chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Scan with contrast, Sinus arrhythmia, Spirometry normal, Troponin T normal, Troponin increased
Clinical narrative: Onset of left, substernal throbbing chest pain and dyspnea. Pain worse on 6 Jun after 4-mile run. 3 Jun 16 (post-vaccine date (PVD) 9), onset of chest pain (CP) and shortness of breath. CP increased with deep breaths, also reported nausea, and diaphoresis. 6 Jun 16 (PVD 12), sought evaluation for continued CP (10/10) following 4-mile run. Treated with ZOFRAN, morphine, DILAUDID and TORADOL. ECG with NSR, sinus arrhythmia, rightward axis - borderline ECG. Elevated Troponin, CXR showed pneumomediastinum. Admitted to Hospital for pain management and observation. Discharged on OXYCONTIN for chest pain. Placed on limited duty. 13 Jun 2016 (PVD 19), ER evaluation - c/o SOB, CP and vomited blood x 3; anxious --> ATIVAN. CXR normal. Discharged: anxiety, hematemesis, CP, insomnia r/t medical problems. REC: PFTs, GI eval, albuterol inhaler, repeat ECG, referral to behavioral health. As of FEB 2017, patient continues to have ongoing chest wall pain. Additional cardiology evaluations do not support pain is cardiac in origin.
Age: 19.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: X-ray normal
Clinical narrative: Onset of left, substernal throbbing chest pain and dyspnea. Pain worse on 6 Jun after 4-mile run. 3 Jun 16 (post-vaccine date (PVD) 9), onset of chest pain (CP) and shortness of breath. CP increased with deep breaths, also reported nausea, and diaphoresis. 6 Jun 16 (PVD 12), sought evaluation for continued CP (10/10) following 4-mile run. Treated with ZOFRAN, morphine, DILAUDID and TORADOL. ECG with NSR, sinus arrhythmia, rightward axis - borderline ECG. Elevated Troponin, CXR showed pneumomediastinum. Admitted to Hospital for pain management and observation. Discharged on OXYCONTIN for chest pain. Placed on limited duty. 13 Jun 2016 (PVD 19), ER evaluation - c/o SOB, CP and vomited blood x 3; anxious --> ATIVAN. CXR normal. Discharged: anxiety, hematemesis, CP, insomnia r/t medical problems. REC: PFTs, GI eval, albuterol inhaler, repeat ECG, referral to behavioral health. As of FEB 2017, patient continues to have ongoing chest wall pain. Additional cardiology evaluations do not support pain is cardiac in origin.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to two patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 24-JAN-2017 and 31-JAN-2017, each patient was vaccinated respectively with an improperly stored dose of ZOSTAVAX lot # M041510, expiration date 27-JUL-2017 (dose and route of administration were not provided) for prophylaxis. There were no adverse effects reported. Administered doses of ZOSTAVAX were exposed to a temperature excursion of total time >-10°C but <8°C (>14°F but <46°F) for 10 hours. Data logger was involved. There were previous excursions reported as follows: total time >-10°C but <8°C (>14°F but <46°F) for 22 hours and total time >-15°C but <-10°C (>5°F but <14°F) for 1 hour. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA002298: US-009507513-1703USA002299: US-009507513-1703USA002300.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received on 20-FEB-2017 from the medical assistant who reported an unspecified patient (age and gender not reported) was administered the first dose of GARDASIL 9 on 09-FEB-2015 for the indication of prophylaxis.  The patient was administered the second dose of GARDASIL 9 on 15-APR-2016 for the indication of prophylaxis and administered the third dose of GARDASIL 9 on 13-FEB-2017 for the indication of prophylaxis. The strength, dose, route of administration, Lot number, and expiration date were not reported for any of the three vaccinations. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive, Ultrasound scan
Clinical narrative: This spontaneous pregnancy report as received from a physician refers to a 20 year old female patient with no known drug allergies and seizures. The patient's concomitant medications were not provided. On 30-NOV-2016, the patient was vaccinated with GARDASIL 9, dose 1, lot # M031557 and expiration date: 07-APR-2019 (route was not provided). On 30-JAN-2017, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (route, lot # and expiration date were not provided). The patient was found to be pregnant on 30-JAN-2017 which was confirmed by an unspecified pregnancy test and through an ultrasound on 14-FEB-2017. The patient's was currently at 9 weeks gestation. The date of last menstrual period and the expected date of delivery were not provided. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to three patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 01-FEB-2017 and 11-FEB-2017, 2 patients and 1 patient were vaccinated respectively with an improperly stored dose of PNEUMOVAX 23 lot # M040804, expiration date 20-MAY-2018 (dose and route of administration were not provided) for prophylaxis. There were no adverse effects reported. Administered doses of PNEUMOVAX 23 were exposed to a temperature excursion of >8°C but <25°C (>46°F but <77°F) for 10 hours. Data logger was involved. There were previous excursions reported as follows: >8°C but <25°C (>46°F but <77°F) for 10 hours. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA007980: US-009507513-1703USA002298: US-009507513-1703USA002300.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Antinuclear antibody negative, Discomfort, Erythema, Full blood count normal, Metabolic function test normal
Clinical narrative: Rec'd BEXERO 12/5/16 - within 24 hours pt. had red/swollen/tingling toes and distal feet. Persistent signs and symptoms x 2 months. Patient is uncomfortable. Attempted topical ointment (steroid) without relief. No fever. Similar incident with BEXSERO #1 8/1/2016 - lasted approx 10 days.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Rec'd BEXERO 12/5/16 - within 24 hours pt. had red/swollen/tingling toes and distal feet. Persistent signs and symptoms x 2 months. Patient is uncomfortable. Attempted topical ointment (steroid) without relief. No fever. Similar incident with BEXSERO #1 8/1/2016 - lasted approx 10 days.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: According to school nurse, child has red, swollen, hot area on (L) arm size 11 cm x 11 cm. Spoke with father on 3/3/17, reports unsure when arm reaction began went to ER today. Was advised to put warm cloth.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Rash generalised
Clinical narrative: Pt went to MD B/C she developed a full body rash (Both arms and hands) then neck was swelling. This occurred 2/19 PM. Pt received Medrol and CLARITIN on 2/22.
Age: 56.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injection site pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, X-ray
Clinical narrative: Developed severe pain at site of injection (left shoulder). Several days after, seen at Urgent care 12/31/16, (x-ray), primary doctor 1/13/17 and Orthopedic doc 1/13/17. Prescribed pain killers, anti inflammatories and Physical Therapy (5 weeks). Pain is still severe and limiting.
Age: 8.0
Sex: M
Vaccine: HEP, TYP
Symptoms: Erythema, Pruritus
Clinical narrative: Left arm redness and itching. Tried BENADRYL.
Age: 37.0
Sex: F
Vaccine: FLU4, MMR, TDAP
Symptoms: Hypoaesthesia oral, Rash, Tongue disorder
Clinical narrative: At 12:43 PM, pt began complaining of "thick tongue" feeling as well as numb lips and rash. No urticaria observed. Pt requested BENADRYL due to her numerous allergy history and stated these symptoms were the same as previous reaction symptoms. Pt stated symptoms resolved at 13:03, 10 minutes after BENADRYL.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Joint range of motion decreased, Pain in extremity
Clinical narrative: The patient had a very sore arm and limited range of motion for several days then presented with erythema at injection site 7 days later. The redness was about the size of a half dollar.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dysgeusia, Hypoaesthesia oral, Paraesthesia, Throat tightness
Clinical narrative: 5 mins after administration, patient reported slight throat constriction and bad taste in mouth. Patient was given water and reported feeling better, but refused to sit down, saying it made her feel worse. After 10 mins, she reported tingly scalp and numbing tongue. She was given 50mg liquid diphenhydramine at approximately 12:50pm. Patient then left the pharmacy sometime thereafter.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: SWELLING AND BLISTERS AT SITE OF INJECTION, TENDERNESS AND PAIN WITH ERYTHEMA TO COVER POSTERIOR RIGHT ARM ABOVE THE ELBOW.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site vesicles, Pain, Peripheral swelling, Pruritus
Clinical narrative: SWELLING AND BLISTERS AT SITE OF INJECTION, TENDERNESS AND PAIN WITH ERYTHEMA TO COVER POSTERIOR RIGHT ARM ABOVE THE ELBOW.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MEN, MMR, TDAP, VARCEL
Symptoms: Blepharospasm, Facial paralysis, Muscle spasms, Muscle twitching, Rash
Clinical narrative: Patient presented in clinic today 3/6/17, stating that she had a reaction to the vaccines she received on 2/23/17. Patient stated the reaction started on 2/24/17. Patient stated the left side of her face has began drooping, her left eye was twitching and she stated a rash appeared on both arms and legs and cramping in her hands. Patient stated she did not take any medication and that the above symptoms improved over the past days. Patient states that she has never had a reaction to a vaccine. Today she was seen by Alina Leigh, NP. Today there appeared to be no facial drooping. She did have a small rash on both arms and legs, minimal facial twitching to the left side of her face. Patient denies any fever or pain at this time. Vital signs were 114/87, pulse 80 , temp 99.1. height 60 inches, weight 121 lbs.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 16-FEB-2017, the patient was vaccinated with an inappropriate storage dose of PROQUAD (dose, frequency and route not reported), lot # M033215 with expiration date of 09-JAN-2018; and with a properly stored dose of VARIVAX (dose, frequency, route, lot and expiration date not reported). No adverse effects were reported. The temperature excursion of the PROQUAD vaccine was greater than 14 °F but less than 46 °F, for a time frame of 2 months. No previous temperature incursion was reported. No product quality complaint was involved (PQC). Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 17-FEB-2017 from a registered nurse, which refers to unspecified patients (age and gender not reported). The patients' pertinent medical history, current conditions and concomitant medications were not reported. The registered nurse reported that some improperly stored doses of GARDASIL 9 (Lot number M034780, expiration date 15-APR-2019), PNEUMOVAX 23 (Lot number M038359, expiration date 13-MAY-2018) and PEDVAXHIB (Lot number M036612, expiration date 19-MAY-2019) were administered to unspecified patients on 15-FEB-2017 and 16-FEB-2017. No adverse effects reported. The vaccines were exposed to temperatures as reported: Temperature: between 32F and 36F for 6 hours 40 minutes, also below 32F for 20 minutes. Time frame: 7 hours. There were no previous excursions reported. The call was because of a data logger. No additional information was provided. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Dizziness, Flushing, Headache
Clinical narrative: Information had been received on 20-FEB-2017 from a nurse practitioner regarding an unspecified male patient (age unknown) with hypertension, diabetes, hyperlipidemia, morbid obesity, asthma and allergy to erythromycin. Nurse practitioner reported that she administered PNEUMOVAX 23 (lot# M041394, expiration 23-MAY-2018) (dose and route of administration not reported) to the patient on 17-FEB-2017. Concomitant medications included GLUCOPHAGE, lisinopril, NORVASC, ALLEGRA, albuterol and LIPITOR. Nurse practitioner reported that the patient was seen in the office today with complaints of headaches, flushing, chills, shaking, sweating, and temperature of 102.6 on 17-FEB-2017. The patient treated self with ibuprofen. On 18-FEB-2017, patient stated that he continued with a temperature, dizziness and flu like symptoms. Nurse practitioner performed flu test and strep test that were both negative. Patient's left arm was red at injection site. Patient's present status was reported as recovering. Patient was given unspecified treatment for his adverse events. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Hyperhidrosis, Influenza like illness, Influenza virus test negative, Injection site erythema, Streptococcus test negative
Clinical narrative: Information had been received on 20-FEB-2017 from a nurse practitioner regarding an unspecified male patient (age unknown) with hypertension, diabetes, hyperlipidemia, morbid obesity, asthma and allergy to erythromycin. Nurse practitioner reported that she administered PNEUMOVAX 23 (lot# M041394, expiration 23-MAY-2018) (dose and route of administration not reported) to the patient on 17-FEB-2017. Concomitant medications included GLUCOPHAGE, lisinopril, NORVASC, ALLEGRA, albuterol and LIPITOR. Nurse practitioner reported that the patient was seen in the office today with complaints of headaches, flushing, chills, shaking, sweating, and temperature of 102.6 on 17-FEB-2017. The patient treated self with ibuprofen. On 18-FEB-2017, patient stated that he continued with a temperature, dizziness and flu like symptoms. Nurse practitioner performed flu test and strep test that were both negative. Patient's left arm was red at injection site. Patient's present status was reported as recovering. Patient was given unspecified treatment for his adverse events. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Information had been received on 20-FEB-2017 from a nurse practitioner regarding an unspecified male patient (age unknown) with hypertension, diabetes, hyperlipidemia, morbid obesity, asthma and allergy to erythromycin. Nurse practitioner reported that she administered PNEUMOVAX 23 (lot# M041394, expiration 23-MAY-2018) (dose and route of administration not reported) to the patient on 17-FEB-2017. Concomitant medications included GLUCOPHAGE, lisinopril, NORVASC, ALLEGRA, albuterol and LIPITOR. Nurse practitioner reported that the patient was seen in the office today with complaints of headaches, flushing, chills, shaking, sweating, and temperature of 102.6 on 17-FEB-2017. The patient treated self with ibuprofen. On 18-FEB-2017, patient stated that he continued with a temperature, dizziness and flu like symptoms. Nurse practitioner performed flu test and strep test that were both negative. Patient's left arm was red at injection site. Patient's present status was reported as recovering. Patient was given unspecified treatment for his adverse events. No further information was provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Mom reported that patient felt pain, warmth and swelling at the injection site within the hour he had a fever of 101. Fever of 102.8 on next day with puffy swelling from shoulder to elbow.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site discolouration, Injection site swelling
Clinical narrative: Injection site black and swollen. Patient feels warm.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Major Hair loss- Eyelashes, Eye brows, Head- Treatment has been cortisone shots into scalp various steroidal creams and lotion, which have not worked so far.
Age: 0.17
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Muscle contractions involuntary, Seizure like phenomena, Tremor
Clinical narrative: Hep B shot - started to have breathing problems and seizure-like activity, drawing her hands up and shaking head. Was admitted to hospital, discharged Saturday. Never drew blood at hospital, only there one night for observation.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Attention deficit/hyperactivity disorder, Condition aggravated, Tic
Clinical narrative: Patient has developed motor tics and vocal tics and worsening of ADHD following vaccination of MMR 02/16/2015 and 06/02/2015 and especially the Tdap 07/16/2015.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Decreased appetite, Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Child starting complaining that her brain was hot and wanted a cloth for her forehead, however there was no fever. Next day she was lethargic, no appetite, and vomited. Two days later her arm swelled and was red and hot and painful from shoulder to elbow.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth, Lethargy, Vomiting
Clinical narrative: Child starting complaining that her brain was hot and wanted a cloth for her forehead, however there was no fever. Next day she was lethargic, no appetite, and vomited. Two days later her arm swelled and was red and hot and painful from shoulder to elbow.
Age: 0.42
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Mother stated injection site was okay after appointment, two hours later the injection site formed a hard bump and took two weeks to go away.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Feeling cold, Influenza like illness, Mobility decreased, Myalgia
Clinical narrative: Arm suddenly became extremely sore, and needed to use other arm to lift it- and then flu like symptoms started. Super painful joints and muscles and feeling cold and wanting to just get into fetal position.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Arm suddenly became extremely sore, and needed to use other arm to lift it- and then flu like symptoms started. Super painful joints and muscles and feeling cold and wanting to just get into fetal position.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site reaction with pruritis warmth and erythema.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Rash
Clinical narrative: Rash, burn sensation, progressed to rash, blister under arm on arms on chest. His personal dr diagnosed that he has shingles, and prescribed acyclovir 800mg 5x day and tramadol for pain 1 bid.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Dermatitis diaper, Rash erythematous
Clinical narrative: Started as diaper rash within hours of receiving vaccinations. Started small, about size of dime, and spread to testicles, covering surrounding genitals, in folds of thighs. Bright red, with bumps at edge of rash. Treated with A and D ointment, DESITIN, and AQUAPHOR diaper rash cream with no relief. Taken to doctor 03/01/2017, prescribed Nystatin cream and KEFLEX for possible bacterial infection.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL, HEPA, MNQ, VARCEL
Symptoms: Pyrexia, Rash pruritic, Rash pustular
Clinical narrative: Pt. received Var shot 2/17/17. On 3/1/17, pt. had rash that looked like pus filled blisters, very itchy, fever 101-103 F since 2/28/17. Pt. came in 3/1/17 and confirmed Dx varicella with Dr. Pt. was stable. Pt. returned to Dr. and was given ABX, acyclovir and VIROPTIC Drops, on 3/3/17.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL, HEPA, MNQ, VARCEL
Symptoms: Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Pt. received Var shot 2/17/17. On 3/1/17, pt. had rash that looked like pus filled blisters, very itchy, fever 101-103 F since 2/28/17. Pt. came in 3/1/17 and confirmed Dx varicella with Dr. Pt. was stable. Pt. returned to Dr. and was given ABX, acyclovir and VIROPTIC Drops, on 3/3/17.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Musculoskeletal stiffness, Pain
Clinical narrative: (L) shoulder pain/stiffness. Pain on abduction and extension. Decreased ROM. Hurts to sleep on (L) side.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder, X-ray limb
Clinical narrative: (L) shoulder pain/stiffness. Pain on abduction and extension. Decreased ROM. Hurts to sleep on (L) side.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Decreased appetite, Lethargy
Clinical narrative: Lethargy and decreased appetite; supportive care and observation.
Age: 77.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Hyperhidrosis
Clinical narrative: Patient started having ongoing uncontrolled perspiration 4 days after vaccine administration. Patient reported to pharmacist on 3/5/17.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Complaint of soreness in area of IM injection. Some redness and heat as well. Complaint made 3 days after injection.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 10-12 cm area of redness and warmth on R thigh at site of DTaP injection started 24 hrs after immunization.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received ZOSTAVAX injection on 3/3/17. Patient called back on 3/5/17 and said site was swollen, red, heat to the touch and bruised at injection site. I called MD on 3/5/17 and they called patient and recommended TYELNOL and BENADRYL. patient to see MD on3/6/17 AM. Left msg with pt for update. Per MD ofc; no further treatment needed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Received KINRIX on left thigh. Mother noticed swelling, redness and itching on 3/5/17 near injection site. Erythema to left thigh noted as 13 x 14 cm during office visit.
Age: 60.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Upper 3/4 of R arm red, swollen, itchy and warm post injection, outer aspect only.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Eyelid oedema, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's left arm felt stiff the night after the injection. The next morning she was not able to move her arm due to pain. Two days after the injection, patient noticed erythema, swelling and warm at the injection site. She rates the pain as 10/10 the day after the injection and 7/10 currently, 4 days later. She also states that her left upper eyelid was swollen the next morning after the injection. No conjunctivitis, discharge or erythema around the eyelid noted. Nasal congestion present. Patient reported to doctors office on 3/6/17.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Musculoskeletal stiffness, Nasal congestion, Pain in extremity
Clinical narrative: Patient's left arm felt stiff the night after the injection. The next morning she was not able to move her arm due to pain. Two days after the injection, patient noticed erythema, swelling and warm at the injection site. She rates the pain as 10/10 the day after the injection and 7/10 currently, 4 days later. She also states that her left upper eyelid was swollen the next morning after the injection. No conjunctivitis, discharge or erythema around the eyelid noted. Nasal congestion present. Patient reported to doctors office on 3/6/17.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Bacterial test positive, Injection site plaque, Injection site reaction, Rash vesicular, Staphylococcus test positive
Clinical narrative: This unsolicited misuse case was received on 23 Feb 2017 via a third party query tool search on the VAERS database, under reference number 667508. This case involves a 20-year-old male patient who was vaccinated with a dose of ACAM2000 (Lot number- VV04003A, expiry date, dose, dose in series were unknown) via intradermal route in right arm on 08-NOV-2016. The current Illness at time of vaccination was reported as none and patient had reported no known drug allergy. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed injection site reaction, diffuse vesicular rash with some group plaques on right shoulder, bilateral hands and forearms, bilateral feet and lower legs, Staphylococcus test positive and Bacterial test positive. The patient required emergency visit. It was a case of inappropriate route of vaccination. Other laboratory investigation included Aerobic Culture of sores which showed few and moderate Staph. Corrective treatment were not reported. The outcome of the events were reported as unknown. List of documents held by sender: none.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of an unknown gender approximately under 15 years of age. The patient's medical history, concurrent conditions, concomitant medications, and drug reactions or allergies, were not reported. On an unknown date in June 2016, the patient was vaccinated with a dose of GARDASIL (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided) as prophylaxis. Subsequently, on 16-FEB-2017, the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided) as prophylaxis. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 06-FEB-2017, the patient received an expired dose of PNEUMOVAX 23 Lot # L024129 with expiration date: 21-JAN-2017 (dose and route of administration were not reported) for prophylaxis. No adverse effect was reported. There was no product quality complaint involved. Additional information has been requested.
Age: 0.58
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report has been received from a nurse reporting on a 7 month patient of an unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. On 07-FEB-2017, inadvertently the patient was vaccinated with an intramuscular dose of PNEUMOVAX 23 (lot # M037669 and expiration date 09-MAY-2017) (dose and frequency were unknown) instead of been vaccinated with PREVNAR (lot #, expiration date, dose, and frequency were not reported) for prophylaxis. There were no adverse effects reported. The reporter confirmed that this was not related to a product confusion and that it was due to a human error. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug dispensing error, Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a female patient of unknown age. The patient's medical history, concomitant medications, and laboratory values are unknown. The patient received the ZOSTAVAX at an unknown dose, route, and frequency on an unknown date, lot # M010472, expiration date: 01-JUN-2017, for an unknown indication from the pharmacy to be dispensed unreconstituted for administration by a health care professional at the hospital where she worked. On 08-FEB-2017, the patient's pharmacy delivered the ZOSTAVAX vial without the diluent to the patient and provided a pharmacy label on the product instructing her to store it in the refrigerator, which was considered a dispensing error. It was not known if the patient was instructed to use within 72 hours after refrigeration. On 12-FEB-2017, the patient brought the vial to the hospital where she worked for a nurse to reconstitute and administer to her. At this time, on 12-FEB-2017, it was discovered that the diluent was not provided with the ZOSTAVAX vial, and the patient stated that she was concerned that the vaccine may no longer be okay to use since she had stored it in the refrigerator since 08-FEB-2017. On 12-FEB-2017, the patient's nurse contacted the Merck National Service Center and decided to not administer the ZOSTAVAX in question to the patient. As of 12-FEB-2017, the patient had not received the ZOSTAVAX and the outcome of the ZOSTAVAX dispensing error and the concern experienced by the patient was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a physician via a company representative, concerning a female patient of an unknown age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unknown date, the patient was vaccinated intramuscularly with the first dose of GARDASIL 9 (dose, frequency, lot # and expiration date were not reported) for prophylaxis, and experienced swelling on the injection site. On an unspecfied date, the patient recovered of the aforementioned adverse event. No product quality complaint (PQC) was involved. The causality between the mentioned adverse event and the GARDASIL 9 was unknown. Additional information has been requested.
Age: 22.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a 22 years old patient of an unknown gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date in February 2016, the patient was vaccinated with the first dose of GARDASIL (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis, and on 16-FEB-2017, the patient received the second dose of the mentioned vaccine, that was longer than the recommend interval between doses. No adverse effects were reported. No product quality complaint (PQC) was involved.  Additional information has been requested.
Sex: U
Vaccine: MMR, MNQ
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-FEB-2017, the patient who was indicated to receive a dose of M-M-R II subcutaneous injection (therapy type, dose, frequency, lot # and expiration date were not reported) for prophylaxis, might have accidentally received MENACTRA instead. The pharmacist confirmed that the patient received M-M-R II or MENACTRA via the intramuscular route (which was outside of the recommendations in the M-M-R II prescribing information). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered nurse concerning a female patient on an unknown age with latex sensitivity. The patient's medical history, historical drugs and concomitant therapies were not reported. On 17-FEB-2017, the patient was vaccinated with VARIVAX "in the upper arm" (dose, route, lot number and expiration date were not reported) for varicella vaccination. On 17-FEB-2017 in the evening (reported as by the evening of the same day), the patient experienced edema, heat, redness, tenderness and soreness that extended about 50 millimeters from the injection site. All the events were described as being cellulitis (injection site cellulitis) by the nurse. The patient was treated with unspecified "comfort measures and elevation of the arm". On 20-FEB-2017, the  symptoms improved greatly and actually they were almost fully recovered, but not completely healed. No laboratory diagnostics were performed.  The causal relationship between the event and VARIVAX was not reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received on 21-FEB-2017 from a pharmacist concerning a female patient. The female patient had no pertinent medical history, no concomitant medications and no drug reactions/allergies. The pharmacist reported that the female, at an unknown age, on an unknown date at an unspecified facility, received her first dose of MMRII (Dose, route of administration, site of administration, Lot number, and expiration date were not reported.) The pharmacist does not know if the female had experienced an adverse effect after she had received her first dose of MMRII. The pharmacist reported that on 21-FEB-2017, the female patient, presently aged 25 years old, not pregnant, received her booster dose of MMRII (Lot number L041457, expiration date 22-OCT-2017), subcutaneously left tricep region, and developed an area of redness the size of an adult hand at her injection site within a minute of the administration of the dose. The patient reported that the injection site felt warm, but the pharmacist did not think that the area felt any warmer than it had before the dose was injected. The pharmacist monitored the patient for approximately 5 minutes, and the area of redness began to improve. No laboratory studies performed. The patient left the pharmacy to go home independently in no apparent distress. [The therapy reason for use of MMRII was also reported as routine vaccination.] No treatment was given for the adverse experience. Outcome of the adverse experience reported patient as recovering. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning a 16 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 19-DEC-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017, dose and route unspecified) for prophylaxis. It was reported as a "13-DEC-2016 temperature incident". The vaccines were stored at 11.6 degree centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree centigrade for 50 minutes. It was reported that the excursion involved a total of three lots of GARDASIL 9. The nurse later confirmed that there were two lot numbers, L024993 and M024261 were actually administered to patients after the "temperature incident". No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008047: US-009507513-1612USA007442: US-009507513-1703USA002792: US-009507513-1703USA002793: US-009507513-1703USA002794: US-009507513-1703USA002795: US-009507513-1703USA002796: US-009507513-1703USA002797: US-009507513-1703USA002798: US-009507513-1703USA002799:
Age: 1.33
Sex: M
Vaccine: MMR, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse referring to a 16 month old male patient. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies.   On 15-FEB-2017, the patient was vaccinated with a dose of PROQUAD (lot # M036159, expiration date: 12-FEB-2018, in the right leg, dose and route were unknown) and a dose of M-M-R II (in the left leg, dose, route, lot# and expiration date were unknown)both for prophylaxis.  On 15-FEB-2017, the patient at night time experienced redness and swelling in his right and left leg. The nurse stated that the patient's mother gave her child advil for 2 days. The redness and swelling in the right and left leg was no longer present. The patient recovered from the events on an unknown date of February 2017. No lab diagnostics studies performed. The patient did not seek medical attention. Causality was not provided. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old patient of unknown gender. The patient's concomitant therapy, concurrent condition, historical condition and drug reaction were not provided. On 31-JAN-2017 the patient was vaccinated with GARDASIL 9 (strength, dose, lot# and expiration date were unknown) intramuscularly for prophylaxis (Inappropriate schedule of vaccine administered). No adverse effects reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 57 year old female patient. There were no drug reactions/allergies. Information about concurrent condition, medical history or concomitant therapy was not reported. On 21-FEB-2001 the patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot# not reported) for prophylaxis. It was reported that on an unspecified date in February 2017 the patient's injection site was a larger area of redness and had a blister at the injection site. There was no lab diagnostics studies performed. The pharmacist reported that the patient continued with redness at the injection site and had applied an unspecified topical ointment to the area and BENADRYL. The causality was not reported. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA002680.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an approximately71 years old male patient. Concomitant therapies included methotrexate (manufacturer unknown), MIRAPEX, metoprolol and CELEBREX. Information about concurrent condition and medical history was not provided. The patient had no drug allergies/reactions. On 12-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX (strength: 19400 plaque forming unit (PFU); dose unknown, lot# M035693, expiry date: 07-NOV-2017) subcutaneously for prevention shingles. After vaccination with ZOSTAVAX, the patient had a new prescription for prednisone (manufacturer unknown) 50mg/day for an unknown reason (considered as an adverse event) in February 2017. No lab diagnostics study was performed. At the time of reporting, the outcome of adverse event was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from a health care professional via Pfizer (2017057438) and refers to a patient of unknown demographics. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, route and anatomical location not reported), for prophylaxis. On an unknown date, the patient had an allergic reaction to PNEUMOVAX23 (hence considered to be related to vaccine). Outcome of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report has been received from a pharmacist referring to unspecified number of patients. Information about concurrent condition, medical history or concomitant therapy was not reported. On unspecified dates the patients were vaccinated with ZOSTAVAX (dose, frequency, route and lot# not reported) for prophylaxis. It was reported that on an unspecified date the patients experienced redness at the injection sites. The outcome of the patients and the causality was not reported. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1702USA011420.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an 11 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 12-JAN-2017, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017, dose and route unspecified) for prophylaxis. The vaccines were stored at 11.6 degree centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree centigrade for 50 minutes. No adverse effect was reported. It was reported that the excursion involved a total of three lots of GARDASIL 9. Two lots (L024993 and M024261) were involved in the event "doses of GARDASIL 9 administered after 13-DEC-2016 temperature incident". This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008047: US-009507513-1703USA002793: US-009507513-1703USA002794: US-009507513-1703USA002795: US-009507513-1703USA002796: US-009507513-1703USA002797: US-009507513-1703USA002798: US-009507513-1703USA002799: US-009507513-1612USA007442: US-009507513-1702USA010448:
Age: 40.0
Sex: F
Vaccine: DTAP, HEPAB, TDAP
Symptoms: Ear swelling, Urticaria
Clinical narrative: Hives and swollen ears.
Age: 40.0
Sex: F
Vaccine: DTAP, HEPAB, TDAP
Symptoms: Body temperature increased, Flushing, Urticaria
Clinical narrative: Hives and swollen ears.
Age: 54.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: ZOSTAVAX vaccine caused Pain, itching, swelling and more redness than comfortable with in right arm, per pt. Pt seen PA. PA prescribed KEFLEX to fend off any infection and daily dose of ZYRTEC along with cold compresses.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Loss of personal independence in daily activities
Clinical narrative: FELT FINE AT FIRST, AND AS TIME PROGRESSED STARTED GETTING MORE SEVERE MUSCLE PAIN AT SITE OF INJECTION TO THE POINT PATIENT STRUGGLED TO REMOVE COAT AND NEEDED ASSISTANCE. USING OTC TYLENOL AND IBUPROFEN AND HEAT PADS.
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This spontaneous report as received from an unspecified person who found a study refers to an unspecified number of female patients of unknown age. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, frequency, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patients experienced premature ovarian failure. The outcome of the event was not reported. The relatedness between vaccination with GARDASIL and the event was not reported. This is one of several reports from the same source. Additional information is not expected.; Sender's Comments: GB-009507513-1604GBR014439: US-009507513-1702USA006689: IE-009507513-1508IRL006083: GB-009507513-1702BGR004046:
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: This spontaneous report as received from an unspecified person who found a study refers to an unspecified number of female (girls) patients of unknown age. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, frequency, lot# and expiration date were not reported) for prophylaxis. On an unknown date (reported as since 2016), the patients experienced long term absent periods. The outcome of the event was not reported. The relatedness between vaccination with GARDASIL and the event was not reported. This is one of several reports from the same source. Additional information is not expected. Sender's Comments: US-009507513-1702USA004704: IE-009507513-1508IRL006083: GB-009507513-1604GBR014439: GB-009507513-1702BGR004046.
Sex: F
Vaccine: PPV, TTOX
Symptoms: Dry skin, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Initial unsolicited report received from a consumer on 23-Feb-2017. This case involves a female patient (onset age not reported) who was vaccinated with a dose of PNEUMOCOCCAL VACCINE (Pneumococcal) and TETANUS TOXOID (Tetanus Vaccine) (batch number, expiration date, dose, dose in series, route and site of administration were not reported for both the vaccines) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination the patient skin was gradually getting drier and did not notice it until the skin was split on her thumbs and a red hot welt at the injection site, it was burning, hot to the touch, and itched like crazy. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site warmth, Urticaria
Clinical narrative: Initial unsolicited report received from a consumer on 23-Feb-2017. This case involves a female patient (onset age not reported) who was vaccinated with a dose of PNEUMOCOCCAL VACCINE (Pneumococcal) and TETANUS TOXOID (Tetanus Vaccine) (batch number, expiration date, dose, dose in series, route and site of administration were not reported for both the vaccines) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination the patient skin was gradually getting drier and did not notice it until the skin was split on her thumbs and a red hot welt at the injection site, it was burning, hot to the touch, and itched like crazy. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.