chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to an approximately 61 year old female patient with hypothyroid and Bactrim allergy. On an unknown date the patient experienced a generalized rash to an unspecified formulation of Bactrim. On an unknown date in October 2013 the patient was vaccinated with ZOSTAVAX 9lot number and expiry date not reported) (dosing regimen and frequency unknown) subcutaneously (also reported as routine vaccination). Concomitant therapies included Levothyroxine sodium (manufacturer unknown). On October 2013 the patient experienced knot at the right arm injections site which was warm and reddened. There were no lab diagnostic studies performed. The knot at the right arm injection site which was warm and reddened improved each day and resolved on an unspecified date. The outcome of knot at the right arm injections site which was warm and reddened was reported as recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Syringe issue
Clinical narrative: This spontaneous report refers to a patient who is also a pharmacy student (reporter) unknown age. On 05-NOV-2013, the patient was exposed to ZOSTAVAX vial (dose, lot and expiry date unknown). The pharmacy student informed that some of the ZOSTAVAX might have spilled on her face, and possibly in her mouth, due to the leakage from the syringe. This is 2 of 2 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 22-OCT-2013 the patients were vaccinated with M-M-R II. Dose, route and frequency were not provided. On 22-OCT-2013, the patients were vaccinated with M-M-R II stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via field employee refers to an unspecified number of patients of unknown demographics. Medical history and current conditions for the patients were unknown. On an unknown date the patient was vaccinated with ZOSTAVAX (refrigerated vial 19400 PFU) (dose, lot and expiry date unknown). On an unknown date the patients developed shingles after receiving a dose of ZOSTAVAX (refrigerated vial 19400 PFU). The physician treated the patients with acyclovir (manufacturer unknown). The outcome of shingles is unknown. No patient contact details were available. Varicella Zoster Virus Identification Program (VZVIP) packet was faxed. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Back pain, Emotional distress, Muscle spasms, Muscle tightness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 years old female patient. Concurrent condition included, ADHD, borderline hypertension and hyperlipidemia. The patient was vaccinated with FLUVIRIN on 02-OCT-2013. On 14-NOV-2013, the patient was vaccinated with ZOSTAVAX (lot # J006155, expiry: 30-AUG-2014) 0.65 ml, subcutaneous in the left arm. Concomitant therapies included simvastatin tablets and ADDERALL tablets. Since an unknown date in November 2013 the patient experienced very severe lower back pain, tightness and muscle spasms of the back. The patient could not even walk and was upset regarding the event he experienced. The patient had sought medical attention and contacted a pharmacist. The outcome of very severe lower back pain, muscle spasms of the back, tightness of the back and could not even walk was reported as not recovered. The reporter considered the event of "patient could not even walk" to be disability. Additional information has been requested.
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative regarding a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX in the arm (dosing regimen and lot number unspecified). Other suspect therapies included influenza virus vaccine (manufacturer unknown) (dosing regimen and lot number unspecified). No concomitant medications were reported. On an unknown date the patient experienced cellulitis when ZOSTAVAX and flu vaccine were given on the same arm. On an unknown date, a medication error was reported as ZOSTAVAX and flu vaccine were given on the same arm. Patient sought medical attention and saw the physician. The outcome of the event cellulitis and medication error were unknown. Causality assessment of the event cellulitis with ZOSTAVAX was not provided. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Lip swelling, Paraesthesia, Paraesthesia oral
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old male patient. No medical history or drug allergies were reported. On 07-OCT-2013 the patient was vaccinated with dose 1 of ZOSTAVAX, subcutaneously. Concomitant therapies included GLUMETZA, ALTACE, COREG, aspirin, PLAVIX and niacin. On 11-OCT-2013, the patient experienced lip swelling, which went away on an unknown date in 2013 with use of BENADRYL. On an unknown date in 2013, the lip swelling returned along with numbness and tingling in his lips and gums. It was reported that the numbness and tingling goes up the patient's ear and nasal passage. Laboratory tests performed were reported as none. The outcome of the recurred event of lip swelling along with numbness and tingling on the lips and gums and the numbness and tingling reaching up to the patient's ear and nasal passage was reported as not recovered. The relatedness of the events with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age. On 05-NOV-2013 the patient was vaccinated with ZOSTAVAX vial (dose, lot and expiry date unknown), subcutaneous. The patient was inadvertently administered a partial dose of ZOSTAVAX due to a separation of the syringe from the hub of the needle. The pharmacy student adds that some of the ZOSTAVAX may have gotten on her face, and possibly in her mouth, due to the leakage from the syringe (linked case 1311USA008437). This is 1 of 2 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with ZOSTAVAX vial (dose, lot number and expiry date not provided) for vaccination. On an unknown date the patient experienced swelling and redness at the injection site after receiving the vaccine. The outcome of the events was unknown. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Laboratory test abnormal, Malaise, Migraine, Nausea, Orthostatic hypotension
Clinical narrative: Patient contacted the Vaccine Healthcare Centers Network to report possible vaccine adverse events. She was in her usual state of good health which included exercising 5x/week with running, circuit weight training and dance exercise classes. Her only chronic medication was SYNTHROID which she took for controlled hypothyroidism. On 6 Feb '13 patient received anthrax vaccine #1 and the typhoid vi vaccines. The anthrax injected arm became extremely sore and she used ice packs for 2 days to relieve pain. Within 1-3 days she developed flu-like symptoms and headache. She is unsure of how long the symptoms lasted but she had documented in text messages that on 9 and 10 Feb she was too ill to participate in family activities and 2 weeks later on 20 Feb she left work early due to a migraine. On 15 Mar '13 she received anthrax #2 and again developed an extremely sore arm- so severe she could not type or write for 3 days. She reports her arm "felt like it was broken". She again developed severe flu-like symptoms i.e. headache, chills and body aches and sought medical evaluation on 21 Mar for persisting symptoms. She missed work for several days during this period and took leave from 27-29 Mar '13 to continue her recovery. She never felt totally well again. She gradually developed episodes of dizziness, fatigue, new onset migraine headaches and exercise intolerance. In Apr and May she sought treatment several times for these symptoms and was found to have both orthostatic hypotension and orthostatic tachycardia and received IV fluid infusions multiple times. Her thyroid was evaluated and found to be normal. Echocardiogram was normal. On 29 May she was admitted to MC for observation due to her multiple clinic and ER visits for presyncope. A tilt test was performed and she was found to have POTS. INDERAL, FLORINEF and midodrine were prescribed. In June '13 she was referred to Cardiology and salt tablets were added. In August '13 she was referred to Neurology where she continues to be treated for an autonomic nervous system disorder, which is characterized by both postural orthostatic tachycardia syndrome (neuropathic type) and neurally mediated hypotension. In Oct '13 she underwent additional autonomic testing at Neurology specialist. Results again confirmed postural orthostatic tachycardia syndrome. Her QSART testing was abnormal and was consistent with a postganglionic sympathetic sudomotor abnormality like that seen in small fiber neuropathy. Her current medications are INDERAL 20mg bid, midodrine 2.5 mg bid, salt supplements and SYNTHROID 88 mcg/day. Recently pyridostigmine 30mg bid was added. Patient also drinks 2-3 liters of fluids/day and uses liberal table salt. She attempts to report for work 40 hours/week but frequently requires sick days or needs to work from home. She is unable to exercise and continues to have headaches and episodes of lightheadedness and nausea upon standing. Her condition has progressed to include symptoms in multiple body systems which is consistent with dysautonomia.
Age: 39.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Thyroid function test normal, Tilt table test positive
Clinical narrative: Patient contacted the Vaccine Healthcare Centers Network to report possible vaccine adverse events. She was in her usual state of good health which included exercising 5x/week with running, circuit weight training and dance exercise classes. Her only chronic medication was SYNTHROID which she took for controlled hypothyroidism. On 6 Feb '13 patient received anthrax vaccine #1 and the typhoid vi vaccines. The anthrax injected arm became extremely sore and she used ice packs for 2 days to relieve pain. Within 1-3 days she developed flu-like symptoms and headache. She is unsure of how long the symptoms lasted but she had documented in text messages that on 9 and 10 Feb she was too ill to participate in family activities and 2 weeks later on 20 Feb she left work early due to a migraine. On 15 Mar '13 she received anthrax #2 and again developed an extremely sore arm- so severe she could not type or write for 3 days. She reports her arm "felt like it was broken". She again developed severe flu-like symptoms i.e. headache, chills and body aches and sought medical evaluation on 21 Mar for persisting symptoms. She missed work for several days during this period and took leave from 27-29 Mar '13 to continue her recovery. She never felt totally well again. She gradually developed episodes of dizziness, fatigue, new onset migraine headaches and exercise intolerance. In Apr and May she sought treatment several times for these symptoms and was found to have both orthostatic hypotension and orthostatic tachycardia and received IV fluid infusions multiple times. Her thyroid was evaluated and found to be normal. Echocardiogram was normal. On 29 May she was admitted to MC for observation due to her multiple clinic and ER visits for presyncope. A tilt test was performed and she was found to have POTS. INDERAL, FLORINEF and midodrine were prescribed. In June '13 she was referred to Cardiology and salt tablets were added. In August '13 she was referred to Neurology where she continues to be treated for an autonomic nervous system disorder, which is characterized by both postural orthostatic tachycardia syndrome (neuropathic type) and neurally mediated hypotension. In Oct '13 she underwent additional autonomic testing at Neurology specialist. Results again confirmed postural orthostatic tachycardia syndrome. Her QSART testing was abnormal and was consistent with a postganglionic sympathetic sudomotor abnormality like that seen in small fiber neuropathy. Her current medications are INDERAL 20mg bid, midodrine 2.5 mg bid, salt supplements and SYNTHROID 88 mcg/day. Recently pyridostigmine 30mg bid was added. Patient also drinks 2-3 liters of fluids/day and uses liberal table salt. She attempts to report for work 40 hours/week but frequently requires sick days or needs to work from home. She is unable to exercise and continues to have headaches and episodes of lightheadedness and nausea upon standing. Her condition has progressed to include symptoms in multiple body systems which is consistent with dysautonomia.
Sex: U
Vaccine: VARCEL
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 07-NOV-2013 the patient was vaccinated with an expired dose of VARIVAX, (lot# G007630, exp date 05-AUG-2013), (dose, route, strength and indications not reported). No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This is one of 3 reports from the same reporter source (other MARRS #1210USA012540 and 1210USA012575). Information has been received from a registered nurse, for a Pregnancy Registry product, concerning a 36 years old female patient. The patient had no drug allergies. The patient's medical history included hypothyroidism. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with lot # (1291AA), 0.5 ml GARDASIL by intramuscularly on 10-OCT-2012 (expired date: 12-APR-2014). The patient became pregnant with an LMP of 22-MAR-2012 and an EDD of 27-DEC-2012. At the time of the report, the patient's gestation was 29 weeks and 6 days. The patient was exposed to GARDASIL during trimester 3. On 19-OCT-2012 the pregnant patient was administered GARDASIL. No treatment was given for the event. No adverse effects reported. The outcome for the event was pending. Additional information was received. The estimated date of delivery was reported to be 30-DEC-2012. Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician and a pharmacist refers to an 87 year old male patient with diabetes, essential hypertension, hypothyroidism and hyperlipidemia. The patient had experienced diarrhea with historical drug metformin (manufacturer unknown). On 03-SEP-2013 the patient was vaccinated with ZOSTAVAX vial (dose unknown, lot # J001698, expiry date 08-MAY-2013 (reported as May 2014) via subcutaneous route. Concomitant therapies included Levothyroxine Sodium (manufacturer unknown), Flomax, Fenofibrate (manufacturer unknown), Vitamin 12, Rosuvastatin (manufacturer unknown) Altace, Vitamin D (unspecified) (manufacturer unknown) and Liraglutide (manufacturer unknown). On 06-NOV-2013 (reported as today), 65 days after onset of therapy, the patient had presented with a case of shingles. No treatment was given for the event. Lab diagnostic studies performed were none. The outcome of shingles was reported as not resolved. The patient sought medical attention by presenting himself to the primary care physician. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of Varicella virus vaccine live (Oka/MERCK) (manufacturer unknown) (lot number, expiry date, dose and route unspecified) (reported as "may have been VARIVAX"). No concomitant therapy was reported. On an unknown date, the result of pregnancy test, which may have been a pregnancy blood test, was positive for pregnancy. Outcome was unknown. No PQC involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Condition aggravated, Dysarthria, Headache, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old female patient. The patient concurrent condition included headache, reflux sympathetic dystrophy (RSD), slurred speech and vomiting. On 10-OCT-2013 the patient was vaccinated with GARDASIL (dose unknown). No concomitant medications were reported. Approximately on 11-OCT-2013, the day after vaccination, the patient experienced worsening of slurred speech, vomiting and headache. The outcome of the events was reported not recovered/not resolved. The patient sought medical attention and was taken to an emergency department in which CAT scan was conducted. CAT scan showed no irregularities and the patient was discharged. The event was ongoing. The patient had follow up scheduled with an unspecified neurologist on an unknown date. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified numbers of patient of unknown ages. On an unknown date the patients was vaccinated with VARIVAX (Merck) (dose unknown). No concomitant medications were reported. The nurse reported that the patients may have been administered VARIVAX (Merck) that went through an unsupported temperature excursion. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered pharmacist via a company representative regarding a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, intramuscular (dosing regimen and lot number unspecified). On an unknown date the patient experienced injection site reaction which included injection site soreness, injection site itching, injection site swelling and patient was given ZOSTAVAX by the intramuscular route. Patient sought medical attention. The outcome of injection site reaction, injection site soreness, injection site itching, injection site swelling and medication error were unknown. Causality assessment was not provided. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site urticaria, Oral herpes
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 59 year old female patient with Macrobid allergy (unknown reactions) and penicillin allergy. The patient's medical history included two cases of shingles one year ago in 2012 and herpes simplex. On 05-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # J003796, expiry date 28-JUN-2014) subcutaneously. No concomitant medications were reported. On 05-NOV-2013, the patient developed a welt at the injection site. The patient was advised to apply ice compress to the site of the reaction and to take an unspecified antihistamine (manufacturer unknown). The patient had sought medical attention and called the pharmacy to report the symptoms. The pharmacist adds that the patient's symptoms have improved but the patient still has a lump at the injection site and had also developed a recurrence of cold sores. The outcome of developed a welt at the injection site, cold sores and lump at the injection site was reported as recovering. The relatedness of the events to the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 30-OCT-2013 the patients were vaccinated with ROTATEQ lot number J003465. Dose, route and frequency were not provided. On 30-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007696, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 21-OCT-2013 the patients were vaccinated with MMRII lot number J002505. Dose, route and frequency were not provided. On 21-OCT-2013, the patients were vaccinated with MMR II stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to 1311USA008054, 1311USA007704, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA0077700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Bronchitis, Chest X-ray normal, Pulmonary function test normal
Clinical narrative: This spontaneous report as received from a 57 year old female healthcare worker regarding herself with high blood pressure, prednisone allergy, shellfish allergy and unspecified thyroid disorder. On an unknown date in 2000 the patient received a first dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) vaccine (lot number and expiry date not reported) (dosing regimen and frequency unknown). ON an unknown date in 2005 (also reported as about 5 years later) the patient received a second dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) vaccine. Concomitant medications  included unspecified blood pressure medications and unspecified thyroid medication (manufacturer unknown). ON an unknown date approximately in November 2012 (also reproted as about a year ago) the patient developed bronchitis which lasted for about 4 months. On an unknown date a chest X-ray and a pulmonary function test were performed which showed that her lungs were fine. On an unknown date approximately in March 2013 (also reported as lasted for about 4 months) the bronchitis cleared up without treatment. It was reported that the patient sought medical attention and   went to physician's office. ON an unknown date in 2013 the patient received a third dose of an unspecified pneumococcal vaccine, polyvalent (23-valent) on an unspecified date after the bronchitis resolved. The healthcare worker reported that the third dose of the unspecified pneumococcal vaccine was administered by an unspecified physician. The outcome of bronchitis was reported as recovered. The relatedness of the event bronchitis to the therapy with pneumococcal vaccine, polyvalent (23-valent) was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 28-OCT-2013 the patients were vaccinated with ROTATEQ lot number J003465. Dose, route and frequency were not provided. On 28-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 30-OCT-2013 the patients were vaccinated with ROTATEQ lot number H020558. Dose, route and frequency were not provided. On 30-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA0008055, 1311USA000906 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 29-OCT-2013 the patients were vaccinated with oral ROTATEQ lot number J004874. Dose, route and frequency were not provided. On 29-OCT-2013, the patients were vaccinated with oral ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 18-OCT-2013 the patients were vaccinated with ROTATEQ lot number J002505. Dose, route and frequency were not provided. On 18-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 21-OCT-2013 the patients were vaccinated with ROTATEQ lot number J003465. Dose, route and frequency were not provided. On 21-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 28-OCT-2013 the patients were vaccinated with ROTATEQ lot number J002505. Dose, route and frequency were not provided. On 28-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007697, 1311USA007057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 25-OCT-2013 the patients were vaccinated with ROTATEQ lot number J002505. Dose, route and frequency were not provided. On 25-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 24-OCT-2013 the patients were vaccinated with M-M-R II lot number J002505. Dose, route and frequency were not provided. On 24-OCT-2013, the patients were vaccinated with M-M-R II stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 29-OCT-2013 the patients were vaccinated with ROTATEQ lot number J003465. Dose, route and frequency were not provided. On 29-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 31-OCT-2013 the patients were vaccinated with M-M-R II lot number J002505. Dose, route and frequency were not provided. On 31-OCT-2013, the patients were vaccinated with M-M-R II stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 24-OCT-2013 the patients were vaccinated with ROTATEQ lot number J003465. Dose, route and frequency were not provided. On 24-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 23-OCT-2013 the patients were vaccinated with M-M-R II lot number J002505. Dose, route and frequency were not provided. On 23-OCT-2013, the patients were vaccinated with M-M-R II stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 30-OCT-2013 the patients were vaccinated with M-M-R II lot number J002528 (not valid). Dose, route and frequency were not provided. On 30-OCT-2013, the patients were vaccinated with M-M-R II stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 22-OCT-2013 the patients were vaccinated with M-M-R II lot number H011907. Dose, route and frequency were not provided. On 22-OCT-2013, the patients were vaccinated with M-M-R II stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 18-OCT-2013 the patients were vaccinated with M-M-R II lot number H011907. Dose, route and frequency were not provided. On 18-OCT-2013, the patients were vaccinated with M-M-R II stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 22-OCT-2013 the patients were vaccinated with ROTATEQ lot number J003465. Dose, route and frequency were not provided. On 22-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 25-OCT-2013 the patients were vaccinated with ROTATEQ lot number J003465. Dose, route and frequency were not provided. On 25-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to Marrs case numbers 1311USA008054, 1311USA007702, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA7703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061 (same reporter link). Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received form a 73 year old female patient regarding herself. No drug reactions were reported. On an unknown date in October 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported) one injection. Concomitant therapies included CELEXA (reproted as selexa) and estrogens (unspecified). On an unknown date in approximately in October 2013, the patient experienced shingles in spite of being vaccinated for shingles the previous year. No laboratory tests were performed. Patient sought medical attention. The outcome of the recurred shingles was unknown. The relatedness of the event shingles with ZOSTAVAX was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Injection site anaesthesia, Injection site pain
Clinical narrative: Pain and numbness of extremity (left arm - site of GARDASIL).
Age: 0.12
Sex: M
Vaccine: PNC
Symptoms: Blood test normal, Cochlea implant, Ear disorder, Mastoiditis
Clinical narrative: This is a spontaneous report from a contactable nurse. A 9-month-old male patient received the first and second doses of PREVNAR, intramuscular on 06Jan2010 (Lot Number: E13861; Expiration Date: Sep2013) in the left thigh and 01Mar2010 (Lot Number: D94433; Expiration  Date: Apr2012); and the first dose of PREVNAR 13, intramuscular on 19May2010 (Lot Number: E44527; Expiration Date: May2011) in the left thigh; all at 0.5 ml single doses as part of the vaccine schedule. Relevant medical history included unspecified issues in the ear and ongoing at event onset. Relevant sibling information included the patient had two siblings. The patient's concomitant medications were not reported. The patient previously received the first and second doses of ACTHIB intramuscularly on an unknown date, first dose of ACTHIB intramuscular injection on left thigh, and first and second doses of ENGERIX; all on unknown dates. In Aug2010, the patient had a cochlear implant in right ear. In Dec2010, he had mastoiditis. On 04Jan2011, he was given the second dose of PREVNAR 13 (Lot Number: 915192) as part of the vaccine schedule. Relevant lab data included unspecified blood work in Mar2011 and the results were found to be normal. The clinical outcome of the events, cochlear implant in right ear and mastoiditis, was unknown.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 16 week old male patient. On 08-NOV-2013 the patient was vaccinated with ROTATEQ (lot # and expiry date not provided) orally. The nurse practitioner reported that on 08-NOV-2013 the patient was 16 weeks 0 days of age and was administered his first dose of ROTATEQ. No adverse effect reported. There was no product quality complained involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 12 month old patient of unknown gender. On an unknown date the patient was vaccinated with VARIVAX injection (dose, route, lot# and expiration date unknown). On the same day the child was also given PROQUAD (Merck) vaccination (dose, route, lot# and expiration date unknown). No adverse effect was reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired drug administered, Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 72-year-old female subject who was vaccinated with TWINRIX. On 17 July 2013 at 10:00 the subject received 1st dose of TWINRIX (1 ml, unknown route, left arm) and experienced expired vaccine used. On 17 JULY 2013, 10 minutes after vaccination with TWINRIX, the subject experienced injection site pain. At the time of reporting the events were resolved on the same date of 17 JULY 2013.
Age: 54.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Blood pressure increased, Heart rate increased, Pharyngeal oedema, Throat tightness
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of throat tightness in a 54 year-old male subject who was vaccinated with TWINRIX. Concurrent medical conditions included allergy to fish, egg allergy and latex allergy. Concurrent vaccination included tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine., absorbed; GlaxoSmithKline; unknown, unknown give on 9 AUGUST 2013. Concurrent medications included NEXIUM, ZYRTEC, SINGULAIR, DILTIAZEM, Asprin, Doxycycline, SPIRIVA, ALLEGRA, PULMICORT, VENTOLIN, HALOBETAZOL, and MUCINEX. On 09-AUGUST-2013 at 10:30 the subject received 1st dose of TWINRIX (1 ml, unknown route, left deltoid). ON 09-AUGUST-2013 at 13:15, 2 hours and 45 minutes after vaccination with TWINRIX, the subject experienced throat tightness, throat swelling, increase in pulse, increased blood pressure and possible le allergic reaction. The nurse reported that she "believes the reaction may be latex related, as the BOOSTRIX he received concomitantly was from a vial and the TWINRIX was from a syringe". The subject has a latex allergy (possible allergic reaction). The subject was evaluated at the emergency room. At the time of reporting the events were resolved. The healthcare professional considered the events were related to vaccination with TWINRIX.
Age: 28.0
Sex: M
Vaccine: HEPAB
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Fatigue, Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of body pain in a 28-year-old male subject who was vaccinated with TWINRIX. On 3 AUGUST 2013 the subject received 1st dose of TWINRIX (unknown, left arm). In AUGUST 2013, less than one day ("within 24 hours") after vaccination with TWINRIX, the subject experienced body pain, sensation of fever, ("feels/felt feverish") and fatigue and on 13 AUGUST 2013, 10 days after vaccination with TWINRIX, the subject experienced elevated aspartate aminotransferase (AST) and elevated alanine aminotransferase (ALT). The nurse practitioner reported that the subject experienced body aches, fatigue, and felt feverish. The subject was seen by the reporting nurse practitioner on 13 AUGUST 2013 and the events were ongoing. The nurse practitioner clarified that the subject did not actually have a fever so his feeling feverish was subjective. It was also discovered at this appointment that the subject had "elevated LFT's" (liver function tests). According to the nurse practitioner, his AST was 70 and  his ALT was 147 and the "other levels were within normal range". At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with TWINRIX.