chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown age and gender. No medical history or concurrent condition were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, vial 19400 PFU (lot number, dose, frequency and route of administration not provided). Co-suspect or concomitant therapies were not reported. On an unknown date, the patient received ZOSTAVAX and later developed shingles. At the time of the report, the outcome of the event was unknown. The causal relationship between the event and ZOSTAVAX was unknown. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to her 81 year old female friend. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, strength, dosage, anatomical location and route unknown). No pertinent medical history was reported. On an unknown date the patient experienced itching after receiving ZOSTAVAX. The patient visited the office on unspecified date. No treatment was given for the event and no lab diagnostics studies was performed. The outcome of itching was not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a consumer, as part of a marketing research program conducted by agency, refers to consumer's older daughter (patient's age, pertinent medical history and drug reactions/allergies were not provided). On an unknown date, the patient received a first dose of GARDASIL, (route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. On an unknown date, it was reported that after the first shot in the GARDASIL series, the patient had a very painful, severe complication. At the time of the report, the patient's outcome and the relatedness between the events and suspect therapy were not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 23-SEP-2014, the patient was vaccinated with the third dose of ROTATEQ vial, oral route, (lot # J001254; Exp. Date: 19-SEP-2014), oral (strength not provided). Co-suspect or concomitant therapies were not reported. The dose received by the patient was expired. The ROTATEQ did not have any previous temperature excursions and was found to be supported with in-house post-expiry data. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 20-AUG-2014, the patients were vaccinated with a dose LIQUID PEDVAXHIB (lot number J014280, Expiry date 15-SEP-2016, dose and route were not reported) that was improperly stored at 48F for 39 minutes. Concomitant medications were not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 20-AUG-2014, patients were vaccinated with a dose LIQUID PEDVAXHIB (lot number J013944, Expiry date 13-AUG-2016, dose and route were not reported) that was improperly stored at 48F for 39 minutes. Concomitant medications were not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 20-AUG-2014, patients were vaccinated with a dose of PEDVAXHIB (lot number K004541, Expiry date 04-DEC-2016, dose and route were not reported) that was improperly stored at 48F for 39 minutes. Concomitant medications were not reported.  No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Radiotherapy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 74 years old female patient. The patient's pertinent medical history was not provided. On an unspecified date in approximately 2013 (reported as on an unspecified date approximately one year ago), the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, route of administration, lot # and expiration date were not reported). No concomitant medications were provided. Later, on an unknown date, the patient had radiation and then, on an unknown date, she developed shingles. As a treatment, the patient received unspecified antiviral therapy. The reporter stated that the patient's shingles lesion have resolved on an unknown date, however the patient continued to have pain and itching. The outcome of the shingles was reported as recovering/resolving. The outcome of radiation was unknown. The relatedness between the events and ZOSTAVAX was unknown. Additional information is not expected because there is no reporter's consent to follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. The nurse reported that since 05-SEP-2014 improperly stored VARIVAX was administered to one patient (dose, route of administration, anatomical location, lot#, expiration date not reported) (in approximately September 2014, exact date unspecified). No adverse effects were reported. Concomitant medications were not reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, aching. Both occurred the day after administration and lasted 2 days.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Confusional state, Headache, Local reaction, Pain
Clinical narrative: Severe local reaction, H/A, confusion, ? fever, within 5 hours of receiving PNEUMOVAX vaccine - Right deltoid - 20 hours after vaccine pt has mild local reaction, mild headache, body aches.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Swollen tongue, Throat irritation, Tongue disorder
Clinical narrative: Scratchy throat with possible swelling. Red splotches on tongue and swelling.} 4:30 pm Later developed breathing difficulties. Treated and observed at hospital for 2 hours before returning home.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 47 year old female patient who on 22-SEP-2014 was vaccinated with an expired dose of M-M-R II (lot # H016132, expiration date: 31-AUG-2014) (dose and route not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a nursing assistant referring to an unspecified number of patients of unknown age and gender. On an unknown date, years ago, the patients were vaccinated with an unspecified flu vaccine (manufacturer, route, lot # and expiration date were not provided) and after PNEUMOVAX 23 (route, lot # and expiration date were not provided). On an unknown date, years ago, couple of times, the patients developed red and swollen arms. It was unknown if the patient's sought medical attention. At the time of the report, the patients status was unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, redness surrounding injection site the morning after receiving FLUZONE HD. On 9/24/14 - Pt visited allergies, is taking BENADRYL. Pt reports symptoms improving but still red.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. On an unknown date the two patients were vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expired date were not reported) which were improperly stored. This was supported. Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist who received a call from another patient refers to 6 patients of unknown age and gender. On 09-SEP-2014 the patients were respectively vaccinated with a dose of PNEUMOVAX 23 (strength, dosage and route unknown) lot # K004184, expiration date: 10-MAY-2014. On unknown date in September 2014, the patients had unspecified injection site reactions. The outcome of the event was unknown. Pharmacist was requesting a lot check on lot#K004148 exp. 10-MAY-2014. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist via a field employee refers to a female patient of unknown age. Medical history was not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23, (route, lot number and expiration date were not provided). Start date of therapy was unknown. Concomitant therapies included INFLUENZA. Vaccines were applied at separate injection sites on separate arms. On an unknown date the patient developed a "bump" at the injection site of PNEUMOVAX 23. The outcome was unknown. It is not known whether or not the patient had ever received PNEUMOVAX 23 in the past or if the patient notified her healthcare provider. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Administered flu shot, patient passed out within seconds.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Chills, fever, flu like symptoms.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action taken was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received from the register nurse on 04-SEP-2014. The register nurse reported vaccine storage temperature dipped to 0-1 degree (units not reported) X 18 different episodes according to the min/max. All recorded temperatures were within 2-8 degrees (units not reported). No adverse events reported. The register nurse reported patient was a female. The patient was vaccinated with the first dose of RECOMBIVAX HB on 27-JUN-2014 at 00:42 hours, lot number J012520, expiration date 31-JAN-2016. The nurse also reported patient did not have siblings. This is one of several reports from the same source. Additional information has been requested.
Age: 0.69
Sex: F
Vaccine: DTAPIPVHIB, FLU3, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Child had reactions of redness at injection sites for the MMR (L) VL/SQ and varicella (R)VL/SQ. Advised mother to give infant TYLENOL and alternate w/childs MOTRIN as recommended. On bottle, to continue to watch her for fever. To exercise her legs for soreness and use warm compress.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Dizziness, Feeling of body temperature change, Headache, Mononucleosis heterophile test negative
Clinical narrative: Dizziness, weakness, hot and cold, low grade fever, pressure in back of head, stiff neck. She is being treated with ibuprofen 600mg every 6 hours and butalbital/APAP.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: Dizziness, weakness, hot and cold, low grade fever, pressure in back of head, stiff neck. She is being treated with ibuprofen 600mg every 6 hours and butalbital/APAP.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Rash
Clinical narrative: Rash, swelling of arm.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) arm is swollen at injection site, slightly red and is painful to touch in the underarm region as well as injection site. She was referred to PCP.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Rash maculo-papular, Skin lesion
Clinical narrative: Dusky erythematous macular papular lesions at (B) lower legs.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Patient had friend call stating patient had muscle pain. Described pain at injection site and lower extremities.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Pain, Swelling
Clinical narrative: 9/22/14 Received pneu. vaccine at office visit. By evening noticed pain and swelling. Next morning redness, pain and edema. 9/24/14 pt notified office, came in for MD to evaluate. Advised continue cool compresses, BENADRYL and prednisone for 2 days.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Pain
Clinical narrative: Upon administration, hurt more upon initial injection than previous. Site has continued to be extremely sore, resolved some, but now has become worse. When rotates arm has shooting pain down upper arm. Popping started 9/17.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Pain in extremity
Clinical narrative: Pt received pneumonia vaccine on 9/19/2014. C/O severe arm pain on the evening of 9/19/14 and all day 9/20/14. She took hydrocodone 5/325 2 three times daily. This took the edge off of her pain but did not relieve it. Also used warm and cold compresses. No swelling or redness noted. Quarter size bruise at injection site. Pt on COUMADIN.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site infection, Injection site reaction
Clinical narrative: Flu shot was administered in the tricep area intramuscularly broke out a large reaction from elbow all the way up to back of deltoid. MD rxed AUGMENTIN for reaction/infection.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient was given FLUVIRIN multidose vaccination and after 5 minutes whilst still in the store felt very dizzy and lightheaded and passed out for few minutes. No loss of consciousness. ER - vasovagal - common in kids.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Patient received one intramuscular vaccine in left lateral thigh. One vaccine in right lateral thigh IM. One vaccine in both legs subcutaneously. No symptoms present. Given estimated 9/9/14 at 4:30 pm.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed swelling, tenderness to touch, redness at site of PNEUMOVAX injection on left upper arm. as well as flu-like syndrome.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Hyperhidrosis, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Patient had extreme left arm muscle pain (where vaccine administered), muscle pain, sweating, fever, vomiting, coughing.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient had extreme left arm muscle pain (where vaccine administered), muscle pain, sweating, fever, vomiting, coughing.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Injection site reaction -> red, sore and tender.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Blepharospasm, Diarrhoea, Fatigue, Impaired work ability, Oropharyngeal pain
Clinical narrative: Pt did not mention to walk-in-clinic MD that this was possibly related to getting flu-vaccine: symptoms mentioned to pharmacist: fever, eye twitch, facial droop, diarrhea, sore throat, fatigue. Loss of work 1.5-2 wks.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, VIIth nerve paralysis
Clinical narrative: Pt did not mention to walk-in-clinic MD that this was possibly related to getting flu-vaccine: symptoms mentioned to pharmacist: fever, eye twitch, facial droop, diarrhea, sore throat, fatigue. Loss of work 1.5-2 wks.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Varicella administered 9/2, left upper arm. (L) upper arm sore, red and hot and swollen. 60 mm x 50 mm.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Patient had complaints of nausea and fatigue. Patients arm was red and swollen at site of injection which caused patient to come in and be examined. This was patients right arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient says 10 days after ZOSTAVAX vaccine was administered, she got the shingles. Her MD put her on anti-viral and she is recovering well. She came in pharmacy on 9/16/14 to let us know.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: After 7-10 days patient developed rash in facial area; red and itchy.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Patient reported 9/18/2014 that his (Rt) deltoid was red, itchy, swollen, sore and the skin was hot and scaly.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth, Skin exfoliation
Clinical narrative: Patient reported 9/18/2014 that his (Rt) deltoid was red, itchy, swollen, sore and the skin was hot and scaly.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Conjunctivitis, Headache, Malaise
Clinical narrative: Conjunctivitis, malaise, mild headache.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Dyspnoea
Clinical narrative: Chills. Temperature > 101 degrees F. Difficulty breathing. TYLENOL, oxygen.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 9/17 1:13 pm Patient's mother called our office stating patient received immunizations on 09-15-14 and her left leg is red raised, and warm to touch. Mother states patient complained of hurting once, but is playing as per normal. Mother was advised to apply cool compresses and use TYLENOL prn. 9/17 7:18 pm: Mother states leg looks better now.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 27 year old female patient. On 19-AUG-2014 the patient was vaccinated with the third dose of GARDASIL (lot # K004204, expiry date: 12-JAN-2017) 0.5 ml, intramuscular. The vaccination date of the first and second doses of vaccine was unknown. She was pregnant after vaccination with last menstrual period (LMP) of 22-JUL-2014 and estimated delivery date (EDD) of 28-APR-2015. Initial exposure to GARDASIL was at 4 weeks. The pregnancy outcome was outcome pending. No adverse effect was reported. No lab test was performed. Patient had sought medical attention via calling doctor. Additional information has been requested.
Sex: U
Vaccine: MMR
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 17-SEP-2014 the patient was vaccinated with an expired dose of M-M-R II (lot # was reported as 8014646, (lot number 8014646 is an invalid lot number for measles, mumps, and rubella virus vaccine), expire date 03-AUG-2014, dose, frequency and route unspecified). No adverse effect reported. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain
Clinical narrative: This spontaneous report as received from a 77 year old male patient with hypertension and spinal stenosis refers to himself. On 05-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX, lot # J013449, expire date 24-JAN-2015, 1 injection , (route unspecified). Concomitant therapies included metformin hydrochloride, omeprazole (manufacturer unknown), amlodipine, bisoprolol fumarate, ZIAC, FLONASE, and FLOMAX. ON 30-JUL-2014 (also reported as mid to early July) the patient experienced a steady annoying pains both night and day that did not go away located on his lower left ribcage. His symptoms increased in intensity throughout 09-SEP-2014 and were so persistent that he went to the Emergency to seek medical attention. The treating Emergency Room physician did not rule out a case of shingles; however, the patient did not have a rash at or around the area causing his pain. The primary physician of the patient could not diagnose the patient with shingles and was referring him to a neurologist (unknown name and demographics). No treatment was given for the event. The outcome of the event was unknown. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: No adverse events. Vaccine given 8/21/14 by mistake. Expiration date 8/10/14. Patient had no adverse reaction.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Experienced severe pain in arm for several days after receiving vaccination.
Age: 53.0
Sex: F
Vaccine: YF
Symptoms: Differential white blood cell count normal, Fatigue, Full blood count normal, Headache, Insomnia
Clinical narrative: Was given YF vaccination on 8/25/14. 48 hours after receiving the vaccine, she developed fatigue, insomnia, headaches and "whole body" nerve pain. These symptoms are still present.
Age: 53.0
Sex: F
Vaccine: YF
Symptoms: Neuralgia, Red blood cell sedimentation rate normal
Clinical narrative: Was given YF vaccination on 8/25/14. 48 hours after receiving the vaccine, she developed fatigue, insomnia, headaches and "whole body" nerve pain. These symptoms are still present.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: 30-45 min after shot, sharp pain in shoulder. Pain got worse for about 1 hour. Pain would shoot down leg into toes during that time. 90 mins after that the pain went away.
Age: 76.0
Sex: M
Vaccine: FLUC3, VARZOS
Symptoms: Pruritus, Rash generalised
Clinical narrative: Rash starting on buttocks then proceeded down legs then now all over. Itching.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Left thigh red, warm to touch, multiple bumps. Reaction area measured at 3 1/4 inches.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Flushing, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Pt received PNEUMOVAX. The next day developed painful, erythematous eruption on inner arm. Rash enlarged over 2-3 days and then chest, arms and legs developed red flushing.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Injection site pain
Clinical narrative: Pt states he has had pain at injection site since administered on 9/11/14. He reports burning sensation during administration, and achiness in the left deltoid. Pain continues to today.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant refers to a 30 year old female patient. On 07-JUL-2014, the pregnant patient was inadvertently vaccinated with GARDASIL lot # J009788, 0.5 ml, intramuscular. The patient sought medical attention in the office. The patient became pregnant with LMP of 23-NOV-2013 and EDD of 30-AUG-2014. No adverse effects reported. No further information provided. Follow up information has been received from medical assistant concerning a female patient with bacterial infection due to streptococcus, group B (GBS) carrier and no known drug allergies. Medical history included a previous pregnancy (macrosomic infant, male born in 2010 at 40 weeks from LMP). The patient was a smoker and occasional drinker. On 03-FEB-2014, at 10 weeks pregnant, the pregnancy test, result was Urine Serum. On 18-MAR-2014, at 16 weeks pregnant, the Rhesus antibodies (ABO/RH) A+ and the Alpha 1 foetoprotein (AFP4) was negative. On 03-APR-2014, at 19 (also reported as "19/2") weeks pregnant, results was reported as Nml. On 12-MAY-2014, at 24 weeks pregnant, the glucose was 118 (unit not reported). On 07-AUG-2014, at 36 weeks pregnant, the B-strep was positive. Concomitant therapies included Prenatal DHA one every day, oral since 13-MAR-2014 for pregnancy and iron (unspecified) 325 mg, oral, one every day since 26-AUG-2014 for anemia. On 26-AUG-2014 (also reported as 26-AUG-2013), at 39.3 weeks of pregnancy, live birth, the patient delivered a single male baby by cesarean section and position of breech. Conflict information was reported as the patient had an abortion on an unknown date, but the pregnancy ended as a live birth on 26-AUG-2014 at 39.3 weeks from LMP. The male baby born normal, without any congenital anomalies, the Apgar score was 8 at 1 minute and 9 at 5 minutes and the birth weight was 9 lb 14 oz. The patient was not admitted to the hospital or stay prolonged due to complication after the delivery. Neither the baby or the mother experienced complications during the delivery. At delivery baby had an bacterial infection due to streptococcus, group B (captured into MARRS #1409USA012155). Upon internal review cesarean section was considered as important medical events. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Beta haemolytic streptococcal infection, Blood glucose normal, Breech presentation, Caesarean section
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant refers to a 30 year old female patient. On 07-JUL-2014, the pregnant patient was inadvertently vaccinated with GARDASIL lot # J009788, 0.5 ml, intramuscular. The patient sought medical attention in the office. The patient became pregnant with LMP of 23-NOV-2013 and EDD of 30-AUG-2014. No adverse effects reported. No further information provided. Follow up information has been received from medical assistant concerning a female patient with bacterial infection due to streptococcus, group B (GBS) carrier and no known drug allergies. Medical history included a previous pregnancy (macrosomic infant, male born in 2010 at 40 weeks from LMP). The patient was a smoker and occasional drinker. On 03-FEB-2014, at 10 weeks pregnant, the pregnancy test, result was Urine Serum. On 18-MAR-2014, at 16 weeks pregnant, the Rhesus antibodies (ABO/RH) A+ and the Alpha 1 foetoprotein (AFP4) was negative. On 03-APR-2014, at 19 (also reported as "19/2") weeks pregnant, results was reported as Nml. On 12-MAY-2014, at 24 weeks pregnant, the glucose was 118 (unit not reported). On 07-AUG-2014, at 36 weeks pregnant, the B-strep was positive. Concomitant therapies included Prenatal DHA one every day, oral since 13-MAR-2014 for pregnancy and iron (unspecified) 325 mg, oral, one every day since 26-AUG-2014 for anemia. On 26-AUG-2014 (also reported as 26-AUG-2013), at 39.3 weeks of pregnancy, live birth, the patient delivered a single male baby by cesarean section and position of breech. Conflict information was reported as the patient had an abortion on an unknown date, but the pregnancy ended as a live birth on 26-AUG-2014 at 39.3 weeks from LMP. The male baby born normal, without any congenital anomalies, the Apgar score was 8 at 1 minute and 9 at 5 minutes and the birth weight was 9 lb 14 oz. The patient was not admitted to the hospital or stay prolonged due to complication after the delivery. Neither the baby or the mother experienced complications during the delivery. At delivery baby had an bacterial infection due to streptococcus, group B (captured into MARRS #1409USA012155). Upon internal review cesarean section was considered as important medical events. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive, Rhesus antibodies positive, Streptococcus test positive, Ultrasound scan normal
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant refers to a 30 year old female patient. On 07-JUL-2014, the pregnant patient was inadvertently vaccinated with GARDASIL lot # J009788, 0.5 ml, intramuscular. The patient sought medical attention in the office. The patient became pregnant with LMP of 23-NOV-2013 and EDD of 30-AUG-2014. No adverse effects reported. No further information provided. Follow up information has been received from medical assistant concerning a female patient with bacterial infection due to streptococcus, group B (GBS) carrier and no known drug allergies. Medical history included a previous pregnancy (macrosomic infant, male born in 2010 at 40 weeks from LMP). The patient was a smoker and occasional drinker. On 03-FEB-2014, at 10 weeks pregnant, the pregnancy test, result was Urine Serum. On 18-MAR-2014, at 16 weeks pregnant, the Rhesus antibodies (ABO/RH) A+ and the Alpha 1 foetoprotein (AFP4) was negative. On 03-APR-2014, at 19 (also reported as "19/2") weeks pregnant, results was reported as Nml. On 12-MAY-2014, at 24 weeks pregnant, the glucose was 118 (unit not reported). On 07-AUG-2014, at 36 weeks pregnant, the B-strep was positive. Concomitant therapies included Prenatal DHA one every day, oral since 13-MAR-2014 for pregnancy and iron (unspecified) 325 mg, oral, one every day since 26-AUG-2014 for anemia. On 26-AUG-2014 (also reported as 26-AUG-2013), at 39.3 weeks of pregnancy, live birth, the patient delivered a single male baby by cesarean section and position of breech. Conflict information was reported as the patient had an abortion on an unknown date, but the pregnancy ended as a live birth on 26-AUG-2014 at 39.3 weeks from LMP. The male baby born normal, without any congenital anomalies, the Apgar score was 8 at 1 minute and 9 at 5 minutes and the birth weight was 9 lb 14 oz. The patient was not admitted to the hospital or stay prolonged due to complication after the delivery. Neither the baby or the mother experienced complications during the delivery. At delivery baby had an bacterial infection due to streptococcus, group B (captured into MARRS #1409USA012155). Upon internal review cesarean section was considered as important medical events. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Cold sweat, Joint stiffness, Migraine, Musculoskeletal stiffness
Clinical narrative: This 27 year old patient reported receipt of AVA #3 (lot #FAV371A on 8/2/2014 in preparation for upcoming deployment on 8/25/2014 (later canceled)). Approximately 8/13/2014 (11 days after receipt of 8/2/2014 AVA vaccine), he complained of diffuse joint pain (fingers, neck-shoulders), myalgia (all over), fever/night sweats, and headaches - see below timeline of events. He was using MOTRIN for pain/fevers. Timeline of events: 8/2/2014: Received AVA #3. Site burned and sore x5 days. 8/8/2014: at gym, bench pressing up to and over 200 lbs (normal). 8/13/2014: all joints and neck sore. 8/14/2014: night sweats and shivering - couldn't turn head ear/shoulder (ok chin to chest). 8/15/2014: headache, fever, shivering. 8/16/2014: to ER, negative blood work, no X-rays, no fever and sent home. 8/19/2014: throat sore, limited mobility neck ear-shoulder or chin to shoulder but okay chin to chest, neck hurts paraspinal muscles. Seen at hospital. Recalls tick bite 2 months ago but no red target lesion. Advised normally exercises 5x/wk in gym, not this week due to sore muscles all over. Joints hut in PIP knuckles 5/10 bilaterally. Neck pain 8/10 without MOTRIN-advised neck feels like it's swollen and muscles hurt to touch. HA 8/10 and dizziness...pain to front of head over eyes, no visual changes. Dizziness is room spinning and feels like balance is off. 8/20/2014: Eval by MD: considering Lyme disease. 8/25/2014: lab positive for Lyme disease, on antibiotics and feeling much better. During his evaluation, he recalls being bitten by a tick 2 months prior to receipt of his AVA vaccine. Lab findings were positive for Lyme disease and he was placed on antibiotics with easing of all symptoms on 8/25/2014.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Balance disorder, Blood test normal, Borrelia test positive, Chills
Clinical narrative: This 27 year old patient reported receipt of AVA #3 (lot #FAV371A on 8/2/2014 in preparation for upcoming deployment on 8/25/2014 (later canceled)). Approximately 8/13/2014 (11 days after receipt of 8/2/2014 AVA vaccine), he complained of diffuse joint pain (fingers, neck-shoulders), myalgia (all over), fever/night sweats, and headaches - see below timeline of events. He was using MOTRIN for pain/fevers. Timeline of events: 8/2/2014: Received AVA #3. Site burned and sore x5 days. 8/8/2014: at gym, bench pressing up to and over 200 lbs (normal). 8/13/2014: all joints and neck sore. 8/14/2014: night sweats and shivering - couldn't turn head ear/shoulder (ok chin to chest). 8/15/2014: headache, fever, shivering. 8/16/2014: to ER, negative blood work, no X-rays, no fever and sent home. 8/19/2014: throat sore, limited mobility neck ear-shoulder or chin to shoulder but okay chin to chest, neck hurts paraspinal muscles. Seen at hospital. Recalls tick bite 2 months ago but no red target lesion. Advised normally exercises 5x/wk in gym, not this week due to sore muscles all over. Joints hut in PIP knuckles 5/10 bilaterally. Neck pain 8/10 without MOTRIN-advised neck feels like it's swollen and muscles hurt to touch. HA 8/10 and dizziness...pain to front of head over eyes, no visual changes. Dizziness is room spinning and feels like balance is off. 8/20/2014: Eval by MD: considering Lyme disease. 8/25/2014: lab positive for Lyme disease, on antibiotics and feeling much better. During his evaluation, he recalls being bitten by a tick 2 months prior to receipt of his AVA vaccine. Lab findings were positive for Lyme disease and he was placed on antibiotics with easing of all symptoms on 8/25/2014.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Dizziness, Headache, Injection site pain, Local swelling, Mobility decreased
Clinical narrative: This 27 year old patient reported receipt of AVA #3 (lot #FAV371A on 8/2/2014 in preparation for upcoming deployment on 8/25/2014 (later canceled)). Approximately 8/13/2014 (11 days after receipt of 8/2/2014 AVA vaccine), he complained of diffuse joint pain (fingers, neck-shoulders), myalgia (all over), fever/night sweats, and headaches - see below timeline of events. He was using MOTRIN for pain/fevers. Timeline of events: 8/2/2014: Received AVA #3. Site burned and sore x5 days. 8/8/2014: at gym, bench pressing up to and over 200 lbs (normal). 8/13/2014: all joints and neck sore. 8/14/2014: night sweats and shivering - couldn't turn head ear/shoulder (ok chin to chest). 8/15/2014: headache, fever, shivering. 8/16/2014: to ER, negative blood work, no X-rays, no fever and sent home. 8/19/2014: throat sore, limited mobility neck ear-shoulder or chin to shoulder but okay chin to chest, neck hurts paraspinal muscles. Seen at hospital. Recalls tick bite 2 months ago but no red target lesion. Advised normally exercises 5x/wk in gym, not this week due to sore muscles all over. Joints hut in PIP knuckles 5/10 bilaterally. Neck pain 8/10 without MOTRIN-advised neck feels like it's swollen and muscles hurt to touch. HA 8/10 and dizziness...pain to front of head over eyes, no visual changes. Dizziness is room spinning and feels like balance is off. 8/20/2014: Eval by MD: considering Lyme disease. 8/25/2014: lab positive for Lyme disease, on antibiotics and feeling much better. During his evaluation, he recalls being bitten by a tick 2 months prior to receipt of his AVA vaccine. Lab findings were positive for Lyme disease and he was placed on antibiotics with easing of all symptoms on 8/25/2014.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Myalgia, Neck pain, Night sweats, Oropharyngeal pain, Pyrexia
Clinical narrative: This 27 year old patient reported receipt of AVA #3 (lot #FAV371A on 8/2/2014 in preparation for upcoming deployment on 8/25/2014 (later canceled)). Approximately 8/13/2014 (11 days after receipt of 8/2/2014 AVA vaccine), he complained of diffuse joint pain (fingers, neck-shoulders), myalgia (all over), fever/night sweats, and headaches - see below timeline of events. He was using MOTRIN for pain/fevers. Timeline of events: 8/2/2014: Received AVA #3. Site burned and sore x5 days. 8/8/2014: at gym, bench pressing up to and over 200 lbs (normal). 8/13/2014: all joints and neck sore. 8/14/2014: night sweats and shivering - couldn't turn head ear/shoulder (ok chin to chest). 8/15/2014: headache, fever, shivering. 8/16/2014: to ER, negative blood work, no X-rays, no fever and sent home. 8/19/2014: throat sore, limited mobility neck ear-shoulder or chin to shoulder but okay chin to chest, neck hurts paraspinal muscles. Seen at hospital. Recalls tick bite 2 months ago but no red target lesion. Advised normally exercises 5x/wk in gym, not this week due to sore muscles all over. Joints hut in PIP knuckles 5/10 bilaterally. Neck pain 8/10 without MOTRIN-advised neck feels like it's swollen and muscles hurt to touch. HA 8/10 and dizziness...pain to front of head over eyes, no visual changes. Dizziness is room spinning and feels like balance is off. 8/20/2014: Eval by MD: considering Lyme disease. 8/25/2014: lab positive for Lyme disease, on antibiotics and feeling much better. During his evaluation, he recalls being bitten by a tick 2 months prior to receipt of his AVA vaccine. Lab findings were positive for Lyme disease and he was placed on antibiotics with easing of all symptoms on 8/25/2014.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abdominal distension, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Very big swelling of arm. Upset stomach, fever 102 degrees, chills, very sick. Still have large knot on arm. Red rash, blurred vision, sore throat. Itching all over. Still not normal. Two vaccines same spot.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Very big swelling of arm. Upset stomach, fever 102 degrees, chills, very sick. Still have large knot on arm. Red rash, blurred vision, sore throat. Itching all over. Still not normal. Two vaccines same spot.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abdominal discomfort, Chills, Local swelling, Malaise, Mass
Clinical narrative: Very big swelling of arm. Upset stomach, fever 102 degrees, chills, very sick. Still have large knot on arm. Red rash, blurred vision, sore throat. Itching all over. Still not normal. Two vaccines same spot.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Nodule, Oropharyngeal pain, Pruritus generalised, Pyrexia, Rash erythematous
Clinical narrative: Very big swelling of arm. Upset stomach, fever 102 degrees, chills, very sick. Still have large knot on arm. Red rash, blurred vision, sore throat. Itching all over. Still not normal. Two vaccines same spot.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Vision blurred, Visual acuity reduced
Clinical narrative: Very big swelling of arm. Upset stomach, fever 102 degrees, chills, very sick. Still have large knot on arm. Red rash, blurred vision, sore throat. Itching all over. Still not normal. Two vaccines same spot.
Age: 5.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Gastric dilatation, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Swelling in leg, fever 101 degrees, very sick, chills. Two vaccines same place. Red rash. Feeling better. He gotten a different vaccine then my daughter and I.
Age: 5.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Swelling in leg, fever 101 degrees, very sick, chills. Two vaccines same place. Red rash. Feeling better. He gotten a different vaccine then my daughter and I.
Age: 5.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Chills, Local swelling, Malaise, Pyrexia, Rash erythematous
Clinical narrative: Swelling in leg, fever 101 degrees, very sick, chills. Two vaccines same place. Red rash. Feeling better. He gotten a different vaccine then my daughter and I.
Age: 16.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abdominal distension, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Swelling of arm, fever 101 degrees, upset stomach, chills, belly swelling, very sick for 5 days, still sick. Two vaccines same spot. Red rash. Still not normal.
Age: 16.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Swelling of arm, fever 101 degrees, upset stomach, chills, belly swelling, very sick for 5 days, still sick. Two vaccines same spot. Red rash. Still not normal.
Age: 16.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abdominal discomfort, Abdominal distension, Chills, Local swelling, Malaise
Clinical narrative: Swelling of arm, fever 101 degrees, upset stomach, chills, belly swelling, very sick for 5 days, still sick. Two vaccines same spot. Red rash. Still not normal.
Age: 16.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Swelling of arm, fever 101 degrees, upset stomach, chills, belly swelling, very sick for 5 days, still sick. Two vaccines same spot. Red rash. Still not normal.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Axillary pain, Diarrhoea, Lymph node pain, Pyrexia
Clinical narrative: A few hours after her place of employment gave her the vaccine in left deltoid, pt felt feverish and had left axillary pain. Saw me at Student Health the next day, no fever but tender 2 cm left axillary node. A 2 cm node left supraclavicular noted 9/22/14 on recheck by me with persistence of L ax node. Pt also having persistent arthragias, had diarrhea on 9/19 and 9/20 that resolved.
Age: 18.0
Sex: M
Vaccine: HEPAB, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak on proximal posterior left thigh.
Age: 9.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Computerised tomogram head, Erythema, Full blood count, Hypoaesthesia, Local swelling
Clinical narrative: Left arm redness, pain, swelling, numbness, tingling, which radiated to her left leg.
Age: 9.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Metabolic function test, Pain in extremity, Paraesthesia
Clinical narrative: Left arm redness, pain, swelling, numbness, tingling, which radiated to her left leg.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13, RV5
Symptoms: Condition aggravated, Intestinal obstruction, Intestinal operation, Pyrexia, Vomiting
Clinical narrative: HIS VOMITING BECAME WORSE, HE HAD A FEVER AND ENDED UP WITH ANOTHER BLOCKAGE. HE'S HAD 5 SURGERIES SINCE.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bone pain
Clinical narrative: Bone aching and joint pain.
Age: 1.25
Sex: F
Vaccine: FLUX, HIBV, MMR
Symptoms: Gait disturbance, Toe walking, Weight bearing difficulty
Clinical narrative: Patient received MMR & Hib in left thigh and flu in right thigh at 12:15pm. At 4:15 pm, after waking from a nap, patient completely refused to bear weight on left leg. After administration of Motrin & warm compresses, patient would bear weight on left leg but would only toe walk with severe limp. On day #2, patient ambulated with limp. On day #3, patient began toe walking again. Toe walking was worse after waking in the morning, after sitting for extended periods, and after taking nap. Patient limped for total of 8 days but limp resolved completely by the evening of 9/23. There were no other symptoms. There was no erythema, swelling, or induration of left leg. Patient's leg had full range of motion and full strength throughout the 8 days. No fevers. Patient did not seem in pain or seem overly irritable.
Age: 1.35
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Body temperature increased, Eye movement disorder, Febrile convulsion, Somnolence, Swelling face
Clinical narrative: Pt was seen for 15 month WCC on 9/16. Pt received Dtap and Hib vaccines. About 36 hours later on 9/17, pt awoke from sleep, mom noted swelling of his entire face, pt put his arm to his chest, his eyes rolled back and he had whole body shaking for 30 seconds. Pt was unresponsive during the episode and was sleepy for 30 minutes afterwards. Pt was evaluated in the ER. Pt's temp was 100.2 in the ER, pt received motrin, was diagnosed with simple febrile seizure, and instructed to follow up with PCP. Per mom, pt did not have a fever at home prior to seizure, pt did not feel warm during event, and pt did not receive any anti-pyretic at home. Pt did not have any associated nasal drainage/congestion, ear pain, vomiting, diarrhea, or rash around the time of the event.
Age: 1.35
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Pt was seen for 15 month WCC on 9/16. Pt received Dtap and Hib vaccines. About 36 hours later on 9/17, pt awoke from sleep, mom noted swelling of his entire face, pt put his arm to his chest, his eyes rolled back and he had whole body shaking for 30 seconds. Pt was unresponsive during the episode and was sleepy for 30 minutes afterwards. Pt was evaluated in the ER. Pt's temp was 100.2 in the ER, pt received motrin, was diagnosed with simple febrile seizure, and instructed to follow up with PCP. Per mom, pt did not have a fever at home prior to seizure, pt did not feel warm during event, and pt did not receive any anti-pyretic at home. Pt did not have any associated nasal drainage/congestion, ear pain, vomiting, diarrhea, or rash around the time of the event.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth and swelling of right thigh.  Not hard or indurated.  Non tender.  No discharge or drainage.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Muscle in right arm extremely sore and noticed a big red swollen area about an inch lower than the point of injection.  I went to bed, woke up on 9/24/14 and thee's now 4 large thick swollen lines across my arm.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Myalgia
Clinical narrative: Muscle in right arm extremely sore and noticed a big red swollen area about an inch lower than the point of injection.  I went to bed, woke up on 9/24/14 and thee's now 4 large thick swollen lines across my arm.
Age: 18.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea
Clinical narrative: Extreme nausea and dizziness.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall, Somnolence, Unresponsive to stimuli
Clinical narrative: 10 minutes after shot, walked away felt dizzy and fell. Called facility and 911 became more unresponsive. Felt sleepy. EMT arrived more responsive but took to hosp.