chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received via social media who reported multiple patients (unknown age and gender) who on an unspecified date were vaccinated with a dose of GARDASIL (dose and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that on an unspecified date, the patients died from the vaccine. No treatment information was reported. At the time of the report, the patients outcome for the adverse event was fatal. The relatedness for the adverse event was related for GARDASIL. This is one of the several reports from the same source. Additional information is not expected.
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, who in March 2012, was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly (lot number and expiration date were not reported) and on 01-JAN-2013 was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscularly (lot number and expiration date were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient (age gender unknown). On 15-JAN-2013, the patient was vaccinated with ZOSTAVAX (lot number reported; exp date on 13-JAN-2013) (route and dose not reported). No other co-suspects were reported. No concomitant medications were reported. On 15-JAN-2013, ZOSTAVAX with a expiration date of 13-JAN-2013, was accidentally administered to an unspecified patient. No adverse effect reported. The outcome of ZOSTAVAX with an expiration date of 13-JAN-2013, was accidentally administered to an unspecified patient on 15-JAN-2013 was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from an other via social media refers to a consumer of unknown age, who on an unspecified date was vaccinated with a dose of GARDASIL (dose and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that she affected. No treatment information was reported. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for GARDASIL. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 10-JAN-2013 the patient was vaccinated intramuscularly with a 0.5 ml expired dose of PNEUMOVAX23 (Lot# 667912/0933Z, expired on 25-FEB-2012). The patient was revaccinated on 14-JAN-2013 using 0.5 ml dose PNEUMOVAX23 (Lot# reported as H010515, expired on 13-FEB-2014), intramuscularly. No adverse effects were reported. It was not known if the patient sought medical attention. This is one of several reports received from a same source. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 58 years old female patient. On 17-JAN-2013 the patient received an expired 0.5 ml dose of PNEUMOVAX23 (Lot# 670718/0454AA, expired on 09-JAN-2013) intramuscularly in left arm. No adverse effect had been observed or reported. The dose was her primary vaccination with PNEUMOVAX23. It was not known if the patient sought medical attention. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Nasopharyngitis, Pyrexia, Rhinorrhoea
Clinical narrative: This spontaneous report as received from a physician refers to a 12 months old female patient. The patient was vaccinated into right thigh with first standard dose of VARIVAX (merck) (lot # H016057, expired date unspecified) on 03-JAN-2013. No other co-suspects were reported. Concomitant medications included PREVENAR into left thigh and PREVNAR into left thigh. On 14-JAN-2013 the patient experienced a 101 degree fever and a slight cold with runny nose. The patient sought treatment with her HCP on 15-JAN-2013 the patient experienced a 101 degree fever and a slight cold with runny nose. The patient sought treatment with her HCP on 15-JAN-2013. The patient was recovering at the time of the reported. The relatedness for a 101 degree fever and a slight cold with runny nose was unknown for VARIVAX (Merck). Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dyspnoea, Hypersensitivity, Pharyngeal oedema, Vision blurred
Clinical narrative: This spontaneous report was received from 58 year old female patient with sulfa drugs allergy, asthma, irregular heart beat and pre-cancer low immune system. On 14-NOV-2011, the patient was vaccinated with a dose of live ZOSTAVAX (lot number, expiry date, dose unspecified), subcutaneously in the arm. No concomitant medications were reported. On 14-NOV-2011, the patient experienced allergic reaction, shortness of breath and her throat was almost swollen shut. On an unknown date in approximately January 2013 (now), she believed that she might be getting shingles again in her left eye. This had a blister in the corner of her eye and her vision was blurry. She did not seek any medial attention till 16-NOV-2011. She was treated with PEPCID, doxycycline by injection, PERCOCET and a warm compress to arm at injection site. She would consult her physician on 10-JAN-2013 (today). The outcomes of all the events were unknown. The relatedness for all the events were unknown for live ZOSTAVAX. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report was received from a 57 years old male consumer (who is also a Registered Nurse) reporting on himself who on 17-JAN-2013 was vaccinated intramuscularly with a dose of ZOSTAVAX (lot #, and dose not reported) and on the other arm at the same visit was vaccinated with a doe of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxo (dose, lot # and route not reported). The patient said the injection was painful and he still has some soreness in the injected arm (onset date: 17-JAN-2013). Patient's outcome was unknown. The relatedness for injection site pain was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received via social media refers to a consumer of unknown age, who on an unspecified date was vaccinated with a dose of GARDASIL (dose and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that the patient was affected from the vaccine. No treatment information was reported. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was related for GARDASIL. This is one of the several reports from the same source. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Abdominal pain upper, Blood test, Constipation, Decreased appetite, Diarrhoea
Clinical narrative: Dizziness, nausea, stomach ache, diarrhea, constipation, loss of appetite, bruises easily.  No treatment.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Increased tendency to bruise, Nausea
Clinical narrative: Dizziness, nausea, stomach ache, diarrhea, constipation, loss of appetite, bruises easily.  No treatment.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oedema peripheral, Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a  80 years old female patient with no allergies and takes unspecified medication for blood pressure, cholesterol and thyroid. The patient was vaccinated with one dose of 0.65 ml live ZOSTAVAX (Lot # H019999, expiry: 02-FEB-2014), subcutaneous injection on 15-JAN-2013. The patient developed a rash at the injection location in triceps area 2 days later. Rash described as big red circle, painful, itchy, not raised. No treatment reported. No lab diagnostics were performed. The patient sought medical attention by consulting the pharmacist. At the time of the report the patient did not recovered from the events. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a  80 years old female patient with no allergies and takes unspecified medication for blood pressure, cholesterol and thyroid. The patient was vaccinated with one dose of 0.65 ml live ZOSTAVAX (Lot # H019999, expiry: 02-FEB-2014), subcutaneous injection on 15-JAN-2013. The patient developed a rash at the injection location in triceps area 2 days later. Rash described as big red circle, painful, itchy, not raised. No treatment reported. No lab diagnostics were performed. The patient sought medical attention by consulting the pharmacist. At the time of the report the patient did not recovered from the events. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Depression, Fatigue, Immediate post-injection reaction
Clinical narrative: Felt incredibly tired immediately afterward.  This continued for 5 days and was accompanied by feelings of severe depression and anxiety.
Age: 26.0
Sex: F
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: L55XW45 Left arm (tricep) area red, swollen, warm to touch. Pt stated it was tender in area. Pt did not apply ice to area or take any anti-inflammatory at onset of reaction.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Irritability, Pyrexia, Rash morbilliform, Rash pruritic, Teething
Clinical narrative: Rash and low grade fever (max recorded 100.7), irritable. Family sought care at ER and in the office over concern about irritability sister with cerebellar atresia which presented after 12 month vaccines. Rash was morbiliform in appearance. Seemed to be pruritic. No unusual adenopathy or hepatosplenomegaly. Only additional positive finding was that lower molars were starting to erupt.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Injection site pain, Insomnia, Pain, Tenderness
Clinical narrative: Tenderness of RUE within hours, but gradually over months RUE became weaker than of Left, tenderness persists and pain radiates from injection site either down into elbow or up into shoulder and neck, certain ROM or positioning of RUE exacerbate the pain, unable to lie on right shoulder for sleeping.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Cough, Ear pain, Limb discomfort, Mobility decreased
Clinical narrative: Parent called to report child complaining of being unable to move arm because of discomfort, earache, and has a cough this morning.  Attempted to review side effects as per Vaccine Information Statements with parent and refer to primary care physician/urgent care center if concerned.  Parent uncooperative with answering questions for VAERS report.  Parent hung up phone before nurse able to ask further questions about status.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Rash vesicular
Clinical narrative: On 1/15/13 patient returned to pharmacy to report soreness/redness at injection site and "chicken pox" like eruptions (3) on left cheek/forehead. Reported some resolution on 1/16/13 and was seen by Dr on 1/17/13, determined to be injection reaction.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Oedema peripheral, Tenderness, Vaccination site pain, Vaccination site swelling
Clinical narrative: AVA #7 (FAV283) on 7/25/2011 to left arm and AVA #8 (FAV309) to left arm on 12/14/2012. He also received typhoid vaccine 12/14/2012 to right arm. This active patient reported receipt of first 6 AVA vaccinations without adverse event. He reported being in good health upon receipt of AVA #7 on 7/25/2011. Approximately 24 hours later he complained of left upper arm vaccine site redness, swelling and tenderness that gradually progressed down to include his mid-upper arm (about 4 inch around the vaccination site). He also had axillary tenderness but no streaking. While there was tenderness and swelling to the arm, his ROM was not limited and he could perform all ADL requirements. He denied any paresthesia, fevers, headache, or any other symptom. He denied any trauma to his arm, band-aids or tape over injection site, new soaps, detergents, clothing, or other changes to normal routine. He presented to medical on day 2 and was advised this "was a normal site reaction" and to return if things worsened. He advised full resolution of symptoms within 4 days. He received IM influenza (SP - UT424AA) on 10/4/2011, yellow fever (UH271AA) on 2/21/2012 and IXIARO on 5/30/2012 with no reported adverse events. On 12/14/2012 he received AVA #8 (FAV309) to left deltoid and typhoid ViCP (WA G1541) and IM influenza (CSL P58907) to right deltoid. Approximately 24 hours later he complained of left arm vaccine site redness, swelling, tenderness and itching that again processed to mid upper arm with axillary tenderness similar to prior reaction in 2011. He again denied any trauma, fever, paresthesia, weakness, or any other symptom. He denied any problems with right arm vaccination sites. He did not seek medical care or take any medication letting symptoms resolve on their own about 5 days later. He has had no further complications from these reactions (last 2 AVA shot) and now requests AVA exemption because of these reactions.
Age: 17.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Received MMR right arm on 1/22/2013. Patient noticed itching to area around 5pm (1 hour after injection) and noticed redness and swelling. Came to clinic at 1/23/2013 at 12:30pm because of itching. Redness 6 cm x 6 cm area, warm, itching. Given BENADRYL & ice pack.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site irritation, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 4 years old female patient. The patient started to get local swelling at the injection site after receiving (Merck) PROQUAD (lot # H015643; exp. Date was unknown; dose 2; 0.5 ml) on 11-JAN-2013 which may have been exacerbated by the patient scratching the site. The patient sought medical attention. The patient's reaction was now healing. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This spontaneous report as received from a physician refers to a 5 years old male patient. The patient was vaccinated with dose 2, 0.5 ml of PROQUAD (merck) (lot # (H015643)) on 07-JAN-2013. On 07-JAN-2013 the patient experienced local reaction at the injection site. The patient did not develop a fever. TYLENOL was given as treatment. It was unknown if the patient had sought medical attention. The patient was recovered. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 years old female patient. The patient was vaccinated with a dose of 0.65 live ZOSTAVAX on an unspecified date. In the last month and a half, approximately in December 2012, the day after getting live ZOSTAVAX, the patient developed a 4" x4" red hot area that "kind of looked like a rash." The patient had sought medical attention. The patient was treated with BENADRYL, the AE improved a couple of days after starting BENADRYL. The outcome of the event was recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (registered nurse) refers to a patient of unknown age. The patient was inadvertently vaccinated with a dose of 0.5 ml live VARIVAX (Merck) (lot # 0025AA) SQ, on 16-JAN-2013 that had expired on 18-DEC-2012. No adverse effects reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Aphasia, Asthenia, Chest pain, Death, Gait disturbance
Clinical narrative: Hospitalized 12/12/12 through 12/22/12 at medical center.  Complaints of 6 months' increasing edema in hands and feet, current unsteady gait, decreased strength.  Diagnosed with Guillain-Barre Syndrome. Readmit 1/3/13 with worsening weakness, dysphasia. 1/5/13, expired during transport by ambulance.  Stopped at community hospital while en route.  DOA at community hospital.  Medical center reporting seen at another medical center prior to current medical center 1/3/13 admission for chest pain.  Ruled out MI at that time.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Oedema peripheral
Clinical narrative: Hospitalized 12/12/12 through 12/22/12 at medical center.  Complaints of 6 months' increasing edema in hands and feet, current unsteady gait, decreased strength.  Diagnosed with Guillain-Barre Syndrome. Readmit 1/3/13 with worsening weakness, dysphasia. 1/5/13, expired during transport by ambulance.  Stopped at community hospital while en route.  DOA at community hospital.  Medical center reporting seen at another medical center prior to current medical center 1/3/13 admission for chest pain.  Ruled out MI at that time.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Aphasia, Asthenia, Chest pain, Condition aggravated, Death
Clinical narrative: Hospitalized 12/12/12 through 12/22/12 at medical center.  Complaints of 6 months' increasing edema in hands and feet, current unsteady gait, decreased strength.  Diagnosed with Guillain-Barre Syndrome. Readmit 1/3/13 with worsening weakness, dysphasia. 1/5/13, expired during transport by ambulance.  Stopped at community hospital while en route.  DOA at community hospital.  Medical center reporting seen at another medical center prior to current medical center 1/3/13 admission for chest pain.  Ruled out MI at that time.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Oedema peripheral
Clinical narrative: Hospitalized 12/12/12 through 12/22/12 at medical center.  Complaints of 6 months' increasing edema in hands and feet, current unsteady gait, decreased strength.  Diagnosed with Guillain-Barre Syndrome. Readmit 1/3/13 with worsening weakness, dysphasia. 1/5/13, expired during transport by ambulance.  Stopped at community hospital while en route.  DOA at community hospital.  Medical center reporting seen at another medical center prior to current medical center 1/3/13 admission for chest pain.  Ruled out MI at that time.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Fever, swelling of left arm from elbow to shoulder, redness, warmth. Pt also having chills, nausea & vomiting. Differential diagnosis included possible pneumonia. Pt discharged next day with Augmentin.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: Fever, swelling of left arm from elbow to shoulder, redness, warmth. Pt also having chills, nausea & vomiting. Differential diagnosis included possible pneumonia. Pt discharged next day with Augmentin.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This spontaneous report was received from an advanced registered nurse practitioner via a company representative concerning a 14 year old female patient. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, dose, route unspecified). No concomitant medications were reported. Her parents called the nurse practitioner office on an unknown date and stated that the patient went into menopause (date unspecified) and unspecified type of symptoms were reported. The outcomes of the events were unknown. The relatedness for the events was unknown for GARDASIL. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site erythema, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old female patient. The patient was vaccinated with live ZOSTAVAX (lot number not provided) in December 2012. No other co-suspects were reported. No concomitant medications were reported. The patient might have received a partial dose due to leakage from the syringe. In December 2012 the patient experienced a small area of redness at the injection site. No treatment information was reported. The outcome of small area of redness at the injection site was not reported. The relatedness for small area of redness at the injection site was not provided for live ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. The patient was vaccinated with dose 1 of GARDASIL on 02-AUG-2012. On 09-OCT-2012, the patient was vaccinated with dose 2 of GARDASIL and the patient was vaccinated with the third dose on 08-JAN-2013. No dosage information or route of administration was reported. It was reported that the patient received the third dose of GARDASIL one day before the 22nd week. No adverse symptoms were reported. Additional information was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to an unknown number of patients (age and gender unspecified). On an unknown date, the patients were vaccinated with improperly stored GARDASIL (lot number, expiration and route not reported). No concomitant medications were reported. No adverse event reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Arthritis rubella
Clinical narrative: This spontaneous report as received from a doctor of pharmacist concerning a female patient of unknown age who on approximately 1993. More than 20 year ago was vaccinated with M-M-R II, (manufacturer and brand unspecified was also reported) (dose, route and lot number not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced severe arthritis like reaction to rubella containing vaccine. No treatment information was reported. The outcome of severe arthritis like reaction to rubella containing vaccine was reported as recovered/resolved. Severe arthritis like reaction to rubella containing vaccines was related to M-M-R II (manufacturer and brand unspecified was also reported). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient. She reports that the patient was vaccinated with the first dose 0.5 ml GARDASIL on 27-FEB-2007 and received her second dose 0.5 ml GARDASIL (lot # 0475AE and exp unspecified) 25-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Muscle spasms, Pain
Clinical narrative: Patient received flu shot at pharmacy, about three hours later patient woke up from nap after going home. Had body aches, chills, reports muscles spasms, sweating & fever of 109 degrees. EMS was called and took her to the hospital where she was treated for flu-like symptoms & given fever reducing medications & IV fluids. Pt kept overnight filled TAMIFLU & Ibuprofen the next day.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient received flu shot at pharmacy, about three hours later patient woke up from nap after going home. Had body aches, chills, reports muscles spasms, sweating & fever of 109 degrees. EMS was called and took her to the hospital where she was treated for flu-like symptoms & given fever reducing medications & IV fluids. Pt kept overnight filled TAMIFLU & Ibuprofen the next day.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Injection site vesicles, Laceration
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 25 years old female nurse. The patient was vaccinated with a 0.5 ml dose of (Merck) VARIVAX (lot # reported as H016715; expiration date: 07-SEP-2014) intradermally on 12-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the skin at her insertion site had fluid-filled blister, like the solution did not go in deep enough, The nurse clarified that the blister did not look like a varicella-like rash, but more like a single collection of fluid immediately beneath the surface of her skin. The nurse who received the dose of (Merck) VARIVAX told the pharmacist that it looked like the dose was injected intradermally. When the nurse took off the bandage that was covering her injection site, she reported to the pharmacist that her skin ripped off. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hot flush, Syncope
Clinical narrative: 30 min after immunization patient had chills & hot flashes then fainted. She got up and then fainted a 2nd time.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pallor, Slow response to stimuli, Tension
Clinical narrative: I was called for help pt was gripping chair tense and not responding properly. I could not see her face so I moved hair she was conscious and breathing and able to respond. Slight nausea and pale. Responses abnormal and slow recovery called 911 for further assessment. Possible seizure according to friend who was with her.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Left arm swelling, hot to touch.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Blood pressure abnormal, Headache, Malaise, Migraine, Myalgia
Clinical narrative: Slight headache on waking.  Muscle soreness.  General malaise.  As morning progressed developed a headache like a migraine.  Did not feel like blood pressure was elevated but took anyway.  BP was 171/110.  Remained in that range through afternoon. Called and reported to my doctor all symptoms.  Told to rest.  I took Tylenol 650 mgs which helped relieve the headache.  BP down to 140/90 at night.  By 9am BP was normal 123/82.  I do not take BP medicine.  I constantly monitor BP so found this to be unusual. Still have slight headache and body aches.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Pain
Clinical narrative: Slight headache on waking.  Muscle soreness.  General malaise.  As morning progressed developed a headache like a migraine.  Did not feel like blood pressure was elevated but took anyway.  BP was 171/110.  Remained in that range through afternoon. Called and reported to my doctor all symptoms.  Told to rest.  I took Tylenol 650 mgs which helped relieve the headache.  BP down to 140/90 at night.  By 9am BP was normal 123/82.  I do not take BP medicine.  I constantly monitor BP so found this to be unusual. Still have slight headache and body aches.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Woke up with a red itchy rash all over my body and low grade fever.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. The patient was vaccinated with PNEUMOVAX23 on 14-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient had possibly been vaccinated twice with PNEUMOVAX23 in one week. The patient received an injection with PNEUMOVAX23 on 14-JAN-2013. However, the patient may or may not have been administered another dose of PNEUMOVAX23 by another doctor earlier in the week. No adverse effect was reported. The patient did not seek medical attention because of the possible second administration of PNEUMOVAX23. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cyanosis, Injection site discolouration, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: When shot was administered, I was itchy for about 5 minutes.  Later, I got black & blue where administered.  Then there was swelling, redness, the area is warm.  The redness is spreading on my arm but the black & blueness is disappearing. I called my physician on 1/23/13, was told that there is really nothing that can be done and to apply warm compresses.  Also, was told it could be a week before all symptoms may disappear.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pruritus
Clinical narrative: When shot was administered, I was itchy for about 5 minutes.  Later, I got black & blue where administered.  Then there was swelling, redness, the area is warm.  The redness is spreading on my arm but the black & blueness is disappearing. I called my physician on 1/23/13, was told that there is really nothing that can be done and to apply warm compresses.  Also, was told it could be a week before all symptoms may disappear.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Mobility decreased
Clinical narrative: Shot given on left side, severe swelling of lymph nodes under arm & clavicle area, could not lift or use arm for 48hrs.  Took Benadryl 3 times daily as well as ibuprofen.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site pain, Injection site reaction, Injection site swelling, Rash vesicular
Clinical narrative: Had burning when first administered for about 5 minutes.  Then 1/23/13 have one spot where shot was administered that looks like a chicken pox or shingle, soreness and a little swelling.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: Pt stated she was feeling tired and not right. Laid patient down on exam table. She stated she felt much better. BP 116/71. Patient sat up and BP 96/68 and she felt fine to sit up. Patient stood up and BP 149/63 and patient was fine to walk. Walked patient to car and informed her if she didn't feel well again lay down and go to ER if needed. Walked patient to car.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Discomfort, Dyspnoea, Fatigue
Clinical narrative: Woke up 8 hrs after injection having difficulty breathing - loud wheezing, chills, great discomfort. Sat up - the symptoms subsided in 2 hours, I was able to fall asleep after applying Vaporub to chest. ONLY respiratory issue and chills - nothing else. Next day feeling well now, just a little tired and achy (joints) but possibly to lack of sleep.  I decide to report it because I never had a bad reaction to any shot, have no asthma or other chronic breathing issues - this is the first time I experienced the wheezing/lack of breath.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Pain, Wheezing
Clinical narrative: Woke up 8 hrs after injection having difficulty breathing - loud wheezing, chills, great discomfort. Sat up - the symptoms subsided in 2 hours, I was able to fall asleep after applying Vaporub to chest. ONLY respiratory issue and chills - nothing else. Next day feeling well now, just a little tired and achy (joints) but possibly to lack of sleep.  I decide to report it because I never had a bad reaction to any shot, have no asthma or other chronic breathing issues - this is the first time I experienced the wheezing/lack of breath.
Age: 0.37
Sex: M
Vaccine: HIBV, PPV, RV1
Symptoms: Crying, Diarrhoea, Irritability, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever, Vomiting, Congestion, Fussiness, Crying, Diarrhea.
Age: 0.37
Sex: M
Vaccine: HIBV, PPV, RV1
Symptoms: Vomiting
Clinical narrative: Fever, Vomiting, Congestion, Fussiness, Crying, Diarrhea.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender with no drug reactions or allergies and no pertinent medical history who on 16-JAN-2013, was vaccinated intramuscular on right upper arm with, 0.5 ml PNEUMOVAX23 (lot }# not provided). Other suspect therapies included subcutaneously on right arm live ZOSTAVAX (dose and lot # not provided) on 16-JAN-2013. No concomitant medications were reported. The nurse stated that on 16-JAN-2013 patient experienced right shoulder pain and stiffness since that date. The patient was administered a 0.5 ml dose of PNEUMOVAX intramuscular ly and a single dose of ZOSTAVAX subcutaneously at separate locations in the right upper arm. The patient sought medical attention called the nurse. The patient has used hot and cold compresses, as well as TYLENOL, but the symptoms have not improved at the time of the report. No further information provided. The outcome of right shoulder pain and stiffness was reported as not recovered/not resolved. The relatedness for right should pain and stiffness was unknown for PNEUMOVAX23 and ZOSTAVAX. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: PARENT NOTED LAST NIGHT (01/23/2013), RIGHT UPPER ARM AREA WHERE SHOT WAS GIVEN: REDNESS, REDNESS MEASURED 2in.x4in-OVAL SHAPE, WARM TO TOUCH, HARD. NO FEVER. USING ICE, IBUPROFEN AT NIGHT.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Migraine, Pain, Pruritus, Pruritus generalised
Clinical narrative: Developed itchy skin all over body (no hives). Developed migraine headache and aches from my elbow to my chest radiating from the site of the injection on my arm. Symptoms lasted 48-72 hours.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Dizziness, Feeling abnormal, Headache
Clinical narrative: Patient given an HPV immunization (Gardasil) at a school based immunization clinic.  A few minutes after the injection she c/o feeling funny and light headed.  Patient was directed to lie down on the cot in the nurses room.  Patient rested for about a half an hour then stated she felt well enough to go back to class. Patient ended up going home from school early that day and felt poorly with aching hips and legs, tingling in her legs, a headache behind her eyes, and some dizziness. Patient went to the doctor the next day (01/18/13) at which time she was reassured and no other actions taken.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Patient given an HPV immunization (Gardasil) at a school based immunization clinic.  A few minutes after the injection she c/o feeling funny and light headed.  Patient was directed to lie down on the cot in the nurses room.  Patient rested for about a half an hour then stated she felt well enough to go back to class. Patient ended up going home from school early that day and felt poorly with aching hips and legs, tingling in her legs, a headache behind her eyes, and some dizziness. Patient went to the doctor the next day (01/18/13) at which time she was reassured and no other actions taken.
Age: 4.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Dyspnoea
Clinical narrative: Woke up having diffculty breathing was gasping for air, took a him outside and then put him in the shower and seemed to allow for better breathing. Sounds almost like he has croup.
Age: 4.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Cough, Croup infectious
Clinical narrative: Woke up having diffculty breathing was gasping for air, took a him outside and then put him in the shower and seemed to allow for better breathing. Sounds almost like he has croup.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Development cellulitis (R) deltoid region < 48 hours post Tdap injection.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Oropharyngeal pain
Clinical narrative: Throat pain when swallowing.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unknown number of patients of unknown age and genders who on unspecified date were vaccinated with RECOMBIVAX HB (Doses, lots # and routes not provided). Other suspect therapies included on unspecified date, VAQTA (Doses, lots # and routes not provided). No concomitant medications were reported. The medical assistant stated that an unknown number of patients have received improperly stored RECOMBIVAX HB and VAQTA. No adverse event reported. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: DTAP
Symptoms: Back pain, Chondropathy, Headache, Lumbar spinal stenosis, Nausea
Clinical narrative: He complains of a moderately severe headache for 1 week(s).   Location: bilateral in the frontal area and back of neck and upper back. Associated signs and symptoms include nausea x 1 day + fever.
Age: 36.0
Sex: M
Vaccine: DTAP
Symptoms: Neck pain, Neurological examination abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Pyrexia, Spondylolisthesis
Clinical narrative: He complains of a moderately severe headache for 1 week(s).   Location: bilateral in the frontal area and back of neck and upper back. Associated signs and symptoms include nausea x 1 day + fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Abdominal cramping and diarrhea.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling and it was extremely hot and hard as a rock at injection area.  It did hurt really bad.
Age: 1.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Local reaction
Clinical narrative: Patient has a large local reaction about two weeks after immunizations were given.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Macule, Papule
Clinical narrative: Patient had two erythematous nodules on top left thigh some induration. No pustule. No warmth. No surrounding erythema scattered erythematous macules and papules (blanching) along suprapubic area. Sandpapery feel to area.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Injection site erythema, Skin warm, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain, swelling, redness 5cm, rash at vaccination site, warmth.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Cellulitis, Extensive swelling of vaccinated limb, Injection site infection, Injection site swelling, Pain
Clinical narrative: Pain, swelling, redness 5cm, rash at vaccination site, warmth.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Skin discolouration
Clinical narrative: Pain, swelling, redness 5cm, rash at vaccination site, warmth.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Raised welts on torso, very itchy and red.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Balance disorder, Blood test, Electromyogram
Clinical narrative: Numbness, paresthesias and muscle pain in both legs started within 7-10 days after flu shot. Gait was off. Numbness right ball of foot and middle three toes. Pain progressed in severity and included lower back and both flanks, and included hips to lower legs. Had intense muscle cramps in lower legs and both feet with flexion and at night that kept waking me if I was able to sleep at all. Pain in muscles and legs was so severe I couldn't sleep at night. Felt unstable in regard to balance. Almost fell. Muscle weakness both legs and difficulty climbing stairs and getting up from sitting. Saw a physiatrist and two neurologists and my internist over the course of October into December.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Flank pain, Gait disturbance, Hypoaesthesia, Insomnia, Muscle spasms
Clinical narrative: Numbness, paresthesias and muscle pain in both legs started within 7-10 days after flu shot. Gait was off. Numbness right ball of foot and middle three toes. Pain progressed in severity and included lower back and both flanks, and included hips to lower legs. Had intense muscle cramps in lower legs and both feet with flexion and at night that kept waking me if I was able to sleep at all. Pain in muscles and legs was so severe I couldn't sleep at night. Felt unstable in regard to balance. Almost fell. Muscle weakness both legs and difficulty climbing stairs and getting up from sitting. Saw a physiatrist and two neurologists and my internist over the course of October into December.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging spinal, Pain in extremity
Clinical narrative: Numbness, paresthesias and muscle pain in both legs started within 7-10 days after flu shot. Gait was off. Numbness right ball of foot and middle three toes. Pain progressed in severity and included lower back and both flanks, and included hips to lower legs. Had intense muscle cramps in lower legs and both feet with flexion and at night that kept waking me if I was able to sleep at all. Pain in muscles and legs was so severe I couldn't sleep at night. Felt unstable in regard to balance. Almost fell. Muscle weakness both legs and difficulty climbing stairs and getting up from sitting. Saw a physiatrist and two neurologists and my internist over the course of October into December.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Urine analysis
Clinical narrative: Numbness, paresthesias and muscle pain in both legs started within 7-10 days after flu shot. Gait was off. Numbness right ball of foot and middle three toes. Pain progressed in severity and included lower back and both flanks, and included hips to lower legs. Had intense muscle cramps in lower legs and both feet with flexion and at night that kept waking me if I was able to sleep at all. Pain in muscles and legs was so severe I couldn't sleep at night. Felt unstable in regard to balance. Almost fell. Muscle weakness both legs and difficulty climbing stairs and getting up from sitting. Saw a physiatrist and two neurologists and my internist over the course of October into December.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: She has had a local reaction where the flu shot was  given: 10 cm diameter area of induration, heat, erythema, tenderness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Chest pain, Electrocardiogram, Herpes zoster
Clinical narrative: Started having chest pains and painful skin (like sunburn) on left side chest, radiating to left shoulder blade.  Thought I might be having a heart attack.  That was ruled out.  8 days later developed the characteristic rash of shingles and was seen again and started on acyclovir and pain meds.  Am recovering now.   By the way, I reported this through MedWatch because I was unable to access VAERS through the FDA/CDC portal, so you'll get this twice.  Simply meant to add to the body of info regarding post market efficacy.  Thanks.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain of skin
Clinical narrative: Started having chest pains and painful skin (like sunburn) on left side chest, radiating to left shoulder blade.  Thought I might be having a heart attack.  That was ruled out.  8 days later developed the characteristic rash of shingles and was seen again and started on acyclovir and pain meds.  Am recovering now.   By the way, I reported this through MedWatch because I was unable to access VAERS through the FDA/CDC portal, so you'll get this twice.  Simply meant to add to the body of info regarding post market efficacy.  Thanks.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4, MNQ
Symptoms: Abdominal pain upper, Anxiety, Arthralgia, Asthenia, Blood test
Clinical narrative: Headaches all the time, dizziness, nausea, shortness of breath, wheezing, joint pains unusual tiredness, weakness, leg pain, generally feeling unwell and being sick all the time, stomach pains, depression, anxiety, the shot has caused me to fall (reported at the doctors that I fell and twisted my knee, this was after the first shot. I was getting up off the couch and I felt horrible joint pain in my knee, it made me fall because it hurt so bad, and also miss alot of school at the time, its really hard for me to work now.  I have pains all over and Drs still dont know why. My mom told me last night that her co workers friend has fibromyalgia from the shot and maybe that is what I have because of the shot.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4, MNQ
Symptoms: Depression, Dizziness, Dyspnoea, Fall, Headache
Clinical narrative: Headaches all the time, dizziness, nausea, shortness of breath, wheezing, joint pains unusual tiredness, weakness, leg pain, generally feeling unwell and being sick all the time, stomach pains, depression, anxiety, the shot has caused me to fall (reported at the doctors that I fell and twisted my knee, this was after the first shot. I was getting up off the couch and I felt horrible joint pain in my knee, it made me fall because it hurt so bad, and also miss alot of school at the time, its really hard for me to work now.  I have pains all over and Drs still dont know why. My mom told me last night that her co workers friend has fibromyalgia from the shot and maybe that is what I have because of the shot.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4, MNQ
Symptoms: Joint injury, Malaise, Nausea, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Headaches all the time, dizziness, nausea, shortness of breath, wheezing, joint pains unusual tiredness, weakness, leg pain, generally feeling unwell and being sick all the time, stomach pains, depression, anxiety, the shot has caused me to fall (reported at the doctors that I fell and twisted my knee, this was after the first shot. I was getting up off the couch and I felt horrible joint pain in my knee, it made me fall because it hurt so bad, and also miss alot of school at the time, its really hard for me to work now.  I have pains all over and Drs still dont know why. My mom told me last night that her co workers friend has fibromyalgia from the shot and maybe that is what I have because of the shot.