chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the registered nurse concerning to an approximately 76 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 11-FEB-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot number: K005402 with unknown expiration date) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with PNEUMOVAX 23 was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health professional (nurse) refers to a patient of unknown demographics. Patient's pertinent medical history and drug reactions/allergies were unspecified. On 08-JUN-2015 the patient was inadvertently administered with an expired dose of MMR II subcutaneous (lot # J006953, expiry date: 07-JUN-2015). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and mild swelling upper arm site.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to 2 patients of unknown demographics. Medical history and concurrent conditions were not reported. On an unknown date 2 patients were vaccinated with a dose of PROQUAD (Merck) (lot # K009473, expiry date: 03-JAN-2016, 0.5 ml, frequency reported as once, subcutaneous) which was improeprly stored. Concomitant medications were unspecified by reporter. No adverse effects and product quality ocmplaint was reported. The outcome of the events was unknown. No additional information was reported. Additional informatino has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Sore arm/ache starting 6/4/15. Rash at injection site started 6/9/15. Patient came into pharmacy on 6/10/15. Arm was red, slightly swollen and warm only at injection site. Marked area and advised patient to take BENADRYL, MOTRIN and ice. Will follow up 6/11/15.
Sex: U
Vaccine: BCG, HEP, RVX
Symptoms: Death
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse who obtained the information from the web site where read an article which refers to two baby patients of unknown ages and genders. Concurrent conditions or pertinent medical history were not reported. On unknown date the patients were unsafe administer with a dose of hepatitis b vaccine (recombinant) (manufacturer unknown), rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) orally, and BCG (manufacturer unknown) (lot #, expiration date, route of administration (for hepatitis B vaccine (recombinant) and BCG)) and doses were not reported for either vaccines). On unspecified dates, the two babies died (due to an unspecified reason) after receiving those vaccines. It was unknown if autopsy was performed. The nurse also mentioned that the consumer was now scared about having her child vaccinated in other country, therefore, the nurse would like to know any comparative information between the vaccines produced in different countries as lot#s and ingredients used or if those vaccines were in question. The relatedness of the suspected vaccines with death was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, swelling, slight discomfort at site of injection.  Patient contacted us and was instructed to use ice packs, Tylenol/Ibuprofen for pain, and Benadryl for redness and itching.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Head injury
Clinical narrative: Pt felt faint while seated after HPV and Hep A vaccine and mom reports eyes rolled back and he slid off the chair to the side, hitting his right side and head, though not hard per mom. She called for help and the MA went in and I was right behind her. We got him moved to a supine position on the table with close observation and he was talking/ appropriate during this time. His color came back. No HA or dizziness. Pt remained supine for 10-15 min and was doing very well. Mom to watch for any signs of concussion ie. HA, dizziness/ fogginess.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Patient was here for a nurse visit to receive the HPV vaccine. Vaccine was administered and about 2 minutes later mom came out of the room yelling for help. When I entered the room the patient was passed out in her chair. I assured mom that this can happen with HPV vaccines. Patient waited for about 10 more minutes in the room while the clinical staff continued to check on her. Patient walked out of our office feeling well.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Alanine aminotransferase normal, Anion gap normal, Arthralgia, Aspartate aminotransferase normal, Basophil count normal
Clinical narrative: I felt a bit feverish, but when I took my temperature, it was lass than 98.6. For several days thereafter, I has serious muscle and joint aches. On 4/28/2015, I started having night sweats. These got worse and worse to the point that I was having to change my T-shirt 2 or 3 times a night. The aches gradually dissipated over 4 or 5 days, but the night sweats continued until about the 26th of May, when I had my first night with no sweating since the whole business started. Sweating continued occasionally through about the 5th of June.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Basophil percentage, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased
Clinical narrative: I felt a bit feverish, but when I took my temperature, it was lass than 98.6. For several days thereafter, I has serious muscle and joint aches. On 4/28/2015, I started having night sweats. These got worse and worse to the point that I was having to change my T-shirt 2 or 3 times a night. The aches gradually dissipated over 4 or 5 days, but the night sweats continued until about the 26th of May, when I had my first night with no sweating since the whole business started. Sweating continued occasionally through about the 5th of June.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: I felt a bit feverish, but when I took my temperature, it was lass than 98.6. For several days thereafter, I has serious muscle and joint aches. On 4/28/2015, I started having night sweats. These got worse and worse to the point that I was having to change my T-shirt 2 or 3 times a night. The aches gradually dissipated over 4 or 5 days, but the night sweats continued until about the 26th of May, when I had my first night with no sweating since the whole business started. Sweating continued occasionally through about the 5th of June.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Blood thyroid stimulating hormone, Blood urea increased, Blood urine absent, Carbon dioxide normal, Culture urine negative
Clinical narrative: I felt a bit feverish, but when I took my temperature, it was lass than 98.6. For several days thereafter, I has serious muscle and joint aches. On 4/28/2015, I started having night sweats. These got worse and worse to the point that I was having to change my T-shirt 2 or 3 times a night. The aches gradually dissipated over 4 or 5 days, but the night sweats continued until about the 26th of May, when I had my first night with no sweating since the whole business started. Sweating continued occasionally through about the 5th of June.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Eosinophil count normal, Eosinophil percentage, Glucose urine absent, Granulocyte count, Granulocyte percentage
Clinical narrative: I felt a bit feverish, but when I took my temperature, it was lass than 98.6. For several days thereafter, I has serious muscle and joint aches. On 4/28/2015, I started having night sweats. These got worse and worse to the point that I was having to change my T-shirt 2 or 3 times a night. The aches gradually dissipated over 4 or 5 days, but the night sweats continued until about the 26th of May, when I had my first night with no sweating since the whole business started. Sweating continued occasionally through about the 5th of June.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Haematocrit normal, Haemoglobin decreased, Lymphocyte count normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal
Clinical narrative: I felt a bit feverish, but when I took my temperature, it was lass than 98.6. For several days thereafter, I has serious muscle and joint aches. On 4/28/2015, I started having night sweats. These got worse and worse to the point that I was having to change my T-shirt 2 or 3 times a night. The aches gradually dissipated over 4 or 5 days, but the night sweats continued until about the 26th of May, when I had my first night with no sweating since the whole business started. Sweating continued occasionally through about the 5th of June.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Monocyte count increased, Monocyte percentage increased, Myalgia
Clinical narrative: I felt a bit feverish, but when I took my temperature, it was lass than 98.6. For several days thereafter, I has serious muscle and joint aches. On 4/28/2015, I started having night sweats. These got worse and worse to the point that I was having to change my T-shirt 2 or 3 times a night. The aches gradually dissipated over 4 or 5 days, but the night sweats continued until about the 26th of May, when I had my first night with no sweating since the whole business started. Sweating continued occasionally through about the 5th of June.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Night sweats, Nitrite urine absent, Platelet count normal, Protein total normal, Protein urine absent
Clinical narrative: I felt a bit feverish, but when I took my temperature, it was lass than 98.6. For several days thereafter, I has serious muscle and joint aches. On 4/28/2015, I started having night sweats. These got worse and worse to the point that I was having to change my T-shirt 2 or 3 times a night. The aches gradually dissipated over 4 or 5 days, but the night sweats continued until about the 26th of May, when I had my first night with no sweating since the whole business started. Sweating continued occasionally through about the 5th of June.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Red blood cell count decreased, Red blood cells urine positive, Red cell distribution width normal, Specific gravity urine normal
Clinical narrative: I felt a bit feverish, but when I took my temperature, it was lass than 98.6. For several days thereafter, I has serious muscle and joint aches. On 4/28/2015, I started having night sweats. These got worse and worse to the point that I was having to change my T-shirt 2 or 3 times a night. The aches gradually dissipated over 4 or 5 days, but the night sweats continued until about the 26th of May, when I had my first night with no sweating since the whole business started. Sweating continued occasionally through about the 5th of June.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Urinary sediment present, Urine ketone body absent, Urine leukocyte esterase, White blood cell count normal, pH urine normal
Clinical narrative: I felt a bit feverish, but when I took my temperature, it was lass than 98.6. For several days thereafter, I has serious muscle and joint aches. On 4/28/2015, I started having night sweats. These got worse and worse to the point that I was having to change my T-shirt 2 or 3 times a night. The aches gradually dissipated over 4 or 5 days, but the night sweats continued until about the 26th of May, when I had my first night with no sweating since the whole business started. Sweating continued occasionally through about the 5th of June.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pain in extremity
Clinical narrative: Extreme arm pain, arm hurt with movement.
Age: 44.0
Sex: M
Vaccine: HEPAB
Symptoms: Urticaria
Clinical narrative: Broke out in hives on trunk and extremities. Also began using a new liquid soap at the same time. Took 50 mg Benadryl and hives resolved, but broke out again the next day. Has continued to use soap.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Pain, Pyrexia, Rash macular
Clinical narrative: Fine, macular rash to shoulder and trunk which spread to abdomen and face along with fever, body aches and chills.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Injection site haematoma, Injection site mass, Liver function test normal, Rash, Yellow nail syndrome
Clinical narrative: First noticed lump at injection site, was told by phsician that it was hematoma. Three days later notice rash on back, stomach, arms and face and fingernails were yellow. Given prednisone by physician x 8 days. Treatment successful.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Flu like symptoms; fever, chills, aches. Large, red, swollen, tender injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Flu like symptoms; fever, chills, aches. Large, red, swollen, tender injection site.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Red itching rash in area of injection.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient states received Tdap in left arm on 6/5/2015, began to have fever that night that resolved 6/9/2015.  States fever ran from 39-40 degrees Celsius.  Took medicine but was not able to sleep well due to fever.  6/8/2015 began to have redness and swelling in arm.  States injection site from a childhood vaccine was also hard and red, which has never happened before.  States both new and old injection sites were painful.  On 6/10/2015 states most recent injection site is hard and painful.  Old injection site is red, painful, swollen.  Denies itching.  States entire upper arm, from shoulder to elbow, feels hard.  States she does not feel feverish today.  Current temperature is 98.2 degrees Fahrenheit.  Upon examination, newest injection site appears asymptomatic, but has small induration noted on palpation.  Site where patient states she had injection as a child is reddened, raised, and feels hard.  Patient winces upon palpation of both sites.  States each day, pain and hardness seems to progress further down arm.  Referred to Dr. and given acetaminophen to take at home and instructed on use.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Poor quality sleep, Pyrexia
Clinical narrative: Patient states received Tdap in left arm on 6/5/2015, began to have fever that night that resolved 6/9/2015.  States fever ran from 39-40 degrees Celsius.  Took medicine but was not able to sleep well due to fever.  6/8/2015 began to have redness and swelling in arm.  States injection site from a childhood vaccine was also hard and red, which has never happened before.  States both new and old injection sites were painful.  On 6/10/2015 states most recent injection site is hard and painful.  Old injection site is red, painful, swollen.  Denies itching.  States entire upper arm, from shoulder to elbow, feels hard.  States she does not feel feverish today.  Current temperature is 98.2 degrees Fahrenheit.  Upon examination, newest injection site appears asymptomatic, but has small induration noted on palpation.  Site where patient states she had injection as a child is reddened, raised, and feels hard.  Patient winces upon palpation of both sites.  States each day, pain and hardness seems to progress further down arm.  Referred to Dr. and given acetaminophen to take at home and instructed on use.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: 3 by 3 inch rash at injection site, itching at injection site.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives to both arms and hands, itching 1-2 hrs after injection. BENADRYL orally.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Induration with edema surrounding vaccination injection site with TTP no fever.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to an 84 year old female patient. Patient's pertinent medical history and drug reactions/allergies were not reported. The patient was not pregnant. On 06-JUN-2015 the patient was vaccinated with PNEUMOVAX 23 (.5 ml, unspecified frequency, lot # K009105, expiry date: 21-JAN-2016). Concomitant medications were not reported. Reporting pharmacist stated that the patient experienced redness, swelling, irritation and tenderness at the injection site after being vaccinated with PNEUMOVAX 23. No treatment was provided for the adverse events. Outcome of all the events was reported as recovering. Causality assessment was not provided. This is one of the three reports received from the same source (MARRS # 1506USA005494 and MARRS # 1506USA005495). Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to an 54 year old female patient. Patient's pertinent medical history and drug reactions/allergies were not reported. The patient was not pregnant. On 06-JUN-2015 the patient was vaccinated with PNEUMOVAX 23 (.5 ml, unspecified frequency, lot # K009105, expiry date: 21-JAN-2016). Concomitant medications were not reported. Reporting pharmacist stated that the patient experienced redness, swelling, irritation and tenderness at the injection site after being vaccinated with PNEUMOVAX 23. No treatment was provided for the adverse events. Outcome of all the events was reported as recovering. Causality assessment was not provided. This is one of the three reports received from the same source (MARRS # 1506USA005260 and MARRS # 1506USA005495). 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 medical assistant refers to multiple patients of unknown age and gender with no pertinent medical history, drug reactions or allergies reported. On an unknown date, the patients were vaccinated with VARIVAX (dose, lot number and route were not provided) that was stored improperly. No adverse effects were reported. This is one of two cases from the same source. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Blood glucose normal, Cold sweat, Muscle rigidity, Tremor
Clinical narrative: Pt received vaccine and left office. Father reported that when pt entered the car, he had a 3 second episode of rigidity and shaking. Returned to office and was cool and clammy.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Pain in extremity, Peripheral swelling, Rash, Somnolence
Clinical narrative: Rash left arm, fatigue, tiredness, drowsiness, (L) arm pain, swelling.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to an 48 year old female patient. Patient's pertinent medical history and drug reactions/allergies were not reported. The patient was not pregnant. On 06-JUN-2015 the patient was vaccinated with PNEUMOVAX23 (.5 ml, unspecified frequency, lot # K009105, expiry date: 21-JAN-2016). Concomitant medications were not reported. Reporting pharmacist stated that the patient experienced redness, swelling, irritation and tenderness at the injection site after being vaccinated with the PNEUMOVAX23. No treatment was provided for the adverse events. Outcome of all the events was reported as recovering. Causality assessment was not provided. This is one of the three reports received from the same source (MARRS # 1506USA005260 and MARRS # 1506USA005494). Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Joint manipulation, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Severe pain and limited motion of shoulder (same as flu shot).
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Periarthritis, X-ray
Clinical narrative: Severe pain and limited motion of shoulder (same as flu shot).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: 3 by 3 inch rash at injection site.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient start feeling itchy on nose area then developed rash on forehead.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Feeling hot, Swelling
Clinical narrative: Swelling, Redness, Hot, Blistery.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture, Body temperature increased, Culture urine
Clinical narrative: Temperature of 102.2 axillary, treated with Tylenol.
Age: 48.0
Sex: M
Vaccine: MEA
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Headache, joint pain, tiredness, chills, fever, some nausea.
Age: 48.0
Sex: M
Vaccine: MEA
Symptoms: Pyrexia
Clinical narrative: Headache, joint pain, tiredness, chills, fever, some nausea.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Grand Mal Seizure.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Malaise, Pain in extremity
Clinical narrative: X 48 h. after vaccination "felt ill" and arm painful - then red and itchy at injection site -> ice, antihistamine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Warm, tender, red area around vaccine injection site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood sodium normal, Eye movement disorder, Incontinence, Pallor, Syncope
Clinical narrative: Within a few minutes after receiving vaccines, patient turned pale and collapsed with eyes rolled back, no seizure activity. Lasted less than 1 minute. Also lost bladder control. BP 106/75 P 71 O2 Sat 100% Re-check 83/55 90/62
Age: 4.0
Sex: M
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness to left upper arm. OTC BENADRYL and cool compresses.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Redness and warmth with slight induration of left thigh at vaccine site.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pt soreness to arm of injection fever >102. Counsel to place cold compress to area and take TYLENOL for fever. Pt also spoke with doctor.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness
Clinical narrative: Dizziness after vaccine administration.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Red and swollen-ice.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Lethargy
Clinical narrative: Redness at site of injection-onset 6 days later. Lethargy since date of injection-till present (6/4/15-6/10/15).
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender with no pertinent medical history, drug reactions or allergies reported. On an unknown date, the patients were vaccinated with PROQUAD (Merck) (dose, lot number and route were not provided) that was stored improperly. No adverse effects were reported. This is one of two cases from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant concerning to about 6 unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant medication was not provided. The reporter stated that between 21-MAY_2015 and 18-MAY-2015, the aforementioned patients received doses of improperly stored PEDVAXHIB (dose, dose number, route of administration, lot number or expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route not reported). On an unknown date the patient experienced a red, hard rash around the unspecified injection site area described as "it was about 3 inches across the injection area and it was getting larger". Outcome of the event was unknown. Causality assessment was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Electromyogram normal, Hypertrophy, Intervertebral disc protrusion, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shoulder pain ina 46-year-old female patient who received FLUARIX. On 2nd October 2014, the patient received FLUARIX (injection). In October 2014, less than a week after receiving FLUARIX, the patient experienced shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints. On an unknown date, the outcome of the shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints to be related to FLUARIX. Reporter stated an employee received a FLUARIX vaccination on October 2, 2014. He was unsure as to whether the patient received the trivalent or quadrivalent FLUARIX. The employee is experiencing burning, heaviness, and aching in the upper right arm and shoulder. Also she has limited range of motion with the right shoulder. She went to the ER on October 6, 2014 and stated that whoever gave her the vaccine went too high in her arm. The reporter said that the employee described to the ER staff that she has experienced pain since getting the vaccination. She also saw the nurse practitioner on October 8, 2014. She has seen a neurologist but the reporter was not able to provide a date for that appointment. The neurologist was unable to determine the cause of the pain. The employee was prescribed pain medication and the patient has declined physical therapy and wants an MRI and an orthopaedic consult. The reporter did not have the lot number or expiration date for the FLUARIX vaccine. Also, no information as to whether the employee received any other vaccinations at the time of the FLUARIX vaccination. He will have the nurse that provided the immunization call to provide more information. The nurse's information is provided in this adverse event report.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Thyroid disorder, X-ray normal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shoulder pain ina 46-year-old female patient who received FLUARIX. On 2nd October 2014, the patient received FLUARIX (injection). In October 2014, less than a week after receiving FLUARIX, the patient experienced shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints. On an unknown date, the outcome of the shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints to be related to FLUARIX. Reporter stated an employee received a FLUARIX vaccination on October 2, 2014. He was unsure as to whether the patient received the trivalent or quadrivalent FLUARIX. The employee is experiencing burning, heaviness, and aching in the upper right arm and shoulder. Also she has limited range of motion with the right shoulder. She went to the ER on October 6, 2014 and stated that whoever gave her the vaccine went too high in her arm. The reporter said that the employee described to the ER staff that she has experienced pain since getting the vaccination. She also saw the nurse practitioner on October 8, 2014. She has seen a neurologist but the reporter was not able to provide a date for that appointment. The neurologist was unable to determine the cause of the pain. The employee was prescribed pain medication and the patient has declined physical therapy and wants an MRI and an orthopaedic consult. The reporter did not have the lot number or expiration date for the FLUARIX vaccine. Also, no information as to whether the employee received any other vaccinations at the time of the FLUARIX vaccination. He will have the nurse that provided the immunization call to provide more information. The nurse's information is provided in this adverse event report.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Discomfort, Drug administered at inappropriate site, Immediate post-injection reaction, Joint range of motion decreased, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shoulder pain ina 46-year-old female patient who received FLUARIX. On 2nd October 2014, the patient received FLUARIX (injection). In October 2014, less than a week after receiving FLUARIX, the patient experienced shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints. On an unknown date, the outcome of the shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints to be related to FLUARIX. Reporter stated an employee received a FLUARIX vaccination on October 2, 2014. He was unsure as to whether the patient received the trivalent or quadrivalent FLUARIX. The employee is experiencing burning, heaviness, and aching in the upper right arm and shoulder. Also she has limited range of motion with the right shoulder. She went to the ER on October 6, 2014 and stated that whoever gave her the vaccine went too high in her arm. The reporter said that the employee described to the ER staff that she has experienced pain since getting the vaccination. She also saw the nurse practitioner on October 8, 2014. She has seen a neurologist but the reporter was not able to provide a date for that appointment. The neurologist was unable to determine the cause of the pain. The employee was prescribed pain medication and the patient has declined physical therapy and wants an MRI and an orthopaedic consult. The reporter did not have the lot number or expiration date for the FLUARIX vaccine. Also, no information as to whether the employee received any other vaccinations at the time of the FLUARIX vaccination. He will have the nurse that provided the immunization call to provide more information. The nurse's information is provided in this adverse event report.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Pain, X-ray normal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shoulder pain ina 46-year-old female patient who received FLUARIX. On 2nd October 2014, the patient received FLUARIX (injection). In October 2014, less than a week after receiving FLUARIX, the patient experienced shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints. On an unknown date, the outcome of the shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints to be related to FLUARIX. Reporter stated an employee received a FLUARIX vaccination on October 2, 2014. He was unsure as to whether the patient received the trivalent or quadrivalent FLUARIX. The employee is experiencing burning, heaviness, and aching in the upper right arm and shoulder. Also she has limited range of motion with the right shoulder. She went to the ER on October 6, 2014 and stated that whoever gave her the vaccine went too high in her arm. The reporter said that the employee described to the ER staff that she has experienced pain since getting the vaccination. She also saw the nurse practitioner on October 8, 2014. She has seen a neurologist but the reporter was not able to provide a date for that appointment. The neurologist was unable to determine the cause of the pain. The employee was prescribed pain medication and the patient has declined physical therapy and wants an MRI and an orthopaedic consult. The reporter did not have the lot number or expiration date for the FLUARIX vaccine. Also, no information as to whether the employee received any other vaccinations at the time of the FLUARIX vaccination. He will have the nurse that provided the immunization call to provide more information. The nurse's information is provided in this adverse event report.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Electromyogram normal, Hypertrophy, Intervertebral disc protrusion, Nuclear magnetic resonance imaging spinal abnormal, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shoulder pain ina 46-year-old female patient who received FLUARIX. On 2nd October 2014, the patient received FLUARIX (injection). In October 2014, less than a week after receiving FLUARIX, the patient experienced shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints. On an unknown date, the outcome of the shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints to be related to FLUARIX. Reporter stated an employee received a FLUARIX vaccination on October 2, 2014. He was unsure as to whether the patient received the trivalent or quadrivalent FLUARIX. The employee is experiencing burning, heaviness, and aching in the upper right arm and shoulder. Also she has limited range of motion with the right shoulder. She went to the ER on October 6, 2014 and stated that whoever gave her the vaccine went too high in her arm. The reporter said that the employee described to the ER staff that she has experienced pain since getting the vaccination. She also saw the nurse practitioner on October 8, 2014. She has seen a neurologist but the reporter was not able to provide a date for that appointment. The neurologist was unable to determine the cause of the pain. The employee was prescribed pain medication and the patient has declined physical therapy and wants an MRI and an orthopaedic consult. The reporter did not have the lot number or expiration date for the FLUARIX vaccine. Also, no information as to whether the employee received any other vaccinations at the time of the FLUARIX vaccination. He will have the nurse that provided the immunization call to provide more information. The nurse's information is provided in this adverse event report.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased, Limb discomfort, Musculoskeletal pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shoulder pain ina 46-year-old female patient who received FLUARIX. On 2nd October 2014, the patient received FLUARIX (injection). In October 2014, less than a week after receiving FLUARIX, the patient experienced shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints. On an unknown date, the outcome of the shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, heaviness in extremities, joint range of motion decreased and burning sensation in joints to be related to FLUARIX. Reporter stated an employee received a FLUARIX vaccination on October 2, 2014. He was unsure as to whether the patient received the trivalent or quadrivalent FLUARIX. The employee is experiencing burning, heaviness, and aching in the upper right arm and shoulder. Also she has limited range of motion with the right shoulder. She went to the ER on October 6, 2014 and stated that whoever gave her the vaccine went too high in her arm. The reporter said that the employee described to the ER staff that she has experienced pain since getting the vaccination. She also saw the nurse practitioner on October 8, 2014. She has seen a neurologist but the reporter was not able to provide a date for that appointment. The neurologist was unable to determine the cause of the pain. The employee was prescribed pain medication and the patient has declined physical therapy and wants an MRI and an orthopaedic consult. The reporter did not have the lot number or expiration date for the FLUARIX vaccine. Also, no information as to whether the employee received any other vaccinations at the time of the FLUARIX vaccination. He will have the nurse that provided the immunization call to provide more information. The nurse's information is provided in this adverse event report.
Age: 65.0
Sex: F
Vaccine: PNC13, PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a Medical Assistant reporting on behalf of a 65 year old female patient. The patient's pertinent medical history included varicose veins, depression, anxiety and hypercholesterol. The patient had no drug reaction or allergies. Concomitant therapies included CELEXA, FLONASE and pravastatin. On an unknown date, the patient was vaccinated with PNEMOVAX23 (dose was not provided), intramuscular, lot # K0009106, expiration date 25-FEB-2016. On 14-MAY-2014, the patient experienced disability of being able to lift her arm. The patient received FLEXERIL as a treatment of the adverse event. No lab diagnostics studies were performed. The patient sought medical attention by calling the doctor. The outcome of event was reported as recovered on an unspecified date in 2015. The relatedness between event and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13, PPV, PPV
Symptoms: Movement disorder
Clinical narrative: This spontaneous report as received from a Medical Assistant reporting on behalf of a 65 year old female patient. The patient's pertinent medical history included varicose veins, depression, anxiety and hypercholesterol. The patient had no drug reaction or allergies. Concomitant therapies included CELEXA, FLONASE and pravastatin. On an unknown date, the patient was vaccinated with PNEMOVAX23 (dose was not provided), intramuscular, lot # K0009106, expiration date 25-FEB-2016. On 14-MAY-2014, the patient experienced disability of being able to lift her arm. The patient received FLEXERIL as a treatment of the adverse event. No lab diagnostics studies were performed. The patient sought medical attention by calling the doctor. The outcome of event was reported as recovered on an unspecified date in 2015. The relatedness between event and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: On onset was a really bad headache which has been ongoing since then arm pain too and also some numbness in hands and fingers on 06/10/2015.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Computerised tomogram normal, Dyskinesia, Electroencephalogram abnormal, Generalised tonic-clonic seizure
Clinical narrative: Partial seizures (repetitive head turning), progressed to grand mal seizure 12/11/2014, 12/14/2014, 1/10/2015, 1/21/2015, 6/4/2015. DILANTIN effective to control, switch to KEPPRA not effective, addition of VIMPAT effective to control seizures. Missed dose 6/4/2015 caused seizure.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Partial seizures
Clinical narrative: Partial seizures (repetitive head turning), progressed to grand mal seizure 12/11/2014, 12/14/2014, 1/10/2015, 1/21/2015, 6/4/2015. DILANTIN effective to control, switch to KEPPRA not effective, addition of VIMPAT effective to control seizures. Missed dose 6/4/2015 caused seizure.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Activities of daily living impaired, Agitation, Asthenia, Crying
Clinical narrative: Within about an hour after receiving the MMR vaccine my son said that he didn't feel right. He said that something felt really wrong. He suddenly became extremely fatigued and then he began to start crying out of control and act really out of character. He kept repeating that something was not right and that something was seriously wrong. He was very upset and agitated. These symptoms continued for about 4 months to five months everyday following the vaccine. During that time, he was extremely fatigued to the point that he didn't even have the energy to even play. I was very concerned as a parent and contribute it to the vaccine. I am not sure whether or not he has fully recovered from this incident. He has developed sensory integration and dyspraxias.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Dyspraxia, Emotional distress, Fatigue, Feeling abnormal, Sensory integrative dysfunction
Clinical narrative: Within about an hour after receiving the MMR vaccine my son said that he didn't feel right. He said that something felt really wrong. He suddenly became extremely fatigued and then he began to start crying out of control and act really out of character. He kept repeating that something was not right and that something was seriously wrong. He was very upset and agitated. These symptoms continued for about 4 months to five months everyday following the vaccine. During that time, he was extremely fatigued to the point that he didn't even have the energy to even play. I was very concerned as a parent and contribute it to the vaccine. I am not sure whether or not he has fully recovered from this incident. He has developed sensory integration and dyspraxias.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site joint movement impairment, Injection site pain, Metabolic function test normal, Pain in extremity
Clinical narrative: 72 y/o female presents complaining of right arm pain. Received the Prevnar 13 vaccine this morning at 0900 during her yearly physical, tolerated it at that time. About 2 hours after the injection she began having soreness in the right shoulder at the injection site. Pain increased over the next couple of hours to the point that any movement of the shoulder causes severe shooting pains down the arm, she is now unable to forward flex her shoulder due to pain. No difficulties with elbow, wrist, and hand ROM. No numbness or tingling. Received the Pneumovax 23 valent vaccine in 2012 without difficulty and no prior adverse reactions to vaccines.
Age: 0.38
Sex: M
Vaccine: DTAP, PNC13, RV1
Symptoms: Appendicectomy, Colonoscopy, Diverticulectomy, Explorative laparotomy, Intussusception
Clinical narrative: Pt began to vomit on 5/22/15 continued to get worse, pt taken to ED was transferred to hospital. Pt underwent exploratory laparotomy manual reduction of intussusception, Meckel diverticulectomy appendectomy and colonoscopy.
Age: 0.38
Sex: M
Vaccine: DTAP, PNC13, RV1
Symptoms: Vitello-intestinal duct remnant, Vomiting
Clinical narrative: Pt began to vomit on 5/22/15 continued to get worse, pt taken to ED was transferred to hospital. Pt underwent exploratory laparotomy manual reduction of intussusception, Meckel diverticulectomy appendectomy and colonoscopy.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unspecified date in 2014, "approximately one year ago" the patient was vaccinated with the first dose of GARDASIL (route, anatomical location, lot# and expiration date were not reported). On 20-MAY-2015, the patient was vaccinated with the second dose of GARDASIL (anatomical location, lot# and expiration date were not reported), intramuscular. There was no concomitant therapy reported. No adverse event was reported. Additional information is not expected because the reporter did not provided the physician's contact and stated that they do not want any further contact regarding this case.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about concomitant medications, concurrent conditions and medical history provided. On 26-MAY-2015, the patient received an expired dose of PNEUMOVAX 23 0.5 ml (lot # J013555, expiration date 02-MAY-2015) intramuscular. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 01-JUN-2015 the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # K004281, expiration date 22-MAR-2015 (dose, dose number, route and anatomical location were unspecified). Concomitant therapies were not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a multiple unspecified patients, who on an unknown dates were vaccinated with a dose of PEDVAXHIB (dose and route were not reported) (Lot K015462, exp 10-JUL-2017) that had experienced temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.