chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No pertinent medical history, drug reactions/ allergies or concurrent were reported. On approximately 15-JUN-2016 (reported as "about 7 days ago"), the patient was vaccinated with ZOSTAVAX, subcutaneously (the dose, dosage number, anatomical location, lot # and expiration date were unknown). No concomitant medications were reported. The patient stated that, on the same day as the day of the vaccination, she developed shingles. No information was provided regarding whether the patient sought any treatment for this event. Moreover, at the time of reporting, the outcome of the event was unknown. The reporter also failed to provided a causality assessment between the event was unknown. The reporter also failed to provide a causality assessment between the event and the vaccination with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown gender and unknown age. The patient's pertinent medical history and drug reactions/allergies were not provided. On an unknown date, the patient received a dose of PROQUAD (rHA, lot # L046508, expiration date 17-MAY-2017, 0.5ml/frequency unspecified), which had been exposed to -14 Celsius degree for 6.5 hours (incorrect product storage), subcutaneously. No adverse effects were reported. Additional information is not expected as the physician does not want to be contacted.
Age: 0.45
Sex: U
Vaccine: HPV9, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: 6-17-16, Date of event at 12:10 vaccines given. 6-18-16, No symptoms or signs of anything. 6-21-16, Patient stable no symptoms or signs.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Vaccination site swelling
Clinical narrative: Given vaccine in left arm. Arm was swollen around vaccine site the next day. Followed up in our office 2 days later.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Patient states she had a lot of pain in arm, felt ill and arm was swollen, red and itchy. By the time she reported it (6 days after administration) she says she feels better but arm still red and swollen.
Age: 41.0
Sex: F
Vaccine: HEP, HEPA, PPV, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Patient received vaccines on 6/16/16. Patient diagnosed with cellulitis on left bicep on 6/20/16, treated with KEFLEX 500 mg QID x 7 D starting 6/20/16.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Headache, Pain, Peripheral swelling, Pruritus
Clinical narrative: Extreme pain and itching. Swollen area from shoulder to elbow - "orange skin" swollen area very firm. Headache, cough/congestion.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Respiratory tract congestion, Skin discolouration
Clinical narrative: Extreme pain and itching. Swollen area from shoulder to elbow - "orange skin" swollen area very firm. Headache, cough/congestion.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Pt. called says she has severe pain from top of arm to wrist. Took 2 NORCO and it still hurt. No swelling, or redness, trouble moving arm.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Pt. called says she has severe pain from top of arm to wrist. Took 2 NORCO and it still hurt. No swelling, or redness, trouble moving arm.
Age: 1.01
Sex: F
Vaccine: DTAPHEPBIP, MMR, PNC13, VARCEL
Symptoms: Cough, Erythema, Papule, Pyrexia, Rash maculo-papular
Clinical narrative: Fever 102.2,  coryza, cough, maculopapular eruption, sparsely, mostly in limbs, 2mm red, raised papules.
Age: 1.01
Sex: F
Vaccine: DTAPHEPBIP, MMR, PNC13, VARCEL
Symptoms: Rhinitis
Clinical narrative: Fever 102.2,  coryza, cough, maculopapular eruption, sparsely, mostly in limbs, 2mm red, raised papules.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Large local reaction at injection site.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Tuberculin test, Urticaria
Clinical narrative: Day after receiving Hepatitis B vaccine had rash/hives to chin, neck area. No shortness of breath. No treatment.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood thyroid stimulating hormone normal, Chest pain, Fatigue, Insomnia, Lipids
Clinical narrative: 6 mos after vaccine mom brought to office with concerns of fatigue, costochondral chest pain, not sleeping well, weight gain. Mom believes has some depression. Believes all were caused by HPV and wanted reported. Have recommended counseling.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Thyroxine free, Weight increased
Clinical narrative: 6 mos after vaccine mom brought to office with concerns of fatigue, costochondral chest pain, not sleeping well, weight gain. Mom believes has some depression. Believes all were caused by HPV and wanted reported. Have recommended counseling.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Feeding disorder, Feeling hot, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: One hour after vaccine patient said she became hot and was sweating. The site got red, swollen and started itching. She had a fever, headache and couldn't eat. She felt like she was going to vomit, patient took ADVIL to treat. Site red and swollen down to elbow.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: One hour after vaccine patient said she became hot and was sweating. The site got red, swollen and started itching. She had a fever, headache and couldn't eat. She felt like she was going to vomit, patient took ADVIL to treat. Site red and swollen down to elbow.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Pain in extremity, Skin warm
Clinical narrative: Next day lump and redness. By the next day whole upper arm (oval) red, hurts, warm to touch.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Muscle spasms
Clinical narrative: PPSV23 given at 9:15. At 15:35 pt came back to clinic - left deltoid appeared in spasm. Doctor evaluated. Recommended heat/ice, ibuprofen, rest arm. 5/3/16 pt reports arm is improving. Patient referred to PT.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cyanosis, Peripheral coldness
Clinical narrative: Developed blue/cold b/l lower extremities almost 24 hours after vaccines. More prominent on (L) side (LE). Acting normally, eating and drinking and wetting diapers. No redness at injection site.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood pressure decreased, Cold sweat, Dizziness, Pallor
Clinical narrative: Dizzy, pale, clammy skin - decreased B/P - pt layed down - elevated feet - juice given - cold compress to head - B/P - HR monitored by MD and nurse.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Maculopapular rash to all his body, that he developed within 2 weeks after administration. No fever.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Electrocardiogram, Nausea, Palpitations
Clinical narrative: Tdap given at 10:30 am., 3:00 pm. started having lightheadedness, weakness, nausea, vomiting and then heart palpitations. Seen in ER that evening and instructed to follow up with primary doctor and return to ER if symptoms recur.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Troponin, Vomiting
Clinical narrative: Tdap given at 10:30 am., 3:00 pm. started having lightheadedness, weakness, nausea, vomiting and then heart palpitations. Seen in ER that evening and instructed to follow up with primary doctor and return to ER if symptoms recur.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever, chills, fatigue - lasted for 12 hours after administration. Patient took TYLENOL twice.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dysphagia, Dyspnoea, Muscle tightness, Pyrexia
Clinical narrative: 5/24/16 Fever, chills, neck tightness, difficulty swallowing, shortness of breath. Pt was given BENADRYL and nebulizer treatment with relief. Seen in ER 5/24/16 per pt.
Age: 79.0
Sex: F
Vaccine: TD
Symptoms: Axillary pain, Cellulitis, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Left arm turned red from elbow to armpit and shoulder. Very painful and itchy. Got worse every day. Got redder - hurt to touch and the itch was unbearable. Lasted 10 days.
Age: 79.0
Sex: F
Vaccine: TD
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Left arm turned red from elbow to armpit and shoulder. Very painful and itchy. Got worse every day. Got redder - hurt to touch and the itch was unbearable. Lasted 10 days.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Rash pruritic, Skin warm
Clinical narrative: Vaccine administered on 4/26 (Tuesday). Pt states about 2 days later, her arm became swollen, warm to the touch, and she had a rash. The rash was itchy. She stated by 5/3 it had been getting better.
Age: 51.0
Sex: U
Vaccine: TD
Symptoms: Pyrexia, Swelling
Clinical narrative: Swelling and fever.
Age: 24.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Severe deltoid pain with some slight swelling, took TYLENOL for pain and swelling, swelling and pain resolved.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Malaise, Pallor
Clinical narrative: A few minutes after vaccines were given while waiting in exam rm, pt was sitting on exam table mom went onto to other exam room where sister is being seen-nursing staff heard a loud noise and saw pt slumped on the floor in the hallway. Looked pale, was stable after a few minutes able to drink water. Child doesn't recall what happened. Remembered getting the shot but doesn't remember going out of the room. She said she "felt sick after shots".
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Temp to 101.4 6-28-16 7:00 am. No redness or tenderness at site of vaccines.
Age: 18.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Herpes zoster
Clinical narrative: 10 days after receiving vaccinations (VARIVAX) - was diagnosed with shingles just distal to injection site. MD gave antivirals (VALTREX).
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Swelling, Tenderness
Clinical narrative: Swelling, tenderness.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Presyncope, Syncope, Vomiting
Clinical narrative: After vaccine patient had a fainting and vomiting episode. There was no respiratory compromise and patient recovered by lying down and cold compresses to forehead and apple juice. Resolution within 15 minutes. Vasovagal reaction.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Reported hives occurring approximately 6 hours after vaccination. Self-treated with BENADRYL 50 mg x 1. Also took ZYRTEC 10 mg the following morning(takes as maintenance for allergies). Hives resolved within 24 hours of vaccination.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Patient reports fever of 3 day duration following vaccine. Higher on days 1 and 2, but not recorded.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Redness that turned into rash and swelling that itched and covered most of underside of upper left arm. Black and blue mark that spread across entire region from injection site. Sore throat and nausea. Difficulty breathing. 6/9/16-6/17/16 still some black and blue discoloration.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Oropharyngeal pain
Clinical narrative: Redness that turned into rash and swelling that itched and covered most of underside of upper left arm. Black and blue mark that spread across entire region from injection site. Sore throat and nausea. Difficulty breathing. 6/9/16-6/17/16 still some black and blue discoloration.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Dermatitis allergic, Erythema, Skin warm
Clinical narrative: Mild-Chill, cutaneous hypersensitivity - maybe had a RXN to PREVNAR. Red heat chill and skin hypersensitivity shot at same area he had a staph abscess in past he is better today. Warmth pink no induration or abscess. Continue APAP MOTRIN and ice pack. Add ADR and DOXY. The patient received PNEUMOVAX 0.5ml IM today in Left Deltoid. Merck Lot # and Expiration Date: L029306 EXO 3/26/2017.
Age: 93.0
Sex: F
Vaccine: FLUC3
Symptoms: Cardiac failure congestive, Death, General physical health deterioration
Clinical narrative: Case number PHHY2016US007438, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 605086) website on 18 Jan 2016. This report refers to a 93 year old female patient. Historical conditions included cardiomyopathy, hypothyroidism and renal insufficiency. Current condition included diabetes mellitus II, glaucoma, osteoporosis and allergy to sulfa. Concomitant medication included LASIX, MSIR, HALDOL, ZOFRAN, TYLENOL, allopurinol, amlodipine, COREG, glipizide. The patient was vaccinated with FLUCELVAX (batch number: 173538) intramuscularly into left arm on 08 Oct 2015. After vaccination on 10 Oct 2015, the patient was terminally diagnosed with a congestive heart failure and she was a home care hospice patient, patient had no reaction to vaccine but she began to rapidly decline over the next few days ultimately died on 15 Oct 2015. Cause of death was not reported. It was unknown if autopsy was performed. Causality of the events was not reported. Batch review report reference number (1011342) received from quality assurance department on 09 Feb 2016: Based on the document review, it was stated that the concerned FLUCELVAX batch number (173538) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from quality assurance department (QA reference number: 1011342) on 25 Jan 2016: Updated QA number only. Follow up information received from quality assurance department (QA reference number: 1011342) on 09 Feb 2016: Added expanded investigation batch summary report.
Age: 51.0
Sex: F
Vaccine: FLUC3, PPV
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Case number PHHY2016US007681 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 607779) website on 18 Jan 2016. This report refers to a 51 year old female patient. Medical history and concomitant medication were not reported. Concurrent condition included diabetes. The patient was vaccinated with FLUCELVAX (batch number: 173253) intramuscularly in the right arm and PNEUMOVAX (batch number: L007720, other manufacturer) intramuscularly in the right arm on 03 Nov 2015. On 05 Nov 2015, the patient experienced redness, swelling, hot and he was diagnosed with cellulitis. Outcome of the events was reported as unknown. Seriousness and causality of the events was not reported. Seriousness of the event cellulitis was upgraded based on the Novartis important medical events (IME) list. Batch review report (1011344) received from quality assurance department on 09 Feb 2016: Based on the document review, it was stated that the concerned FLUCELVAX batch number (173253) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from a Quality assurance department on 25 Jan 2016; QA reference number (1011344) was updated in the case. Follow up information received from a Quality assurance department on 09 Feb 2016; Added expanded investigation summary report.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Pyrexia, Tinnitus
Clinical narrative: Short breath, pain, redness, swelling, hardening of upper arm, unable to raise the arm - duration 4 days. Fever day 3-4th day - sheets sweat damp. 5th day could raise arm again - swelling-hardness redness.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Erythema, Hyperhidrosis, Induration, Pain
Clinical narrative: Short breath, pain, redness, swelling, hardening of upper arm, unable to raise the arm - duration 4 days. Fever day 3-4th day - sheets sweat damp. 5th day could raise arm again - swelling-hardness redness.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Short breath, pain, redness, swelling, hardening of upper arm, unable to raise the arm - duration 4 days. Fever day 3-4th day - sheets sweat damp. 5th day could raise arm again - swelling-hardness redness.
Sex: M
Vaccine: TDAP
Symptoms: Balance disorder, Gait disturbance, Muscular weakness, Paraesthesia
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 26 May 2016. This case involves a male patient (age was not reported) who was vaccinated with a first dose of Adacel (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date (reported as two weeks ago). It was reported that patients neurologists and a pharmacist advised him to get the vaccine. Patient's illness at time of vaccination was reported as CIVP (not specified) since 2000 and the symptoms stopped in 2005. Patient had a brief relapse in 2010. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergy and no other medical conditions. Concomitant medications were reported as none. On an unspecified date, 12 hours post vaccination, the patient had experienced tingling in feet which stops for 2-3 hours and then returns. On an unspecified date, post vaccination, the patient had experienced balance issues and calf muscles felt weak while walking and had overpronation. The patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Altered state of consciousness, Blood calcium normal, Blood magnesium normal, Blood phosphorus normal, Computerised tomogram head normal
Clinical narrative: Approx. 30-60 seconds after receiving her first Trumenba injection, the nurse reported that the pt slouched over, had impaired consciousness, and began to have tonic-clonic movements of her upper extremities which lasted 5-10 seconds and was followed by a brief post-ictal state. I was the called to the room and approx. 1-2 minutes later the pt had another seizure-like episode, which I witnessed, identical to the first. The pt had not received any other vaccines.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Full blood count normal, Metabolic function test normal, Postictal state, Seizure like phenomena, Tonic clonic movements
Clinical narrative: Approx. 30-60 seconds after receiving her first Trumenba injection, the nurse reported that the pt slouched over, had impaired consciousness, and began to have tonic-clonic movements of her upper extremities which lasted 5-10 seconds and was followed by a brief post-ictal state. I was the called to the room and approx. 1-2 minutes later the pt had another seizure-like episode, which I witnessed, identical to the first. The pt had not received any other vaccines.
Age: 1.05
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, 103 degrees. Vomiting the following morning at 9 AM.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Dyspnoea, Fatigue, Full blood count, Headache
Clinical narrative: I started getting body aches and a headache. By the next day, I developed severe, severe body aches, fever, shortness of breath, cough and fatigue. I am still dealing with shortness of breath and cough.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: I started getting body aches and a headache. By the next day, I developed severe, severe body aches, fever, shortness of breath, cough and fatigue. I am still dealing with shortness of breath and cough.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blood culture, C-reactive protein, Chest discomfort, Chills, Dyspnoea
Clinical narrative: Fever, chills, body aches, difficulty breathing, tight chest, nausea, muscle aches, a stiff neck and back and headache.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Full blood count, Headache, Metabolic function test, Musculoskeletal stiffness, Myalgia
Clinical narrative: Fever, chills, body aches, difficulty breathing, tight chest, nausea, muscle aches, a stiff neck and back and headache.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, difficulty breathing, tight chest, nausea, muscle aches, a stiff neck and back and headache.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Itching @ site of injection with big, hard knot red rash @ site of injection. Temperature (client did not have thermometer) and h/a. Took Tylenol that day and woke up sweaty and normal temperature. Used Benadryl for itching.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itching @ site of injection with big, hard knot red rash @ site of injection. Temperature (client did not have thermometer) and h/a. Took Tylenol that day and woke up sweaty and normal temperature. Used Benadryl for itching.
Age: 40.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Administerd adult hep B, instead of adult Tdap. Patient advised, and correct vaccine administered.
Age: 39.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient administered adult hep B instead of Tdap. Patient advised, and correct vaccine given.
Age: 0.62
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Body temperature increased, Irritability, Pain in extremity, Rhinorrhoea
Clinical narrative: Temp 99.0 F, irritable, runny nose, pain in legs.
Age: 65.0
Sex: M
Vaccine: VARCEL
Symptoms: Loss of consciousness, Road traffic accident
Clinical narrative: Black out resulting in auto accident.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 84 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-APR-2016, the patient was vaccinated with PNEUMOVAX 23 lot number reported as 035882, verified as L035882 (strength, dose, frequency, route of administration and expiration date were not reported). On 19-MAY-2016, the patient sought medical attention and was subsequently hospitalized the same day. it was suspected that PNEUMOVAX 23 caused the patient to develop Guillain Barre Syndrome. On 28-MAY-2016, the subject was discharged from the hospital. No further information was provided. The outcome of the event was unknown. No product quality complaint was involved in this case. The relatedness of the event with PNEUMOVAX 23 was unknown. The reporter considered the event to be life threatening. Upon internal review the event was considered to be medically significant. Follow up information has been received on 27-JUN-2016. Lot number 035882 has been verified to be a not valid lot number for PNEUMOVAX 23. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Tenderness
Clinical narrative: Received flu shot in employee health services. Soreness noted. 2nd day achiness back of shoulder, mild pain with arm overhead and extending back. (+) point tender. Therapy (physical) ordered.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Local reaction
Clinical narrative: Local reaction on left thigh upper 3/4 cm of redness and knot a little tender not much is getting better.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Late in afternoon following receiving flu shot, child's left upper arm became red and swollen, worsened by following day (shoulder to just above elbow) - significant local reaction - ice pack and NSAIDs.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Pyrexia
Clinical narrative: HEADACHE, FEVER OF 102 DEGREES FAHRENHEIT.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Dyskinesia, Joint stiffness, Local reaction, Myalgia
Clinical narrative: The Tdap vaccine was injected into my left arm. The initial symptoms were local reactions in the site of injection including painful and swelling arm as well as swelling hand. Then in the morning of June 17, I started having cogwheel-like jerks in my left fingers when I try to make a fist. After taking 20mg Prednisone a day for 6 days and Benadryl for 2 days as prescribed by the doctor, the swelling arm and hand went away. However, 11 days after receiving the vaccine, the cogwheel-like movements still persist. I also couldn't do heavy weight-lifting with my left arm - the muscles would become sore. My elbow, wrist and finger joints also hurt at times when I move. Starting this morning (June 29), my right finger joints felt a little stiff and slightly displayed cogwheel-like movements as well when I try to make a fist.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Peripheral swelling, Weight bearing difficulty
Clinical narrative: The Tdap vaccine was injected into my left arm. The initial symptoms were local reactions in the site of injection including painful and swelling arm as well as swelling hand. Then in the morning of June 17, I started having cogwheel-like jerks in my left fingers when I try to make a fist. After taking 20mg Prednisone a day for 6 days and Benadryl for 2 days as prescribed by the doctor, the swelling arm and hand went away. However, 11 days after receiving the vaccine, the cogwheel-like movements still persist. I also couldn't do heavy weight-lifting with my left arm - the muscles would become sore. My elbow, wrist and finger joints also hurt at times when I move. Starting this morning (June 29), my right finger joints felt a little stiff and slightly displayed cogwheel-like movements as well when I try to make a fist.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 19.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Angiogram, Borrelia test, Clostridium test, Computerised tomogram, Decreased appetite
Clinical narrative: Loss of appetite, diarrhea, fever day of shot; fatigue, shoulder pain and pain at injection site, numbness and tingling arms, hand, legs, jaw. Blurred vision in R eye occurred in the next few days.
Age: 19.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Diarrhoea, Fatigue, Hypoaesthesia, Injection site pain, Laboratory test
Clinical narrative: Loss of appetite, diarrhea, fever day of shot; fatigue, shoulder pain and pain at injection site, numbness and tingling arms, hand, legs, jaw. Blurred vision in R eye occurred in the next few days.
Age: 19.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Loss of appetite, diarrhea, fever day of shot; fatigue, shoulder pain and pain at injection site, numbness and tingling arms, hand, legs, jaw. Blurred vision in R eye occurred in the next few days.
Age: 19.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Pyrexia, Thyroid function test, Vision blurred
Clinical narrative: Loss of appetite, diarrhea, fever day of shot; fatigue, shoulder pain and pain at injection site, numbness and tingling arms, hand, legs, jaw. Blurred vision in R eye occurred in the next few days.
Age: 19.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Diarrhoea, Hypoaesthesia, Musculoskeletal discomfort, Nausea, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Loss of appetite, diarrhea, fever day of shot; fatigue, shoulder pain and pain at injection site, numbness and tingling arms, hand, legs, jaw. Blurred vision in R eye occurred in the next few days.
Age: 19.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Nuclear magnetic resonance imaging brain normal, Pain, Pain in jaw, Tendonitis, Weight decreased
Clinical narrative: Loss of appetite, diarrhea, fever day of shot; fatigue, shoulder pain and pain at injection site, numbness and tingling arms, hand, legs, jaw. Blurred vision in R eye occurred in the next few days.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain, Asthenia, Blood pressure increased, Diarrhoea, Erythema
Clinical narrative: Client states that she received vaccine on Thursday 6-2-16.  (Records show it was actually done on 5-31-16)  Client states that her arm was swollen and reddened but she went to work that evening and was able to work okay.  Client states Friday night, Saturday morning around 2:30am she started to have abdominal pain and vomiting and diarrhea.  Client states that she went to ER Saturday afternoon 6-4-16 and was given IV Zofran and amlodipine because her B/P was high.  Client states at the time her arm was just tight.  Client states that vomiting and diarrhea was less on Sunday.  Client states on Monday she was still vomiting and was weak and her B/P was going up and done so she went back to the ER.  Client states that she was given Norvasc and Tylenol and sent home and referred for follow up with her cardiologist.  Filed per client's request.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Skin tightness, Vomiting
Clinical narrative: Client states that she received vaccine on Thursday 6-2-16.  (Records show it was actually done on 5-31-16)  Client states that her arm was swollen and reddened but she went to work that evening and was able to work okay.  Client states Friday night, Saturday morning around 2:30am she started to have abdominal pain and vomiting and diarrhea.  Client states that she went to ER Saturday afternoon 6-4-16 and was given IV Zofran and amlodipine because her B/P was high.  Client states at the time her arm was just tight.  Client states that vomiting and diarrhea was less on Sunday.  Client states on Monday she was still vomiting and was weak and her B/P was going up and done so she went back to the ER.  Client states that she was given Norvasc and Tylenol and sent home and referred for follow up with her cardiologist.  Filed per client's request.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Mobility decreased, Pain in extremity, Skin warm, Swelling
Clinical narrative: Arm warm to the touch and presented with reddened skin below injection site. Slightly swollen. Patient had some difficulty moving the arm due to pain.
Age: 1.28
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Lethargy, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Low-grade fever, lethargy, sleepiness, not eating, after a few days covered from head to toe in red bumps.
Age: 1.28
Sex: F
Vaccine: MMR
Symptoms: Somnolence
Clinical narrative: Low-grade fever, lethargy, sleepiness, not eating, after a few days covered from head to toe in red bumps.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abnormal behaviour, Decreased appetite, Emotional distress, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of thigh started within hours of immunization and infant was inconsolable for several hours that evening.  She was subdued, slightly withdrawn and had decreased appetite for three weeks after vaccination.  Similar symptoms occurred following next set of immunizations at 4 months of age (12/8/15) and behavioral changes again lasted about three weeks before resolving.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Social avoidant behaviour
Clinical narrative: Redness and swelling of thigh started within hours of immunization and infant was inconsolable for several hours that evening.  She was subdued, slightly withdrawn and had decreased appetite for three weeks after vaccination.  Similar symptoms occurred following next set of immunizations at 4 months of age (12/8/15) and behavioral changes again lasted about three weeks before resolving.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Back pain, Chills, Exposure during pregnancy, Headache
Clinical narrative: She has cough and reports green sputum production that she feels started after the Pneumovax. She developed a sore, red, swollen area over most of right upper arm by 2 days after vaccination. Patient reports development of right upper extremity pain and swelling, fevers, chills, and headache after receiving her Pneumovax. Site of injection with warm, erythematous, and exquisitely tender demarcated region. She also developed sore throat, back pain, neck pain, light sensitivity, bilateral shoulder pain and bilateral hip pain. She states that she hurts all over.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal pain
Clinical narrative: She has cough and reports green sputum production that she feels started after the Pneumovax. She developed a sore, red, swollen area over most of right upper arm by 2 days after vaccination. Patient reports development of right upper extremity pain and swelling, fevers, chills, and headache after receiving her Pneumovax. Site of injection with warm, erythematous, and exquisitely tender demarcated region. She also developed sore throat, back pain, neck pain, light sensitivity, bilateral shoulder pain and bilateral hip pain. She states that she hurts all over.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Oropharyngeal pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: She has cough and reports green sputum production that she feels started after the Pneumovax. She developed a sore, red, swollen area over most of right upper arm by 2 days after vaccination. Patient reports development of right upper extremity pain and swelling, fevers, chills, and headache after receiving her Pneumovax. Site of injection with warm, erythematous, and exquisitely tender demarcated region. She also developed sore throat, back pain, neck pain, light sensitivity, bilateral shoulder pain and bilateral hip pain. She states that she hurts all over.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Photophobia, Productive cough, Pyrexia, Soft tissue inflammation, Sputum discoloured
Clinical narrative: She has cough and reports green sputum production that she feels started after the Pneumovax. She developed a sore, red, swollen area over most of right upper arm by 2 days after vaccination. Patient reports development of right upper extremity pain and swelling, fevers, chills, and headache after receiving her Pneumovax. Site of injection with warm, erythematous, and exquisitely tender demarcated region. She also developed sore throat, back pain, neck pain, light sensitivity, bilateral shoulder pain and bilateral hip pain. She states that she hurts all over.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound scan abnormal
Clinical narrative: She has cough and reports green sputum production that she feels started after the Pneumovax. She developed a sore, red, swollen area over most of right upper arm by 2 days after vaccination. Patient reports development of right upper extremity pain and swelling, fevers, chills, and headache after receiving her Pneumovax. Site of injection with warm, erythematous, and exquisitely tender demarcated region. She also developed sore throat, back pain, neck pain, light sensitivity, bilateral shoulder pain and bilateral hip pain. She states that she hurts all over.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Paraesthesia, Skin warm, Swelling
Clinical narrative: Initial swelling below injection site was size of golf ball, red, and hot. Pt describes tingling and soreness in arm. 48 hrs after injection swelling had increased to larger than a grapefruit, redness and heat had decreased and tingling was gone, but arm was still sore. Pt used ice pack on swollen site.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: AFTER APROX 2 MIN. AFTER HPV VACCINE PT GOT OFF TABLE FELT DIZZY AND PASSED OUT.
Age: 1.52
Sex: M
Vaccine: DTAP, FLUX, DTAP, FLUX
Symptoms: Alopecia
Clinical narrative: Lost patches of hair on his head. Took months to grow back. 6 months later he lost more patches of hair.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching and injection site redness reported. Treated with Children's Benadryl.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Constipation, Flatulence, Pyrexia
Clinical narrative: 102.5 fever, excessive gas, constipation.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Central venous catheterisation, Injection site reaction, Monoplegia
Clinical narrative: Information had been received on 28-JUN-2016 from the husband of a 60 year old female with penicillin allergy who reported that his wife received a dose of PNEUMOVAX 23 0.5ml intramuscular injection on 18-JUN-2016 (lot #/expiration date unknown by reporter). The next day, 19-JUN-2016, "the patient's arm went paralyzed near the injection site". The patient visited her doctor to seek medical attention and "currently has a peripherally inserted central catheter (PICC) line in her arm to help treat the paralysis". On an unknown date, patient underwent "blood work" (results not provided). Patient's present status was reported as not recovered. Concomitant medication and pertinent medical history were unknown by reporter. Patient's husband called to request compensation and assistance to pay for patient's medical bills due to her arm being paralyzed and having to use a PICC line in her arm. No further adverse event information was provided. Upon internal review, "the patient's arm went paralyzed near the injection site"/"currently has a peripherally inserted central catheter (PICC) line in her arm to help treat the paralysis" was determined to be a medically significant event. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates (before expiration dates), the patients were vaccinated with improperly stored VARIVAX (lot # 0661AE, expiration date 28-MAR-2014; lot # H013398, expiration date 10-JUL-2014; lot # reported as 1910AA, expiration date 05-DEC-2013; lot # H017879, expiration date 27-SEP-2014; route and dose were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date the patient was vaccinated with an expired dose of VARIVAX (dose, route and lot # not provided). Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of an unknown gender and gage. Concurrent conditions and medical history were not provided. On 20-JUN-2016, the patient was vaccinated with an expired dose of M-M-R II (subcutaneous, lot # K008815, expiration date: 19-JUN-2016)(strength, dose and frequency were not provided). There were no concomitant medications reported. No adverse events were reported. There were no product quality complaints involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates (before expiration dates), the patients were vaccinated with improperly stored VAQTA (lot # K008254, expiration date 12=NOV-2015; lot # L004439, expiration date 15-FEB-2015; lot # K015827, expiration date 11-MAR-2016; lot # L013380, expiration date 04-NOV-2017; lot # L023232, expiration date 25-FEB-2017; lot # L022259, expiration date 06-APR-2017; lot # L030442, expiration date 19-DEC-2016; lot # L042631, expiration date 16-FEB-2016; route and dose were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates (before expiration date), the patients were vaccinated with improperly stored ROTATEQ (lot # K006805, expiration date 24-MAR-2016; lot #   K010325, expiration date 10=MAY-2016; lot # reported as L004453, expiration date 27-MAY-2016; lot # K011948, expiration date 07-JUN-2016; lot # K020183, expiration date 25-JUN-2016; lot # K024700, expiration date 30-JUL-2016; lot # L006184, expiration date 13-DEC-2016, lot # L013203, expiration date 28-JAN-2017; oral; dose was not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect route of drug administration, Vaccination failure
Clinical narrative: This spontaneous report was received from a pharmacist concerning an approximately 74 year old male patient. The patient's medical history, concomitant therapy and concurrent conditions were not provided. The patient had no known drug allergies. On an unknown date in APRIL 2015 (when the patient was 73-year-old), the patient was vaccinated intramuscularly with a dose of ZOSTAVAX (lot #, expiration date and dose were not reported). The reporting pharmacist stated, that the patient came to the pharmacy with a prescription for antivirals because the patient had shingles (onset date was unknown). The reporter discussed vaccination failure. The patient received unspecified treatment. The outcome of the event was unknown by the reporter (also reported as the event did not improve). The causality assessment between the event and ZOSTAVAX was not reported.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of  unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates (before expiration date), the patients were vaccinated with improperly stored PNEUMOBAX23 (lot # K008410, expiration date 26-FEB-2016; dose and route were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 5 year old male patient. ON 28-MAR-2016 at 10:09, the patient was intramuscularly vaccinated with improperly stored (Temperature: 32F-Time frame: 5 minutes) dose of VAQTA (second dose, lot # K012457, dose was unknown) in right deltoid. No adverse effect was reported. This is ne of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site rash
Clinical narrative: This case was reported by a  nurse via call center representative and described the occurrence of injection site rash in a 4-year-old female patient who received KINRIX (batch number 2A947, expiry date 31st OCTOBER 2017). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced injection site rash. The patient was treated with non-drug therapy (Cold Compress) and cetirizine. On an unknown date, the outcome of the injection site rash was recovered/resolved. The reporter considered the injection site rash to be related to KINRIX. Additional details were provided as follows: The patient's age at vaccination was not reported. The reporter stated that, the patient experienced rash that started at the injection and spread over the entire deltoid.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot # K008879, expiration date 30-MAR-2017, lot # K016964, expiration date 16-JUL-2017; lot # K026533, 07-AUG-2017; lot # L004740, expiration date 16-NOV-2017; lot # L014426, expiration date 08-MAR-2018; lot # L014428, expiration date 12-MAR-2018; dose and route were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 4 month old female patient. On 22-MAR-2016 at 14:23, the patient was orally vaccinated with improperly stored (temperature: 32F - Time frame: 5 minutes) dose of ROTATEQ (second dose, lot # L013202, dose was unknown). NO adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.57
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 6 month old female patient. On 28-MAR-2016 at 11:18, the patient was orally vaccinated with her third improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of ROTATEQ (lot # L013202, dose was unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.