chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Radiating neck pain, severe headache, dysphagia/tightness of throat, chest heaviness, difficulty taking deep breath, lower back ache, disorentation, overall weakness, tremors, febrile (101-103 degrees).
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Pain, Rash papular, Rash pruritic, Urticaria
Clinical narrative: Itchy bumps on ankle around 8:00pm on 10/20.  Next morning she began to have itchy bumps on hands, feet, knees, elbows.  The following day painful and itchy hives from feet to ears.  Received two steroid medication, one liquid and one cream for 10 days.
Age: 77.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: Patient states he is having deep left shoulder pain. Shoulder hurts if moved. States he has limited use of arm. Patient stated reaction started day after in the evening when vaccine was given. Adverse event was reported 10/28/14.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Day of injection and thru Day 2-c/o aches "not feeling right" Redness. Day 3- Marked swelling and erythema at the site. Fever. Day 4- s/s resolved.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Day of injection and thru Day 2-c/o aches "not feeling right" Redness. Day 3- Marked swelling and erythema at the site. Fever. Day 4- s/s resolved.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood test, Cognitive disorder, Computerised tomogram, Convulsion, Developmental delay
Clinical narrative: GENERALIZED TONIC CLONIC SEIZURE (STATUS).
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Electroencephalogram, Grand mal convulsion, Lumbar puncture
Clinical narrative: GENERALIZED TONIC CLONIC SEIZURE (STATUS).
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging brain, Nystagmus, Vertigo
Clinical narrative: The next morning when I woke up I had Vertigo and Nystagmus.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Slowly developing hive that eventually covered most of my bicep. Got red, raised, hot and painful. Lasted a week or so. Took aspirin for the discomfort.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Slowly developing hive that eventually covered most of my bicep. Got red, raised, hot and painful. Lasted a week or so. Took aspirin for the discomfort.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Cold sweat, Feeling cold, Feeling of body temperature change
Clinical narrative: Pt states about 8pm he started have stabbing muscle/joint pains then a few minutes later "hypothermia"-shivering, freezing, shaking.  Bundled up under the covers and after about 2 hours it finally stopped and he went to sleep.  States the next day 10/24/14 he had mild hot and cold sweats throughout the day.  States he did not check his temperature but did not feel warm to the touch so did not think he had a fever.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Hypothermia, Myalgia, Tremor
Clinical narrative: Pt states about 8pm he started have stabbing muscle/joint pains then a few minutes later "hypothermia"-shivering, freezing, shaking.  Bundled up under the covers and after about 2 hours it finally stopped and he went to sleep.  States the next day 10/24/14 he had mild hot and cold sweats throughout the day.  States he did not check his temperature but did not feel warm to the touch so did not think he had a fever.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain
Clinical narrative: Soreness that improves but does not go away.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site pain
Clinical narrative: Soreness that improves but does not go away.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Area of bright redness of skin measuring from area of injection (left deltoid) down 28 cm to the antecubital region, approx 10 cm wide. Minimally painful. Slightly swollen.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Blood thyroid stimulating hormone normal, Dizziness, Electrocardiogram normal, Full blood count normal
Clinical narrative: Woke up with extreme dizziness, imbalance and nausea.  Room was spinning. Symptoms have been going on for 4 weeks.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Human chorionic gonadotropin normal, Metabolic function test normal, Nausea, Red blood cell sedimentation rate normal
Clinical narrative: Woke up with extreme dizziness, imbalance and nausea.  Room was spinning. Symptoms have been going on for 4 weeks.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Syncope
Clinical narrative: Received flu shot on 10/10/14 and fever started on 10/12/2014 and SPIKED at 103.5 degrees Mon 6 AM 10/13/2014 again fever rose to 103.5 degrees early MON AM. AFLURIA Syringe by CSL lab via Pharmacy.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Dyspnoea, Rash
Clinical narrative: Rash on left arm, slight trouble breathing (patient stated the trouble breathing similar to her asthma).
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Stiffness and pain in shoulder, neck, arm and back. To Urgent Care, ER, and doctors office for unbearable pain. Treatment includes muscle relaxers, Vicodin and steroids.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Back pain, Myalgia, Neck pain
Clinical narrative: Stiffness and pain in shoulder, neck, arm and back. To Urgent Care, ER, and doctors office for unbearable pain. Treatment includes muscle relaxers, Vicodin and steroids.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Complain of severe pain to right arm and stiffness.
Sex: M
Vaccine: HEP
Symptoms: Autopsy, Death, Intensive care, Laboratory test normal, Malaise
Clinical narrative: My son was born a healthy 7lb baby boy with no underlying issues. On his 2nd day of life he quickly became ill and died within hours of being sent to the NICU. He was given Hep B vaccine the day before. Autopsy and WES test were all normal.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Received her Flu shot Friday. Woke up Monday morning with pressure in her chest like someone was sitting on her chest and it felt like it was difficult to breathe. Felt fine and it was gone by Tuesday morning.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: She developed a "weakened" version of the shingles per her MD. She had a rash on her abdomen/chest. Patient reported minor distress.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Heart rate increased, Myalgia
Clinical narrative: Joint pain, muscle sore, faster heartbeat.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Asthenia, Headache, Influenza like illness, Joint warmth
Clinical narrative: Flu-like symptoms (fever, headache, body aches, weak, knee joint-hot). had to stay home from work the next day.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Flu-like symptoms (fever, headache, body aches, weak, knee joint-hot). had to stay home from work the next day.
Age: 1.52
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Erythema multiforme, Rash
Clinical narrative: Got shots on 10/15. Rash started on 10/17. Patient seen 10/21 and had erythema multiforme. Other than rash she was fine so we did not treat or give steroids. As of 10/23 rash slowly ending based on phone call to mom.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Acne, Erythema, Pain, Swelling, Vaccination site reaction
Clinical narrative: Patient reported that appearance of a "pimple" on his arn after vaccination at site of vaccination. Patient was afraid it might be an infection and scheduled an appointment with MD. Also reported pain, redness and swelling.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Erythema, Fatigue, Headache
Clinical narrative: Fever/chills, cough, muscle aches, fatigue, headache, itching and redness on lower legs.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pruritus, Pyrexia
Clinical narrative: Fever/chills, cough, muscle aches, fatigue, headache, itching and redness on lower legs.
Age: 12.0
Sex: F
Vaccine: FLU3, HEP, HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Had redness and swelling of (L) deltoid area 10 mm x 7 mm. Red, warm to touch. No itching or pain no difficulty breathing or swallowing. Rx BENADRYL, ibuprofen, and ice to arm.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Within 24 hours developed fever and watery diarrhea.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Chest pain, Pyrexia
Clinical narrative: Received FLUMIST later that night spiked fever of 102.5 and chest pain.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: 30 minutes laters arm swelled up, it became a big area but put some ice and went down 20 minutes later. Pt. mentioned this to pharmacist on 10/26.
Age: 21.0
Sex: U
Vaccine: FLU4, MNQ
Symptoms: Abdominal distension, Faeces discoloured, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, dark stool, bloating
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure increased, Chills, Dizziness, Dysgeusia, Nausea
Clinical narrative: Metallic taste, dizziness, nausea, chills, elevated BP 158/108, HR 85 all within 5 minutes.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Ear pain, Nasal congestion
Clinical narrative: Sever otalgia, nasal congestion- exam- engorged boggy nasal turbinates. No op/ facial edema or wheezing. Given BENADRYL PRN.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia, Respiratory distress, Wheezing
Clinical narrative: Fever (101), wheezing with some respiratory distress. No history of asthma or wheezing in past.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site warmth, Skin reaction
Clinical narrative: Circular 2" x 1 1/4" lot, firm induration at injection site. No visible signs of cellulitis or lymph node involvement. No fever.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inflammation
Clinical narrative: Severe local inflammation and getting worse over time from PNEUMOVAX 23. MD prescribed Doxycycline 100 BID x 10d.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Lip blister, Lip swelling, Oedema mouth
Clinical narrative: Mouth and lips swollen. Blister appeared on upper lip. Mouth felt numb. No treatment.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives, fever, majority of hives on trunk and face. Took BENADRYL until hives subsided.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Onset the evening of influenza vaccine administration, chills, fever, body aches. Duration 3 days
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Myalgia, Pyrexia, Tachycardia
Clinical narrative: Pt c/o fever, chills, myalgia about 4 hours after receiving vaccine, also Tachycardia (131p). Called ambulance in advise of Health Dept.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Nasopharyngitis, Respiratory tract infection
Clinical narrative: This case was reported by a consumer and described the occurrence of respiratory virus in a 60-year-old female patient who received Flu Seasonal TIV Dresden (influenza vaccine unspecified 2011-12 season). Concurrent medical conditions included asthma. Concomitant products included FLOVENT, VENTOLIN HFA and lisinopril. In 2011, the patient received Influenza vaccine unspecified 2011-12 season. In 2011, 14 days after receiving Influenza vaccine unspecified 2011-12 season, the patient experienced respiratory virus and viral cold. On an unknown date, the outcome of the respiratory virus and viral cold were unknown. It was unknown if the reporter considered the respiratory virus and viral cold to be related to Influenza vaccine unspecified 2011-12 season Additional details: The patient received the flu shot from the unknown manufacturer in the fall 2011. 14 days after vaccination the patient experienced a viral cold affecting the respiratory tract.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Erythema, Local swelling
Clinical narrative: Pt received both Flu and PNEUMOVAX 23 shots on the samd day. She came back to the pharmacy next morning to report swelling, pain, redness on right armpit. She also has a hx of breast cancer.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Injection site reaction, Ligament sprain, Muscle strain
Clinical narrative: Developed a shoulder strain - one week after her flu shot and now presents with a left deltoid muscle strain.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Epistaxis, Injection site cellulitis, Peripheral swelling, Skin warm
Clinical narrative: Pt was hospitalized 10.13.14 for epistaxis. Vaccines were given on discharge. Reported 10.15.14 to PCP warm, swollen arm. PCP Dx cellulitis, noting it completely circled upper arm. Pt was started on cefdinir 300mg po bid. Complete recovery was reported. (This was right arm).
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site induration, Injection site vesicles, Injection site warmth, Non-cardiac chest pain
Clinical narrative: Pt hospitalized 10/16-10/17 for chest pain, probable non-cardiac. Vaccines given on discharge. That evening site was hard, hot but not red with fluid filled area noted. Edema went half way down arm, completely circling the arm, causing fingers to tingle. Pt had a temp at home, area became red. Took OTC meds for fever/pain. Resolved without further treatment by 10:20. Pt described as "awful bad." (This was the right arm).
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain, Paraesthesia, Pyrexia
Clinical narrative: Pt hospitalized 10/16-10/17 for chest pain, probable non-cardiac. Vaccines given on discharge. That evening site was hard, hot but not red with fluid filled area noted. Edema went half way down arm, completely circling the arm, causing fingers to tingle. Pt had a temp at home, area became red. Took OTC meds for fever/pain. Resolved without further treatment by 10:20. Pt described as "awful bad." (This was the right arm).
Age: 19.0
Sex: F
Vaccine: FLU4, HEPA, PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Arm was hurting and swelling, was hot to touch and red by 7 pm. By 9 pm the redness was going up the arm past the shoulder hand and fingers were numb. Call emergency room was told to take BENADRYL. Called pharmacist on Sunday and was told to keep taking it. If it got worse to see a dr. By Tuesday swelling was down but still red. Feeling in hand and fingers was coming back.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: Pt. states arm very sore all the way down the forearm. Also circle around area where shot was given.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13
Symptoms: Herpes zoster, Varicella virus test positive
Clinical narrative: Pt received varicalla vaccine 9/25/12 - no history of varicella disease. Diagnosed with shingles 10/13/14.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: Redness and swelling at injection site (L). pain and tingling traveling down to hand. Swelling of left index finger.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt got flu and pneumonia shot on 10/14 - swelling and redness of pneumonia injection site and fever after 24 hours 10/15. Pt called her doctor. Her physician said to take TYLENOL. Pt called to report to us 10/18/14.
Age: 76.0
Sex: M
Vaccine: FLUC3, VARZOS
Symptoms: Blister, Rash, Skin irritation
Clinical narrative: Patient has a rasied, irritated blister on left leg that presented approximately 48 hrs after injection.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Pt received Pneumo shot 10/22. Noticed arm swelling and red, went to MD and came in to show pharmacist 10/24/14.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient had redness and swelling at site next day but then 2 days after injection also experienced soreness and pain under arm hurts to move arm. Patients PCP was consulted and did not advise treatment.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose, Syncope
Clinical narrative: Patient fainted after shot administered, 911 was called. patient has history of fainting after shots.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness, Pain
Clinical narrative: Patient stated having numbness and weakness in arm that vaccine was given in. Also was achy - was better after sleeping thru the PM but worsened as used it on the following day - was increasing with use.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nerve damage, Pain in extremity
Clinical narrative: Patient complains of pain in the arm that got the Flu shot (Right Arm) and pain radiates down to her hands and fingers. Pt's MD said it must hit the nerve!!
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Skin lesion, Vaccination site inflammation
Clinical narrative: Patient returned to pharmacy, shaved vaccinated arm and her arm was very inflamed and red with a few red sores on the area, but about 4 inches below the injection site. The injection site is not affected. It appears to have only affected lower arm. Went to MD who presented Cephalexin and BENADRYL.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Patient received Flu shot Morning of 10/27/14 that evening patient developed fever of 100.2 degree F was vomiting and had chills and loose stools. Followed up with patient 10/28/14 and she was feeling much better but weak. No vomiting 10/28/14 and temp had gone down.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Full blood count normal, Hypoaesthesia, Lethargy, Metabolic function test normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Received normal dose (not HD) flu vaccine around October 13. On October 20 had sudden onset of numbness of left face, jaw, and neck. No weakness. 50% resolution by next day, but 10% residual one week later. Has been lethargic since 10/13.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Urine analysis normal
Clinical narrative: Received normal dose (not HD) flu vaccine around October 13. On October 20 had sudden onset of numbness of left face, jaw, and neck. No weakness. 50% resolution by next day, but 10% residual one week later. Has been lethargic since 10/13.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Throat irritation
Clinical narrative: Pt reported 9/30/14 that a few hours after she got her Flu vaccine 9/29/14. Her throat became scratchy and her eyelid swelled. No hives, no respiratory, Distress. She took BENADRYL and her Sx resolved.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Pt. called 10/27/14 reported c/o sore throat, congestion, coughing, and tiredness. Stated no fever or nausea/vomiting. Started day after shot with sore throat and progressed to all other s/s. Reports can't afford to go to doctor. Inst. To go to ER for condition or worsens.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Given decreased dose than recommended by manufacturer
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect storage of drug
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Given decreased dose than recommended by manufacturer
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Given decreased dose than recommended by manufacturer
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Given decreased dose than recommended by Manufacturer
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 1.88
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Pain
Clinical narrative: Patient experienced redness and soreness at site but 3 days later developed pain under arm, it hurt to move arm. Pain lasted appx 24 hrs then resolved. Patient's PCP was consulted, she did not advise treatment.
Sex: U
Vaccine: RV5, HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and office manager and refers to patient of unknown age and gender. On 16-SEP-2014 the patient was vaccinated with PEDVAXHIB, (lot # K000331, expiry 23-OCT-2016, dose, dose # and route unspecified), that was exposed to temperatures outside of the proper storage range on unspecified dates. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with improperly stored doses of ROTATEQ oral (dose and lot # were not reported). No adverse effects were reported. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, TDAP
Symptoms: Drug administered to patient of inappropriate age, Rash
Clinical narrative: Incorrect vaccine administered to underage infant. Had mild rash about 24 hrs after vaccine given.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose ROTATEQ (dose, lot# and route of administration were not reported). The vaccine had been exposed to 33F for a maximum of 36 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria, Rash pruritic, Urticaria
Clinical narrative: Patient developed an itchy rash with hives to chest it then spread to neck/face/axilla and rest of torso. No SOB, no malaise. Slowly resolved on own. More concentrated finding to site of injection.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: C/O (L) arm and shoulder extremely painful day of shot. Can't lift it straight up. Pain in joint and shoulder blade. Now whole arm hurts and (L) shoulder.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (registered nurse) refer to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, the unspecified number of patients were vaccinated with ROTATEQ for an unknown indication (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date unspecified number of patients received ROTATEQ after being improperly stored. No adverse effects reported. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Patient received Tdap vaccine and had hard lump form at site of injection with red area about 1 inch in diameter form. Very tender to touch.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 16-OCT-2014, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (dose, route and lot # unknown). No adverse effects reported. Doses of GARDASIL and PNEUMOVAX were also stored improperly, but none of these doses were administered to patients. Additional information is not expected as the nurse cannot be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (Healthcare worker) refers to a patient of unknown age. Current conditions and medical history was not reported. On 23-JUL-2014 the patient was vaccinated with VAQTA injection 25/0.5 (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On 22-OCT-2014, the patient received second dose of VAQTA. No adverse symptoms reported. Product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (Licensed Practical Nurse) refers to a patient of unknown age. Current conditions and medical history was not reported. On 23-OCT-2014, the patient was vaccinated with M-M-R II injection, lot number- H018948, expiry date- 18-OCT-2014, 0.5 milliliter, subcutaneously. Concomitant medications were not reported. On 23-OCT-2014, patient was administered an expired dose of vaccinated with M-M-R II. No adverse events were reported. Product quality complaint was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 69 year old female patient. Current conditions and medical history was reported as none. On 21-OCT-2014, the patient was vaccinated with ZOSTAVAX, lot number K009770, expiry date 09-OCT-2015 (dose, route and frequency were not reported). Concomitant medications were reported as none. On an unknown date approximately in October 2014, the patient developed severe rash after receiving ZOSTAVAX. Patient called the pharmacy on 22-OCT-2014 and reported having severe rash. Reporting Pharmacist was not the pharmacist who actually spoke to patient about rash. No treatment was given for the rash. No lab diagnostics studies performed. The outcome severe rash was reported as not recovered. Causality assessment was not reported. Product quality complaint was not reported. Varicella Zoster Virus Identification Program (VZVIP) packet faxed to pharmacist. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (medical assistant) refers to a patient of unknown age. Current conditions and medical history was not reported. On 21-OCT-2014, the patient was vaccinated with VARIVAX injection, 0.5 milliliter, subcutaneous. Lot number was reported as H018527 and expiry date was 09-OCT-2014. Concomitant medications were not reported. On 21-OCT-2014, the patient received an expired dose of VARIVAX (Merck). No symptoms reported. Product quality complaint was not reported. Additional information has been requested.
Age: 1.55
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician via a other health professional refers to a 18 month old male patient. There were no drug allergies, family history and prior medical history. Patient who began on PREVNAR 13 0.5 ml (milliliters) intramuscular injection on an unknown anatomical site at an unknown time on an unknown date. Vaccines given on the same day included Hib (Sanofi) vaccine and DTaP (GSK) vaccine. Vaccines taken within the last four weeks since 18-JUL-2014 were none. On 18-JUL-2014 the patient was vaccinated with PNEUMOVAX 23 lot # K004930; expiry: 16-MAR-2015, dose #: 4 (dose, route and anatomical location of the administration of the vaccine were unknown). Relevant concomitant medications were unknown. On 18-JUL-2014, it was reported that the patient received 4th dose of adult PNEUMOVAX 23 vaccine instead of PREVNAR 13. Diagnostic tests: unknown. No emergency room or doctor visit was required. No adverse event was reported. The outcome of patient received 4th dose of adult PNEUMOVAX 23 vaccine instead of PREVNAR 13 is unknown. Action taken was not applicable (also reported as dose not changed). Causality was provided as not related by the reporter. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown gender. On 17-OCT-2014. 16 weeks and 4 days old patient was vaccinated with a first dose of ROTATEQ (lot number, expiration date, dose were not reported), oral. No adverse effects were reported. Additional information is not expected due to no consent for follow up.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (Registered nurse) refers to a patient of unknown age. Current conditions and medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL for an unknown indication (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date the patient was administered improperly stored dose of GARDASIL. No adverse effect reported. Product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and office manager and refers to patient of unknown age and gender. On 09-SEP-2014 the patient was vaccinated with PEDVAXHIB, (lot # K000331, expiry 23-OCT-2016, dose, dose # and route unspecified), that was exposed to temperatures outside of the proper storage range of unspecified dates. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Patient given a second dose of PNEUMOVAX 23 instead of PREVNAR 13 booster.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Excoriation, Rash pruritic
Clinical narrative: Pruritic rash w/white centers, many excoriated, on RFA, (L) abd and groin, (L) buttock, and (R) side of face even behind ears starting 10/22/14. Tx: Hydroxyzine 10 mg 1 tab q6 hours PRN.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site mass, Pruritus, Swelling
Clinical narrative: This spontaneous report as received from a 25 year old non-pregnant female patient with unspecified drug reactions or allergies refers to herself. On 10-OCT-2014 the patient was vaccinated with 0.5 ml dose of GARDASIL, (in the arm, intramuscular, lot #, expiration date not reported). There were unspecified concomitant medications. Right after the vaccination, on 10-OCT-2014 the patient experienced swelling, redness and itching. On 21-OCT-2014 (reported also as: two weeks later) the patient noticed a small bump on her arm at the site of the injection. The patient reported that the bump was "pea-sized" and noticeable. She also reported that it could be felt underneath the skin when it was touched. There were no laboratory test performed. There were no treatment given for the events. Product quality complaint (PQC) was not involved. The outcome of the events was unknown. The patient did not seek medical attention. The relatedness between the therapy with GARDASIL and events was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (registered nurse) refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, the unspecified number of patients were vaccinated with GARDASIL (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date unspecified number of patients received GARDASIL after being improperly stored. No adverse effects reported. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and office manager and refers to patient of unknown age and gender. On 16-SEP-2014 the patient was vaccinated with PEDVAXHIB, (lot # K000331, expiry 23-OCT-2016, dose, dose # and route unspecified), that was exposed to temperatures outside of the proper storage range on unspecified dates. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and office manager and refers to patient of unknown age and gender. On 12-SEP-2014 the patient was vaccinated with PEDVAXHIB, (lot # K000331, expiry 23-OCT-2016, dose, dose # and route unspecified), that was exposed to temperatures outside of the proper storage range on unspecified dates. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (registered nurse) refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, the unspecified number of patients were vaccinated with M-M-R II (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date unspecified number of patients received M-M-R II after being improperly stored. No adverse effects reported. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 76 year old female patient with acid reflux refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX parenteral (dose, lot # not reported). Concomitant therapies included SYNTHROID and NEXIUM. On 12-OCT-2014 the patient experienced shingles after receiving ZOSTAVAX. The patient visited physician on 14-OCT-2014 and acyclovir 800mg was given as a treatment. There was no lab diagnostic studies performed. The patient did not recovered from shingles. Relatedness between the event and ZOSTAVAX was not specified. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Pruritus
Clinical narrative: This spontaneous report as received from a 85 year old female patient with unspecified reactions/allergies to: either MACROBID or clarithromycin otherwise not specified; OMNARIS, allergies to bee stings, and with chronic cough refers to herself. The patient's medical history included dizzy spells and tuberculosis (TB) history. On 18-OCT-2014 the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot#, expiration date not reported). Concomitant therapies included losartan potassium (manufacturer unknown (reported also as: Losartin)), metformin, simvastatin (manufacturer unknown) and ZYRTEC. On 19-OCT-2014, the patient experienced itching. On 20-OCT-2014 the patient experienced red rash at the injection site. The patient reported also that the skin felt smooth at the injection site. The patient reported also that her husband received ZOSTAVAX and did not experience an injection site reaction. There was no treatment given for the events. The outcome of events was unknown. The patient sought medical attention and contacted pharmacy where she received ZOSTAVAX and was advised to contact her physician. The relatedness between the therapy with ZOSTAVAX and the reported events was not reported. Additional information is not expected since there is no consent to contact the physician.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Pruritus, Rash, Urticaria
Clinical narrative: Itching, rash, large hive ("baseball-sized") swelling on the injection arm.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On 30-JUL-2010, the patient was vaccinated with first dose of GARDASIL dose 0.5 ml, intramuscular (anatomical location was not reported). On 09-SEP-2010, the patient was vaccinated with second dose of GARDASIL dose 0.5 ml, intramuscular (anatomical location was not reported). On 29-AUG-2011 the patient was vaccinated with the third dose of GARDASIL dose 0.5 ml, intramuscular (anatomical location was not reported). On 23-OCT-2014 the patient inadvertently was vaccinated with fourth dose of GARDASIL dose 0.5 ml, intramuscular (anatomical location was not reported). There was no adverse experience reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with PNEUMOVAX 23 (lot #, expiration date, dose, frequency, route unspecified) that were improperly stored. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with GARDASIL (lot #, expiration date, dose, frequency, route unspecified) that were improperly stored. No adverse effect was reported. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported that the patient received an expired dose of ZOSTAVAX, lot # J008432, expiration date 11-OCT-2014, 0.65 ml, subcutaneous on 24-OCT-2014. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (registered nurse) refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, the unspecified number of patients were vaccinated with VAQTA (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date unspecified number of patients received VAQTA after being improperly stored. No adverse effects reported. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (registered nurse) refers to unspecified number of patients of unknown age. Current conditions and medical history was not reorted. On an unknown date, the unspecified number of patients were vaccinated with RECOMBIVAX HB for an unknown indication (dose, route, lot number and frquency were not reproted). Concomitant medications were not reported. On an unknown date unspecified number of patients received RECOMBIVAX HB after being improperly stored. No adverse effects reported. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Patient given a second dose of PNEUMOVAX 23 instead of PREVNAR 13 booster.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a 54 year old female patient refers to herself. No concurrent conditions or medical history were provided. On 18-OCT-2014, the patient was vaccinated at the pharmacy with a dose of ZOSTAVAX injection (strength, dose, route of administration, indication, lot # and expiry date unspecified). No concomitant medications were reported. In October 2014 (exact date unknown), the patient developed redness at the injection site. It was also stated that at the time of report (reported as "still"), her arm hurt and the patient felt very painful after the vaccination. The outcome of redness at the injection site was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 06-AUG-2014, the patient was vaccinated with the first dose of RECOMBIVAX HB 10/1.0 microgram/ml injection and, on  22-OCT-2014 (reported as "today"), the patient was coming into the office to receive the second dose of RECOMBIVAX HB (dose, route of administration, indication, lot# and expiry date unspecified for both). No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient with prior history of rheumatoid arthritis. On 10-OCT-2014 the patient was vaccinated with ZOSTAVAX, (0.65 ml, subcutaneously). No concomitant therapies reported. In October 2014 after vaccination, the patient experienced mild to moderate pain associated with an exacerbation of her rheumatoid arthritis. Physician would like to begin treatment with methotrexate, but at the time of report treatment had not started. Patient sought medical attention (office visit to unspecified physician). The outcome of mild to moderate pain associated with an exacerbation of her rheumatoid arthritis was reported as not recovered/not resolved. Relatedness between event and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose of GARDASIL (dose, lot# and route of administration were not reported). The vaccine had been exposed to 33F for a maximum of 36 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose of VAQTA (dose, lot# and route of administration were not reported). The vaccine had been exposed to 33F for a maximum of 36 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis staphylococcal, Injection site erythema
Clinical narrative: Patient reported injection site erythema to pharmacy 10/27/14 PM. Advised to apply warm compress to site and report in the AM. AM 10/28/14 warm compress helped but erythema remained. Nurse at patient's work suggested seeking medical attention. Patient reported to MD who prescribed doxycycline for cellulitis staph.