chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: (This case has been evaluated by agency) The pt. stated that he had received the SPV (primary) on 5/9/14 in his upper left arm. Additionally, he received a typhoid and AVA #1 on 5/8/14. The pt. was in his normal state of good health at the time of the vaccinations. The pt. reports that he has had constant, substernal chest pain (8/10) for 16 hours. He states that he applied "icy/hot" to his chest without improvement. The pain is made worse with lying down, taking a deep breath and leaning forward. The pain is improved when the pt. is in a "slouching" position. He denied SOB, radiation of the pain, diaphoresis, N, V or palpitations. The pt. reported that he basically had rested all day without improvement of his chest pain. He also related that the vaccination site was red, warm, swollen and tender and that the lymph nodes in his neck and armpit were also tender. The pt. was instructed to proceed to the ER for evaluation for possible myopericarditis. He was instructed to provide the ER staff with the number to the Cell Center so that a copy of the Clinical Guidelines for Post-Smallpox Vaccine Associated Myopericarditis could be provided. The pt. reported to Medical Center. His vital signs were stable 117/78, 73, 16, 98% SpO2; PE revealed: RRR, no murmur; Normal breath sounds, no respiratory distress/rales/wheezes, no chest wall tenderness. Labs showed normal Troponin T, BMP and CBC (see below). His also had a normal CXR and EKG (SR with ST elevation-probably early repolarization). The pt. was discharged with instruction to follow-up with his PCM on 5/19/14. This provider instructed the pt. to take MOTRIN 600-800 mg tid with food. Consulted with NP, provider on call. Requested that the pt. be evaluated with a repeat EKG, cardiac enzymes (Troponin I and CKMB), ESR, CRP and a possible echocardiogram (See note dated 5/18/14). The pt was seen at the Clinic on 5/20/14. The pt. reported "feeling better" but that his chest pain had not completely resolved - he complained of pain, N, V or diaphoresis. On PE it was noted that no murmurs, gallops or pericardial friction rub were heard. An ESR (wnl) and CRP (8.3H) were done. The EKG showed NSR with early repolarization. The pt. was placed on a light duty profile and given a medical temporary exemption for further vaccinations. The pt was seen by dr, cardiology and cardiovascular services, on 5/22/14. The pt. reported that the chest pain had resolved except for mild "epigastric and retrosternal chest tenderness". The PE was normal. The EKG showed NRS with diffuse ST elevation "most compatible with benign early repolarization. An echocardiogram was normal (EF 60%, no pericardial effusion) with the exception of mild mitral valve regurgitation. It was determined that the pt's chest pain was non-cardiac in nature; he was cleared to resume vigorous activity and to return to full employment.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Urticaria
Clinical narrative: Fever, raised red welt larger than a half dollar, painful to touch, over the two days following the vaccine, I visited a med clinic, was out on antibiotic and rx strength cortisone cream on 5/28/2014, the following day out was worse, so Dr aced a prednisone pack to what I was already taking. 5/30/2014 finally getting better.
Age: 33.0
Sex: M
Vaccine: FLU3, MNQ, PPV, RAB
Symptoms: Body temperature increased
Clinical narrative: LOW GRADE TEMP OF 99-101 DEGREES F, CURRENTLY LASTING 6-7 HRS.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. Concomitant medication, pertinent medical history, drug reaction or allergies were not reported. Cancer, overdose, hospitalization, life threatening, significant disability or incapacity were not reported. On 30-APR-2014 the patient was vaccinated with ZOSTAVAX, intramuscular, dose, anatomical location and lot unknown. On 30-APR-2014, the patient experienced pain, swelling and redness at the injection site after receiving ZOSTAVAX. Reporter stated that symptoms persisted and enhanced a few days after the injection. The representative confirmed the "therapy route" was an "intramuscular injection" which is other than indicated in the prescribing information. BENADRYL and hydrocortisone (both unspecified dose/frequency and manufacturer) were reported as treatment given for adverse events. Patient did not seek medical attention. Lab diagnostics studies were not performed. The outcome of events was reported as recovered/resolved on 04-MAY-2014. Relatedness between pain, swelling and redness at the injection site and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medication were not provided. On 19-MAY-2014, the patient was inadvertently administered MMR II, subcutaneously (dose and lot number were not reported) which expired on 17-MAY-2014. No adverse effects were reported. Additional information has been requested.
Age: 1.14
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 13 month old female patient. The patient's medical history was not reported. On 04-APR-2014 the patient was vaccinated with her original M-M-R II (lot # J006953, Expiry date :04-JUN-2015) (Dose/Frequency: 1 injection, Therapy Route: Intramuscular). Concomitant medications were none. On 16-MAY-2014 the patient was vaccinated with second dose of M-M-R II. It was reported that the patient received the second dose of M-M-R II earlier than what was indicated. It was reported that the patient did not have any noticeable adverse reaction to the M-M-R II injection while in the office. The outcome of received second dose M-M-R II earlier that what was indicated and did not have any noticeable adverse reaction was unknown. The patient did not sought medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray normal, Injection site erythema, Injection site inflammation, Injection site swelling, Tuberculin test negative
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a 13 year old female patient with amoxicillin (manufacturer unknown) allergy. The patient's historical drug included BCG vaccine (manufacturer unknown), received when 10 months old. On 15-MAR-2014 the patient was vaccinated with GARDASIL (lot # J015378, expiry date: 09-APR-2016). Concomitant medications were none. On 17-MAY-2014 the patient was vaccinated with second dose of GARDASIL. Approximately on 19-MAY-2014 (reported as 48 hours later), the patient's arm blew up and got inflamed at the site where the patient previously received a BCG vaccine (manufacturer unknown). Also reported as patient experienced injection site redness after receiving GARDASIL. The physician reported that the patient was an adopted child, who received a routine BCG vaccine (manufacturer unknown) in a foreign country. The physical also reported that in this country everyone gets BCG vaccine (manufacturer unknown). It was reported that the patient was administered BCG vaccine (manufacturer unknown) in another foreign country in the same arm prior to receiving GARDASIL. When 12 months of old the patient had PPD and a PPD response, which was a 10 by 10 millimeter (mm) area at the site of the PPD and the patient had a negative chest x-ray, 3 months later on an unspecified date, the patient had another PPD test and developed another PPD response, which was a 7 by 10 mm area at the PPD site. The physician mentioned that the patient did not receive any treatment. The patient had another PPD test on 15-NOV-2004 which was negative. The outcome of injection site redness and her arm blew up and got inflamed at the site was reported as recovering/resolving. The causality was not reported. The patient sought medical attention by visiting the physician's office. Additional information has been requested.
Age: 47.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 47 year old patient of unknown gender. On 19-MAY-2014 the patient was vaccinated with PNEUMOVAX lot # H013847; exp date 15-MAR-2014, 0.5 ml (milliliters), intramuscular injection. On 19-MAY-2014 the patient had a medication error for expired dose of vaccine administered and no adverse effect was reported. There was no product quality complaint (PWC) involved. Patient sought no medical attention. The outcome of expired dose of vaccine administered and no adverse effect was reported is unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 13-MAY-2014 the patient was vaccinated with ROTATEQ (lot # J001254, expiration date: 19-SEP-2014, strength was not reported) which was exposed to 63F for 6 days (not supported with in-house stability data), 2 ml oral. No adverse symptoms reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Myalgia, Vaccination site pain, Vaccination site warmth
Clinical narrative: Within 10 mins of vaccination generalized muscle and joint pain/headache. No GI symptoms. No pain. Vaccination site 3d later mild sore and slight warm to touch no erythema no joint swelling or limited ROM. TX - Ibuprofen OTC prn.
Age: 1.57
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red warm lime size swelling at site of dtap vaccine (L) thigh.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Papule
Clinical narrative: Several small (1 mm) papules on 3rd/4th/5th fingers of right hand around the nailbed. Vaccine given in (L) arm.
Age: 0.59
Sex: M
Vaccine: HIBV, RV5
Symptoms: Rash generalised
Clinical narrative: Parent (mother) called stating child hand a rash around lips and on check shortly after recieving vaccines, this rash vanished from face, but then presented on upper back/neckline and left leg thigh, and on abdomen, pictures of the rash were uploaded into chart, appearing as a slight rash no treatment required.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: PNEUMONIA VACCINE GIVEN VIA THE IV ROUTE INSTEAD OF IM. NO VISIBLE SIDE EFFECT OCCURRED.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: C/o arm pain, decreased mobility of arm due to the pain.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Anaemia, Dyskinesia, Dysstasia, Fall, Fatigue
Clinical narrative: Possible seizure. Patient suddenly lost the ability to stand and the majority of muscle control. She would get onto her knees and immediately fall backwards. Blank look on her face. After several falls, she laid in the floor trembling. I picked her up and hot her to nurse and she was fine after eating, just a bit fatigued. Entire episode lasted 3-5 minutes. Called 24 hour nurse line and was told to watch her for 2 hours and if symptoms presented again I should take her to the ER.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Staring, Tremor
Clinical narrative: Possible seizure. Patient suddenly lost the ability to stand and the majority of muscle control. She would get onto her knees and immediately fall backwards. Blank look on her face. After several falls, she laid in the floor trembling. I picked her up and hot her to nurse and she was fine after eating, just a bit fatigued. Entire episode lasted 3-5 minutes. Called 24 hour nurse line and was told to watch her for 2 hours and if symptoms presented again I should take her to the ER.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Convulsion, Dyskinesia, Dysstasia, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Possible seizure. Patient suddenly lost the ability to stand and the majority of muscle control. She would get onto her knees and immediately fall backwards. Blank look on her face. After several falls, she laid in the floor trembling. I picked her up and hot her to nurse and she was fine after eating, just a bit fatigued. Entire episode lasted 3-5 minutes. Called 24 hour nurse line and was told to watch her for 2 hours and if symptoms presented again I should take her to the ER.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Injection site swelling, Skin exfoliation
Clinical narrative: Severe headache, redness, swelling at injection site, skin peeling.
Age: 19.0
Sex: F
Vaccine: MMRV
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Localized itching, edema and itching bilaterally in arm pits and upper arms.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Inflammation, Pain, Skin warm, Swelling
Clinical narrative: Swelling, inflammation, redness, sore, warm to touch.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Mother states that three hours after receiving MMR, Kinrix, VZV immunizations, child developed pruritic urticarial rash which persists today. No fever or other symptoms. Mother applied Caladryl. I prescribed diphenhydramine today.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Abdominal pain upper, Arthralgia, Chills, Vomiting
Clinical narrative: Stomach cramps, chills.  Woke with "sore ankles." Ate breakfast okay. Tried to eat snack at school but couldn't. Sent to health room, where he vomited.  Temperature at 12:25 is 97.3 (so just a bit low).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received Dtap and IPV at 5yr well visit. Both given in same arm. Pt developed red, hot, swollen upper arm. Rx for 3-5 days. Rx'ed with cool compress, BENADRYL and MOTRIN. Pt recovers. Pt had similar reaction to FLUZONE past 2 yrs.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 4 year old male patient. On 27-MAY-2014, the patient was vaccinated with the second dose of PROQUAD (Merck) lot # H015639, expiration date 23-FEB-2014. On 27-MAY-2014, an expired dose of PROQUAD (Merck) was administered. No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash around injection site (fairly large).
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Headache, Musculoskeletal pain, Pain in extremity
Clinical narrative: Fever 100.3 - about 4 days; severe shoulder pain (both shoulders); headaches/chills; weakness/leg pain; Began to recover after 2 wk. Saw doctor.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever 100.3 - about 4 days; severe shoulder pain (both shoulders); headaches/chills; weakness/leg pain; Began to recover after 2 wk. Saw doctor.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site pain, Pain
Clinical narrative: Extreme pain in arm where vaccine was administered. Painful to lift arm. Since I'm pregnant, I can only take TYLENOL and use ice.
Age: 26.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Blood glucose decreased, Face injury, Fall, Syncope
Clinical narrative: Pt. fainted after receiving 2 vaccines (BOOSTRIX and Typhoid). Paramedics were called and they found pt. had low blood sugar and they gave glucose. When she fainted, she did fall and hit the left side of her face.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Pt was treated 5/23/14 for possible cellulitis post ZOSTAVAX administration 5/20/14.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 5/27/14: Seen in office - developed itching at site and then redness and warmth was increasing x 1 wk after administration. Moderate erythema with minimal warmth over upper left arm without tenderness or drainage. Redness decreased. Resolving tx with ice and hydrocortisone.
Age: 18.0
Sex: F
Vaccine: IPV, MNQ, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PNEUMOVAX and MENACTRA given 5/19/14. Patient developed swelling and redness at site and up arm.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Mobility decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Ongoing muscle soreness/stiffness with onset approx 2 weeks after Tdap injection. Sx reported as bilateral muscle soreness and stiffness over much of her lower body and extending into shoulders and neck, with difficulty raising arms over her head. Taking Ibuprofen for pain. F/up 5/23 pt. has had cortisone injection through PCP and pain relief - will follow with neurologist soon.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dyspnoea, Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Immunized on 5-12-14 in the A.M. On 5-13-14 8:30 p.m. c/o itching and red lump warm at injection site and small lumps/hive started on the rest of body. BENADRYL given 9:15, 2 a.m., and 6:30 am hive got worse and spread over entire body. TYLENOL given also. Contacted family to see how patient did over the weekend and his Mother explained that he had another flare up on Friday, May 16th and went to the Emergency Room. Client stated it was hard to breathe or regulate his breathing. There was mention that the doctor was concerned about the steroids he was taking. He did also see a Pediatrician in follow up from the E.R. visit and was given an EPI-PEN. He did have a flare up that evening but not too bad. On Saturday, May 17th mom stated he had a huge flare up. She did realize that he seemed to be panicking and once she was able to calm him his breathing improved. He did have hives all day Saturday she gave him prescribed medications (ZANTAC and a lotion) and he continued with hives until around 2 a.m. Sunday morning. After that he began to clear and has been clear since. Mother did state that the doctor said this certainly was an atypical reaction to the injection. She also shared that there is an aunt in the family who also had a reaction to this shot.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Panic attack, Urticaria
Clinical narrative: Immunized on 5-12-14 in the A.M. On 5-13-14 8:30 p.m. c/o itching and red lump warm at injection site and small lumps/hive started on the rest of body. BENADRYL given 9:15, 2 a.m., and 6:30 am hive got worse and spread over entire body. TYLENOL given also. Contacted family to see how patient did over the weekend and his Mother explained that he had another flare up on Friday, May 16th and went to the Emergency Room. Client stated it was hard to breathe or regulate his breathing. There was mention that the doctor was concerned about the steroids he was taking. He did also see a Pediatrician in follow up from the E.R. visit and was given an EPI-PEN. He did have a flare up that evening but not too bad. On Saturday, May 17th mom stated he had a huge flare up. She did realize that he seemed to be panicking and once she was able to calm him his breathing improved. He did have hives all day Saturday she gave him prescribed medications (ZANTAC and a lotion) and he continued with hives until around 2 a.m. Sunday morning. After that he began to clear and has been clear since. Mother did state that the doctor said this certainly was an atypical reaction to the injection. She also shared that there is an aunt in the family who also had a reaction to this shot.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Hyperhidrosis, Nausea, Pain, Pyrexia, Tremor
Clinical narrative: Parent reported child with fever spike to 103 F, nausea, body ache, slight tremors which went away and mild sweating.  Parent spoke with school nurse the next morning and also called her physician.  Physician advised hourly temp check and stated this was a normal response to Tdap/Hep A.  Parent declined to use a fever reducer - Tylenol or ibuprofen.  Physician aware of parent's decision.  24 hours later child's symptoms were improving with decrease in body temperature.  48 hours later, 5/30/14,  I spoke with the mother via phone and gathered information for Vaers report.  Mother states child is improving.  Fever now reduced to 100 F.  All other symptoms have subsided. She informed me of her discussion with her physician's office and school nurse.  I advised her of normal after shot care for child which can include Tylenol/Ibruprofen.  She is aware of this option, but wishes to let her child fight fever naturally.  Child is improving.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site inflammation, Insomnia
Clinical narrative: I received the Pneumovax vaccine in my left arm from my private physician's nurse on Wednesday, May 28. The physician recommended the vaccine because of my HIV status. At bedtime on May 28, I began experiencing significant chills and over the course of the night was unable to sleep. By the next morning, I was soaked in sweat and had difficulty lifting my left arm without experiencing moderate to severe pain. The following afternoon, I noticed substantial inflammation and reddness around the injection site extending up my upper arm and down past my elbow. My skin was also warm and painful to the touch. At the advise of my physician, I took Benadryl on the evening of May 29. The pain and inflammation subsided by the morning of Friday, May 30, but my arm remains sore and its range of motion limited.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Movement disorder, Pain in extremity, Skin warm
Clinical narrative: I received the Pneumovax vaccine in my left arm from my private physician's nurse on Wednesday, May 28. The physician recommended the vaccine because of my HIV status. At bedtime on May 28, I began experiencing significant chills and over the course of the night was unable to sleep. By the next morning, I was soaked in sweat and had difficulty lifting my left arm without experiencing moderate to severe pain. The following afternoon, I noticed substantial inflammation and reddness around the injection site extending up my upper arm and down past my elbow. My skin was also warm and painful to the touch. At the advise of my physician, I took Benadryl on the evening of May 29. The pain and inflammation subsided by the morning of Friday, May 30, but my arm remains sore and its range of motion limited.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: Chills, headache, tired, chills, body aches, sore joints.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Inflammation, Injection site erythema, Injection site warmth, Local reaction, Lymphadenopathy
Clinical narrative: Redness at the site with warmth, 2 in by 3 in left deltoid.  Enlarge lymph node in axilla area, seen after mom picked up from school.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Vaccination site swelling
Clinical narrative: R ARM felt numb down to the hand. Swollen where the vaccine was given. It didn't hurt and not warm. Ice compress applied with improvement of symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Gaze palsy, Ophthalmological examination normal
Clinical narrative: Recurrent upward gaze of eyes w/ minimal brow furrowing. No prior hx of tics. Normal vision/exam (x mvmt issues) in office today.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, 6VAX-F, PNC13, RVX
Symptoms: Apnoea, Endotracheal intubation, Resuscitation, Unresponsive to stimuli
Clinical narrative: Was notified by ER that he was flown there via helicopter today after being unresponsive at home where first responders started CPR. Was responsive when arrived at ER but was having spells of apnea. Patient was intubated and admitted to critical care.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, 6VAX-F, PNC13, RVX
Symptoms: Cyanosis, Endotracheal intubation, Gastrointestinal tube insertion, Obstructive airways disorder, Resuscitation
Clinical narrative: Was notified by ER that he was flown there via helicopter today after being unresponsive at home where first responders started CPR. Was responsive when arrived at ER but was having spells of apnea. Patient was intubated and admitted to critical care.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, 6VAX-F, PNC13, RVX
Symptoms: Vomiting
Clinical narrative: Was notified by ER that he was flown there via helicopter today after being unresponsive at home where first responders started CPR. Was responsive when arrived at ER but was having spells of apnea. Patient was intubated and admitted to critical care.
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to two patients of unknown age and gender. Medical history was not reported. On an unknown date the patients were vaccinated with VARIVAX (Merck) (first dose, dose, route of administration, anatomical location, lot number was not reported). No concomitant medications were reported. On an unknown date both patients developed a reaction the first time they had VARIVAX (Merck) - both experienced rash bigger than a quarter and maybe some chicken pox lesions. Action taken and outcome was not reported. The relatedness between both events and VARIVAX (Merck) was not reported. The outcome of the events was unknown. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large area erythema, warmth, tenderness at injection site, noted w/in 24 hrs.
Age: 53.0
Sex: M
Vaccine: HEPAB
Symptoms: Asthenia, Pyrexia
Clinical narrative: Fever and generalized weakness.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 15 patients of unknown age and gender. The nurse stated that on an unknown date, 15 GARDASIL were improperly stored outside of temperature range that was in the prescribing information and those vaccines (dose, route of administration, lot#, expiry date not reported) were administered to unspecified patients (patient information not provided) on an unknown date. No adverse effects were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old female patient. At the time of reporting the patient was not pregnant. No other pertinent medical history was reported. On 13-JUN-2012 the patient was vaccinated with GARDASIL (dose 1, 0.5 ml, intramuscular, anatomical location and lot number was not reported). The reporter stated that there was no information available as to whether there were any adverse effects after the first dose was administered. On 13-MAY-2014 the patient was vaccinated with GARDASIL (dose 2, 0.5 ml, intramuscular, anatomical location and lot number was not reported). No concomitant medications were reported. On 16-MAY-2014 the patient had developed hives all over her body after her injection, but more concentrated on her legs. None lab diagnostics studies were performed. It was unclear if the patient received any treatment. The outcome of event was reported as resolved (on 19-MAY-2014). The relatedness between event and GARDASIL. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 14 year old male patient with an allergic rhinitis. The patient's medical history included hives. He had no drug allergies or reactions. On 05-NOV-2013, the patient received the first "standard dose" 0.5ml of GARDASIL (lot #, expiration date and route were unspecified) with "no issues". On 24-JAN-2014, the patient received the 2nd "standard dose" 0.5ml of GARDASIL intramuscular (lot # J012212, expiration date: 18-FEB-2016, dose unspecified). Concomitant medications were not reported. On approximately 31-JAN-2014 (reported as "a week later"), the patient developed hives. The patient was seen at the office, on an unspecified date, and was given ZYRTEC (dose and frequency unspecified) for treatment. The patient's status, at the time of the report, was stated by the reporter that he had persistent hives. The outcome of hives was reported as not recovered/not resolved. The relatedness between hives and vaccination with GARDASIL was unknown. The patient sought medical attention. No lab diagnostics studies were performed. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Health care worker pharmacy technician refers to a unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with ROTATEQ lot # J008739 exp 25-MAR-2015, oral (dose not provided), ROTATEQ lot # J012525 exp 09-APR-2015, oral (dose not provided), ROTATEQ lot # J18367 exp 02-APR-2015, oral (dose not provided) and ROTATEQ lot # J004875 exp 17-OCT-2014, oral (dose not provided). Health care worker (pharmacy technician) stated than an unspecified number of patients may have received vaccines (doses and dose in series unspecified) that were improperly stored on 28-FEB-2014 at 9.5 C for 50 minutes. No adverse effects reported. The outcome of incorrect product storage was unknown. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The nurse stated that on an unknown date, RECOMBIVAX HB was improperly stored outside of temperature range that was in prescribing information and that dose of RECOMBIVAX HB was administered (dose, route of administration, lot#, expiry date not provided) to a patient on an unspecified date. No adverse effects were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Health care worker pharmacy technician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with VAQTA (lot # J000337 exp 25-SEP-2015) 1 adult dose (dose and route not provided). Health care worker (pharmacy technician) stated that one patient may have received vaccine (dose and dose in series unspecified) that were improperly stored on 28-FEB-2014 at 9.5C for 50 minutes. No adverse effects reported. The outcome of incorrect product storage was unknown. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Health care worker pharmacy technician refers to a unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with GARDASIL lot # J008423 exp 21-JAN-2016 (dose and route not provided), GARDASIL lot # J009788 exp 17-MAR-2016 (dose and route not provided) and GARDASIL lot # J013324 exp 12-FEB-2016 (dose and route not provided). Health care worker (pharmacy technician) stated that an unspecified number of patients may have received vaccines (doses and dose in series unspecified) that were improperly stored on 28-FEB-2014 at 9.5C for 50 minutes. No adverse effects reported. The outcome of incorrect product storage was unknown. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Health care worker pharmacy technician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with VAQTA (lot # J012963 exp 21-SEP-2015) 1 pediatric dose (dose and route not provided). Health care worker (pharmacy technician) stated that one patient may have received vaccine (dose and dose in series unspecified) that were improperly stored on 28-FEB-2014 at 9.5C for 50 minutes. No adverse effects reported. The outcome of Incorrect product storage was unknown. This is one of several reports from same source. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain, Back pain, Dyspnoea, Neck pain
Clinical narrative: SOB, abdominal pain, neck pain and back pain. Sxs occurred almost 12 hours after injection was given. Sxs resolved on their own.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Health care worker pharmacy technician refers two patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (lot # J012515 14-APR-2016) 1 adult dose (dose and route not provided) and RECOMBIVAX HB (lot # J010164 exp 03-FEB-2016) 1 adult dose (dose and route not provided). Health care worker (pharmacy technician) stated that two patients may have received vaccine (dose and dose in series unspecified) that were improperly stored on 28-FEB-2014 at 9.5C for 50 minutes. No adverse effects reported. The outcome of incorrect product storage was unknown. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Health care worker pharmacy technician refers to a patient of unknown age and gender. On an unknown dates the patient was vaccinated with PNEUMOVAX 23 SDV lot # J009689 exp 29-JAN-2015 (dose and route not provided). Health care worker (pharmacy technician) stated that the patient may have received vaccines (doses and dose in series unspecified) that were improperly stored on 28-FEB-2014 at 9.5C for 50 minutes. No adverse effects reported. The outcome of incorrect product storage was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Health care worker pharmacy technician refers two patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (lot # J007329 27-MAR-2015) 1 pediatric dose (dose and route not provided) and RECOMBIVAX HB (lot # J009049 exp 27-MAR-2015) 1 pediatric dose (dose and route not provided). Health care worker (pharmacy technician) stated that two patients may have received vaccine (dose and dose in series unspecified) that were improperly stored on 28-FEB-2014 at 9.5C for 50 minutes. No adverse effects reported. The outcome of incorrect product storage was unknown. This is one of several reports from same source. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Injection site erythema, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: This spontaneous report as received from a 56 year old female patient with abnormal blood pressure and none drug reactions/allergies refers to herself. The patient's medical history included very bad case of chickenpox when she was a child. The patient stated that on 21-MAY-2014 was vaccinated with ZOSTAVAX (lot#, expiration date not provided, one time vaccine (1 DF), injection). Concomitant therapies included PROCARDIA (blood pressure medication). The patient also stated that "last night (on 21-MAY-2014) noticed 10 itchy red dots, warmth and red at injection site". On approximately 07-MAY-2014 the patient had blood work and urine test done with unknown result. The patient stated that "everything came back fine". The patient did not seek medical attention. The outcome of noticed 10 itchy red dots, warmth and red at injection site was unknown. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Urine analysis normal
Clinical narrative: This spontaneous report as received from a 56 year old female patient with abnormal blood pressure and none drug reactions/allergies refers to herself. The patient's medical history included very bad case of chickenpox when she was a child. The patient stated that on 21-MAY-2014 was vaccinated with ZOSTAVAX (lot#, expiration date not provided, one time vaccine (1 DF), injection). Concomitant therapies included PROCARDIA (blood pressure medication). The patient also stated that "last night (on 21-MAY-2014) noticed 10 itchy red dots, warmth and red at injection site". On approximately 07-MAY-2014 the patient had blood work and urine test done with unknown result. The patient stated that "everything came back fine". The patient did not seek medical attention. The outcome of noticed 10 itchy red dots, warmth and red at injection site was unknown. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to unknown number of patients of unknown demographics. On an unknown date the patients were vaccinated with MMR II (dose, dosage schedule and route of adminitration were not provided). On an unknown date MMR II vaccine was improperly stored and administered to unknown number of patients. The vaccine was exposed to 9 C for total of 60 hours. No adverse effects reported. This is one of 5 reports received from the same reporter (case # 1405USA009347, 1405USA009350, 1405USA009349, 1405USA009348). Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash on abd 5 days after vaccine administered.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Pt noticed rash (itching) under right breast and left side and right side at 10 am 1 week after vaccination. Pain rated #5 then used an anti itch spray and this brought the discomfort to a# 1-2.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patients right upper arm, at injection site, appears red, swollen, and warm and hard to touch. Swelling induration of 5 cm round. Patient stated area is painful to touch and itchy.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: Patients right upper arm, at injection site, appears red, swollen, and warm and hard to touch. Swelling induration of 5 cm round. Patient stated area is painful to touch and itchy.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to unknown number of patients of unknown demographics. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (dose, dosage schedule, route of administration, lot number and expiration date were not provided). On an unknown date PNEUMOVAX 23 vaccine was improperly stored and administered to unknown number of patients. The vaccine was exposes to 9 degrees C for total of 60 hours. No adverse effects reported. This is one of 5 reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Angioedema, Swelling face
Clinical narrative: Patient is a 63 year old male with history of HTN, HLD, prostate CA (Gleason 7) who presented with acute onset left sided facial swelling. He arrived on 09/19/13 to get his flu shot at 11:00am and follow up with Urology for his prostate cancer. At 2:30pm the patient noted the sudden onset of left sided facial swelling that continued to worsen. He then presented to the ED for further management. He denies any difficulty breathing or difficulty swallowing. He denies any pain, numbness, or tingling. No mouth ulcers or sores. No recent illnesses, fevers or chills. Patient was also taking lisinopril since 05/26/2010. In the ED, facial swelling attributes to angioedema from lisinopril versus a reaction to the influenza vaccine. Ranitidine 50 mg once, methylprednisolone 125 mg once, diphenhydramine 50 mg once.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Right arm and shoulder pain with numbness and weakness.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Hypoacusis, Immediate post-injection reaction, Pallor, Presyncope
Clinical narrative: Immediately after vaccine administration patient turned pale said he was lightheaded advised him to lay down. As patient laid down he had near syncope episode. His eyes were open but unable to speak or hear. Patient alert and vocal in 8-10 seconds. Patient had not eaten breakfast and fear of needles. Monitored BP and pulse for 30 min. Patient ate several (2) popsicles and was able to leave office (walking) and went home to eat and he was doing well at discharge without any symptoms.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Speech disorder
Clinical narrative: Immediately after vaccine administration patient turned pale said he was lightheaded advised him to lay down. As patient laid down he had near syncope episode. His eyes were open but unable to speak or hear. Patient alert and vocal in 8-10 seconds. Patient had not eaten breakfast and fear of needles. Monitored BP and pulse for 30 min. Patient ate several (2) popsicles and was able to leave office (walking) and went home to eat and he was doing well at discharge without any symptoms.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Eye movement disorder, Tremor, Vomiting
Clinical narrative: Mom reports after leaving the office, the patient started vomiting, his eye rolled back, and he was shaking. She took him directly to the ER and was seen at 11:11 am. He was stable, given ZOFRAN, monitored, and discharged home.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Pruritus, Pyrexia, Tenderness
Clinical narrative: Fever at 102 degrees. Local erythema/swelling/tenderness with itching no abscess.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with PEDVAXHIB which had been stored improperly. No adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to unknown number of patients of unknown demographics. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose, dosage schedule, route of administration, lot number and expiration date were not provided). On an unknown date RECOMBIVAX HB was improperly stored and administration to unknown number of patients. The vaccine was exposes to 9 degrees C for total of 60 hours. No adverse effects reported. This is one of 5 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to unknown number of patients of unknown demographics. On an unknown date the patients were vaccinated with ROTATEQ (dose, dosage schedule, lot number and expiration date was not provided). On an unknown date ROTATEQ was improperly stored and administered to unknown number of patients. The vaccine was exposed to 9 c for total of 60 hours. No adverse effects reported. This one of 5 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple sclerosis patients. On unknown dates the patient were vaccinated with (Oka/Merck) VARIVAX which had been stored improperly. No adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple sclerosis patients. On unknown dates the patients were vaccinated with VAQTA which had been stored improperly. No adverse events reported. This is one several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with PROQUAD which had been stored improperly. No adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. In approximately May 2012 (reported as "about two years ago") the patient was vaccinated subsequently with an unspecified dose of ZOSTAVAX. In approximately May 2012 (reported as "this occurred two years ago") the patient experienced blister like rash around the injection site resulting in a visit to an unspecified emergency room visit (also reported as the patient sought medical attention). It was reported as unknown if patient was admitted to the hospital or discharged from the emergency room. The outcome of blister like rash around the injection site was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report was received from a pharmacist referred to a patient of unknown age and gender. The patient's relevant medical history, relevant concomitant medications, and relevant past drug history are unknown to the reporter. On 22-MAY-2013 the patient was vaccinated with PNEUMOVAX23 (Lot# unspecified), dose 1 (dose, frequency, route and indication unspecified). On 24-MAY-2014, the patient was given another PNEUMOVAX 23 by a nurse who didn't realize that the patient had already received PNEUMOVAX 23 2 days ago. It was unknown if there is relevant lab data. As of 24-MAY-2014, the outcome of the event was unknown. Additional information is not expected.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Fever and diarrhea. Used Tylenol for fever and highest was 103 and diarrhea lasted 2 weeks and was treated by giving probiotics.