chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Sensation of heaviness, Urticaria
Clinical narrative: 10/8/14 Redness/Swelling at injection site, hives and itching on body intermittently. 10/9/14 Increased swelling at injection site, left fingertip numbness, itching intermittently on body. 10/10/14 Facial numbness on left side of face, right/left side facial numbness in PM, tingling. 10/15/14 Facial numbness, scalp numbness intermittently, "heaviness" in arms bilaterally. Denies difficulty with speech, coordination. Reports reaction at age 21 after PPD test (Redness, burning, swelling, numbness).
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: NOTICES RED ITCHY RASH TO BOTH CHEEKS PUT DAUGHTERS RASH CREAM ON FACE.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Local swelling, Tenderness
Clinical narrative: Swelling and tender to the touch L arm.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Headache, Musculoskeletal pain, Nausea
Clinical narrative: Chills, fever, headache, night sweats, shoulder pain, fever blister, tiredness, nausea.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Night sweats, Oral herpes, Pyrexia
Clinical narrative: Chills, fever, headache, night sweats, shoulder pain, fever blister, tiredness, nausea.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus generalised, Rash erythematous
Clinical narrative: Red rash & itching over most of body; came to our office today for assessment; no shortness of breath, angioedema; treated with Medrol dose pack & hydroxyzine.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Lip swelling, Throat tightness, Urticaria
Clinical narrative: Hives, top lip swollen. Urgent care given adrenalin shot and corticosteroid medication. Returned to Hospital ER at 1201 AM on 10/10/2014 throat constriction admistered epi shot.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: PATIENT DEVELOPED VERY ITCHY URTICARIA - SMALL BUMPS BEHIND HIS ARMS, ON HIS BACK, TORSO, CHEEKS.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain
Clinical narrative: Fatigue, headache, nausea and vomiting (2) and severe body/muscle aches.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Fatigue, headache, nausea and vomiting (2) and severe body/muscle aches.
Age: 1.8
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site swelling, Injection site warmth, Irritability, Weight bearing difficulty
Clinical narrative: Mother called 10/14/2014 stating child inconsolable during evening and night. Refuses to put weight on legs and walk as she usually does. Evaluation by MD in office showed warmth and swelling at two injection sites right thigh and one injection site left thigh but normal strength and reflexes.  Mother to continue home treatment of Advil and Tylenol with ice to site if tolerated.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: PT NOTICED A WARM AND RED SPOT ABOUT THE SIZE OF A SILVER DOLLAR BUT HAD NOT SEEKED ANY MEDICAL ATTENTION.  I ADVISED HER TO TRY BENADRYL AND TO HAVE IT CHECKED OUT IF IT DOES NOT IMPROVE.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, tenderness and warms 10x6cm around injection site.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Feeling hot, Headache, Myalgia, Nausea
Clinical narrative: Patient self reported feeling hot, nauseated, and with headache that evening.  Following day, patient self reported temp of 101 degrees, headache and muscle ache.  By 8 pm on 10/11/2014 symptoms had abated.
Age: 12.0
Sex: F
Vaccine: FLUN4, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Immediately after removing needle from clients arm, she fainted. Client was placed in a chair with her head down between her legs, two ice packs were placed on her. Clients pulse and blood pressure were monitored. Client remained seated in clinic room from 4:05PM to 4:27PM when she left with her mother.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Hemi-circumferencial swelling at injection site on R deltoid with redness and warmth, about 5x5 cm.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Disorientation, Eye discharge, Immobile, Incoherent
Clinical narrative: Weak; white pus in eyes; disorientated; incoherent; immobile; symptoms lasted two days.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Pain and inflammation at injection site for 2 days.
Age: 0.76
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Pyrexia
Clinical narrative: High fever up to 104.1 with lethargy.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Malaise, Mental impairment
Clinical narrative: Severe weakness, a fainting feeling, profuse sweating, body aches & an all over feeling of unwellness.  I experienced a funny feeling of not being able to see or think straight.  All of these effects went away within one and 1/2 hrs except the body aches.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Visual impairment
Clinical narrative: Severe weakness, a fainting feeling, profuse sweating, body aches & an all over feeling of unwellness.  I experienced a funny feeling of not being able to see or think straight.  All of these effects went away within one and 1/2 hrs except the body aches.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Chills, fever, vomiting diarrhea. Painful bones for 12 hours.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site and around area.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site erythema, Injection site pain, Nausea, Vomiting
Clinical narrative: Patient reported with redness at injection site with a red marl 2"x3/4" and soreness in entire arm. The donor also reported nausea/vomiting with dizziness.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Aphagia, Asthenia, Chills, Pyrexia
Clinical narrative: Pt experienced fever-like symptoms, severe chills, could not eat for 2 days and became extremely weak (unable to walk) -- recovered on her own - weakness lasted 4 days.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site joint movement impairment, Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe shoulder pain, difficulty moving, limited mobility in left shoulder and arm.
Age: 33.0
Sex: F
Vaccine: FLUN4
Symptoms: Nasal congestion, Respiratory tract congestion, Sneezing
Clinical narrative: Congestion, stuffy nose, sneezing.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash to left side of face, arm, and leg. Timing of onset uncertain but was in days following vaccine. Patient was seen by outside physician and given a one-week course of Benadryl, after which rash resolved.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Nausea
Clinical narrative: Dizziness entire day, weakness, chills, slight nausea.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Flushing, Heart rate increased, Lymphadenopathy, Oral discomfort
Clinical narrative: Swollen glands in neck, wheezing, cough, flushing of face, increased heart rate, discomfort in mouth and throat.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal discomfort, Wheezing
Clinical narrative: Swollen glands in neck, wheezing, cough, flushing of face, increased heart rate, discomfort in mouth and throat.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Local swelling
Clinical narrative: Swollen deltoid area, very red, tender at injection site.
Age: 58.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pain in arm and within 30 minutes pain become intense and unbearable.  Range of motion dramatically decreased. Pain and decreased range of motion lasted approx. 20 hours.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Skin warm
Clinical narrative: PATIENT CALLED ON 10/15, SAID SHE GOT REDNESS, BURNING SENSATION 3 TO 4 INCH BELOW SHOULDER UP TO ELBOW AND AROUND CHEEKS. SHE FEELS HOT AT THAT AREA.
Age: 6.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 8 cm circular area of erythema and minimal swelling on right upper arm, area warm to touch.
Age: 6.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 8 cm circular area of erythema and minimal swelling on right upper arm, area warm to touch.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Musculoskeletal discomfort
Clinical narrative: Got a flu shot at pharmacy along with a shingles vaccine. Had trouble in my shoulder and joint all winter and most of this summer 2014.
Age: 87.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain
Clinical narrative: This spontaneous report as received from a nurse refers to her 87 year old mother with diabetes. On 30-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (deltoid, lot # was not reported). Concomitant therapies included an unspecified FLU vaccine in a different arm on the same date. The patient was experiencing tenderness, itching and redness that was approximately 4 inches down from vaccine site. The nurse reported that the itching and tenderness started approximately 2 to 3 days after vaccine was administered, no specific date provided, and they noticed the redness for the first time yesterday on 08-OCT-2014. The patient did not seek help and no treatment was given. No lab was performed. The outcome of the adverse events was unknown. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a 57-year-old female patient who received Influenza vaccine. Concurrent medical conditions included penicillin allergy, sulfonamide allergy, food allergy (milk, eggs, wheat, rice, yeast, spinach, mustard, soybeans, lettuce, appels, squash, mushrooms), allergy to animals (dogs, cats, horses), allergic reaction (various pollens, dust, dust mites, mold, some parfumes and other scents and other environmental allergies, both indoor and outdoor), asthma and chronic obstructive pulmonary disease. On an unknown date, the patient received influenza vaccine at an unknown dose. On an unknown date, Unknown after receiving Influenza vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine. Additional details: This report was received via Patient support program.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a 67 year old female patient refers to herself. The patient had no pertinent medical history, no drug reactions or allergies. On 29-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23, injection, 1 single shot (route and lot # unknown). Concomitant therapies included CRESTOR and lorazepam. On 29-SEP-2014, after receiving PNEUMOVAX 23, the patient experienced swelling and redness at the injection site. The patient could barely lift her arm. The patient sought medical attention and was treated with KEFLEX. There were no lab diagnostics studies performed. The outcome of events was reported as recovering/resolving at reporting time. The causality was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased
Clinical narrative: This spontaneous report as received from a 67 year old female patient refers to herself. The patient had no pertinent medical history, no drug reactions or allergies. On 29-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23, injection, 1 single shot (route and lot # unknown). Concomitant therapies included CRESTOR and lorazepam. On 29-SEP-2014, after receiving PNEUMOVAX 23, the patient experienced swelling and redness at the injection site. The patient could barely lift her arm. The patient sought medical attention and was treated with KEFLEX. There were no lab diagnostics studies performed. The outcome of events was reported as recovering/resolving at reporting time. The causality was not reported. Additional information has been requested.
Age: 76.0
Sex: U
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: After receiving vaccine patient started shaking resembling Parkinson's like motion. Taken by ambulance to E.R. where she was given BENADRYL and prednisone. Went home after 4 hours in E.R.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Pt. received flu shot Sanofi UI 173AB on 10/9/14 and on 10/11/14 woke with swelling, redness and bruising in (L) deltoid area. Rx'd w/Prednisone 10mg x1, BENADRYL 50 mg, TYLENOL 750 mg
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, itching with itching getting worse. Warm to touch.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Throat tightness
Clinical narrative: Pt was administered flu vaccine and approx 3 mins later, felt heart racing, and throat closing/tightening. Went to ER for eval.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Body temperature increased, Burning sensation, Fatigue, Hyperhidrosis
Clinical narrative: As soon as she gave it felt burning in arm so took ibuprofen. Around 1pm arm was really hurting so took MOTRIN. Hurting through Sunday. Sunday night had temp because felt like if sweating. Both arms get numb and tingly which continued for 4 days. Hands ice cold when this happened. Went to employee care on Wednesday but was told it could not be related to vaccine. Still get back and forth tingling on arms but 10/7 joint and muscle pain started, also felt exhausted. Yesterday was first day without numbness and tingling but it came back today.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Myalgia, Pain, Paraesthesia
Clinical narrative: As soon as she gave it felt burning in arm so took ibuprofen. Around 1pm arm was really hurting so took MOTRIN. Hurting through Sunday. Sunday night had temp because felt like if sweating. Both arms get numb and tingly which continued for 4 days. Hands ice cold when this happened. Went to employee care on Wednesday but was told it could not be related to vaccine. Still get back and forth tingling on arms but 10/7 joint and muscle pain started, also felt exhausted. Yesterday was first day without numbness and tingling but it came back today.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral coldness
Clinical narrative: As soon as she gave it felt burning in arm so took ibuprofen. Around 1pm arm was really hurting so took MOTRIN. Hurting through Sunday. Sunday night had temp because felt like if sweating. Both arms get numb and tingly which continued for 4 days. Hands ice cold when this happened. Went to employee care on Wednesday but was told it could not be related to vaccine. Still get back and forth tingling on arms but 10/7 joint and muscle pain started, also felt exhausted. Yesterday was first day without numbness and tingling but it came back today.
Age: 18.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse reaction. Pt. pregnant.
Sex: U
Vaccine: HPV4
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. The medical assistant reported for temperature excursion and that on unknown dates some improperly stored GARDASIL (lot#, dose, route and frequency were not provided) had been administered to patients. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Tendonitis, Tenosynovitis
Clinical narrative: Tendinitis, tenosynovitis or inflammation of tendon sheath lining biceps muscle. BICIPITAL.
Sex: U
Vaccine: RV5
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. The medical assistant reported for temperature excursion and that on unknown dates some improperly stored ROTATEQ ("suspension 2", oral, lot#, dose and frequency were not provided) had been administered to patients. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site pain, Pyrexia, Throat irritation, Tinnitus
Clinical narrative: Chills, fever (99.7), some tenderness at injection site, throat feels little strange, ears ringing. Pt took BENADRYL and ibuprofen, then husband took her to urgent care clinic. They gave her shot (steroid I assume).
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Pain in extremity, Sensation of heaviness
Clinical narrative: This spontaneous report as received from a veterinarian refers to a her currently 11 years old daughter with no pertinent medical history and known allergies. On 13-AUG-2014 the patient was vaccinated with first dose of GARDASIL (dose and route of administration were not reported). No concomitant medication were reported. On unknown date (approximately in August 2014) the patient experienced pain in the arm of the injection for two days after receiving the GARDASIL. Patient stated that her arm  "felt like it weighed a ton" and she had difficulty moving it and participating in sports. It was also reported that she would not go back to receive her second and third dose since the first dose was so painful. No treatment was given for the adverse events. Patient did not seek medical attention. The outcome of the events was reported as recovered after 2 days after vaccination (exact date unknown (approximately in August 2014)). Relatedness between the events and vaccination was not reported. This report is linked with MARRS#1410USA004370 (concerning patient's sister, same reporter link). Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 76 year old male patient concerning himself. Patient's current condition with high blood pressure and cholesterol. Drug reactions or allergies was reported as none. Approximately on an unknown date in 2007 (also reported as 7 years ago) the patient was vaccinated with ZOSTAVAX (dosing regimen unspecified). The consumer also stated that he uses other medications (unspecified names, dose/frequency and manufacturer) as concomitant medications. On 25-SEP-2014 the patient was diagnosed with the shingles, after receiving ZOSTAVAX about seven years ago. Unspecified labs/diagnostics were performed. Treatment included Valacyclovir (manufacturer unspecified) (unspecified dose/frequency) and Prednisone (manufacturer). The outcome of shingles was reported as not recovered/not resolved. There was no product quality complaint (PQC) involved. Patient sought medical attention and had an office visit on an unspecified date. Causality assessment was not provided. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Muscular weakness, Myalgia
Clinical narrative: This spontaneous report was received from a other health professional refers to a 24 year old female patient. On 17-SEP-2014 the patient was vaccinated with GARDASIL dose 1, 0.5 ml (milliliters), intramuscular (lot # unspecified). On 17-SEP-2014, the same day of vaccination the patient experienced upper abdominal pain, muscle weakness and widespread muscle tenderness. The patient was evaluated at a local emergency room on 17-SEP-2014. No details of the emergency room visit and treatment were provided. The patient was not admitted to the hospital. The outcome of upper abdominal pain, muscle weakness and widespread muscle tenderness was reported as recovered/resolved on 18-SEP-2014. There was no product quality complaint (PQC) involved. Patient sought medical attention visited the emergency room. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to 6 patients of unknown demographics. The patient's medical history and current conditions are not reported. On 16-SEP-2014 the 6 patients were inadvertently administered improperly stored RECOMBIVAX HB injection 10 Y (strength, dose and frequency not reported) (Lot # and expiry date not reported). No adverse effects reported. Product quality complaint was not involved. The outcome of the events was unknown. This is one of the several reports received from the same reporter and Linked to cases MARRS # (1410USA007243, 1410USA007242, 1410USA007240 and 1410USA007241). Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash, Rash pruritic
Clinical narrative: Left deltoid area of arm swollen, red, rash. Lower left arm has itchy bumps around 5. Patient's arm hurts to touch.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Left deltoid area of arm swollen, red, rash. Lower left arm has itchy bumps around 5. Patient's arm hurts to touch.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to 3 unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with ZOSTAVAX refrigerated subcutaneous injection. No concomitant therapies were reported. Approximately on an unknown date in 2012 (also reported as within the past two years) the patient experienced shingles. The physician reported to the representative that three anonymous patients experienced shingles while using ZOSTAVAX, within the past two years. No demographics were provided for the patient. Unspecified treatment was provided. The outcome of shingles was reported as recovered/resolved on an unknown date. There was no product quality complaint (PQC) involved. Patient sought medical attention and visited doctor. Causality assessment was not provided. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain, Pruritus, Rash
Clinical narrative: Received in left arm pneumococcal vaccine 9-12-14. Came to primary care clinic to assess swelling (local), pain, and rash (general) and itchiness. Stated rash occurred 9-26-14. Itchiness 9/25 evening. Sent to emergency room. He received liquid BENADRYL, prednisone and antibiotic.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a healthcare worker refers to two patients of unknown gender and age. On an unknown date, the patients were vaccinated with PNEUMOVAX23 injection (dose, dose number, lot/batch number, expiration date were not reported). On an unknown date, the patients developed cellulitis at the injection site after receiving PNEUMOVAX23. No product quality complaint (PQC) involved. The outcome of cellulitis at the injection site was unknown. The relatedness between the event and PNEUMOVAX23 was not reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient called the pharmacy the morning after her flu shot and said she can't lift her arm and it is beyond sore. No signs of redness or bruising reported.
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 unspecified pediatric patients of unknown age. On 13-OCT-2014, patients was vaccinated with improperly stored VARIVAX (Merck) (lot# reported as K003423, expiration date not reported, dose, route not reported). No adverse effects reported. Additional information is not expected.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Intermittent raised rash over torso, neck and arms, urticaria.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown patients of unkonwn age. On an unknown date since 10-JUN-2014, patients was vaccinated with doses GARDASIL (lot#, expiration date, dose, route not reported) which were improperly stored. No adverse effects reported. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown patients of unknown age. On an unknown date since 10-JUN-2014, patients was vaccinated with doses PNEUMOVAX 23 (lot#, expiration date, dose, route not reported) which were improperly stored. No adverse effects reported. This is one of the several reports from the same source. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: States cannot lift (R) arm Kw/o aid of (L) arm.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse concerning a patient of unknown age and gender. Patient's medical history, concurrent conditions and drug reactions or allergies were not reported. On 07-OCT-2014, the patient was vaccinated with an expired dose of PNEUMOVAX23 (multidose vial) (0.5 ml, dose, frequency and route of administration were not reported) (lot # J006921, exp date: 09-AUG-2014 also reported as 08-SEP-2014). No adverse experience was reported. Product quality Complaint (PQC) was not involved. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: Pt. states sweling occurred at administration site that went from deltoid to elbow pt states arm was painful and hot to touch. She took BENADRYL and used ice packs on her arm. She also took ibuprofen at the advice school nurse. Symptomology lasted at 4 days. She did not go to MD but is worried at long term effects. She states ache in her arm still and she had dizziness the friday following shot.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Headache, Hyperhidrosis, Nausea
Clinical narrative: Vomiting incident after the High Dose flu vaccine. Severe nausea, headache, excessive perspiration 24 hours after flu shot. Dizzy, tired. Patient states "feeling better this afternoon" (10/9/14 4:29 PM). 10/10/14 - triage RN advised to go to ER for evaluation.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vomiting incident after the High Dose flu vaccine. Severe nausea, headache, excessive perspiration 24 hours after flu shot. Dizzy, tired. Patient states "feeling better this afternoon" (10/9/14 4:29 PM). 10/10/14 - triage RN advised to go to ER for evaluation.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (medical assistant) refers to a patient of unknown demographics. Patient's pertinent medical history and drug reactions were not reported. On 08-OCT-2014 the patient was inadvertently vaccinated with M-M-R II dose 1, intramuscular. It was reported as a result of this the patient was administered a second dose of M-M-R II subcutaneously at the same visit. No adverse effects were reported. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with M-M-R II. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Injection site erythema, Injection site pruritus, Pruritus generalised
Clinical narrative: Pt developed 3 inch ring of redness at injection site. Redness turned into a band and began itching profusely. Within 8 hours, whole body had itching and burning. Medications to relieve itching given with success. Itching continued for 5 days.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus, Skin irritation, Swelling
Clinical narrative: Redness/swelling/irritation/pain/itching. Used ice pack for 10-15 min. After 45 min was almost back to normal. Pt felt fine.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Nurse Practitioner refers to an unspecified number of patients of unknown age and gender. On an unknown date the unspecified number of patients were vaccinated with LIQUID PEDVAXHIB (dose, strength, route and site of administration was not reported). The reporter stated that those doses of LIQUID PEDVAXHIB were exposed to temperatures outside of the proper storage range. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Pt. rec'd vaccination Friday afternoon 10/10/14. Rash, hives developed Saturday afternoon. Pt was given injection of KENALOG and DECADRON and advised to take CLARITIN for next several days. Rash and hives present on arms and upper torso.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Nurse Practitioner refers to an unspecified number of patients of unknown age and gender. On an unknown date the unspecified number of patients were vaccinated with GARDASIL (dose, strength, route and site of administration was not reported). The reporter stated that those doses of GARDASIL were exposed to temperatures outside of the proper storage range. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Blister, Body temperature increased, Culture wound negative, Erythema, Tenderness
Clinical narrative: Pt. received MMR and Varicella vaccine in outer (R) thigh on 10/6/14. On day 1 after vaccine developed erythema, tenderness area 15 cm in diameter. Day 2 after vaccine given developed blistering lesion over both sites and temp of 102. Resolved by 10/10/14.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received  from a pharmacist refers to a patient of unknown  demographics .On unknown date, the patient was vaccinated with ZOSTAVAX dose 1, 0.65 ml (also reported as 19400 PFU (plaque-forming units), subcutaneously. On 08-OCT-2014, the patient received a second dose of ZOSTAVAX. No adverse effects were reported. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with ZOSTAVAX. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 year old male patient. On 10-OCT-2014, the patient was inadvertently vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported). No adverse effects were noted. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Joint stiffness, Joint swelling, Musculoskeletal stiffness
Clinical narrative: Approx 6-8 hours after receiving flu shot pt c/o having a temperature, severe chills, swelling et stiffness to joints and muscles. Pt. also reports rash onset on 10-12-14 to chest, arms and legs. Pt. also reported nausea onset on 10-11-14 et 10-12-14. On 10-14-14 pt reported s/s as improving.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Rash
Clinical narrative: Approx 6-8 hours after receiving flu shot pt c/o having a temperature, severe chills, swelling et stiffness to joints and muscles. Pt. also reports rash onset on 10-12-14 to chest, arms and legs. Pt. also reported nausea onset on 10-11-14 et 10-12-14. On 10-14-14 pt reported s/s as improving.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to 6 patients of unknown demographics. The patient's medical history and current conditions were not reported. On 20-SEP-2014 the 6 patients were inadvertently administered improperly stored RECOMBIVAX HB injection 10 Y (strength, dose and frequency not reported) (Lot # and expiry date not reported). No adverse effects reported. Product quality complaint was not involved. The outcome of the events was unknown. This is one of the several reports received from the same reporter and Linked to cases MARRS # (1410USA000627, 1410USA007242, 1410USA007240 and 1410USA007241). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown demographics. No relevant medical history of the patient was reported. On 13-OCT-2014, the patient was vaccinated with an expired lot of PNEUMOVAX 23 (lot # H014653; expiry date: 19-APR-2014) (strength, dose, route of administration, and site of administration were not reported). There were no concomitant medications reported. The nurse reported that the PNEUMOVAX 23 did not have any previous temperature excursions and PNEUMOVAX 23 was found to be supported with post expiry data. No adverse symptoms were reported. There was no product quality complaint (PQC) involved. The outcome of the patient received expired PNEUMOVAX 23 was unknown. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dysphonia, Eye swelling, Headache, Lip swelling
Clinical narrative: Fever, headache, hoarseness, swelling of eyes and lips, hives, muscle aches, weakness, racing heart.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Palpitations, Pyrexia, Urticaria
Clinical narrative: Fever, headache, hoarseness, swelling of eyes and lips, hives, muscle aches, weakness, racing heart.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to 2 patients of unknown demographics. The patient's medical history and current conditions are not reported. On 25-SEP-2014 the 2 patients were inadvertently administered improperly stored RECOMBIVAX HB injection (strength, dose and frequency not reported) (Lot # and expiry date not reported). No adverse effects reported. Product quality complaint was not involved. The outcome of the event was unknown. This is one of the several reports received from the same reporter and Linked to cases MARRS # (1410USA007243, 1410USA007242, 1410USA007240 and 1410USA000627). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to 2 patients of unknown demographics. The patient's medical history and current conditions are not reported. On 24-SEP-2014 the 2 patients were inadvertently administered improperly stored RECOMBIVAX HB injextion 10 Y (strength, dose and frequency not reported) (Lot # and expiry date not reported). No adverse effects reported. Product quality complaint was not involved. The outcome of the event was unknown. This is one of the several reports received from the same reporter and Linked to cases MARRS # (1410USA007243, 1410USA000627, 1410USA007240 and 1410USA007241). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Large local reaction to flu vaccine left deltoid - slight warm to touch - scant elevated pink swelling to elbow - swelling to axilla and upper chest pink blotchy rash along (L) clavicle.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Local swelling, Rash erythematous, Rash macular
Clinical narrative: Large local reaction to flu vaccine left deltoid - slight warm to touch - scant elevated pink swelling to elbow - swelling to axilla and upper chest pink blotchy rash along (L) clavicle.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Faeces discoloured
Clinical narrative: This spontaneous report as received from a 68 year old male patient refers to himself. Patient had no medical history not drug reactions/allergies. On 10-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose:1 ml, "somewhere in the arm", lot# reported as 7002602200, expiration date: October 2015). Concomitant therapies included Lisinopril (manufacturer unknown) for high blood pressure. On 11-OCT-2014 the patient experienced change in color of his bowel movements. He reported that the color was a "Kelly green and unusual"  and lasted for 3 days (from 11-OCT-2014 to 13-OCT-2014). Hi did not seek medical attention. No treatment was given. The patient reported that the color change started to clear up around 13-OCT-2014 into 14-OCT-2014. Hi didn't experience any other symptoms. The outcome of the event was reported as recovering/resolving. Relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to 6 patients of unknown demographics. The patient's medical history and current conditions are not reported. On 21-SEP-2014 the 6 patients were inadvertently administered improperly stored RECOMBIVAX HB injection (strength, dose and frequency not reported) (Lot # and expiry date not reported). No adverse effects reported. Product quality complaint was not involved. The outcome of the event was unknown. This is one of the several reports received from the same reporter and Linked to cases MARRS # (1410USA007243, 1410USA007242, 1410USA000627 and 1410USA007241). Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Rash
Clinical narrative: Low grade temperature, rash on arms/chest, injection site red swollen and warm to touch.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 1/2 hr after receiving vaccine developed "baseball" sized swelling, redness, soreness and warmth at left upper arm (Tuesday). Pt. saw MD on Thursday and Dx with "cellulitis" and placed on "cephalexin 500mg tid". Today, patient stated "a little pain, less red and swollen" (1 wk later).
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 19-AUG-2014 the patient was inadvertently vaccinated with an expired dose of MMR II (dose was not reported, subcutaneously, HSA; lot # H014977, expiration date 09-AUG-2014). No adverse effects were reported. No PQC (product quality complaint) was involved. This is the one of two reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Flushing, Swelling
Clinical narrative: Swelling of nostrils and flushing in malar area.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Chest pain, Feeling abnormal, Painful respiration, Vaccination site pain
Clinical narrative: Achy feeling spread from site of vaccination (arm) to entire chest. For a week and a half, couldn't run or do any exercise as the flexing of muscles, arm movement, and any touch or pressure to my chest resulted in my ribcage feeling like it was about to crack. (Pushups were impossible). Breathing was not affected, just hurt a bit on very deep breaths. I will not continue vaccine.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Oedema, Pain, Swelling
Clinical narrative: Fatigue, body aches, "puffy and swollen", edema +1. Treatment: antihistamines, NSAIDs. Dr. recommends no flu shots in future.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Local swelling, Skin warm
Clinical narrative: PNEUMOVAX 23 and FLUZONE HD given on 10/8/14. Patient comes back to pharmacy 10/11/14. Injection site fine, but 2 inches above elbow and 4 inches below elbow is visibly swollen, red and hot to touch. Advised to see MD. MD diagnosed patient with cellulitis and gave patient doxycycline as treatment.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Abdominal pain, Dizziness, Syncope
Clinical narrative: Light headed, syncope, abdominal pain 1 day after the vaccines. No treatment needed.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Eyelid oedema, Pyrexia, Rash
Clinical narrative: Woke morning of 10/8/14 with severe rash on face. Both eyes almost swollen shut. Child spiked a temperature of 104 deg. Parent took to ER. Epinephrine given at ER. Dx:Delayed RN to FLUMIST.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient was administered the AFLURIA flu vaccine on 10/8/14 at 8:15 a.m. No adverse event reported until 10/13/14 - patient said her (L) arm was sore in the evening of 10/8/14 and continued to hurt until 10/13/14. On 10/14/14 - it was "about the same". She was not sure if it was due to an injury since she had a large student she was working with physically has to deal with him when he gets agitated.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria, Wheezing
Clinical narrative: Hives, rash -> stomach, arms. Wheezing. Started about 630pm 10-14-14. BENADRYL 25mg 630pm -> to ER. Recieved epinephrine and BENADRYL 25 mg PO.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: Knot at injection size (golf gall size); heat and redness 4-6 inches; itching.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Patient called Monday morning said swelling began at site of flu vaccine and stated she went to emergency room.
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 patient of unknown age and gender. Patient's medical history, concurrent condition and drug reactions or allergies were not reported. On 10-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose: 0.65 ml, subcutaneous, frequency, indication and lot # were not provided), that underwent a supported temperature excursion (on an unknown date). Concomitant medication was not reported. No adverse experience was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Woke up about 12 hours after receiving vaccination with hives covering the trunk of the body. Took BENADRYL to help with the hives.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: Fever, chills, rash
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Patient states that vaccine caused her to have Shingles virus 48 hours after Influenza vaccine administered.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a veterinarian refers to a her currently 14 years old daughter. On an unknown dates the patient was vaccinated with GARDASIL (she completed 3 dose series; dose, indication and route of administration were not reported). On an unknown date the patient experienced a lot of pain at injection site and in the arm of the injection after receiving GARDASIL. The mother stated when administering the third dose in the series of the GARDASIL (on an unspecified date) they had to hold her daughter down to receive the vaccine since it was so painful the last 2 times she had received it. The outcome of a lot of pain at injection site and in the arm of the injection was unknown. Relatedness between a lot of pain at injection site and in the arm of the injection and vaccination was not reported. This report is linked with MARRS # 1410USA007251 (concerning patient's sister; same reporter link). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Oedema
Clinical narrative: Joint pain, pitting edema to legs.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a one-hundred to more than one-hundred adolescent (exact age was not provided) female patients. Patient's medical history, concurrent conditions and drug reaction or allergies were not reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, frequency, route of administration, indication and lot # were not reported). Concomitant medications were not reported. On an unknown date also reported as "several days after administration of unspecified dose of GARDASIL", the patients experienced fainting. On an unknown date, the patients were examined by unspecified local physicians which found that "there was nothing wrong with them". Product quality complaint (PQC) was not involved. The outcome of fainting was unspecified by the reporting physician. The relatedness between the event and GARDASIL was not reported. Additional information is not expected, as the reporting physician did not wish to be contacted.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Pain in arm below the injection site. Unable to bend arm back without pain. Has lasted for 2.5 weeks. Has been taking TYLENOL. Also feels shoulder pain.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Received vaccine (R) deltoid at approximately 1:30 pm -> by 5 pm the same day noticed redness, swelling, pain. No itching. Pt used ice to area and took ADVIL.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Incontinence, Syncope
Clinical narrative: Patient had a syncopal episode which lasted approximately 15 seconds after two vaccine injections. Patient also had a loss of continence during the episode.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: Rt arm sore after few hours. About 8-9 hrs after injection started with headache, sweating, sharp pains throughout body. Vaccine given 10/14 in AM. Pt called 24 hours later to report events and stated she stil had HA and general achiness. Wasn't sure is she had fever. Arm not red or swollen.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Conjunctival scar, Sensation of foreign body
Clinical narrative: Patient received high dose FLUZONE and PNEUMOVAX at 10:15 on 10/14/14; patient developed foreign body sensation in throat at which, bilateral conjunctival injection and tearing at or before 2pm.