chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Trismus
Clinical narrative: My primary physician suggested I contact you. My arms seized up with absolutely no warning approximately 26 hours after I received an injection of Zostavax.  My arms were crossed with my hands on my chest like a dead person in a coffin.  My jaw seized up in another 6 hours.  The pain in my arms, from below the shoulder and above the elbows was excruciating...it never let up. Because of my jaw being seized shut I could not explain to the Hospitalist on call that this was not arthritis pain.  I have had arthritis for 53 years.  I KNOW what arthritis pain feel like. I still have a knot in my arm, although tiny now, in which I received the injection.  Even today, when I press on the tiny knot I faintly feel the same pain. Is it possible this was caused by an allergic reaction or an improperly administered injection. I am giving you the following so you will know this actually has happened. Clinic $726.92; Hospital $18,812.95; Hospitalist for clinic $367.00; ER visit 171.10 Hospital visit & Discharge. I need to see someone re my lower dentures for, due to the strong pressure in my jaws while they were seized up, my lower dentures now do not fit.  Cost for this is unknown at this time. Thank you for your attention to this problem. Should you have any questions and/or suggestions please feel free to contact me for I certainly NEVER want to go through this again.
Sex: F
Vaccine: HEPAB, TYP, HEPAB, TYP
Symptoms: Dyspnoea, Rash
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 13 August 2013 with additional information received on 14 August 2013. A female patient (age not reported) had received an injection of TYPHIM VI, Sanofi Pasteur and TWINRIX, GSK (lot numbers, routes and sites of administration not reported) on 06 August 2013. One day later on 07 August 2013, the patient experienced an anaphylactic type reaction. The patient is under the care of an allergist to determine the cause. Treatment included prednisone, ATARAX and XYZAL twice a day. Outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: HEPAB, TYP, HEPAB, TYP
Symptoms: Anaphylactoid reaction
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 13 August 2013 with additional information received on 14 August 2013. A female patient (age not reported) had received an injection of TYPHIM VI, Sanofi Pasteur and TWINRIX, GSK (lot numbers, routes and sites of administration not reported) on 06 August 2013. One day later on 07 August 2013, the patient experienced an anaphylactic type reaction. The patient is under the care of an allergist to determine the cause. Treatment included prednisone, ATARAX and XYZAL twice a day. Outcome was not reported. Documents held by sender: None.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Abnormal behaviour, Aggression, Confusional state, Face oedema, Insomnia
Clinical narrative: On date of discharge, later that evening she exhibited confusion, severe preservative speech issues, sleeplessness, compulsive issues, sporadic clothing stripping, combativeness. Readmitted to hospital on Aug 8 with edema on face, neck present and rash on legs.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Localised oedema, Obsessive-compulsive disorder, Rash, Speech disorder
Clinical narrative: On date of discharge, later that evening she exhibited confusion, severe preservative speech issues, sleeplessness, compulsive issues, sporadic clothing stripping, combativeness. Readmitted to hospital on Aug 8 with edema on face, neck present and rash on legs.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an approximately 74 year old female patient with no pertinent medical history and no drug reactions or allergies. On 09-AUG-2013, the patient was vaccinated with the first dose of PNEUMOVAX23 (lot # J004747 and expiry date: 20-JUL-2014), intramuscularly from a multi-dose vial. Concomitant therapy included PERCOCET. On 09-AUG-2013 (reported as the same day), the patient developed cellulitis at the injection site. The patient sought medical attention. The patient was seen at an emergency department in a hospital. The patient was admitted to the hospital with a diagnosis of cellulitis and stayed there for five days. The patient was currently discharged from the hospital and would be coming for a follow up visit to the office today (19-AUG-2013). The patient was provided with an unspecified treatment. It was unspecified if any lab tests were performed. The outcome of cellulitis at the injection site was unknown. The office requested a lot check of the PNEUMOVAX23. The relatedness for cellulitis at the injection site was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Initial information received from a healthcare professional who is the patient on 16 August 2013. On 6 August 2013, a 42 year old female patient was administered ADACEL, batch U4655AA into the right deltoid (route not reported). The patient's medical history was reported as severe gluten allergy, celiac of the skin, dermatitis herpetiformis, grass, sulfa, quinolones and shellfish allergies. The patient was immunized with Tetanus only vaccine in the past on an unreported date. Concomitant medications and laboratory tests were not reported. On Friday 09 August 2013, the patient experienced a rash which started on her neck and spread to her chest, back, legs. It was raised, itchy with no drainage. No fever was noted and the rash was not hot to the touch. The patient took BENADRYL, route and dose not reported and unspecified topical hydrocortisone. The patient continues to experience the rash, but it is improving now. The patient is an RN and did not seek medical advice. The patient outcome was reported as not recovered. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram, Myocarditis, Nuclear magnetic resonance imaging normal, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 14 August 2013. A 24-year-old male subject was found to have other and unspecified acute myocarditis and non-specific myocarditis 11 days after receiving the following vaccines on 06 June 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax (manufacturer, lot number, route and site of administration not reported), and TYPHIM VI (sanofi pasteur SA, lot number, route and site of administration not reported). Relevant laboratory data included an abnormal Troponin I value of 00.15 (units not reported) on 17 June 2013, normal Echocardiogram on 17 June 2013, normal MRI of the heart on 20 June 2013. The results of ECG were not available. MRI of brain and spinal cord, and lumbar puncture were not performed. Treatments were not reported. The subject had no significant past medical history. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Pericardial disease, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 14 August 2013. A 23-year-old male subject was found to have unspecified disease of pericardium 13 days after receiving an injection of ACAM2000 (lot number, route and site of administration not reported) on 21 May 2013 and 20 days after receiving a dose of TYPHIM (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported) on 14 May 2013. Relevant laboratory data included abnormal troponin I at 00.70 and a normal ECG and echocardiogram on 03 June 2013. Treatments were not reported. Past medical history included chest pain, abnormal ECG (electrocardiogram), dizziness/fainting spells, shortness of breath, and eczema. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Angina pectoris, Chest pain, Electrocardiogram abnormal, Troponin I, Troponin normal
Clinical narrative: This study case was received from the investigator in the trial on 16 August 2013. A 39-year-old male subject was found to have other and unspecified angina pectoris 9 days after receiving the following vaccines on 28 March 2011: an injection of ACAM2000 (lot number, route and site of administration not reported) and anthrax (manufacturer, lot number, route and site of administration not reported). The subject also experienced other, chest pain 10 days after vaccination. Relevant laboratory data included an abnormal ECG on 06 April 2011 and normal troponin I on 07 April 2011. Treatments were not reported. Past medical history included elevated cholesterol, chest pain, chest pressure, abnormal ECG (electrocardiogram), shortness of breath, and headaches. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Chest discomfort, Dyspnoea, Respiratory distress, Wheezing
Clinical narrative: Pt. started having breathing difficulty 36 hours after vaccine admin. Pt had wheezing with tightness in chest O2 Sat 78%. Required O2. Transported to local ER via ambulance admitted for resp distress.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test abnormal, Herpes simplex
Clinical narrative: This spontaneous report as received from a 66 year old female consumer refers to herself. In May 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose, route, indication not reported). Approximately in July 2013 (14 months later) the patient was tested for Herpes II and the test was positive for Herpes II. The patient felt that this was a "false positive" though. This was because the patient believed that ZOSTAVAX had caused her ZOSTAVAX test to be positive. The outcome of the event was unknown. Additional information is not expected.
Age: 0.08
Sex: F
Vaccine: HEP, HEPA
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to his 4 week old (also reported as one month old) daughter. The patient was administered the Hepatitis A vaccine (injection, in the left leg), at an unspecified strength, in a pediatric office on 22-AUG-2013, instead of the Hepatitis B vaccine, which was the intended administration. The reporter was unable to confirm that the vaccine was VAQTA. Before leaving the office, the parents were informed of the error. The baby was able to go home with her parents. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 2 year old male patient. On 24-JUL-2013 the patient was vaccinated with M-M-R II (lot number reported as H015824, expiration date unspecified; dose, route and site unknown). The patient presented to the office with a fever and roseola-type rash "about ten days later" approximately on 03-AUG-2013. The outcome of fever and roseola-type rash was reported as recovered/resolved (date unspecified). Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Antibody test abnormal
Clinical narrative: This spontaneous report as received from a physician refers to his now 25 year old son with no medical history or drug reactions/allergies. The patient was administered "two doses of M-M-R II on unspecified dates as per recommended timing when he was a child. He had titers drawn for antibodies to M-M-R when was an undergraduate student on an unspecified date and the results were equivocal. He was now applying to medical school and the medical school would not accept the equivocal titer results." Subsequently, the patient had a third dose of M-M-R II (lot #, expiration, route unspecified) administered on 16-AUG-2013. No concomitant medication. No treatment was given. At the time of report, the outcome of the event was unknown. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company presentative refers to a 13 year old patient (gender unknown). ON an unknown date when the patient was 12 months old, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expiry date and route was not reported). On an unknown date at the age of 9 or 10 years, the patient developed shingles. Treatment was rendered for the event but it was unspecified. The outcome of developed shingles was reported as recovered. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: Hives on arms and legs within an hour of receiving the vaccines.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Convulsion, Laboratory test, Pyrexia
Clinical narrative: Seen in office on 8/12/13. Fever for 4 days started on 8/8/13. First 2 days 102-103 and then 101. When seen no fever for 12-14 hrs. Generalized seizure on 8/13/13, seen in ER.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site swelling
Clinical narrative: Localized redness and mild swelling around point of injection. Erythema 7 1/2 cm wide by 9 cm long.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Dyskinesia, Immediate post-injection reaction, Syncope, Unresponsive to stimuli
Clinical narrative: Pt. received vaccine injection in (R) deltoid and immediately after fainted and had spastic movement Pt placed in supine position and became responsive shortly after (1-2 mins). C/O feeling dizzy and seeing red light just prior to fainting.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Visual impairment
Clinical narrative: Pt. received vaccine injection in (R) deltoid and immediately after fainted and had spastic movement Pt placed in supine position and became responsive shortly after (1-2 mins). C/O feeling dizzy and seeing red light just prior to fainting.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site swelling, Pain, Pain in extremity, Skin warm
Clinical narrative: Pt noticed around 3AM 9/6/13 arm pain, hot arm and swelling at site of injection and redness both arms also achy feeling all over. Benadryl given 50 mg.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a patient of unknown age. On 15-AUG-2013 the patient was vaccinated with an expired dose of GARDASIL (lot # 0692AA, Exp 13-AUG-2013) (dose, frequency and route unspecified). No adverse effect reported. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash on back then spread through whole body.
Age: 0.06
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Irritability, Pain, Pyrexia, Rash morbilliform
Clinical narrative: Severe measles type rash 11 days post vaccine - fever, fussy and painful.
Age: 0.06
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Irritability, Pain, Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: Severe measles type rash 11 days post vaccine - fever, fussy and painful.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis surrounding injection site. Treated with cephalexin.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: States she had a zoster shot 7/15/13. Starting breaking out in a rash on 7/17/13. Seen in my office 7/19/13 with a rash that resembled zoster.
Age: 1.08
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Local swelling, Pyrexia
Clinical narrative: Fever 101 degrees (axillary), swelling and erythema of left arm (5x6 area).
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient. On 10-APR-2013 the patient received the first dose of RECOMBIVAX HB, second dose on 14-MAY-2013 and the third dose on 20-AUG-2013 (lot # not reported), "10 mcg/3 doses", intramuscular. No adverse effect. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history provided. The reporter stated that improperly M-M-R II (Indication: vaccination) may have been administered. No concomitant medications were provided. No adverse event was reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history provided. The reporter stated that improperly stored GARDASIL may have been administered. No concomitant medications were provided. No adverse event was reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. No medical history or drug allergies/reactions were reported. The healthcare worker reported that the patient was administered on an unspecified date in April 2012, the first dose of GARDASIL (lot #, dose and route not provided), then the patient received the second dose on an unspecified date in October 2012 of GARDASIL (lot #, dose and route not provided); and then the patient was in the physician's office on 14-AUG-2013, to received the third dose of GARDASIL (lot #, dose and route not reported). No adverse effect was reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, Influenza
Clinical narrative: This spontaneous report as received from a 36 year old female, non pregnant consumer with no drug reactions or allergies and no pertinent medical history, who is also the patient. On 01-JAN-2013 the patient was vaccinated with the first dose of GARDASIL (dose, route and site of administration) (lot number and expiration date were not reported). There was no concomitant medications.  The patient was due to receive her third dose on 01-JUL-2013, but she decided to postpone getting her final dose of GARDASIL, because she developed the flu "a couple of weeks ago" (exact date unspecified), in 2013. The patient did not seek medical attention. No lab tests were performed. She was given TYLENOL as a treatment of adverse event. At the time of the report the patient's condition was not improved and she did not recover from the flu. The relatedness between the vaccination with GARDASIL and flu was not reported. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Colitis, Diarrhoea, Haematochezia
Clinical narrative: This spontaneous report as received from a physician refers to an infant patient of unknown age and gender. No medical history or drug reactions/allergies were reported. Approximately 2 months ago, in approximately June 2013, the patient was vaccinated with the second dose of ROTATEQ (lot# and dose not reported) oral. The physician reported that in approximately June 2013, after administering the second dose, the infant developed bloody stool and diarrhea and was diagnosed with colitis. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: Patient is a 69 year old female who presents for ER f/u. On 8/1/13, she was given the PNEUMOVAX vaccine in the left deltoid in this office. Within an hour or two of having received the shot, she developed swelling and pain in the area of the injection as well as red streaking distal to the injection site. Symptoms started to relieve with BENADRYL. In ER, she was in no respiratory distress and was given one PO dose of KEFLEX and Rx for KEFLEX for 5 days for prophylaxis, thought there was no cellulitis present at the time. She was advised to continue BENADRYL and discharged home. Symptoms have entirely resolved since that time. She continues the BENADRYL three times daily, and doesn't think she needs anymore ibuprofen. She has received vaccines and flu shots in the past with no problems. Is unsure if she had ever received a PNEUMOVAX prior to 8/1/13. She shows me a picture on her phone of what her left arm looked like after the injection it is noticeable red and swollen around the entire upper arm.
Age: 1.42
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Croup infectious
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 months old male patient. The mother of the patient reported to the nurse that the patient began wheezing on 29-JUL-2013. On 30-JUL-2013 the aptient was vaccinated with a doe of MMR II, subcutaneous injection (dose, site of administration were not reported) (lot # reported as H017433; exp. date unspecified). Other suspect therapies included a dose of VARIVAX (Merck) (indication, strength, dose, subcutaneously and site of administration were not reported) (lot # reported as J001181, exp date unspecified) administered on 30-JUL-2013. On 31-JUL-2013 the patient came back to the office and was diagnosed with a croup. The patient was prescribed oral steroid ORAPRED as a treatment. The outcome of croup was reported as not recovered. The relatedness between therapy with MMR II and VARIVAX (Merck) and croup was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous report as received from the mother of a patient of unknown age and gender. On 2009 the patient was vaccinated with GARDASIL dose 2 (dose, route, site and lot number not provided). 12 hours after receiving the vaccine, the patient became numb from neck to toes. Everything went away within a year and she blamed the numbness on the vaccine. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient's medical history was unknown. On 12-JUL-2013, the patient was vaccinated with ZOSTAVAX, to prevent shingles. The dose was 0.65 ml. No co-suspected or concomitant medications were reported. On 28-JUL-2013, the patient experienced hives. The patient called the physician and was instructed to come to the office for an evaluation on 29-JUL-2013. The physician prescribed the patient an unspecified corticosteroid to help manage the symptoms. The outcome of hives is unknown. The physician did not provide a causality assessment for ZOSTAVAX and the adverse event hives. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site warmth, Urticaria
Clinical narrative: 8-16-13 Vaccine administered at 2:30pm. 8-17-13 Patient seen in pharmacy presenting 2" welt, warmth and pain at injection site. Told to take BENADRYL and TYLENOL and use cool compresses at 4pm. 8-18-13 Patient presented with 2 welts on left arm, each about 3" in diameter with complaints of warmth and pain. Patient was sent to Urgent Care facility by pharmacist at 4pm. Patient received a SOLU-MEDROL injection at 4:30pm. 8-19-13 Patient was seen again at Urgent Care for another shot of SOLU-MEDROL and was given a prescription for prednisone 10 mg. Dr. at Urgent Care reported improvement at that time.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to a patient of unknown age and gender. On 06-AUG-2013, the patient was vaccinated with a dose of GARDASIL (lot# H021346, expiration date 01-OCT-2015) that underwent unsupported temperature excursions. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 12.0
Sex: U
Vaccine: PPV, TDAP
Symptoms: Wrong drug administered
Clinical narrative: MA was going in w/ Provider to assist w/ Biopsy. She shouted out both immunizations needed. I misheard her, she said meningococcal not pneumococcal Pneumococcal given. MOC notified. We will start verifying all immunizations. We usually do however MOC kept saying she was in a hurry to leave w/out double checking with another MA.
Sex: U
Vaccine: PPV, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Age: 80.0
Sex: F
Vaccine: PNC
Symptoms: Burning sensation, Chest discomfort, Dyspnoea, Erythema, Injection site erythema
Clinical narrative: Redness at injection site, spreading to upper arm and chest area - swelling, burning - shortness of breath and pressure in chest.
Age: 80.0
Sex: F
Vaccine: PNC
Symptoms: Swelling
Clinical narrative: Redness at injection site, spreading to upper arm and chest area - swelling, burning - shortness of breath and pressure in chest.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Thigh had a local reaction, red, warm. Swollen - approx 12cm by 10cm. Appt with a provider 2 days later. No treatment but to rest a few days.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: 8-19-2013 at 10:55 pt. comes with mother and report onset of rash on chest and back two days after Tdap vaccine (7-30-2013). Denies fever, malaise or itchiness. Rash noted on all back and upper chest. Recommend to see the doctor for eval.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 16 year old female patient. On 19-AUG-2013 the patient was vaccinated with RECOMBIVAX HB thimerosal status is not provided (dose 1, lot number 668558/894AA exp 17-MAY-2013; route and dosage unknown). The nurse reported that the patient received the first dose of RECOMBIVAX HB that was expired. No adverse event reported. This case is related to MARRS case no. 1308USA010053 (same reporter link; patient's sister). Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Diarrhoea, Dizziness, Erythema, Paraesthesia
Clinical narrative: Pt came in - she had a reaction on arm (red and itchy). She was dizzy, lightheaded, had diarrhea and tingling. Pt went to MD office and MD prescribed antibiotics and a cream.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Pt came in - she had a reaction on arm (red and itchy). She was dizzy, lightheaded, had diarrhea and tingling. Pt went to MD office and MD prescribed antibiotics and a cream.
Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: Bradycardia, Gaze palsy, Hyperhidrosis, Hypotension, Syncope
Clinical narrative: Fainting, hypotension, bradycardia, eyes rolled back and diaphoretic.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient became dizzy and lost consciousness for a period of less than 10 seconds approximately 10 minutes after receiving the HPV vaccine. Required no formal treatment.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: 8-19-13 seen in clinic by ARNP. Lump that is read and warm on left inner upper arm (injection site) 2 cm of light erythema, 5 cm of induration. Rx'd cephalexin.
Age: 13.0
Sex: M
Vaccine: HPV4, MMR, MNQ, TDAP, VARCEL
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Tdap given in (R) deltoid IM, five minutes after administering vaccine, area noted to have red rash, small amount swelling. No pain noted. Drs. was notified, BENADRYL 25 mg P.O. given. Temp 98.5 (Tympanic, Pulse 85, Resp 20). Child left office with father without further complaints.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Pt called 2 days after vaccine. 24 hours after vaccine, 4 fingers on arm that received vaccine went numb and are still numb. Advised pt to call PCP.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given shingles vaccine 8/19/13. She called clinic to report site symptoms - red, swollen, warm, tender - instructed pt to take BENADRYL, and to follow up if worsens or does not improve.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling/erythema right upper arm and elbow two days after receiving pneumonia vaccine in right deltoid.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Rash typical of varicella.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Erythema, Immediate post-injection reaction, Pyrexia, Urticaria
Clinical narrative: Right after injection patient developed red, raised, whelp. 1 hour after injection he began to run fever of 101.8. Mother brought him into ER. Was instructed to take BENADRYL and TYLENOL. He then developed diarrhea that lasted 8 hours.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest pain, Chills, Echocardiogram, Electrocardiogram change, Pyrexia
Clinical narrative: 1 week post administration, fever/chills, chest pain with EKG changes, and mildly positive troponins.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Troponin increased
Clinical narrative: 1 week post administration, fever/chills, chest pain with EKG changes, and mildly positive troponins.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest pain, Chills, Echocardiogram, Pyrexia, Troponin increased
Clinical narrative: 1 week post administration, fever/chills, chest pain with EKG changes, and mildly positive troponins.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease, Troponin I increased
Clinical narrative: 1 week post administration, fever/chills, chest pain with EKG changes, and mildly positive troponins.
Age: 0.21
Sex: M
Vaccine: RV5
Symptoms: Crying, Pallor, Respiratory arrest, Retching
Clinical narrative: When administering rotavirus vaccine, child appeared to gag for a second.  He then became pale and still, but still awake and alert and was not breathing.  He did not change color nor appear in distress at any time.  He slowly fell asleep, then started crying weakly and gradually recovered fully over approx. 5-10 minutes.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Lymphadenopathy
Clinical narrative: Redness that spread after receiving Smallpox vaccine in left arm.  Redness has continued to spread and was see by PCM on 26 Aug, and was told to report back if redness went outside the drawn circle. Pt reported back on 8/27/13 and redness had indeed gone outside the line.  Pt was walked into PCM for medication treatment.  Swollen lymph nodes in L arm.
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Exposure to communicable disease
Clinical narrative: 3 weeks ago, patient was around children that had the chicken pox.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Hot flush, Influenza like illness
Clinical narrative: Hot flashes and flu-like symptoms all day.  Felt like I had a fever.
Age: 59.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Drug administered at inappropriate site, Feeling abnormal, Inflammation, Injected limb mobility decreased, Injection site pain
Clinical narrative: I had 3 serial injections of rabies vaccine: on 7/16/13, 7/23/13, and 8/13/13. All were into left upper arm. The first two were uneventful. The third injection felt different- with the sensation that it was "spreading out" during the injection. I also noted that the bandaid over the sight was a bit higher and more anterior than usual. Beginning after the injection and over the next several days, instead of getting the usual deltoid tenderness, I had increasing pain over the anterior shoulder, and with abduction, anterior flexion, arc. Over the 2 weeks since the injection the pain has been increasing, and range-of-motion of my Left shoulder is decreasing. I was evaluated by orthopedic shoulder specialist's office. They think that the 8/13/13 vaccine injection probably went into my subacromial space, and is causing intense inflammation of my rotator cuff. Please note: I do not currently have information re brand/manufacturer. The clinic will have this.
Age: 59.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Injection site reaction
Clinical narrative: I had 3 serial injections of rabies vaccine: on 7/16/13, 7/23/13, and 8/13/13. All were into left upper arm. The first two were uneventful. The third injection felt different- with the sensation that it was "spreading out" during the injection. I also noted that the bandaid over the sight was a bit higher and more anterior than usual. Beginning after the injection and over the next several days, instead of getting the usual deltoid tenderness, I had increasing pain over the anterior shoulder, and with abduction, anterior flexion, arc. Over the 2 weeks since the injection the pain has been increasing, and range-of-motion of my Left shoulder is decreasing. I was evaluated by orthopedic shoulder specialist's office. They think that the 8/13/13 vaccine injection probably went into my subacromial space, and is causing intense inflammation of my rotator cuff. Please note: I do not currently have information re brand/manufacturer. The clinic will have this.
Age: 59.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Inflammation, Joint range of motion decreased, Musculoskeletal pain, Sensory disturbance
Clinical narrative: I had 3 serial injections of rabies vaccine: on 7/16/13, 7/23/13, and 8/13/13. All were into left upper arm. The first two were uneventful. The third injection felt different- with the sensation that it was "spreading out" during the injection. I also noted that the bandaid over the sight was a bit higher and more anterior than usual. Beginning after the injection and over the next several days, instead of getting the usual deltoid tenderness, I had increasing pain over the anterior shoulder, and with abduction, anterior flexion, arc. Over the 2 weeks since the injection the pain has been increasing, and range-of-motion of my Left shoulder is decreasing. I was evaluated by orthopedic shoulder specialist's office. They think that the 8/13/13 vaccine injection probably went into my subacromial space, and is causing intense inflammation of my rotator cuff. Please note: I do not currently have information re brand/manufacturer. The clinic will have this.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash vesicular
Clinical narrative: Onset of vesicular rash consistent with varicella, against which he was immunized 3 weeks before.
Age: 1.76
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Erythema, Swelling, Wheezing
Clinical narrative: Mother of child called, stating that child was playing outside with dad. Dad saw wasp swarming near child. Child began crying, but no evidence of sting was found. 45 minutes later, child began to have facial redness, swelling, shortness of breath, and wheezing. Mother questioned whether related to possible wasp sting or vaccine. I instructed her to follow-up with the emergency room immediately. Mom states at the ER, the MD stated symptoms were vaccine related. Treated with Benadryl, Tylenol, and Motrin and symptoms resolved.
Age: 60.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Asthenia, Fatigue, Influenza, Injection site discolouration, Pain
Clinical narrative: WEAK, TIRED, ACHY, HEAVY ARMS, FLU SYMPTOMS, BLACK AND BLUE ON SITE OF INJECTION.
Age: 60.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Sensation of heaviness
Clinical narrative: WEAK, TIRED, ACHY, HEAVY ARMS, FLU SYMPTOMS, BLACK AND BLUE ON SITE OF INJECTION.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Shingles vaccine given 8/20/13 - Itching and redness at site of shot, dermatologist applied Cloderm, redness enlarged that night and felt hot to touch.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Laboratory test, Pyrexia
Clinical narrative: ER f\up. Was seen on 8/22 at clinic, given routine TDaP. Pt was seen on 8/25 at facility for adverse reaction to vaccine. Records unavailable at time of visit. Right upper arm red, swollen and painful. Had fever up to 103 before being evaulated in the ER. Swelling is improving. No medications. Per pt report normal WBC in ER, no abx were indicated.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Vaccination complication, White blood cell count normal
Clinical narrative: ER f\up. Was seen on 8/22 at clinic, given routine TDaP. Pt was seen on 8/25 at facility for adverse reaction to vaccine. Records unavailable at time of visit. Right upper arm red, swollen and painful. Had fever up to 103 before being evaulated in the ER. Swelling is improving. No medications. Per pt report normal WBC in ER, no abx were indicated.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Axillary mass, Axillary pain, Erythema, Injection site pain, Lymphadenopathy
Clinical narrative: The first sign was a small swollen spot in my right armpit, the side of my body on which the vaccination was given. The spot was painful, and by the evening of that day, August 23rd, both the hard lump in my armpit and my entire right upper arm was painful and aching. The next day the aching in the arm subsided a bit, but the swelling in the armpit did not. On the third day, the pain was almost gone but there was a lot of redness under the armpit which had not been there before. On this same day, August 25th, I woke up with the same process beginning on the left side of my body. While my right side was experiencing very little pain, redness, or swelling, the left side had quite become swollen and painful overnight. The aching and pain in the left side was more contained the the shoulder and armpit region than it had been days before on the right side. The left side seems to have swollen up more around the spot of lymph node, so the hard nickel sized lump has been almost lost in the swollen flesh surrounding it. Today, August 27th, the right side has no swelling or pain surrounding the lymph node, but the node itself is still a hard lump in my armpit. The left pain and swelling on the left side has receded, and there is now redness on the node and the upper armpit that resembles what the right side looked like two days ago when the pain started subsiding. There is still some pain and considerable swelling on that side, however, in addition to the hard lymph node.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Oedema peripheral, Pain in extremity, Swelling
Clinical narrative: The first sign was a small swollen spot in my right armpit, the side of my body on which the vaccination was given. The spot was painful, and by the evening of that day, August 23rd, both the hard lump in my armpit and my entire right upper arm was painful and aching. The next day the aching in the arm subsided a bit, but the swelling in the armpit did not. On the third day, the pain was almost gone but there was a lot of redness under the armpit which had not been there before. On this same day, August 25th, I woke up with the same process beginning on the left side of my body. While my right side was experiencing very little pain, redness, or swelling, the left side had quite become swollen and painful overnight. The aching and pain in the left side was more contained the the shoulder and armpit region than it had been days before on the right side. The left side seems to have swollen up more around the spot of lymph node, so the hard nickel sized lump has been almost lost in the swollen flesh surrounding it. Today, August 27th, the right side has no swelling or pain surrounding the lymph node, but the node itself is still a hard lump in my armpit. The left pain and swelling on the left side has receded, and there is now redness on the node and the upper armpit that resembles what the right side looked like two days ago when the pain started subsiding. There is still some pain and considerable swelling on that side, however, in addition to the hard lymph node.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: 102 fever, very sore arm, achy.
Age: 1.01
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Blood glucose normal, Blood test normal, Chest X-ray normal, Convulsion, Full blood count normal
Clinical narrative: Pt developed a fever to 105 degree the evening of the vaccine.  Fever returned the next day and she had a seizure.  She was taken to the local ER.  Blood work and CXR negative.  Assumed reaction to vaccine.
Age: 1.01
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pyrexia
Clinical narrative: Pt developed a fever to 105 degree the evening of the vaccine.  Fever returned the next day and she had a seizure.  She was taken to the local ER.  Blood work and CXR negative.  Assumed reaction to vaccine.
Age: 12.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Headache
Clinical narrative: Headaches.
Age: 20.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 49.0
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Local swelling, Nausea, Oedema peripheral
Clinical narrative: She felt the injection hurt more than it should have but didn't think much of it.  Approximately 20 minutes after getting the vaccine and once she had left the clinic she began to have severe nausea and profuse vomiting.  She also had a headache.  Her arm was sore that evening and by the following day she had some localized swelling.  The headache persisted for several days. Yesterday her arm started to swell more and became extremely painful to the point where she felt she could hardly move her arm.  Symptoms continued on 08/14/13 so patient called for appointment.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Vomiting
Clinical narrative: She felt the injection hurt more than it should have but didn't think much of it.  Approximately 20 minutes after getting the vaccine and once she had left the clinic she began to have severe nausea and profuse vomiting.  She also had a headache.  Her arm was sore that evening and by the following day she had some localized swelling.  The headache persisted for several days. Yesterday her arm started to swell more and became extremely painful to the point where she felt she could hardly move her arm.  Symptoms continued on 08/14/13 so patient called for appointment.
Age: 8.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Stomach ache initially at 9 pm., vomited at 11:00 pm.  No treatment given.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to 2 unspecified patients of unknown demographics. On 15-AUG-2013, the two patients were vaccinated with a dose of GARDASIL (lot # J002641, expiration date 10-DEC-2015) that underwent unsupported temperature excursions. No adverse effects reported. This is one of 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 was received from an office manager refers to a patient of unknown age and gender. On 30-JUL-2013, the patient ws vaccinated with a dose of GARDASIL (lot # H021346, expiration date 01-OCT-2015) that underwent unsupported excursions. No adverse effects reported. This is one of 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 was received from an office manager refers to patient of unknown age and gender. On 14-AUG-2013, the patient was vaccinated with a dose of GARDASIL (lot#J002641, expiration date 10-DEC-2015) that underwent unsupported temperature excursions. No adverse effects reported. This is one of 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 was received from an office manager refers to 2 unspecified patients of unknown demographics. On 13-AUG-2013, the two patients were vaccinated with a dose of GARDASIL (lot#J002641, expiration date 10-DEC-2015) that underwent unsupported temperature excursions. No adverse effects reported. This is one of 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 was received from an office manager refers to a patient of unknown age and gender. On 31-JUL-2013, the patient was vaccinated with a dose of GARDASIL (lot # H021346, expiration date 01-OCT-2015) that underwent unsupported temperature excursions. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 16 year old female patient. On 19-AUG-2013 the patient was vaccinated with RECOMBIVAX HB thimerosal status is not provided (dose 1, lot number 668558/0894AA exp 17-MAY-2013; route and dosage unknown). The nurse reported that the patient received the first dose of RECOMBIVAX HB that was expired. No adverse event reported. This case is related to MARRS case no 1308USA012700 (same reporter link; patient's brother). Additional information is not expected.
Sex: F
Vaccine: PPV, PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to a female patient of unknown age who on 22-AUG-2013, was vaccinated with an expired dose of PNEUMOVAX23 (lot # 672370/1851AA, expiration date, 05-AUG-2013) 0.5 ml, intramuscular. No adverse event reported. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Attention deficit/hyperactivity disorder, Convulsion, Expired drug administered, Gastrooesophageal reflux disease, Hemiparesis
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to a female patient of unknown age who on 22-AUG-2013, was vaccinated with an expired dose of PNEUMOVAX23 (lot # 672370/1851AA, expiration date, 05-AUG-2013) 0.5 ml, intramuscular. No adverse event reported. Additional information has been requested.