chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Ultrasound antenatal screen
Clinical narrative: Information has been received from a pharmacist, a Pregnancy Registry product, concerning a 25 year old female patient with no pertinent medical history, no drug reactions/allergies who on 19-AUG-2011 was vaccinated with GARDASIL (Lot # 668262/0841AA, Exp 08-APR-2013). There was no concomitant medication. The pharmacist reported that the patient received the first 0.5 ml dose of vaccine and after the injection was administered the office did urine for pregnancy test the same day. She was positive for pregnancy. The urine pregnancy test was followed by a blood test for pregnancy. No date available. Also 2 ultrasound for pregnancy were performed. The patient's last menstrual period was on 28-JUL-2011. The estimated delivery date was on 03-MAY-2012. Follow up information as received from the physician refers to the patient whose estimated delivery date (EDD) was 08-MAY-2012 (previously reported as 03-MAY-2012). The reporter stated that the patient did not continue her case with the reporter. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 19-FEB-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # J000492, expiration 19-JAN-2014, 0.65 ml once, subcutaneous for shingles prevention. The pharmacist states the date was noted to be past expiration. An unspecified staff from the office providing the vaccination reported to pharmacist on 21-FEB-2014 about expiration date. No adverse effects were reported. The patient did not seek medical attention. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia, Pain, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to an 80 year old female patient with drug reactions/allergies, but details not specified. The patient stated that she had shingles 10 times before having had the ZOSTAVAX vaccine. In 2008 (reported as "about a year ago" at the time of report) the patient experienced a light case of shingles. On 12-FEB-2014 (reported as "about a week ago" at the time of report) the patient experienced another case of shingles that was severe and included a rash with blisters and pain. Patient explained that she had been given unspecified pain medication and nerve medication for her shingles associated nerve pain. patient also stated that she had been prescribed FAMVIR antiviral to be taken as soon as she feels pain. Patient had taken the FAMVIR for 8 days. The outcome of the events was unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. None relevant history, including preexisting medical conditions was reported. Concomitant medications and past drug history was unknown. On 31-JAN-2014 the patient was vaccinated with ZOSTAVAX (single dose, into right arm, once, lot # J011339, exp. date: 13-DEC-2014, route of administration not reported). On 01-FEB-2014 the patient noticed an injection site reaction. On 02-FEB-2014, she went to the pharmacy to show the pharmacist. The reaction site was about 4 inches on the right arm, it was warm/hot to the touch, pink and red and has 2 blisters. The patient reported it kept looking like it got better and then came back. The patient used some hydrocortisone cream on it but did not call her doctor. It was reported that it was unknown if the patient will ever have the ZOSTAVAX again. The relatedness between ZOSTAVAX and events was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. None relevant history, including preexisting medical conditions was reported. Concomitant medications and past drug history was unknown. On 31-JAN-2014 the patient was vaccinated with ZOSTAVAX (single dose, into right arm, once, lot # J011339, exp. date: 13-DEC-2014, route of administration not reported). On 01-FEB-2014 the patient noticed an injection site reaction. On 02-FEB-2014, she went to the pharmacy to show the pharmacist. The reaction site was about 4 inches on the right arm, it was warm/hot to the touch, pink and red and has 2 blisters. The patient reported it kept looking like it got better and then came back. The patient used some hydrocortisone cream on it but did not call her doctor. It was reported that it was unknown if the patient will ever have the ZOSTAVAX again. The relatedness between ZOSTAVAX and events was not reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chest X-ray normal, Chills, Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: Non-congestive cough not significantly relieved by medication Dec 1, 2012 2 weeks. Mar 18, 2013 Went to Dr, ZPAK, cheratussin AC syrup. 7-29-2013 Went to Dr. 8-8-13 Hydrocodone/chlorophen ER and cephalexin - 8-16-13 back to Dr - benzonatate capsules, hydrocodone-acetamino. Nov 11, 2013 and Dec 2, 2013 no temp didn't go to Dr. Before Dec. 2012 I very seldom had problems with a cough. I was given the Tdap vaccine on 8-21-2012. A year later when I had my physical Aug 21, 2013 I was still having the worst experience I have ever had with a respiratory infection which started on July 29, 2013 and lasted several more weeks. This was the 3rd one and the worst. In reviewing the paperwork given to me at my exam, I saw that Tdap vaccine was not approved for those over 65. I was 71 when I got mine. Being concerned that this may have caused my problems, I wrote a letter to Dr. about my concerns. After several weeks she sent me a letter I have included. I made an appointment to go in and talk with her. She assured me she would refer my case to you that day. On my 6 month follow up 2-24-2014, she admitted that she had not done so. Her thinking was that it was not necessary and complained about the amount of paperwork it would generate. I have therefore tried to do it myself. It is important to me. Thank you for your help. If you think this is useless to pursue let me know.
Age: 71.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Rhinitis
Clinical narrative: Non-congestive cough not significantly relieved by medication Dec 1, 2012 2 weeks. Mar 18, 2013 Went to Dr, ZPAK, cheratussin AC syrup. 7-29-2013 Went to Dr. 8-8-13 Hydrocodone/chlorophen ER and cephalexin - 8-16-13 back to Dr - benzonatate capsules, hydrocodone-acetamino. Nov 11, 2013 and Dec 2, 2013 no temp didn't go to Dr. Before Dec. 2012 I very seldom had problems with a cough. I was given the Tdap vaccine on 8-21-2012. A year later when I had my physical Aug 21, 2013 I was still having the worst experience I have ever had with a respiratory infection which started on July 29, 2013 and lasted several more weeks. This was the 3rd one and the worst. In reviewing the paperwork given to me at my exam, I saw that Tdap vaccine was not approved for those over 65. I was 71 when I got mine. Being concerned that this may have caused my problems, I wrote a letter to Dr. about my concerns. After several weeks she sent me a letter I have included. I made an appointment to go in and talk with her. She assured me she would refer my case to you that day. On my 6 month follow up 2-24-2014, she admitted that she had not done so. Her thinking was that it was not necessary and complained about the amount of paperwork it would generate. I have therefore tried to do it myself. It is important to me. Thank you for your help. If you think this is useless to pursue let me know.
Age: 71.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Cough, Drug administered to patient of inappropriate age, Respiratory tract infection
Clinical narrative: Non-congestive cough not significantly relieved by medication Dec 1, 2012 2 weeks. Mar 18, 2013 Went to Dr, ZPAK, cheratussin AC syrup. 7-29-2013 Went to Dr. 8-8-13 Hydrocodone/chlorophen ER and cephalexin - 8-16-13 back to Dr - benzonatate capsules, hydrocodone-acetamino. Nov 11, 2013 and Dec 2, 2013 no temp didn't go to Dr. Before Dec. 2012 I very seldom had problems with a cough. I was given the Tdap vaccine on 8-21-2012. A year later when I had my physical Aug 21, 2013 I was still having the worst experience I have ever had with a respiratory infection which started on July 29, 2013 and lasted several more weeks. This was the 3rd one and the worst. In reviewing the paperwork given to me at my exam, I saw that Tdap vaccine was not approved for those over 65. I was 71 when I got mine. Being concerned that this may have caused my problems, I wrote a letter to Dr. about my concerns. After several weeks she sent me a letter I have included. I made an appointment to go in and talk with her. She assured me she would refer my case to you that day. On my 6 month follow up 2-24-2014, she admitted that she had not done so. Her thinking was that it was not necessary and complained about the amount of paperwork it would generate. I have therefore tried to do it myself. It is important to me. Thank you for your help. If you think this is useless to pursue let me know.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Electroencephalogram normal, Epilepsy, Nuclear magnetic resonance imaging normal
Clinical narrative: Seizures, epilepsy. I'm now on Lemotrigine. One tablet twice a day.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Allergic colitis, Diarrhoea, Faeces discoloured, Gastroenteritis, Haematochezia
Clinical narrative: This spontaneous report was received from a physician's assistant, who is also the patient's mother, concerning a 4 month old female patient. No pertinent medical history, drug reactions or allergies were reported. On 23-AUG-2013 the patient was vaccinated with the first dose of ROTATEQ, oral, (strength, lot number and expiration date were not reported). It was reported that the patient did not have any reaction to the first dose; however in between the first dose and the second dose of ROTATEQ, on an unknown date in 2013 the patient experienced blood in the stool and was diagnosed with milk and soy protein intolerance. On 01-NOV-2013 the patient was vaccinated with ROTATEQ dose 2, oral (strength, lot number and expiration date were not reported). No concomitant medications were reported. On 02-NOV-2013, the patient experienced 12 episodes of green frothy diarrhea and some blood in stool (hospitalization) and was hospitalised from 12-NOV-2013 to 14-NOV-2013. Patient was diagnosed with gastroenteritis (hospitalization) and was treated with intravenous fluids and observation. Upon follow up with an unspecified gastroenterologist on an unknown date, the patient was diagnosed with allergic colitis (hospitalization). The patient had sought medical attention by hospitalisation. It was unknown whether any lab diagnostic studies were performed. There was no product quality complaint involved. The patient did not receive the six month dose of ROTATEQ. The outcome of gastroenteritis, milk and soy protein intolerance, experienced blood in stool, experienced 12 episodes of green frothy diarrhea and some blood in stool and allergic colitis were unknown. The causality of the events were not provided. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Incomplete course of vaccination
Clinical narrative: This spontaneous report was received from a physician's assistant, who is also the patient's mother, concerning a 4 month old female patient. No pertinent medical history, drug reactions or allergies were reported. On 23-AUG-2013 the patient was vaccinated with the first dose of ROTATEQ, oral, (strength, lot number and expiration date were not reported). It was reported that the patient did not have any reaction to the first dose; however in between the first dose and the second dose of ROTATEQ, on an unknown date in 2013 the patient experienced blood in the stool and was diagnosed with milk and soy protein intolerance. On 01-NOV-2013 the patient was vaccinated with ROTATEQ dose 2, oral (strength, lot number and expiration date were not reported). No concomitant medications were reported. On 02-NOV-2013, the patient experienced 12 episodes of green frothy diarrhea and some blood in stool (hospitalization) and was hospitalised from 12-NOV-2013 to 14-NOV-2013. Patient was diagnosed with gastroenteritis (hospitalization) and was treated with intravenous fluids and observation. Upon follow up with an unspecified gastroenterologist on an unknown date, the patient was diagnosed with allergic colitis (hospitalization). The patient had sought medical attention by hospitalisation. It was unknown whether any lab diagnostic studies were performed. There was no product quality complaint involved. The patient did not receive the six month dose of ROTATEQ. The outcome of gastroenteritis, milk and soy protein intolerance, experienced blood in stool, experienced 12 episodes of green frothy diarrhea and some blood in stool and allergic colitis were unknown. The causality of the events were not provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Malaise, Throat tightness
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 17 year old female patient with BACTRIM allergy. The patient received dose one of the GARDASIL injection series about four months ago (in approximately October 2013) (lot #, expiry date, dose and route unknown). Concomitant therapies included amitriptyline (manufacturer unknown) and CARAFATE. The nurse reported that since revealing the GARDASIL, the patient had not felt very well-explained as having a feeling that a hand was around her throat. The nurse reported that because of this sensation, the patient had visited the Ear, Nose and Throat doctor. Patient had CT (computerized tomogram) scans of the area and results were negative. No treatment was given for the event. The patient was not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster
Clinical narrative: This spontaneous report as received from a treating physician via a company representative refers to a female patient in her 70's (years). In February 2010 (3-4 years ago), the patient was vaccinated with a dose of ZOSTAVAX, (lot#, dose and route not reported). In February 2010 (3-4 years ago), the patient developed shingles on her head after receiving ZOSTAVAX and also developed a headache that lasted for about 4-5 days. The outcome of the events was unknown. The patient had sought medical attention by office visit. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous pregnancy report as received from a consumer who called to report her daughter, a 15 years old female patient. The patient's history of previous pregnancies and live births is not known. Patient had no pertinent medical history and no drug reactions/allergies. On an unknown date within 6 months (estimated as June 2012), the patient was vaccinated with GARDASIL (lot#, dose and route unspecified), and patient got her last injection on 04-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 05-DEC-2012 the patient got pregnant during her GARDASIL regime. The LMP and EDD is not known. Initial exposure to GARDASIL was at 0 week(s) (reported as Pregnant Gestation: 1 Trimester). No treatment information was reported and no lab diagnostics studies performed. The outcome of the event was unknown. Patient sought medical attention: called physician. No further information is available. Follow up information as received from the physician who reported that the baby was born full term and was normal and healthy with no anomalies. Additional information is not expected.
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. The pharmacist reported that the patient was inadvertently administered with an expired dose of M-M-R II. On 19-FEB-2014 the patient was vaccinated with M-M-R II (lot # 1896AA, albumin status HSA) subcutaneously, while the expiration date was 02-DEC-2013. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old infant patient. Drug allergies, reactions and medical history were not reported. On 19-DEC-2013 the patient was vaccinated with an expired ROTATEQ (oral, lot # H010052, expiration date 02-NOV-2013, dose 2 ml). No concomitant medications were reported. No adverse effect were reported. This case is linked to the same reporter cases MARRS 1402USA013045, 1402USA013519 and 1402USA013520. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a healthcare worker refers to 3 patients of unknown demography. On an unknown date, the 3 patients were vaccinated with PNEUMOVAX 23 lot # J006921 (Expiry: 09-AUG-2014), 0.5 ml, intramuscular. It was reported that the three patients have received PNEUMOVAX 23 for the first time. On an unknown date after 2 to 3 hours after vaccination with PNEUMOVAX 23, the three patients experienced severe redness and swelling of their arms at the injection site. The three patients sought medical attention. The outcome of the events severe redness and swelling of their arms at the injection site was unknown. The reporter did not provide the causality between the event and the suspect drug. This case is linked to case 1403USA001356 (same reporter link). Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 month old infant patient. Drug allergies, reactions or medical history were not reported. On 26-FEB-2014, the patient received two doses of oral ROTATEQ. One expired dose of 2 ml of oral ROTATEQ (oral, lot # H010052, expiration date 02-NOV-2013) and one doe of 2 ml of oral ROTATEQ (lot #, expiration date and not reported) that was not expired. No concomitant medications were reported. No adverse effect reported. This case is linked to the same reporter cases MARRS # 1402USA013518, 1402USA013519 and 1402USA013520. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old infant patient. Drug allergies, reactions and medical history were not reported. On 11-DEC-2013 the patient was vaccinated with ROTATEQ (oral, lot # H010052, expiration date 02-NOV-2013, dose 2 ml). No concomitant medications were reported. No adverse effect was reported. This case is linked to the same reporter cases: MARRS 1402USA013045, 1402USA013518 and 1402USA013519. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema
Clinical narrative: C/o 2 red areas around injection site of hep B vaccine. Enc to seek care or ER or MD if needed. Enc to RTC to let RN evaluate arm. Pt did not return. Pt called arm ok 2/28/14.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old infant patient. Drug allergies, reactions and medical history were not reported. On 09-DEC-2013 the patient was vaccinated with expired ROTATEQ (oral, lot # H010052, expiration date 02-NOV-2013, dose 2 ml). No concomitant medications were reported. No adverse effect was reported. This case is linked to the same reporter cases: MARRS 1402USA013045, 1402USA013518 and 1402USA012520. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and frequency were not reported). On an unknown date, the patient experienced redness and swelling of the arm at the injection site after receiving PNEUMOVAX 23. The outcome of the events redness and swelling of the arm at the injection site was unknown. The reporter did not provide the causality between the events and th suspect drug. This case is linked to the case 1402USA012785 (same reporter link). Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Erythema, warmth, edema with (Left upper arm) pruritis at site of injection approx 6 x 5 in. No systemic symptoms.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy, concerning a female customer (age not reported) who on an unspecified date was vaccinated with a flu vaccine (manufacturer unspecified) and "your company's" PNEUMOVAX23 and had an adverse reaction. (The date of vaccinations was not specified). The "date of loss" was reported as 29JAN2014. No details were provided. Treatment and outcome of adverse reaction was unknown. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 year old male patient with no medical history, drug reactions or allergies. The reporter is the mother of the patient. On 18-FEB-2014 the patient was vaccinated intramuscularly with the first dose of GARDASIL (dose, lot number and expiration date not reported). No concomitant medications were reported. On 20-FEB-2014 the reporter stated that her son's axillary lymph node became extremely swollen and measured 3 inches long and 2 and 3/4 inches wide. There was no lab diagnostic studies performed. There was no treatment given for the event. The patient sought medical attention by the office visit. The outcome of the event was reported as recovering. The relatedness between the event and suspect product was not reported. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unspecified dates, the patient may have been vaccinated with a dose of MMR II (dose, route, lot and expiration date were not provided) that was improperly stored. No adverse effect reported. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 month old patient (gender not reported). Medical history, drug reactions or allergies were not reported. On an unknown date, when the patient was "15 months old", the patient was vaccinated with a first dose of VAQTA (LOT #, BATCH #, dose, expiration date, concentration and route of administration was not reported) and when the patient was "18 months old", he/she received the second dose of VAQTA (LOT #, BATCH #, dose, expiration date, concentration and route of administration was not reported). The reporter stated that there was no adverse effect. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 29 year old female who on 03-SEP-2010 was vaccinated with the first dose of GARDASIL (therapy route and lot # not provided). On 09-MAY-2011 the patient was vaccinated with the second dose of GARDASIL (therapy route and lot # not provided). On 29-MAY-2011 patient had a positive urine pregnancy test. Patient's last menstrual period (LMP) and estimated delivery date (EDD) were not provided. The patient was tested on 05/09/2011 also and at that time the test results were negative. There were no adverse events reported. It was unspecified if patient sought medical attention. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a consumer reporting herself, a 63 year old female patient with penicillin allergy, allergy to DURICEF and allergy to DIFLUCAN. The patient's medical history included stage four breast cancer and three prior cases of shingles. Approximately in November 2013, reported as three months ago, the patient was vaccinated with ZOSTAVAX (strength, lot number and expiration date were not reported)(dose reported as one injection). Concomitant therapies included LYRICA, exemestane, CYMBALTA, Bupropion hydrochloride and OXYCONTIN. On 14-FEB-2014, the patient reported that after administration of ZOSTAVAX, she experienced "a rash that is sensitive to the touch". The patient stated "the rash looks like it could be shingles". At the time of the report he outcome was unknown. The patient did not received any treatment or seek medical attention for these events. Also she did not performed any lab studies. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a physician for VARIVAX (Merck) and GARDASIL, two Pregnancy Registry products concerning a 32 year old female patient, who on unknown date was vaccinated with a dose of VARIVAX (Merck) (lot # 671030/1064AA, Expiration date 05-JUL-2013) (dose and route not reported). Secondary suspect therapy included GARDASIL (lot # 0121AE, Expiration date 29-SEP-2014) (dose and route not reported) and hepatitis A vaccine (manufacturer unspecified) (lot # AHAVB406AA, Expiration date 10-SEP-2012) (dose and route not reported) on the same day. It was reported that the patient was vaccinated while she was 13 weeks pregnant. It was reported that the patient's last menstrual period was on 25-FEB-2012 an estimated delivery date is 01-DEC-2012. No adverse events reported. The patient sought unspecified medical attention. Follow up information was received from the physician indicating that the patient's pregnancy outcome was a normal infant with no congenital anomaly (date unknown). Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender, whose age was reported as less than 50 years. Drug reactions, allergies or medical history were not reported. On 24-FEB-2014 the patient received ZOSTAVAX (dos, route and lot # were not reported) instead of VARIVAX (Merck). No adverse symptoms reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Pt had meningococcal vaccine yesterday at well visit, broke out in hives last night.  Had welts covering him from his head/hairline, down his torso, and on his arms.  Mom called nurse on call and was told to give Benadryl.  Seemed to help a little, this morning still had the hives.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Feeling abnormal, Induration, Local swelling, Muscle twitching, Pain
Clinical narrative: Fever, twitching/vibrating legs, very out of it/spacey, site was sore and hard bump. Gave Tylenol.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Pyrexia
Clinical narrative: Fever, twitching/vibrating legs, very out of it/spacey, site was sore and hard bump. Gave Tylenol.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Urticaria
Clinical narrative: CHILD NOTICED SMALL RED BUMPS EARLIER BY 10P MOM STATES CHILD COVERED IN HIVES.  MOM CONTACTED PCP AND WAS TOLD TO GIVE CHILD HER ALLERGY MEDICINE, BY MORNING HIVES WERE GONE.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Enema administration, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Intussusception diagnosed by ultrasound reduced by air enema October 9th, 2013. Observed overnight, discharged home in good condition October 10th, 2013.
Age: 52.0
Sex: F
Vaccine: FLUC3, PPV, TDAP, FLUC3, PPV, TDAP
Symptoms: Deafness, Feeling abnormal, Hypoaesthesia, Pain in extremity
Clinical narrative: Patient reports loss of hearing, head numb, left arm pain and felt awful.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Patient had pain and swelling up to twice the normal size in the lower half of her left arm.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Adnexa uteri pain, Fungal infection, Increased appetite, Pregnancy test positive, Smear cervix
Clinical narrative: Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning her 16 year old daughter with no known drug reactions/allergies and a history of bladder infection who on 17-AUG-2011 and 20-JAN-2012 was vaccinated with her two doses of GARDASIL (lot # not reported) respectively. There was no concomitant medication. The patient had a yeast infection and pain in her ovaries. Her acne on her face cleared up and her appetite increased. On 23-APR-2012 a pregnancy test was performed. In January 2012, Pap smear was performed. The patient was found pregnant. The patient had called the nurse. The patient's LMP (last menstrual period) was 14-OCt-2011 and EDD (estimated date of delivery) was 20-JUL-2012. At the time of the report, outcome of the patient was unknown. Follow up information has been received from the nurse practitioner's receptionist who stated that on 23-APR-2012, the patient was given a pregnancy test. The patient was not seen back in the office until 20-JUN-2013 due to vaginal spotting and vaginal discharge. There was no information available about the outcome of the pregnancy in the patient's chart. The patient's vaginal spotting and vaginal discharge outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Therapeutic response unexpected, Vaginal discharge, Vaginal haemorrhage
Clinical narrative: Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning her 16 year old daughter with no known drug reactions/allergies and a history of bladder infection who on 17-AUG-2011 and 20-JAN-2012 was vaccinated with her two doses of GARDASIL (lot # not reported) respectively. There was no concomitant medication. The patient had a yeast infection and pain in her ovaries. Her acne on her face cleared up and her appetite increased. On 23-APR-2012 a pregnancy test was performed. In January 2012, Pap smear was performed. The patient was found pregnant. The patient had called the nurse. The patient's LMP (last menstrual period) was 14-OCt-2011 and EDD (estimated date of delivery) was 20-JUL-2012. At the time of the report, outcome of the patient was unknown. Follow up information has been received from the nurse practitioner's receptionist who stated that on 23-APR-2012, the patient was given a pregnancy test. The patient was not seen back in the office until 20-JUN-2013 due to vaginal spotting and vaginal discharge. There was no information available about the outcome of the pregnancy in the patient's chart. The patient's vaginal spotting and vaginal discharge outcome was unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Vaccination site papule, Vaccination site pruritus
Clinical narrative: Localized redness and papule with pruritus at site of vaccine only. No fever or other rash - papule developed 14 days after vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Patient developed pain at injection site day after administration. She removed band aid 2 days later and stated area dark in color and "itchy". Pain subsided in 3 days but area remained dark and small "bumps" appeared and disappeared on and off for 3 months, dark area remained at all times. Went to PCP in Dec but didn't show him. Called office 2/3/14 to report symptoms. Given methylprednisone pack and OTC antifungal cream to use for 10 days. Instructed to f/u with her dermatologist if symptoms persist. F/u 2/24/14 area better but still present. Instructed to f/u with her dermatologist.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Limb discomfort, Local swelling, Pyrexia, Throat irritation
Clinical narrative: Entire upper arm swollen, red, sore, fever and red throat. Last year had a similar reaction but much less severe. The spot where the shot was given was only about the size of an orange. This year my entire upper arm was affected. 2 doctors have told me not to get the flu shot next year. The reaction lasted about 5 days. I had the senior dose.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Hospitalized for Guillain-Barre syndrome on Dec. 4, 2013, for 9 days. Treated with intravenous steroids. In nursing home (for rehab therapy) for 5 weeks. Currently doing home physical and occupational therapy.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Convulsion, Dysarthria
Clinical narrative: Received quad vaccine - influenza/pneumococcal shingle/whooping cough on 1/31/14 - 4:00 PM. Admitted to hospital 11:00 AM. Symptom - confused/slurry speech/200+ blood pressure - originally thought being a stroke - re-evaluated as brain seizure.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 07-FEB-2014, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot and expiration were not reported). Co-suspect and concomitant therapies were not reported. On 19-FEB-2014, the patient was given a prescription for methotrexate (manufacturer unknown) for an unspecified condition, started in approximately February 2014. At the time of the report outcome was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Vaccination site swelling
Clinical narrative: (L) posterior arm reddened, swollen at site of vaccine. T-100. Dx: cellulitis, treated with cephalexin.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Bursitis, Musculoskeletal pain, Pain
Clinical narrative: Very painful at time of injection and I commented to my dad very high on shoulder and painful. Unusual pain for wks got some better with ADVIL - but pain continued. I endured it for months but will not heal. I went to my family doc. and later to therapy - I'm currently on 2nd rehab trip. First I experienced pain at the time of the injection, which I have never experienced before and I also noticed how high the shot was given in my shoulder. I have experienced some soreness after previous flu shots but it usually lasts a short period of time. This time my shoulder was very sore and it hurt to raise my arm so I started taking ADVIL and it would get some better until I use it and then it will get worse for weeks. After months of this cycle I visited my family doctor I told him I did not know how I hurt my shoulder I mentioned I had a flu shot in that arm and he dismissed that thought and I agreed that sounded odd. He did a standard x-ray and said the thought I had fluid issues related to my bursa and bursitis. He prescribed CELEBREX which I took for a while but it bothers my stomach so I stopped taking it. He also later agreed that physical therapy may help so I completed my first session and saw some improvement. So now I am going to my second session with little improvement. Looking back I am sure my problem is related to my flu shot and I fear I will need surgery and not be able to work for an extended period of time. I went to the pharmacy by my home where I received the shot to make this report and the nurse said she had never filled out an Adverse Reaction Form and she called her supervisor in my presence and they agreed to call me but as of today they have not.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No reaction noted. Accidentally administered KINRIX when DTaP was required. DTaP was meant to be given.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash beginning near injection site and spreading up ipsilateral side vaccine administer 2/6/14; rash began 2/7/14.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Morning after vaccine, pt noticed hard, red rash at injection site. As day went on, rash became very itchy and painful. Pt tried hydrocortisone cream to help itch.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Measles antibody positive, Mumps antibody test, Pyrexia, Rash generalised
Clinical narrative: Symptoms began 10 days after vaccination and lasted 5 days: Fever > 102; chills, rigor, rash, all over.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: Symptoms began 10 days after vaccination and lasted 5 days: Fever > 102; chills, rigor, rash, all over.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: Day after vaccination patient went to ER with a rash at injection site that turned out to be cellulitis.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Local swelling
Clinical narrative: (L) arm swelling.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Rash developed in red spots on chest area noticed signs on body on 12-30-2013 until now. January 2014 notice of pain in my wrist area both wrist and elbow area. Went to the doctor on or about January 3, 2014 put on cream and methylprednisolone. Rash developed on stomach area and arm started 2-1-2014. Rash is continue over body. Due to see my doctor and continue on cream prescribed.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Flushing, Injection site urticaria, Leukocytoclastic vasculitis, Urticaria
Clinical narrative: MD called into room within a few minutes after vaccines given. Child had developed 2 urticarial lesions. Wheal and flare. One on each thigh. Urticaria corresponded to Varicella on (L) thigh and MMR on (R) thigh. Child also had flushing on cheeks. No breathing difficulty. Lungs clear. 10mg BENADRYL given. Reaction resolved.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hypotonic-hyporesponsive episode
Clinical narrative: Hypotonic - hyporesponsive episode likely due to pertussis immunization.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase, Paraesthesia, Paraesthesia oral, Transaminases
Clinical narrative: Tingling arms and legs.
Age: 25.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Pt. developed soreness from legs - lower extremities to upper extremities and weakness on 12/30/13 and 12/31/13. On 1/2/14 pt. flown to hospital.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old female patient with drug reaction/allergies to opioids/morphine and penicillin. There was no other pertinent medical history. On 21-NOV-2013, the patient was vaccinated with ZOSTAVAX. Dose, route, lot number and expiration date were not reported. Other suspect therapies included PNEUMOVAX 23. The pharmacist was not sure when the patient received PNEUMOVAX 23 because the patient did not receive PNEUMOVAX 23 in her pharmacy (approximately in 2013). Dose, route, lot number and expiration date were not reported. There was no concomitant medication. Approximately in 2013 the patient developed pain, redness and swelling around the injection sites after receiving both ZOSTAVAX and PNEUMOVAX 23. The pharmacist stated the patient mentioned her symptoms lasted for 6 weeks (stop date 02-JAN-2014) following the administration of ZOSTAVAX. The causality was not reported. Lab diagnostic studies were not performed. The patient sought medical attention, contacted pharmacist. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Injection site reaction, Skin lesion
Clinical narrative: Suspicous cluster of skin lesions right near vaccine site.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Severe muscular pain. Unable to move or use arm for 2 weeks, then most pain resided but soreness lingered until today. Today is over 8 weeks post-immunization and the more severe pain is returning. This is also happening with my mother and my sister, whom received vaccination at same place and time.
Age: 25.0
Sex: M
Vaccine: YF
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: Felt like scratch, swelling and hot where vaccination was administered. The next day the patient felt more swelling and heat at the location and it was vissible red.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Unsightly rash beside my nose down past my mouth on the right cheek, under the left eye, above both eyes, dotted across forehead. It did not itch or burn but looked like a burn scar, humped up. Treated with Benadryl Cream. Lasted 3 weeks.
Age: 0.35
Sex: F
Vaccine: DTAPH
Symptoms: Crying
Clinical narrative: Cried inconsolably for hours after 4:30 none of her usual tricks worked.
Age: 63.0
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Began vomiting and continued doing so until 5:45PM that day (16 hrs). Incidents were every 15 minutes, then tapered off to every half hour, then 45 minutes until stopping. Had very real concerns about becoming dehydrated, but was unable to get myself to the ED or Urgent Care Center for treatment.
Age: 54.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Fatigue, Influenza like illness, Malaise, Pruritus, Rash generalised
Clinical narrative: WORKER STATED SHE STARTED ITCHING IN THE SHOWER AND NOTICED SMALL PINK DOTS ON HER CHEST, UPPER BACK, AND ARMS. AS THE DAY PROGRESSED, THE RASH SPREAD TO HER ENTIRE BODY. THE FOLLOWING DAY SHE STATED THAT SHE DEVELOPED FLU LIKE FATIGUE AND JUST DIDN'T FEEL WELL. THIS REPORT WAS FILED ON DAY 2.
Age: 54.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Skin discolouration
Clinical narrative: WORKER STATED SHE STARTED ITCHING IN THE SHOWER AND NOTICED SMALL PINK DOTS ON HER CHEST, UPPER BACK, AND ARMS. AS THE DAY PROGRESSED, THE RASH SPREAD TO HER ENTIRE BODY. THE FOLLOWING DAY SHE STATED THAT SHE DEVELOPED FLU LIKE FATIGUE AND JUST DIDN'T FEEL WELL. THIS REPORT WAS FILED ON DAY 2.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal discomfort, Musculoskeletal pain
Clinical narrative: (L) shoulder soreness and pain. MD visit. Prescribed ALEVE.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Pain, Tenderness
Clinical narrative: Sore, tender and ache (L) arm until present. Went to MD x 2 weeks later and was prescribed Rx.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Soreness in right arm. States had to do some lifting and movements. Hurts to do push ups.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort
Clinical narrative: Sore when lifting arm x 5 days - painful. Saw MD, prescribed TORADOL and naproxen. Had PT x 3 wks.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Shoulder and upper arm stiff. Pain decreased after two weeks.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age who on an unknown dates, were vaccinated subcutaneously with a doses of ZOSTAVAX (dose and lot numbers not reported). On an unknown date ,the patients were diagnosed with shingles after being vaccinated with ZOSTAVAX. At the time of the report, the patient's outcome was unknown. The relatedness for shingles and ZOSTAVAX was unknown. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Immunization given on 2/25/14, c/o pain in right thigh 2/26/14, warm and indurated on 2/27/14. Was seen in the office on 2/28/14. Rt thigh with 7x7 cm area of erythema and induration around the injection site. Antibiotics were used for pain.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse regarding an unspecified co-worker of an unknown age and gender who had a diagnosis of breast cancer and was receiving chemotherapy. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose and lot number were not provided). On an unknown date, the patient contracted the shingles shortly after preparing and administering the ZOSTAVAX. VZVID Packet not offered as this took place years ago.  At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient from an unspecified nursing home. (No patient demographics provided). On 24-FEB-2014, patient was vaccinated with a dose of PNEUMOVAX 23, injection (Lot: H010916; Exp. Date: 15-FEB-2014) (Dose, route and strength not provided). Co-suspect or concomitant therapies were not reported. The pharmacist reported the patient that was vaccinated with an expired PNEUMOVAX 23 vaccine. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: FLU3, MMRV
Symptoms: Injection site erythema, Injection site vesicles, Vaccination site rash, Varicella post vaccine
Clinical narrative: Rash around vaccine site/blistering/redness.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Continued redness, bump, and itchiness at site of Fluzone Intradermal Influenza Virus Vaccine for 4 months after administration.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site streaking
Clinical narrative: Called office at 3:00pm to report red streaks on right arm (site of PPSV injection).
Age: 7.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given DTaP at age 7 years. No reaction to vaccine has been documented.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort
Clinical narrative: Symptoms of tightness of chest began about 1 to 1 1/2 hours after vaccination given.Went to ED, O2Sat 80, received epi, solumedral and benydral.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Fatigue, Rash vesicular
Clinical narrative: Mild chicken-pox like rash, not itchy. A little bit tired. No fever. Otherwise well.