chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 29-OCT-2014, the patient was inadvertently vaccinated with a dose of expired ZOSTAVAX (lot # J007208, expiration date 20-SEP-2014, dose, route not reported). No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Oral herpes
Clinical narrative: This spontaneous report as received from a male physician of unknown age refers to himself via company representative. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, lot number not provided) for prevention for shingles. On an unknown date, the patient experienced rash at the injection site and cold sore on his lip. The physician treated himself with acyclovir (unspecified dose/frequency and manufacturer). The outcome of rash at the injection site and cold sore on his lip was reported as recovered/resolved. Additional information is not expected.
Age: 1.1
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a physician via a field representative on 06-NOV-2014 refers to a 13 months old patient of unknown gender. On 06-OCT-2014 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # K003423, expiration date: 06-MAR-2016) 1 shot, injection in the left thigh for vaccine. Other suspect therapies included VAQTA (strength, dose, route and lot# were unknown) started on 06-OCT-2014 (also reported as on the same date). On an unknown date of October 2014 the patient developed a varicella-like blister at injection site after receiving (Oka/Merck) VARIVAX. No treatment given for adverse event. The outcome of the event was not provided. The reaction was reported to the office of the physician on 17-OCT-2014. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. The physician stated that her refrigerator and freezer units began to have temperature excursions as of 05-MAY-2014. PNEUMOVAX 23 was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range) since 05-MAY-2014 and also to 49F for 12 hours. On unspecified dates since 05-MAY-2014, an unspecified number of patients received PNEUMOVAX 23 which was improperly stored. No product complaint was reported for PNEUMOVAX 23. This case is linked to 1411USA004432, 1411USA004433, 1411USA004434, 1411USA004435, 1411USA004436, 1411USA004437, 1411USA004438, 1411USA004439, 1411USA004440, 1411USA004441 and 1411USA004442 (same reporter link). Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Localized itching and tenderness to site on 11/6 also erythema at injection site.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Diarrhoea, Dizziness, Nausea, Vision blurred
Clinical narrative: Within a few hours of receiving TDAP, developed nausea, dizziness and diarrhea. Also had chest tightness and blurry vision.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: Redness, pain on 11/8/`4. Approx 1 inch below injection site. Diagnosis by dr. Cellulitis.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 year old patient, gender was not reported. Medical history and concurrent conditions were not reported. On 27-OCT-2014, the patient was vaccinated with VARIVAX (Merck) (dose, strength, route and lot number were not reported) Secondary and concomitant therapies were not reported. Medical assistant reported that the patient was inadvertently administered two doses of VARIVAX (Merck) during the same office visit today. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 04-AUG-2014 the patient was vaccinated with the first dose of GARDASIL (strength and lot # unknown) 0.5 ml, intramuscular. The patient was administered the second dose of GARDASIL on 03-OCT-2014 and the third dose of GARDASIL on 22-OCT-2014. No adverse effects reported. Additional information is not expected because the reporter doesn't want to be contacted.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a 72 year old female patient refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and frequency were unknown, route was reported as injection) for the prevention of shingles. On an unknown date the patient experienced injection site pain after receiving ZOSTAVAX. No treatment was given for the adverse event. The patient sought for medical attention by office visit on 29-OCT-2014. The outcome of injection site pain was reported as not recovered/not resolved. Additional information is not expected because no patient or physician's contact information was provided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 61 year old female patient. On 24-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K000994, expiration date 06-MAR-2015, 1 injection), subcutaneous in the left arm. On 24-OCT-2014, 8 hours after vaccination, the patient experienced moderate redness and swelling at the injection site that covered the tricep area of the left arm. The patient describes the irritated area as being three inches wide and 6 inches long. The patient also reported a bilateral tingling sensation in her lower extremity area on 24-OCT-2014. The patient did not seek medical attention and no treatment was given for the events. The outcome of the events was reported as recovered/resolved on an unspecified date in October 2014. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date in January 2013, the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, route, frequency and lot number not provided). On 22-OCT-2014, the patient was vaccinated with the second dose of PNEUMOVAX 23 (dose, route, frequency and lot number not provided). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The reporter reported that an unspecified number of patients were administered doses of ZOSTAVAX (lot#, dose, dose# and route unspecified) which were improperly stored since an unspecified date in June 2014. No adverse events were reported. The outcome of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received form a pharmacist refers to a patient of unknown age and gender. On 04-NOV-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot# reported as 0956Z, expiry date 17-DEC-2011, 0.5ml, once, intramuscular). No adverse effects reported. (Potency not supported). The outcome of the event was not reported. The reporter stated that immunization pharmacist had more patient details. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health worker on 03-NOV-2014 refers to two patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored LIQUID PEDVAXHIB (also reported as PEDVAX HIB) (strength, dose and lot # were unknown). The vaccine was at 31 F for 8 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a field representative refers to a 40 year old female patient. No information about medical history, concurrent conditions was reported. On 28-OCT-2014 the patient was vaccinated with ZOSTAVAX (lot#, dose, route not reported). No concomitant medications were reported. The pharmacist reported to the representative that the patient had requested to receive ZOSTAVAX because she has experienced shingles prior to receiving ZOSTAVAX. The representative states that the patient has not experienced shingles since she received ZOSTAVAX. No adverse experience was reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction, Hypersensitivity
Clinical narrative: This spontaneous report as received from a physician via Pfizer, Inc. (MFR number 2014292668) refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, dose, route not reported). Concomitant therapies were not provided. The physician mentioned that the patient had been considered allergic or had a bad reaction with PNEUMOVAX23 on an unknown date. The outcome of the events were unknown. Additional information is not expected, since no additional health care professional contact details provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse. On an unknown date, unspecified number of patients received improperly stored GARDASIL. No adverse effects reported. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Balance disorder, Blood test normal, Computerised tomogram normal, Gait disturbance
Clinical narrative: Stiff neck, sore achey muscles and joints lasting until 10/21/14. Extreme weakness in legs, feet, arms and numbness/tingling all over. Also, trouble with walking and balance beginning 10/29/14 and ongoing.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Muscular weakness, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: Stiff neck, sore achey muscles and joints lasting until 10/21/14. Extreme weakness in legs, feet, arms and numbness/tingling all over. Also, trouble with walking and balance beginning 10/29/14 and ongoing.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Urine analysis normal
Clinical narrative: Stiff neck, sore achey muscles and joints lasting until 10/21/14. Extreme weakness in legs, feet, arms and numbness/tingling all over. Also, trouble with walking and balance beginning 10/29/14 and ongoing.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Muscular weakness, Musculoskeletal stiffness, Myalgia, Paraesthesia
Clinical narrative: Stiff neck, sore achey muscles and joints lasting until 10/21/14. Extreme weakness in legs, feet, arms and numbness/tingling all over. Also, trouble with walking and balance beginning 10/29/14 and ongoing.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urine analysis normal
Clinical narrative: Stiff neck, sore achey muscles and joints lasting until 10/21/14. Extreme weakness in legs, feet, arms and numbness/tingling all over. Also, trouble with walking and balance beginning 10/29/14 and ongoing.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eye pruritus, Eye swelling, Eyelid oedema, Eyelids pruritus
Clinical narrative: Swelling and itching around eyes and eyelids and lips, dizziness, headache, nausea.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Lip swelling, Nausea, Pruritus
Clinical narrative: Swelling and itching around eyes and eyelids and lips, dizziness, headache, nausea.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Shingles rash left wrist dermatome C6 (prior history of chicken pox, no prior history of shingles.) Child is 8 and otherwise healthy with no illness prior to flu vaccine.)
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Blindness unilateral, Eye pain, Nuclear magnetic resonance imaging normal, Optic neuritis
Clinical narrative: 9/26 = Left eye became sore to touch; 9/28 = Left eye vision loss; 9/29 = Primary eye MD referred her to ophthalmologist; 9/30 = ophthalmologist ordered MRI due to optic neuritis; 9/31 = MRI completed; 10/2 = Ophthalmologist ordered her to be admitted to hospital for further work-up. She received high doses of steroids and was admitted for 3 days; 11/4 = followed-up with neurologist. Outcome = optic neuritis has improved and she has regained most of her vision in the left eye.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy skin, Eczema, Erythema, Immune system disorder, Local swelling
Clinical narrative: Day after Flu Vaccine was administered, patient's left arm became swollen, red and painful. 3-4 days later, a bumpy, itchy, red rash developed near the injection site and soon spread to right arm. On Nov 02, 2014, rash appeared on front and back of both legs. Patient saw dermatologist on November 2, 2014 and a biopsy was done. Patient received a diagnosis of eczema, acute hyperimmune reaction to the flu shot.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: Day after Flu Vaccine was administered, patient's left arm became swollen, red and painful. 3-4 days later, a bumpy, itchy, red rash developed near the injection site and soon spread to right arm. On Nov 02, 2014, rash appeared on front and back of both legs. Patient saw dermatologist on November 2, 2014 and a biopsy was done. Patient received a diagnosis of eczema, acute hyperimmune reaction to the flu shot.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Local reaction, Pyrexia, White blood cell count normal
Clinical narrative: 6 hours after administration, patient had fever of 100.4 F. Dx: Rigors. Patient had large local reaction and required hospitalization. At hospital patient was afebrile and had normal WBC.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: 10/18/14 warm sensation to right foot. 10/19/14 pins and needles and numbness both feet. 10/20 progression of paresthesia. 10/21 progression upwards involving legs, thighs, abdomen, arms, hands. 10/23 perioral and facial numbness.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Patient states that she noted soreness at the injection site and the underside of her arm immediately following the injection administration and continuing but improving through present. Patient also noted redness below the injection site and the underside of her arm in the am of 11/12/14.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Dysphonia, Headache, Injection site pain, Ocular hyperaemia
Clinical narrative: Hoarseness, intense coughing with phlegm, "lump" in throat sensation, headache, red eyes, sore arm at injection site, jaw pain on same side of body as injection.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in jaw, Productive cough, Sensation of foreign body
Clinical narrative: Hoarseness, intense coughing with phlegm, "lump" in throat sensation, headache, red eyes, sore arm at injection site, jaw pain on same side of body as injection.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Headache, Malaise, Myalgia, Nausea, Wheezing
Clinical narrative: Wheezing, muscle ache, headache, nausea. I took Mucinex and Tylenol and it seemed to help. Still did not feel well on 11/12/2014.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Dyspnoea, Influenza like illness
Clinical narrative: Wheezing, muscle ache, headache, nausea. I took Mucinex and Tylenol and it seemed to help. Still did not feel well on 11/12/2014.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Headache, Malaise, Myalgia, Nausea, Wheezing
Clinical narrative: Has flu like symptoms with shortness of breath about 7 hours after injection. He took MUCINEX and feeling better. He called MD.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Dyspnoea, Influenza like illness
Clinical narrative: Has flu like symptoms with shortness of breath about 7 hours after injection. He took MUCINEX and feeling better. He called MD.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Swelling face, Urticaria
Clinical narrative: Hives-10/31/2014, Fatigue and headache 11/01/2014-11/03/2014, as well as hives continued. 11/04/2014 Facial swelling and hives. 11/05/2014-11/11/2014- Hives. 11/12/2014- Facial swelling.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Dyspepsia, Eye pain
Clinical narrative: Symptoms: Intense indigestion, freezing/chills, extreme dizziness, rapid heart beat, very weak, eye sockets hurt, major body aches.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Heart rate increased, Pain
Clinical narrative: Symptoms: Intense indigestion, freezing/chills, extreme dizziness, rapid heart beat, very weak, eye sockets hurt, major body aches.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain
Clinical narrative: Patient experienced redness and pain. Redness was over a wide area and extended around the arm like a band.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injection site reaction, Lymphadenopathy
Clinical narrative: Pt received shot in right deltoid. Pt claim right shoulder caused bursitis and lymph enlargement.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Rash
Clinical narrative: Patient expereinced redness/rash that covered a wide area.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Experienced pain at injection site almost immediately. Ibuprofen taken with some relief. Fever of 101.5 in afternoon of 10/28/2014. Pain radiates down arm when raising arm with burning sensation in lower arm.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Myalgia, Pyrexia
Clinical narrative: Significant myalgias, fever, and increased dypnea requiring resumption of oxygen (had been tapered off the day before).
Sex: F
Vaccine: HIBV, MEN, PPV
Symptoms: Erythema, Injection site erythema, Injection site reaction, Injection site warmth, Local reaction
Clinical narrative: Initial information received on 03 November 2014 from a healthcare provider. An unidentified adult female patient was vaccinated on 29 October 2014 with ACTHIB, batch UI098AA and MENOMUNE, batch UH325AA for a splenectomy. The routes and sites of administration were not reported. At an unspecified date later, the patient experienced a local reaction of redness and swelling and was hospitalized. The patient is being treated with IV antibiotics. The patient's concomitant medications and laboratory tests were not reported. The reporter refused to provide any further information. No further details were available at the time of this report. The patient outcome is unknown. Follow-up information received on 05 November 2014 from a healthcare professional via a company representative. The reporter described the adverse event as "red hot myositis" which occurred in the left deltoid area at the site of PNEUMOVAX 23 and MENOMUNE injections. Details of the PNEUMOVAX 23 vaccine, manufacturer, batch and route were not reported. ACTHIB was given in the right deltoid. The MENOMUNE lot number was confirmed as UH325AA. No further details were available at the time of the report. Documents held by sender: none.
Sex: F
Vaccine: HIBV, MEN, PPV
Symptoms: Myositis, Swelling
Clinical narrative: Initial information received on 03 November 2014 from a healthcare provider. An unidentified adult female patient was vaccinated on 29 October 2014 with ACTHIB, batch UI098AA and MENOMUNE, batch UH325AA for a splenectomy. The routes and sites of administration were not reported. At an unspecified date later, the patient experienced a local reaction of redness and swelling and was hospitalized. The patient is being treated with IV antibiotics. The patient's concomitant medications and laboratory tests were not reported. The reporter refused to provide any further information. No further details were available at the time of this report. The patient outcome is unknown. Follow-up information received on 05 November 2014 from a healthcare professional via a company representative. The reporter described the adverse event as "red hot myositis" which occurred in the left deltoid area at the site of PNEUMOVAX 23 and MENOMUNE injections. Details of the PNEUMOVAX 23 vaccine, manufacturer, batch and route were not reported. ACTHIB was given in the right deltoid. The MENOMUNE lot number was confirmed as UH325AA. No further details were available at the time of the report. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with no known allergies. About one week ago (approximately 23-OCT-2014) the patient was vaccinated with ZOSTAVAX (lot # was not provided), 0.65 ml, subcutaneous in the left arm. On the same day, the patient also vaccinated with Influenza virus vaccine (manufacturer unknown) (strength, dose, frequency, route, lot # and indication were not provided). Pharmacist stated patient's husband called the pharmacy on behalf of his wife (patient), and reported the patient experienced swelling, redness, itching at the injection site and no rash in October 2014. Pharmacist stated the swelling had decreased somewhat. Pharmacist stated the client contacted their health care provider and was told to keep monitoring the event. The treatment was not given. The outcome of events was reported as not recovered/not resolved. No further details provided. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient reports continued ache at injection site, beginning date of injection. Also reports decreased mobility in left arm, causes a more intense ache when raised. Causing a good deal of discomfort. NO previous trouble with flu shots. Encouraged to see his physician.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Local swelling, Pain, Pain in extremity
Clinical narrative: Sore swollen arm, ache all over, headache, fatigue, swollen neck/face.  3 days.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: Sore swollen arm, ache all over, headache, fatigue, swollen neck/face.  3 days.
Age: 66.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Drug administration error, Incorrect route of drug administration
Clinical narrative: Plunger on PREVNAR 13 syringe was depressed before needle was fully inserted so vaccine was probably injected into subcutaneous tissue instead of intramuscularly.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, warm, and swollen.  Not improving after 2 days. Antihistamines taken by patient without improvement.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site pain, Mobility decreased
Clinical narrative: Pain in left shoulder - Hand mobility reduced, cannot raise hand over head, Difficulty wearing shirt or touching head with left hand.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Pain in extremity, X-ray
Clinical narrative: On 9/25/14 patient received a flu shot at pharmacy. Approximately a week or 2 afterward she stated here arm still hurt and was instructed to take ibuprofen. Patient returned on 11/5/14 stating her arm still hurt and had been evaluated at an urgent care clinic. She states she has bursitis.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Inflammation, Pain in extremity, Skin warm
Clinical narrative: Pt received PREVNAR 13 vaccine on 11-6-14. She noticed redness with inflammation to her (lt) arm. Pt came to office on 11-11-14 and see dr. Erythema noted to lt arm. Lt arm painful and warm to touch.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Colposcopy, Emotional distress, Human metapneumovirus test positive, Human papilloma virus test positive
Clinical narrative: This spontaneous report was received from a female patient of unknown age without pertinent medical history, drug reactions and allergies. Patient was not pregnant at the time of the report. On unknown date in 2007 the patient was vaccinated with the first dose of GARDASIL, intramuscular (dose and lot # were not reported). Patient completed doses of GARDASIL intramuscular on unknown date in 2008. There were not concomitant medications. In February 2009 a pap smear showed that the patient's cells were abnormal. It was reported that the patient had been testing positive for human papilloma virus (HPV) from unknown date. Patient stated that she did not contract this through sexual contact. Patient sought medical attention on unknown date. She did not receive any treatment for the adverse events. The outcome of the events was reported as not recovered/not resolved. Follow-up information had been received via a letter on 04-NOV-2014 sent by the patient. Patient noted that she had become HPV positive since receiving GARDASIL vaccination. Patient received the first vaccination on 16-AUG-2007. Since receiving the vaccination, patient noted she was diagnosed with pelvic inflammatory disease (date not reported). With medication, she was able to get rid of that. However, in January 2009, patient went to her family doctor for routine Pap smear and was found out to have an abnormal Pap smear. Patient was referred to a gynecologist and was only given the vinegar base solution due to the fact that she was pregnant. On 05-MAY-2009, patient had a miscarriage and went for a colposcopy shortly after that. Since then, patient had been having routine Pap smear to check the levels of HPV. However, January 2014, patient went in for her six-week checkup after giving birth to her son (MARRS# 1411USA004788) and physician informed her that she needed to have a colposcopy done again as she was HPV positive. Patient had to repeat Pap smear done on 18-SEP-2014 and had to have another one redone again in March 2015. Patient noted that she had not had any problems before receiving this vaccination and being that she was HPV positive her chances for cervical cancer had increased tremendously. Patient noted that she was only 24 years old and just beginning her life and it was very devastating going through Pap smear after Pap smear. Patient noted that being HPV positive was really causing great emotional distress. She was constantly worried about this and if her everyday life routine would contribute to anything such as eating habits, daily activities, etc. Upon internal review, miscarriage was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure before pregnancy, Pelvic inflammatory disease, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a female patient of unknown age without pertinent medical history, drug reactions and allergies. Patient was not pregnant at the time of the report. On unknown date in 2007 the patient was vaccinated with the first dose of GARDASIL, intramuscular (dose and lot # were not reported). Patient completed doses of GARDASIL intramuscular on unknown date in 2008. There were not concomitant medications. In February 2009 a pap smear showed that the patient's cells were abnormal. It was reported that the patient had been testing positive for human papilloma virus (HPV) from unknown date. Patient stated that she did not contract this through sexual contact. Patient sought medical attention on unknown date. She did not receive any treatment for the adverse events. The outcome of the events was reported as not recovered/not resolved. Follow-up information had been received via a letter on 04-NOV-2014 sent by the patient. Patient noted that she had become HPV positive since receiving GARDASIL vaccination. Patient received the first vaccination on 16-AUG-2007. Since receiving the vaccination, patient noted she was diagnosed with pelvic inflammatory disease (date not reported). With medication, she was able to get rid of that. However, in January 2009, patient went to her family doctor for routine Pap smear and was found out to have an abnormal Pap smear. Patient was referred to a gynecologist and was only given the vinegar base solution due to the fact that she was pregnant. On 05-MAY-2009, patient had a miscarriage and went for a colposcopy shortly after that. Since then, patient had been having routine Pap smear to check the levels of HPV. However, January 2014, patient went in for her six-week checkup after giving birth to her son (MARRS# 1411USA004788) and physician informed her that she needed to have a colposcopy done again as she was HPV positive. Patient had to repeat Pap smear done on 18-SEP-2014 and had to have another one redone again in March 2015. Patient noted that she had not had any problems before receiving this vaccination and being that she was HPV positive her chances for cervical cancer had increased tremendously. Patient noted that she was only 24 years old and just beginning her life and it was very devastating going through Pap smear after Pap smear. Patient noted that being HPV positive was really causing great emotional distress. She was constantly worried about this and if her everyday life routine would contribute to anything such as eating habits, daily activities, etc. Upon internal review, miscarriage was considered to be medically significant. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information had been received from a female for GARDASIL (MARRS# 1410USA006736). The patient reported that in January 2014, she went in for her six-week checkup after giving birth to her son (actual date of birth not reported). This is one of two reports concerning the same patient. No further information is anticipated.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Limb discomfort, Mobility decreased, Myalgia
Clinical narrative: Muscle soreness, states could hardly raise arm r/t discomfort day 1 after vaccine, soreness/ discomfort has lessened, but remains present 30+ days after vaccination.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Blood test, Gait disturbance, Mobility decreased, Myalgia
Clinical narrative: Severe muscle aches. Couldn't lift arms or legs, couldn't get out of chair, couldn't walk without help. Needed help getting dressed, bathing and any common movements, went on for 3 months before diagnosed as polymyalgia rheumatica, caused by the shingles shot.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging, Polymyalgia rheumatica, Ultrasound scan
Clinical narrative: Severe muscle aches. Couldn't lift arms or legs, couldn't get out of chair, couldn't walk without help. Needed help getting dressed, bathing and any common movements, went on for 3 months before diagnosed as polymyalgia rheumatica, caused by the shingles shot.
Age: 1.35
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, MMRV, PNC
Symptoms: Injection site erythema, Vaccination site cellulitis, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling redness and tenderness at vaccine site (cellulitis)- parent went to ER and then to clinic 11/12/14 for evaluation, cellulitis persisted for 20 days.
Age: 28.0
Sex: M
Vaccine: YF
Symptoms: Chest pain, Dyspnoea, Eye pruritus, Pruritus
Clinical narrative: Within 5-10 minutes of administration of vaccine, patient began to experience shortness of breath/difficulty breathing, itching of face and eyes, chest pain.  Ambulance called. Albuterol MDI administered prior to arrival of patient at ER at 1209.  At ER, IVF of NS started and patient given Zantac 50 mg IV x1, Benadryl 50 mg IV x1, SoluMedrol 125 mg IV x1.  Discharge medications were given and patient was dc'ed home at 1400.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Blood test normal, Diarrhoea, Electrocardiogram normal, Laboratory test normal
Clinical narrative: Passed out with sudden stomach ache, followed by extreme vomiting and diarrhea. Taken by ambulance to Hospital.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: Passed out with sudden stomach ache, followed by extreme vomiting and diarrhea. Taken by ambulance to Hospital.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain in arm, burning at injection site, decreased ability to use left arm, numbness, tingling in hand, still after three weeks.  Trying anti inflammatory, not working or helping.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Pain
Clinical narrative: Sore, achy muscle at the site of injection-going on three weeks now Feels like it is bruised. Hurts upon movement or if touching area, keeps patient awake at night since she can no longer sleep on that side.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Patient had receive a flu shot on 10/7/14 from his doctor. A 2nd shot was administered on 11/4/14.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Arm pain around injection site.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity, Swelling, Urticaria
Clinical narrative: Hives were found all over my entire stomach, buttocks, and thighs.  The hives on my thighs caused swelling over the rashy areas.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash macular
Clinical narrative: Erythematous macular rash at injection site.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Redness at injection site started within 1 day of vaccination. Patient then developed large amount of bruising and tenderness at the site. Patient reported this reaction to the office on 11-10-14 at 9:51 AM. Patient refused to come for office visit so we could.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Says arm still hurts, 5 weeks after shot.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Bursa injury, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Pain in LA after immunization. Diagnosed with rupture of supracromial bursa by orthopedist.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Nausea, Pruritus
Clinical narrative: 8 x 5 cm induration, pruritus, nausea.
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Vaccination site reaction
Clinical narrative: Extreme fatigue lasting a week. Vax site feels as if it has "been harpooned".
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspepsia, Pain
Clinical narrative: Initial soreness, overall achiness, severe indigestion, about 3 hrs, no tx sought as subsided.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: (R) deltoid - red, hard, warm area and painful noted where Influenza vaccine given.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Oral pain, Pain in jaw
Clinical narrative: Patient said the evening of vaccine/overnight, patient said her chest felt tight, the inside of her mouth was sore and her jaw was sore. She said she felt ok the following day.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Genital warts.
Age: 17.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Urticaria
Clinical narrative: Hives on legs, shoulder, abdomen that are intermittent. patient seen in clinic on 11/12/14 with hives on leg, no respiratory symptoms.  Benadryl and topical steroid prescribed.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Left Deltoid red, warm, itchy. Came to clinic for PPD reading & revealed vaccine site.  Skin intact, red & warm. Has full movement of left arm.
Age: 84.0
Sex: F
Vaccine: FLUC3
Symptoms: Back pain, Blood test normal, Computerised tomogram normal, Injection site pain, Muscular weakness
Clinical narrative: Severe pain in low back on movement.  Pain varied from day to day.  Had no pain killers.  On the 26th of Oct. increased pain in back and left shoulder caused me to go to the emergency room.  All lab tests and CT scan were normal.  Sent home with Motrin and Tylenol. Pain killers help, but low back continues on movement.  Sometimes so severe it makes my legs weak.
Age: 84.0
Sex: F
Vaccine: FLUC3
Symptoms: Pain, Urine analysis normal
Clinical narrative: Severe pain in low back on movement.  Pain varied from day to day.  Had no pain killers.  On the 26th of Oct. increased pain in back and left shoulder caused me to go to the emergency room.  All lab tests and CT scan were normal.  Sent home with Motrin and Tylenol. Pain killers help, but low back continues on movement.  Sometimes so severe it makes my legs weak.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Bradycardia, Immediate post-injection reaction, Lethargy, Neonatal hypoxia, Tachypnoea
Clinical narrative: Patient experienced increased tachypnea, desaturated, bradycardia, and lethargy right after receiving both Haemophilus and Pediarix vaccines.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: 103 degree fever, gave Motrin.
Age: 64.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: Itchiness and shingles rash developed on right side of stomach at the site of previous case of shingles had in 1984-85. Doctor confirmed on 11/10-2014 at 9:30 AM.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash generalised
Clinical narrative: Total body rough rash.
Age: 0.39
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Dyspnoea, Tachypnoea
Clinical narrative: Patient started experiencing increased in tachypnea, increased work of breathing requiring Xopenex and Prelone right after receiving Pediarix and Haemophilus vaccines.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Abdominal distension, Bradycardia, Neonatal hypoxia
Clinical narrative: Patient experienced increase desaturations and bradycardia, borderline temp, and abdominal distention after receiving Pediarix & Haemophilus vaccines. Patient also experienced same symptoms when Prevnar was given the following day (10/24/14) at 11:57 am.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram, Epistaxis, Influenza, Migraine, Nasopharyngitis
Clinical narrative: COLD SYMPTOMS for a couple days, and then it felt like SEVERE FLU for about a week. I started to have SEVERE MIGRAINE HEADACHES & BLOODY NOSE for about one (1) hour, for three (3) days.
Age: 61.0
Sex: F
Vaccine: FLU3, HEP, HIBV, IPV, MMR, PPV, TD
Symptoms: Anaphylactic reaction, Cough, Dyspnoea
Clinical narrative: Coughing, shortness of breath. Anaphylactic reaction.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Vaccine positive rechallenge
Clinical narrative: Rash, starting evening of administration, about 1 inch above and growing to about 6 inches below site. Pt states it happens every year, no egg, latex or neomycin allergy.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal sensation in eye, Dizziness, Dysgeusia, Dyspnoea, Eye swelling
Clinical narrative: Pt felt light headed, then had trouble breathing with metallic taste in mouth, then swelling or pressure in the Rt eye, then nauseous.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Pt felt light headed, then had trouble breathing with metallic taste in mouth, then swelling or pressure in the Rt eye, then nauseous.
Age: 51.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Myalgia, Orthosis user
Clinical narrative: Joint and muscle pain, requiring analgesic, includ hydrocodone, for 2+weeks, knee and elbow braces.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Insomnia, Nausea
Clinical narrative: Patient stated that soon after she received the vaccine, she felt slight dizziness, nausea, and feeling of warmth. The patient stated the symptoms disappeared within 5 minutes from when they initially occurred. I followed up with patient later the same day at 7:10 PM she stated she was completely fine and felt the reaction may have been due to her lack of sleep/insomnia recently.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site warmth, Nausea
Clinical narrative: Had lump underneath my arm at the site of injection, large red spot and very very warm. Felt nausea at times, but passed. Finally went to urgent care on 11/04/2014 and they determined it was Cellulitis. Put on Clindamycin 300 mg x3 for 10 days. Area is much better today. Husband received the same shot by the same person, same place and never had any adverse effects. Person at pharmacy was the one who gave us the shots.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pain, Injection site rash
Clinical narrative: Patient developed a rash and knot with pain at injection site. She did not say what time she noticed it.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Barium enema, Diarrhoea, Diarrhoea haemorrhagic, Enema administration, Irritability
Clinical narrative: Fever, lethargy, 24 hours later had diarrhea x 3, episodic irritability and lethargy, at 06:00 AM 11/8/14 had bloody diarrheal stool, then vomited x 3 and was taken to E.D.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Lethargy, Pyrexia, Surgery, Ultrasound scan, Vomiting
Clinical narrative: Fever, lethargy, 24 hours later had diarrhea x 3, episodic irritability and lethargy, at 06:00 AM 11/8/14 had bloody diarrheal stool, then vomited x 3 and was taken to E.D.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: X-ray
Clinical narrative: Fever, lethargy, 24 hours later had diarrhea x 3, episodic irritability and lethargy, at 06:00 AM 11/8/14 had bloody diarrheal stool, then vomited x 3 and was taken to E.D.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia, Impaired work ability, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Sore throat, low grade fever, hoarseness, soreness/redness/swelling around injection site. Unable to work and stayed home sick 11/11/2014. Felt better around 3:00 PM on 11/11/2014.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, low grade fever, hoarseness, soreness/redness/swelling around injection site. Unable to work and stayed home sick 11/11/2014. Felt better around 3:00 PM on 11/11/2014.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Fatigue, Headache, Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: Shot given in upper left deltoid, blood soaked bandaid, and tolerable soreness set in immediately.  Random "pins and needles" in left arm and hand occasionally throughout day, at 6pm, though severe neck pain set in, with pressure headache, fatigue, and back soreness down to lower back.  I will likely miss work for the pain. Will report to doctor or clinic if not better in 24 hours.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain, Paraesthesia
Clinical narrative: Shot given in upper left deltoid, blood soaked bandaid, and tolerable soreness set in immediately.  Random "pins and needles" in left arm and hand occasionally throughout day, at 6pm, though severe neck pain set in, with pressure headache, fatigue, and back soreness down to lower back.  I will likely miss work for the pain. Will report to doctor or clinic if not better in 24 hours.
Age: 23.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Fatigue, Headache
Clinical narrative: Headache, fatigue, diarrhea.
Age: 18.0
Sex: M
Vaccine: ANTH
Symptoms: Hypothyroidism
Clinical narrative: Hypothyroid.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Endoscopy, Stridor, X-ray
Clinical narrative: 3 day history of stridor, cough, progressively worsening. Mom states started within few hours of FLUMIST given. Received dexamethasone, racemic epinephrine.
Sex: U
Vaccine: FLU3
Symptoms: Abasia, Swelling
Clinical narrative: This case was reported by a other health professional and described the occurrence of inability to walk in a unk patient who received FLUARIX TRIVALENT (batch number CA775, expiry date 30th June 2015). In 2014, the patient received FLUARIX TRIVALENT (unknown). In 2014, less than a year after receiving FLUARIX TRIVALENT, the patient experienced inability to walk (serious criteria hospitalization and GSK medically significant) and swelling. On an unknown date, the outcome of the inability to walk and swelling were unknown. It was unknown if the reporter considered the inability to walk and swelling to be related to FLUARIX TRIVALENT. Additional information received: The suspect vaccine initially reported was FLUARIX QUADRIVALENT but the batch number reported corresponded to FLUARIX TRIVALENT. Therefore the suspect vaccine was replaced by FLUARIX TRIVALENT.