chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: About 48 hours after ZOSTAVAX administration patient developed a raised, red, tender rash about 5 inches in diameter near administrative site.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Injection site swelling, Paraesthesia, Pruritus
Clinical narrative: Patient began to experience mild-to-moderate signs of allergic reaction about 10-15 seconds post-IM injection, including local swelling in deltoid region, redness, minor itching, and "tingling" that spread up and down (R) arm. Emergency squad transported patient to ER where she received BENADRYL 25 mg injection and was discharged in "stable" condition.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Pain in extremity, Skin warm, Swelling
Clinical narrative: Red arm, swollen, hot, hard, painful. Site of injection look fine, but had bug bite on spot below from early summer.
Age: 17.0
Sex: M
Vaccine: HPV4
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. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 17-year old male patient, who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with a third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 20-JAN-2016, in the left arm, route not reported) on 23-JAN-2014 at 10:00 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). Parent were going to consult with physician. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. 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: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm (deltoid) swollen. About 5 x 5 inches red and puffy. Feels warm to tuoch. Painful.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching.
Age: 14.0
Sex: M
Vaccine: HPV4
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. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 14-year old male patient, who had a rash while on previous therapy with amoxicillin and had no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with a third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported) on 23-JAN-2014 at 3:40 PM. 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). Parents notified to re-vaccinate and declined to re-vaccinate. No adverse event was reported for the patient. Outcome was reported by the reporter as unknown. 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: 10.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pruritus
Clinical narrative: Vaccine administered 9/24/14, developed pruritus 9/28/14, now indurated, erythematous warm to touch area noted (L) upper arm.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Headache, Nasal congestion, Nasopharyngitis
Clinical narrative: Symptoms began day after vaccine, but consistent with highly prevalent URI in veteran patient community. Pt also c/o cold symptoms 2 weeks prior causing zoster vaccine to be rescheduled. Headache and fatigue, cough, rhinorrhea, nasal congestion.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: Symptoms began day after vaccine, but consistent with highly prevalent URI in veteran patient community. Pt also c/o cold symptoms 2 weeks prior causing zoster vaccine to be rescheduled. Headache and fatigue, cough, rhinorrhea, nasal congestion.
Age: 26.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Flushing, Gingivitis, Hallucination, Pyrexia, Stomatitis
Clinical narrative: Fever, gingivitis, stomatitis, flushing, hallucinations.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Throat tightness
Clinical narrative: 2 days after vaccination; arm red, itchy at injection site. Patient states throat tight. Prednisone ordered, triamcinolone cream, as well as BENADRYL.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse events noted. Given HPC instead of MENACTRA as ordered by MD. Last HPV #3 given 7-29-14.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 83 year old female patient. The patient's medical history included shingles. On 05-SEP-2014 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX. (lot#, strength, frequency and route unspecified). Within 24 hours after vaccination (approximately on 05-SEP-2014) the patient developed an active case of shingles. The outcome of shingles was reported as not recovered. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis rt deltoid.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Fever, chills.
Sex: U
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site inflammation, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient od unknown age and gender. On 09-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX23 (strength, dosage and route unknown) lot # K004148, expiration date: 10-MAY-2014. On unknown date in September 2014, the patient had a fever and had soreness at injection site after receiving the PNEUMOVAX23. The reporter stated that the patient had to leave work due to injection site being red and inflamed and Pharmacist was requesting a lot check on lot#K004148 exp. 10-MAY-2014. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient od unknown age and gender. On 09-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX23 (strength, dosage and route unknown) lot # K004148, expiration date: 10-MAY-2014. On unknown date in September 2014, the patient had a fever and had soreness at injection site after receiving the PNEUMOVAX23. The reporter stated that the patient had to leave work due to injection site being red and inflamed and Pharmacist was requesting a lot check on lot#K004148 exp. 10-MAY-2014. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (dose, route and lot number were not provided). No adverse effects were noted. Follow up information was received from the registered nurse. The registered nurse stated that she did not have patient identifiers or dates of vaccine administration available at this time. On an unknown date unspecified number of patients were vaccinated with PROQUAD (lot# K001850, expiration date 06-AUG-2015). No further information was available at this time. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored (oka-merck) PROQUAD (dose, route and lot number were not provided). No adverse effects were noted. Follow up information was received from the registered nurse. The registered nurse stated that she did not have patient identifiers or dates of vaccine administration available at this time. On an unknown date unspecified number of patients were vaccinated with (oka-merck) PROQUAD (lot# K000709, expiration date 16-JUL-2015). No further information was available at this time. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored (oka-merck) PROQUAD (dose, route and lot number were not provided). No adverse effects were noted. Follow up information was received from the registered nurse. The registered nurse stated that she did not have patient identifiers or dates of vaccine administration available at this time. On an unknown date unspecified number of patients were vaccinated with (oka-merck) PROQUAD (lot# K005883, expiration date 24-OCT-2015). No further information was available at this time. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Feeling cold, Injection site swelling, Local swelling
Clinical narrative: She was freezing after she got the shots whole body hurts, chills. Arm is red and swollen and hot to touch. She arm swollen at injection site (Pneumonia).
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Skin warm
Clinical narrative: She was freezing after she got the shots whole body hurts, chills. Arm is red and swollen and hot to touch. She arm swollen at injection site (Pneumonia).
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Ear discomfort, Headache, Pyrexia
Clinical narrative: Pt symptoms were headache, dizziness, fever, chills, drainage (nasal), clogged ears.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Pt symptoms were headache, dizziness, fever, chills, drainage (nasal), clogged ears.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Patient complain of "shakes" from High Dose Flu shot.
Age: 46.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Left arm was red and swollen. Pt went to hospital for evaluation and treatment. Was given KEFLEX 500mg #28 1 QID.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Hypersomnia, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Shoulder and chest area in lots of pain. Really stiff. Slept for 13 hr. From 4:30pm-6am next morning.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Pt describes feeling "hot" the day after receiving the vaccine and redness is observed at the site of injection. Pt states he's feeling better since the reaction 2 days ago.
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her sister of unknown age. On an unknown date the patient was vaccinated with M-M-R II (Albumin status, strength, frequency, dose, routed and lot # not reported) which was expired. No adverse experiences were reported. Additional information is not expected as there is no reporter's contact information provided.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Pain
Clinical narrative: Called on 09/29/2014 stating that she was in a great deal of discomfort/pain. She felt that the pharmacist had possibly injected her in her joint.  She wanted to report the event because she has never had such discomfort with a previous vaccination/flu shot.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Eye discharge, Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: Fussiness; Low grade Fever of 100.8; Yellow sticky gunk coming out of eyes; Runny nose.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue
Clinical narrative: Extreme fatigue.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Cognitive disorder, Confusional state, Glassy eyes, Muscle rigidity, Seizure like phenomena
Clinical narrative: Patient collapsed to the floor and appeared to be in a seizure-like state (rigid arms and body, glazed eyes and unresponsive to verbal stimulus) at 6PM.  State lasted approximately 3 to 5 minutes. Patient was confused when first coming out of seizure-like state and slowly over approximately 30 minutes regained cognition and was able to answer specific questions correctly. Patient was evaluated by EMS at pharmacy and refused to be taken to the emergency department for further evaluation.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Patient collapsed to the floor and appeared to be in a seizure-like state (rigid arms and body, glazed eyes and unresponsive to verbal stimulus) at 6PM.  State lasted approximately 3 to 5 minutes. Patient was confused when first coming out of seizure-like state and slowly over approximately 30 minutes regained cognition and was able to answer specific questions correctly. Patient was evaluated by EMS at pharmacy and refused to be taken to the emergency department for further evaluation.
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Gait disturbance, Grip strength decreased, Local swelling, Pain
Clinical narrative: Began to have itching on the bottom of my right foot, swelling began, red rash started, and foot became painful to walk on.  The following morning I awoke to the rash spreading up between my toes on my right foot, and both of my palms were red and itch, and my fingers were swollen.  There was a continuous tingling feeling in my hands and right foot, and when my fingers and toes needed to be moved to walk or hold something, the feeling was that of an extreme sunburn.  By evening, the rash had spread up between my fingers, and it began spreading up my forearm.  By the 2nd day, the rash and itching had started on my left foot. I saw my family doctor on the 3rd day and received a prednisone shot and a course of prednisone pills.  They helped some, but now on day 6, I am still itching, but the redness and pain has mostly subsided.
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity, Palmar erythema, Paraesthesia, Pruritus, Rash
Clinical narrative: Began to have itching on the bottom of my right foot, swelling began, red rash started, and foot became painful to walk on.  The following morning I awoke to the rash spreading up between my toes on my right foot, and both of my palms were red and itch, and my fingers were swollen.  There was a continuous tingling feeling in my hands and right foot, and when my fingers and toes needed to be moved to walk or hold something, the feeling was that of an extreme sunburn.  By evening, the rash had spread up between my fingers, and it began spreading up my forearm.  By the 2nd day, the rash and itching had started on my left foot. I saw my family doctor on the 3rd day and received a prednisone shot and a course of prednisone pills.  They helped some, but now on day 6, I am still itching, but the redness and pain has mostly subsided.
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Rash erythematous, Swelling
Clinical narrative: Began to have itching on the bottom of my right foot, swelling began, red rash started, and foot became painful to walk on.  The following morning I awoke to the rash spreading up between my toes on my right foot, and both of my palms were red and itch, and my fingers were swollen.  There was a continuous tingling feeling in my hands and right foot, and when my fingers and toes needed to be moved to walk or hold something, the feeling was that of an extreme sunburn.  By evening, the rash had spread up between my fingers, and it began spreading up my forearm.  By the 2nd day, the rash and itching had started on my left foot. I saw my family doctor on the 3rd day and received a prednisone shot and a course of prednisone pills.  They helped some, but now on day 6, I am still itching, but the redness and pain has mostly subsided.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Developed chills, started sweating and low grade fever.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Feeling abnormal, Nausea, Palpitations, Psychomotor hyperactivity
Clinical narrative: Hyper, heart-racing, off-balance, foggy-mind, nausea.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Vaccine was administered on 9/18/14, patient reported on 10/1/14 that 12 hours after he received the flu shot he had an anaphylactic reaction at home and had to call 911 and go to the hospital.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Redness, swelling, warmth.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain, Headache, Meningitis bacterial, Nausea, Pyrexia
Clinical narrative: Severe headache, fever, nausea, vomiting, abdominal pain.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Severe headache, fever, nausea, vomiting, abdominal pain.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: Patient described as discomfort to the injection site with severe redness and pain.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Face oedema, Periorbital oedema
Clinical narrative: Barking cough relieved with Albuterol Nebulizer treatment then next morning facial and peri-orbital edema reported.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site bruising, Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: Injection site swelling, bruising and warm to touch with red streaks going down right arm to wrist with sharp pain radiating to neck with right ear ringing.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Neck pain, Tinnitus
Clinical narrative: Injection site swelling, bruising and warm to touch with red streaks going down right arm to wrist with sharp pain radiating to neck with right ear ringing.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: Resident found with generalized tremors, BP 156/73, P 129, R 24, T 98.4 O2 sat 83% on room air, increased to 93% on 2 liters NC, vomiting clear emesis. Sent to ER at 09:10 AM 10/2/2014.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warm to the touch at injection site.  Tylenol given at home.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis left upper arm at injection site.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Blister, Burning sensation, Erythema, Pruritus
Clinical narrative: Initial report received on 24 September 2014 from a consumer who is the patient. A 60 year old female patient with a history of erythromycin and tramadol allergy, sarcoid, rheumatoid arthritis, discoid lupus, Sjogren's syndrome and a temperature of 100.3 was vaccinated intramuscularly with Influenza Quadrival A-B Vaccine (batch number UI159AB into the right deltoid and intramuscularly with PNEUMOVAX vaccine (batch number and manufacturer not reported into the left deltoid) on 12 September 2014. The patient gets a flu shot every year. Concomitant medications were not reported. On 13 September 2014, 12 hours after vaccination, the patient developed red, raised, crop circles on her cheeks, chin and forehead and burning and itching on her face. The blisters lasted one week and she had intense systemic joint pain. The redness remains. The patient tried steroid cream and BENADRYL for itching. The patient was seen by a rheumatologist and was advised to report the symptoms to the manufacturer. Laboratory tests were not reported. The patient outcome was unknown. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling face
Clinical narrative: Initial report received on 24 September 2014 from a consumer who is the patient. A 60 year old female patient with a history of erythromycin and tramadol allergy, sarcoid, rheumatoid arthritis, discoid lupus, Sjogren's syndrome and a temperature of 100.3 was vaccinated intramuscularly with Influenza Quadrival A-B Vaccine (batch number UI159AB into the right deltoid and intramuscularly with PNEUMOVAX vaccine (batch number and manufacturer not reported into the left deltoid) on 12 September 2014. The patient gets a flu shot every year. Concomitant medications were not reported. On 13 September 2014, 12 hours after vaccination, the patient developed red, raised, crop circles on her cheeks, chin and forehead and burning and itching on her face. The blisters lasted one week and she had intense systemic joint pain. The redness remains. The patient tried steroid cream and BENADRYL for itching. The patient was seen by a rheumatologist and was advised to report the symptoms to the manufacturer. Laboratory tests were not reported. The patient outcome was unknown. Documents held by sender: None.
Age: 62.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Blood culture positive, Headache, Malaise, Meningococcal infection, Nausea
Clinical narrative: Initial report was received from a healthcare professional on 24 September 2014. A 66-year-old male patient, with a history of Crohn's Disease, received an intramuscular right arm injection of MENACTRA, lot number U375AA not a valid sanofi pasteur lot number) on 09 March 2011. The patient received the vaccination due to his employment in a manufacturing facility. In addition, the patient also received Pneumo 23 vaccine, other manufacturer, lot number not reported) on 09 March 2011. On 16 September 2014, i.e. 3.5 years post-vaccination, the patient developed headache, nausea, and vomiting. On 17 September 2014 he was admitted to the hospital "extremely ill"; blood cultures confirmed Neisseria meningitides serotype A. The patient remained in the hospital and was recovering at the time of the report. The reporter considered the event to be life-threatening. Notification of the patient's diagnosis was received from the Department of Health on 19 September 2014, with confirmation of his receipt of MENACTRA vaccine on 24 September 2014. Documents held by sender: None.
Age: 62.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Vomiting
Clinical narrative: Initial report was received from a healthcare professional on 24 September 2014. A 66-year-old male patient, with a history of Crohn's Disease, received an intramuscular right arm injection of MENACTRA, lot number U375AA not a valid sanofi pasteur lot number) on 09 March 2011. The patient received the vaccination due to his employment in a manufacturing facility. In addition, the patient also received Pneumo 23 vaccine, other manufacturer, lot number not reported) on 09 March 2011. On 16 September 2014, i.e. 3.5 years post-vaccination, the patient developed headache, nausea, and vomiting. On 17 September 2014 he was admitted to the hospital "extremely ill"; blood cultures confirmed Neisseria meningitides serotype A. The patient remained in the hospital and was recovering at the time of the report. The reporter considered the event to be life-threatening. Notification of the patient's diagnosis was received from the Department of Health on 19 September 2014, with confirmation of his receipt of MENACTRA vaccine on 24 September 2014. Documents held by sender: None.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Dehydration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: My left arm (Injection site)  began to hurt (On a scale of 1 to 10, it was a 5). Turn red (4 3/4" X 4 1/2") Hot to the touch. I had a fever and became dehydrated.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: My left arm (Injection site)  began to hurt (On a scale of 1 to 10, it was a 5). Turn red (4 3/4" X 4 1/2") Hot to the touch. I had a fever and became dehydrated.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Malaise, Oropharyngeal pain, Pallor, Vomiting
Clinical narrative: Throat hurt/ almost vomited, didn't feel well, and pale.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and redness along bicep on arm given only. There was pain along with the redness.  It has gone away except for some slight bruising.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Muscle spasms, Muscular weakness, Pain in extremity
Clinical narrative: Patient exhibited muscle spasms and pain in middle of lower back. Pain and muscle spasms in right leg with some weakness. This occurred about 5 minutes after injection. After about 30 minutes patient was able to stand and walk with some soreness. EMS checked her vital signs and patient was able to go home by herself.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Blood test, Computerised tomogram, Culture, Diarrhoea
Clinical narrative: Patient exhibited muscle spasms and pain in middle of lower back. Pain and muscle spasms in right leg with some weakness. This occurred about 5 minutes after injection. After about 30 minutes patient was able to stand and walk with some soreness. EMS checked her vital signs and patient was able to go home by herself.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Groin pain, Hypertension, Muscle spasms, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Patient exhibited muscle spasms and pain in middle of lower back. Pain and muscle spasms in right leg with some weakness. This occurred about 5 minutes after injection. After about 30 minutes patient was able to stand and walk with some soreness. EMS checked her vital signs and patient was able to go home by herself.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting, X-ray
Clinical narrative: Patient exhibited muscle spasms and pain in middle of lower back. Pain and muscle spasms in right leg with some weakness. This occurred about 5 minutes after injection. After about 30 minutes patient was able to stand and walk with some soreness. EMS checked her vital signs and patient was able to go home by herself.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever per mom by palpation and vomiting.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Obstructive airways disorder
Clinical narrative: Coughing & airway obstruction.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Feeling cold, Hallucination, visual, Headache
Clinical narrative: Awoke with shaking chills and unable to get warm.  At 2 AM still very cold, temp at 2AM was 99.7 PO.  Coldness and chills and intermittent headache continued until 5AM.  Also noticed visual hallucination of blue pulsating light at times.  Spoke with patient at 11 AM Temp 99 PO and no longer chills.  Will call PCP to report symptoms.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Noted on morning of 01Oct2014. 3 cm x 2 cm urticarial wheal surrounding injection site, pink, slightly pruritic. still present as of afternoon of 02Oct2014.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Leg redness and swelling, cellulitis.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Immediate post-injection reaction, Injection site swelling, Throat irritation
Clinical narrative: Immediately developed swelling at site of injection; twenty minutes later developed lightheadedness, scratchy throat, emesis, and coughing.  Received IM epinephrine, prednisone, diphenhydramine, ranitidine, prednisone.  Symptoms resolved within minutes of receiving epinephrine.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Immediately developed swelling at site of injection; twenty minutes later developed lightheadedness, scratchy throat, emesis, and coughing.  Received IM epinephrine, prednisone, diphenhydramine, ranitidine, prednisone.  Symptoms resolved within minutes of receiving epinephrine.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 23-SEP-2014, the patient was vaccinated with an expired dose of ZOSTAVAX, injection (dose, route of administration and indication unspecified; lot # 0566AE with expiry date: 01-APR-2013). No concomitant medications were reported. No adverse effects were reported. 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 Registered Nurse refers to unspecified number of patients of unknown age and gender. On 08-SEP-2014 unspecified number of patients were vaccinated with PNEUMOVAX23 (dose, route, lot # not reported) that had been improperly stored. No adverse event symptoms were reported. This is one of several reports from the same reporter. Additional information is not expected as the reporter did not give a consent for contact.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report was received from another health care professional, a practice manager concerning a 25 year old pregnant female patient. On 30-SEP-2014 the patient was vaccinated with a dose of GARDASIL lot # K001500 expiration date 06-NOV-2016, 0.5 ml, intramuscular in error as the patient was supposed to received Tdap at patient 36 weeks pregnant. The healthcare professional stated that the patient who administered the dose of GARDASIL did not confused this vaccine with Tdap. She stated that the error was not related to the product or labeling confusion; she just grabbed it. The patient's last menstrual period (LMP) was 19-JAN-2014, the estimated date of conception was 02-FEB-2014 and the approximate date of delivery (due date) was 26-OCT-2014. No adverse events were 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. On 08-SEP-2014 unspecified number of patients were vaccinated with LIQUID PEDVAXHIB (dose, route, lot # not reported) that had been improperly stored. No adverse event symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not give a consent for contact.
Age: 15.0
Sex: F
Vaccine: HPV4
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 am unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one 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 referred to a 15-year-old female patient with attention deficit/hyperactivity disorder (ADHD), Diabetes Mellitus Type 1, scoliosis, who was allergic to penicillin, dust mites, and shellfish. It was not reported whether the patient had any other illness at time of vaccination. The reported informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 28-JAN-2014 at 3:40 PM. 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 informed and declined to revaccinate. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown, although date of recovery was written as 18-APR-2014. 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: 24.0
Sex: F
Vaccine: FLUX, HPV4, HPV4
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: Was supposed to receive TDAP vaccine for pregnant women.  Instead received Gardasil vaccine for HPV prevention due to nurse error.  Waiting to determine any birth defects/adverse/congenital defects on baby.
Age: 24.0
Sex: F
Vaccine: FLUX, HPV4, HPV4
Symptoms: Exposure during pregnancy, Product name confusion, Wrong drug administered
Clinical narrative: Was supposed to receive TDAP vaccine for pregnant women.  Instead received Gardasil vaccine for HPV prevention due to nurse error.  Waiting to determine any birth defects/adverse/congenital defects on baby.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Headache, stiff neck, achy body, unusually sore injection site (more than normal). Later in the day-fever, chills, weakness -general awful feeling. Next day, still not feeling 100% better. Sore/stiff neck, sore injection site, tired, sick feeling.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Malaise, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: Headache, stiff neck, achy body, unusually sore injection site (more than normal). Later in the day-fever, chills, weakness -general awful feeling. Next day, still not feeling 100% better. Sore/stiff neck, sore injection site, tired, sick feeling.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Headache, stiff neck, achy body, unusually sore injection site (more than normal). Later in the day-fever, chills, weakness -general awful feeling. Next day, still not feeling 100% better. Sore/stiff neck, sore injection site, tired, sick feeling.
Age: 87.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Influenza
Clinical narrative: Developed full cascade of FLU symptoms.
Age: 87.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cough, Influenza, Malaise, Pain, Upper-airway cough syndrome
Clinical narrative: Developed full cascade of FLU symptoms.
Age: 87.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Influenza
Clinical narrative: Developed full FLU symptoms. Nasal drip, total body aching, malaise, cough.
Age: 87.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cough, Influenza, Malaise, Pain, Upper-airway cough syndrome
Clinical narrative: Developed full FLU symptoms. Nasal drip, total body aching, malaise, cough.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Localized redness and swelling of injection site. Affected area the size of a golfball and hot to touch. Treatment included Benadryl, cool compress to area, and Tylenol or ibuprofen as needed.
Age: 48.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Pain in extremity
Clinical narrative: Flu shot administered by wellness nurse. The patient reported to her school nurse on 9/22/2014 that her left arm had been hurting since her injection and that it was not better. Followed up by phone with the patient on 9/23/2014 and she stated that her left arm still hurt and had not improved. Stated the arm bothered her worse at night when she turned on her left side in her sleep. Advised the patient to see her personal physician if symptoms did not improve.
Age: 48.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Drug administered at inappropriate site, Injury, Mobility decreased
Clinical narrative: Flu shot administered by wellness nurse. The patient reported to her school nurse on 9/22/2014 that her left arm had been hurting since her injection and that it was not better. Followed up by phone with the patient on 9/23/2014 and she stated that her left arm still hurt and had not improved. Stated the arm bothered her worse at night when she turned on her left side in her sleep. Advised the patient to see her personal physician if symptoms did not improve.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised, Rash
Clinical narrative: PATIENT REPORTED A RASH UNDER ARMS AND AROUND WAIST AND ITCHING ALL OVER BODY. ADVISED HER TO GO TO ER. ER ADVISED PATIENT TO TAKE BENADRYL EVERY 6 HOURS AND RANITIDINE EVERY 12 HOURS UNTIL SYMPTOMS RESOLVED.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient had a rash develop on both arms and legs. Patient reports it being itchy.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 27-FEB-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J006953, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
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 referred to a 15-year-old female patient, who had no known drug allergy. The reporter stated that it was unknown if the patient had any illness at time of vaccination. The reported informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 04-FEB-2014 at 3:30 PM. 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 informed and revaccinated on 22-APR-2014 at no charge. The reporter reported the outcome as recovered. 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.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 18-FEB-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J006953, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 24-FEB-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J006953, expiration date: 07-JUN-2015. that may had been improperly stored since February2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be   confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported.  This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a two patients of unknown age and gender. On an unspecified dates in 2014 (also reported as "since 07-AUG-2014"), two doses of improperly stored ZOSTAVAX (dose, route of administration, lot numbers and expiration dates were not provided) was dispensed to patients. No adverse effects were noted. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pyrexia
Clinical narrative: This spontaneous report as received from an 87 year old consumer with allergy to penicillin who refers to herself. On an unknown date, approximately in 2010 (reported as "four years ago") the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, dose, lot# and expiration date were not reported). The patient was taking unspecified concomitant medication. On 01-JUN-2014 the patient had a fever and went to the hospital (went to the Emergency Room but was not admitted to the hospital). The patient had laboratory test performed in the hospital. The doctor told the patient that it was shingles. When the patient left the hospital, the doctor instructed her to see her intern the next day (on 02-JUN-2014). The patient did not explain who her intern was. The patient reported that at the time of the report she experienced a burning sensation in her arm, "between the elbow and up about 6 inches or so". The patient was taking unspecified prescription medication for the treatment (date unspecified, in 2014). The patient said that she had recovered from having shingles but she still was experiencing symptoms (date unspecified, in 2014) (the outcome of the event was recovered with sequelae). The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected, because there was no consent for further contact.
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 patient 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 registered nurse regarding 1 day old female patient who on 06-JUL-2014 at 20:42 was vaccinated with improperly stored first dose of RECOMBIVAX HB (lot # J012520, expiration date 30-JAN-2016) intramuscularly. The reporter stated that, between 14-MAY-2014 and 21-JUL-2014, vaccine storage temperature dropped to 0-1 degree in 18 different episodes, and that according to minimum and maximum, all recorded temperatures were supposed to be between 2-8 degrees. No symptoms reported. Additional information is not expected because all follow up information was received.