in legs after receiving vaccines. Started 1-2 hours after vaccines given. Pt reports feeling better the next day. Pt was told to seek medical attention, but decided to wait it out.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Oedema peripheral, Pain in extremity
Clinical narrative: After receiving flu shot, patient came in 2 days later complaining of numbness, pain and swelling of the hand. Patient went to hospital and was given a script for the pain.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pain
Clinical narrative: Extreme pain in right arm, nausea, body aches. Pain spread to neck, shoulder, and armpit. Swelling and redness at injection site, lasting for about a week.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injected limb mobility decreased, Pain, Pain in extremity, Rash
Clinical narrative: Pain and immobility in left arm starting approximately 8 hours after shots. Chills, body aches, pain and rash across upper arm. Dr. prescribed antibiotics and steroids. Pain was relieved within a day but rash lasted over a week.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Migraine, Nausea, Pain in extremity
Clinical narrative: Migraine starting within an hour of the vaccines and lasting about a day and a half. Nausea for about 4 days. Pain in both arms.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Extreme pain in neck, shoulder, and arm lasting about four days.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching, swelling at the injection site (left arm).
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma
Clinical narrative: Bruising on arm vaccine was administered. Bruising was spread 1 inch lower.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Laboratory test normal, Migraine, Paraesthesia
Clinical narrative: 25 hrs after vaccine given noticed vision changes and dizziness. 2 hrs later noticed right sided facial numbness and tingling, then right arm numbness. Admitted to ER and received IV BENADRYL & IV Droperidol. Sx resolved. Diagnosed with complex migraine caused by inflammatory response.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Feeling hot, Laboratory test, Myalgia, Pallor
Clinical narrative: Severe muscle pain and weakness. Feeling hot episodes come & go, paleness. All started morning after receiving the vaccine & symptoms are just starting to improve as of 10/31/12.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Headache, Nasal congestion, Nausea, Oropharyngeal pain
Clinical narrative: Fever, chills, nausea, headache, sore throat, runny/stuffy nose. Symptoms lasted about five days. Did not see Dr. but treated with ibuprofen.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Fever, chills, nausea, headache, sore throat, runny/stuffy nose. Symptoms lasted about five days. Did not see Dr. but treated with ibuprofen.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Oropharyngeal pain, Pyrexia, Swelling
Clinical narrative: 1st symptom coughing (non-stop) like allergies. Pt states she has allergies. Tongue not swollen, but under tongue felt swollen. Throat was sore. Pt had chills and fever over 101 degrees for 2 hours.
Age: 29.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: Very bad headache and extremely sore arm for about 3 days. Nausea, chills, dizziness for 2 days.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site reaction
Clinical narrative: Vaccine site reaction.
Age: 1.02
Sex: U
Vaccine: DTAP, FLU3, HEPA, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash, Varicella post vaccine
Clinical narrative: 10/20/12 - Pt develops fever 101 for 2 days. 10/23/12 - Develops rash et taken to doctor et diagnosed with chicken pox. Spot/rash on face, trunk, arms & legs. <50 spots noted, no itching.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Headache, Malaise, Nausea, Pain
Clinical narrative: 1.5 hrs after vaccination felt like coming down with something. 4.5 hrs later fever 100. Had fever 101-102 until 2 AM 10/19/12 when fever broke. Had fever again 10/19/12 AM until 5 PM (100.6-101.2) also had aches, nausea, headache, malaise. Lasted 28 hrs.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 1.5 hrs after vaccination felt like coming down with something. 4.5 hrs later fever 100. Had fever 101-102 until 2 AM 10/19/12 when fever broke. Had fever again 10/19/12 AM until 5 PM (100.6-101.2) also had aches, nausea, headache, malaise. Lasted 28 hrs.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain, swelling, redness at injection site starting a few hours after. Headache and fever starting the next day. All symptoms lasted about a week.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Decreased appetite, Fatigue, Injection site pain, Injection site rash
Clinical narrative: Chills, pain and rash at injection site, vomiting, fever of 101, no appetite, exhaustion. Symptoms less severe by day 2. Rash lasted about a week.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Chills, pain and rash at injection site, vomiting, fever of 101, no appetite, exhaustion. Symptoms less severe by day 2. Rash lasted about a week.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 3 days of flu-like symptoms - severe aching, headache, stiff neck; swollen, red and hot arm at injection site - nurse prescribed ice and pain meds.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: 3 days of flu-like symptoms - severe aching, headache, stiff neck; swollen, red and hot arm at injection site - nurse prescribed ice and pain meds.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None. Pt had received FLUMIST 10-19-12, then on 10-23-12 received FLUZONE IM 0.5 ml. No reaction.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Expected normal soreness of (R) arm. Starting the day after was unable to reach above my head, to remove a loose fitting shirt. Pain upon range of motion. This is pain which interferes with ADL. Please investigate as there is no other cause or trauma I can think of.
Age: 0.77
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Cough, Dysphagia, Rash
Clinical narrative: Developed rash on face and cough, hard to swallow. Went to E.R. last night they suggested BENADRYL. Mom will get BENADRYL.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: C/O pain (L) shoulder since vaccine given no redness or bruising. MOTRIN, ice and home PT exercises given.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Neck in front began itching, noticed a rash, call Health Dept, was seen by nurse. Applied Cortisone cream to area.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary mass, Injection site pain, Nausea, Neck pain, Tenderness
Clinical narrative: 10/16 Immediately or with 5 minutes after getting shot had neck pain, nausea. Approximately neck pain continued off & on worse in the night - nauseated in the night no emesis. Pain at injection site and kinda the upper arm. Felt good on Wed 10/17. Took ADVIL. Night of 10/17-18 felt tenderness in my Rt armpit. In AM noted 8cm soft lump in the Rt axilla. Has happened with previous flu shots. No other time.
Age: 92.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site haematoma, Injection site reaction, Urticaria
Clinical narrative: Patient on warfarin. Had large red-blue bruised area with golf-ball sized welt at injection site.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Infection, Lymphadenopathy, Vaccination complication
Clinical narrative: Noted swollen lymph nodes (L) side of neck 10/23/12. Noted swollen lymph nodes (L) side of neck increased in size 10/24/12 at 1530. Sent to see PCP. He thought probably some sort of reaction vs infection secondary to shot. Placed on abx and ZYRTEC.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Received injection around 9:30 AM on 10-11-12. Itching started that night around 7:00 pm. Hives started a couple of days later. Saw PCP on 10-24-12 given cortisone injection and oral medication.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Pain in extremity
Clinical narrative: Patient said arm was painful the night after immunization. Visited Dr the next day, diagnosed with cellulitis around administration site. Prescribed antibiotic.
Age: 15.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Angioedema, Fatigue, Immediate post-injection reaction
Clinical narrative: Immediate fatigue & angioneurotic edema of face.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Mass, Oedema peripheral, Pain in extremity
Clinical narrative: On 10/22/12 pt stated her arm (L) was swollen, sore, red and warm to touch. She also stated that she felt a lump. She tried taking IBU which helped with pain some but she went to MD on 10/24 and received steroid and antibiotic Rx for cellulitis.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: On 10/22/12 pt stated her arm (L) was swollen, sore, red and warm to touch. She also stated that she felt a lump. She tried taking IBU which helped with pain some but she went to MD on 10/24 and received steroid and antibiotic Rx for cellulitis.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pyrexia, Rhinorrhoea, Streptococcus test negative, Vomiting
Clinical narrative: Within 12 hours of flu shot patient had 4 episodes of vomiting, fever to 103 for 24 hours and sore throat and runny nose.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria
Clinical narrative: Hives. Infusion in (R) deltoid.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Eye swelling, Flushing, Skin warm
Clinical narrative: Flushed, ears felt hot, eyes felt like swelling, EPIPEN.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Pt developed a 5 inch red circle the day after receiving ZOSTAVAX. Also had a band-aid-sized area in the middle of red circle that was hard and swollen. Reaction was decreasing slowly on its own over next several days. Told pt. to use hydrocortisone cream if needed.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Rash papular
Clinical narrative: (L) shoulder soreness, mild raised red rash of shoulder onto (L) chest wall and axillary region. Applied heat, taking BENADRYL.
Age: 0.76
Sex: F
Vaccine: FLUX, HEP, IPV
Symptoms: Blood test, CSF culture negative, Erythema, Febrile convulsion, Pyrexia
Clinical narrative: 24 hrs after IPV given to right thigh, pt developed fever to 102 degrees, redness/swelling, had 2 febrile seizures.
Age: 0.76
Sex: F
Vaccine: FLUX, HEP, IPV
Symptoms: Swelling, Urine analysis, White blood cell count normal
Clinical narrative: 24 hrs after IPV given to right thigh, pt developed fever to 102 degrees, redness/swelling, had 2 febrile seizures.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Patient has pain in her arm where shot was administered. She is on medication for the pain. Patient was notified of common side effects prior to shot. Dr. contacted pt. the day the complaint was received.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Tinnitus
Clinical narrative: Eyes swelled, achy, buzzing in head / ears.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Erythema, Injection site pain, Pruritus, Sneezing
Clinical narrative: Redness, swelling, itching, sneezing, coughing, body aches at site of injection. Came to pharmacy with script for anti-inflammatory.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Redness, swelling, itching, sneezing, coughing, body aches at site of injection. Came to pharmacy with script for anti-inflammatory.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Peripheral coldness, Sensation of heaviness
Clinical narrative: Vaccine was administered on 10/15/12. Patient awaken the next morning between 6:45-7am on 10/16/12 experiencing coldness within the injection arm and the site was warm to touch. Plus patient complained arm felt weighted down.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash erythematous, Swelling
Clinical narrative: Patient received both vaccinations on Monday 10/22/12 9:30 am. On Tues eve, patient noticed a red rash where his short sleeve touches his arm on the right arm. On Wed, the rash and swelling traveled down halfway->.
Age: 6.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Swelling & induration of injection site. No pain at all. Even with deep palpation. No fevers. N other symptoms.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Testicular swelling, Throat tightness
Clinical narrative: Approx 2 hrs post flu vaccine administration patient began to have throat tightening and swelling of the face & eyes - self administered 50 mg of BENADRYL repeated thru a 24 hrs.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Body temperature increased, Headache, Throat irritation
Clinical narrative: He came to school clinic about hour after receiving FLUMIST. Said he had headache. T 101.8 degrees. Called Mom, when she got here temp was 102.8 degrees. Mom said he had a scratchy throat this morning. Advised Mom to call his doctor.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Urticaria
Clinical narrative: Pt received flu shot on 10/26/12. Broke out with hives on 10/28/12. Hives were on legs & all over torso by 10/29/12. Her primary care MD told her to take BENADRYL 50mg every 4 hours. Seemed to help. Left eye was swollen.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Haemorrhage, Rash pruritic
Clinical narrative: Patient complained of a rash that itch so bad that he scratch it until it bleed.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pain
Clinical narrative: Pt felt pain immediately. She first went to Dr. 2 wks after receiving shot. She was given Prednisone at that time. She reports she is still in significant pain & has done a second round of prednisone.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Patient received a ZOSTAVAX instead of a Varicella vaccine.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Pain
Clinical narrative: Weakness, lack of appetite, soreness.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Red area where vaccine given. Pt. states some pain & stiffness in arm - pt placed ice pack on area.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Nausea, Ocular hyperaemia, Vision blurred
Clinical narrative: Within 3 hrs, she experienced eye irritation, eye redness, blurry vision, nausea.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema
Clinical narrative: Customer had flu and pneumonia shot on 10/24/12. Developed localized redness - cellulitis on left upper arm. Patient was advised by Dr to ice down, take pain reliever. Patient went to MD treated her cellulitis with antibiotics. Patient wants pharmacy to pay her 2 office visits copay.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pruritus, Injection site swelling, Muscle tightness
Clinical narrative: Patient described swelling and itching at injection site. Also stated "tightness" up the left arm up into the neck. Patient went to a doctor where she worked and received BENADRYL.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthma, Dysphonia, Local swelling, Oedema peripheral
Clinical narrative: Patient described swelling and itching at injection site. Also stated "tightness" up the left arm up into the neck. Patient went to a doctor where she worked and received BENADRYL.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Neck pain, Pruritus, Rash
Clinical narrative: Pt. developed swelling & pain on left side of neck 24-48 hrs. after getting flu shot. She also had itching & a rash. It went away after a week.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Loss of consciousness
Clinical narrative: Pt. passed out at home in the afternoon after receiving HD Flu vaccine around 9:15 AM. Pt. reported having chills. Advised husband to call physician.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling of the site of injection, redness & induration. I gave Rx for prednisone and BENADRYL. No other symptoms.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient reports right-sided rash developed 5-6 hours after immunization. Rash is red & sl. itchy. Patient called 10/23/12 to report rash. Patient reports previously completing Hep B series in '1990's - never had titre done. Advised to get titre drawn & see PCP for evaluation of rash & discussed comfort measures. Advised not to get further Hep B vaccines if titre "positive". 10/29/12 - rash persists. No fever, no malaise, no N & V. Not recovered from rash on torso as of 10/30/12.
Age: 1.26
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site urticaria, Rash
Clinical narrative: Rash started on 10/17. Patient seen in office with hives on 10/23 that extend from left knee to hip.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Pt. describes her arm becoming very sore to the extent of almost going to the E.R. This happened 3 hrs after the shot and resolved several hrs later.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Hypersensitivity, Rash generalised
Clinical narrative: Patient got vaccinated on 10-20-2012. Tdap, MCV & Varicella. Presented with rash all over body on 10-22-2012.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine administered 10/27/12. On 10/30/12 patient called to report she has a 1/4" raised, hot, palm-sized swelling at site of injection. Itches.
Age: 0.56
Sex: M
Vaccine: HEP, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Given expire vaccine PENTACEL lot # C3853AA LT exp: 10/28/12 Sanofi Pasteur.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture, Cellulitis, Full blood count, Headache, Metabolic function test
Clinical narrative: (L) arm pain, swelling, cellulitis, headaches. BACTRIM, KEFLEX 500 mg, ibuprofen 600 mg, triamcinolone acetonide, ROCEPHIN gram, ketorolac tromethamine, IV hydration.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Mononucleosis heterophile test, Pain in extremity, Swelling
Clinical narrative: (L) arm pain, swelling, cellulitis, headaches. BACTRIM, KEFLEX 500 mg, ibuprofen 600 mg, triamcinolone acetonide, ROCEPHIN gram, ketorolac tromethamine, IV hydration.
Age: 45.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cellulitis, Injection site erythema, Pyrexia
Clinical narrative: (Lt) arm where injection given very red. Spread down upper arm to axilla - developed cellulitis. Treated with ANCEF, prednisone and then BACTRIM. Had fever with reaction.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Grip strength decreased, Injection site pain, Injection site swelling, Oedema peripheral, Pain
Clinical narrative: Patient received vaccine at about 10:15 am on 10/23/12 at about 7 pm pt reported a swollen, throbbing arm (arm was arm of injection) that was not red. Patient reported not being able to grip keys w/finger. Pt went to ER where he found out he had received the same vaccine about 2 years ago. Patient symptoms were improved when followed up on 10/24/12.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Chills, all joints ached, low grade fever, headache (pounding) sore throat (3 days).
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 8 x 3 area of erythema with slight edema at the right upper arm.
Age: 85.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pruritus, Injection site rash, Injection site scab, Skin lesion
Clinical narrative: Severe itching at site and formation of multiple small bumps surrounding injection site injection given and still having problems w/bumps, itching, scabbed lesions on Oct.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Malaise, Pain, Pharyngitis streptococcal, Pyrexia, Streptococcus test positive
Clinical narrative: 10/14 0830 Pt reports fever, malaise, body aches that started on 10/13 approx 6pm. Pt advised to report to nearest ER. Pt was diagnosed with Acute Strep Pharyngitis and given appropriate antibiotic treatment. Report states his symptoms are due to combination of strep throat and a normal physiological response to the anthrax vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Woke up next morning to find left arm, where I got the IM shot to be swollen ( football size) painful, red (rash 4" x 4 1/2") and hot. After 2 days of BENADRYL po & topical, ice & elevate limb, I return to MD who also recommended topical hydrocortisone 2%. Took 2 wks to resolve. Still have discolorization at injection site.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.14
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Crying
Clinical narrative: Persistent crying for more than 3 hours that started about 2 hours after receiving vaccines.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Ultrasound scan normal
Clinical narrative: Patient experienced severe swelling, pain, and redness on arm when spread - patient  had an ultrasound to rule out phlebitis and was then started on an antibiotic as a precaution due to possible infection.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. given DTaP shot 10/18/12. Mother noticed redness/swelling at injection site. Mother took pt. to ER 10/19/12. ER advised if not better within 2 day to take pt. to Dr. Pt. seen at clinic 10/21/12 at 12:40 PM. Left arm still slightly red, but better per Mom. Pt. given prescription to take daily and advised to f/up with provider if not improved or resolved over next few days.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Hot, red, rashy area on right arm. Took BENADRYL and prednisone.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: About 32 hrs after injection = swelling, redness and pain at injection site. Day 2 - Localized rash and itching, increased pain spreading to (R) side of neck. Day 3 - ZYRTEC 10mg after increased symptoms. Day 5 - Redness in (R) side of face. Treated with Triamcinolone 0.1% cream TID. Day 9 - Decreased swelling, decreased redness, no itching, no rash. Still slight tenderness at injection site.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: About 32 hrs after injection = swelling, redness and pain at injection site. Day 2 - Localized rash and itching, increased pain spreading to (R) side of neck. Day 3 - ZYRTEC 10mg after increased symptoms. Day 5 - Redness in (R) side of face. Treated with Triamcinolone 0.1% cream TID. Day 9 - Decreased swelling, decreased redness, no itching, no rash. Still slight tenderness at injection site.
Age: 16.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given Pneumonia vaccine when he asked for Meningitis vaccine. No adverse event reported with incorrect vaccine requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site from shoulder to elbow - no fever or chills. Lasted until 10/14/12.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Computerised tomogram normal, Loss of control of legs, Pyrexia
Clinical narrative: Patient reports that legs gave out when standing/walking 3 times over the past day. He has also had the chills and fever-like symptoms. He went to urgent care on 10/20/12 and had a CT scan and blood pressure taken with negative results. MD told to him to watch for any other symptoms.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. It was reported that "three years ago', in 2009 the patient was administered "the first two doses in the GARDASIL (lot # not reported) vaccination schedule". This physician noted the patient would be administered intramuscularly the third dose in the GARDASIL (lot # not reported) vaccination schedule on 26-OCT-2012. No adverse effect reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to a patient who was vaccinated with the first dose of GARDASIL at a health care facility over 2 years ago. The patient did not receive any the subsequent doses for GARDASIL after their initial injection. The patient was being seen through the physician's office and the physician re-started the series for the patient recently. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age. It was reported that many patients came into the office later than recommended schedule in the GARDASIL prescribing information. Number of patients and lot numbers were unspecified. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL in March 2011 and the second dose in November 2011 and the third dose on 26-OCT-2012. Lot numbers of the vaccines were not reported. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. The outcome of the patient was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with dose 1 GARDASIL on an unknown date in 2009 (route of administration was not provided). No other co-suspects were reported. No concomitant medications were reported. The patient received the second dose of GARDASIL On 18-SEP-2012 (route of administration was not provided). No adverse event was reported. No treatment information was reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Blood glucose decreased, Dizziness, Rheumatoid factor positive
Clinical narrative: This spontaneous report has been received from the mother of a 18 years old female consumer. The patient's medical history included low blood sugar, ovarian cysts, slow bowel syndrome, drug reaction/allergy to an unspecified laxative, and constipation. The patient was vaccinated with her first dose of GARDASIL on 13-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 13-SEP-2012, about a month after vaccination, the patient experienced joint pain. On an unknown date the patient experienced low blood sugar at 58, rheumatoid level of 20 and dizziness. No treatment information was reported. The outcome of rheumatoid level of 20, dizziness, joint pain and low blood sugar at 58 is unknown. The relatedness for joint pain, rheumatoid level of 20, dizziness and low blood sugar of 58 was not reported for GARDASIL. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Gastrointestinal disorder
Clinical narrative: This spontaneous report as received from a physician refers to a 18 years old female patient. The patient had no pertinent medical history and no history of drug reactions/allergies. The patient was vaccinated intramuscularly with dose 1 GARDASIL (lot number not specified) in approximately October 2008 ("about 4 years ago"). The patient was vaccinated intramuscularly with dose 2 GARDASIL (lot number not specified) on 22-OCT-2012. The patient used no concomitant medications. After the first dose of GARDASIL the patient experienced a gastrointestinal complaint. No treatment was given for the event. The patient had recovered. The physician did not know when after the vaccination the complaint occurred or the exact date the patient recovered. The relatedness for gastrointestinal complaint was not reported for GARDASIL. Additional information has been requested.