chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Oropharyngeal pain, Sinus headache, Sneezing, Throat irritation
Clinical narrative: Began getting scratchy throat just after lunch time, then around 3:00 pm started minor sneezing, about 5:00 pm had stuffy nose and more "productive" sneezing, took Nyquil about 10:00 pm and went to bed.  Awakened about 4:00 am 9/30 with very sore throat (postnasal drip) and sinus headache.  Took Advil and Ricola cough drop about 4:45 am.  "Steam cleared" sinuses in hot shower about 7:00 am.  Took Advil Cold and Sinus at 9:00 am but still experiencing sinus headache.  Sneezing has ceased for now and sore throat eased but not gone.  Could possibly not be related to the flu shot, but uncertain.  Husband had been fighting a cold for past three weeks or so and I had no symptoms earlier, plus I was at community activities on 9/27 and 9/28 and could have been exposed to other viruses at those venues, though I am usually careful about washing my hands regularly and not putting my hands near my face.  I did though, at both weekend events eat something after touching "shared use" pens for filling out forms, without first washing my hands.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Upper-airway cough syndrome
Clinical narrative: Began getting scratchy throat just after lunch time, then around 3:00 pm started minor sneezing, about 5:00 pm had stuffy nose and more "productive" sneezing, took Nyquil about 10:00 pm and went to bed.  Awakened about 4:00 am 9/30 with very sore throat (postnasal drip) and sinus headache.  Took Advil and Ricola cough drop about 4:45 am.  "Steam cleared" sinuses in hot shower about 7:00 am.  Took Advil Cold and Sinus at 9:00 am but still experiencing sinus headache.  Sneezing has ceased for now and sore throat eased but not gone.  Could possibly not be related to the flu shot, but uncertain.  Husband had been fighting a cold for past three weeks or so and I had no symptoms earlier, plus I was at community activities on 9/27 and 9/28 and could have been exposed to other viruses at those venues, though I am usually careful about washing my hands regularly and not putting my hands near my face.  I did though, at both weekend events eat something after touching "shared use" pens for filling out forms, without first washing my hands.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MNQ, HPV4
Symptoms: Blood test, Dizziness, Electrocardiogram, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately felt like her skin was on fire.  She then felt light headed following and still feels light headed and dizzy, her skin is tingly and she has had fainting spells where she blacks out and doesn't remember what happened along with shaking uncontrollably.  She has been seen in the emergency room and has had numerous tests done and is about to undergo even more tests.  She was a very healthy athlete upon getting this immunization she is not.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MNQ, HPV4
Symptoms: Paraesthesia, Skin burning sensation, Syncope, Tremor
Clinical narrative: Immediately felt like her skin was on fire.  She then felt light headed following and still feels light headed and dizzy, her skin is tingly and she has had fainting spells where she blacks out and doesn't remember what happened along with shaking uncontrollably.  She has been seen in the emergency room and has had numerous tests done and is about to undergo even more tests.  She was a very healthy athlete upon getting this immunization she is not.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MNQ, HPV4
Symptoms: Burning sensation, Convulsion, Dizziness, Malaise
Clinical narrative: Immediately felt like her skin was on fire.  She then felt light headed following and still feels light headed and dizzy, her skin is tingly and she has had fainting spells where she blacks out and doesn't remember what happened along with shaking uncontrollably.  She has been seen in the emergency room and has had numerous tests done and is about to undergo even more tests.  She was a very healthy athlete upon getting this immunization she is not.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Lethargy, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Nausea/Vomiting; Soreness; Lethargy; Fever.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Anaphylactic reaction, Angioedema, Dyspnoea
Clinical narrative: Difficulty breathing; Anaphylaxis; Angioedema.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, X-ray
Clinical narrative: Pain in the arm/area where vaccine was given.  Difficulty lifting arm over ahead, bringing arm across chest and chronic ache.  Went to Dr. to diagnosis, xray and Physical Therapy.  Dull ache continues.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Back pain, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Fatigue, malaise, generalized myalgias, headache, back pain, neck pain.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Neck pain
Clinical narrative: Fatigue, malaise, generalized myalgias, headache, back pain, neck pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Patient received vaccine on 9/27. On 9/28, she noticed a rash around the injection site. By the evening of 9/29, she had developed rash on both arms and both legs. By 9/30, rash has also appeared on her abdomen.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: I do not know the onset dates, but her Primary Care Doctor and Gynecologist should have all the records.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Headache, Lethargy, Nausea, Pyrexia
Clinical narrative: Nausea, headache, lethargy, and mild fever.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Patient had a runny nose and sore throat and cough.
Age: 73.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: At this time no adverse reactions reported.  Patient received Zostavax 08/23/2013 and 09/30/2014.
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance
Clinical narrative: This spontaneous report has been received from a physician via the field employee refers to a female patient of unknown age. On an unspecified date, the patient was vaccinated with GARDASIL. No concomitant therapy was reported. Physician reported that there was a video, where a girl stated that she had difficulty walking (disability) after her second dose of GARDASIL on an unspecified date. Whether the patient sought medical attention was not specified. No product quality complaint was involved. The physician heard about that video from his patients. The present status and the outcome of the event was unknown. The reporter causality assessment was not reported. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt awoke with pain and redness in upper arm in area where it was administered.  She states the area is hot to the touch.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Full body hives, raised welts x5 days. Benadryl given PO x3.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site hypersensitivity, Injection site vesicles
Clinical narrative: Injection spot bled quickly. Bubble appeared under skin at injection site. Seemed to be immediate allergic reaction or blood had formed a pocket under the skin.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haematoma
Clinical narrative: Pt had hematoma develop at injection site.
Age: 0.76
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash papular
Clinical narrative: Grandmother came to clinic today 09/30/2014 said child got rash the day after the vaccines was administered. Generalized papular rash noted to include head and soles of feet.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Flat erythematous area 4" x 6" in size.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Left deltoid has lump which itches and very sore and sensitive.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Chest pain, Dizziness, Headache
Clinical narrative: Felt lightheaded and had headache that started about 20 min post injection. Got progressively worse. Began having chest pain around 11am. Took a dose of Benadryl. Did not subside. Went to ER and was given "something for anxiety".
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Ear swelling, Eye swelling, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Swelling, pain, itching and redness to injection site.  By the next morning patient had swollen ears and left eye and hives.  Went to Urgent Care- tx: Benadryl and prednisone.  By Sunday morning swelling increased to whole face, hives increased to whole body.  Went to ER, tx: injection of Benadryl and Prednisone.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Swelling face, Urticaria
Clinical narrative: Swelling, pain, itching and redness to injection site.  By the next morning patient had swollen ears and left eye and hives.  Went to Urgent Care- tx: Benadryl and prednisone.  By Sunday morning swelling increased to whole face, hives increased to whole body.  Went to ER, tx: injection of Benadryl and Prednisone.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Pt. receive a Zostavax vaccination on 3/15/2014. Pt. stated he had a rash at the injection site and on left side of his abdomen. He did not mention when the reaction occurred however he did state that he saw his primary care physician and his doctor state, "That's good." He also stated the rash is gone.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Pyrexia, Urticaria
Clinical narrative: FEVER 9/15. HIVES, FEVER 102 9/16. TYLENOL, ADVIL AND BENADRYL GIVEN. 9/17 RESOLVED FEW HIVES NO FEVER RESOLVED BY AFTERNOON.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: PATIENT DEVELOPED A RED RASH AT THE INJECTION SITE DAYS AFTER THE VACCINE. THE RASH HAS BEEN OCCURRING INTERMITTENTLY SINCE VACCINE ADMINISTRATION.
Age: 0.41
Sex: M
Vaccine: DTAP
Symptoms: Consciousness fluctuating, Crying, Eye movement disorder, Hypotonia, Loss of consciousness
Clinical narrative: Intense crying/screaming followed by loss of consciousness (eyes rolled back, went limp in my arms). After a while I was able to rouse him, but he passed out off and on for about 3 minutes.
Age: 0.41
Sex: M
Vaccine: DTAP
Symptoms: Screaming
Clinical narrative: Intense crying/screaming followed by loss of consciousness (eyes rolled back, went limp in my arms). After a while I was able to rouse him, but he passed out off and on for about 3 minutes.
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Pharyngeal oedema, Swelling face, Urticaria
Clinical narrative: Hives on face, swelling of the face and throat, difficulty breathing.  Epinephrine injection was administered.  Events continued every 4-6 hours.  Epinephrine injection was required again on 09/26/2014 at 3:15PM.  On 09/27/2014 at 6:15 PM patient required emergency room visit again due to difficulty breathing.
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Speech disorder, Swelling face
Clinical narrative: Hives on face, swelling of the face and throat, difficulty breathing.  Epinephrine injection was administered.  Events continued every 4-6 hours.  Epinephrine injection was required again on 09/26/2014 at 3:15PM.  On 09/27/2014 at 6:15 PM patient required emergency room visit again due to difficulty breathing.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Lethargy, Pain
Clinical narrative: Body aches, lethargic, possible fever, site pain with redness.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Electrocardiogram normal, Syncope
Clinical narrative: Syncopal episode during exercise.
Age: 77.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Dyspnoea, Headache, Heart rate irregular, Injection site rash
Clinical narrative: Headache, rash/swelling at site. 9/22/14 developed shortness of breath, dizziness, heart irregularity; took Prednisone and symptoms gradually subsided.
Age: 77.0
Sex: F
Vaccine: VARCEL
Symptoms: Testicular swelling
Clinical narrative: Headache, rash/swelling at site. 9/22/14 developed shortness of breath, dizziness, heart irregularity; took Prednisone and symptoms gradually subsided.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Vomiting
Clinical narrative: VOMITING 4 TIMES IN THE NIGHT. ON THE FLUIDS ALL DAY HOWEVER VOMITING CONTINUED.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Patient had a local reaction, with swelling and redness around the injection site that was raised and about 5 inches long and 2 inches wide. Started as a small reaction the morning of 9/30/14 and increased to be much larger as of 3:15pm 9/30/14.
Age: 11.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm swollen and warm to touch. Large raised circle 2.25 inches in diameter. Smaller raised circle 1.5 inches in diameter. Complains of pain from right shoulder to elbow.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Dizziness, Injection site erythema, Respiratory tract congestion
Clinical narrative: Within 10 minutes: lightheaded, dizzy. Within 20 minutes: redness at injection site, global congestion, angioedema.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ
Symptoms: Erythema, Induration, Local swelling, Skin warm
Clinical narrative: Large indurated hot to touch 7cm x 3cm size erythematous swelling over L arm; no blisters or vesicles.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose increased, Cellulitis, Erythema, Pain in extremity, Pyrexia
Clinical narrative: Celluitis of the L arm. Pt presented with painful, red L arm along with fever and elevated blood glucose.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Enema administration, Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Vomiting for one day; intussusception diagnosed.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blindness, Blood blister, Dizziness, Headache, Nausea
Clinical narrative: Approx 15 min after shot, while standing at check out, dizziness to vision black out, to syncope.  BP drop to 70/50, pale, nausea, severe headache, severe pain in arm.  Hours later - spontaneous blood blister appeared on inside of leg.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity, Pallor
Clinical narrative: Approx 15 min after shot, while standing at check out, dizziness to vision black out, to syncope.  BP drop to 70/50, pale, nausea, severe headache, severe pain in arm.  Hours later - spontaneous blood blister appeared on inside of leg.
Age: 36.0
Sex: M
Vaccine: TTOX
Symptoms: Headache, Lethargy
Clinical narrative: REPORTED HEADACHE AND LETHARGY STARTING  09/24/2014 AND RESOLVING 0N 09/27/2014. NO REPORTED TREATMENT.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Incorrect dose administered, Injected limb mobility decreased, Injection site pain, Pruritus, Pyrexia
Clinical narrative: Site of shot upper arm very sore, feverish, following day could barely lift arm. Two days later had a red rash over chest, back, neck and arm. Third day I began itching..Fourth day..rash gone but arm sore but usable. Monday symptoms lessens.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rash, Rash erythematous, Rash generalised
Clinical narrative: Site of shot upper arm very sore, feverish, following day could barely lift arm. Two days later had a red rash over chest, back, neck and arm. Third day I began itching..Fourth day..rash gone but arm sore but usable. Monday symptoms lessens.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Local swelling, Musculoskeletal stiffness
Clinical narrative: Patients states she woke up the next morning with unusually stiff arm. Upper arm was swollen and very badly bruised. Patient reported reaction to pharmacy on 9/30/14. Arm is no longer swollen but bruise approximately 2x2 inches still very apparent.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Epistaxis
Clinical narrative: Patient's nose started bleeding and wouldn't stop for at least 15 minutes.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Dysgeusia, Fatigue
Clinical narrative: LOSS OF BALANCE, FATIGUE, METALLIC TASTE IN MOUTH.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site.  Given Bactrim DS 1 tablet twice daily for 10 days.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Basophil count decreased, Blood bilirubin increased, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Cardiac stress test abnormal
Clinical narrative: At 10:15pm, patient started having left chest discomfort last 2.5 hours and then finally improved.  AM of 12/02/2013, "felt some pressure or a funny feeling" in left chest area and shortness of breath.  12/02/13 at 11:30, patient saw a PA in the clinic whom reviewed case with the PA's Dr. 12/06/2014 - saw Cardiologist and started Advil 2 PO t.i.d.  Impression is the chest pain more consistent with pericarditis and inflammatory process.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Lymphocyte count decreased
Clinical narrative: At 10:15pm, patient started having left chest discomfort last 2.5 hours and then finally improved.  AM of 12/02/2013, "felt some pressure or a funny feeling" in left chest area and shortness of breath.  12/02/13 at 11:30, patient saw a PA in the clinic whom reviewed case with the PA's Dr. 12/06/2014 - saw Cardiologist and started Advil 2 PO t.i.d.  Impression is the chest pain more consistent with pericarditis and inflammatory process.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pericarditis, Scan myocardial perfusion normal, Troponin I increased, White blood cell count decreased
Clinical narrative: At 10:15pm, patient started having left chest discomfort last 2.5 hours and then finally improved.  AM of 12/02/2013, "felt some pressure or a funny feeling" in left chest area and shortness of breath.  12/02/13 at 11:30, patient saw a PA in the clinic whom reviewed case with the PA's Dr. 12/06/2014 - saw Cardiologist and started Advil 2 PO t.i.d.  Impression is the chest pain more consistent with pericarditis and inflammatory process.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Croup infectious, Nasopharyngitis
Clinical narrative: 9/23 Received vaccine in setting prolonged cold, no fever, no h/o asthma. 9/25 at 3 AM hospitalized for croup.
Age: 69.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old female patient. The patient's relevant medical history, relevant concomitant medications, and relevant past drug history are unknown. On 05-SEP-2014, the patient received a dose of PNEUMOVAX23 (strength, dose, and route not reported, lot # J004080) that had expired on 22-AUG-2014, for an unknown indication. It was unknown if there was relevant lab data. As of 05-SEP-2014, it was unknown if the patient was still on PNEUMOVAX23 and the outcome of receiving expired PNEUMOVAX23 was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
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. On 19-AUG-2014 the patient was vaccinated with an improperly stored (Oka/Merck) VARIVAX (lot # J009728, expiration date: 07-AUG-2015, dose , units, route of administration, anatomical location were not reported). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 19-SEP-2014, the patient was vaccinated with PROQUAD, 0.5 ml, subcutaneously, lot number and expiration date not reported and VARIVAX dose, lot number, expiration date not reported. No adverse effect reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dysphagia
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a 16 year old female patient.  On 15-JUL-2014 the patient was vaccinated with the first dose of GARDASIL, dose/frequency: 0.5 ml once, (route and lot # not reported). Concomitant therapies included ORTHO TRI-CYCLEN LO. On 16-SEP-2014, the patient reported to office that she had experienced chronic stomach aches since first shot and difficulty eating food (AE onset date was reported as 16-SEP-2014). Patient sought medical attention by  contacting the office. The outcome of events was reported as unresolved. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown ages and gender. On an unknown date the patients were vaccinated with a dose of ZOSTAVAX (strength, dose, route and lots unkbown) and a dose of (Oka/Merck) VARIVAX (strength, dose, route and lot # unknown) which were improperly stored. No adverse effects reported. Additional information has been requested,
Sex: U
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with HepB (manufacturer unknown) (dose, route of administration, lot and expiry date were not reported). On an unknown date the patient experienced severe unspecified allergic reaction to a HepB (manufacturer unknown). The patient's outcome was not reported. The event was considered to be related to HepB (manufacturer unknown). Additional information is not expected because the reporter does not wish to be contacted.
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. On 18-AUG-2014 the patient was vaccinated with an improperly stored VARIVAX (Merck) (lot # J012328, expiration date: 02-OCT-2015, dose, units, route of administration, anatomical location were not reported). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from medical assistant via other company refers to a 45 year old female adult patient. Patient's concurrent conditions included low IgA levels. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose and route unspecified). Concomitant medications were unknown. The patient had no antibody response. The medical assistant reported that the immunologist recommended PREVNAR 13. The reporter asked the appropriate dose of PREVNAR 13 for the patient and whether they get an repeat dose at a later time. The outcome of the events was unknown. The causality of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Erythema, Limb discomfort, Pain
Clinical narrative: Red, sore and painful to touch. Could not move arm comfortably. Patient was given shot on 9/19/14 and pain did not subside until 9/22/2014. But pain has subsided on 9/24/14 and continues to improve.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified patients of unknown age. The unspecified patient's medical history was not reported. On an unknown date, the unspecified patients were vaccinated with 7 doses of VAQTA (dose, frequency and route were not reported) which were improperly stored. No adverse events were reported. No product quality complaint was reported for VAQTA. This case is linked to 1409USA014917 and 1409USA014918 (same reporter link). Additional information has been requested.
Age: 0.07
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 3 week old female patient. On 20-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 lot number was J004387 with expiry date of 04-JAN-2015. On 21-SEP-2014, 2 days after onset of therapy the patient experienced cellulitis. The patient sought medical attention. Doxycycline was given for the event. The outcome of cellulitis was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified patients of unknown age. The unspecified patient's medical history was not reported. ON an unknown date, the unspecified patients were vaccinated with 8 doses of GARDASIL Idose, frequency, and route were not reported) which were improperly stored. No adverse events were reported. No product quality complaint was reported for GARDASIL. This case is linked to 1409JSA012424 and 1409USA014919 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 12-AUG-2014, an unknown number of patients were vaccinated with improperly stored single dose PNEUMOVAX 23 (lot#, dose, dose number and route were unspecified). No adverse effect was noted. This is one of several reports received from the same reporter. Follow up information has been received from the office manager regarding the patients. The office manager was able to share the lot# K009105 (expiration date 21-JAN-2016) for the PNEUMOVAX 23 that experienced a temperature excursion. The office manager had no patients' information or dates of vaccination available to share at this time. This is one of several reports received from the safe office manager. 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. On an unknown date the patient was vaccinated with M-M-R II lot number was H015829 with 24-AUG-2014. Medical assistant reported that five patient received doses of M-M-R II after the expiration date. The doses were administered on 28-AUG-2014, 17-SEP-2014, 22-SEP-2014, 23-SEP-2014. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referred to unspecified number of patients of unknown ages and genders. On unspecified dates in 2014, doses of ROTATEQ (Lot# and expired date unspecified) and other vaccines (captured in MARRS#1409USA008509, 1409USA008512, 1409USA006676, 1409USA008510, 1409USA008511, 1409USA008514) were administered to unspecified patients (doses, frequency and route unspecified), after exposed to temperatures of 10 C degree for 37.5 hours/temperature excursions with other vaccines on 08-AUG-2014, 13-AUG-2014 and 28-AUG-2014. No adverse effect has been reported. This is of the several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to a male patient of unknown age. On 16-SEP-2014 the patient was vaccinated with the first dose of GARDASIL typical dose, (lot #, strength and route unknown). On 16-SEP-2014, the patient experienced being light headed, breathing  heavy and dizzy after taking GARDASIL. The medical staff told the patient to stay calm bu tit was unknown whether the patient "passed out" or not. The outcome of breathing heavy, dizzy and light headed was unknown. The patient was given unspecified treatment. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, (lot# and expiration date not reported), 0.65 ml, subcutaneous. The pharmacist reported that the patient developed an unspecified rash on their stomach near their belly button a "week" after receiving ZOSTAVAX. The outcome of the event was reported as not recovered. The patient was seen by the physician on an unspecified date. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a multiple unspecified group of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (dose, frequency, lot #: not specified) that was improperly stored. Concomitant medication was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. 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 registered nurse refers to a multiple unspecified group of patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ (dose, frequency, lot #: not specified, orally) that was improperly stored. Concomitant medication was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site oedema, Injection site pain, Urticaria
Clinical narrative: ADACEL given 9/22/14. Patient developed 7 cm wheal - edema and pain at injection site within 48 hours of administration.
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site cyst
Clinical narrative: This spontaneous report as received from a company representative concerning an 8 month old male child. On an unknown date the patient was vaccinated with PEDVAXHIB. Concomitant therapies included PEDIARIX. On the same date the patient experienced asymptomatic cyst around the injection site after being administered PEDVAXHIB. The patient sought medical attention. The outcome of asymptomatic cyst around the injection site was reported as not recovered/not resolved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Pts. Left thigh was swollen with splotch red/pink skin warm to touch and painful. Pt was started on antibiotics for 10 day treatment. Per FNP reaction to DTAP and need to be reported.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Rash macular
Clinical narrative: Pts. Left thigh was swollen with splotch red/pink skin warm to touch and painful. Pt was started on antibiotics for 10 day treatment. Per FNP reaction to DTAP and need to be reported.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified patients of unknown age. The unspecified patients medical history was not reported. On an unknown date, the unspecified patients were vaccinated with 7 doses of ROTATEQ (dose and frequency were not reported) which were improperly stored. No adverse events were reported. No product quality complaint was reported for ROTATEQ. This case is linked to 1409USA012424 and 1409USA014917 (same reporter link). Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Pyrexia, Rash, Skin warm
Clinical narrative: Fever, chills, fatigue, rash, warm to touch.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Breast inflammation, Erythema, Skin irritation
Clinical narrative: Breast inflammation near nipple next morning for 2 days. Only on side of body where flu shot was given. Redness and slightly irritating.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Patient diagnosed with cellulitis. Pt currently on doxycycline therapy.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient received her flu shot on 9/20/14 and after receiving the vaccine she fainted.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Pyrexia
Clinical narrative: Pt reported feeling dizzy, weak, and feverish several hours after vaccine administration. No reaction at injection site.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity, Periarthritis
Clinical narrative: Frozen and painful arm and shoulder. Unable to move shoulder for 5 days.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Patient received vaccine and developed swelling (3" x 6"), redness, warm to touch on arm.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed redness-swelling at site of vaccination.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site infection
Clinical narrative: Infection at site. Patient showed arm (left) to Rph - very red in region of injection (2). Dr started abx but not sure of any other markers of infection. No pus/drainage.
Age: 22.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Whole arm swollen after carrying child. Red, hard, hot from injection site to fingers (L) arm. Pt treated with ice and 400 mg MOTRIN PO, reaction resolved in approximately 15 min.
Age: 22.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Local swelling, Skin warm
Clinical narrative: Whole arm swollen after carrying child. Red, hard, hot from injection site to fingers (L) arm. Pt treated with ice and 400 mg MOTRIN PO, reaction resolved in approximately 15 min.
Age: 1.37
Sex: F
Vaccine: MMR, PNC13
Symptoms: Dizziness, Nasal congestion, Rash
Clinical narrative: Transient rash. Mom says pt dizzy from nasal congestion.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Patient's arm swelled up, became very red, and itchy for 4 days.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Injection site started to swell 90 minutes after injection and became itchy. Patient said the site became swollen to the size of a baseball. She iced the injection site and was instructed to take cetirizine on 9/17/14 by a nurse at her place of work. She said the injection site continued to flare up and flare down for about 4 days.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Disorientation, Dizziness, Hallucination, Pain, Pyrexia
Clinical narrative: Fever - 101.2, ached all over, hallucinating, disoriented, even hair hurt. Shot at 11am - dizzy by 5:00pm. Lasted about 24 hours.
Age: 0.15
Sex: M
Vaccine: DTAP, HIBV, RV5
Symptoms: Blood culture, Chest X-ray normal, Computerised tomogram head normal, Convulsion, Culture urine
Clinical narrative: Vaccines were administered on 9-9-14 and patient had fever on 9-12-14 and 2 seizures on 9-15-14 along with irritability. Seen in ER and prescribed KEPPRA and DIASTAT PRN.
Age: 0.15
Sex: M
Vaccine: DTAP, HIBV, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Vaccines were administered on 9-9-14 and patient had fever on 9-12-14 and 2 seizures on 9-15-14 along with irritability. Seen in ER and prescribed KEPPRA and DIASTAT PRN.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist concerning a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was unknown. On 13-SEP-2014 the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot number: J009827 with expiry date of 10-AUG-2014) (0.5 ml) intramuscularly. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, Local swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a 52 year old female patient who was allergic to macrolides, tetracycline, morphine and salicylates. The patient had experienced pain and swelling at the injection site in the past after receiving unspecified flu vaccines. On 19-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (in the left arm, 0.5 ml, intramuscularly, lot # H014653, expiration date, 19-APR-2014). Concomitant therapies included budesonide, SYMBICORT, XOPENEX, ibuprofen, SINGULAIR and NEXIUM. In September 2014 (exact date unspecified, reported as after receiving expired PNEUMOVAX 23) the patient was experiencing swelling and pain of her left arm. The patient was told to apply ice packs to her arm and to take BENADRYL. The patient sought medical attention via calling the pharmacy. The outcome of events was not reported. The relatedness between events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Dyspnoea, Ear discomfort, Headache, Oropharyngeal pain
Clinical narrative: Headache, fever starting 3 days after administration. SOB, throat closing up, sore throat, cough, ear discomfort.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Throat tightness
Clinical narrative: Headache, fever starting 3 days after administration. SOB, throat closing up, sore throat, cough, ear discomfort.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a multiple unspecified group of patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (dose, frequency, lot #: not specified) that was improperly stored. Concomitant medication was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to multiple number of patients (reported as 10-15) of unknown age and gender. Patients concurrent conditions and relevant medical history was not reported. The reporter stated that since 12-AUG-2014, unspecified number of patients (about 10-15) have been vaccinated with VARIVAX (Merck) (dose, lot number and route unspecified) which was improperly stored. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with VARIVAX (Merck) was not reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Red 3-4 inches below site of injection. Warm and painful.
Age: 0.32
Sex: F
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report refers to a 4-months old patient of unspecified gender, with no known drug allergies and no illness at time of vaccination.. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 11-JAN-2014 at 9:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient was revaccinated on 01-APR-2014 (the reporter reported the outcome as recovered on 01-APR-2014). No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 20.0
Sex: F
Vaccine: HPV4, PPV, TYP, YF
Symptoms: Cellulitis, Erythema, Injection site streaking, Injection site swelling, Oedema peripheral
Clinical narrative: 12/4 after shots patient reported red streaks and swelling in right armpit and around upper arm. Arm tender to touch painful with movement, bearing weight. 12/6 was seen by provider, arm still red/tender. Was treated for cellulitis with Clindamycin and Zyrtec.
Age: 20.0
Sex: F
Vaccine: HPV4, PPV, TYP, YF
Symptoms: Pain, Tenderness, Weight bearing difficulty
Clinical narrative: 12/4 after shots patient reported red streaks and swelling in right armpit and around upper arm. Arm tender to touch painful with movement, bearing weight. 12/6 was seen by provider, arm still red/tender. Was treated for cellulitis with Clindamycin and Zyrtec.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient with none drug reactions or allergies. On 16-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (in the left arm, intramuscular, 0.5 ml, lot # K006681, expiration date: 21-OCT-2015). Concomitant medications included ADACEL and unspecified influenza virus vaccine (reported as flu vaccine). In September 2014 (exact date unspecified, reported as after receiving PNEUMOVAX 23) the patient's left arm became swollen and red at the injection site and that also she felt sick and had no energy. None lab diagnostics studies were performed. The patient sought medical attention via calling the pharmacy. The pharmacist requested a lot check for PNEUMOVAX 23 (lot # K006681, expiration date: 21-OCT-2015) and requested a call back regarding the results of the lot check. The outcome of events was reported as recovering. The relatedness between events and PNEUMOVAX 23 was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DT, HIBV, IPV, PNC13, RV5
Symptoms: Screaming
Clinical narrative: Screaming continually > 5 hours. No treatment.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Headache, Influenza, Local swelling
Clinical narrative: Pt stated day after vaccinations she developed the flu stated temp of 103 degrees, headache, body aches lasting 2 days. Stated she was having the same symptoms her friend was having after receiving flu shot. Stated red swollen arm. When called if she could come in, stated no all better now. Pt displayed notable cognitive improvement.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: Pt stated day after vaccinations she developed the flu stated temp of 103 degrees, headache, body aches lasting 2 days. Stated she was having the same symptoms her friend was having after receiving flu shot. Stated red swollen arm. When called if she could come in, stated no all better now. Pt displayed notable cognitive improvement.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills
Clinical narrative: Chills without noticeable or measured fever.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Head injury, Loss of consciousness, Syncope
Clinical narrative: Pt stood up per MA did then fainted. Fell to the floor and hit her head on door. Lost consciousness for 5-10 seconds and then came to - sent to ER.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site mass, Injection site pain
Clinical narrative: Gave FLUVIRIN vaccine to patient. Patient bled and a tender lump formed where administered. Held patient for 10 minutes, no further symptoms. Told patient to ice area and call with any questions or worsens.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Rash erythematous
Clinical narrative: Red rash; flu like symptoms for several hours.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, IPV, MMRV
Symptoms: Incorrect dose administered, Wrong drug administered
Clinical narrative: Patient given a PENTACEL vaccine instead of a DAPTACEL and an IPV at the 4 yr physical. This meant that pt got an extra IPV and Hib.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Neuralgia
Clinical narrative: This spontaneous report was received from a consumer refers to a male patient of 73 years with shingles on and off for the last 5 years approximately on an unknown date in 2009. The patient's symptoms included blisters that eventually went away, but left scars that were white in color. About three years ago approximately on an unknown date in 2011 the patient informed his physician that he wanted to take the ZOSTAVAX. The patient encourage his physician to write a prescription to allow him to get the ZOSTAVAX even though he already had several severe shingles outbreaks. Concomitant therapies included tramadol hydrochloride and gabapentin. Since receiving the ZOSTAVAX approximately on an unknown date in 2011, the patient was still experiencing nerve pain in his neck and jaw area. Patient sought medical attention. No Product Quality Complaint (PQC) was involved. The outcome of still experiencing nerve pain in his neck and jaw area was unknown. Causality was not provided by the reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Blood potassium, Campylobacter infection, Decreased appetite, Diarrhoea, Headache
Clinical narrative: Fever, decreased appetite, (+) diarrhea, headaches. Inhalers, CLARITIN, (campylobacteriosis).
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Neutrophil count, Pyrexia, Red blood cell sedimentation rate, White blood cell count
Clinical narrative: Fever, decreased appetite, (+) diarrhea, headaches. Inhalers, CLARITIN, (campylobacteriosis).
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: Rash and nausea, vomiting. Methylprednisolone 125 mg once, diphenhydramine 1 tab PRN.