chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 15-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 14-JUN-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During the year 2016, the patient was treated at a medical center for the onset of a repeated and severe vesicular eruptions accompanied by weakened immune systems, which was diagnosed as herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, and pain and suffering , and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 15-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 01-SEP-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During August of 2016, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune systems, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 15-AUG-2017, the patient was vaccinated with VARIVAX (dosing details unknown) from lot # L016123 that had expired on 06-MAY-2017 for prophylaxis. The reporter further stated that the vaccine was exposed to a temperature excursion of 5.9 degree Fahrenheit for 1.5 hours prior to administration. No adverse symptoms were reported. There was no previous temperature excursion. Data logger was involved. Product quality complaint was not involved.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 05-JUL-2017 the patient was vaccinated with GARDASIL 9 lot # M033583 dose 4 for prophylaxis. On 05-JUL-2017, 1 day after onset of therapy the patient experienced extra dose administered. On an unknown date the patient experienced inappropriate schedule of drug administration and no adverse event. The outcome of extra dose administered, no adverse event and inappropriate schedule of drug administration is unknown. The reporter considered extra dose administered, no adverse event and inappropriate schedule of drug administration to be not related to GARDASIL 9.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Had swelling, redness and itching/pain at injection site. She showed me the arm and it was still red and slightly warm to the touch.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site nodule, Pyrexia, Vomiting
Clinical narrative: Mom states patient started running a fever a couple of hours after vaccines were given and had a fever for 48 hours. She took child to walk in clinic and they told her to give him BENADRYL, TYLENOL, and ibuprofen. After the fever subsided, he started vomiting and the next day had fever again. On 8/16/17 she took the child to ER and said they told her to follow up with PCP. The child has an appointment on 8/18/17 with PCP. Mom stated that he also has a knot in his left thigh. Mom was told to be sure to keep appointment with PCP and take the child back to the ER if there is any difficulty breathing or if his fever gets any higher.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Rash papular, Rash pruritic
Clinical narrative: New onset of papular rash covering body from neck down onto chest, back, abdomen, arms and legs. Not on face. Itchy rash.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Chest X-ray, Laboratory test, Pyrexia, White blood cell count increased
Clinical narrative: Fever max 105.2, MOTRIN, fluids, TYLENOL.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ, UNK
Symptoms: Anticonvulsant drug level, Blood group O, Blood osmolarity decreased, Blood urea increased, Mean cell haemoglobin concentration increased
Clinical narrative: Seizure occurred while driving.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ, UNK
Symptoms: Monocyte percentage increased, Protein urine present, Seizure, Urine analysis abnormal
Clinical narrative: Seizure occurred while driving.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient awoke morning after vaccine to very sensitive/sore arm. Realized had redness and swelling extending from injection site down to elbow. Being prescribed ranitidine, prednisone, and BENADRYL to treat.
Age: 22.0
Sex: F
Vaccine: HPV9, IPV, PPV, RAB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Pt received PNEUMOVAX 23 on 8/15/17 at approx. 2:30 in the afternoon. At that time, she was advised her left shoulder may feel unusually sore. She was encouraged to continue using the arm and apply pain relief measures such as warm and/or cold compress and ibuprofen prn. That evening around 9 pm she began feeling some significant soreness, so she took ibuprofen 400 mg. The morning of the 16th she woke with increased soreness which significantly limited her shoulder mobility  had difficulty dressing or putting her hair in a ponytail. She took ibuprofen 400 mg at 9 am, then again at 12 noon due to increasing soreness. She repeated the dose again at 3:45 pm.
Age: 22.0
Sex: F
Vaccine: HPV9, IPV, PPV, RAB
Symptoms: Limb discomfort, Loss of personal independence in daily activities, Pain, Peripheral swelling, Pruritus
Clinical narrative: Pt received PNEUMOVAX 23 on 8/15/17 at approx. 2:30 in the afternoon. At that time, she was advised her left shoulder may feel unusually sore. She was encouraged to continue using the arm and apply pain relief measures such as warm and/or cold compress and ibuprofen prn. That evening around 9 pm she began feeling some significant soreness, so she took ibuprofen 400 mg. The morning of the 16th she woke with increased soreness which significantly limited her shoulder mobility  had difficulty dressing or putting her hair in a ponytail. She took ibuprofen 400 mg at 9 am, then again at 12 noon due to increasing soreness. She repeated the dose again at 3:45 pm.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Accidental exposure to product, Exposure via skin contact
Clinical narrative: This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender (who is a healthcare worker). On 31-JUL-2017, the patient was vaccinated with M-M-R II, lot # reported as "N034856" and expiration date 27-JUL-2017 for prophylaxis. Other suspect therapies included sterile diluent (MRK). On 31-JUL-2017, after administration to a patient, the patient accidentally exposed to the product via skin contact. The nurse reported that the patient felt a small drop of the vaccine on her face. The nurse reported that the healthcare worker did not feel any vaccine get into her eyes, but flushed them with saline as a precaution. No adverse event reported.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Emotional distress, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 22-MAR-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-SEP-2016, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster involving dermatome. On or about 01-FEB-2017, the patient was treated again by a physician for ongoing and worsening symptoms, diagnosed as herpes zoster cervical dermatome.  The patient has been prescribed valacyclovir hydrochloride (VALTREX), prednisone, and tramadol hydrochloride (TRAMADOL) for the management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical center treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain suffering, and other damages. Upon internal review, worsening symptoms diagnosed as herpes zoster cervical dermatome has been determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received 15-AUG-2017 from a lawyer regarding a case in litigation concerning a male plaintiff of unspecified age. It was claimed the plaintiff was inoculated with ZOSTAVAX on or about 21-DEC-2009 at a pharmacy in his residing state, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused him to contract a persistent strain of herpes zoster. On or about 04-DEC-2012, the plaintiff was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. He was prescribed valacyclovir, gabapentin and TYLENOL for management of his painful symptoms. It was claimed that as a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-SEP-2015 the patient was vaccinated with ZOSTAVAX, 1 DF, (route and lot# unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. Information regarding pertinent medical history and drug reactions or allergies was not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L042265 with expiration date 26-OCT-2017 (dose, route, anatomical location, lot# and expiry date not reported) for prophylaxis. The sterile diluent (MRK) used for reconstitution did not undergo a temperature excursion. No adverse effects were reported. The administered doses experienced a temperature excursion between 15 degree Fahrenheit to 46 degree Fahrenheit for 15 hours 16 minutes. The previous temperature excursion was between 15 degree Fahrenheit to 46 degree Fahrenheit for 14 hours. The call was because of a data logger. There was no Product Quality Complaint (PQC) involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route, anatomical location, lot# and expiry date not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. The administered doses experienced a temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit for 10 days. There was no previous temperature excursion. The call was because of a data logger. There was no Product Quality Complaint (PQC) involved.
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Feeling abnormal, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable female consumer through the Pfizer sponsored program, reporting for herself. A female patient of an unspecified age and ethnicity started to receive PREVNAR 13 at single dose on 31Jul2017 for immunisation. The patient medical history and concomitant medications were not reported. That day of the shot it didn't do anything. The day after vaccination, on 01Aug2017, she started feeling bad and red on her arm. For 2 weeks she broke out all over with fever, chills, body aches. She was completely out of it, in bed. The doctor's office told her to take BENADRYL and MOTRIN which didn't help at all. Patient had an upcoming appointment with the doctor that administered the shot. The outcome of the events was unknown.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, HPV4, IPV, MMR, TD
Symptoms: Immediate post-injection reaction, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Client came into clinic to receive required school vaccinations. Patient chart reviewed by nurse, allergies and history reviewed with patient?s Father. Client had no significant medical history, therefore Hepatitis B, Td and IPV vaccines administered into patient?s left arm. And Hepatitis A, HPV and MMR administered into the right arm. At 12:05 PM immediately after administration of the MMR vaccine, patient ?slumped? in the chair, patient became unresponsive for 2-3 seconds. Father and nurse attempted to arouse her by using gentle, yet, firm shaking. Client quickly regained consciousness and began talking to Father. Vital signs collected on patient, all vitals WNL. A second set of vitals collected on patient before being allowed to leave office, all WNL. Patient and family advised what signs and symptoms to look out for overnight and when to visit ED/Urgent Care or M.D. Father stated an understanding. Follow-up call placed to client and family to check status of client, however, there was no answer, voicemail left.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Back pain, Dizziness, Fatigue, Muscle twitching
Clinical narrative: Fatigue, fever, back pain, left leg twitching, subjective weakness, dizziness.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: Fatigue, fever, back pain, left leg twitching, subjective weakness, dizziness.
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient woke day after injection with a tennis ball size swelling at the injection site. It was firm, red, hot, and tender to the slightest touch. He applied heat only. Did not seek medical care. Patient was seen 3 days after injection with a little improvement. On day 4 the swelling and redness is resolving.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Localized reaction induration and redness at the injection site. Plan of care use BENADRYL and antihistamine. Expect full resolution.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at area of injection extending down left arm. Dx Cellulitis.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Patient reported having a slight fever and feeling sweaty on the day of vaccination.  She is feeling better today on 8-17-17.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Myalgia, Skin tightness, Skin warm, Swelling
Clinical narrative: The day after the shot I experienced redness and raised circle about 1 1/2 inch wide. Along with muscle pain. The next 2 days the swelling increased, and spread to the whole upper arm. Warmness, tenderness, swollen, tight, redness.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: The day after the shot I experienced redness and raised circle about 1 1/2 inch wide. Along with muscle pain. The next 2 days the swelling increased, and spread to the whole upper arm. Warmness, tenderness, swollen, tight, redness.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Developed chicken pox as diagnosed family doctor. He already had an upcoming appointment scheduled.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Loss of consciousness, Muscle twitching, Syncope
Clinical narrative: Administered both vaccines. Patient was sitting upright during administration. After about 1 minute, pt fainted. I was able to catch patient and lay her down. Patients body twitched a several times before pt gained consciousness. Pt was unconscious for about 15 seconds. Dr. examined pt afterward. Pt rested in supine position for about 15 minutes following event.
Age: 17.0
Sex: F
Vaccine: HEP, HPV4, IPV, MENB, MMRV, TD
Symptoms: Dizziness, Tinnitus
Clinical narrative: Dizziness and ringing of ears. For about 2 minutes. VS checked BP 118/74 heart 88 Temp 96.7 Patient recovered and able to responded alert and oriented. The father was present. Nurse watched for 15 minutes no further symptoms occurred.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Blood pressure decreased, Hypoacusis, Presyncope, Visual impairment
Clinical narrative: Nearly fainted. Vision turned black, hearing became very muffled, and blood pressure dropped significantly. I lied down on the table and rested until everything returned to normal.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Swollen, redness.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, RV1, UNK
Symptoms: Pyrexia
Clinical narrative: Fever after 6 hours. Worse 24hrs after.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site urticaria
Clinical narrative: Urticaria surrounding injection site and beyond that began two days following vaccine.
Age: 79.0
Sex: F
Vaccine: TYP
Symptoms: Chills, Pyrexia
Clinical narrative: Fever, Chills over 2 days. Ok after 2 days.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Myalgia
Clinical narrative: Patient had mild injection site reaction swelling, not much pain reported besides the mild under the muscle pain from the vaccine. No redness detected from the swelling. I advised patient to observe and take Benadryl one dose 10mg and Tylenol 500mg 1 dose if needed one to two days as needed.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Nausea, Pyrexia
Clinical narrative: PT STARTED HAVING FEVER, NAUSEA AND VOMITING A COUPLE OF NIGHTS AFTER GETTING VACCINATION. DID NOT TAKE ANY MEDICATION FOR SYMPTOMS, REPORTED THAT FEVER IS GETTING BETTER. IN AREA OF INJECTION PT REPORTS A TENNIS BALL SIZE DIAMETER OF RASH/REDNESS AND ELEVATED.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: PT STARTED HAVING FEVER, NAUSEA AND VOMITING A COUPLE OF NIGHTS AFTER GETTING VACCINATION. DID NOT TAKE ANY MEDICATION FOR SYMPTOMS, REPORTED THAT FEVER IS GETTING BETTER. IN AREA OF INJECTION PT REPORTS A TENNIS BALL SIZE DIAMETER OF RASH/REDNESS AND ELEVATED.
Age: 1.33
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eyelid oedema, Immediate post-injection reaction, Respiratory rate increased, Urticaria
Clinical narrative: Hives, rapid breathing and puffy eyes starting immediately following the vaccines. He was gave BENADRYL and watched for a while, I continued BENADRYL through the rest of the day to ensure the reaction was kept at bay.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Pt came in 6 days later and reported that her shoulder had turned red, swollen, hot to the touch, hurt to move. She said she had received many flu shots and never had any reactions. She had not reported any allergies at time of vaccine but today reported a latex allergy. Gloves, band-aids, and vaccines listed as latex free. Today (day 6), her arm had no redness, swelling or any sign of injection. She did not report any pain today.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site larger than a quarter size. Pain. No fever, no loss of motion, no sickness.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Pyrexia
Clinical narrative: High fever (104.1 F) within 24 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Patient called on 8/17/17 reporting raised red itchy area at vaccine site in the diameter of a "fifty cent piece". She reported that the itching was much more severe earlier in the day but had since lessened. Patient was instructed to apply ice to the affected area and potentially take tylenol of appropriate symptoms presented.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site mass, Injection site urticaria
Clinical narrative: PATIENT DEVELOPED A LARGE LUMP ON HER RIGHT BICEP JUST UNDER THE SITE WHERE THE SHOT WAS GIVEN IN THE RIGHT DELTOID. THE PA WHO EXAMINED HER SAID THE LUMP AND REDNESS THAT SURROUNDED IT WAS A HIVE AND LOOKED LIKE AN ALLERGIC REACTION. HE ADVISED HER TO TAKE ZYRTEC AND NAPROXEN OTC.
Age: 46.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient said he experienced redness and warm skin in the area around both injection sites.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Diverticulitis, Influenza like illness
Clinical narrative: Flu like and diverticulitis symptoms-had to go to hospital.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Feeling cold, Headache
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of diarrhea in a 17-year-old female patient who received BEXSERO. On 1st August 2017, the patient received the 2nd dose of BEXSERO. On 1st August 2017, 30 min after receiving BEXSERO, the patient experienced diarrhea. In August 2017, the patient experienced nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain. On an unknown date, the outcome of the diarrhea, nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain were unknown. It was unknown if the reporter considered the diarrhea, nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain to be related to BEXSERO. Additional details were provided as follows: On 1st August 2017, at 4 pm, the patient received BEXSERO. The patient woke up early morning as she was feeling cold. Next day at 4 am, the patient started to vomit, had nausea, muscle spasm and abdominal pain until 1 pm. In morning, the patient had fever and then joint pain started in knees, elbow and hips. On 2nd August 2017, the body temperature was recorded as 101 degree F. Two hours ago, the hives began on her arms and back. She had tingling of arms where she had shot.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Muscle spasms, Nausea, Paraesthesia, Pyrexia, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of diarrhea in a 17-year-old female patient who received BEXSERO. On 1st August 2017, the patient received the 2nd dose of BEXSERO. On 1st August 2017, 30 min after receiving BEXSERO, the patient experienced diarrhea. In August 2017, the patient experienced nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain. On an unknown date, the outcome of the diarrhea, nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain were unknown. It was unknown if the reporter considered the diarrhea, nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain to be related to BEXSERO. Additional details were provided as follows: On 1st August 2017, at 4 pm, the patient received BEXSERO. The patient woke up early morning as she was feeling cold. Next day at 4 am, the patient started to vomit, had nausea, muscle spasm and abdominal pain until 1 pm. In morning, the patient had fever and then joint pain started in knees, elbow and hips. On 2nd August 2017, the body temperature was recorded as 101 degree F. Two hours ago, the hives began on her arms and back. She had tingling of arms where she had shot.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Urticaria, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of diarrhea in a 17-year-old female patient who received BEXSERO. On 1st August 2017, the patient received the 2nd dose of BEXSERO. On 1st August 2017, 30 min after receiving BEXSERO, the patient experienced diarrhea. In August 2017, the patient experienced nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain. On an unknown date, the outcome of the diarrhea, nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain were unknown. It was unknown if the reporter considered the diarrhea, nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain to be related to BEXSERO. Additional details were provided as follows: On 1st August 2017, at 4 pm, the patient received BEXSERO. The patient woke up early morning as she was feeling cold. Next day at 4 am, the patient started to vomit, had nausea, muscle spasm and abdominal pain until 1 pm. In morning, the patient had fever and then joint pain started in knees, elbow and hips. On 2nd August 2017, the body temperature was recorded as 101 degree F. Two hours ago, the hives began on her arms and back. She had tingling of arms where she had shot.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Feeling cold, Injection site paraesthesia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of diarrhea in a 17-year-old female patient who received BEXSERO. On 1st August 2017, the patient received the 2nd dose of BEXSERO. On 1st August 2017, 30 min after receiving BEXSERO, the patient experienced diarrhea. In August 2017, the patient experienced nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain. On an unknown date, the outcome of the diarrhea, nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain were unknown. It was unknown if the reporter considered the diarrhea, nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain to be related to BEXSERO. Additional details were provided as follows: On 1st August 2017, at 4 pm, the patient received BEXSERO. The patient woke up early morning as she was feeling cold. Next day at 4 am, the patient started to vomit, had nausea, muscle spasm and abdominal pain until 1 pm. In morning, the patient had fever and then joint pain started in knees, elbow and hips. On 2nd August 2017, the body temperature was recorded as 101 degree F. Two hours ago, the hives began on her arms and back. She had tingling of arms where she had shot.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Muscle spasms, Nausea, Pyrexia, Urticaria, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of diarrhea in a 17-year-old female patient who received BEXSERO. On 1st August 2017, the patient received the 2nd dose of BEXSERO. On 1st August 2017, 30 min after receiving BEXSERO, the patient experienced diarrhea. In August 2017, the patient experienced nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain. On an unknown date, the outcome of the diarrhea, nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain were unknown. It was unknown if the reporter considered the diarrhea, nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain to be related to BEXSERO. Additional details were provided as follows: On 1st August 2017, at 4 pm, the patient received BEXSERO. The patient woke up early morning as she was feeling cold. Next day at 4 am, the patient started to vomit, had nausea, muscle spasm and abdominal pain until 1 pm. In morning, the patient had fever and then joint pain started in knees, elbow and hips. On 2nd August 2017, the body temperature was recorded as 101 degree F. Two hours ago, the hives began on her arms and back. She had tingling of arms where she had shot.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Skin warm
Clinical narrative: Red, warm, discomfort.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis LUA
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Red, itchy, edema to right upper arm on 8-11-17, was noticed by patient in the AM. Prescribed: diphenhydramine 25 mg - 1 tab every 6 hours for 5 days. Provided ice packs to apply to site.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient seen in clinic 8/17/17 by provider. Left arm, deltoid arm, had a circular ring of erythema, no TTP, no excessive warmth noted. Patient reports it is not painful, just itchy, AOX3, NAD, VSS, afebrile. BENADRYL Rx sent, area marked to monitor, picture taken for chart, advised MOC to monitor and rtc is s/s persist/worsen, ER precautions given.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt received Tdap 8/14/17 (Monday). Monday night noticed redness without pain under bandaid. Tuesday/Wednesday increased redness and pain. Taking MOTRIN/using ice. Site is unchanged 8/17/17.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Rash pruritic, Rash vesicular, Varicella
Clinical narrative: Pt. w/vesicular discrete pruritic rash consistent w/varicella 2 wks. post-imm.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Limb discomfort
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 19-year-old female patient who received BEXSERO (batch number 16B101, expiry date 28th February 2019). On 11th August 2017 11:30, the patient received the 2nd dose of BEXSERO. On 11th August 2017 16:00, 4 hrs 30 min after receiving BEXSERO, the patient experienced fever, feelings of weakness, headache, lower extremities weakness of, heaviness in limbs, felt faint, fatigue and feeling unwell. The patient was treated with MOTRIN. On an unknown date, the outcome of the fever, feelings of weakness, headache, lower extremities weakness of, heaviness in limbs, felt faint, fatigue and feeling unwell were not recovered/not resolved. It was unknown if the reporter considered the fever, feelings of weakness, headache, lower extremities weakness of, heaviness in limbs, felt fatigue and feeling unwell to be related to BEXSERO. Additional details were provided as follows: Around 4 pm, the patient did not feel well described as, developed a fever of 101 degrees, her legs felt heavy and weak along with fatigue, an extreme headache, felt weak, and even felt faint while driving. The patient returned the office to be seen and was given MOTRIN as treatment. The healthcare professional did not believe the symptoms were disabling, or life threatening.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Malaise, Muscular weakness, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 19-year-old female patient who received BEXSERO (batch number 16B101, expiry date 28th February 2019). On 11th August 2017 11:30, the patient received the 2nd dose of BEXSERO. On 11th August 2017 16:00, 4 hrs 30 min after receiving BEXSERO, the patient experienced fever, feelings of weakness, headache, lower extremities weakness of, heaviness in limbs, felt faint, fatigue and feeling unwell. The patient was treated with MOTRIN. On an unknown date, the outcome of the fever, feelings of weakness, headache, lower extremities weakness of, heaviness in limbs, felt faint, fatigue and feeling unwell were not recovered/not resolved. It was unknown if the reporter considered the fever, feelings of weakness, headache, lower extremities weakness of, heaviness in limbs, felt fatigue and feeling unwell to be related to BEXSERO. Additional details were provided as follows: Around 4 pm, the patient did not feel well described as, developed a fever of 101 degrees, her legs felt heavy and weak along with fatigue, an extreme headache, felt weak, and even felt faint while driving. The patient returned the office to be seen and was given MOTRIN as treatment. The healthcare professional did not believe the symptoms were disabling, or life threatening.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Cervical radiculopathy, Device malfunction, Dysgeusia, Extra dose administered, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cervical neuralgia in a 17-year-old female patient who received MENVEO (batch number M16073, expiry date 30th March 2018). Previously administered products included MENVEO (received 1st dose on 6th March 2012 and experienced no vaccine related adverse events that time). Concurrent medical conditions included cochlea implant (Right ear), penicillin allergy and shellfish allergy. Concomitant products included GARDASIL 9. On 14th March 2017, the patient received the 2nd dose of MENVEO (intramuscular) 1 ml. On 14th March 2017, less than a day after receiving MENVEO, the patient experienced cervical neuralgia, taste metallic, rash and extra dose administered. On an unknown date, the outcome of the cervical neuralgia was unchanged and the outcome of the taste metallic was recovering/resolving and the outcome of the rash was recovered/resolved and the outcome of the extra dose administered was unknown. The reporter considered the cervical neuralgia to be almost certainly related to MENVEO. The reporter considered the taste metallic and rash to be probably related to MENVEO. Additional details were reported as follows: On 14th March 2017, the patient received 2nd dose of MENVEO in the right deltoid. This led to administration of extra dose. At the same visit, the patient received GARDASIL 9 in the left deltoid intramuscularly. The healthcare provider stated that the patient reported metallic taste, rash, and nerve pain in neck which caused her right-sided cochlear implant to stop working. The patient visited her audiologist about 4 times since vaccination and they were unable to fix the implant. The patient still complained of nerve pain in her neck and was unable to hear out of her right ear.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chills, Crying, Diet refusal, Headache, Nausea
Clinical narrative: According to the mother, 45 minutes after receiving the vaccines, while on their way home in the car she started crying with a bad headache having chills and nausea and didn't want to eat. Around 9 pm (Approx 5 hours later) after getting some sleep, she started eating and feeling better.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Blood sodium decreased, Computerised tomogram head normal, Dyskinesia, Eye pain, Headache
Clinical narrative: Received BEXSERO yesterday afternoon about 1500 without issues --- some immediate soreness but seemed fine. Went to volleyball practice in A/C'ed gym after with no issues. Finished practice and went to friends game in a non-air-conditioned gym but was not doing anything but watching. About 2100 began to get a worsening HA (but had some HA on the two days PRIOR to the vaccine as well) and it hurt to "open her eyes". She began shaking a lot, some muscle twitching and "wringing of her neck". She described muscle spasms as the cause of these movements. Mom felt temp. 100.9 in the ER on arrival. Taken to the ER for evaluation. Labs WNL except low Na of 133, rest normal including CT of the head. Once she got a bolus of NS in the ER she significantly improved. No prior episodes of similar symptoms. No family HX of neuromuscular disorders.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Muscle spasms, Muscle twitching, Pain, Tremor
Clinical narrative: Received BEXSERO yesterday afternoon about 1500 without issues --- some immediate soreness but seemed fine. Went to volleyball practice in A/C'ed gym after with no issues. Finished practice and went to friends game in a non-air-conditioned gym but was not doing anything but watching. About 2100 began to get a worsening HA (but had some HA on the two days PRIOR to the vaccine as well) and it hurt to "open her eyes". She began shaking a lot, some muscle twitching and "wringing of her neck". She described muscle spasms as the cause of these movements. Mom felt temp. 100.9 in the ER on arrival. Taken to the ER for evaluation. Labs WNL except low Na of 133, rest normal including CT of the head. Once she got a bolus of NS in the ER she significantly improved. No prior episodes of similar symptoms. No family HX of neuromuscular disorders.
Age: 68.0
Sex: U
Vaccine: PPV, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm swelling and redness. Onset PM after PNEUMOVAX.
Age: 9.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Blood glucose normal, Dizziness, Hypotonia
Clinical narrative: HPV and TDaP given at 9:02 and while patient is sitting on the examining table. Mom said that he became limp with eyes closed while being observed as per protocol. Was immediately laid down by mom and assistant. His eyes were closed, no color changes, as soon as he was laying down, open his eyes and asked what happened to him. He said he got dizzy then did not know what happen to him. BP = 102/65 HR = 88 81. He was observed, he was coherent, was feeling dizzy for a while, given few sips of PEDILYTE pops, stated feeling better. Gradually allowed to sit then stand. Discharged at 9:50AM stable vital signs.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site swelling, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: HPV given 8-9-17, (L) arm swelling and pain noticed on 8-16-17. (L) deltoid with raised slightly warm mass. No fever, numbness or weakness. Increased pain with activity. Tx: 5 days prednisone 40 mg Q day to help with swelling.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Local reaction - swelling and redness.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Abscess, Injection site pain, Injection site swelling
Clinical narrative: Shoulder pain and achiness to Lt. side. Noted ball like area to under skin where vaccine was admin. Afebrile at this time. Tx: warm compress to area, F/U in 10 days w/ Health Center.
Age: 52.0
Sex: M
Vaccine: HEPAB
Symptoms: Balance disorder, Coordination abnormal, Disorientation, Dizziness, Fall
Clinical narrative: Pt experienced light headedness, dizziness, loss of coordination and balance and fell to ground. Pt's mother said he was having a seizure, however when I saw pt, he was on ground outside of floor and seem disoriented. He was awake and said he was ok. Pulse was ok. Pt refused further treatment.
Age: 52.0
Sex: M
Vaccine: HEPAB
Symptoms: Seizure
Clinical narrative: Pt experienced light headedness, dizziness, loss of coordination and balance and fell to ground. Pt's mother said he was having a seizure, however when I saw pt, he was on ground outside of floor and seem disoriented. He was awake and said he was ok. Pulse was ok. Pt refused further treatment.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blood creatine phosphokinase, Myalgia, Pain, Pain in extremity
Clinical narrative: Pain within 24 hours of injection, muscles tender to touch, and a few blisters to her right shoulder. Left arm pain x 1 month.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red swollen rash 7+ days will keep covered.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Rt shoulder pain approx 5 hrs after injection then had myalgias, joint fatigue and subjective fever.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 22 cm x 15 cm area of redness without fluctuance (R) upper arm. Mild TTP. Iced at home. Topical BENADRYL applied.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Vaccine give IM and SQ to (R) deltoid on 8/16/17. Today presents with red, swollen, warm to touch area on arm 2" x 3.5" area (circular).
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Dizziness, Erythema, Facial pain, Fatigue, Headache
Clinical narrative: (L) arm Pt had redness, soreness, swelling approx 3-4hrs later. Also jaw/cheek pain, dull headache, felt fatigue and dizzy in evening. Told pt to see provider-given Cephalexin 500 3x/day x 7d. SMZ-TMP DS 800/60 2x/day-7d.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pain in extremity, Pain in jaw, Peripheral swelling
Clinical narrative: (L) arm Pt had redness, soreness, swelling approx 3-4hrs later. Also jaw/cheek pain, dull headache, felt fatigue and dizzy in evening. Told pt to see provider-given Cephalexin 500 3x/day x 7d. SMZ-TMP DS 800/60 2x/day-7d.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Inflammation, Pain
Clinical narrative: Arm is red 2-3 inches, sore - advised to apply cool compress throughout the day don't rub or scratch. Mark area with pen, watch for spreading. Give Ibpro for inflammation come in if redness spreading rapidly or any streaks.
Age: 4.0
Sex: M
Vaccine: HEPA, IPV
Symptoms: Irritability, Vomiting
Clinical narrative: Vomited x 2, fussy.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Chills, Decreased appetite, Diarrhoea, Erythema
Clinical narrative: Pain 100.4, fever, swelling 3/4 of upper arm down ot just above elbow, redness, 3/4 of arm to just above elbow hot to touch, fatigue, anorexia, diarrhea, chills and achy body. Seen in ER for adverse reaction, blood drawn, IV fluids and high dose prednisone taper started.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Pain 100.4, fever, swelling 3/4 of upper arm down ot just above elbow, redness, 3/4 of arm to just above elbow hot to touch, fatigue, anorexia, diarrhea, chills and achy body. Seen in ER for adverse reaction, blood drawn, IV fluids and high dose prednisone taper started.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Arthritis, Arthroscopic surgery, Bursitis, Limb discomfort, Mobility decreased
Clinical narrative: 2 hours after flu vaccine my became heavy and extremely sore. went to doctor on 12/11/15 at 2:30 pm due to pain and arm freezing up on me. Doctor ordered therapy which started on 12/21 but my therapists referred me back to doctor because she didn't see improvement. Doctor sent me for MRI which indicated bursitis, arthritis and tendonitis. Doctor operated on 9/1/16.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Tendonitis
Clinical narrative: 2 hours after flu vaccine my became heavy and extremely sore. went to doctor on 12/11/15 at 2:30 pm due to pain and arm freezing up on me. Doctor ordered therapy which started on 12/21 but my therapists referred me back to doctor because she didn't see improvement. Doctor sent me for MRI which indicated bursitis, arthritis and tendonitis. Doctor operated on 9/1/16.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, HIBV
Symptoms: Cafe au lait spots, Idiopathic urticaria, Injection site mass, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age with prophylaxis. On 06-MAR-2014 the patient was vaccinated with LIQUID PEDVAXHIB lot # J009714 dose 1, intramuscular for prophylaxis. Other suspect therapies included PEDVAXHIB. On 2015 the patient experienced injection site pruritus and injection site mass. On OCT-2015 the patient experienced limb mass. On DEC-2016 the patient experienced rash. On an unknown date the patient experienced cyst, urticaria and product quality issue. The outcome of injection site mass, rash, urticaria, injection site pruritus, limb mass and cyst was reported as not recovered/not resolved. The outcome of product quality issue is unknown.