chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Axillary pain, Chills, Erythema, Headache, Injection site pain
Clinical narrative: Head ache, muscle aches, very sore at site of injection, chills and fever, redness and soreness at arm pit opposite injection site.
Age: 67.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Head ache, muscle aches, very sore at site of injection, chills and fever, redness and soreness at arm pit opposite injection site.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Generalised erythema, Injection site erythema, Injection site pruritus, Injection site urticaria, Pruritus generalised
Clinical narrative: As a staff RN, I received a yearly flu vaccine through occupational health during one of my nightshifts. Approx 15-20 minutes after receiving the vaccine, I began having itching, redness and hives to my upper arms, neck, upper back, chest, and face. Symptoms continued for a couple of hours and eventually resolved after a second dose of 25mg Benadryl by mouth (total of 50mg).
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: As a staff RN, I received a yearly flu vaccine through occupational health during one of my nightshifts. Approx 15-20 minutes after receiving the vaccine, I began having itching, redness and hives to my upper arms, neck, upper back, chest, and face. Symptoms continued for a couple of hours and eventually resolved after a second dose of 25mg Benadryl by mouth (total of 50mg).
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient is getting severe pain in the shoulder/arm where the injection was given. Patient is having difficulty moving/lifting the arm.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal disorder, Pain in extremity
Clinical narrative: Patient is getting severe pain in the shoulder/arm where the injection was given. Patient is having difficulty moving/lifting the arm.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient said her arm was very sore for several days and still is.  She has been unable to do everyday tasks with the arm such as lifting. She is not able to move the arm in full range of motion.  She thinks maybe a tendon was hit by injection?? She said she had a rotator cuff injury in her other arm previously and said that is what her arm feels like now.
Age: 5.0
Sex: M
Vaccine: IPV, MMR, TD, VARCEL
Symptoms: Erythema, Hypersensitivity, Skin warm, Swelling, White blood cell count normal
Clinical narrative: Redness size of baseball on evening of shot following day now is approx. 8inches by 6inches, hot to touch and swelling.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Swelling and pain in the Shoulder join. Injection site looks fine. Took Tylenol, applied ice and then heat because ice wasn't making it feel better. Hurt so bad she went to the ER where they gave her Benadryl, Prednisone, and Norco 5/325mg. Husband brought in RXs later that day for Prednisone and Norco 5/325mg.
Age: 0.36
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Redness around vaccination site.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Swelling
Clinical narrative: Swelling and injection site reaction.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Back pain, Discomfort, Rash
Clinical narrative: Pt called today. Started having some back pain/discomfort 3 days ago. Wife looked and he has a pimply rash on his back. Looks like small pimples. Rash on right side only at this time. Getting increasingly uncomfortable. Has not gone to see a physician yet. Recommended pt keep rash covered (loose t-shirt) at night so wife does not come in contact with. Also watch rash and follow up with MD if worsening pain. Call back to pharmacy if any other questions.
Age: 19.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Swelling face, Swollen tongue, Throat irritation, Urticaria
Clinical narrative: Hives, face swelling, tongue swelling, itchy throat.
Age: 19.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Hives, face swelling, tongue swelling, itchy throat.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Musculoskeletal pain
Clinical narrative: Back shoulder pain.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Headache
Clinical narrative: Pt experienced head (temples) and inner ear throbbing/pulsating without pain. Pt had symptoms starting Saturday and reported it Thursday as sx continued.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Loss of consciousness, Pyrexia
Clinical narrative: Afternoon of flu shot developed chills and high fever. Patient passed out and ambulance called, taken to hospital.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of arthralgia in unspecified number of patients who received FLUARIX QUADRIVALENT. On an unknown date, the patients received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patients experienced arthralgia. On an unknown date, the outcome of the arthralgia was unknown. It was unknown if the reporter considered the arthralgia to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was reported by a nurse via sales representative via call center representative. The reporter when speaking with a sales representative made the general statement that there have been more complaints of arthralgia from unspecified number of patients this year than in the past with the FLUARIX QUADRIVALENT vaccine. The reporter did not note the number of patients that had received the vaccine nor their identification. The representative called to report what little information he had been provided with. The representative tried to get more specific about the patients and the number of patients. He did note that the hospital had purchased 4000 doses of the vaccine.
Age: 54.0
Sex: F
Vaccine: FLU3, HEP, HEPA, TDAP
Symptoms: Anxiety, Chest discomfort, Chest pain
Clinical narrative: Self report by patient of anxiety, chest tightness/pain. Follow up appointment offered to patient but refused. Patient was not seen in our office post vaccine administration.
Age: 35.0
Sex: F
Vaccine: FLUR3
Symptoms: Dyspnoea, Erythema, Immediate post-injection reaction, Rash, Skin warm
Clinical narrative: Immediately after flu vaccination adm., rashes B/L UE were visible, skin red and warm on chest, no resp distress noted. Resp are even and labored.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Immediate post-injection reaction, Swelling
Clinical narrative: Patient stated that redness and swelling were immediate following the vaccination.
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling
Clinical narrative: Lip swelling resolved after a few hours.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Neuralgia, Paraesthesia
Clinical narrative: No issue on day of immunization. Patient returned to pharmacy 3 days post and complained of (L) arm nerve pain, numbness and tingling down arm will follow up 9/29/15.
Age: 1.32
Sex: F
Vaccine: FLU3, HIBV, PNC13
Symptoms: Erythema, Peripheral swelling, Rash, Rash macular
Clinical narrative: 5 min. after vaccines administered mom came out of room and stated child had a rash. Face blotchy and red. (R) arm sl. swollen and red. Blotchiness spread a little to trunk/arm.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Erythema, Fatigue, Pyrexia, Rash
Clinical narrative: The day after vaccine administered rash, redness on lower back with pains, fever 99.5, fatigue. No swelling. (Treatment with steroids).
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site bruising, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: Client called clerk on 9/27/15 c/o of Rt arm hurting and swollen from flu shot. Today 10-1-15 called stating arm is bruised at site (RA), barely moving rt arm without assistance. C/O of pain in rt arm and shoulder area. Applied ice to arm today for several minutes.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Impaired work ability, Paraesthesia oral, Tongue disorder
Clinical narrative: Tongue felt funny-tingly, funny taste, felt thick observed and given BENADRYL 35 mg po symptoms improved after 20 min hard to work.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations
Clinical narrative: September 25, 2015 11:20 AM patient received FLUZONE HD vaccine experienced heart palpitations shortly after received shot.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: C-reactive protein, Culture, Culture urine, Diarrhoea, Full blood count
Clinical narrative: 9/25 pt received vaccine. 9/26 pt febrile. Seen at urgent care 9/27. 9/28 began vomiting with diarrhea. Seen in our office dxd with proteinuria and bilirubin in urine.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Metabolic function test, Proteinuria, Red blood cell sedimentation rate, Urine analysis, Urine bilirubin increased
Clinical narrative: 9/25 pt received vaccine. 9/26 pt febrile. Seen at urgent care 9/27. 9/28 began vomiting with diarrhea. Seen in our office dxd with proteinuria and bilirubin in urine.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Vomiting
Clinical narrative: 9/25 pt received vaccine. 9/26 pt febrile. Seen at urgent care 9/27. 9/28 began vomiting with diarrhea. Seen in our office dxd with proteinuria and bilirubin in urine.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis
Clinical narrative: Patient develop bursitis three days after received the vaccine on 9/25/15.
Age: 84.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Developed a rash 2 inches in size on left arm where PREVNAR was given. Rash felt hot and was swollen. Per patient, using cold compress and ibuprofen. Checkin in 12 hours and hotness and swelling has gone. Getting better. Stil has a rash.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Pt describes symptoms of feeling faint for a day and half after receiving vaccination. Pt called 9/30/15. Followed up with pt 10/1/15 and she reported feeling better; no dizziness.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 24-AUG-2015, the patient was vaccinated with a dose of improperly stored VAQTA, lot # K007791, expiration date 22-AUG-2016 (strength, dose and route of administration were not provided). No adverse effect was reported. This is one of several reports received from the same source. 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 medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-SEP-2015 the patient was vaccinated with a dose of improperly stored PROQUAD 0.5 ml once subcutaneous lot # L023113 and expiry date of 24-DEC-2016. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to patients of unknown age and gender. No medical history and concurrent conditions reported. On an unknown date the patient were inadvertently administered with improperly stored, oral ROTATEQ lot # K020181 exp: 24-JUN-2016 (dose, route, therapy type not reported). No adverse effects reported. The outcome of the events were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to patients of unknown age and gender. No medical history and concurrent conditions reported. On an unknown date the patients were inadvertently administered with improperly stored, M-M- R II (lot # K018990 exp: 15-OCT-2016), (lot # K024038 exp: 26-NOV-2016) (dose, route, therapy type not reported). No adverse effects reported. The outcome of the events were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: This spontaneous report was received from a retired nurse (who was also the patient's wife) and refers to a 68 years old male patient. The patient had a history of bladder cancer in 2011 that was treated with unspecified chemotherapy at an unspecified hospital. While on chemotherapy in 2011 the patient developed an unusual full body rash which was attributed to doxycycline (manufacturer unknown) or omeprazole (manufacturer unknown). On 28-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose, route of administration and anatomical location were not reported). On the same date, the patient was also concomitantly vaccinated with PREVENAR 13. Other concomitant therapies included unspecified blood pressure medicine. On an unknown date in September 2015, the patient developed headache and soreness at the injection site after vaccination. The patient also stated that "it felt like needle went in pretty deep, not under the skin". The patient was not treated for the symptoms he had experienced. No lab diagnostic studies were performed. The outcome of the events was reported as recovering. The patient did not seek medical attention. The relatedness between the events and ZOSTAVAX was not reported. This is one of two reports received from the same reporter and concerning the same patient. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 14-AUG-2015, the patient was vaccinated with a dose of improperly stored VAQTA, lot # K007791, expiration date 22-AUG-2016 (strength, dose and route of administration were not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 25-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL, lot # J010668, expiration date 29-APR-2016 (strength, dose and route of administration were not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 27-AUG-2015, the patient was vaccinated with a dose of improperly stored VAQTA, lot # K007791, expiration date 22-AUG-2016 (strength, dose and route of administration were not provided). No adverse effect was reported. This is one of several report received from the same source. Additionoal information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VAQTA, lot # K007791, expiration date 22-AUG-2016 (strength, dose and route of administration were not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Muscle tightness, Pain in extremity, Pyrexia
Clinical narrative: Reports fever x 2 weeks post injection on 8/31/15. Severe (L) arm pain, decreased ROM, muscle tightness since injection. Was given NSAIDS, ROM activity, physical therapy referral, MRI ordered, she is using massage and chiropractics also. Seeing improvement.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Joint range of motion decreased, Pain
Clinical narrative: Left upper arm/deltoid erythematous and swollen. MOTRIN and BENADRYL (dose per age/wt) given x 24 hours. Erythema and swelling improved with decreased pain and increased ROM. Will continue MOTRIN and BENADRYL x 48 hrs.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Diarrhea.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On 24-SEP-2015 the patient was vaccinated with a dose of TWINRIX (lot number, expiration date, dose and route were not reported). Five years later, on 29-SEP-2015 the patient was vaccinated with a dose of RECOMBIVAX HB (dose and route not reported, lot # reported as L019299 with expiration date 15-APR-2017)). No adverse experience was reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dizziness, Feeling hot
Clinical narrative: Pt. received a Hepatitis A vaccine in (L) deltoid and a Typhoid Vi vaccine in (R) deltoid. After the second vaccine was administered pt. complained of feeling dizzy and warm. Place pt. in a reclined position. Offered pt juice. Pt. stated she had eaten a small breakfast and no lunch. Placed cold pack behind neck, for 10 minutes, instructed pt. to rest an additional 10 minutes was able to stand up without dizziness and walk out of clinic by 2 pm (1400).
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Rash macular
Clinical narrative: Localized macular rash that developed around the Hep A at the site. Generalization to legs and cheeks, no issues breathing.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Within 3 hours of vaccination, mother states her daughter could not feel her legs from knees down - numb. By 24h after vaccination, numbness subsiding but still tingling. By Monday (9-28-15), resolved.
Age: 60.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old female patient with depression. The patient's medical history included headaches. The patient did not have drug reactions/allergies. On 10-SEP-2015 the patient was vaccinated a dose of with ZOSTAVAX (dose, route and lot # were not reported) and a dose of PREVNAR (dose, route and lot # were not reported) at the same location on the same arm. There was no concomitant therapy. Later that same day, the patient developed a rash that extended from the injection site area down to the patient's elbow. The patient went to see the pharmacist and a physician and was given an unspecified antibiotic (manufacturer unspecified). No lab diagnostics studies were performed. At the time of the report, the patient did not recover. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Pt complained of welt larger than silver dollar.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Redness at vaccination site. Rt. upper arm.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The reporter stated that the patient had been receiving every five years (dates unspecified), a dose of PNEUMOVAX23 injection 9doses, administration dates, route and lot # were not provided). Product quality complaint (PQC) was not involved. No adverse effects were reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Foetal disorder, Premature delivery
Clinical narrative: This is a prospective pregnancy case. This 21-year-old female subject was enrolled in a study to detect and described any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during pregnancy or within 28 days preceding conception. The subject received BOOSTRIX (intramuscular) .5 ml on 17th March 2015. The subject's last menstrual period was on 19th August 2014 and estimated date of delivery was 26th May 2015. The subject received BOOSTRIX at week 30 of the pregnancy and during the third trimester of pregnancy. On 17th March 2015, an unknown time after receiving BOOSTRIX, the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the vaccine exposure during pregnancy to be related to BOOSTRIX. Additional details were provided as follows: This was a normal conception. Follow-up information received on 28 April 2015 from nurse: Some of the patient's details were provided. The VAERS details were provided. Follow-up information received on 30 September 2015 form nurse: The subject had no previous pregnancies. 28 days after receiving BOOSTRIX and after 34 weeks of gestation, the subject gave premature birth to a female neonate via vaginal delivery with no apparent congenital anomaly. The neonate weighed 1831 grams (4lbs 1oz) at birth. APGAR scores were 8/9. It was unknown if the reporter considered the live birth to be related to BOOSTRIX>
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Began to have increasing pain swelling and pain (R) deltoid - measured at 10 cm at urgent care. Was placed on antibiotics.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse concerning an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with improperly stored M-M-R II lot # K004949, expiration date 04-APR-2016, (dose, dose number, route and anatomical location were unspecified). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lethargy, Rash
Clinical narrative: Pt had orange size rash, no pain or itching. Pt had headache and lethargy when resolved overnight. Pt w/a f/u w/PCP.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse concerning an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX23 lot # K008409, expiration date 04-MAR-2016, (dose, dose number, route and anatomical location were unspecified). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Benign soft tissue neoplasm, Contusion, Fat necrosis, Mass excision, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from a 67 year old female patient with cataracts and drug hypersensitivity to VIOXX. The patient's medical history included breast cancer and lymphadenectomy of one arm (dates were not specified). On 08-JAN-2014, the patient was vaccinated in the patient's arm where she had the lymphadenectomy with PNEUMOVAX 23 (lot number, expiration date, route of administration and strength were not reported). There was no concomitant medication. On approximately 09-JAN-2014 (reported as "a day or two" after vaccination), the patient noticed that the arm where she was vaccinated was swollen, and it looked bruised as she had a "blue and purple" discoloration of her arm. On 16-JAN-2014, the patient sought medical attention, and the physician put her on an unspecified antibiotic. On an unspecified date (reported as "a few months ago"), the patient felt a lump in the same arm, the lump stayed consistently. Therefore, she sought medical attention and the physician told her she should have it looked at. In September 2015, the patient went to an outpatient facility for surgery and had the lump removed from her arm. The pathology report described the lump as a "benign inflamed fibroid tissue and fat necrosis". At the reporting time, the outcome of peripheral swelling and contusion was reported as recovered on an unspecified date in 2014 (reported as "took about 2 or 3 months before she fully recovered") and benign soft tissue neoplasm was reported as recovered in September 2015. The reporter stated that any physician was sure if the benign soft tissue neoplasm was related to PNEUMOVAX 23. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pathology test, Peripheral swelling, Surgery, Upper extremity mass
Clinical narrative: This spontaneous report was received from a 67 year old female patient with cataracts and drug hypersensitivity to VIOXX. The patient's medical history included breast cancer and lymphadenectomy of one arm (dates were not specified). On 08-JAN-2014, the patient was vaccinated in the patient's arm where she had the lymphadenectomy with PNEUMOVAX 23 (lot number, expiration date, route of administration and strength were not reported). There was no concomitant medication. On approximately 09-JAN-2014 (reported as "a day or two" after vaccination), the patient noticed that the arm where she was vaccinated was swollen, and it looked bruised as she had a "blue and purple" discoloration of her arm. On 16-JAN-2014, the patient sought medical attention, and the physician put her on an unspecified antibiotic. On an unspecified date (reported as "a few months ago"), the patient felt a lump in the same arm, the lump stayed consistently. Therefore, she sought medical attention and the physician told her she should have it looked at. In September 2015, the patient went to an outpatient facility for surgery and had the lump removed from her arm. The pathology report described the lump as a "benign inflamed fibroid tissue and fat necrosis". At the reporting time, the outcome of peripheral swelling and contusion was reported as recovered on an unspecified date in 2014 (reported as "took about 2 or 3 months before she fully recovered") and benign soft tissue neoplasm was reported as recovered in September 2015. The reporter stated that any physician was sure if the benign soft tissue neoplasm was related to PNEUMOVAX 23. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Developed 6 vesicle like lesions on right abdomen 13 days after varicella vaccine administration.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 29-SEP-2015, the patient was inadvertently vaccinated with an expired dose of pediatric VAQTA 25/0.5, lot # J000366 with exp date on 22-AUG-2015, (route was not provided). The nurse did not specify dose in VAQTA. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker/certified medical assistant refers to 4 patients of unknown demographics. Approximately in September 2015 (reported as within the past 2 weeks) the patients were vaccinated with improperly stored ROTATEQ (lot # K023535, expiry date: 22-MAY-2016). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. The case is also related to MARRS# 1510USA000389 (same reporter link). Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker/certified medical assistant refers to a patient of unknown demographics. Approximately in September 2015 (reported as within the past 2 weeks) the patient was vaccinated with improperly stored GARDASIL (lot # K005881, expiry date: 14-JAN-2017). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. The case is also related to MARRS# 1509USA014899 (same reporter link). Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (L.P.N.) refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On 29-SEP-2015, the patients were vaccinated with improperly stored PROQUAD (Merck) injection (lot # L019994, expiry date: 02-DEC-2016, route and site of administration not reported) or VARIVAX (Merck) (captured in MARRS # 1510USA000576). No adverse events were experienced. The outcome of the reported events were unknown. No product quality complaint (PQC) was filed. This is one of two reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Full blood count, Increased tendency to bruise, Platelet count decreased
Clinical narrative: Patient received GARDASIL and MENVEO Tdap 7-27-15. One week later started bruising easily. I saw her 9-1-15. Platelets were 16. They are stable.
Age: 1.02
Sex: M
Vaccine: DTAP
Symptoms: Hyporesponsive to stimuli, Trismus
Clinical narrative: Onset of episodic brief 15-30 sec. repetitive jaw movements with partial opening/closing of mouth within hours of vaccine administration. No obvious change in mental status; decr. responsiveness during episodes otherwise acting normally. No increase in frequency or development of other symptoms over days.
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Irritability, Local swelling, Skin warm
Clinical narrative: Red, hot, swollen 2 in circle, fussiness.
Age: 66.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Discomfort, Hemiparesis
Clinical narrative: 8-24-15 - Hep B - 1st dose. Week after first shot pt. developed pain in left hip and knee and general weakness of that side of body. 9-24-15 - 2nd Hep B - on 9-28-15 pt. woke up with feeling of pressure on right side. Shot given right arm.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness several days after injection swelling and warmness to touch.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (L.P.N.) refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On 29-SEP-2015, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot number L016124, expiry date: 06-MAY-2017, dose, route and site of administration not reported) or PROQUAD (Merck) (captured in MARRS # 1510USA000438). No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. No further information provided. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to patients of unknown age and gender. No medical history and concurrent conditions reported. On an unknown date the patients were inadvertently administered with improperly stored, PEDVAXHIB lot # L002866 exp: 10-NOV-2017 (dose, route, therapy type not reported). No adverse effects reported. The outcome of the events were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Fatigue, Gastric disorder
Clinical narrative: This spontaneous report as received from a consumer (the patient's mother) refers to a 19 year old non-pregnant female patient with depression. Concomitant therapies included LEXAPRO. The patient did not have drug reactions or allergies. On an unknown date the patient was vaccinated with GARDASIL or GARDASIL 9 (lot# and expiration date not reported, 0.5ml, intramuscularly, dose number not reported). The reporter could not confirm which vaccine was used. On an unknown date, the patient experienced hair loss, fatigue and unspecified stomach issues after receiving the vaccine. The patient used an unspecified prescription and over the counter (OTC) antacids to treat her stomach problems and an unspecified steroid lotion and steroid injections for her scalp. The patient discontinued series of the suspect vaccine. The patient sought medical attention by calling an office. The outcome of the adverse events was not reported. The relatedness between the adverse events and the suspect vaccines was not provided. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician assistant student via a company representative referring to an 18 year old male patient. Concurrent conditions, pertinent medical history or concomitant medications were not reported. On an unknown date in 2013 (reported as summer of 2013), the patient was vaccinated with the first dose of GARDASIL (lot#, expiration date, dose, route of administration and frequency were unspecified) and he experienced a rash. Then, on an unspecified date, the patient was vaccinated with a second dose of GARDASIL (lot#, expiration date, dose, route of administration and frequency were unspecified) and he experienced a more severe rash. It was stated that the patient chose to not get his  third dose of GARDASIL because of the described reactions to this vaccine, that there was not intervention to prevent serious criteria (reported as "I did not think so"), that rash was not significant disability or incapacity and that no PQC was involved. At the time of the report, the outcome of rash was reported as recovered on an unknown date. The relatedness of GARDASIL with rash was not reported. Additional information has been requested.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated at the same visit with an unknown dose of PNEUMOVAX 23 (route, lot# and expiry date were not reported) and with an unknown dose of PREVENAR 13 (route, lot# and expiry date were not reported). No adverse effect was reported. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis infective, Extra dose administered, Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to his mother: currently 85 year old female patient with asthma, high blood pressure, eczema and allergy to sulfur. On an unspecified date around May 2015, the patient was received first dose of ZOSTAVAX (dose, frequency and route of administration were not reported). The patient was vaccinated a second time with ZOSTAVAX around August of 2015 because her pharmacy inadvertently gave her ZOSTAVAX again when she was supposed to get a Pneumonia vaccine in August. The reporter also mentioned that his mother developed a "bad infection" in her knee in between the time she had received the two vaccinations of ZOSTAVAX (in approximately 2015). Reporter stated that his mother ended up going to the emergency room to treat the infection but she was not admitted to the hospital. The infection was treated with potent, unspecified antibiotics. Unspecified lab work done every year. The outcome of the knee infection was reported as recovering (the patient was still experienced pain in her knees). Causality assessment was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Painful erection, Urinary tract disorder, Urine analysis normal
Clinical narrative: This spontaneous report was received from a physician and refers to a male patient of unknown age with concurrent conditions of asthma, benign prostatic hyperplasia, gastroesophageal reflux disease, irritable bowel syndrome with diarrhoea, seasonal allergies and hyperlipidaemia. The patient is allergic to unspecified statins, niacin, unspecified sulfa drugs and red yeast rice. The patient's medical history included prostatitis, tinea cruris and fibromyalgia. The physician also reported that the patient has a history of unspecified allergy to unspecified statins (manufacturer unspecified). It was unspecified whether these unspecified products were Merck products. On 09-JUL-2015, the patient was vaccinated with ZOSTAVAX vial of dose 0.65 ml once (lot number, route and site of administration not reported). Concomitant therapies included SINGULAIR, albuterol, omeprazole, AVODART, TYLENOL EXTRA STRENGTH and probiotics (unspecified) (PD-8). The physician reported that within 10 days (on 19-JUL-2015) after vaccination the patient developed generalized burning sensation all over the body. The patient also developed urine dysfunction and painful penile erections in 2015 and the physician felt that this could be related to pre-existing prostatitis. The patient sought for the medical attention and visited the office. On 27-AUG-2015, urinalysis was performed which showed as negative. The patient was treated with CIPRO for the adverse events. The reporter adverse events were not recovered. The causality of the  generalized burning sensation, urine dysfunction and painful penile erections were not reported. No additional information regarding these adverse effects was provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date approximately in 1995 (reported as "20 years ago"), the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (dose, route and site of the administration, lot#, expiry date were not reported) and with a dose of influenza virus vaccine (manufacturer unknown) (dose, route and site of the administration, lot#, expiry date were not reported). On an unknown date approximately in 1995 (reported as "20 years ago"), the patient experienced swelling and a rash at the injection site. The outcome of the events was unknown. The relatedness between the pneumococcal vaccine (manufacturer unknown) and the events was not reported. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 1 year old male patient, without siblings, or any allergy, birth defects, medical conditions or concomitant medications. On 07-AUG-2015 at 11:57 a.m. the patient was vaccinated with the second dose of VARIVAX (Merck) (dose was not reported) (lot # K018959, expiration date 15-OCT-2016) subcutaneous in the right leg, that had been improperly stored. The patient was not ill at the time of the vaccination and did not present any adverse event prior or after the vaccination. This is one of the two cases from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Dyskinesia
Clinical narrative: This spontaneous report was received from an unspecified reporter via a company representatives and refers to a patient of unknown age and gender. No medical history, concurrent conditions or concomitant therapies were reported. On an unknown date, the patient was vaccinated with a second dose of GARDASIL or GARDASIL 9 intramuscular for prevention of HPV (lot #, dose and anatomical location were not reported). It was not confirmed if the patient received GARDASIL or GARDASIL 9. On an unknown date, the patient experienced severe involuntary muscle movements. The outcome of the event was unknown. The relatedness between the event and suspect vaccine was not reported. Additional information is not expected, as no contact details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a male patient of unknown age, who was also a pharmacist. Approximately on an unknown date in 2010 (reported as approximately 5 years ago), the patient was vaccinated with ZOSTAVAX (dose and frequency were unknown) subcutaneously. Concomitant medications were unspecified. Approximately in 2010 (reported as approximately for 1 week after the vaccination), the patient's unspecified arm was swollen. The outcome of the event was reported as recovered/resolved (reported as for 1 week). The causality of the event to ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On an unknown date in 2014, the patient had received ZOSTAVAX (dose, lot # unknown). On 25-SEP-2015 the patient was vaccinated again with ZOSTAVAX (lot # L012477 and expiry 10-JUL-2015). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, Injection site erythema
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown date in 2015 (reported as "between 01-MAY-2015-09-SEP-2015"), the patients were vaccinated with doses of improperly stored M-M-R II (dose and route were not reported) lot # K024824, expiration date 02-DEC-2016 and lot # K007107 expiration date 16-JUN-2016. On an unknown date in 2015 (reported as "between 01-MAY-2015-09-SEP-2015"), the patients experienced redness at the injection site. There was no treatment given for adverse event. The outcome of redness at the injection site was unknown. The relatedness between redness at the injection site and suspected therapy was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, Injection site erythema
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified patients of unknown age and gender. The patient' medical history and current conditions were not provided. on an unknown date in 2015 (reported as "between 01-MAY-2015-09-SEP-2015"), the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (dose and route were not reported) lot # K018960, expiration date 13-MAY-2017 and lot # K018960 expiration date 15-OCT-2016. On an unknown date in 2015 (reported as "between 01-MAY-2015"), the patients experienced redness at the injection site. There was no treatment given for adverse event. The outcome of redness at the injection site was unknown. The relatedness between redness at the injection site and suspected therapy was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: This unsolicited case was received on 30 July 2010 via a search on the VAERS database, under reference number (VAERS ID 384168). A 20-year-old male patient received the following vaccinations on 22 March 2010: ACAM2000, lot number VV04-003-A, TYPHIM VI, lot number B1026-2, BIOTHRAX, lot number FAV230. On 31 March 2010, nine days post vaccination, the patient experienced a macular papular rash on his face, torso, bilateral arms and back which was also reported as "going down both legs". The patient also experienced a low grade fever the day before (onset also reported as 31 March 2010). Corrective treatments and recovery status were not reported. Follow up information received from a healthcare professional on 10-Aug-2015 via a third party query tool search on the VAERS database. The VAERS ID reference number for this case is was 384168. The patient had received first dose of ACAM2000 vaccine (manufacturer: Sanofi Pasteur Biologics Co.) via intradermal route in the left arm, first dose of BIOTHRAX vaccine (manufacturer: Emergent) via intramuscular route in the right arm and first dose of TYPHIM VI vaccine (manufacturer: Sanofi Pasteur SA) via intramuscular route in the right arm. It was reported that patient was a health reserved component patient and had no medical history. The other medications and prior vaccinations were not reported. Patient required emergency visit for the events. Laboratory investigations and corrective treatment was not provided. At the time of this report, outcome of the event was not reported. Documents held by sender: None.