chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: PROQUAD vaccine was administered to 13 year old child, appropriate age was suppose to be at 12 years of age. Prior to administering vaccine, I asked the age, mother stated that she is 12 years old. Later I checked the medical record and discovered patient is actually 13 years of age. Action plan repeat MMR and Varicella vaccine administration as separate doses.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Asthenia, Crying, Cytogenetic analysis, Electroencephalogram, Laboratory test
Clinical narrative: My husband and I went to vaccine our baby boy 2 months old, after vaccination he start to sleep and start crying for his milk very slow, when we try to wake up him, he can't. We make different things and he wake up. Then he start to present episodes of stare and loss of muscle strength, for 7 times. His visiting a neurologist, gastroenterologist and now it's going to a geneticist.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Metabolic function test, Nuclear magnetic resonance imaging, Somnolence, Staring
Clinical narrative: My husband and I went to vaccine our baby boy 2 months old, after vaccination he start to sleep and start crying for his milk very slow, when we try to wake up him, he can't. We make different things and he wake up. Then he start to present episodes of stare and loss of muscle strength, for 7 times. His visiting a neurologist, gastroenterologist and now it's going to a geneticist.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture, Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: I was admitted overnight 1/27/2018 to 1/28/2018 and underwent an I&D for a vulvar abscess 1/28/2018 AM. At time of discharge, I was offered the pneumonia shot. I consented and received a subcutaneous injection to my right posterior upper arm. The nurse pinched the skin lightly about halfway between my shoulder and elbow (posterior upper arm) over my triceps muscle. She then injected the vaccine horizontally starting cephalad and moving caudally (parallel to triceps muscle in subcutaneous fat tissue). I have never had a pneumonia shot before, so I was not familiar with the process of injection. I was discharged home. As the day progressed, my arm became more and more tender. By 7:00 PM, I had a tender palpable lump about the size of a quarter at the injection site. Upon awakening AM 1/29/2018, the lump had increased in size to about a small plum, skin became reddened and warm to touch. Pain was increased, as well. I was awakened overnight 1/29/2018 to 1/30/2018 by moderately severe pain. My posterior right upper arm was angry red and the hardened lump was about the size of a tennis ball. I went to work 1/30/2018, I was in significant pain. I received a post-discharge follow-up call from hospital. I told the nurse that my vulvar area was much improved with very little pain or discomfort; however, I told her about my pneumonia injection site reaction. She spoke with a physician in my gynecologist's office, I was told to trace the outline of the reddened area with a sharpie or pen and if the size of the reaction increased, I was to go to the ER if redness spread. It did, I went to the ER that evening and was given oral antibiotics (BACTRIM and clindamycin) as well as a gluteal injection of an antibiotic (I think clindamycin). I was discharged home and instructed to return if redness continued to spread. It did spread, continued to experience high level of pain. I returned to the ER and was given IV vancomycin then IV clindamycin for approximately 2.5 days. I was told by staff and pharmacist that the vaccination should have been administered intramuscularly, not subcutaneously. Sent home on oral clindamycin.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Laboratory test, Middle insomnia, Pain
Clinical narrative: I was admitted overnight 1/27/2018 to 1/28/2018 and underwent an I&D for a vulvar abscess 1/28/2018 AM. At time of discharge, I was offered the pneumonia shot. I consented and received a subcutaneous injection to my right posterior upper arm. The nurse pinched the skin lightly about halfway between my shoulder and elbow (posterior upper arm) over my triceps muscle. She then injected the vaccine horizontally starting cephalad and moving caudally (parallel to triceps muscle in subcutaneous fat tissue). I have never had a pneumonia shot before, so I was not familiar with the process of injection. I was discharged home. As the day progressed, my arm became more and more tender. By 7:00 PM, I had a tender palpable lump about the size of a quarter at the injection site. Upon awakening AM 1/29/2018, the lump had increased in size to about a small plum, skin became reddened and warm to touch. Pain was increased, as well. I was awakened overnight 1/29/2018 to 1/30/2018 by moderately severe pain. My posterior right upper arm was angry red and the hardened lump was about the size of a tennis ball. I went to work 1/30/2018, I was in significant pain. I received a post-discharge follow-up call from hospital. I told the nurse that my vulvar area was much improved with very little pain or discomfort; however, I told her about my pneumonia injection site reaction. She spoke with a physician in my gynecologist's office, I was told to trace the outline of the reddened area with a sharpie or pen and if the size of the reaction increased, I was to go to the ER if redness spread. It did, I went to the ER that evening and was given oral antibiotics (BACTRIM and clindamycin) as well as a gluteal injection of an antibiotic (I think clindamycin). I was discharged home and instructed to return if redness continued to spread. It did spread, continued to experience high level of pain. I returned to the ER and was given IV vancomycin then IV clindamycin for approximately 2.5 days. I was told by staff and pharmacist that the vaccination should have been administered intramuscularly, not subcutaneously. Sent home on oral clindamycin.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness, Ultrasound scan
Clinical narrative: I was admitted overnight 1/27/2018 to 1/28/2018 and underwent an I&D for a vulvar abscess 1/28/2018 AM. At time of discharge, I was offered the pneumonia shot. I consented and received a subcutaneous injection to my right posterior upper arm. The nurse pinched the skin lightly about halfway between my shoulder and elbow (posterior upper arm) over my triceps muscle. She then injected the vaccine horizontally starting cephalad and moving caudally (parallel to triceps muscle in subcutaneous fat tissue). I have never had a pneumonia shot before, so I was not familiar with the process of injection. I was discharged home. As the day progressed, my arm became more and more tender. By 7:00 PM, I had a tender palpable lump about the size of a quarter at the injection site. Upon awakening AM 1/29/2018, the lump had increased in size to about a small plum, skin became reddened and warm to touch. Pain was increased, as well. I was awakened overnight 1/29/2018 to 1/30/2018 by moderately severe pain. My posterior right upper arm was angry red and the hardened lump was about the size of a tennis ball. I went to work 1/30/2018, I was in significant pain. I received a post-discharge follow-up call from hospital. I told the nurse that my vulvar area was much improved with very little pain or discomfort; however, I told her about my pneumonia injection site reaction. She spoke with a physician in my gynecologist's office, I was told to trace the outline of the reddened area with a sharpie or pen and if the size of the reaction increased, I was to go to the ER if redness spread. It did, I went to the ER that evening and was given oral antibiotics (BACTRIM and clindamycin) as well as a gluteal injection of an antibiotic (I think clindamycin). I was discharged home and instructed to return if redness continued to spread. It did spread, continued to experience high level of pain. I returned to the ER and was given IV vancomycin then IV clindamycin for approximately 2.5 days. I was told by staff and pharmacist that the vaccination should have been administered intramuscularly, not subcutaneously. Sent home on oral clindamycin.
Sex: M
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report as received from a lawyer refers to a male patient of unknown age. The patient experienced mild diverticulosis, constipation, hiatal hernia, unexplained weight loss and drug administration error while on therapy with BENICAR (case # {1709USA014984}). There was no information about the patient's concurrent conditions and concomitant therapies provided. On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced allergy to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). The outcome the event was not provided. The reporter considered the event to be related to suspected therapy. This is one of the several reports received from the same reporter concerning the same patient. Sender's Comments: US-009507513-1709USA014984.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Rash maculo-papular
Clinical narrative: PT STARTED GETTING INCREASED REDNESS AND PRURITUS OVER SITE WHERE VARICELLA WAS INJECTED. HE CAME THE NEXT MORNING TO CLINIC, AND HE HAD A MACULOPAPULAR RASH ON RIGHT THIGH WHERE THE VACCINE WAS INJECTED. HE WAS INSTRUCTED TO TAKE BENADRYL 4 TIMES DAILY UNTIL CLEAR.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: Patient experienced red, soreness, tenderness, and warm to touch at sight of injection. These symptoms started the evening of 2/24. Patient also developed nausea and diarrhea starting on 2/27 and continued this morning. Patient was recommended to follow-up with PCP.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Product preparation error
Clinical narrative: Patient was given only the diluent portion of the ROTARIX vaccine.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: The patient was age 3 days, received a Hepatitis B vaccine, UNKNOWN LOT, UNKNOWN MAKE since it was in the hospital and less than 5 hours later he developed hives on both legs, lower back and his groin lasting about 4 days.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Activated partial thromboplastin time normal, Full blood count normal, Henoch-Schonlein purpura, International normalised ratio normal, Prothrombin time normal
Clinical narrative: Henoch Schonlein purpura starting 1 day after influenza vaccine given.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Urine analysis normal
Clinical narrative: Henoch Schonlein purpura starting 1 day after influenza vaccine given.
Age: 1.17
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Febrile convulsion, Influenza virus test negative, Pyrexia
Clinical narrative: ER 1 day later with high fever and febrile seizure. Negative for flu.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Culture urine negative, Cyanosis, Pyrexia, Respiratory viral panel, Urine analysis normal
Clinical narrative: Fever 103 and lips turning blue which prompted 2 ER visits.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Back pain, Chest pain, Hyperhidrosis, Nausea
Clinical narrative: 30 minutes post vaccination complained of chest pain which did not resolve after 15 minutes of rest. Reported having anxiety attack approximately 3.5 hours prior to vaccination and taking BENADRYL. Reported feeling this event was another anxiety attack initially. Reported pain 10/10 to epigastric region and back, sweating, nausea, with history of enlarged heart and family history of cardiac issues.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Fever, rash 1 week after vaccination rash resolved for 24-48 hours then came back as gives-like rash.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse and refers to a currently 18 year old female patient. There was no concurrent conditions or medical history and it was unknown if the patient had concomitant therapies. On 26-JAN-2018, the patient was vaccinated with her third dose of GARDASIL 9 (concentration, dose, route and anatomical place of vaccination were not reported), with a lot # N021733 and expiration date of 01-FEB-2020, for prophylaxis. On 27-JAN-2018, an urine and blood test confirmed that the patient was pregnant; it was unknown if the patient received any kind of treatment or if she sought medical attention. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known. The pregnancy outcome was pending.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report refers to a 20 year old female patient. Patient's concomitant medications were not reported. The patient's medical history included allergy to codeine. On an unknown date in December 2017, the patient was vaccinated with VARIVAX (dose, frequency, lot number and expiry date not reported), intramuscularly (product use issue) reconstituted with sterile diluent (MERCK) for prophylaxis. The patient was determined to be pregnant on 23-FEB-2018 via urine human chorionic gonadotropin (HCG) test. Nurse reported that gestation age was determined to be 13 weeks and 6 days. Last menstrual period (LMP) was estimated as 18-NOV-2017 and estimated date of delivery (EDD) was 25-AUG-2018. The pregnancy outcome was unknown. No adverse effects were reported. No further information was provided. Product quality complaint was not present.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II lot number M045401 with expiration date on 14-NOV-2018, for prophylaxis (dose, route of administration and anatomical location were not reported) with a well storage sterile diluent. The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F (53.5°F) for 2 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. Sender's Comments: US-009507513-1802USA013807: US-009507513-1802USA013806.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II lot number N009172 with expiration date on 20-MAR-2019, for prophylaxis (dose, route of administration and anatomical location were not reported) administrated with a well storage sterile diluent. The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F (53.5°F) for 2 hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. Sender's Comments: US-009507513-1802USA013807: US-009507513-1802USA013718.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot number N010707 with expiration date on 03-DEC-2018, for prophylaxis (dose was not reported). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F (53.5°F) for 2 hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. Sender's Comments: US-009507513-1802USA013718: US-009507513-1802USA013806.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, IPV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 10.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMRV
Symptoms: Feeling abnormal, Gait disturbance, Slow response to stimuli, Slow speech
Clinical narrative: Walking asymmetry, as if unsteady, slow to speak, foggy demeanor/slow response for 36 hr.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient described a 4 inch ring of swelling and redness around the lower left side of her left arm corresponding to PNEUMOVAX 23 site 2 shots on left side.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination site pain
Clinical narrative: Severe pain at vaccination site from 9-22-15 through 9-25-15. Applied ice pack and took Extra Strength Acetaminophen. Moderate pain began 9-21-15. Pain varied back and forth between moderate and mild. Moderate pain June 2016. Pain for 9 months! Moderate pain in May 2016.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Urticaria
Clinical narrative: Rash/Hives covering most of body. Admin 2/1/18, reported adverse RXN 2/9/18.
Age: 1.5
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: On the afternoon of the immunization, patient started to have a severe headache and sore arm. The next morning, the muscle where the immunization was given was tender to touch, warm, and red.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: On the afternoon of the immunization, patient started to have a severe headache and sore arm. The next morning, the muscle where the immunization was given was tender to touch, warm, and red.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Wrong drug administered
Clinical narrative: No adverse event. Pt was given BEXSERO instead of TRUMENBA as a second dose.
Age: 84.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: Persistent arm pain (left arm).
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash, Tremor
Clinical narrative: Very bad shakes, fever, rash, arm still hurts, doesn't want 2nd dose.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Administered in subcutaneous tissue instead of intramuscular. Larger round, red, itchy, hot area of skin at injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Administered in subcutaneous tissue instead of intramuscular. Larger round, red, itchy, hot area of skin at injection site.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient developed rash, soreness, swelling around the injection site later on that day. Patient describes that it does not seem to be improving 48 hours after the injection.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed rash, soreness, swelling around the injection site later on that day. Patient describes that it does not seem to be improving 48 hours after the injection.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Hypersensitivity, Injection site erythema, Injection site nodule, Injection site pain, Pain in extremity
Clinical narrative: Less than 12 hours after administering shot patients arm became sore to touch and red on injection site. Also, had a knot under the skin. By the 02/21/2018 mom called to report that the entire arm was hurting, it felt "heavier" and the redness had spread and the most part of his upper arm and the knot under his arm was larger. We recommended for patient to ice his arm, taking TYLENOL and to also take BENADRYL for the allergic reaction. By 2/23/2018 all affects from medication had resolved.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient complained of redness around injection site on the arm that PREVNAR was injected in. She said it was a little itchy at first and then the redness started. She presented to pharmacy to show us. Her arm is red from lower shoulder and half way down her upper arm. Very red.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Acupuncture, Chiropractic, Intervertebral disc protrusion, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: I felt nauseous after the injection and had pain in my arm, neck and shoulder for several days. I had a neck MRI on 4/3/2017 which showed a bulging disc. After physical therapy, the neck pain subsided somewhat but the shoulder continued to hurt. I saw a sports med doctor and was diagnosed with "frozen shoulder". X-rays showed no evidence of arthritis. I went to physical therapy for 7 months and saw improvement. After more than a year, I still have some shoulder pain and less range of motion than is normal. I am no longer receiving physical therapy but do have a lasting effect. I have also tried chiropractic care, massage and acupuncture.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Neck pain, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging neck, Pain in extremity
Clinical narrative: I felt nauseous after the injection and had pain in my arm, neck and shoulder for several days. I had a neck MRI on 4/3/2017 which showed a bulging disc. After physical therapy, the neck pain subsided somewhat but the shoulder continued to hurt. I saw a sports med doctor and was diagnosed with "frozen shoulder". X-rays showed no evidence of arthritis. I went to physical therapy for 7 months and saw improvement. After more than a year, I still have some shoulder pain and less range of motion than is normal. I am no longer receiving physical therapy but do have a lasting effect. I have also tried chiropractic care, massage and acupuncture.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Periarthritis, X-ray limb normal
Clinical narrative: I felt nauseous after the injection and had pain in my arm, neck and shoulder for several days. I had a neck MRI on 4/3/2017 which showed a bulging disc. After physical therapy, the neck pain subsided somewhat but the shoulder continued to hurt. I saw a sports med doctor and was diagnosed with "frozen shoulder". X-rays showed no evidence of arthritis. I went to physical therapy for 7 months and saw improvement. After more than a year, I still have some shoulder pain and less range of motion than is normal. I am no longer receiving physical therapy but do have a lasting effect. I have also tried chiropractic care, massage and acupuncture.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Injection site erythema, Pain in extremity, Pruritus
Clinical narrative: Pt presented with pain in arm from vaccine. Itching, redness, warm, headache on one side of head. Red area 8 in. in width, and 5 in length below the injection site. Pain started 8 hours after injection. Tx: pt was given prednisone, and she will be monitored.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Pt presented with pain in arm from vaccine. Itching, redness, warm, headache on one side of head. Red area 8 in. in width, and 5 in length below the injection site. Pain started 8 hours after injection. Tx: pt was given prednisone, and she will be monitored.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: She was seen on 2.23.2018 and given PREVNAR 13. Initially had some pain at site of infection but yesterday, she noticed red bumps in area and this morning larger area involved. Tenderness with some pruritus. Did have T 99 when she had PREVNAR but no further fevers/chills. No CP, SOB. No tongue swelling. Tx: prednisone, betamethasone topical cream.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Heart rate increased, Hypersomnia, Myalgia
Clinical narrative: Immune response that included dizziness, severe headache, muscle pains, accelerated heart rate for a short burst, sleeping for 24 hours with brief times of being awake. 36 hours after the vaccination, symptoms subsided.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Heart rate decreased, Lethargy, Pain in extremity, Pallor
Clinical narrative: After receiving vaccines at about 4:25, mother walked client down hall to bathroom. He ambulated without difficulty. After using the bathroom, mom came back down the hall with child about 4:30 and he was pale and lethargic. He was taken to a clinic room and laid down on a bed. He then vomited. Heart rate was slower than when taken earlier, and we were unable to hear his BP. He stated he felt "sleepy". Although lethargic, he did not lose consciousness. EMS was called about 4:35 and he was transported to the hospital ER about 4:50. After examination by the ER doctor, he was discharged home. I spoke with his mother about 3:50 today and she states his arms are sore, but he is feeling better today.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Somnolence, Vomiting
Clinical narrative: After receiving vaccines at about 4:25, mother walked client down hall to bathroom. He ambulated without difficulty. After using the bathroom, mom came back down the hall with child about 4:30 and he was pale and lethargic. He was taken to a clinic room and laid down on a bed. He then vomited. Heart rate was slower than when taken earlier, and we were unable to hear his BP. He stated he felt "sleepy". Although lethargic, he did not lose consciousness. EMS was called about 4:35 and he was transported to the hospital ER about 4:50. After examination by the ER doctor, he was discharged home. I spoke with his mother about 3:50 today and she states his arms are sore, but he is feeling better today.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Joint range of motion decreased, Pain in extremity, Vaccination complication
Clinical narrative: Patient called the pharmacy to report adverse reaction to administered vaccine. Vaccine was administered on Thursday. Patient reported that Friday morning she woke with a "very sore" arm that had limited range of motion and was "extremely painful" during the days following vaccine administration. Patient said it was not tender to the touch but has been sore. It showed slight improvement by Saturday afternoon and had improved more as of Tuesday. All symptoms indicate typical injection site reaction.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Mobility decreased
Clinical narrative: Patient described extreme dizziness 2 days after the vaccine. She stated she could not get up to stand.  She said this lasted for 2 days.
Sex: F
Vaccine: HEPA, HPV9, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of female patients of unknown age. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with ROTATEQ per oral, lot # N010709 with expiration date 05-DEC-2018; GARDASIL 9 (route of administration was not reported) lot # N017686 with expiration date 02-DEC-2020, lot # M031557 with expiration date 07-APR-2019, lot # reported as M021407 with expiration date 30-APR-2018, and lot # M024261 with expiration date 30-JUL-2018; PNEUMOVAX 23 (route of administration was not reported) lot # N014946 with expiration date 01-FEB-2019 and lot # N011491 with expiration date 04-NOV-2018; and VAQTA (route of administration was not reported) lot # N026997 with expiration date 10-NOV-2018 and lot # N017094 with expiration date 31-AUG-2018; all for prophylaxis. It was also reported that the patients were administered with improperly stored NUVARING vaginally, lot # N024432 with expiration date 30-SEP-2020 and lot # 0000690070 with expiration date 31-JUN-2020 (dose, frequency and indication were not reported). No adverse effects were reported. It was reported that the vaccines were exposed to a temperature of 78 Fahrenheit degrees or warmer and the NUVARING to a temperature of 79.1 Fahrenheit degrees; all products for 6 hours and 31 minutes. A previous temperature excursion was reported for all vaccines with a temperature between 47 to 77 Fahrenheit degrees for 15 hours and 34 minutes. Additionally, a previous excursion for NUVARING was reported with a temperature of 75.2 Fahrenheit degrees for 5 hours and 34 minutes. Lot number M021407 is an invalid lot number for GARDASIL 9.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Parents state that child developed a rash to both upper legs that lasted for about 2 weeks. The rash didn't seem to bother him. Just red and raised. Did not happen at the 2 month vaccine visit.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Red maculopapular rash trunk and UE. Clearing central B UE around vaccination sites. Cetirizine HCl 10mg Tablet Take 1 tablet(s) by mouth daily #10 (Ten) tablet(s) Refills: 0, Diphenhydramine HCl 25mg Tablet 1 po TID prn itching/rash #15 (Fifteen) tablet(s) Refills: 0, Triamcinolone Acetonide 0.1% Cream apply to affected skin BID; avoid face #15 (Fifteen) gm Refills: 0, Famotidine 10mg Tablet 1 po BID #14 (Fourteen) tablet(s) Refills: 0.
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Back pain, Haemorrhage, Injection site pain, Pain in extremity
Clinical narrative: Patient reports feeling pain in his upper right arm since shortly after being given the intramuscular shot of SHINGRIX. He received SHINGRIX in the right arm where he reports pain and FLUZONE QUADRIVALENT in the left arm intramuscularly but only feels pain in the right. At the time of the injection the arm that received SHINGRIX bleed more than the arm receiving FLUZONE which did not bleed at all. It is February 28th 2018 at the time this event is being reported. Patient reported taking tramadol which he has for back pain and his back pain was eased but his arm continued to ache. He is in more pain now than he was on the first day of the shot.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Foetal death
Clinical narrative: Fetal Demise 3 days after receiving seasonal influenza vaccine at 10 weeks pregnant.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Starting out with sore arm where injection was- which was normal- then gradually the weakness and pain in arm got worse and now after 4 months has graduated to severe pain when using right arm- lifting my arm or using arm muscles at all causes pain and weakness in the exact spot of the injection-upper right arm.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Soreness and redness at injection site shortly after injection, persisting on day 3. Onset of fever/chills 8-9 hours after injection, interfered w/sleep, temp of 101 measured 8-9 hours later, responded to TYLENOL/ADVIL. Fatigue x ~24h.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Sleep disorder
Clinical narrative: Soreness and redness at injection site shortly after injection, persisting on day 3. Onset of fever/chills 8-9 hours after injection, interfered w/sleep, temp of 101 measured 8-9 hours later, responded to TYLENOL/ADVIL. Fatigue x ~24h.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: Email from patient today: "I just wanted to let you know I had a terrible reaction to the shingles vaccine I received. I had horrible nausea, fever, chills, and my arms, neck, shoulders and back were clenched and totally locked up so that my arms were behind me and my head was pulled back. Today, the nausea, fever and chills are gone but I feel like I was hit by a truck, my entire body aches. I would greatly appreciate it if you report this reaction to the necessary parties (drug manufacturer and/or CDC). If that is not something you do, please let me know and I will look into it."
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Posture abnormal, Pyrexia
Clinical narrative: Email from patient today: "I just wanted to let you know I had a terrible reaction to the shingles vaccine I received. I had horrible nausea, fever, chills, and my arms, neck, shoulders and back were clenched and totally locked up so that my arms were behind me and my head was pulled back. Today, the nausea, fever and chills are gone but I feel like I was hit by a truck, my entire body aches. I would greatly appreciate it if you report this reaction to the necessary parties (drug manufacturer and/or CDC). If that is not something you do, please let me know and I will look into it."
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site irritation
Clinical narrative: Patient stop by to pharmacy to let us know that she had slight irritated skin at the site of injection.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Fatigue, Malaise, Vomiting
Clinical narrative: Vomiting, Diarrhea, Exhaustion and general Malaise.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Allergy test positive, Angioedema, Epinephrine
Clinical narrative: Have been having frequent episodes of angioedema after random foods and events. Had allergy testing and only allergic to shellfish and oysters, avoided all of these and had two 911 ambulance transports, plus numerous EPIPEN administrations since shot.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angioedema
Clinical narrative: Have been having frequent episodes of angioedema after random foods and events. Had allergy testing and only allergic to shellfish and oysters, avoided all of these and had two 911 ambulance transports, plus numerous EPIPEN administrations since shot.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Administration site swelling, Injection site erythema, Injection site warmth
Clinical narrative: Approx. 2 hours after vaccination the administration site became red and swollen. At approximately 24 hours the redness and swelling had extended to the elbow. Pt reports warmth as well. No anaphylactic symptoms present. Advised pt to seek medical care if swelling continues to progress down the arm or if she develops any difficulty breathing or other symptoms of anaphylaxis.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Nausea, Peripheral swelling
Clinical narrative: Patient called later on the evening he received vaccination. Stated that his arm was very painful and red at injection site. Told him to ice it and call me back next day to let me know if any worse. He called next day and said pain was diminished but he had experienced chills and nausea that did go away but his arm was swelled up down to elbow and skin was very saggy. Told him if no improvement by next day or if worse to go to ER/doctor to have it checked out.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient woke up in the middle of the night and said her arm was painful and the pain moved up to her neck and she felt like her whole body ached, like the flu. She took ibuprofen 200mg and went to sleep. Felt better in the morning, but then felt the same later in the day and took another ibuprofen 200mg. She felt better and is feeling okay now, more than 24 hours later.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Patient called in on Sunday Feb 25,2018 and said her arm had a small red area about 2 inches in size. I told her to draw a mark around it and if the red started going outside the mark she should call her doctor or go to ER. She came in the next morning and I looked it was much larger and going down her arm. She went to physician assistant and she was given BENADRYL 25mg capsules and CIPRO 500 mg twice a day. It is now clearing up.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Swelling
Clinical narrative: PATIENT REPORTED TO THE PHARMACY ABOUT 20 MINUTES AFTER THE VACCINE WITH COMPLAINTS OF ITCHING AND SWELLING. THE PATIENT WAS RECOMMENDED AND RECEIVED ONE DOSE OF 25 MG DIPHENHYDRAMINE AND WAS MONITORED FOR 15 MINUTES. PATIENT DENIED COLD PACK. PATIENT WAS COUNSELED ON S/S OF ANAPHYLAXIS AND WAS INSTRUCTED TO CALL 911 IF THE SYMPTOMS SHOWED UP. PATIENT WAS RELEASED AFTER 15 MINUTES OF MONITORING.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Fall, Muscular weakness
Clinical narrative: Reports experiencing rubbery arms and legs and fell off the toilet onto the bathroom floor on his chest later in the evening after being given PREVENAR 13 in clinic on May 9, 2017. Patient refused to seek medical evaluation for fall.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 21st February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st February 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and injection site erythema. On an unknown date, the outcome of the pain in arm and injection site erythema were not recovered/not resolved. The reporter considered the pain in arm and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The circumference of the arm redness was larger than the size of a can of soup. The patient was concerned about the arm redness because, her husband also received the vaccine on the same day and did not experienced arm redness. The call was transferred to the medical information for discussion.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020. On 19th February 2018, the patient received SHINGRIX (intramuscular). .5 ml. On 21st February 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, rash and swelling arm. On an unknown date, the outcome of the pain in arm, rash and swelling arm were not recovered/not resolved. The reporter considered the pain in arm and swelling arm to be possibly related to SHINGRIX. The reporter considered the rash to be probably related to SHINGRIX. Additional information was provided as follows: The patient received SHINGRIX on the left arm. Concomitant medication was unknown. The patient experienced rash, swelling and pain in his left arm. The pharmacist reported that the events had started on Monday when she gave him a SHINGRIX injection and they had continued. The healthcare professional's call was transferred to Medical Information System for discussion on events. Only documented information was asked.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a male patient who received SHINGRIX. On 15th February 2018, the patient received SHINGRIX. On 15th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site tenderness. On 21st February 2018, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site tenderness, injection site swelling, injection site erythema, injection site warmth and injection site induration were unknown. It was unknown if the reporter considered the injection site tenderness, injection site swelling, injection site erythema, injection site warmth and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX shot on the left arm at pharmacy on Thursday evening, and had very little issues and almost no pain in the shot area unless pressed. On the date of reporting, the patient noticed the area of the shot was swollen to a little degree and there was large area about 3 inches high by 5 inches on the surface of the left arm that had some redness and warm to the touch. On 21st February 2018, 6 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site induration. The muscle tissue under this red area was hard compared to the surrounding tissues. The patient had no concern at the reporting point but was just wondering if this swelling and firmness of the muscle tissue was a known side effect of the shot. The patient would keep an eye on the area and advise pharmacist of this effect.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 59-year-old male patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). On 19th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th February 2018, 1 days after receiving SHINGRIX, the patient experienced fever, general body pain and fatigue. On an unknown date, the outcome of the fever, general body pain and fatigue were unchanged. The reporter considered the fever, general body pain and fatigue to be possibly related to SHINGRIX. Additional information was reported as follows: The other healthcare professional reported that the patient did not have any other symptoms such as nasal congestion or cough, so it was possible that the events had occurred because of the vaccine.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Computerised tomogram normal, Dizziness, Ear injury, Head injury
Clinical narrative: Patient fainted at home 2 hours after vaccine and hit her head and ear. She had a CT scan in ER that was negative but since then has presented to ER and primary care with lightheadedness, dizziness, weakness.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient fainted at home 2 hours after vaccine and hit her head and ear. She had a CT scan in ER that was negative but since then has presented to ER and primary care with lightheadedness, dizziness, weakness.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope, Urinary incontinence
Clinical narrative: Patient had a fainting episode and urinated herself at about 4:45pm. We layed patient down took vitals once patient was stable we lifted her up to the sitting position and gave her some juice to drink. This was about 4:55pm.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Gait disturbance, Generalised erythema, Joint swelling, Pain in extremity
Clinical narrative: 1 hr after vaccine - blothiness and redness all over body, feet swollen, legs swollen, questionable knee swelling. Legs felt heavy/wobbly leg pain/joint pain and swelling.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Rash macular
Clinical narrative: 1 hr after vaccine - blothiness and redness all over body, feet swollen, legs swollen, questionable knee swelling. Legs felt heavy/wobbly leg pain/joint pain and swelling.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Feeling hot, Pruritus, Urticaria
Clinical narrative: Hives, redness, itching and hot.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, X-ray normal
Clinical narrative: C/O right shoulder and arm pain, and limited ROM after PNEUMOVAX 23 2/27/18. Pt was seen by PCPC day after, 2/28/18. Ibuprofen as needed every 6 hrs, ice to area, follow-up as needed.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Injection site rash, Pyrexia
Clinical narrative: Low fever, large rash at site "doesn't feel right".
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blister in a 74-year-old male patient who received SHINGRIX. Concomitant products included FAMVIR. On 13th February 2018, the patient received SHINGRIX (intramuscular). On 15th February 2018, 2 days after receiving SHINGRIX, the patient experienced blister. On 16th February 2018, the patient experienced chest tenderness. On an unknown date, the outcome of the blister and chest tenderness were recovering/resolving. The reporter considered the blister and chest tenderness to be unrelated to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the right deltoid. The patient experienced blisters on left side of back. Three days after vaccination with SHINGRIX, the patient's left side of chest was sensitive to touch. The patient stated that, his physician was aware of the adverse effects and had prescribed antibiotic for seven days which would end on 26th February 2018. The patient was advised to continue to follow-up with his physician regarding the issues. The patient denied permission to contact his physician.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Musculoskeletal chest pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blister in a 74-year-old male patient who received SHINGRIX. Concomitant products included FAMVIR. On 13th February 2018, the patient received SHINGRIX (intramuscular). On 15th February 2018, 2 days after receiving SHINGRIX, the patient experienced blister. On 16th February 2018, the patient experienced chest tenderness. On an unknown date, the outcome of the blister and chest tenderness were recovering/resolving. The reporter considered the blister and chest tenderness to be unrelated to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the right deltoid. The patient experienced blisters on left side of back. Three days after vaccination with SHINGRIX, the patient's left side of chest was sensitive to touch. The patient stated that, his physician was aware of the adverse effects and had prescribed antibiotic for seven days which would end on 26th February 2018. The patient was advised to continue to follow-up with his physician regarding the issues. The patient denied permission to contact his physician.