chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Pt seen at ER - do not have records. Pt referred to Neurology clinic after ER visit.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Swelling
Clinical narrative: 5 x 6 inch area of erythema and induration. Swelling and redness were gone by 5/5/13.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Lip swelling, Pruritus generalised
Clinical narrative: Visible signs are total body itching. Tb swollen, res and itchy. Patient stated she was short of breath and lips swollen which were not evident to this nurse.
Age: 0.36
Sex: F
Vaccine: DTAPIPV, HIBV, PNC, RV1
Symptoms: Wrong drug administered
Clinical narrative: Patient was accidentally given KINRIX instead of PEDIARIX for DTAP-POLIO vaccination.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated by an unspecified healthcare provider with an expired PNEUMOVAX 23, dosing information, lot number and expiration date were not provided. No adverse effects were reported. Additional information is not expected.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Mumps, Swelling
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 6 year old female patient with no medical history or drug reactions or allergies, who on 14-JAN-2008, was vaccinated with a dose of MMR II. Secondary suspect therapies reported included a dose of PROQUAD (Merck) on 19-NOV-2012. NO concomitant medication was reported. The physician reported that in approximately 2012 after been vaccinated with MMR II and PROQUAD (Merck) the patient had experienced swelling that was suspected to be mumps. The patient was treated with OMNICEF. No lab diagnostics studies were performed. The patient visit the physician's office on an unspecified date for medical attention. Patient's outcome of mumps on 2008 was not reported. At the time of the report the patient had not recovered from mumps of 2012. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician who is the female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). On an unknown date the patient experienced pain and swelling at injection site. The patient sought medical attention via doctor visit. It was unspecified whether laboratory diagnostic studies were performed. The outcome of pain and swelling at injection site was reported as recovered/resolved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On 15-MAY-2013 the patient was vaccinated with GARDASIL dose 3, intramuscular. It was reported that on an unknown date the second dose of GARDASIL was administered to he in her buttocks at another provider's office. Dosing information was not provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age (gender unspecified). On 04-NOV-2011 the patient was vaccinated with the first dose of GARDASIL. Lot# and administration route was unspecified. On 15-MAY-2013, the patient was in the office to receive the second dose. No adverse event reported. Additional information is not expected.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic
Clinical narrative: This spontaneous report was received from a physician reporting to himself a 86 year old male with allergy on amoxicillin and a history of shingles (three times). In May 2010 the patient was vaccinated subcutaneously with a dose of ZOSTAVAX, (Lot number, expiration date and dose was not reported). In April 2013 the patient experienced shingles located in his right eye. The patient sought medical attention and received antivirals treatment. The patient queried should he continue using antivirals, after getting the shingles for the fourth time. The outcome of shingles in right eye is unknown. The relatedness between adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient in his 70's. No medical history was reported. On an unknown date in October 2012, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry, route not reported) from an unspecified pharmacy. The pharmacist reported that this patient came to the pharmacy today complaining of radiating pain in the arm he received his ZOSTAVAX. Pharmacist reported this patient stated he has had this pain for the last week (since May 2013). No treatment was given. Patient sought medical attention (asked pharmacy). The outcome of radiating pain in the arm was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Cold sweat, Feeling cold, Muscle spasms
Clinical narrative: This spontaneous report as received from a 70 year old female patient with high blood pressure, "thyroid", depression and drug reactions/allergies to "scapalamine" and "sulfa", reporting on herself, who on 10-MAY-2013, was vaccinated subcutaneously with a dose of ZOSTAVAX 1 time vaccine (dose and lot # not reported). The patient stated that on 12-MAY-2013, she was experiencing her body being extremely cold, she had nausea (no vomiting), abdominal pain and cramping and an upset stomach. She had scheduled appointment with her physician. No treatment was given for the events. The patient also stated that she was not as cold now, but the abdominal pain (also reported as abdominal pain and cramping) was still there. The outcome of nausea and upset stomach were unknown. The relatedness of the events to therapy with ZOSTAVAX was not reported. No laboratory diagnostic studies were performed. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: This spontaneous report as received from a 70 year old female patient with high blood pressure, "thyroid", depression and drug reactions/allergies to "scapalamine" and "sulfa", reporting on herself, who on 10-MAY-2013, was vaccinated subcutaneously with a dose of ZOSTAVAX 1 time vaccine (dose and lot # not reported). The patient stated that on 12-MAY-2013, she was experiencing her body being extremely cold, she had nausea (no vomiting), abdominal pain and cramping and an upset stomach. She had scheduled appointment with her physician. No treatment was given for the events. The patient also stated that she was not as cold now, but the abdominal pain (also reported as abdominal pain and cramping) was still there. The outcome of nausea and upset stomach were unknown. The relatedness of the events to therapy with ZOSTAVAX was not reported. No laboratory diagnostic studies were performed. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site induration
Clinical narrative: This spontaneous report was received from a pharmacist refers to a approximately 71 year old female patient. No medical history was reported. On 26-MAR-2013, the patient possibly was vaccinated with a dose of ZOSTAVAX (lot#, expiry, route not reported) but the pharmacist was not sure. No concomitant medications were reported. Since an unknown date, the patient had been experiencing an injection site reaction. The injection site was hard and there was a dark pigmented area that circled around the injection site. Patient sought medical attention-contacted pharmacy. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a nurse via a field representative refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On an unknown date in 2013 the patient was vaccinated with PNEUMOVAX13 dose 2. Dose, route and frequency were not provided. Lot number was not provided. The first dose of PNEUMOVAX23 was years ago in 2010. On an unknown date in 2013 the patient experienced an adverse reaction localized at the injection site, which was termed as a 2010 cellulitis type infection. The outcome of cellulitis type infection at the injection site was unknown. The reporter causality was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. No medical history was reported. The physician reported that the patient was vaccinated with 3 doses of GARDASIL (lot#, expiry, route not reported) sporadically over a 2.5 year time period. The patient is not experiencing any known symptom. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a 73 year old female patient with no medical history and no drug reactions/allergies. On 20-MAY-2013 the patient was vaccinated with ZOSTAVAX (subcutaneous, 1 time vaccine, lot#, dose/frequency were unspecified). No concomitant medication was taken. The consumer stated the vaccine was given in her left hip, and she had pain at the site of insertion on 21-MAY-2013. Patient did not seek medical attention. No lab diagnostics studies were performed and no treatment was given for the event. The outcome of pain at the site of insertion was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a physician refers to a several female patients of unknown age who on an unknown dates, were vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (dose and lot number not reported). It was reported that over the past two weeks in approximately May 2013, the patients complained of headaches after receiving GARDASIL. No lab diagnostics studies were performed. At the time of the report the patient outcome was unknown. The patients did not seek medical attention. The relatedness for headache and GARDASIL was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age. On 20-MAY-2013, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # 672074/1502AA, expiry date 19-MAY-2013. Concomitant medications were not reported. No symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a female patient of unknown age, reporting on herself, who was vaccinated with a dose of VARIVAX (Merck) single standard dose (dose, route and lot # not reported). The patient explained that she was 5 months and 2 weeks pregnant and had now received the VARIVAX (Merck) vaccine today (on 17-MAY-2013). The patient was exposed in the second trimester. Last menstrual period was approximately on 03-DEC-2012, Estimated delivery date would be approximately on 09-SEP-2013. The pregnancy outcome was outcome pending. Fetal outcome was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Fatigue, Headache, Joint swelling, Nausea
Clinical narrative: 5/15/13 pt given Tdap - felt pain that night to (L) arm. Since then and (R) arm pain, swelling rt knee, fever 100.2, general fatigue, achiness throughout body, abd pain, h/o, nausea.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: 5/15/13 pt given Tdap - felt pain that night to (L) arm. Since then and (R) arm pain, swelling rt knee, fever 100.2, general fatigue, achiness throughout body, abd pain, h/o, nausea.
Age: 38.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Has hives over most of her body, is taking BENADRYL and using hydrocortisone ointment. Had called PCP stated to wait a few days to see if rash subsides if not call back for apt. Pt stated she has sensitive skin. But had not changed any product.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site rash, Rash
Clinical narrative: Pinpoint rash on trunk and back, thighs and legs, neck and injection site on each leg. No difficulty breathing.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Herpes zoster, Injection site pain, Injection site reaction
Clinical narrative: Pt received shingles vaccine 5/17/13 had redness, swelling and pain lower elbow cam to have nurse check 5/21/13. Inj site with shingles lesion, painful
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Pt received shingles vaccine 5/17/13 had redness, swelling and pain lower elbow cam to have nurse check 5/21/13. Inj site with shingles lesion, painful
Age: 36.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: 20.5 x 9.5 cm red raised tender swelling around and distal to injection site.
Sex: F
Vaccine: MNQ, TYP, YF
Symptoms: Dizziness
Clinical narrative: Vaccination completed at 4:35 p.m. At 4:55 p.m. patient c/o dizziness. Patient feet elevated while lying on exam table. By 5:05 p.m. noted feeling better. Stated I'm OK.
Age: 4.0
Sex: M
Vaccine: MNQ, YF
Symptoms: Chest pain, Cough, Pruritus
Clinical narrative: Patient administered Menactra and Yellow Fever vaccinations due to travel abroad.  Completed vaccinations at approximately 4:35pm. Upon completing paper work and providing records to parents at approx. 5:45pm, parents noted child complained of coughing, chest hurting, early back-side itching. Benadryl IM given, 911 called, EMS assessment and transport to hospital.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Patient developed a slight non itchy red rash on face. I immediately advised her dr who advised just BENADRYL. She spoke with dr who said she's fine. I spoke with her 5/21 4 pm still fine with last dose BENADRYL 5/20.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Nurse states expired GARDASIL (lot # reported as 1397AA, Exp Date 09-APR-2013) (dose, route and indication were not reported) was administered to a patient. Concomitant medications were not reported. No adverse effects reported. The outcome of the patient was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Allergy to metals, Pain
Clinical narrative: This spontaneous report as received from a medical assistant via a social media site refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number not reported) (dose and route not reported). Concomitant medications were not reported. On an unspecified date the medical assistant reported that the patient experienced "chronic pain due to an aluminum allergy," while using GARDASIL. The patient sought medical attention in an office visit on an unspecified date. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
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. Pharmacist reported that a patient was vaccinated on 15-MAY-2013 with GARDASIL (lot # reported as 1397AA, exp Date: 09-APR-2013) (route, dose and indication were not reported). No other concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer (the patient's spouse) refers to a 79 year old male patient with high blood pressure. The patient did not have any drug reaction allergies. On approximately 14-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose and route not reported, in the left arm). Concomitant therapy included lovastatin (manufacturer unknown) and metoprolol. On 14-MAY-2013, the patient developed shingles after receiving ZOSTAVAX. Laboratory diagnostic studies were not performed. The patient went to the dermatologist and was treated with valacyclovir. At the time of the report the patient's outcome was not recovered. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a male patient (age not reported) who on 07-MAY-2013 received the second dose of GARDASIL (indication not reported) (Lot # H021346, exp. 01-OCT_2015). It was reported that on 15-JUN-2012, the patient received the first dose of GARDASIL. The patient did not experience any adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown ages. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX (Lot # not reported). The physician reported that within a month of vaccination, the patients experienced shingles. The outcome of shingles was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose and lot# not reported) subcutaneously. On an unknown date the patient experienced shingles within a few days after vaccination of ZOSTAVAX. The patient sought medical attention with the physician and was treated with VALTREX. At the time of reporting, the outcome of shingles was unknown. The patient was not reintroduced. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Caesarean section, Exposure during pregnancy, Full blood count, Laboratory test, No adverse event
Clinical narrative: Information has been received from a Registered Nurse (RN), for VARIVAX (Merck), a Pregnancy Registry product, concerning a 29 year old female patient with no pertinent medical history or known drug reactions/allergies who in "late August 2011" was vaccinated with a dose of VARIVAX (Merck) (lot #, dose, route and site of administration not reported). Concomitant therapy included prenatal vitamins (unspecified). The Registered Nurse reported that the patient became pregnant at unspecified time following vaccination with VARIVAX (Merck). The patient's last menstrual period was on 01-AUG-2011 and her estimated delivery date was on 07-MAY-2012. Pregnancy test, routine lab work and CBC were performed (results not provided). No adverse effect was reported. The patient sought medical attention (office visit). No treatment was given to the patient due to the vaccine exposure during pregnancy. Follow up information has been received from the Registered Nurse. She reported that the patient delivered a full term healthy baby boy on 04-May-2012 without any congenital anomalies. The uncomplicated delivery of the infant was by a scheduled repeat C-section. The nurse did not have the infant's birth weight or height but was positive the infant was not of low birth weight and was a healthy thriving baby on 20-MAY-2013 "today". She did not know what dose of VARIVAX (Merck) was given since their office did not administer the vaccine. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Pregnancy test positive
Clinical narrative: Information has been received from a Registered Nurse (RN), for VARIVAX (Merck), a Pregnancy Registry product, concerning a 29 year old female patient with no pertinent medical history or known drug reactions/allergies who in "late August 2011" was vaccinated with a dose of VARIVAX (Merck) (lot #, dose, route and site of administration not reported). Concomitant therapy included prenatal vitamins (unspecified). The Registered Nurse reported that the patient became pregnant at unspecified time following vaccination with VARIVAX (Merck). The patient's last menstrual period was on 01-AUG-2011 and her estimated delivery date was on 07-MAY-2012. Pregnancy test, routine lab work and CBC were performed (results not provided). No adverse effect was reported. The patient sought medical attention (office visit). No treatment was given to the patient due to the vaccine exposure during pregnancy. Follow up information has been received from the Registered Nurse. She reported that the patient delivered a full term healthy baby boy on 04-May-2012 without any congenital anomalies. The uncomplicated delivery of the infant was by a scheduled repeat C-section. The nurse did not have the infant's birth weight or height but was positive the infant was not of low birth weight and was a healthy thriving baby on 20-MAY-2013 "today". She did not know what dose of VARIVAX (Merck) was given since their office did not administer the vaccine. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Emotional distress, Exposure during pregnancy, Injection site erythema, Injection site pain, Local reaction
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse practitioner concerning her approximately 23 year old daughter with no pertinent medical history. Current conditions of the patient included CECLOR allergy and amoxicillin allergy. Approximately on 07-MAY-2013 (reported as on 07-MAY-2013 or 08-MAY-2013), the patient was vaccinated with 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date unspecified), subcutaneously. There was no concomitant medication. On 13-MAY-2013, the patient discovered that she was pregnant and was followed in an unspecified prenatal clinic. The patient was easily upset. Pregnancy test was performed at home and in clinic. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known. The pregnancy outcome was pending. Approximately on an unknown date in May 2013, the patient experienced local reaction where injection site was red and the size of a half dollar and painful. The patient did not seek any medical attention. Ice was applied to local reaction. Outcome of the events was unknown. The relatedness for the event was unknown for VARIVAX (Merck). The patient had received an unspecified varicella vaccine at age 4 and had mild case of chicken pox 2 year later that started and ended in one day. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse practitioner concerning her approximately 23 year old daughter with no pertinent medical history. Current conditions of the patient included CECLOR allergy and amoxicillin allergy. Approximately on 07-MAY-2013 (reported as on 07-MAY-2013 or 08-MAY-2013), the patient was vaccinated with 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date unspecified), subcutaneously. There was no concomitant medication. On 13-MAY-2013, the patient discovered that she was pregnant and was followed in an unspecified prenatal clinic. The patient was easily upset. Pregnancy test was performed at home and in clinic. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known. The pregnancy outcome was pending. Approximately on an unknown date in May 2013, the patient experienced local reaction where injection site was red and the size of a half dollar and painful. The patient did not seek any medical attention. Ice was applied to local reaction. Outcome of the events was unknown. The relatedness for the event was unknown for VARIVAX (Merck). The patient had received an unspecified varicella vaccine at age 4 and had mild case of chicken pox 2 year later that started and ended in one day. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Gastric disorder, Hypopnoea, Nausea
Clinical narrative: This spontaneous report as received from a 58 year old female consumer reporting on herself with medical history of celiac disease, PRILOSEC allergy and REGLAN allergy. On 12-DEC-2012 the patient was vaccinated with PNEUMOVAX 23 (Lot # not reported) 0.5 ml, intramuscular. No other co suspects were reported. No concomitant therapy was reported. On 12-DEC-2012, the patient experienced stomach disorder, nausea and shallow breathing. The patient sought unspecified medical attention. The outcome of stomach disorder, nausea and shallow breathing was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to two to three patients of unknown ages and genders. The reporter stated that on unspecified dates, since 02-APR-2013, the patients received ROTATEQ dose, route application site were unspecified)(lot#1710AA; exp date 11-JUL-2013), and six patients received GARDASIL MARRS# 1305USA002203. The reporter stated that the ROTATEQ were exposed to an unsupported temperature excursion. These vaccines were exposed multiple times into the freezing range, the lowest temperature being 23F; the total time frame being 1 month. The number of excursions into the freezing range exceeded 5 times. The exact number of times these entered the freezing range was unspecified. No known adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (C.M.A.) via a company representative refers to an 11 year old male patient. On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot # not reported) intramuscularly in the left arm. Concomitant therapies included ADACEL and MENACTRA which were vaccinated on the right arm on the same day. The patient experienced patient's left arm swelled up at the injection site shortly after GARDASIL was vaccinated. Patient sought medical attention by office visit and not treatment was given to patient. The outcome of patient's left arm swelled up at the injection site was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Musculoskeletal pain, Swelling
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated subcutaneously with a single injection of 0.65 ml ZOSTAVAX (lot number, expiry date and site not reported) to prevent herpes zoster - shingles. No concomitant medication information was reported. On an unknown date the patient experienced swelling, redness and a sore shoulder for one week and the symptoms had resolved. The patient was fully recovered. The outcome of the events was reported as recovered/resolved (date unknown). It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a 60 year old female nurse, who was also the patient, refers to a herself. The patient's medical history included a mild headache with other injections. There was no concomitant medication. On approximately 24-APR-2013, "about two weeks ago", the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous for shingles prophylaxis. The nurse noted she "initially developed a mild headache as well swelling and a red bumpy rash at the injection site that was maybe an inch or two in length. The size of the rash grew to about six inches. Cold compresses were given for the patient. No lab diagnostics studies were performed. The reactions subsided about six to seven days ago, on approximately 02-MAY-2013. The outcome of the events was reported as recovered. This is one of several reports from the same reporter (other MARRS # 1305USA004815). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Information has been received from a registered nurse for the pregnancy Registry for GARDASIL concerning a 15 year old female patient with no allergies or drug reactions who on 30-AUG-2011, was vaccinated with the first dose of GARDASIL, intramuscularly (lot number 668262/0841AA). On the same day, the patient was vaccinated with a dose of VARIVAX (Merck) (route, dose and lot number not reported). On an unknown date, the patient became pregnant after she had received first dose of GARDASIL and VARIVAX (Merck). The patient sought unspecified medical attention. At the time of the report the outcome of the patient was unknown. Follow-up received. The pregnancy outcome was reported as 'lost to follow-up'. Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Laparotomy, Ultrasound scan abnormal, Vomiting, X-ray gastrointestinal tract abnormal
Clinical narrative: (+) vomiting 5/13 Dx: Intussusception -> (Had surgery 5/14/13 Laparotomy for reduction).
Age: 25.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Anti-SS-B antibody, Antinuclear antibody, Fatigue, Pain
Clinical narrative: Pain, fatigue.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pruritus, Rash vesicular
Clinical narrative: Varicella-like rash on right, back shoulder. Pain started on right upper arm and worked its way up.  Rash appeared days later and was located on the right shoulder blade.  She says that it is painful and itches.
Age: 9.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Crying, Mobility decreased, Pain, Rash, Rash macular
Clinical narrative: Extreme pain - crying - not able to lift arm, in the morning he had a quarter size rash by 8:00 PM the rash had grown to cover half of his arm - hot splotchy (hives?). Painful.
Age: 16.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: CLIENTS MOTHER CALLED THE HEALTH DEPT CONCERNED ABOUT SWELLING AND REDNESS TO THE LEFT ARM AT THE INJECTION SITE.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site swelling
Clinical narrative: 5-9-13 mild swelling left deltoid in AM becoming excessive after school. Redness extending from shoulder to elbow. Afebrile. To Dr evening of 5-9-13 low-dose steroid given.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Diarrhoea, Fatigue, Feeling abnormal, Nausea
Clinical narrative: Pt reports via phone: not feeling good the next morning with a temp that runs between 99 and 102 degrees, feeling tired, then at around 2pm feels terrible, have diarrhea, nausea.  Per pt. all of the above symptoms happened the next day after vaccine administered.  The next feeling better but just tired from being sick the day before.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 85 year old female patient with no known relevant medical history or drug allergy. On 03-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # H019040, expiry date 17-JAN-2014), 0.65 ml, subcutaneous. Concomitant therapies included omeprazole(manufacturer unknown) and lisinopril(manufacturer unknown). Approximately 2 days later (05-MAY-2013) the patient experienced mild itching at the injection site. Pharmacist inspected patient's arm and there was hotness at the injection site but there was no rash, no redness and no swelling. Patient did not seek medical attention. No lab test done. Patient has applied ice to the area of the injection in an attempt to cool the area down. At the time of reporting the events persisted. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 20 year old patient. On 30-MAY-1995, the patient was vaccinated with one dose of VARIVAX (merck) (lot # not reported). On 19-JUN-2008, the patient was vaccinated with another dose of VARIVAX (merck) (lot # not reported). The nurse reported that the patient's varicella titer showed negative when it was taken on 01-MAY-2013. At the time of reporting, the outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient developed a fever, and itchiness, pain, redness and swelling at the unspecified injection site. The outcome of event was reported as recovered/resolved. The patient has sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The reporter stated that the patient received first dose GARDASIL on 24-MAR-2013. On 08-MAY-2013, the reporter administered second dose GARDASIL which was expired (Lot # was reported as 1271Z, expiry 11-DEC-2012). No adverse effects reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a healthcare worker, refers to a 35 year old female patient. The patient's medical history included drug reaction to sulfonamides. On 08-MAY-2013, the patient was vaccinated with GARDASIL lot # H019495 and expiry date 15-AUG-2015, intramuscular. Concomitant therapies included prenatal vitamins. The patient became pregnant with LMP of 19-OCT-2012 and EDD of 26-JUL-2013. Initial exposure to GARDASIL was at 28 week(s). On 08-MAY-2013, the patient is 35 years old and the patient received 1 GARDASIL dose in error. The patient's last menstrual period was on 19-OCT-2012, and the patient is pregnant. No known adverse effects. The outcome of patient is pregnant, no known adverse effects, patient received 1 GARDASIL dose in error and patient is 35 years old is unknown. The reporter considered patient is pregnant, patient received 1 GARDASIL dose in error, patient is 35 years old and now known adverse effects to be not related to GARDASIL. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Injection site reaction, Skin reaction
Clinical narrative: This spontaneous report as received from a female medical assistant of unknown age via a company representative refers to herself. The patient was vaccinated subcutaneously with M-M-R II (lot number, expiry date, dose, site not reported) on an unknown date "10 years ago" approximately in May 2003. The patient experienced severe M-M-R II localized reaction at the injection site, on an unknown date "10 years ago" approximately in May 2003. No treatment was given, but the event subsided and the patient made a full recovery. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Diarrhoea, Feeling abnormal, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with high cholesterol and thyroid problem. The patient's medical history include shingles in 1986 which affected the left side of her face and a drug reaction/allergies to KYALIN. On 03-MAY-2013, the patient was vaccinated (route not provided) with ZOSTAVAX (lotnumber and expiry date not provided) in the right arm. Concomitant therapies included thyroid and LIPITOR. On 07-MAY-2013, 5 days after onset of therapy the patient noticed red bumps in a strip around her torso. The patient claims the rash doesn't really itch. The patient describes the bumps as small fluid filled blisters. The patient says on that day she felt very "yucky" and ran a 101 degree fever all day. On 08-MAY-2013, the patient says she was nauseated and had diarrhea and still felt "yucky". On 09-MAY-2013, the patient felt fine but still has the blisters coming out. The patient said she took some BENADRYL but it did not help at all. The patient mentioned that she will be calling her doctor right away this morning and attempt and appoint for this afternoon. The outcome of she felt very "yucky", red bumps in a strip around her torso, ran a 101 degree fever all day, diarrhea and nauseated is unknown. The reporter did not assess the relationship between the events and ZOSTAVAX. Additional information has been yucky.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with high cholesterol and thyroid problem. The patient's medical history include shingles in 1986 which affected the left side of her face and a drug reaction/allergies to KYALIN. On 03-MAY-2013, the patient was vaccinated (route not provided) with ZOSTAVAX (lotnumber and expiry date not provided) in the right arm. Concomitant therapies included thyroid and LIPITOR. On 07-MAY-2013, 5 days after onset of therapy the patient noticed red bumps in a strip around her torso. The patient claims the rash doesn't really itch. The patient describes the bumps as small fluid filled blisters. The patient says on that day she felt very "yucky" and ran a 101 degree fever all day. On 08-MAY-2013, the patient says she was nauseated and had diarrhea and still felt "yucky". On 09-MAY-2013, the patient felt fine but still has the blisters coming out. The patient said she took some BENADRYL but it did not help at all. The patient mentioned that she will be calling her doctor right away this morning and attempt and appoint for this afternoon. The outcome of she felt very "yucky", red bumps in a strip around her torso, ran a 101 degree fever all day, diarrhea and nauseated is unknown. The reporter did not assess the relationship between the events and ZOSTAVAX. Additional information has been yucky.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (R) upper arm (injection site) is tender swollen with violaceous/erythematous patches. Induration.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Eye pain, Feeling abnormal, Herpes zoster ophthalmic, Pain
Clinical narrative: This spontaneous report as received from a female consumer refers to a 88 year old patient (reported as husband). On an unknown date in 2011 the patient was vaccinated (reported as we got shingles shot) with ZOSTAVAX (dose, route and lot number not reported). The reported stated that the patient has got shingles "bug" since an unknown date in 2011. At first he experienced some discomfort on his face/jaw area. He visited Emergency Room and a dentist to diagnosed the cause of pain. The consumer stated that on ER they did not know what was causing the pain but they suggested it might be shingles. It was reported that the dentist stated that patient looked like he were coming down with shingles. On the next day he was "broken out" down the left side of his face from the top of his head to his lip area. The patient was pretty miserable and finally found relief with CAPZASIN. On that time "the shingles were" all around the eye area. It was also reported that patient's eye socket was still painful, red area on the left side still bother him. In December 2012 (reported as on Christmas 2012) the pain still continued to bother the patient (reported as still has a lot pain in the area). The left eye was affected and patient could not read for too long without it hurting. He also used iced packs that helped numb. At the time of the report patient state for the shingles were all around the eye area, pain bother him, cannot read for too long without it (left eye) hurting was not recovered and for miserable was unknown. The relatedness between event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.42
Sex: M
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (healthcare worker) refers to a approximately 5 month old male patient. No medical history was reported. On 21-MAY-2013, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot number, expiry not reported), intramuscularly after temperature excursion of 28 degree Fahrenheit (F) for 8 hours. No adverse effects reported. No treatment was given to the patient. No medical attention was sought. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site swelling, Nausea, Pruritus, Vomiting
Clinical narrative: Reported N/V and chills 5/20/13 resolved 5/21/13. Reported pruritis, raised red inj site 5/22/13.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 year old female patient with allergies to penicillin-unknown type and no pertinent medical history;. On 30-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # and route not reported) at a local pharmacy. On 08-MAY-2013, the patient developed redness at the injection site. The patient called the office to report the adverse symptoms to the nurse and described the area as "2 inches of redness around the site of injection". The patient sought medical attention by calling the office. No treatment was given. No lab diagnostics studies were performed. The outcome of redness at the injection site was reported as not recovered/resolved. Additional information is not expected.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: (Lt) arm hot to touch, some swelling, bump, and pain.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling
Clinical narrative: Both injection sites with moderate redness, swelling approximately 3 inches in diarrhea.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Lip swelling
Clinical narrative: Lips swollen 05-18-13 and sore deltoid muscle. Treated at home with BENADRYL - resolved. Minor lip swelling reoccured 05-21-13. Mother reports similar sx 2 yrs ago, unknown cause.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth at injection site. Advised to monitor his symptoms and report to his local ER if he experiences any shortness of breath, fever, redness extending down/up arm or chills. Joint pain reported RN 5/16/13.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Arthralgia, Hallucination, Pyrexia
Clinical narrative: Fever, arthralgia probably hallucinations presented to ER on 5/17/13 at 9:23am and discharged at 11:10 am. Patient was given 400 mg MOTRIN po and TYLENOL 640 mg po. Stable and improved on discharge.
Age: 19.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Induration, Injection site warmth, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Left arm swelled to 3x size. Became hard and injection site and hot. Pt developed fever and body aches. Than in morning he began to vomit.
Age: 19.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Vomiting
Clinical narrative: Left arm swelled to 3x size. Became hard and injection site and hot. Pt developed fever and body aches. Than in morning he began to vomit.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Pt received GARDASIL (L) arm IM on 5/20/13 at 10am that evening pt developed itchy red rash on (R) wrist which spread to (R) inner elbow and then to back and belly and finally to (L) arm near inj site. No difficulty breathing. Parent called MD. BENADRYL given at 10 pm 5/20 and 330 am 5/22. Rash gone by 7 am 5/21/13.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Myalgia
Clinical narrative: Myalgias and arthralgias. Pt went to urgent care and exam normal. She's feeling much better.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age with no pertinent medical history and no known drug reactions or allergies. There was no concomitant medication. In "mid-April 2013" the patient was administered his one and only dose of VARIVAX (merck), subcutaneous. The patient then developed "breakthrough chickenpox" starting on 06-MAY-2013. The physician noted "the lesions started at the site of injection and then spread all over his body; the patient currently has 40 lesions." Mother of the patient called and spoke with the reporting physician. No treatment was given for the patient. No lab diagnostics studies were performed. At the time of the report, the outcome of breakthrough chickenpox was reported as not recovered. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Pt received TDaP at 1155 left deltoid. Began experience itching symptoms to face, neck and left arm at 1205 nurses contacted at this time. EPI was given at 1216. Vitals taken and provider notified. Pt taken to primary care and monitored for 2 hours. No further medications given. Patient d/c ed by provider at 215 pm.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Barium enema, Diarrhoea, Haematochezia, Intussusception, Occult blood negative
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an approximately 10 week old patient. On 30-APR-2013 the patient was vaccinated orally with first dose of 2 ml oral ROTATEQ (lot # H010052). the patient developed diarrhea, bloody stool and experienced possible abdominal pain after receiving the first dose of oral ROTATEQ. The infant was breast fed, and was seen in the physician's office on 09-MAY-2013 and on 12-MAY-2013. During the 12-MAY-2013 visit, the patient's stool was negative for blood and positive for rotavirus. Intussusception was suspected and the patient was scheduled to see an unspecified surgeon and had a barium enema. The patient was treated with fluids and dextrose, electrolytes (unspecified) (PEDIALYTE). The patient's father told the physician that he was sure that oral ROTATEQ was the cause of this condition. The action taken of oral ROTATEQ and outcome of the events were unknown. Additional information has been requested.