chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt stopped by pharmacy and notified us that her arm is still hurting after her flu shot. She can manage doing her routine daily work but painful when she wants to change her clothing/some specific movements. no redness/bruise on the arm.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Pain
Clinical narrative: Pain/Inflammation/Redness at injection site. Patient has soreness when lifting her arm.  Prednisone/NSAID given by Dr.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Reports onset of "rash" with redness/itching to right side of face, back of hands and inner thighs/buttocks on evening of 10/27/2017.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Pruritus, Rash
Clinical narrative: Mother reports onset rash to bilat lower legs with itching.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Pain, Swelling, Thrombosis
Clinical narrative: FLUAD was given first followed by PNEUMOVAX given one inch below per protocol. Patient experienced swelling and pain due to what was later determined by Dr. as a calcified thrombus formed because injection passed through the Cephalic vein. Patient went to Urgent Care twice where she was misdiagnosed both times. Later Dr.,  her primary care physician discovered the thrombus. He had her treat with heat, employed medicine for the pain and referred her to physical therapy stating it was only way to resolve the issue.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Drug administered at inappropriate site, Erythema, Haematoma, Mass, Myositis ossificans
Clinical narrative: FLUAD was given first followed by PNEUMOVAX given one inch below per protocol. Patient experienced swelling and pain due to what was later determined by Dr. as a calcified thrombus formed because injection passed through the Cephalic vein. Patient went to Urgent Care twice where she was misdiagnosed both times. Later Dr.,  her primary care physician discovered the thrombus. He had her treat with heat, employed medicine for the pain and referred her to physical therapy stating it was only way to resolve the issue.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Pain, Ultrasound scan normal
Clinical narrative: FLUAD was given first followed by PNEUMOVAX given one inch below per protocol. Patient experienced swelling and pain due to what was later determined by Dr. as a calcified thrombus formed because injection passed through the Cephalic vein. Patient went to Urgent Care twice where she was misdiagnosed both times. Later Dr.,  her primary care physician discovered the thrombus. He had her treat with heat, employed medicine for the pain and referred her to physical therapy stating it was only way to resolve the issue.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient called pharmacy on 11-7-17 concerned that her arm still hurt from the flu shot she got on 9/26/17.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Moderate redness. Pt wanted us to report this although it's consistent with standard adverse effects for the vaccine.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Balance disorder, Chest discomfort, Disorientation, Feeling hot, Hyperhidrosis
Clinical narrative: No more than 5 minutes after receiving the vaccination, the patient felt a little disoriented and started to lose her balance. She said her chest felt weird and she had trouble hearing. Her grandmother said she was feeling very hot and the patient started to sweat. About 20 minutes later the patient started to feel better and said she couldn't remember what her grandmother was saying to her.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoacusis, Memory impairment
Clinical narrative: No more than 5 minutes after receiving the vaccination, the patient felt a little disoriented and started to lose her balance. She said her chest felt weird and she had trouble hearing. Her grandmother said she was feeling very hot and the patient started to sweat. About 20 minutes later the patient started to feel better and said she couldn't remember what her grandmother was saying to her.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Major Arm swelling from the shoulder down to the elbow, redness, chills, fever 101.6.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Extremely sore arm, can't move arm ever since receiving the immunization.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Thrombosis, Ultrasound scan abnormal
Clinical narrative: Swelling at site, went to Dr. and started on blood thinner in case of clot. Everything fine and reappeared. I suggested she see specialist concerning clotting.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Fatigue, Influenza like illness, Nausea, Rash
Clinical narrative: Patient said she experienced flu-like symptoms as well as nausea, vomiting, and diarrhea, and several welts on the same arm she received the vaccinations. She reported this to the pharmacy six days after receiving the shots and stated she was still a bit fatigued and had a mild rash on her right arm, but was no longer experiencing the other symptoms.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urticaria, Vomiting
Clinical narrative: Patient said she experienced flu-like symptoms as well as nausea, vomiting, and diarrhea, and several welts on the same arm she received the vaccinations. She reported this to the pharmacy six days after receiving the shots and stated she was still a bit fatigued and had a mild rash on her right arm, but was no longer experiencing the other symptoms.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Vaccination site erythema
Clinical narrative: Erythema to site of vaccine approx 5 minutes after administration. BENADRYL 12.5 mg chewable 1 tab given at 3:56 pm.
Age: 49.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Increased pain and swelling of the right arm.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site induration, Injection site mass
Clinical narrative: Immediately following injection, patient developed a golf-ball sized hard mass around the injection site. There was a little blood, but the mass didn't appear red or warm after 10 minutes of monitoring. Advised patient to go home and ice injection site, and take some ibuprofen.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Influenza like illness, Pain, Paraesthesia
Clinical narrative: Pt reports flu like symptoms to include tingling down left arm to hand, uncontrollable chills, and body aches for 3 days. Pt reports recovered.
Age: 26.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Sore and redness to the left of the injection. Told patient to take ibuprofen and benadryl. Use cold compress.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Lip swelling, Pruritus
Clinical narrative: Lips swollen, hands and groin red and itchy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site swelling, Pyrexia, Rash
Clinical narrative: Mom stated the patient woke with swelling to his right leg and rash. He did also run a fever. Said she treated him with TYLENOL and BENADRYL. Rash and swelling are gone.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of erythema in a adult female patient who received FLUARIX QUADRIVALENT (batch number 345AX, expiry date 30th June 2018). On an unknown date, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown. The reporter considered the erythema and swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that one of their nurses at a different location received this lot and expiration date and also reported significant redness and swelling. There were no initials, date of birth and date of vaccination available at the time of reporting. This case has been linked with case US2017GSK166153, reported by the same reporter for same events.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt complains of severe pain and immobility of the arm 2 weeks after administration. Pt told to apply ice and take ibuprofen and to contact Physician.
Age: 6.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever 101-103.6F for 48 hours.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: LARGE RASH AROUND INJECTION SITE, SOME SYMPTOMS OF ERYTHEMA, ITCHINESS, AND WARMNESS. SLOWLY GETTING BETTER.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Raised, red nodule at site of injection appeared/noticed by patient roughly 3 weeks after injection. Nodule is non-painful and has remained and possibly increased in size over the last 14 days.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Pain, Pruritus, Swelling
Clinical narrative: Patient experienced pain, itch, swelling and hot four hours after receiving vaccination.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Haemorrhage, Nodule, Pain, Peripheral swelling
Clinical narrative: The patient was injected in the left arm with FLUZONE HD. The patient started to bleed and arm swelled to about the size of a dime/nickel. I stopped the bleeding and recommended ibuprofen/tylenol for swelling/pain and ice. I called the patient later to make sure swelling had subsided. Patient stated that the swelling had gone down and that he had little pain, but there was still a small knot on his arm.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Vomiting
Clinical narrative: Pt experienced nausea and threw up after flu shot.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Eating disorder, Fatigue, Feeling hot, Injection site erythema
Clinical narrative: I was fine until about 2 AM, roughly 10.5 hours after being vaccinated. The pain in the injection site became unbearable, and the whole area turned red and hot to the touch. Then, the fever began. It started as 101° but by mid Sunday I was up to 103°. I had the cold sweats and periods of intense warmth. I was so nauseous I hardly could eat.  My neck hurt so much along with my head. It hurt to rest my head on a pillow but holding my head up was even worse. My whole body ached and I had intermittent joint and muscle pain. I have basically tried to sleep throughout all of this. As I'm writing this, I'm still curled up in bed, nauseated, fatigued, and in pain with a fever of 101.5°.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site warmth, Myalgia, Nasopharyngitis, Nausea
Clinical narrative: I was fine until about 2 AM, roughly 10.5 hours after being vaccinated. The pain in the injection site became unbearable, and the whole area turned red and hot to the touch. Then, the fever began. It started as 101° but by mid Sunday I was up to 103°. I had the cold sweats and periods of intense warmth. I was so nauseous I hardly could eat.  My neck hurt so much along with my head. It hurt to rest my head on a pillow but holding my head up was even worse. My whole body ached and I had intermittent joint and muscle pain. I have basically tried to sleep throughout all of this. As I'm writing this, I'm still curled up in bed, nauseated, fatigued, and in pain with a fever of 101.5°.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: I was fine until about 2 AM, roughly 10.5 hours after being vaccinated. The pain in the injection site became unbearable, and the whole area turned red and hot to the touch. Then, the fever began. It started as 101° but by mid Sunday I was up to 103°. I had the cold sweats and periods of intense warmth. I was so nauseous I hardly could eat.  My neck hurt so much along with my head. It hurt to rest my head on a pillow but holding my head up was even worse. My whole body ached and I had intermittent joint and muscle pain. I have basically tried to sleep throughout all of this. As I'm writing this, I'm still curled up in bed, nauseated, fatigued, and in pain with a fever of 101.5°.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Muscle swelling, Myalgia, Myosclerosis
Clinical narrative: SWELLING AROUND AND ENTIRE DELTOID MUSCLE (HARD, FIRM, ITCHY AND BRIGHT RED) NOT THE INJECTION SITE. SEVERE PAIN AND CANNOT MOVE THE DELTOID MUSCLE, NAUSEA, TINGLING -STARTED WEDNESDAY, 11/1/17 AND LASTED FOR 3 DAYS.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Paraesthesia, Pruritus
Clinical narrative: SWELLING AROUND AND ENTIRE DELTOID MUSCLE (HARD, FIRM, ITCHY AND BRIGHT RED) NOT THE INJECTION SITE. SEVERE PAIN AND CANNOT MOVE THE DELTOID MUSCLE, NAUSEA, TINGLING -STARTED WEDNESDAY, 11/1/17 AND LASTED FOR 3 DAYS.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Pain, Pain in extremity, Sleep disorder
Clinical narrative: **DO NOT KNOW which type of flu vaccine was given. Arm on which flu shot was administered has been hurting for three weeks now. Very difficult to drive, put on clothing, use laptop at work. Pain is further aggravated after exercise. Trouble sleeping on arm. Would wake up to arm throbbing.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Patient presented to pharmacy < 7 days after vaccine complaining of arm pain/discomfort. Was counseled to try OTC analgesics along with heating pad and mobility to help. Also advised to seek Dr recommendation/appointment if did not resolve after treatment attempt. She reappeared about a week later stating that she still had discomfort. She was still reluctant to contact primary care.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, X-ray
Clinical narrative: When lifting my arm it is painful. While sleeping if I move it is very painful. It is still hurting after 5 1/2 weeks after shot.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Hypokinesia, Musculoskeletal pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 60-year-old female patient who received FLUARIX Quadrivalent (batch number 77R93, expiry date 30th June 2018). On 23rd October 2017, the patient received FLUARIX Quadrivalent. In October 2017, less than a month after receiving FLUARIX Quadrivalent, the patient experienced shoulder pain, muscle pain and movements reduced. The patient was treated with ibuprofen. On an unknown date, the outcome of the shoulder pain and muscle pain were not recovered/not resolved and the outcome of the movements reduced was unknown. It was unknown if the reporter considered the shoulder pain, muscle pain and movements reduced to be related to FLUARIX Quadrivalent. Additional details were provided as follows: The patient reported that the HCP told her to put heat on her shoulder. The patient also reported that HCP said to get some rest and not to be active with her shoulder. The shoulder was worse and the patient could not lift her arm over her head. The patient was taking Ibuprofen for pain and declined the steroids that were recommended by the HCP. The patient was advised to contact HCP and medical disclaimer was given to the patient.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 1.25 inches redness, and localized swelling of R thigh at varicella injection site. Advised MOTRIN and cool compresses to site.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain and limited mobility in arm for 8 days.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Respiratory disorder, Respiratory distress
Clinical narrative: Lt. upper arm swelling, hot, reddened, then increase in size - 7 cm. in diameter: Also developed acute resp. issues 4 hours later requiring (2) albuterol resp. Tx's. BENADRYL 50 mg taken at 2100 then S/S resolved slightly then reoccurred the next day w/area swelling and redness accompanied by resp. distress requiring sev. doses of bronchodilators. S/S subsiding and slowly improving.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Musculoskeletal pain
Clinical narrative: Right shoulder pain - ache and sharp pain. Right arm and hand weakness.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Painful flu shot - sore for a couple of days (soreness gradually subsided) - movement affecting daily activities - chiropractor stated may have hit bursa (SIRVA).
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on arm.
Age: 90.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient returned to pharmacy 15 days post immunization stating redness and itching at injection site that spread to elbow. She said she would take BENADRYL every now and then. Reaction is subsiding. Not itching today and redness is fading.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient says injection site is red, warm, swollen size of grapefruit, slight fever. Received FLUZONE shot same day.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient describes pain in upper shoulder.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Pain at time of administration and bruising days after (3 inches in diameter), muscle stiffness of deltoid and neck.
Age: 22.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus generalised, Rash macular
Clinical narrative: Vaccine given about 1024. At 1032 presented with generalized itchiness and macular rash on extremities. BENADRYL 50mg IM given in R deltoid. HR/RR normal, lungs clear. 1045 itchiness spreading to face, no airway involvement, no improvement in symptoms. 1055 EMS arrives to transport patient to local hospital for continued monitoring. Vital signs normal, lungs clear, patient alert/oriented.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain
Clinical narrative: Sore throat aches and pain swollen glands for 4 days.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 12 month old patient. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 29-SEP-2017, the patient was vaccinated with properly stored VARIVAX lot # M039316 with an expiration date 20-SEP-2018, subcutaneous for prophylaxis dose was not reported) and PROQUAD lot number N001488 with an expiration date 12-JUL-2018 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient. The patient's historical drugs reactions/allergies included vancomycin and morphine. The patient's medical history and concomitant therapies were not reported. On 10-OCT-2017, the patient was vaccinated with ZOSTAVAX 19400 PFU, lot # M039452, expiration date 19-DEC-2017, subcutaneous in the right arm, for prevention of shingles (dose was not provided) reconstituted with sterile diluent (MERCK) subcutaneous in her right arm lot # M016886, expiration date 07-DEC-2018 (strength was not reported). Other suspect therapies, included influenza virus vaccine (unspecified) (manufacturer unknown) (strength, dose, route, frequency, lot #, expiration date and indication were not reported). In October 2017 (also reported as on an unspecified date after received ZOSTAVAX, the patient sought medical attention with her pharmacist, who reported that the patient experienced a raised red wheel about 1 1/2 to 2 inches at the site injection on her right arm, that did not hurt or itch. Laboratory diagnostics were not performed and no treatment was given for the events. The outcome of injection site mass and injection site redness was reported as not recovered. The assessment causality between injection site mass and injection site redness with ZOSTAVAX, sterile diluent (MERCK), and influenza virus vaccine (unspecified) (manufacturer unknown) was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 19-OCT-2017, the patient was vaccinated with an expired dose of M-M-R II which had a lot # L024265 with an expiration date on 01-JUL-2017, subcutaneously (strength, dose, frequency were not mentioned) for prophylaxis. However, at the reporting time, no adverse event were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 18-OCT-2017, the patient was vaccinated with improperly stored doses of ROTATEQ lot # N005619, expiration date 29-OCT-2018, orally, for prophylaxis (strength, dose and frequency were not reported). The temperature/Time frame was 34.8° F for 8 hours 23 minutes and 34.8° F for 8 hours 15 minutes. The previous temperature excursion was 47.6° F for 5 minutes. There was a data logger involved. No adverse effects reported. This is one of several cases from the same source. Sender's Comments: US-009507513-1710USA010653: US-009507513-1710USA010655: US-009507513-1710USA010656: US-009507513-1710USA010312.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a child who was a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On 24-OCT-2017, the patient was vaccinated with PROQUAD (lot # N020008, expiry date: 13-JAN-2019) for prophylaxis. The vaccine was reconstituted with 0.6 ml of 0.4% sodium chloride diluent (Sanofi Pasteur) (lot # U1799AAB, expiry date: 01-JUL-2018) (product preparation error). No adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Bursitis
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 25 year old female patient whose medical history, past drugs, concurrent conditions, concomitant medications, drug reactions and allergies were reported as unknown. On 02-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N011867, expiry date: 08-NOV-2018, (one dose) intramuscular in the left arm for prevention of pneumococcal disease. On an unspecified date in October 2017, the patient developed bursitis in her left elbow and bursitis in her right elbow. It was unknown if patient had any lab tests. It was unknown if any treatment was received by the patient for the adverse events. The patient called pharmacist to sought medical attention. On an unspecified date in October 2017, bursitis in the left elbow was resolved. The outcome of bursitis in her right elbow was not reported. The reporter did not provide the causality of events with PNEUMOVAX 23. Product Quality Complaint (PQC) was not involved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with an improperly stored PEDVAXHIB (lot #: M047666, expiration date: 24-OCT-2019) for prophylaxis (dose, frequency and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Digital Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with an improperly stored PEDVAXHIB lot # reported as: M047666, expiration date: 24-OCT-2019 for prophylaxis (dose, frequency and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician via a sales representative, referring to a female patient on her 60's. The patient had no medical history, drug reactions/allergies or concomitant medications to be reported. On an unknown date in 2015 (reported as "about 2 years ago"), the patient was vaccinated with ZOSTAVAX, subcutaneously, for prevention of shingles (dose, lot # and expiry date were unknown). On an unknown date, reported as "shortly after injection", the patient developed a "zoster-like rash" at the injection site. The physician stated that the rash "cleared up by itself" (date unknown). Neither treatment nor laboratory diagnostics were performed. The patient's outcome for rash vesicular was reported as recovered. The causality assessment between the ZOSTAVAX and the aforementioned adverse event was unknown.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Alopecia, Decreased appetite, Dyspnoea, Pain
Clinical narrative: This spontaneous report was received from a consumer referring to her daughter, a female patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown day in 2013, the patient was vaccinated intramuscularly with the first dose of GARDASIL for prophylaxis (strength, dose, units and lot number were not reported) and on 16-MAR-2015, the patient received the second dose of GARDASIL. On an unknown date, the patient experienced full body aches, shortness of breath, loss of appetite, and loss of hair. The patient was admitted to an unknown hospital for unknown adverse event. The patient sought medical attention and received treatment fot the adverse events. Therapy with GARDASIL was discontinued. The outcome of full body aches, shortness of breath, loss of appetite, loss of hair and unknown adverse event was reported as not recovered. The relatedness between the event and GARDASIL was not provided.
Age: 28.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report has been received from a registered nurse referring to a 28 year old female patient. The patient had no drug and allergy history to be reported. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. On 04-OCT-2017, the patient was vaccinated with VARIVAX lot # N008829, expiration date 16-MAR-2019, subcutaneously (strength was not reported) for immigration purposes.  Other suspect therapies included M-M-R II, lot # N005774, expiration date 17-FEB-2019 (strength, route of administration were not reported) for prophylaxis. The patient became pregnant with a last menstrual period (LMP) approximately of 13-SEP-2017 and estimated due date (EDD) of 20-JUN-2018. Initial exposure to VARIVAX and M-M-R II was at 3 weeks of pregnancy (first trimester of exposure). At the time of this report, the pregnancy outcome was unknown. On an unknown date the patient experienced and no adverse event. The outcome of exposure during pregnancy was unknown. No adverse events were reported. At the time of this report, the causality between the event and M-M-R II and VARIVAX was not reported.
Age: 12.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 12 years old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On an unspecified date, the patient was inadvertently vaccinated with an adult formulation dose of VAQTA with lot # M039055 and expiration date on 22-JUL-2018 (strength, dose, frequency and anatomical location were not provided), administered intramuscularly for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 17-OCT-2017, the patient was vaccinated with improperly stored doses of VARIVAX lot # N012131, expiration date 17-APR-2019 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit and 17 degrees Fahrenheit for 3 hours and 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007766.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 15-SEP-2017, the patient was vaccinated with improperly stored doses of VARIVAX lot # N012131, expiration date 17-APR-2019 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit and 17 degrees Fahrenheit for 3 hours and 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007766.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 27-SEP-2017, the patient was vaccinated with improperly stored doses of VARIVAX lot # N012131, expiration date 17-APR-2019 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit and 17 degrees Fahrenheit for 3 hours and 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007766.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 09-OCT-2017, the patient was vaccinated with improperly stored doses of VARIVAX lot # N012131, expiration date 17-APR-2019 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit and 17 degrees Fahrenheit for 3 hours and 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007766.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 16-OCT-2017, the patient was vaccinated with improperly stored doses of VARIVAX lot # N012131, expiration date 17-APR-2019 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit and 17 degrees Fahrenheit for 3 hours and 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007766.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Clonus, Laboratory test, Pyrexia
Clinical narrative: Patient developed fever 102.2 R at approx 930 PM on 11/6/17. He was seen earlier that day for his 2 mo. check-up; vaccines. Sent to ER septic work up and admitted for observation and antibiotics. In hospital noted to have clonus movements remains in hospital.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of erythema in unspecified number of patients who received FLUARIX QUADRIVALENT (batch number 345AX, expiry date 30th June 2018). On an unknown date, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown. The reporter considered the erythema and swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The age at vaccination of the patients was not reported. The nurse reported that several patients had experienced significant redness and swelling after receiving FLUARIX QUADRIVALENT in the reporting year. The office had submitted a VAERS report. The reporter's office sees patients so possibility of private and public funds used for purchase of vaccines. This case was linked with case US2017GSK169703, reported by the same reporter.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: Patient left office and went downstairs for blood test within approximately 10-15 minutes of receiving vaccine, patient had a seizure. No HX of seizures or adverse effects to vaccines or blood draws in the past. Lab had patient lay down and then released patient to go home. Doctor's office was not aware of adverse effect until the next day.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Injection site pain
Clinical narrative: Employee was given the vaccine by a coworker from the peer to peer packet on the unit. The vaccine was given in the upper back side of her left arm and not in the deltoid, she stated it hurt really bad at the time and she continues to still have pain, including numbness that goes up into her neck.
Age: 1.08
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives to back and upper right thigh noted Sunday evening. Tried BENADRYL x once with no relief.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Employee was given the vaccine in her right arm. Site of vaccine was up to high on her arm resulting in pain and limited range of motion.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, hard, and tender at injection site. Also reports dizziness, fever, and nausea.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: Redness, swelling, hard, and tender at injection site. Also reports dizziness, fever, and nausea.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Achiness, redness, and swelling at injection site.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MMRV, MNQ
Symptoms: Rash
Clinical narrative: No symptoms rash.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Chills, Dizziness, Pyrexia
Clinical narrative: Fever, dizzy, unsteady, chills.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: Patient presented to primary care office on Oct. 23, 2017 for 2 month well child check and received routine vaccines PEDIARIX, ACTHIB, Pneumococcal and ROTATEQ. Manager received a phone call for County Department of Health that the child passed away on Nov. 4, 2017.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Myalgia
Clinical narrative: Very, very sore muscles, could not get out of bed, had to cancel Golf outing.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Oedema peripheral, Swelling face
Clinical narrative: 4-5 days after receiving PNEUMOVAX 23, while patient was on vacation, her left arm became edematous, erythematous and somewhat indurated. This spread to her forearm the next day. She reports of her left face also becoming swollen 2 days later, however, as the swelling was not continuous between her arm and her face (neck was not involved) it is unlikely that the 2 events are related. Patient self-treated on vacation with BENADRYL. Swelling has resolved since.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint crepitation, Pain
Clinical narrative: Sharp pain horizontal in L) deltoid. Pain with Range of motion. Shoulder seems to pop. Vaccination injection was 10/10/2017. No swelling, No bruise at the time. Has used occasional ibuprofen and heat with minimal response.
Age: 16.0
Sex: U
Vaccine: HPV9, MEN, MNQ
Symptoms: C-reactive protein, Full blood count, Hypoaesthesia, Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 16-year-old patient (gender not reported). No information regarding the patient's medical history, concomitant therapies, drug reactions and allergies was provided. On 30-AUG-2017, the patient was vaccinated with a dose of GARDASIL 9 injection (dose, frequency, route of administration were not provided; lot # N013276, expiration date 21-JAN-2020), in the left arm. Dose number of GARDASIL 9 was unknown by the reporter. On the same day, the patient was vaccinated with MENACTRA (dose, frequency, route of administration, lot # and expiration date were not provided), in the left arm and meningococcal b outer membrane protein vaccine (detergent) reported as Meningitis B shot (dose, frequency, route of administration, lot # and expiration date were not provided), in the right arm. On approximately 13-SEP-2017 (reported as about 2 weeks later), the patient developed tenderness, soreness and a red lump in the left arm around the injection site. In approximately 2017, the patient experienced numbness and tingling in the fingers of their left hand and the red lump on patient's left arm increased a bit in size. On 10-OCT-2017, the patient sought for medical attention and visited the physician who prescribed ibuprofen to be taken every 6 hours and also did some lab work, diagnostic tests complete blood count, C-reactive protein and erythrocyte sedimentation rate. No product quality complaint involved. The outcome of tenderness, soreness, red lump, numbness and tingling in the fingers of the left hand was not reported. Causality assessment was not provided.
Age: 16.0
Sex: U
Vaccine: HPV9, MEN, MNQ
Symptoms: Injection site pain, Laboratory test, Paraesthesia, Red blood cell sedimentation rate
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 16-year-old patient (gender not reported). No information regarding the patient's medical history, concomitant therapies, drug reactions and allergies was provided. On 30-AUG-2017, the patient was vaccinated with a dose of GARDASIL 9 injection (dose, frequency, route of administration were not provided; lot # N013276, expiration date 21-JAN-2020), in the left arm. Dose number of GARDASIL 9 was unknown by the reporter. On the same day, the patient was vaccinated with MENACTRA (dose, frequency, route of administration, lot # and expiration date were not provided), in the left arm and meningococcal b outer membrane protein vaccine (detergent) reported as Meningitis B shot (dose, frequency, route of administration, lot # and expiration date were not provided), in the right arm. On approximately 13-SEP-2017 (reported as about 2 weeks later), the patient developed tenderness, soreness and a red lump in the left arm around the injection site. In approximately 2017, the patient experienced numbness and tingling in the fingers of their left hand and the red lump on patient's left arm increased a bit in size. On 10-OCT-2017, the patient sought for medical attention and visited the physician who prescribed ibuprofen to be taken every 6 hours and also did some lab work, diagnostic tests complete blood count, C-reactive protein and erythrocyte sedimentation rate. No product quality complaint involved. The outcome of tenderness, soreness, red lump, numbness and tingling in the fingers of the left hand was not reported. Causality assessment was not provided.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a patient's mother refers to the 13 month old male patient. He had no pertinent medical history, drug reactions or allergies and was not taking concomitant medications. On 20-OCT-2017, the patient was vaccinated with VARIVAX 0.5 ml injection once (route of administration, lot # and expiry date were not provided). The following day, the patient developed chicken-pox and more blisters kept coming. The patient did not seek medical attention and no treatment was given for the event. None lab diagnostic studies were performed. At the time of this report, the patient did not recover from the event. Causality assessment was not provided.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with an improperly stored PEDVAXHIB (lot # M047666, expiration date: 24-OCT-2019) for prophylaxis (dose, frequency and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Digital Data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.
Sex: F
Vaccine: HPV2, HPV4
Symptoms: Coeliac disease, Gluten sensitivity
Clinical narrative: This spontaneous report as received from an unspecified reporter via an online media refers unspecified number of female patient's aged 18 to 45 years, in the period from October 2006 to July 2013. Information on pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with GARDASIL (strength, dose, route, anatomical location lot#, expiry date were not reported) for prophylaxis. The online article did  not specify whether the HPV vaccine in question was GARDASIL or CERVARIX. On unknown dates, the patients experienced coeliac disease (gluten intolerance). The outcome of the event was reported as unknown. Causality assessment was reported as unknown. The reporter considered the event to be medically significant.
Sex: U
Vaccine: PNC
Symptoms: Seroconversion test negative
Clinical narrative: This is a spontaneous report from a contactable consumer. A 3-year-old patient of an unspecified ethnicity and gender received PREVNAR, via an unspecified route of administration, on an unspecified date, as single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received the vaccine but did not seroconvert. The outcome of patient received the vaccine but did not seroconvert was unknown.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Peripheral swelling, Skin warm, Swelling
Clinical narrative: SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from a nurse on 25-Oct-2017. This case involves a female patient (age not reported), who was vaccinated with FLUZONE QIV (batch number: UI847AB, expiry date: 30-Jun-2018; dose, dose in series not reported) and PNEUMOVAX (batch number, expiry date, dose, route was not reported) in same arm on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe swelling and cellulitis, warm to touch, elbow to shoulder area was swollen. Lab test and corrective treatment was not reported. Outcome of the events were not reported. Upon internal review the case was considered as serious because of important medical event: cellulitis. Documents held by sender: none. Sender's Comments: Patient experienced Cellulitis after vaccination. Time to onset is not known. Additional information on previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.