chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown demographics. On 30-SEP-2014 (also reported as 30-SEP-2015) the patient was vaccinated with GARDASIL lot # H021861, expiry: 09-OCT-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 30-SEP-2014, the patient received doses that were exposed to temperatures outside of the proper storage range. No adverse effect reported. The outcome of patient received doses that were exposed to temperatures outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender (Patient record # 2878212). On 03-OCT-2014 the patient was vaccinated with improperly stored VAQTA 50 U (lot # J005010 and expiration date 23-OCT-2015 (reported also as 23-OCT-2014)) (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 4-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the first dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 13-JAN-2014 at 11:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant and from a healthcare worker refers to a patient of unknown age and gender. On 19-AUG-2014 the patient was vaccinated with (Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which had been exposed to a supported temperature excursion on 15-AUG-2014. No adverse events were observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Contusion, Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old female patient with allergy to erythromycin, biaxin and penicillin. On 11-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported), 0.5 ml, subcutaneous under the upper left arm. No concomitant medication was reported. Pharmacist stated client was at the pharmacy now with red, swollen, bruised left arm, and client had chills post vaccination. Pharmacist stated client's treatment would be over the counter oral BENADRYL and Ibuprofen. The outcome was reported as not recovered/not resolved. Additional information is not expected since the reporter is not happy to do follow up.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient. On 10-OCT-2013 the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, dose, route were not reported) (indication was default). No concomitant medications were reported. On 17-OCT-2014 the patient came to the pharmacy and stated that for an unknown reason on an unspecified date, she had titers drawn for PNEUMOVAX 23 and the titers came back as negative. The outcome of the event was reported as not recovered. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received form a certified medical assistant refers to a patient of unknown age and gender. On 15-AUG-2014 the patient was vaccinated with (Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a healthcare worker via company representative and to a 3 patients of unknown age, gender not reported. Healthcare worker was reporting on behalf of physician. On an unknown date the 3 patients were given VAQTA from prefilled syringes that met resistance during administration of the medication and not all the contents were able to iject. About 60 to 65% of the medication was inejcted. The plunger was difficult to push on the VAQTA prefilled syringes. No adverse events were reported. Product quality complaints was involved. The outcome of adverse events was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 16-AUG-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursions on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 17-OCT-2014 the patient was vaccinated with an expired dose of GARDASIL, first injection in the series. Lot # reported as 1745AA, expiration date: 13-SEP-2014 (dose and route of administration were unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 19-AUG-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 19-AUG-2014 the patient was vaccinated with (Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a pharmacist and described the occurrence of drug dose administration too long in a unk patient who received ENGERIX B. Concomitant products included HBV. On an unknown date, the patient experienced the 2nd dose of ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced drug dose administration too long. On an unknown date, the outcome of the drug dose administration too long was unknown. It was unknown if the reporter considered the drug dose administration too long to be related to ENGERIX B. Additional information: 1st dose of ENGERIX B was given on 22 May 2014 and the patient has not received the second dose in series that led to drug dose administration too long. No details on patient and lot numbers were available. No symptoms were reported.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Pertinent medical history was unspecified by reporter. On an unknown date unspecified number of unspecified patients vaccinated with oral, ROTATEQ (oral, dose and lot number was unkonwn) that were exposed to temperatures outside of the proper storage range (stored temperatures were unspecified by reporter). No adverse effect reported. The outcome of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Pertinent medical history and concomitant medications were unspecified by reporter. On an unknown date unspecified number of unspecified patients vaccinated with PEDVAXHIB (route of administration, anatomical location, dose and lot number was unknown) that were exposed to temperatures outside of the proper storage range (stored temperatures were unspecified by reporter). No adverse effect reported. The outcome of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Pertinent medical history and concomitant medications were unspecified by reporter. On an unknown date unspecified number of unspecified patients vaccinated with PNEUMOVAX 23 (route of administration, anatomical location, dose and lot number was unknown) that were exposed to temperature outside of the proper storage range (stored temperature were unspecified by reporter). No adverse effect reported. The outcome of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: PPV, RAB, YF
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Head ache, body ache both fairly severe. Fever above 101 for 2 days (104.5 at highest). Redness, swelling and very sore around YF/PNEUMOVAX injection sites over most of upper arm.
Age: 23.0
Sex: F
Vaccine: PPV, RAB, YF
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Head ache, body ache both fairly severe. Fever above 101 for 2 days (104.5 at highest). Redness, swelling and very sore around YF/PNEUMOVAX injection sites over most of upper arm.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Redness, soreness at R thigh, baseball size cellutlis
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Large patch raised, red, burning, itchy in vaccine area.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local reaction, Local swelling, Pruritus, Skin warm
Clinical narrative: Had TDAP 10/08/14. Had local reaction with itch within 15 min of injection. Now warm and local swelling D = 3 3/8" Red and swollen.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Erythema and swelling at injection site approx 6 cm x 2.5 cm with induration but no fluctuation.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Erythema and swelling at injection site approx. 6 cm x 2.5 cm with induration but no flucuation.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Cold sweat, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Syncopal episode immediately following vaccinations: Tdap, MENVEO, varicella (L) deltoid. Initial BP 72/50 P 54 and regular. Clammy pale skin. Elevated legs, cool cloth, remained with pt. Recovered and assisted to vehicle.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: Chills, Headache, Rash
Clinical narrative: Huge rash, chills and headache.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Slight headache that lasts about 5 min. Redness of area around site and is a little swollen and tender. Bandage taken off 10/20/15.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Insomnia, Pain in extremity
Clinical narrative: Left upper arm became red and swollen. Arm became painful as the evening went on, patient took OTC TYLENOL. Pt had trouble sleeping due to pain/discomfort, took a TYLENOL #3. Took OTC TYLENOL on Sunday. Swelling was reducing.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Developed a half-dollar size red (round) area at site of shingles injection that was hot and itchy. Rph recommended ice pack for heat and BENADRYL for itching and ibuprofen for pain. No change in size. No worsening of red area as per call to patient on 10-20-14.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: Developed a half-dollar size red (round) area at site of shingles injection that was hot and itchy. Rph recommended ice pack for heat and BENADRYL for itching and ibuprofen for pain. No change in size. No worsening of red area as per call to patient on 10-20-14.
Age: 0.56
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX given at wrong age.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles, Limb discomfort
Clinical narrative: Site reaction - blisters formed Sunday. Bumped arm Friday-hurting. Saturday-arm uncomfortable.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of VAQTA (dose and site not reported) for prophylaxis which were improperly stored. No adverse effects were reported. This report is linked to MARRS 1410USA009955, 1410USA009956, 1410USA009957, 1410USA009958, 1410USA009959 and 1410USA009960.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician's office via field representative refers to unspecified number of patients of unknown age and demographics. Current conditions and medical history was not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX lot number K000328, expiry date- 06-MAR-2015 (dose, route and frequency were not reported). Concomitant medications were not reported. It was reported that improperly stored ZOSTAVAX (7 doses) have been administered to patients. No adverse effects reported. Product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of 9 patients (demographics unknown). On 07-AUG-2014, the patients received improperly stored VARIVAX (Merck) (dose, lot number, expiration date and route were not provided). No adverse symptoms were reported. The temperature excursion for the VARIVAX (Merck) was supported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of 9 patients (demographics unknown). On 08-AUG-2014, the patients received improperly stored VARIVAX (Merck) (dose, lot number, expiration date and route were not provided). No adverse symptoms were reported. The temperature excursion for the VARIVAX (Merck) was supported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Secretion discharge
Clinical narrative: This spontaneous report was received from a 63 year old female patient reporting on herself. Patient allergic to "penicillin" and allergic "sulfa". On 13-OCT-2014 the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. On 16-OCT-2014 the patient noticed a blister with a cloudy residue on her left hip and it was not where she got the vaccine. Patient wanted to make sure that was not a side effect from getting the vaccine. Patient did not seek for medical attention. The outcome of a blister with a cloudy residue on her left hip was unknown. Additional information is not expected since no permission to contact was given.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 87 year old female patient. On 17-OCT-2014, the patient was vaccinated with second dose of PNEUMOVAX 23, 0.5 ml, intramuscular, approximately one year after patient had received the first dose of PNEUMOVAX 23 (in 2013). No adverse effect was reported. The outcome of patient received a second dose of PNEUMOVAX 23, approximately one year after patient had received the first dose of PNEUMOVAX 23 was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, 7 months later of being vaccinated with a first dose of ZOSTAVAX, the patient was vaccinated with a second dose of ZOSTAVAX, (dose, route, lot number and expiration date not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On 16-OCT-2014, the patient was vaccinated with GARDASIL lot # J009788 expiry date 17-MAR-2016, intramuscular (dose not reported) which underwent an unsupported temperature excursion. Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt received KINRIX at 6 months old.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Quarter size redness (L) lateral thigh, sl induration.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Injection site reaction - induration/redness/swelling at site of injection.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. Doses of (Oka/Merck) PROQUAD that were exposed to a supported temperature excursion on 05-SEP-2014 have been administered to unspecified patients on unspecified dates since 05-SEP-2014. Concomitant therapy was not reported. No adverse effect has been observed or reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. Doses of VARIVAX (Merck) that were exposed to a supported temperature excursion on 05-SEP-2014 have been administered to unspecified patients on unspecified dates since 05-SEP-2014. Concomitant therapy was not reported. No adverse effect has been observed or reported. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Back pain, Injection site pain, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a nurse refers to a 65 year old female patient. On 09-OCT-2014 the patient was vaccinated with PNEUMOVAX 23, lot # K004148, expiry date 10-MAY-2015, 0.5 ml, intramuscular. On 09-OCT-2014, the patient experienced pain at the injection site, pain and weakness radiated to the shoulder and into the upper back. Nurse reported that when patient was seen on 14-OCT-2014, pain had resolved on an unknown date in October 2014, but weakness continued. No treatment was given for the events. The patient had sought medical attention by calling nurse. This is one of several reports from the same reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Euphoric mood
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 25 year old female patient who was a smoker. On 14-OCT-2014, the patient was vaccinated with the first dose of GARDASIL, (lot# reported as K001632, expiration date June 2016), 1 single shot, intramuscular injection. Concomitant therapies included TRI-SPRINTEC and WELLBUTRIN (dosages/frequencies/manufacturers unknown). On 14-OCT-2014, hours after the patient received her first dose of GARDASIL, she called the office stated that she felt dizzy and high as if she had taken pain medication and it was recommended the patient go to the emergency room. The patient sought medical attention by call the office, but it was not confirm if the patient went to the emergency room. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to patients of unknown age and gender. On an unknown date, unspecified number of improperly stored GARDASIL (injection, 120 Y) doses had been administered to patients (dose, route, lot # and expired date were not reported). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 07-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J007059 (expiration date 31-JUL-2014), 0.5 ml, intramuscular. No adverse effects reported. The outcome was unknown. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: DTAP
Symptoms: Cold sweat, Haematocrit normal, Haemoglobin normal, Injection site erythema, Injection site pain
Clinical narrative: Swelling, red left elbow above shoulder painful to touch after pt had shot approx 2 hrs after 2 hours after vaccine - myalgias severe - it pain x 2 days -> cold sweats pink/red rash around site tender and swelled (L) axilla.
Age: 42.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site rash, Injection site swelling, Local swelling, Myalgia, Platelet count normal
Clinical narrative: Swelling, red left elbow above shoulder painful to touch after pt had shot approx 2 hrs after 2 hours after vaccine - myalgias severe - it pain x 2 days -> cold sweats pink/red rash around site tender and swelled (L) axilla.
Age: 42.0
Sex: M
Vaccine: DTAP
Symptoms: Tenderness, White blood cell count increased
Clinical narrative: Swelling, red left elbow above shoulder painful to touch after pt had shot approx 2 hrs after 2 hours after vaccine - myalgias severe - it pain x 2 days -> cold sweats pink/red rash around site tender and swelled (L) axilla.
Age: 40.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Acupuncture, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a other health professional and described the occurrence of arm pain in a 40-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7LE2S, expiry date 30th June 2015). Previously administered products included influenza vaccine with an associated reaction of no adverse event. On 4th September 2014, the patient received FLUARIX QUADRIVALENT. On 4th September 2014, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced arm pain (serious criteria disability and clinically significant/intervention required), shoulder pain (serious criteria disability and clinically significant/intervention required), waking up at night (serious criteria disability and clinically significant/intervention required), chest pain (serious criteria disability and clinically significant/intervention required), back pain (serious criteria disability and clinically significant/intervention required), decreased limb mobility (serious criteria disability and clinically significant/intervention required) and rotator cuff tendinitis. The patient was treated with non-drug therapy (Acupuncture) and prednisolone. On an unknown date, the outcome of the arm pain, shoulder pain, waking up at night, chest pain, back pain, decreased limb mobility and rotator cuff tendinitis were Not Recovered/Not Resolved. The reporter considered the arm pain, shoulder pain, waking up at night, chest pain, back pain, decreased limb mobility and rotator cuff tendinitis to be almost certainly related to FLUARIX QUADRIVALENT.
Age: 40.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Back pain, Chest pain, Middle insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: This case was reported by a other health professional and described the occurrence of arm pain in a 40-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7LE2S, expiry date 30th June 2015). Previously administered products included influenza vaccine with an associated reaction of no adverse event. On 4th September 2014, the patient received FLUARIX QUADRIVALENT. On 4th September 2014, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced arm pain (serious criteria disability and clinically significant/intervention required), shoulder pain (serious criteria disability and clinically significant/intervention required), waking up at night (serious criteria disability and clinically significant/intervention required), chest pain (serious criteria disability and clinically significant/intervention required), back pain (serious criteria disability and clinically significant/intervention required), decreased limb mobility (serious criteria disability and clinically significant/intervention required) and rotator cuff tendinitis. The patient was treated with non-drug therapy (Acupuncture) and prednisolone. On an unknown date, the outcome of the arm pain, shoulder pain, waking up at night, chest pain, back pain, decreased limb mobility and rotator cuff tendinitis were Not Recovered/Not Resolved. The reporter considered the arm pain, shoulder pain, waking up at night, chest pain, back pain, decreased limb mobility and rotator cuff tendinitis to be almost certainly related to FLUARIX QUADRIVALENT.
Age: 40.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Rotator cuff syndrome, Scan abnormal
Clinical narrative: This case was reported by a other health professional and described the occurrence of arm pain in a 40-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7LE2S, expiry date 30th June 2015). Previously administered products included influenza vaccine with an associated reaction of no adverse event. On 4th September 2014, the patient received FLUARIX QUADRIVALENT. On 4th September 2014, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced arm pain (serious criteria disability and clinically significant/intervention required), shoulder pain (serious criteria disability and clinically significant/intervention required), waking up at night (serious criteria disability and clinically significant/intervention required), chest pain (serious criteria disability and clinically significant/intervention required), back pain (serious criteria disability and clinically significant/intervention required), decreased limb mobility (serious criteria disability and clinically significant/intervention required) and rotator cuff tendinitis. The patient was treated with non-drug therapy (Acupuncture) and prednisolone. On an unknown date, the outcome of the arm pain, shoulder pain, waking up at night, chest pain, back pain, decreased limb mobility and rotator cuff tendinitis were Not Recovered/Not Resolved. The reporter considered the arm pain, shoulder pain, waking up at night, chest pain, back pain, decreased limb mobility and rotator cuff tendinitis to be almost certainly related to FLUARIX QUADRIVALENT.
Age: 79.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Local swelling
Clinical narrative: Significant redness, swelling at injection site.
Age: 79.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Significant redness, swelling at injection site.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Death, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Current conditions and medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, 1 injection via unknown route. Concomitant mediations were not reported. On an unknown date, 7 days after onset of therapy, the patient experienced shingles without rash. The patient also had a lot of pain. The outcome of shingles without rash was unknown. Causality assessment was not reported. Product quality complaint was not reported.   Follow up information has been received via internal clarification. This case has been downgraded. The patient did not die.  Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Current conditions and medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, 1 injection via unknown route. Concomitant mediations were not reported. On an unknown date, 7 days after onset of therapy, the patient experienced shingles without rash. The patient also had a lot of pain. The outcome of shingles without rash was unknown. Causality assessment was not reported. Product quality complaint was not reported.   Follow up information has been received via internal clarification. This case has been downgraded. The patient did not die.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Dysphagia, Pyrexia, Throat tightness
Clinical narrative: Throat constriction unusual, chills for 6 hours shaking.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Throat tightness, Tremor
Clinical narrative: Throat constriction unusual, chills for 6 hours shaking.
Age: 54.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Hypoaesthesia, Injection site atrophy, Pain in extremity, Paraesthesia, Ultrasound scan
Clinical narrative: About a week after the vaccination, developed deep indentation in left upper arm.  Developed numbness and weakness.  Went to physician for evaluation due to no improvement.  Warmth and pain to area.  Ordered ultrasound.  Ultrasound revealed small hematoma.
Age: 54.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Asthenia, Haematoma, Hypoaesthesia, Injection site reaction, Pain in extremity
Clinical narrative: About a week after the vaccination, developed deep indentation in left upper arm.  Developed numbness and weakness.  Went to physician for evaluation due to no improvement.  Warmth and pain to area.  Ordered ultrasound.  Ultrasound revealed small hematoma.
Age: 54.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Skin warm, Ultrasound scan abnormal
Clinical narrative: About a week after the vaccination, developed deep indentation in left upper arm.  Developed numbness and weakness.  Went to physician for evaluation due to no improvement.  Warmth and pain to area.  Ordered ultrasound.  Ultrasound revealed small hematoma.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Pruritus generalised, Urticaria
Clinical narrative: Itching all over body, rash that looked like welts all over body, lightheadedness, fatigue.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Chills, Increased upper airway secretion, Injection site pain, Oropharyngeal pain
Clinical narrative: Chills, fever of 100.1, body aches, sore throat, phlegm, bottom of feet burning, arm pain where injected.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Chills, fever of 100.1, body aches, sore throat, phlegm, bottom of feet burning, arm pain where injected.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia
Clinical narrative: Non-muscular joint pain in both elbows.
Age: 1.06
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Blister, Measles post vaccine, Pyrexia, Rash
Clinical narrative: Fever of 102.5 on day 4 followed by 200-300 blisters on hands and feet. Measles rash.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Headache, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: Fever, body aches, sore throat, runny and stuffy nose, headache, coughing, congestion.  These symptoms were not mild. They were severe. Today is the fourth day I am experiencing these symptoms. The real flu could not be much worse.  I took Tylenol for the fever. It helped. Tried nasal spray and Mucinex for congestion. These medicines didn't help at all.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Fever, body aches, sore throat, runny and stuffy nose, headache, coughing, congestion.  These symptoms were not mild. They were severe. Today is the fourth day I am experiencing these symptoms. The real flu could not be much worse.  I took Tylenol for the fever. It helped. Tried nasal spray and Mucinex for congestion. These medicines didn't help at all.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia, Pyrexia, Tremor
Clinical narrative: Chills, shakiness, muscle aches, fever.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Redness, swelling, itching, pain, spontansously resolving over the course of 5 days subsequently.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: Ringing in ears. I am not sure what time I noticed it but definitely started the day after I received the vaccination.  I am contacting my doctor today.
Age: 52.0
Sex: M
Vaccine: FLUC3, TDAP
Symptoms: Incorrect route of drug administration, Local reaction, Pruritus
Clinical narrative: Tdap erroneously administered ID instead of IM. Local reaction on forearm noted on 17 Oct 2014.
Age: 29.0
Sex: F
Vaccine: FLUC3, TDAP
Symptoms: Incorrect route of drug administration, Local reaction, Pruritus
Clinical narrative: Tdap erroneously administered ID instead of IM. Local reaction on forearm noted on 17 Oct 2014.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Local reaction, Pruritus
Clinical narrative: TDaP erroneusly administered ID instead of IM. Local reaction noted on 17 Oct 2014.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Eye discharge, Headache, Malaise
Clinical narrative: Eye discharge, headache, chills, overall malaise.
Age: 26.0
Sex: F
Vaccine: FLUC3, TDAP
Symptoms: Incorrect route of drug administration, Local reaction, Pruritus
Clinical narrative: Tdap erroneuosly administered ID instead of IM. Local reaction noted on forearm on 17 Oct 2014.
Age: 39.0
Sex: M
Vaccine: FLUC3, TDAP
Symptoms: Incorrect route of drug administration, Local reaction, Pruritus
Clinical narrative: Tdap erroneously administered ID insteat of IM. Local reaction on forearm noted on 17 Oct 2014.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: She reports that she had numbness and tingling from elbow to shoulder within about 15 min of the injection, then it got worse by 45 min- 1 hour, then finally subsided by later that afternoon around 4:30PM.
Age: 53.0
Sex: M
Vaccine: FLUC3, TDAP
Symptoms: Incorrect route of drug administration, Local reaction, Pruritus
Clinical narrative: Tdap erroneously administered ID instead of IM. Local reaction on forearm noted on 17 Oct 2014.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea
Clinical narrative: Developed difficulty breathing/swallowing.  Epi-pen administered and patient transferred to Emergency Department for evaluation and treatment (rec'd. intravenous epinephrine, Benadryl, and steroids as well as RX to continue oral Benadryl and steroids).
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Nausea
Clinical narrative: Severe joint pain and nausea.  The patient went to the ER.  They found nothing. No treatment was given.  Patient began to feel better.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Herpes zoster, Pain in extremity, Poor quality sleep, Rash
Clinical narrative: First right inner forearm very sensitive, singles rash appeared above waist line on right side, 10/18/2014 night did not sleep good, 10/19 & 10/20 did not feel like eating just rested as best I could. 10/21/2014 to my primary doctor who said it looked like singles and gave me 7 days of Valacyclovir HCL 1. The shingles are not painful. I am starting to feel better.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Heavy exposure to ultraviolet light, Injection site pain, Lethargy, Migraine
Clinical narrative: Patient had headache at the time of the vaccination. She stated that she had soreness around the injection site. She stated that she had symptoms resembling a migraine with myalgias, nausea and vomiting. She stated that she did have a lot of sun exposure after the vaccination which sometimes leads to less severe, but similar symptoms. The following day at 11:00AM (22 hours after vaccination), she is no longer nauseous, has no appetite, has injection site tenderness, and is still feeling lethargic. She states that she has improved a lot since the reaction. She is only treating symptoms with Aspirin 81 mg every 6 hours.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: Patient had headache at the time of the vaccination. She stated that she had soreness around the injection site. She stated that she had symptoms resembling a migraine with myalgias, nausea and vomiting. She stated that she did have a lot of sun exposure after the vaccination which sometimes leads to less severe, but similar symptoms. The following day at 11:00AM (22 hours after vaccination), she is no longer nauseous, has no appetite, has injection site tenderness, and is still feeling lethargic. She states that she has improved a lot since the reaction. She is only treating symptoms with Aspirin 81 mg every 6 hours.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Fungal skin infection, Fungal test negative, Genital discomfort, Oropharyngeal pain, Pruritus
Clinical narrative: Genital itching/irritation started 10/9.  Treated with Benzocaine 5%/Resorcinol 2% topical ointment for 12 days.  Subsequently developed sore throat and congestion starting 10/13.  Developed fungal rash under breasts and band of itching/hives on scalp, ears and neck beginning 10/14.  Seen by physician 10/15 and started on course of steroids (oral) and fungicide topical ointment.  Responding to treatment (rash almost resolved) as of 10/21/14.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus genital, Respiratory tract congestion, Urticaria
Clinical narrative: Genital itching/irritation started 10/9.  Treated with Benzocaine 5%/Resorcinol 2% topical ointment for 12 days.  Subsequently developed sore throat and congestion starting 10/13.  Developed fungal rash under breasts and band of itching/hives on scalp, ears and neck beginning 10/14.  Seen by physician 10/15 and started on course of steroids (oral) and fungicide topical ointment.  Responding to treatment (rash almost resolved) as of 10/21/14.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Wrong drug administered
Clinical narrative: Incorrect vaccine administered.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Breast pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Golf ball size swelling of lymph nodes above clavical on side where shot was administered two days after.  Pain radiating through arm and breast.  Swollen lymph nodes in breast after three days.  Physician does not think there is a connection with vaccination, ordered biopsy and mamogram.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Muscle twitching, Pain
Clinical narrative: Muscle spasms and twitching in arm.  "Bee sting" like rxn from intradermal injection.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Muscle spasms
Clinical narrative: Patient here with complaints that right arm spasms are getting worse.  It started after she got her flu shot and at the injection site and it lasted two days and then it moved to her right shoulder blade area.  Now she can feel it it in her feet, legs, thumb, knee, arms and back occasionally.  It is not painful, just bizarre.    Area around flu shot was pulsing/fluttering; lasted about two days. Moved towards her back, around the shoulder blade. In the beginning, it was almost constant, but now it is more like one time and then stops. It can be in the hands, fingers, legs, flank (right along the rib cage). Happens most in the legs, some in the feet and thumbs.
Age: 19.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Eye movement disorder, Posture abnormal
Clinical narrative: Patient was given a flu shot in the right arm, then the Menactra vaccine in his left. After receiving the Menactra vaccine, he slumped over and was lowered to the ground. His eyes rolled in to the back of his head, but when his name was called, he immediately responded and woke up.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chest pain, Headache, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms, aching joints, headache, chest pains, fever.
Age: 0.23
Sex: M
Vaccine: DTAP
Symptoms: Crying, Decreased appetite, Dyskinesia, Injection site erythema, Injection site swelling
Clinical narrative: Uncontrollable crying in both (twins), redness and swelling at injection site and leg, sleepiness, loss of appetite, loss of recognition, muscle control, spasms, lethargy.
Age: 0.23
Sex: M
Vaccine: DTAP
Symptoms: Lethargy, Memory impairment, Muscle spasms, Somnolence
Clinical narrative: Uncontrollable crying in both (twins), redness and swelling at injection site and leg, sleepiness, loss of appetite, loss of recognition, muscle control, spasms, lethargy.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Palpitations, Paraesthesia oral, Swelling
Clinical narrative: Heart racing, felt faint, tongue tingling, swollen.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Chills, Heart rate increased, Ocular hyperaemia, Ventricular extrasystoles
Clinical narrative: Red eyes, chills, temperature 101.5, rapid heart rate 120 with 10 PVC's per minute.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Pain in left deltoid - site of injection. Can not lift arm. bruising.
Age: 54.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: Severe pain in arm; difficulty lying down to sleep; extreme pain when moving in bed. Has continued for 2 weeks now with no let up. When will pain (severe pain) go away?
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Muscle ache/soreness later progressed to mild pain, injection site redness.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Swelling
Clinical narrative: PATIENT REPORTED TENDER, RED CIRCLE (1" WIDE) AROUND THE INJECTION SITE ACCOMPANIED BY ITCHING AND PAIN. PATIENT ALSO REPORTED 2 RED, SWOLLEN SPOTS WHICH WERE TENDER TO TOUCH AROUND THE WAIST THAT LOOKED LIKE BUG BITES. Patient reported this morning that spot is less red and tender today.  Appears to be getting better at injection site and spots on waist.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: PATIENT REPORTED TENDER, RED CIRCLE (1" WIDE) AROUND THE INJECTION SITE ACCOMPANIED BY ITCHING AND PAIN. PATIENT ALSO REPORTED 2 RED, SWOLLEN SPOTS WHICH WERE TENDER TO TOUCH AROUND THE WAIST THAT LOOKED LIKE BUG BITES. Patient reported this morning that spot is less red and tender today.  Appears to be getting better at injection site and spots on waist.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster, Musculoskeletal chest pain, Pain of skin, Rash erythematous
Clinical narrative: Pain to right lower rib area and then on 10/12/2014 red rash in area and pain spreading to skin and around back on right side.  Dx with Shingles.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth, Local swelling
Clinical narrative: Swollen arm, large inflamed red area covering most of the left deltoid, upper arm. Hot to touch, very sore and very hot to the touch. Have pictures of area.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Ataxia
Clinical narrative: Patient developed acute ataxia, which was treated with Benadryl and one dose of Decadron.  Symptoms resolved within 24 hours.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Erythema multiforme
Clinical narrative: Patient developed erythema multiforme.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Reaction:  Injection site became hot and swollen.  Management:  Topical steroid cream (details unknown) given to patient to treat inflammation.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 10/18- QUARTER SIZE REDNESS AND SWELLING ON BACK OF RIGHT ARM. 10/19 AND 10/20- REDNESS AND SWELLING CONTINUED TO GROW IN SIZE TO ABOUT 7 CM X 7CM IN DIAMETER. PT ALSO REPORTED ITCHING AND WARMTH AT SITE ON THESE DAYS.