chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a 76 year old female nurse with PROCARDIA allergy and TENORMIN allergy refers to herself. The patient's medical history included generalized neuropathy of the leg. On 09-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route unspecified). Concomitant therapies included estrogens, conjugated PREMARIN. On 10-OCT-2013 (the next day), the patient's arm became extremely sore. Later in the day on 10-OCT-2013 the patient developed swelling, soreness, pain and warmth in an area about 6 inches around the injection site. The nurse stated that she also developed a fever, headache and swollen lymph nodes on 10-OCT-2013. In addition, the nurse developed a rash on the upper part of the arm in which ZOSTAVAX was administered. The patient had sought medical attention via called physician's office. No lab diagnostics studies performed. MOTRIN was given for headache treatment. The nurse reported that she was recovering, on an unspecified date, her fever, headache and swollen lymph nodes went away and the adverse injection site reactions had decreased to only cover an area of about 1.5 inches. The patient stated it was okay to send VZVIP packet to her physician. VZVIP packet faxed. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a male adult patient of unknown age. The patient was administered a 0.5ml pediatric dose of VAQTA (25/0.5 U/ml) injection (lot# unspecified), route and location unspecified on 06-JUL-2012 respectively instead of an adult dose. No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 27-AUG-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 04-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date and route not reported). Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Fatigue, Sensation of heaviness, Vertigo
Clinical narrative: Client came in for flu shot 9/16/13. Left without complaints or signs of illness. Client called 9/17/13 morning stating he had gotten up at 330 am and got dizzy and had to lay on the floor until it passed. Stated he went back to bed and when he got up in the morning he again got dizzy and laid on floor until it passed. States now he feels fine. Recommended if symptoms persists to call his doctor which he agreed to do.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness
Clinical narrative: Client came in for flu shot 9/16/13. Left without complaints or signs of illness. Client called 9/17/13 morning stating he had gotten up at 330 am and got dizzy and had to lay on the floor until it passed. Stated he went back to bed and when he got up in the morning he again got dizzy and laid on floor until it passed. States now he feels fine. Recommended if symptoms persists to call his doctor which he agreed to do.
Age: 49.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 3-4 inch red oblong and warm to (R) deltoid. Previous years flu shots were only "quarter" size she reported to clinic her symptoms. Counseled on future forms of vaccines. She understands and will monitor potential symptoms in the future with vaccines.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP, FLU3, MNQ, TDAP
Symptoms: Asthenia, Bronchospasm, Dysphonia, Dyspnoea
Clinical narrative: Mother specifies that 4 hours after vaccination of flu, MCV and TDAP, the girl started to have difficulty breathing, snoring and weakness.  She took her to the hospital  and was diagnosed with bronchial spasms and was given breathing therapy.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP, FLU3, MNQ, TDAP
Symptoms: Asthenia, Bronchospasm, Dyspnoea, Snoring
Clinical narrative: Mother specifies that 4 hours after vaccination of flu, MCV and TDAP, the girl started to have difficulty breathing, snoring and weakness.  She took her to the hospital  and was diagnosed with bronchial spasms and was given breathing therapy.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient states she had soreness at time of injection that has persisted for several weeks. Contact us today after speaking to a pharmacist. Denies redness, swelling, fever, states there were 2 small bumps on either side of injection site. States arm is very achy and she has difficulty lifting it. Pt encouraged to contact PCP.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site rash, Pain in extremity
Clinical narrative: Patient states she had soreness at time of injection that has persisted for several weeks. Contact us today after speaking to a pharmacist. Denies redness, swelling, fever, states there were 2 small bumps on either side of injection site. States arm is very achy and she has difficulty lifting it. Pt encouraged to contact PCP.
Age: 33.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Abdominal pain upper, Insomnia, Nausea, Pyrexia
Clinical narrative: Patient experienced stomach cramping after 1st pill. Is allergic to casein and dairy.
Age: 33.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Abdominal pain upper
Clinical narrative: Patient experienced stomach cramping after 1st pill. Is allergic to casein and dairy.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: Redness at injection site. Itching at injection site. Knot at injection site.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea haemorrhagic, Faeces discoloured
Clinical narrative: Diarrhea with blood in the diaper.  This is the second dose of the vaccine.  The first vaccine had 2 weeks of green diapers.  This time, this is the third green diaper so far.  The green diapers started one week in.  We are waiting though the night for further events to unfold.  No event outcomes to report yet.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash morbilliform
Clinical narrative: 'Measles-like' rash to trunk of body, arms and legs.  Presentation of symptoms 16 days after administration of MMR vaccine, resulting in doctor visit at MTF.
Sex: U
Vaccine: RV5
Symptoms: Adverse event, Jejunostomy
Clinical narrative: This spontaneous report as received from a pharmacist refers to an infant of unknown age. On an unknown date the patient was vaccinated with ROTATEQ. Dosage and administration information were unspecified. At the reporting time (21-OCT-2013), the patient was now an in-patient in hospital and had a jejunostomy tube (J-tube). The cause of hospitalization was unspecified. The outcome of events were unknown. Upon internal review, jejunostomy was determined to be medically significant event. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: 1-2 minutes after FLUVIRIN vaccination, pt developed lightheadedness, sweat, and blacked out. Then recovered after approx 1 minute of the black out. After additional 15 minutes of observation pt seemed to fully recover and left store on foot. Pt mentioned he had occasional incidents like this. (This was disclosed after the flu shot and that he did not like needles) when he had the lightheadedness.
Age: 20.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Loss of consciousness, Respiratory arrest
Clinical narrative: After 2nd vaccination (FLUVIRIN) pt stopped breathing and lost consciousness. Epi-pen administered, and pt regained breathing/consciousness. Ambulance arrived shortly thereafter.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Hyperaesthesia, Pain, Skin warm
Clinical narrative: Patient reported severe erythema, soreness, and touch sensitivity post injection. Area was also extremely warm to the touch. I examined it 3 days post administration. Still red, patient taking analgesics, and slightly warm to touch. But otherwise improving.
Age: 51.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blister, Nodule, Pain, Pruritus, Skin discolouration
Clinical narrative: Knot under skin increasing. Blisters. Center dark. Itching painful to touch.
Age: 51.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Tenderness, Viral test
Clinical narrative: Knot under skin increasing. Blisters. Center dark. Itching painful to touch.
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female adult patient of unknown age. The patient was administered a 0.5 ml pediatric dose of VAQTA injection (lot # unspecified), route and location unspecified on 06-JUL-2012 and 10-JUL-2012 respectively instead of an adult dose. No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 1 year old patient. On 10-OCT-2013, the patient was vaccinated with a dose of VARIVAX (Merck), (lot number, expiry date and route was not reported) and a dose of PROQUAD, (lot number, expiry date and route was not reported) during the same visit. No symptoms were reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a 56 year old female patient. On 14-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J003359, expiry: 21-JUN-2014). On an unknown date in September 2013, the patient developed a two-inch-by-four-inch red rash within an unspecified timeframe; 24 hours after the appearance of this two-inch-by-four-inch red rash, the rash was three-inches-by-five-inches. No treatment was given for the rash. Subsequent to this, within three to four days, the rash went away approximately on an unknown date in September 2013. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's medical history was unknown. On 11-OCT-2013, the patient was vaccinated with ZOSTAVAX, subcutaneous. No co-suspected or concomitant medications were reported. The pharmacist reported that while administering the ZOSTAVAX, some of the ZOSTAVAX came out of the sides of the syringe and the patient did not receive a full dose of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dysphonia, Fatigue, Headache, Injection site erythema
Clinical narrative: 2 inch area swollen and red at injection site; congestion, hoarseness, sore neck; red eyes, chills but no fever; achy; headache; fatigue.  Self treated with rest and Tylenol.  Checked with endocrinologist.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Neck pain, Ocular hyperaemia, Pain, Respiratory tract congestion
Clinical narrative: 2 inch area swollen and red at injection site; congestion, hoarseness, sore neck; red eyes, chills but no fever; achy; headache; fatigue.  Self treated with rest and Tylenol.  Checked with endocrinologist.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dizziness, Dysphagia, Dysphonia
Clinical narrative: Within minutes of receiving vaccine, pt developed symptoms of dizziness, hoarseness, tightness in the chest and trouble swallowing.  These symptoms progressed over the next hour and pt drove herself to the emergency dept.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Local swelling, Paraesthesia, Pruritus generalised
Clinical narrative: Swollen hands and fingers with numbness and tingling. Within 20 minutes of injection, she developed face tingling and was "itching all over." Recipient worked at a doctor's office, so she was treated with IV fluids and Benadryl 50mg IV.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Lip swelling, Swollen tongue
Clinical narrative: Shortness of breath and tightness in her chest, feeling that her lip and tongue were swelling.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Pain
Clinical narrative: The patient has had body pain (like during flu) since the day after vaccination (10/09/2013) till to date (10/28/2013).
Age: 75.0
Sex: F
Vaccine: FLUC3
Symptoms: Palpitations, Paraesthesia
Clinical narrative: Heart palpations and tingling all of the body took 2 Benadryl within 2 hr. period.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Headache, Pyrexia, Tic
Clinical narrative: Tic disorder began with 3 days of fever 102 - 103 and headache.
Age: 2.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Urticaria
Clinical narrative: Pt developed hives at home, was given Benadryl at home. Pt was doing better but hives came back when Benadryl wore off. Mom gave Benadryl again. No anaphylactic symptoms.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Myalgia, Neck pain, Periarthritis
Clinical narrative: This was not an emergency reaction to the vaccine but apparently something to do with the location of the shot that has caused a prolonged period of muscle pain around the site and beginnings of what my doctor called a frozen shoulder as the pain moved into my neck and down my arm. A week after the shot at our Employee Health dept., I consulted with them about the pain and they asked me to have a doctor evaluation. I saw my doctor the next day, she diagnosed it as frozen shoulder and gave me PT exercises to do. I've been doing these and the frozen shoulder symptoms are going away, although three weeks later I still have a sore arm around the shot location when I move my arm around. I've always had typical 1-2 days of soreness in the past and never any other type of problem with the flu vaccine. I'm hoping the arm pain will eventually go away. I did report my doctor's evaluation back to Employee Health and they asked me to report it here as well.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster, Insomnia, Pain, Pyrexia, Sinusitis
Clinical narrative: Felt like I had a sinus infection that night.  Fever, achy.  Developed isomnia and have had it for 4 days now.  I also developed shingles 2 days ofter administration 10/26/2013.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Abasia, Activities of daily living impaired, Arthralgia, Blood test, C-reactive protein increased
Clinical narrative: Patient received the first Gardasil HPV shot on 2/2/12 and severe nosebleeds and headaches followed the next few weeks.  Patient developed a "rash" although not raised (Livedo Reticularis) on her thighs in mid-March. Patient received the second dose of the Gardasil HPV shot on 4/03/2013 - she passed out at the check out counter at the dr office and started having pain in her hips, tailbone, legs, and pelvic region on 4/17/2012.  Patient was hospitalized on 4/20/2012 for excruciating pain in her hips.  She did not walk for 6 of those days in the hospital.  Her CRP level when she entered the hospital was 166.  She was administered Clindamycin and then Vancomycin via IV as well as morphine and Toradol, oxycodone for pain and what was believed to be an infection deep in her hip muscles and tissues.  She was released with only a follow-up to her pediatrician.  Now 18 months later, patient is still having debilitating pain in her hips. She was forced to stop playing soccer with her school team as the pain was too great.  She is in physical therapy 2x week.  Orthopedic doctor recently did an MRI of her pelvic region which did not show any infection, however, did show that patient has 3 ovarian cysts.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Epistaxis, Headache, Infection, Livedo reticularis, Loss of consciousness
Clinical narrative: Patient received the first Gardasil HPV shot on 2/2/12 and severe nosebleeds and headaches followed the next few weeks.  Patient developed a "rash" although not raised (Livedo Reticularis) on her thighs in mid-March. Patient received the second dose of the Gardasil HPV shot on 4/03/2013 - she passed out at the check out counter at the dr office and started having pain in her hips, tailbone, legs, and pelvic region on 4/17/2012.  Patient was hospitalized on 4/20/2012 for excruciating pain in her hips.  She did not walk for 6 of those days in the hospital.  Her CRP level when she entered the hospital was 166.  She was administered Clindamycin and then Vancomycin via IV as well as morphine and Toradol, oxycodone for pain and what was believed to be an infection deep in her hip muscles and tissues.  She was released with only a follow-up to her pediatrician.  Now 18 months later, patient is still having debilitating pain in her hips. She was forced to stop playing soccer with her school team as the pain was too great.  She is in physical therapy 2x week.  Orthopedic doctor recently did an MRI of her pelvic region which did not show any infection, however, did show that patient has 3 ovarian cysts.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging abnormal, Ovarian cyst, Pain in extremity, Pelvic pain, Rash
Clinical narrative: Patient received the first Gardasil HPV shot on 2/2/12 and severe nosebleeds and headaches followed the next few weeks.  Patient developed a "rash" although not raised (Livedo Reticularis) on her thighs in mid-March. Patient received the second dose of the Gardasil HPV shot on 4/03/2013 - she passed out at the check out counter at the dr office and started having pain in her hips, tailbone, legs, and pelvic region on 4/17/2012.  Patient was hospitalized on 4/20/2012 for excruciating pain in her hips.  She did not walk for 6 of those days in the hospital.  Her CRP level when she entered the hospital was 166.  She was administered Clindamycin and then Vancomycin via IV as well as morphine and Toradol, oxycodone for pain and what was believed to be an infection deep in her hip muscles and tissues.  She was released with only a follow-up to her pediatrician.  Now 18 months later, patient is still having debilitating pain in her hips. She was forced to stop playing soccer with her school team as the pain was too great.  She is in physical therapy 2x week.  Orthopedic doctor recently did an MRI of her pelvic region which did not show any infection, however, did show that patient has 3 ovarian cysts.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Spinal pain, X-ray
Clinical narrative: Patient received the first Gardasil HPV shot on 2/2/12 and severe nosebleeds and headaches followed the next few weeks.  Patient developed a "rash" although not raised (Livedo Reticularis) on her thighs in mid-March. Patient received the second dose of the Gardasil HPV shot on 4/03/2013 - she passed out at the check out counter at the dr office and started having pain in her hips, tailbone, legs, and pelvic region on 4/17/2012.  Patient was hospitalized on 4/20/2012 for excruciating pain in her hips.  She did not walk for 6 of those days in the hospital.  Her CRP level when she entered the hospital was 166.  She was administered Clindamycin and then Vancomycin via IV as well as morphine and Toradol, oxycodone for pain and what was believed to be an infection deep in her hip muscles and tissues.  She was released with only a follow-up to her pediatrician.  Now 18 months later, patient is still having debilitating pain in her hips. She was forced to stop playing soccer with her school team as the pain was too great.  She is in physical therapy 2x week.  Orthopedic doctor recently did an MRI of her pelvic region which did not show any infection, however, did show that patient has 3 ovarian cysts.
Sex: F
Vaccine: VARZOS
Symptoms: Lacrimation increased, Nasal congestion, Nasopharyngitis, Product colour issue, Product quality issue
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, after the vaccination, the patient experienced a cold, watery eyes and a stuffy nose. Product quality complaint (PQC) was filed as the patient thought the color of ZOSTAVAX that was administered, did not look the way it was described in the product information (PI). The outcome of cold, watery eyes and a stuffy nose was unknown. The relatedness for cold, watery eyes and a stuffy nose was unknown for ZOSTAVAX. Additional information is not expected.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dysarthria, Facial paresis, Hypoaesthesia oral, Tinnitus, VIIth nerve paralysis
Clinical narrative: Slurred speech, right-sided facial weakness, incl eyelid and corner of mouth mouth droop, intermittent loud noise rt. ear, tip of tongue, right side, numb.
Age: 35.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Headache, Increased upper airway secretion, Photophobia, Productive cough
Clinical narrative: Light sensitivity, irritation in the throat, continuous clear mucus from the nose, dry cough and then productive cough with yellowish mucus, headache, and the pain in the sinuses during the last two weeks. Tylenol, cold medicine.
Age: 35.0
Sex: F
Vaccine: FLUN4
Symptoms: Rhinorrhoea, Sinus headache, Throat irritation
Clinical narrative: Light sensitivity, irritation in the throat, continuous clear mucus from the nose, dry cough and then productive cough with yellowish mucus, headache, and the pain in the sinuses during the last two weeks. Tylenol, cold medicine.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a female consumer of unknown age with drug reactions/allergies to penicillin and no pertinent medical history refers to herself. On 18-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number not reported). There was no concomitant medication. On 19-OCT-2013, the patient experienced rash at the injection site described as red, raised and about five inches long. It was itchy and warm to the touch, with a knot at the injection site. However, there were no blisters. There was no treatment given for adverse events. No laboratory tests were performed. The patient's outcome of adverse events was unknown. The patient did not seek medical attention. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a female consumer of unknown age with drug reactions/allergies to penicillin and no pertinent medical history refers to herself. On 18-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number not reported). There was no concomitant medication. On 19-OCT-2013, the patient experienced rash at the injection site described as red, raised and about five inches long. It was itchy and warm to the touch, with a knot at the injection site. However, there were no blisters. There was no treatment given for adverse events. No laboratory tests were performed. The patient's outcome of adverse events was unknown. The patient did not seek medical attention. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient with no drug reactions/allergies. On 02-OCT-2013 the patient was vaccinated with PNEUMOVAX23 lot # H010515, intramuscular in arm (dosing information was not provided). Concomitant therapies included FLUZONE (same arm, separate site) and unspecified medications. The pharmacist reported that the patient developed an injection site reaction. The patient informed the pharmacist that the patient's arm became sore immediately after the PNEUMOVAX23 vaccination on 02-OCT-2013. And developed into a red, achy, warm to the touch area just below the injection site on 03-OCT-2013. On 04-OCT-2013 the patient went to the physician. ALEVE and ice packs for the swelling were given as treatment. The outcome of the events was reported as not recovered/not resolved. No reporter causality provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient with no drug reactions/allergies. On 02-OCT-2013 the patient was vaccinated with PNEUMOVAX23 lot # H010515, intramuscular in arm (dosing information was not provided). Concomitant therapies included FLUZONE (same arm, separate site) and unspecified medications. The pharmacist reported that the patient developed an injection site reaction. The patient informed the pharmacist that the patient's arm became sore immediately after the PNEUMOVAX23 vaccination on 02-OCT-2013. And developed into a red, achy, warm to the touch area just below the injection site on 03-OCT-2013. On 04-OCT-2013 the patient went to the physician. ALEVE and ice packs for the swelling were given as treatment. The outcome of the events was reported as not recovered/not resolved. No reporter causality provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age with macrolide antibiotics allergy. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # 669260/0152AA, expiration date 01-MAY-2012) (dose and route unspecified). On an unknown date the patient now had shingles. The reporter stated a physician reported this to the pharmacy. The reporter stated the physician received a shipment of ZOSTAVAX that was shipped out from the pharmacy on June 2011 and given to the patient at an unspecified date. The physician was requesting a lot check to see if other reports of shingles had occurred with this lot number. Physician would like this information sent to him directly. The patient had sought medical attention via office visit. Treatment was given. The event outcome was reported as recovering/resolving. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 28 year old male patient. The patient was supposed to received his first dose of PNEUMOVAX23 but on 10-OCT-2013, the patient was inadvertently vaccinated with a dose of GARDASIL (Lot number was reported as J008423, expiry date was 21-JN-2016), 0.5 milliliter (ml), intramuscular. The nurse stated that the patient had never received any previous doses of GARDASIL. Also PNEUMOVAX23 had not been administered at this time. No adverse effects were reported at this time. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a female patient who is over 26 years of age regarding herself. On an unknown date in August 2013, the over 26 year old patient was vaccinated with the first dose of GARDASIL. No side effects have been reported. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse refers to a 4 month 3 days old patient. On 14-OCT-2013, the patient was inadvertently vaccinated with a dose of 0.5ml VARIVAX (Merck), (lot number, expiry date was not reported), subcutaneous. No adverse effect was reported. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site pain
Clinical narrative: Approx 2 days after receiving HIGH DOSE flu vaccine, a 4 in x 3 in area appeared on arm where shot was given. Appeared to be discolored; sensitive to touch, no swelling.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 16-OCT-2013, the patient was inadvertently administered ROTATEQ (lot # 0209AE, expiry date 28-SEP-2013) orally, that had expired on 28-SEP-2013. No adverse effects reported. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Patient states she has a "dollar bill" size red area where she was given vaccine - states area is warm to the touch.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. In December 2012, the patient was vaccinated (route not provided) with ZOSTAVAX 19400PFU (lot number and expiry date not provided). IN December 2012, the patient may have inadvertently been administered 2 doses of ZOSTAVAX and no adverse effects reports were unknown. The action taken with ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple patients of unknown age and unknown gender. Information concerning concomitant medications and medical history was not provided. On an unknown date the patients were vaccinated with ZOSTAVAX (lot number, dose, and dose number were not provided), subcutaneous. The reporter stated that the majority of the patients that he had vaccinated, experienced a small red spot at the injection site, onset date not reported. The outcome of small red spot at the injection site is unknown. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Hypotension, Urticaria
Clinical narrative: Patient awoke the day after vaccination covered in hives. Presented at Health Center with a low B/P (72/49) and urticaria. Was given .5cc Epinephrine 1:1000 and 50mg BENDARYL PO. EMS was dispatched for transport to hospital.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician's assistant refers to a patient of unknown age and gender. On 12-OCT-2013, the patient was inadvertently administered with a dose of GARDASIL (lot # 1073AA), 0.5 ml, intramuscularly that had expired on 11-OCT-2013. No adverse effects reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Joint swelling, Local swelling, Mobility decreased
Clinical narrative: Initial case received from a healthcare professional (nurse) on 14-Oct-2013. A 58-year-old female patient, with a relevant reported medical history, had received her intramuscular dose of FLUZONE (batch number UH908AA) in the left deltoid on 03-Oct-2013. The patient had a medical history of left knee replacement 10 years ago (2007), hypertension, absent thyroid, arthritis; DILAUDID itching, morphine and codeine vomit. There was no illness at the time of the vaccination. A week prior to reporting, on Wednesday, the patient developed knee pain. Later on, on Friday, Saturday and Sunday, she experienced pain and swelling in the back of the knee. Ortho was called. On Saturday, the patient's condition got worse. On Sunday, she could bear weight. She also had swelling from her thigh to her feet and could not fit her leg. By Monday, she saw her physician, could walk. By Wednesday, she felt more normal, swelling was gone and she could walk as before. The patient was off work for one week. The patient was back to work at the time of the report. She saw her MD. They were unsure of the relationship to vaccine. Unspecified pain meds were prescribed. The patient recovered on an unspecified date.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a doctor of pharmacy via a company representative concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number and expiry date were reported as H016283 and 21-FEB-2014 respectively, dose unspecified), intramuscularly in the arm. No concomitant therapy was reported. On an unknown date, the patient experienced throbbing pain from the deltoid region down to their finger tips. The patient sought medical attention (came back to pharmacy to review the reaction). The patient took over the counter medications for the pain. It was unspecified, if any lab tests were performed. The outcome of throbbing pain from the deltoid region down to their finger tips was reported as resolved (date unspecified). The reporter contacted the other 7 patients who had also been vaccinated from this lot number and expiration date and no other reactions were reported. The relatedness of throbbing pain from the deltoid region down to their finger tips was unknown for PNEUMOVAX23. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. On 16-OCT-2012, the patient was vaccinated with the first dose of VAQTA (route and lot # not reported) and on 12-DEC-2012, the patient received the second dose of VAQTA (route and lot # not reported). No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: This spontaneous report was received from a doctor of pharmacy via a company representative concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number and expiry date were reported as H016283 and 21-FEB-2014 respectively, dose unspecified), intramuscularly in the arm. No concomitant therapy was reported. On an unknown date, the patient experienced throbbing pain from the deltoid region down to their finger tips. On an unknown date, the patient experienced redness at the injection site and was seen in an unspecified emergency department. The patient sought medical attention (came back to the pharmacy to review the reaction). The patient took over the counter medications for the pain. It was unspecified if any lab tests were performed. The outcome of throbbing pain from the deltoid region down to their finger tips was reports as resolved (date unspecified). The outcome of redness at the injection site was unknown. The reporter contacted the other 7 patients who had also been vaccinated from this lot number and expiration date and no other reactions were reported. The relatedness for throbbing pain from the deltoid region down to their finger tips and redness at the injection site was unknown for PNEUMOVAX 23. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 14-OCT-2013, the patient was vaccinated with a expired dose of ROTATEQ (lot # H010696, expiry: 06-OCT-2013) 2 ml, orally. No adverse effect reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Aphasia, Computerised tomogram head normal, Dizziness, Dyspnoea
Clinical narrative: Immediately after receiving IM influenza vaccine patient felt lightheaded. She quickly developed left-sided body numbness, difficulty breathing, inability to walk/talk.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Immediately after receiving IM influenza vaccine patient felt lightheaded. She quickly developed left-sided body numbness, difficulty breathing, inability to walk/talk.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant concerning a 20 year old female patient with penicillin allergy. The patient's medical history included hives. On 17-JUL-2013 the patient had a mumps virus antibody immunoglobulin G (IGG) titer drawn with a result of 0.91 which was equivocal (MARRS # 1310USA004796). On an unspecified date, the patient was vaccinated with a dose of RECOMBIVAX HB (dose, route, lot # and expiration date were not reported). ON 24-JUL-2013, the patient was vaccinated with a dose of RECOMBIVAX HB (dose, route, lot # and expiration date were not reported).  On 17-JUL-2013 the patient experienced a negative titer for hepatitis B. The result of an unspecified test on 03-SEP-2013 was the patient had immunity. The outcome of the event was unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received vaccines 10/15/13 - Developed fever to 103 10/16/13 and upper (R) thigh redness, swelling, tender to touch warmth and limping of (R) leg 10/17/13 morning.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Pyrexia, Streptococcus test positive
Clinical narrative: Received vaccines 10/15/13 - Developed fever to 103 10/16/13 and upper (R) thigh redness, swelling, tender to touch warmth and limping of (R) leg 10/17/13 morning.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood electrolytes, Blood glucose, Blood immunoglobulin E, Blood urea, Enzyme level test
Clinical narrative: 10/19/13 given .5 ml FLULAVAL - flu vaccine. 10/24/13 returned and seen by Nurse Practitioner with symptoms of numbness and tingling of extremities - sent to emergency room, seen neurologist.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Full blood count, Glomerular filtration rate, Hypoaesthesia, Nuclear magnetic resonance imaging brain, Paraesthesia
Clinical narrative: 10/19/13 given .5 ml FLULAVAL - flu vaccine. 10/24/13 returned and seen by Nurse Practitioner with symptoms of numbness and tingling of extremities - sent to emergency room, seen neurologist.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Urine analysis
Clinical narrative: 10/19/13 given .5 ml FLULAVAL - flu vaccine. 10/24/13 returned and seen by Nurse Practitioner with symptoms of numbness and tingling of extremities - sent to emergency room, seen neurologist.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: 10/19/13 given .5 ml FLULAVAL - flu vaccine. 10/24/13 returned and seen by Nurse Practitioner with symptoms of numbness and tingling of extremities - sent to emergency room, seen neurologist.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old patient of unknown gender. On 14-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J005721, expiry date: 29-AUG-2014 as reproted) (dose, location unspecified). In October 2013 the patient experienced a dermatological reaction with redness and swelling (had injection site reactions, size of swelling around injection site and redness, the redness was approximately 3 inches in diameter). At the time of report, the outcome of the events was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a 39 year old female patient with anemia. The patient had no drug reactions/allergies. On 02-APR-2009 the patient was vaccinated with the secondary dose of VARIVAX (Merck) (lot # unspecified) route, dose and location unspecified. No concomitant medication was reported. On 05-OCT-2013 the patient was tested for an immune response to VARIVAX (Merck) and the blood test showed that the patient did not have an immunity to Varicella. The patient did not specify the date of the first shot. No adverse effect was reported. The patient did not seek medical attention. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: Arm turn red, rash, painful.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 3x5 cm area of erythema at injection site to (L) deltoid, slightly tender and warmth to touch.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 58 year old patient (gender unknown). On 01 -OCT-2013, the patient was vaccinated with ZOSTAVAX (lot #, expiry not reported), 0.65 ml, subcutaneously. On an unknown date in October 2013, the patient experienced an unspecified sinus infection after ZOSTAVAX vaccination. Pharmacist stated that an unspecified physician prescribed an unspecified "steroid dose pack for 6 days" that was tapered with first dose exceeding 20 mg to treat unspecified sinus infection. The pharmacist stated that the unspecified "steroid dose pack" prescription had not yet been filled pending discussion with the unspecified physician. The outcome of the unspecified sinus infection was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Dizziness, Incorrect dose administered, Myalgia
Clinical narrative: This spontaneous report was received from a 22 years old female patient regarding herself. Pertinent medical history included a back problem and the patient didn't have drug reactions or allergies. From 2007 to 2008 the patient received the three doses of GARDASIL. Duration and route of administration were not reported. On 03-OCT-2013 the patient received accidentally a fourth dose of GARDASIL for Human Papillomavirus (HPV) prevention. Duration and route of administration were not reported. There were no concomitant medications. On 03-OCT-2013 she started to have joint and muscle pain, felt weak, dizzy, light headed, fever and developed a urinary tract infection (UTI). To treat this, the patient had to go to an unspecified emergency room and there received unspecified antibiotics. It was reported also that patient received an unspecified yeast infection medication. The patient had a urine test on an unknown date and the results were not reported. The outcome of the adverse events was reported as not recovered. The relationship between GARDASIL and the adverse events was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Urinary tract infection, Urine analysis
Clinical narrative: This spontaneous report was received from a 22 years old female patient regarding herself. Pertinent medical history included a back problem and the patient didn't have drug reactions or allergies. From 2007 to 2008 the patient received the three doses of GARDASIL. Duration and route of administration were not reported. On 03-OCT-2013 the patient received accidentally a fourth dose of GARDASIL for Human Papillomavirus (HPV) prevention. Duration and route of administration were not reported. There were no concomitant medications. On 03-OCT-2013 she started to have joint and muscle pain, felt weak, dizzy, light headed, fever and developed a urinary tract infection (UTI). To treat this, the patient had to go to an unspecified emergency room and there received unspecified antibiotics. It was reported also that patient received an unspecified yeast infection medication. The patient had a urine test on an unknown date and the results were not reported. The outcome of the adverse events was reported as not recovered. The relationship between GARDASIL and the adverse events was not reported. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 month old patient. On 18-OCT-2013 the patient was vaccinated with an expires dose of RECOMBIVAX HB (lot # 669599/0231AA, expiration date 14-OCT-2013) 0.5 ml intramuscular (it was unspecified if this was the patient's first or second dose). Concomitant medications were not reported. No adverse effects reported. This case is linked to case 1310USA009308 via same reporter link. Additional information has been requested.
Sex: M
Vaccine: DTAP, FLUX, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative refers to a male patient(who is also the physician) of unknown age. On an unknown date in OCT-2013 (reported as within past 2 weeks) the patient was vaccinated with a dose of PNEUMOVAX23, (lot number, expiry date was not reported)subcutaneous. Concomitant therapies included influenza (manufacturer unknown) and DTAP(manufacturer unknown). On an unknown date in OCT-2013(reported as within past 2 weeks), the patient experienced injection site reaction which included swelling and feeling hot to touch which lasted for few days. Treatment for the events included unspecified antibiotics. The outcome of the events were reported as recovered. The patient sought medical attention. Additional information has been requested.