chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified amount of patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, unspecified amount of patients were vaccinated with improperly stored ZOSTAVAX lot # K009772, expiration date 09-OCT-2015, (dose, route, anatomical location and dose number were unspecified). No concomitant therapies were reported. No adverse effects reported. The outcome of the events was unknown. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history was reported. On 11-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 second dose (Lot#, dose, route were not reported) for an unknown innidiation. No concomitant medication was reported. The first dose of PNEUMOVAX 23 was given on an unknown date. On 11-NOV-2014, 2nd dose of PNEUMOVAX 23 administered inadvertently a few weeks later. No adverse effects were repotted. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse. The nurse reported that the VARIVAX (Merck) (no lot number provided) has been exposed to temperatures warmer than -15C for an unspecified period of time and has been administered to unspecified patients on unspecified dates since 15-OCT-2014. The outcome is unknown. No adverse experience has been observed or reported. No additional information has been provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse who reported that doses of VARIVAX (Merck) (dose in series unspecified) were improperly stored at -4.5C for 68.5 hours cumulatively over 3 months. The nurse stated that 10 doses were administered at an unspecified time between August and October 2014. No adverse effects were reported. Lot numbers involved: J003539 expiry 25-MAR-15; J012328 expiry 02-OCT-2015; Lot K003407 expiry 06-MAR-2016. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age and gender. On 09-DEC-2014 the patient was vaccinated with GARDASIL (lot # K005881, expiry date: 14-JUL-2017, dose, units, route of administration and anatomical location were not reported) that had been through a temperature excursion on that day and possibly a past temperature excursion. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site pain, Lymph node pain, Lymphadenopathy, Mobility decreased
Clinical narrative: Information has been received from a consumer concerning a female patient of unknown age. On 25-NOV-2014 the patient was vaccinated with PNEUMOVAX 23. On 25-NOV-2014, after the patient received PNEUMOVAX 23, she experienced extreme soreness at the injection site, headache, neck stiffness, difficulty moving her arm and her lymph nodes were painfully swollen. Outcome for all of the events was unknown. Additional information is expected.
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness
Clinical narrative: Information has been received from a consumer concerning a female patient of unknown age. On 25-NOV-2014 the patient was vaccinated with PNEUMOVAX 23. On 25-NOV-2014, after the patient received PNEUMOVAX 23, she experienced extreme soreness at the injection site, headache, neck stiffness, difficulty moving her arm and her lymph nodes were painfully swollen. Outcome for all of the events was unknown. Additional information is expected.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product packaging confusion, Wrong drug administered
Clinical narrative: Information has been reported by a physician concerning a male patient who on 26-NOV-2014 received a dose of VARIVAX (Merck) (lot number not reported) instead of a dose of ZOSTAVAX. The physician stated that it is easy to mistake the VARIVAX (Merck) box for the ZOSTAVAX box since they are both the color green. No adverse effects were reported. The causality was not related. The outcome of wrong drug administered and product confusion were unknown. No additional information was provided. Additional information has been requested. This is one of several cases received from same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 12-NOV-2014, the patient was inadvertently vaccinated with a double dose of pediatric VAQTA (lot#, route and site of administration were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date of 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 24-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported) which was improperly stored. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 2-5, units not reported) of unknown gender. On 22-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reproter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 21-OCT_2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date in June 2014 (also reported as "5 months ago"), the patient was vaccinated with an unspecified dose of ZOSTAVAX 19400 PFU, (dose, route, anatomical location, lot number and expiration date were not reported) and on 20-NOV-2014 was inadvertently administered another an unspecified dose of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. No adverse effects were reported. No further information was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of VARIVAX (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot#, expiration date, dose, frequency and route were unknown). The temperature excursion for the GARDASIL was found to be unsupported with in-house stability data. No adverse symptoms reported. Action taken and outcome were not provided. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling to right thigh. 1.1 inches x 1.1 inches. Increased redness. Area tender to touch. Skin intact. No drainage noted. Ice pack applied to area. Will continue to monitor.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Brain natriuretic peptide, Electrocardiogram, Full blood count, Injection site erythema, Injection site oedema
Clinical narrative: Pt had severe pain at injection site and soft tissue swelling without redness approximately 4 hours after immun. Erythema (L) mid to upper arm to elbow developed with edema a little over 48 hours later (on 12-11-14). Pt went to ER 12/9; PCP visit 12/11 and 12/12.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Metabolic function test, Swelling
Clinical narrative: Pt had severe pain at injection site and soft tissue swelling without redness approximately 4 hours after immun. Erythema (L) mid to upper arm to elbow developed with edema a little over 48 hours later (on 12-11-14). Pt went to ER 12/9; PCP visit 12/11 and 12/12.
Age: 7.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash erythematous, Rash pruritic
Clinical narrative: Vaccines administered 12-3-14. KINRIX (right arm), MMRV (Lt arm). Parent called 12-4-14 - complaint right arm itch with some swelling. 12-5-14 - seen in urgent care for increased swelling, redness, itching from rt deltoid, redness posterior right shoulder and 1/3 down right humerus, 2 hives on face. 12-8-14 - seen by PCP - itchy red rash, swelling resolved.
Age: 7.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Vaccines administered 12-3-14. KINRIX (right arm), MMRV (Lt arm). Parent called 12-4-14 - complaint right arm itch with some swelling. 12-5-14 - seen in urgent care for increased swelling, redness, itching from rt deltoid, redness posterior right shoulder and 1/3 down right humerus, 2 hives on face. 12-8-14 - seen by PCP - itchy red rash, swelling resolved.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Onset 6-7 hours after vaccine pain, swelling, redness, itching lasting 4 full days, present on exam 12/12, Rx BENADRYL, cold compresses.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Poor quality sleep, Pruritus
Clinical narrative: Pain, erythema, swelling, tenderness, itching, warmth, induration.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Tenderness
Clinical narrative: Pain, erythema, swelling, tenderness, itching, warmth, induration.
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 9 month old patient. On an unknown date the patient was vaccinated with received the third dose of PEDVAXHIB (lot#, expiry date, dose, frequency unspecified) at 9 month of age rather than at recommended 12-15 month of age. No adverse effects reported. No PQC involved. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Presyncope
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a male patient of unknown age. The patient had no pertinent medical history or drug reactions/allergies. On 12-NOV-2014, the patient was vaccinated with the first dose of GARDASIL (lot # K009482, expiration date and route were not reported) 0.5 ml. There were no concomitant medications. Few minutes afterwards the patient experienced dizziness, near syncopal episode and weakness. The reported stated that the patient lay down for 15-20 minutes and then the patient reported feeling better. Patient did not pass out. The outcome of dizziness, near syncopal episode and weakness was reported as recovered. On 12-NOV-2014, no treatment was given for the adverse events. No lab diagnostics studies were performed. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 01-DEC-2014 the patient was vaccinated with ZOSTAVAX (dose, strength, route and lot number were not reported). Secondary and concomitant therapies were not reported. Pharmacist reported that patient was indicated for VARIVAX (Merck), accidentally received a dose of ZOSTAVAX instead. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Between 16-OCT-2014 and 06-NOV-2014 the patients were vaccinated with an improperly stored dose of VAQTA (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Follow up has been received on 21-NOV-2014: A telephone call was placed to the medical assistant, but she was unavailable at the time of the call. Another certified medical assistant, was available and took the call. The reporter medical assistant was provided lot number and expiration date for VAQTA (lot# K008252, expiration date 24-OCT-2014). The number and gender of the patients who received the vaccinations for this report: 1 female patient. The date range of vaccination administration was 15-OCT-2014 through 27-OCT-2014. This is one of several reports received from the same reporter. 1411USA007510, 1411USA007508, 1411USA007509, 1411USA007507, 1411USA003086, 1412USA005214. Additional information has been requested, regarding the reported incident of incorrect product storage become available.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product packaging confusion, Wrong drug administered
Clinical narrative: Information has been reported by a physician concerning a female patient who on 26-NOV-2014 received a dose of VARIVAX (Merck) (lot number not reported) instead of a dose of ZOSTAVAX. The physician stated that it is easy to mistake the VARIVAX (Merck) box for the ZOSTAVAX box since they are both the color green. No adverse effects were reported. The causality was not related. The outcome of wrong drug administered, product confusion and no adverse effect were unknown. No additional information was provided. Additional information  has been requested. This is one of several cases received from same reporter.
Age: 25.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 25 year old patient. The patient's medical history and current conditions were not reported. On 13-NOV-2014 the patient was vaccinated with the first dose of GARDASIL and an early second dose on 13-NOV-2014. No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-APR-2014, the patient was vaccinated with a first dose of ZOSTAVAX (lot number, Expiry date, dose, route were not reported) indication default. On 02-DEC-2014, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX (lot number, Expiry date, dose were not reported), subcutaneous, indication default. No adverse effect was reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient. Drug reaction and allergies was not provided. On an unknown date the patient was vaccinated with pneumococcal vaccine (manufacturer unknown. (Dose, strength, lot# and expiration date were not provided). On an unknown date the patient reported that she was received a pneumonia vaccine (brand, name and manufacturer were unspecified), every year, for the past 7 years, when she received her flu vaccine. No adverse effect reported. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling cold, Injection site pain, Injection site reaction
Clinical narrative: Left severe arm pain at site of injection w/ cold like sensation.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness and itching at the injection site.  Swelling approximately from shoulder down to elbow of the left arm.
Age: 26.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Back pain, Dizziness, Headache, Local swelling, Mobility decreased
Clinical narrative: Dizzy, severe neck and lower back pain, arm swelling and red spots inability to move arm, nausea, severe head ache.
Age: 26.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nausea, Neck pain, Rash erythematous
Clinical narrative: Dizzy, severe neck and lower back pain, arm swelling and red spots inability to move arm, nausea, severe head ache.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Groin pain, Rash erythematous
Clinical narrative: SMALL RED BUMPS LOOKED LIKE A SPIDER BITE. By next day rash had spread from hip to buttocks and belt line of waist. By day six strong pain developed in groin area near leg.  Went back to doctor and he prescribed nortriptyline and valacyclovir.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Ocular hyperaemia
Clinical narrative: Patient developed redness in eyes without drainage or crusting.
Age: 21.0
Sex: F
Vaccine: FLU3, HEPA, PNC13, TYP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Right deltoid muscle pain, erythema, swelling, reduced arm range of motion. Fever to 101.4. Intermittent nausea. Took acetaminophen, applied ice.  Antihistamines recommended.
Age: 21.0
Sex: F
Vaccine: FLU3, HEPA, PNC13, TYP
Symptoms: Pyrexia
Clinical narrative: Right deltoid muscle pain, erythema, swelling, reduced arm range of motion. Fever to 101.4. Intermittent nausea. Took acetaminophen, applied ice.  Antihistamines recommended.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site is red, a little warm, raised.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Injection site swelling, Nasal congestion, Respiratory tract congestion
Clinical narrative: Tightness in chest, chest congestion, can't take a deep breath, extreme nasal congestion, little or no swelling at injection site.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dizziness, Nausea, Vaccination site swelling
Clinical narrative: Dizziness, weakness, nasusea, swelling of vaccinated area of arm.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Pruritus, Rash erythematous
Clinical narrative: Erythematous bulbous rash on both arms but more prominent on vaccinated arm. Itching in feet. 12/6/14-medrol Dosepack. Rashes still progressed 12/13/14 oral and intra muscular steroid therapy. Rashes regressing. Pt also used OTC Benadryl tablets and gel.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: After I vaccinated the patient, she bruised instantley and her arms swelled where the injection was given. A hard knot formed underneath her skin where the bruise was. The patient, however, felt fine.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Insomnia, Joint range of motion decreased, Muscle mass, Myositis
Clinical narrative: Received flu shot from Pharmacy in left arm. Arm immediately started hurting. Cannot move arm without pain.  Cannot sleep at night because arm throbs.  Went to my personal physician on Dec. 1, 2014.  Had ultrasound done to check for blood clots.  No clots.  He said muscle in arm is inflamed.  There has been a knot in muscle since I received shot.  Have been using heating pad but is not any better.  Loss of range of motion in arm.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Ultrasound scan normal
Clinical narrative: Received flu shot from Pharmacy in left arm. Arm immediately started hurting. Cannot move arm without pain.  Cannot sleep at night because arm throbs.  Went to my personal physician on Dec. 1, 2014.  Had ultrasound done to check for blood clots.  No clots.  He said muscle in arm is inflamed.  There has been a knot in muscle since I received shot.  Have been using heating pad but is not any better.  Loss of range of motion in arm.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Severe headache, fever, nausea, back pain, vomiting, extreme dizziness.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Severe headache, fever, nausea, back pain, vomiting, extreme dizziness.
Age: 1.69
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Dermatitis diaper, Diarrhoea, Urticaria
Clinical narrative: Extreme diarrhea and horrible diaper rash (skin has formed welts).
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort
Clinical narrative: Patient complained of c hest tightness later that day - lasted a few hours.
Age: 61.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Large  redness on (L) upper arm and swelling. Fever and nausea.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Edema of deltoid area to elbow, severe tenderness, erythema
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Large area of edema from shoulder to elbow with erythema and tenderness.
Age: 33.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Paraesthesia, X-ray normal
Clinical narrative: 1 day after influenza vaccination right deltoid patient developed pain in shoulder that has lasted 5 weeks, no previous shoulder pain. MRI 12/11/14 confirmed.  Moderate focal teres minor myotendinous junction edema. Pain at time of entry still present but may be improving.
Age: 33.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Injection site pain, Injection site reaction, Muscle oedema, Nuclear magnetic resonance imaging abnormal
Clinical narrative: 1 day after influenza vaccination right deltoid patient developed pain in shoulder that has lasted 5 weeks, no previous shoulder pain. MRI 12/11/14 confirmed.  Moderate focal teres minor myotendinous junction edema. Pain at time of entry still present but may be improving.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Dizziness, Muscle spasms, Myalgia, Rash
Clinical narrative: I got the Tdap vaccination after my physical on 12/11/2014.  I first got a rash on my chest.  Then, that night my muscles ached badly and I have no appetite.  The next night in conjunction with muscle pain I had camping all night alternating from one calf to the other.  The muscle pain was progressively getting worse during the day so I thought I would go for run hoping to run it out.  Well during the run I experienced vomiting and dizziness, but my legs didn't hurt. After the run the intense muscle pain has returned.  Who knows if the cramps will return tonight? I have gotten a lot of vaccination in my life due to traveling and no other vaccination has cause me even close to this amount of pain.  I really question the medical research concerning this vaccination since this vaccination has only been used since 2006. Is it really necessary to combine all three and since only about 8.2 percent of adults have had this vaccination I reason that the reaction are a lot more adverse than the limited medical research has ascertained.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: I got the Tdap vaccination after my physical on 12/11/2014.  I first got a rash on my chest.  Then, that night my muscles ached badly and I have no appetite.  The next night in conjunction with muscle pain I had camping all night alternating from one calf to the other.  The muscle pain was progressively getting worse during the day so I thought I would go for run hoping to run it out.  Well during the run I experienced vomiting and dizziness, but my legs didn't hurt. After the run the intense muscle pain has returned.  Who knows if the cramps will return tonight? I have gotten a lot of vaccination in my life due to traveling and no other vaccination has cause me even close to this amount of pain.  I really question the medical research concerning this vaccination since this vaccination has only been used since 2006. Is it really necessary to combine all three and since only about 8.2 percent of adults have had this vaccination I reason that the reaction are a lot more adverse than the limited medical research has ascertained.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hyperhidrosis, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever, sweats, pain/swelling/redness over upper arm.
Age: 31.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Joint range of motion decreased, Mobility decreased, Musculoskeletal pain
Clinical narrative: Day 1 Tdap vaccine in left deltoid causing soreness and slight pain in shoulder. Day 2 slightly more painful and hard to raise arm above head. Day 3 to present (day 13) severe pain when attempting to use arm, very limited range of motion. On day 3 began taking Ibuprofen which helped to decrease the pain. Today is day 13 and the pain is still very bad and I'm continuing to take Ibuprofen.
Age: 14.0
Sex: F
Vaccine: FLUX
Symptoms: Computerised tomogram normal, Dehydration, Diplopia, Dizziness, Dyspnoea
Clinical narrative: Dizziness, fainting, weakness in legs, numb feet, unable to stand on own, nausea, dehydration, tingling in legs, pain in legs, low blood pressure, double vision, difficulty breathing, light headed.
Age: 14.0
Sex: F
Vaccine: FLUX
Symptoms: Dysstasia, Electrocardiogram normal, Full blood count normal, Hypoaesthesia, Hypotension
Clinical narrative: Dizziness, fainting, weakness in legs, numb feet, unable to stand on own, nausea, dehydration, tingling in legs, pain in legs, low blood pressure, double vision, difficulty breathing, light headed.
Age: 14.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test abnormal, Muscular weakness, Nausea, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Dizziness, fainting, weakness in legs, numb feet, unable to stand on own, nausea, dehydration, tingling in legs, pain in legs, low blood pressure, double vision, difficulty breathing, light headed.
Age: 14.0
Sex: F
Vaccine: FLUX
Symptoms: Syncope, Urine analysis normal
Clinical narrative: Dizziness, fainting, weakness in legs, numb feet, unable to stand on own, nausea, dehydration, tingling in legs, pain in legs, low blood pressure, double vision, difficulty breathing, light headed.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Very painful and a lot of swelling at injection site.  Then tiredness, achyness, headache, muscle aches, joint pain, vomiting.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Pain, Vomiting
Clinical narrative: Very painful and a lot of swelling at injection site.  Then tiredness, achyness, headache, muscle aches, joint pain, vomiting.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Rash vesicular
Clinical narrative: Patient states a "shingle-like" rash developed on her lower back as well as redness and itching around the site of injection.
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: Hypoaesthesia, Joint range of motion decreased, Muscular weakness, Pain, Paraesthesia
Clinical narrative: Shoulder/arm throbs and will have numbness/tingling down entire arm into hands. Limited range of motion and increased weakness in that arm.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Food intolerance
Clinical narrative: Sensitivity to eating eggs that are less than hard boiled.  Never had an issue with this until patient started to receive vaccine in 2012. Now when patient eats eggs, patient gets diarrhea within a short time of eating them.  Did not make a connection to flu vaccine until this year.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cataract, Discomfort, Eye pain, Iritis
Clinical narrative: Upon awakening I felt a general aching in left eye. The discomfort was not severe and I waited until 12/12/2014 to be seen by a physician where I was diagnosed with iritis. I have a cataract in both eyes, but is worse in left which is the eye always affected by iritis 2 weeks following every flu vaccination I receive.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Dysphonia, Injection site pruritus, Injection site rash, Oropharyngeal pain
Clinical narrative: Sorethroat, sneezing, congestion, 99.9F temperature, scratchy throat, hoarseness, localized breakout L arm around vaccination site with itchiness, bump nickle size on L forearm. Signs and symptoms lasted for 6 days.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Respiratory tract congestion, Sneezing, Throat irritation
Clinical narrative: Sorethroat, sneezing, congestion, 99.9F temperature, scratchy throat, hoarseness, localized breakout L arm around vaccination site with itchiness, bump nickle size on L forearm. Signs and symptoms lasted for 6 days.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: A few hours after receiving a pneumonia vaccine too high in my left shoulder I experienced local arm pain which through the night worsened until I had pain at the top of my shoulder, around my shoulder joint and today down the front of my left arm. Have been treating it with ibuprofen. Red and painful to touch. Planning on going to urgent care tonight.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Asthenia, Crying, Decreased appetite, Diarrhoea, Feeling hot
Clinical narrative: Lots of crying/whining/clinginess. Crying that her neck and legs hurt. No appetite at all, low energy. By 4pm, 102.7 degree fever, listlessness, burning up. The next day, diarrhea all day, couldn't leave the house. Today, less diarrhea but still explosive when it happened first thing in the morning and right before bed. Treated homeopathically throughout the whole illness.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Listless, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Lots of crying/whining/clinginess. Crying that her neck and legs hurt. No appetite at all, low energy. By 4pm, 102.7 degree fever, listlessness, burning up. The next day, diarrhea all day, couldn't leave the house. Today, less diarrhea but still explosive when it happened first thing in the morning and right before bed. Treated homeopathically throughout the whole illness.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Muscular weakness, Pain in extremity
Clinical narrative: I received an IM Fluarix Quadrivalent shot and there was much pain (6 out of 10 scale) in the right arm after administration. I developed a headache for 72 hours after the shot that went away; however, the pain (down to 3 out of 10) in my arm was continued for several weeks and interestingly I also felt pain in my left arm after 1 week of administration. Not sure why. It has been about 2 months and I feel muscle weakness and pain (currently 2 out of 10) in my right arm still. Not sure why this is continuing after the receiving the flu shot.
Age: 19.0
Sex: M
Vaccine: TTOX
Symptoms: Fall, Loss of consciousness
Clinical narrative: Vaccine was administered at 9:27. Donor was sitting on examination bed in the medical room when the donor had LOC and fell forward from the exam bed and onto the floor. Donor recieved one laceration to his forehead, one to the top of his nose, and a broken tooth. Donor was given ice, and donor was able to put pressure on his nose. The medical staff cleaned the laceration areas, and applied two butterfly strips to the forehead and covered the area with a bandage. The donor refused EMS transport, stated that he will see a dentist/doctor when he leaves the center. Donor stated that he has an incident of LOC while getting his lip peirced on 7/7/13. On initial observation of arm there were no adverse reactions. Donor was able to leave the center unassisted.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Antinuclear antibody, Blood creatine phosphokinase, Chills, Ear pain, Full blood count
Clinical narrative: First symptom on Wednesday 12/10/14 was irritation on Left forearm, felt like raw skin or a scratch. On Thursday morning 12/11/14 drying after the shower the skin was sensitive. From there it slowly spread over whole body creating the sensation of a sunburn with hyper-sensitive skin. Sensitivity to touch, cold, frequent chills, progressing to muscle soreness and joint stiffness everywhere. Mostly in legs and back. Final symptom has been head pressure and inner ear pain and extreme scalp sensitivity.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Head discomfort, Hyperaesthesia, Joint stiffness, Metabolic function test, Myalgia
Clinical narrative: First symptom on Wednesday 12/10/14 was irritation on Left forearm, felt like raw skin or a scratch. On Thursday morning 12/11/14 drying after the shower the skin was sensitive. From there it slowly spread over whole body creating the sensation of a sunburn with hyper-sensitive skin. Sensitivity to touch, cold, frequent chills, progressing to muscle soreness and joint stiffness everywhere. Mostly in legs and back. Final symptom has been head pressure and inner ear pain and extreme scalp sensitivity.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Paraesthesia, Red blood cell sedimentation rate, Skin irritation
Clinical narrative: First symptom on Wednesday 12/10/14 was irritation on Left forearm, felt like raw skin or a scratch. On Thursday morning 12/11/14 drying after the shower the skin was sensitive. From there it slowly spread over whole body creating the sensation of a sunburn with hyper-sensitive skin. Sensitivity to touch, cold, frequent chills, progressing to muscle soreness and joint stiffness everywhere. Mostly in legs and back. Final symptom has been head pressure and inner ear pain and extreme scalp sensitivity.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Malaise, Syncope
Clinical narrative: PT claimed not feeling well right after receiving flu shot and she fainted after a few minutes. Before EMT arrived, PT regained consciousness.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Adverse reaction
Clinical narrative: Silver dollar reaction area.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pruritus, Rash, Skin discolouration
Clinical narrative: Pt developed circular colored area with bumps and massive itching. 12/11 - pt talked w/Doctor and Doctor told her to watch and wait.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (nurse) refers to a 52 week old patient. Patient's pertinent medical history and drug reactions were not reported. On 05-DEC-2014 the patient was vaccinated with a dose of M-M-R II, intramuscularly in the right leg (reported as right thigh muscle) (lot # J008729, expiry date: 31-JUL-2015). Concomitant medications were not reported. No adverse effects were observed or reported. No product quality complaint (PQC) was reported. Causality was reported as not related to therapy with M-M-R II. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Patient received expired immunization and opted for reimmunization at another pharmacy (Patient in good health when he returned for refund 12/14/14).
Age: 24.0
Sex: M
Vaccine: HPV4, SMALL, SMALL
Symptoms: Cardiomegaly, Histology abnormal, Myocarditis, Sudden death, Toxicologic test
Clinical narrative: This case was received on 16 June 2014 via a third party query tool search on the VAERS database, under reference number 526687. A 24 year old male patient had received ACAM2000 (lot number not reported) on 07 March 2014. On 19 March 2014, 12 days following vaccination, the patient experienced sudden death and cardiomegaly with four chamber dilation. The patient histologic diagnosis was myocarditis. At the time of this report toxicology is still pending. The patient's other medications, current illnesses and history were reported as none. No further information was available at the time of the report. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient outcome was fatal. Follow-up information for this unsolicited report was received from a healthcare professional on 08 December 2014, and included a redacted copy of the autopsy report. The patient was found unresponsive in his quarters. Cause of death was necrotizing eosinophilic myocarditis, and manner of death was natural. A cardiovascular pathology consultation showed predominant interstitial inflammation, a mixed inflammatory infiltrate of macrophages, neutrophils, eosinophils and lymphocytes, and patchy myocyte necrosis. The impression from the consultation was necrotizing eosinophilic myocarditis with mild concentric left ventricular hypertrophy. A lesion on the left shoulder was consistent with recent smallpox vaccination, and recent smallpox vaccination was confirmed by serology. No ethanol was detected in the blood or vitreous fluid. Acetaminophen and diphenhydramine were detected. The opinion of the examiner was that the patient died of necrotizing eosinophilic myocarditis, temporally related with administration of a smallpox vaccination. Cause and effect relationship between smallpox vaccination and death could not be definitively established or ruled out. Documents held by sender: Redacted autopsy report. Documents held by sender: none.
Age: 24.0
Sex: M
Vaccine: HPV4, SMALL, SMALL
Symptoms: Autopsy, Blood ethanol normal, Cardiomegaly, Cardiovascular evaluation, Eosinophilic myocarditis
Clinical narrative: This case was received on 16 June 2014 via a third party query tool search on the VAERS database, under reference number 526687. A 24 year old male patient had received ACAM2000 (lot number not reported) on 07 March 2014. On 19 March 2014, 12 days following vaccination, the patient experienced sudden death and cardiomegaly with four chamber dilation. The patient histologic diagnosis was myocarditis. At the time of this report toxicology is still pending. The patient's other medications, current illnesses and history were reported as none. No further information was available at the time of the report. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient outcome was fatal. Follow-up information for this unsolicited report was received from a healthcare professional on 08 December 2014, and included a redacted copy of the autopsy report. The patient was found unresponsive in his quarters. Cause of death was necrotizing eosinophilic myocarditis, and manner of death was natural. A cardiovascular pathology consultation showed predominant interstitial inflammation, a mixed inflammatory infiltrate of macrophages, neutrophils, eosinophils and lymphocytes, and patchy myocyte necrosis. The impression from the consultation was necrotizing eosinophilic myocarditis with mild concentric left ventricular hypertrophy. A lesion on the left shoulder was consistent with recent smallpox vaccination, and recent smallpox vaccination was confirmed by serology. No ethanol was detected in the blood or vitreous fluid. Acetaminophen and diphenhydramine were detected. The opinion of the examiner was that the patient died of necrotizing eosinophilic myocarditis, temporally related with administration of a smallpox vaccination. Cause and effect relationship between smallpox vaccination and death could not be definitively established or ruled out. Documents held by sender: Redacted autopsy report. Documents held by sender: none.
Age: 24.0
Sex: M
Vaccine: HPV4, SMALL, SMALL
Symptoms: Histology abnormal, Left ventricular hypertrophy, Pathology test, Sudden death, Unresponsive to stimuli
Clinical narrative: This case was received on 16 June 2014 via a third party query tool search on the VAERS database, under reference number 526687. A 24 year old male patient had received ACAM2000 (lot number not reported) on 07 March 2014. On 19 March 2014, 12 days following vaccination, the patient experienced sudden death and cardiomegaly with four chamber dilation. The patient histologic diagnosis was myocarditis. At the time of this report toxicology is still pending. The patient's other medications, current illnesses and history were reported as none. No further information was available at the time of the report. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient outcome was fatal. Follow-up information for this unsolicited report was received from a healthcare professional on 08 December 2014, and included a redacted copy of the autopsy report. The patient was found unresponsive in his quarters. Cause of death was necrotizing eosinophilic myocarditis, and manner of death was natural. A cardiovascular pathology consultation showed predominant interstitial inflammation, a mixed inflammatory infiltrate of macrophages, neutrophils, eosinophils and lymphocytes, and patchy myocyte necrosis. The impression from the consultation was necrotizing eosinophilic myocarditis with mild concentric left ventricular hypertrophy. A lesion on the left shoulder was consistent with recent smallpox vaccination, and recent smallpox vaccination was confirmed by serology. No ethanol was detected in the blood or vitreous fluid. Acetaminophen and diphenhydramine were detected. The opinion of the examiner was that the patient died of necrotizing eosinophilic myocarditis, temporally related with administration of a smallpox vaccination. Cause and effect relationship between smallpox vaccination and death could not be definitively established or ruled out. Documents held by sender: Redacted autopsy report. Documents held by sender: none.