chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Musculoskeletal pain
Clinical narrative: Mother reported on day 4 after vaccine that child started having swelling and redness at injection site 1 hour after vaccine was given.  Softball sized knot at injection site after one day that was hot to touch and had pain from shoulder to elbow. Mom was told to apply cold compresses, give Benadryl and Tylenol and see MD if does not improve. On day 5 child was much better knot almost gone and only a little soreness in shoulder.
Age: 33.0
Sex: M
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Severe Pruritis around the injection site. Pt unconsciously scratched the site then the severe redness and swelling around the injection site started spreading.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised, Rash macular
Clinical narrative: ITCHING THEN RASH ON FEET AND ANKLES, SPREAD TO ARMS AND STOMACH-"BLOTCHES", TREATED WITH BENADRYL LASTED UNTL 6/22/14 - NO FEVER, OR OTHER SYMPTOMS REPORTED BY CLIENT - DID ATTEMPT TO BE SEEN IN WALK IN CLINIC ON 6/21 BUT DID NOT REGISTER DUE TO NUMBER PEOPLE IN WAITING ROOM.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Diarrhoea, Discomfort, Local swelling, Myalgia
Clinical narrative: body aches at the beginning which was followed by joint pain.  Both of these symptoms progressively became worst throughout the day.  I experienced nausea and loose stool.  Around 2pm I had a headache.  At this point, the joint pain was so severe it was painful to rub lotion on my hands and sitting in a chair was very uncomfortable due to the body aches and joint pain.  When I got home I took my temperature and I had a low grade fever of 100.5.  Friday morning I woke with all of the same symptoms and my fever was now 102.3.  I took some ibuprofen which helped with the pain and fever.  These symptoms continued through Saturday minus the loose stool.  The nausea wasn't as bad on Saturday.  Friday and Saturday my upper left jaw was hurting.  By that evening it had progressed to my lower left jaw.  Sunday, my left side jaw no longer hurt but high in my upper right jaw especially when I opened my mouth.  It's Monday morning and if I cough my head feels like its going to explode and the swelling in my right arm covers a 5"x 6"area and my muscles surrounding that area are sore.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pain in jaw, Pyrexia
Clinical narrative: body aches at the beginning which was followed by joint pain.  Both of these symptoms progressively became worst throughout the day.  I experienced nausea and loose stool.  Around 2pm I had a headache.  At this point, the joint pain was so severe it was painful to rub lotion on my hands and sitting in a chair was very uncomfortable due to the body aches and joint pain.  When I got home I took my temperature and I had a low grade fever of 100.5.  Friday morning I woke with all of the same symptoms and my fever was now 102.3.  I took some ibuprofen which helped with the pain and fever.  These symptoms continued through Saturday minus the loose stool.  The nausea wasn't as bad on Saturday.  Friday and Saturday my upper left jaw was hurting.  By that evening it had progressed to my lower left jaw.  Sunday, my left side jaw no longer hurt but high in my upper right jaw especially when I opened my mouth.  It's Monday morning and if I cough my head feels like its going to explode and the swelling in my right arm covers a 5"x 6"area and my muscles surrounding that area are sore.
Age: 0.43
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site nodule
Clinical narrative: Mother brought patient in for 6 mo well child exam on 6/11/14 and stated knot on right thigh has been there since the immunizations at last visit. No other symptoms.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Computerised tomogram head normal, Electrocardiogram normal, Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: went to urgent care facility after the first does of HBV vaccine for symptoms of sore throat, fever, extreme fatique.  Did not aassocate symptoms with vaccine so recieved the second dose on 6/13/14.  symptoms increased and employee returned to urgent on 6/14/14 and then to ER on 6/19/14.  All xrays and labwork were negative.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Streptococcus test negative, X-ray normal
Clinical narrative: went to urgent care facility after the first does of HBV vaccine for symptoms of sore throat, fever, extreme fatique.  Did not aassocate symptoms with vaccine so recieved the second dose on 6/13/14.  symptoms increased and employee returned to urgent on 6/14/14 and then to ER on 6/19/14.  All xrays and labwork were negative.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Chest pain, Computerised tomogram, Dyspnoea, Injected limb mobility decreased
Clinical narrative: pain in chest, shortness of breath, inability to move right arm (location of vaccination)from elbow to fingers
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Feeling hot, Flushing, Hypoaesthesia, Urticaria
Clinical narrative: HPV vaccine provided at approx 9:30. TC from mother at 10:15. Pt is lightheaded, hives present, flushed and hot, fingers numb. Advised to go immed to E.D. Arrived there at 10:47.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker (medical assistant) regarding unspecified number of patients of unknown gender and age. The reporter states that on an unknown date the patients were vaccinated with GARDASIL (dose, frequency, lot number, expiry date not reported). Also reported that the patient's were administered doses of GARDASIL that were improperly stored and no adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker (medical assistant) regarding unspecified number of patients of unknown gender and age. The reporter states that on an unknown date the patient's were vaccinated with ROTATEQ (dose, frequency, lot number, expiry date not reported) orally. Also reported that the patient's were administered doses of ROTATEQ that were improperly stored and no adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.15
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 8 week old patient of unknown gender. Pertinent medical history, concomitant medication, drug reactions and allergies were not provided. On 27-MAY-2014, the patient was administered an expired dose of ROTATEQ (lot # H017672, expiration date 19-MAR-2014) orally (dose and frequency were not reported). No adverse effect was reported. Product quality complaint (PQC) was not reported. This is one of three 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 health care worker (medical assistant) regarding unspecified number of patients of unknown gender and age. The reporter states that on an unknown date the patient's were vaccinated with RECOMBIVAX HB (dose, frequency, lot number, expiry date not reported). Also reported that the patient's were administered doses of RECOMBIVAX HB that were improperly stored and no adverse events were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 8 week old patient of unknown gender. Pertinent medical history, concomitant medication, drug reactions and allergies were not provided. On 05-MAY-2014, the patient was administered an expired dose of ROTATEQ orally (lot # H015715, expiration date 15-MAR-2014) (dose and frequency were not reported). No adverse effect was reported. Product quality complaint (PQC) was not reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 8 week old patient of unknown gender. Pertinent medical history, concomitant medication, drug reactions and allergies were not provided. On 24-MAR-2014, the patient was administered an expired dose of ROTATEQ orally (lot # H015715, expiration date 15-MAR-2014) (dose and frequency were not reported). No adverse effect was reported. Product quality complaint (PQC) was not reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with first dose of VARIVAX (Merck) at age of 1 year old (indication and lot # not reported), 0.5 ml, subcutaneous. On an unknown date the patient was vaccinated with second dose of VARIVAX (Merck) at age of 17 years old (indication and lot # not reported), 0.5 ml, subcutaneous. No adverse effect reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema
Clinical narrative: REDNESS/CELLUTIS/ DURATION 20-24 MM/ WAD GIVEN  MONITOR/ TAKE MORTRIN/ BY NURSE
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood creatinine normal, Blood glucose normal, Blood urea normal
Clinical narrative: sore thorat, yellow cough, hard to breath, checst hurt from coughing, chills and fever,
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Chills, Dyspnoea, Haemoglobin normal, Neutrophil percentage
Clinical narrative: sore thorat, yellow cough, hard to breath, checst hurt from coughing, chills and fever,
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Oropharyngeal pain, Pain, Platelet count normal, Productive cough, Pyrexia
Clinical narrative: sore thorat, yellow cough, hard to breath, checst hurt from coughing, chills and fever,
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: White blood cell count normal
Clinical narrative: sore thorat, yellow cough, hard to breath, checst hurt from coughing, chills and fever,
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Blood test, Convulsion, Eye movement disorder, Foaming at mouth, Respiratory arrest
Clinical narrative: became unresponsive, stopped breathing, shaking x 4 minutes, foaming at the mouth, eyes rolled back in head.  After seizure, took 3 hours to wake-up and be alert and responsive.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Tremor, Unresponsive to stimuli, Urine analysis, X-ray
Clinical narrative: became unresponsive, stopped breathing, shaking x 4 minutes, foaming at the mouth, eyes rolled back in head.  After seizure, took 3 hours to wake-up and be alert and responsive.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker (medical assistant) regarding unspecified number of patients of unknown gender and age. The reporter states that on an unknown date the patients were vaccinated with VARIVAX (Merck) (dose, frequency, lot number, expiry date not reported). Also reported that on an unknown date, the patients were administered doses of VARIVAX (Merck) that were improperly stored and no adverse events were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. 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 licensed practical nurse refers to nine (9) patients of unknown age and gender. On an unspecified day in May 2014, the GARDASIL was stored improperly. On an unspecified date(s), the nine patients were vaccinated with the GARDASIL, .5 ml, intramuscular. No adverse events were reported. The outcome of improper storage is unknown. Additional information has been requested.
Age: 0.76
Sex: M
Vaccine: PNC13
Symptoms: Blister, Erythema, Rash
Clinical narrative: Evening of 6/16/14, pt developed a rash on his buttocks. Area was red with blisters. Area measure 6x3 in. Rash developed after receiving the PCV-13.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional referring to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with VAQTA, intramuscular after being improperly stored at 33F. No other concomitant therapies reported. No adverse effects reported. The outcome of the event was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 10-JUN-2014 the patient was vaccinated with ZOSTAVAX. On an unspecified date in JUN 2014, the patient experienced a red, warm area around the injection site that was "bigger than a silver dollar" was reported as not recovered/not resolved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema and induration at site of MMR vaccine on left thigh.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Enema administration, Intussusception, Laparoscopic surgery
Clinical narrative: Developed intussusception 5 days after initial dose of ROTATEQ on 6-16-14.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (Merck) temperature excursion and two patients of unspecified age and gender who were vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J003711, exp date: 27-MAR-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. 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 roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (merck) (injection strength, dose, frequency, route of administration and indication were not provided) (lot # J012817, exp date: 10-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received 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 was received from a other health professional referring to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with VAQT, intramuscular after being improperly stored at 33F. No other concomitant therapies reported. No adverse effects reported. The outcome of the event was unknown. Additional information is not expected.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Faeces discoloured, Haematochezia, Occult blood positive
Clinical narrative: Stool had black flecks in it. Did occult stool test and positive for blood.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Urticaria
Clinical narrative: Urticaria on arms legs and (L) abdomen fading on Rt cheek.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist, via a company representative, refers to a patient of unknown age and gender. No information of patient's medical history, concurrent conditions or concomitant drugs was provided. It was reported that on unspecified dates the patient received 2 doses of ZOSTAVAX subcutaneously (dose and lot # not reported). There were no known adverse effects. Additional information has been requested.
Age: 1.19
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Rash on back 10am 6/5/14 and itching. Temp 99 on 6/4/14pm. Baby otherwise well.
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On 18-JUN-2014, the patient was vaccinated with first dose of ROTATEQ. No concomitants were reported. On 18-JUN-2014 the patient vomited vaccine as well as last feeding after administration of ROTATEQ. Patient sought medical attention (patient in office). There was no intervention to previous serious criteria. Action taken with respect to ROTATEQ was not applicable. No product quality complaint (PQC) was involved. The outcome event was resolving. Causality was not provided. No further information provided. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: General physical health deterioration, Medication error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 60 year old patient who was immunocompromised. The patient's medical history included a renal transplant. The nurse reported that another unspecified physician in another practice who assisted in infectious disease consult stated that on an unknown date a post renal transplant patient who was immunocompromised was vaccinated with a dose of ZOSTAVAX accidentally (dose, route, lot number not reported). Concomitant medication included unspecified immunosuppressant. On an unknown date the patient experienced significant deterioration in health within few months of vaccination. It was unspecified if the patient sought medical attention. The outcome of significant deterioration in health was unknown. The relationship between ZOSTAVAX and significant deterioration in health was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker (medical assistant) regarding unknown number of patients of unknown gender and age. The reporter states that on an unknown date the patient's were vaccinated with VAQTA (dose, frequency, lot number, expiry date not reported). Also reported that the patient's were administered doses of VAQTA that were improperly stored and no adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Hive 2 hour after vaccine on 6-17-14. Covered trunk, face, scalp. Resolved in few hours without treatment.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: This spontaneous report as received from an office manager refers to a currently 14 month old (age at the earliest adverse event onset unknown) female patient with none concurrent conditions or medical history. Office manager reported that the patient needed skin testing for VARIVAX (Merck), M-M-R II and VAQTA. They did not have these vaccines available and the patient could not get any from her pediatrician as they were stated supplied. He requested some samples. The reporter stated, that the patient was vaccinated with a dose of VARIVAX (Merck) subcutaneous injection, VAQTA intramuscular injection and M-M-R II subcutaneous injection (dose, route of administration, lot#, expiry date unspecified for all) on an unknown date at another office. No concomitant medications were reported. Patient developed widespread hives on an unspecified date. Then, the patient was evaluated in the office on 25-APR-2014. She was prescribed unspecified corticosteroid medication and was administered a BENADRYL injection. On 26-APR-2014, the hives had resolved but the patient had developed lip and facial swelling. The patient's mother administered oral BENADRYL at home. The patient subsequently recovered on an unspecified date. No laboratory test were provided. The relatedness between events and suspect vaccines was not reported. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Erythema, Injection site induration, Injection site swelling, Local swelling
Clinical narrative: Tdap given 6/17/14 at 6 PM at 610 pt stated she was having a reaction. (L) deltoid swollen and hard. No redness seen Dr evaluated area - determined it looked like a muscle spasm. Ice applied - swelling looked to increase. Warm compress applied. pt felt a little better - discharged at 625 with hot/cold packs. Advised to alternate cold/hot pks - and to take ADVIL if needed.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Pyrexia, Tenderness
Clinical narrative: Tdap given 6/17/14 at 6 PM at 610 pt stated she was having a reaction. (L) deltoid swollen and hard. No redness seen Dr evaluated area - determined it looked like a muscle spasm. Ice applied - swelling looked to increase. Warm compress applied. pt felt a little better - discharged at 625 with hot/cold packs. Advised to alternate cold/hot pks - and to take ADVIL if needed.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via field employee regarding a male patient over 60 years of age. There was no information reported on medical history and concomitant medications. On an unknown date in 2010, the patient was vaccinated with ZOSTAVAX (Lot number, expiry date, dose, frequency, route not reported). The reporter stated that on an unknown date (reported as recently), the patient had an office visit with shingles rash on their forehead and nose are. There was no product quality complaint involved. The outcome of the event was unkonwn. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Hives on face, extremities and torso.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to his 62 years old wife with naproxen and penicillin allergy. The patient had no pertinent medical history. On 08-MAY-2014 the reporting pharmacist administered ZOSTAVAX (subcutaneous, dose, lot # and expiry date were not reported) to his wife. Concomitant therapies included atenolol and escitalopram. On 12-MAY-2014 the patient began to experience a herpes like rash on her neck which radiated to one of her arms and then spread to the other arm. No lab diagnostics were performed. It was reported that this rash seemed to disappear, then return. The patient saw her primary physician who diagnosed her with the shingles, but her allergist said it was not the shingles, although he could not come up with a definitive diagnosis. The allergist prescribed the patient ALLEGRA and ZYRTEC, but both have not helped. The rash has spread to patient's legs, and again it seemed to disappear for some time then reemerged. It was reported that the rash was beginning to subside at the time of the report. The patient's status was reported as not recovered. The relatedness between ZOSTAVAX and herpes like rash and shingles was unknown. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Pt developed mild induration, warmth and erythema at injection site. Doubt infection. Suspect local reaction. Pt to doctor and seek medical care from PCP or ER if worse.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients (age and gender unknown). On unkown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 dose, route of administration and lot# were not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Faeces discoloured, Irritability, Mucous stools, Vomiting
Clinical narrative: Vomiting, diarrhea (foul smelling), fussiness, irritability, orange loose stools with occasional mucus.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 11-JUN-2014 the patient was vaccinated with GARDASIL dose 2. This was "about two weeks" after her first dose of GARDASIL. There were no adverse effects reported. The outcome of inadvertent receipt of second dose only two weeks after the first dose is unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Local reaction at injection site - erythema and induration.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Injection site rash, Myalgia, Pruritus, Rash erythematous
Clinical narrative: Called c/o worsening rash from the flu vaccine site to the arm, shoulder and neck x4 days. Stated it is itchy and red. No blisters yet. I tried hydrocortisone cream. It is not helping. This is a 70 yo male, came to ER with: itching that started a week ago, left arm, neck and hip, seemed to start left shoulder, where he received the flu shot on October 2nd. Pt with 2 or 3 day hx of cough, no SOB, and generalized myalgias since yesterday, particularly in his neck. No swallowing difficulty. Was unable to follow-up with primary care until Wednesday, BENADRYL prescribed here does not seem to be helping.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Called c/o worsening rash from the flu vaccine site to the arm, shoulder and neck x4 days. Stated it is itchy and red. No blisters yet. I tried hydrocortisone cream. It is not helping. This is a 70 yo male, came to ER with: itching that started a week ago, left arm, neck and hip, seemed to start left shoulder, where he received the flu shot on October 2nd. Pt with 2 or 3 day hx of cough, no SOB, and generalized myalgias since yesterday, particularly in his neck. No swallowing difficulty. Was unable to follow-up with primary care until Wednesday, BENADRYL prescribed here does not seem to be helping.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Patient seen in clinic on 6/5/14 and was noted to have erythema and swelling covering the deltoid region of the left arm which Dr noted was a local reaction to immunization. Patient advised to use TYLENOL or ibuprofen for discomfort as well as cold packs if needed for 15 min. at a time.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chest X-ray normal, Chest pain, Cough, Dyspnoea
Clinical narrative: On the last visit...after he received pneumovac...5th of Feb...saw local MD on Feb 7th...because swelling...sore and redness...was transferred to orthopaedic specialists...they thought it to be cellulitis and was given KEFLEX. States in one week ... it was almost cleared. States they thought his infection had spread to his chest...he began to have trouble breathing...productive cough/green sputum...no blood/wheezing was heard. Left ear pressure. Had chest pains with cough. Persistent short of breath. Had course of doxycycline. No GERD type symptoms. Scheduled to see lung specialist in April 2nd chest x-ray...2-28-2007...negative/also started on steroids and oral inhalers. Cephalexin unrecorded.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Ear discomfort, Erythema, Pain, Productive cough, Sputum discoloured
Clinical narrative: On the last visit...after he received pneumovac...5th of Feb...saw local MD on Feb 7th...because swelling...sore and redness...was transferred to orthopaedic specialists...they thought it to be cellulitis and was given KEFLEX. States in one week ... it was almost cleared. States they thought his infection had spread to his chest...he began to have trouble breathing...productive cough/green sputum...no blood/wheezing was heard. Left ear pressure. Had chest pains with cough. Persistent short of breath. Had course of doxycycline. No GERD type symptoms. Scheduled to see lung specialist in April 2nd chest x-ray...2-28-2007...negative/also started on steroids and oral inhalers. Cephalexin unrecorded.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: On the last visit...after he received pneumovac...5th of Feb...saw local MD on Feb 7th...because swelling...sore and redness...was transferred to orthopaedic specialists...they thought it to be cellulitis and was given KEFLEX. States in one week ... it was almost cleared. States they thought his infection had spread to his chest...he began to have trouble breathing...productive cough/green sputum...no blood/wheezing was heard. Left ear pressure. Had chest pains with cough. Persistent short of breath. Had course of doxycycline. No GERD type symptoms. Scheduled to see lung specialist in April 2nd chest x-ray...2-28-2007...negative/also started on steroids and oral inhalers. Cephalexin unrecorded.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Induration, Local reaction, Local swelling, Pain
Clinical narrative: Local title: Outpatient progress noted date of note: FEB 26, 2004 at 13:00 HISTORY OF PRESENT ILLNESS: Patient presents with his wife for evaluation of swelling of his left arm, S/P PNEUMOVAX earlier this a.m. He has had PNEUMOVAX in the past, approximately seven years ago and had no adverse reaction. He states that he started noting swelling of his left arm, approximately two hours after the PNEUMOVAX was given and he became dizzy. He denies any difficulty breathing, shortness of breath, chest pain, swelling of the lips and tongue. Ice was placed on the area which relieved the pain somewhat. IMPRESSION: Local reaction to PNEUMOVAX. PLAN: 1. Continue ice to the area 2. Patient will purchase BENADRYL OTC and take two every six hours PHYSICAL EXAM: VS: BP: 156/110 with repeat blood pressure of 150/90 BP earlier today was 118/83. P: 80 R: 98.4 Pain 0 GENERAL: Well Developed, well-nourished and does not appear to be in any acute distress. Speech is fluent. Tongue and lips are not swollen. LUNGS: CTA x 4, (-) Wheezing, (-) Rales, (-) Rhonchi CARDIAC: RRR, (-) Murmur, (-) Rub EXT: Left arm is swollen and tender to palpation with area of induration and no increased warmth and no erythema.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Local title: Outpatient progress noted date of note: FEB 26, 2004 at 13:00 HISTORY OF PRESENT ILLNESS: Patient presents with his wife for evaluation of swelling of his left arm, S/P PNEUMOVAX earlier this a.m. He has had PNEUMOVAX in the past, approximately seven years ago and had no adverse reaction. He states that he started noting swelling of his left arm, approximately two hours after the PNEUMOVAX was given and he became dizzy. He denies any difficulty breathing, shortness of breath, chest pain, swelling of the lips and tongue. Ice was placed on the area which relieved the pain somewhat. IMPRESSION: Local reaction to PNEUMOVAX. PLAN: 1. Continue ice to the area 2. Patient will purchase BENADRYL OTC and take two every six hours PHYSICAL EXAM: VS: BP: 156/110 with repeat blood pressure of 150/90 BP earlier today was 118/83. P: 80 R: 98.4 Pain 0 GENERAL: Well Developed, well-nourished and does not appear to be in any acute distress. Speech is fluent. Tongue and lips are not swollen. LUNGS: CTA x 4, (-) Wheezing, (-) Rales, (-) Rhonchi CARDIAC: RRR, (-) Murmur, (-) Rub EXT: Left arm is swollen and tender to palpation with area of induration and no increased warmth and no erythema.
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Anaphylactic reaction, Aphasia, Dyspnoea, Throat tightness
Clinical narrative: Anaphylaxis with throat tightness, shortness of breath, unable to talk (no hives).
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Irritability, Pyrexia, Rash vesicular
Clinical narrative: Spot (resembling chickenpox) on face, legs, hands and arms, decreased appetite, diarrhea, increased fussiness, fever.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Vaginal disorder
Clinical narrative: Vaginal.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who were vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Allergy to vaccine, Injection site erythema, Injection site warmth, Vaccination complication
Clinical narrative: DATE OF NOTE: APR 10, 2013 at 16:04 Pt into clinic was seen by Dr on 4/8/13 and was given PNEUMOVAX. Pt comes into clinic with mild reaction of the vaccine. Pt noted to have some redness on the inner aspect of his bicep and warmth to the upper part of the left arm. Dr into see pt and advised pt to do the following: 1) BENADRYL OTC two caps Q 4-6 hours as needed 2) Ibuprofen 200mg OTC one to two prn as needed 4-6 hours 3) Contact clinic tom. if still having issue. BP:132/80 (04/10/2013 16:01) T:98.4 F [36.9 C] (04/10/2013 16:01) P:104 (04/10/2013 16:01) R:18 (04/10/2013 16:01) Pain: 0 (04/10/2013 16:01). Also added PNEUMOVAX to pt's list of allergies. 04/11/2013 ADDENDUM STATUS: COMPLETED TC from pt. Pt calling to report status of mild reaction. Pt reports arm is still red, but fading. States arm is no worse and seems to be improving.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Patient c/o feeling achy and glands swelling, under (R) arm. Onset evening of shot (6/19/14). Has been taking TYLENOL. Patient states she had similar rxn to flu shot yrs ago.
Age: 38.0
Sex: F
Vaccine: JEV1, TYP
Symptoms: Dizziness, Immediate post-injection reaction, Injection site pain, Paraesthesia
Clinical narrative: Immediately following injection pt stated she felt pain at the site, tingling, and lightheadedness. Waited a few minutes and left. Stated pain x48 hours then OK.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Paraesthesia
Clinical narrative: Pt called pharmacy complained of redness and swelling from site of injection down her arm similar to sunburn. Was experiencing numbness/tingling in her pinky. Shot was given 6/14/14 at 5 pm.
Age: 42.0
Sex: F
Vaccine: MMR, MNQ, MMR, MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Pt had injection site reactions at both sites. The MENVEO had a worse reaction resulting in pain, redness and swelling of 2-4 cm. MD suspected cellulitis. Both reaction resolve in 4 days w/o ABX.
Age: 42.0
Sex: F
Vaccine: MMR, MNQ, MMR, MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt had injection site reactions at both sites. The MENVEO had a worse reaction resulting in pain, redness and swelling of 2-4 cm. MD suspected cellulitis. Both reaction resolve in 4 days w/o ABX.
Age: 1.01
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Febrile convulsion
Clinical narrative: Pt had a febrile seizure on 6-13-14, duration 15 seconds.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood test normal, Chest X-ray normal, Chills, Dyspnoea, Injection site pain
Clinical narrative: Approx. 12 hours after the vaccine: fever, chills, nausea, shortness of breath, and pain at the injection site. This lasted about nine hours. Took her to ER, blood work was negative and lungs clear.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Pyrexia
Clinical narrative: Approx. 12 hours after the vaccine: fever, chills, nausea, shortness of breath, and pain at the injection site. This lasted about nine hours. Took her to ER, blood work was negative and lungs clear.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of the events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384 exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right arm, hot to touch, swollen, red in color.
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swollen, hot to touch.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: Fussy, not eating, fever which resolved with TYLENOL or MOTRIN, no swollen ext.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of evens was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. 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 roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F dose 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data cas support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVX (merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. 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 roughly 20 unspecified patients of unkonwn age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Local swelling, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Patient said next day his arm was swollen, tender and painful and he went to his physician and examined him, he is in so much pain, patient is receiving pain relievers, also he reported fever.
Age: 47.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Blood test abnormal, Infection, Injection site pain, Injection site swelling, Product quality issue
Clinical narrative: Patient said next day his arm was swollen, tender and painful and he went to his physician and examined him, he is in so much pain, patient is receiving pain relievers, also he reported fever.
Age: 47.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Pyrexia, Urine analysis abnormal
Clinical narrative: Patient said next day his arm was swollen, tender and painful and he went to his physician and examined him, he is in so much pain, patient is receiving pain relievers, also he reported fever.
Age: 47.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Blood test abnormal, Injection site pain, Injection site swelling, Product quality issue, Pyrexia
Clinical narrative: Patient said next day his arm was swollen, tender and painful and he went to his physician and examined him, he is in so much pain, patient is receiving pain relievers, also he reported fever.
Age: 47.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Urine analysis abnormal
Clinical narrative: Patient said next day his arm was swollen, tender and painful and he went to his physician and examined him, he is in so much pain, patient is receiving pain relievers, also he reported fever.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Chills, Dizziness, Heart rate increased
Clinical narrative: Felt lightheaded, fast heart rate, chills, weakness. Symptoms started the evening of the vaccine lasted 48 hrs no treatment.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Chest pain, Eyelid oedema, Lip swelling, Oropharyngeal pain, Rash generalised
Clinical narrative: About 5 minutes after administration of the Varicella vaccine the patient began complaining of chest and throat pain. He was observed for further reaction and developed a rapidly progressive generalized macular erythematous rash as well as some slight swelling of the bilateral eyelids and lips. At no time did the patient develop wheezing or shortness of breath or any signs of hemodynamic compromise.