chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies, and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a physician regarding a female patient of unknown age. Information on medical history, past drugs, concurrent conditions, concomitant medications were not reported. On 17-AUG-2016, the patient was vaccinated with GARDASIL 9 injection, (lot number, Expiry date were unknown) for vaccination. On an unspecified date, the patient experienced persistent headache which was lasting for two weeks. Treatment was not given. No lab diagnostic studies were performed. The outcome of headache was unknown. The reporter did not assess the causal relation of event with respect to GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patient's pertinent medical history reported and concurrent conditions. The patient's concomitant therapies included sterile diluent which was properly stored. On an unknown dates started on or after 29-MAR-2017, the patients were vaccinated with improperly stored doses of PROQUAD, lot number M035689 with expiration date 06-FEB-2018, (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperatures between -9 Celsius (C) and 8 Celsius (C) during 39 hours, there was no previous temperature excursion and digital data logger was filed. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA002753.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot numbers M041082, expiry date 04-APR-2018; M042502, expiry date 17-APR-2018; and M046943, expiry date 27-MAY-2018 (strength, dose, frequency and route of administration were not provided) for prophylaxis. The vaccines were administered along with a sterile diluent (MRK) that was properly stored. Administered vaccines experienced a temperature excursion between 6°F and 14°F during 2 hours and 20 minutes. There was a previous temperature excursion (duration and temperatures were not reported). Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patient's pertinent medical history reported and concurrent conditions. The patient's concomitant therapies included sterile diluent which was properly stored.  On an unknown dates started on or after 29-MAR-2017, the patients were vaccinated with improperly stored doses of VARIVAX, lot number M037642 with expiration date 09-JAN-2018, (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperatures between -9 Celsius (C) and 8 Celsius (C)) during 39 hours, there was no previous temperature excursion and digital data logger was filed. This is one of two reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA002207:
Age: 1.5
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Injection site warmth
Clinical narrative: (L) upper extremity tender to touch, mild erythema to area. Slightly warm to touch, pain and soreness in area. Pt. has numbness and tingling in area as well. Instructed to apply cold compresses and take OTC NSAIDS. Will call in 2 days for a follow up.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Injection site rash
Clinical narrative: (L) upper extremity tender to touch, mild erythema to area. Slightly warm to touch, pain and soreness in area. Pt. has numbness and tingling in area as well. Instructed to apply cold compresses and take OTC NSAIDS. Will call in 2 days for a follow up.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site urticaria, Poor quality sleep
Clinical narrative: (L) upper extremity tender to touch, mild erythema to area. Slightly warm to touch, pain and soreness in area. Pt. has numbness and tingling in area as well. Instructed to apply cold compresses and take OTC NSAIDS. Will call in 2 days for a follow up.
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site mass, Injection site pain
Clinical narrative: Pt. called complaining of a hard lump with soreness at the site of injection. Pt. given appt. and checked by Dr. on 6/1/17.
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Pt. called complaining of a hard lump with soreness at the site of injection. Pt. given appt. and checked by Dr. on 6/1/17.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Day after injection there was some swelling at the site. He went to the E.R. and was diagnosed with cellulitis of the right upper extremity.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Diabetes mellitus, Erythema, Mass, Urticaria
Clinical narrative: Day after injection there was some swelling at the site. He went to the E.R. and was diagnosed with cellulitis of the right upper extremity.
Age: 77.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Bronchitis, Diarrhoea, Laboratory test, Nausea, Urticaria
Clinical narrative: Acute Bronchitis from 11/16/16-12/10/16-Z-PAK. Flu-diarrhea, nausea 2/16/17-2/17/17-hospital. Acute Bronchitis from 4/7/17-5/28/17-Z-PAK. Hives, 8 large hives 5/3/17-5/12/17-diphenhydramine. On arms, hands, elbows, neck. Hives, 5 small hives 5/21/17-5/26/17-diphenhydramine. On hands and right arm.
Age: 77.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Bronchitis, Diarrhoea, Influenza, Nausea, Urticaria
Clinical narrative: Acute Bronchitis from 11/16/16-12/10/16-Z-PAK. Flu-diarrhea, nausea 2/16/17-2/17/17-hospital. Acute Bronchitis from 4/7/17-5/28/17-Z-PAK. Hives, 8 large hives 5/3/17-5/12/17-diphenhydramine. On arms, hands, elbows, neck. Hives, 5 small hives 5/21/17-5/26/17-diphenhydramine. On hands and right arm.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: UPPER INNER PART OF LEFT ARM STARTED HURTING AND ITCHING AND BY NEXT DAY SYMPTOMS BECAME MORE PRONOUNCED.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Computerised tomogram, Dyskinesia, Electrocardiogram, Loss of consciousness, Pallor
Clinical narrative: Patient was out in waiting room with mother. He went unconscious and stop breathing, had no palpable pulse. Staff started CPR, after about 5 chest compressions patient started moving and tremor like jerks. Locked his jaw and then took a deep breath. Sometime during this patient had also wet himself. Vitals signs post waking up: HR:50, Breathing:10-12, BP:70/48, A/o: X2, pale, cool. Transferred care to ambulance.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Peripheral coldness, Pulse absent, Respiratory arrest, Resuscitation, Tremor
Clinical narrative: Patient was out in waiting room with mother. He went unconscious and stop breathing, had no palpable pulse. Staff started CPR, after about 5 chest compressions patient started moving and tremor like jerks. Locked his jaw and then took a deep breath. Sometime during this patient had also wet himself. Vitals signs post waking up: HR:50, Breathing:10-12, BP:70/48, A/o: X2, pale, cool. Transferred care to ambulance.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Trismus, Urinary incontinence
Clinical narrative: Patient was out in waiting room with mother. He went unconscious and stop breathing, had no palpable pulse. Staff started CPR, after about 5 chest compressions patient started moving and tremor like jerks. Locked his jaw and then took a deep breath. Sometime during this patient had also wet himself. Vitals signs post waking up: HR:50, Breathing:10-12, BP:70/48, A/o: X2, pale, cool. Transferred care to ambulance.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Bradycardia, Hypotension, Lethargy, Loss of consciousness, Pulse absent
Clinical narrative: Patient was out in waiting room with mother. He went unconscious and stop breathing, had no palpable pulse. Staff started CPR, after about 5 chest compressions patient started moving and tremor like jerks. Locked his jaw and then took a deep breath. Sometime during this patient had also wet himself. Vitals signs post waking up: HR:50, Breathing:10-12, BP:70/48, A/o: X2, pale, cool. Transferred care to ambulance.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Respiratory arrest
Clinical narrative: Patient was out in waiting room with mother. He went unconscious and stop breathing, had no palpable pulse. Staff started CPR, after about 5 chest compressions patient started moving and tremor like jerks. Locked his jaw and then took a deep breath. Sometime during this patient had also wet himself. Vitals signs post waking up: HR:50, Breathing:10-12, BP:70/48, A/o: X2, pale, cool. Transferred care to ambulance.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On 23-MAY-2017, the patients was vaccinated with improperly stored doses of PEDVAXHIB injection (lot # M045206, expiry date 27-JUN-2019, dose, site and route of administration were not provided). Sterile diluent used for vaccines reconstitution was properly stored. The vaccines were stored in the temperature between 47 and 77 degrees Fahrenheit for 24 hours. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA012848.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous report has been received from a registered nurse and referred to a 24-year-old female patient. The patient did not have any relevant medical history, concurrent conditions or concomitant therapies to be reported. On 24-MAY-2017, the patient was vaccinated with a dose of M-M-R II subcutaneously (strength, dose, and frequency were not reported; lot number M044350 with an expiration date 04-NOV-2018) for immunization that was reconstituted with sterile diluent (DILUENT MRK) (lot number M044350 with an expiration date 04-NOV-2018). Subsequently, 20 minutes later on the same day, while the patient was still at the vaccination site, she developed itching of the entire body without the presence of any visible rash. After medical attention, the patient was treated with oral BENADRYL 25 mg. After this, the patient was sent home with instructions to take additional BENADRYL for itching if needed. There were no laboratory diagnostic tests performed. At the time of this report, the outcome of pruritus generalized was unknown. The causality assessment between pruritus generalized with M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a prescriber nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of injectable VARIVAX (lot# M040139 with expiration date on 28-SEP-2018, and lot# M036292 with expiration date on 17-AUG-2018) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion of "-1" Celsius degrees for 4 hours; digital data logger was involved and there were no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown demographics. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX (lot # M042851, expiry date: 18-JAN-2018) for prophylaxis. No information was available for sterile diluent used to re-constitute the improperly stored ZOSTAVAX. No adverse effects were reported. The ZOSTAVAX was stored at a temperature of 70 Fahrenheit (F) for 18 hours (dates were not reported). There were no previous temperature excursions. The digital data logger was not involved. No Product Quality Complaint (PQC) was involved. Additional information is not expected, no contact details were provided.
Age: 1.17
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received via medical records from a licensed practical nurse and refers to a 14 month old White male patient. On 06-OCT-2009, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, lot# and expiration date were not reported). This is one of two reports concerning the same patient. Additional information is not expected. All available medical records will be provided upon request. Sender's Comments: US-009507513-1705USA009103.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hypoaesthesia, Paraesthesia, Restlessness
Clinical narrative: Mother reported that pt complains that left arm was tingling, numb and feels restless at times.
Age: 60.0
Sex: F
Vaccine: MEA
Symptoms: Erythema, Pyrexia, Swelling, Tenderness
Clinical narrative: Redness, swelling, feverish, and tenderness softball size under arm of injection site.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: Rash and fever and sore arm.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm swelling, redness and warm to touch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site swelling, Injection site erythema, Injection site pain
Clinical narrative: Patient reports a half-dollar sized raised red bump at administration site that is tender to the touch.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site mass
Clinical narrative: Red/bruise lump at injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a female patient of unknown age. The patient's medical history, concurrent conditions, drug and allergy history were not reported.    On 27-MAY-2017, the patient was vaccinated with an expired ZOSTAVAX lot # L032184 and expiration date on 27-MAY-2017 (route and dose were not provided) for prophylaxis. The patient's concomitant therapy was not reported. In addition, it was reported that before vaccination, the patient transported the expired vaccine from an unspecified pharmacy to her office and that was exposed to unknown temperatures for an unknown period of time during transport. No adverse symptoms reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Limb discomfort, Musculoskeletal discomfort, Pain
Clinical narrative: Shooting pain and discomfort in shoulder and upper arm.
Age: 1.17
Sex: M
Vaccine: HEPA
Symptoms: Blood test normal, Chest X-ray normal, Crying, Decreased appetite, Diarrhoea
Clinical narrative: Patient, developed a fever the same night as the vaccination which was May 31st, 2017. At his wellness check u where I was advised he was due for shots. Note: he was not sick at this appointment. Patient attended daycare Friday, June 2nd, 2017. At dismissal time his father and I were informed that he felt warm and did not appear to well. He was brought home and given tylenol to bring down his fever of 100.3. Patient appeared to be wheezing so I administered his asthma medication to him that night through his nebulizer, trying to help his discomfort. I monitored him throughout the night. His breathing eased up, only to become worse the following day, which was June, 3rd, 2017. He started to breath at a rapid pace, his entire chest at the base of his neck would sink in only to pop back out, he, was very irritated, high fever, diarrhea, would not eat or drink, and cried hysterically non-stop. At this point I phoned his doctor to inform her what was taking place and was advised to go to the emergency room where, I had begin to proceed anyway. Patient was checked into hospital at approximately 7:00. I was advised he would have to be admitted because he was in no condition to be released from the hospital due to his difficulty breathing and very rapid heart rate.
Age: 1.17
Sex: M
Vaccine: HEPA
Symptoms: Diet refusal, Discomfort, Dyspnoea, Feeling hot, Fluid intake reduced
Clinical narrative: Patient, developed a fever the same night as the vaccination which was May 31st, 2017. At his wellness check u where I was advised he was due for shots. Note: he was not sick at this appointment. Patient attended daycare Friday, June 2nd, 2017. At dismissal time his father and I were informed that he felt warm and did not appear to well. He was brought home and given tylenol to bring down his fever of 100.3. Patient appeared to be wheezing so I administered his asthma medication to him that night through his nebulizer, trying to help his discomfort. I monitored him throughout the night. His breathing eased up, only to become worse the following day, which was June, 3rd, 2017. He started to breath at a rapid pace, his entire chest at the base of his neck would sink in only to pop back out, he, was very irritated, high fever, diarrhea, would not eat or drink, and cried hysterically non-stop. At this point I phoned his doctor to inform her what was taking place and was advised to go to the emergency room where, I had begin to proceed anyway. Patient was checked into hospital at approximately 7:00. I was advised he would have to be admitted because he was in no condition to be released from the hospital due to his difficulty breathing and very rapid heart rate.
Age: 1.17
Sex: M
Vaccine: HEPA
Symptoms: Irritability, Pyrexia, Respiratory rate increased, Wheezing
Clinical narrative: Patient, developed a fever the same night as the vaccination which was May 31st, 2017. At his wellness check u where I was advised he was due for shots. Note: he was not sick at this appointment. Patient attended daycare Friday, June 2nd, 2017. At dismissal time his father and I were informed that he felt warm and did not appear to well. He was brought home and given tylenol to bring down his fever of 100.3. Patient appeared to be wheezing so I administered his asthma medication to him that night through his nebulizer, trying to help his discomfort. I monitored him throughout the night. His breathing eased up, only to become worse the following day, which was June, 3rd, 2017. He started to breath at a rapid pace, his entire chest at the base of his neck would sink in only to pop back out, he, was very irritated, high fever, diarrhea, would not eat or drink, and cried hysterically non-stop. At this point I phoned his doctor to inform her what was taking place and was advised to go to the emergency room where, I had begin to proceed anyway. Patient was checked into hospital at approximately 7:00. I was advised he would have to be admitted because he was in no condition to be released from the hospital due to his difficulty breathing and very rapid heart rate.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient seen for concerns about redness and swelling of left leg, starting approximately 24 hours after administration of 18month vaccines.  Immunizations received 5 June and 24 hours after administration of vaccine, Patient developed swelling and redness around injection site that spread over entire leg on 6 June. 6/7, seems to be somewhat improved. Redness remains, but swelling mostly resolved. No fever, limping, increased irritability. No drainage from injection sites. No respiratory symptoms or change in mental status.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site pain, Injection site reaction, Injection site swelling, Peripheral swelling
Clinical narrative: Started with extreme soreness at shot site. Then are becamse swollen. Swelling continued on and stopped by the next day. Swollen so much that the skin was tight on my upper arm. The following day, my forearm became a little swollen. Around 18:00 I started getting chills. Chills worsed and had to go to bed. Chills so severe that I was literally shaking. Wrote Dr. an email the next day and about 2 hours later an advice RNP called. Described what was going on. No further action taken. Swelling disapated over the week and was gone by the next Friday.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Skin tightness, Tremor
Clinical narrative: Started with extreme soreness at shot site. Then are becamse swollen. Swelling continued on and stopped by the next day. Swollen so much that the skin was tight on my upper arm. The following day, my forearm became a little swollen. Around 18:00 I started getting chills. Chills worsed and had to go to bed. Chills so severe that I was literally shaking. Wrote Dr. an email the next day and about 2 hours later an advice RNP called. Described what was going on. No further action taken. Swelling disapated over the week and was gone by the next Friday.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Reddened area below the injection site, with tenderness and warmth to the area. Denied itching or drainage at the time.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: Patient received vaccination. Several hours later, she experienced swelling and irritation at the injection site. The following day the swelling went away but the area was still warm and irritated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA, MMRV, PNC13
Symptoms: Headache
Clinical narrative: A few minutes after last vaccine administered the patient complained of a headache.
Age: 9.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Fall, Staring
Clinical narrative: After administering MMRV and HepA vaccines to patient (while seated), I told him to let me know if he felt lightheaded or nauseous. I turned to enter the vaccines into the registry and he slithered to the floor. His father confirmed that his son was not acting (the boy had a vacant look on his face). I immediately called 9-1-1. Within less than a minute the patient was responding to verbal commands and trying to rise. We kept him on the floor until paramedics arrived to take over care.
Age: 7.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: 3x6 inch area around injection site red, hard, swollen, itchy.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Exposure during pregnancy, Nausea, Vomiting
Clinical narrative: Severe diarrhea, vomiting, and nausea.
Age: 67.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Myalgia, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of localized muscle pain in a 67-year-old male patient who received BOOSTRIX (batch number ZN937, expiry date 5th July 2019). Concomitant products included Pneumococcal Vaccine. On 12th May 2017, the patient received BOOSTRIX. On 13th May 2017, 1 days after receiving BOOSTRIX, the patient experienced localized muscle pain. The patient was treated with ADVIL. On an unknown date, the outcome of the localized muscle pain was not recovered/not resolved. It was unknown if the reporter considered the localized muscle pain to be related to BOOSTRIX. Additional details were reported as follows: The concomitant product included pneumococcal 23. On the same day of vaccination after going to the gym that evening, returning home and waking up the next morning, the patient experienced severe pain in deltoid with range of motion. The patient returned back to the physician's office that morning and was icing area and took ADVIL with no further treatment options provided at that time. No other symptoms were reported regarding the event. The batch number reported for BOOSTRIX (2N937) did not exist and was updated to ZN937, as per sales database.
Sex: U
Vaccine: HEP
Symptoms: Feeling hot, Nausea, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nausea in a adult patient who received ENGERIX B (batch number XM59T, expiry date unknown). In May 2017, the patient received ENGERIX B. In May 2017, less than a month after receiving ENGERIX B, the patient experienced nausea, feeling hot and pain arm. On an unknown date, the outcome of the nausea, feeling hot and pain in arm were unknown. It was unknown if the reporter considered the nausea, feeling hot and pain in arm to be related to ENGERIX B. Additional details were reported as follows: This case was reported by medical distributor. The patient was also an employee. The age at vaccination was not provided. Limited information was provided by the reporter. This case was 1 of the 5 cases, reported by the same reporter.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, less than a week after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The patient age not provided by the sales representative. The physician reported to the sale representative that she administered the suspect product to herself and stated that she had very sharp intense pain at the injection site for about a week afterward. While injecting vaccine the physician did not stated that where the vaccine was injected and kept pointing to left arm. The timing of this experience was not known. The physician did not mind being contacted related to this complaint. The office purchases vaccines with both private and public funds. The lot and expiration date of the vaccine was asked to the physician but it was not available for this report.
Sex: U
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nausea in a adult patient who received ENGERIX B (batch number XM59T, expiry date unknown). In May 2017, the patient received ENGERIX B. In May 2017, less than a month after receiving ENGERIX B, the patient experienced nausea and vomiting. On an unknown date, the outcome of the nausea and vomiting were unknown. It was unknown if the reporter considered the nausea and vomiting to be related to ENGERIX B. Additional details were reported as follows: The case was received from a medical distributor. The patient was also an employee. The age at vaccination was not reported. This case was 4 of the 5 cases, reported by the same reporter.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Vertigo
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vertigo in a 12-year-female patient who received MENVEO (batch number M16096, expiry date 31st March 2018). On 3rd May 2017, the patient received MENVEO (intramuscular). On 7th May 2017, 4 days after receiving MENVEO, the patient experienced vertigo. In May 2017, the patient experienced headache. On an unknown date, the outcome of the vertigo and headache were unknown. The reporter considered the vertigo to be possibility related to MENVEO. It was unknown if the reporter considered the headache to be related to MENVEO. Additional details were provided as follows: At 1:00 hours, the patient received a dose of MENVEO on left deltoid. In May 2017, less than a month, after receiving MENVEO, the patient experienced headaches.
Age: 79.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: There were no adverse reactions noted. Realized after patient left that vaccine had expired. Patient was called and informed of the mistake.
Sex: U
Vaccine: HEP
Symptoms: Injection site urticaria, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site hives in a adult patient who received ENGERIX B adult (batch number XM59T, expiry date unknown). In May 2017, the patient received ENGERIX B adult. In May 2017, less than a month after receiving ENGERIX B adult, the patient experienced injection site hives and fever. On an unknown date, the outcome of the injection site hives and fever was unknown. It was unknown if the reporter considered the injection site hives and fever to be related to ENGERIX B adult. Additional details were provided as follows: The case was received from a medical distributor. The age at vaccination was not reported. The patient was also an employee who experienced hives around the vaccine site after vaccination. This case was 2nd case out of the 5 cases, reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Injection site reaction, Muscle twitching
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site muscle reaction in an unspecified number of patients who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular) .5 ml. On an unknown date, immediately after receiving BEXSERO, the patient experienced injection site muscle reaction. On an unknown date, the outcome of the injection site muscle reaction was unknown. It was unknown if the reporter considered the injection site muscle reaction to be related to BEXSERO. Additional details were reported as follows: The age at vaccination of the patients was not reported, it could be between 16 to 23 years of age. The physician stated that every time she inserted the needle into the arm of the patients and began to administer the vaccine, she noticed the muscle twitches.
Age: 24.0
Sex: U
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 24-year-old patient who received MENVEO. In April 2017, the patient received MENVEO. On an unknown date, less than a month after receiving MENVEO, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to MENVEO. Additional details were provided as follows: Age at vaccination was not reported but could be 23 or 24 years. At the time of reporting, the patient was 24 years old. One month ago from the date of reporting, the patient received a dose of MENVEO and was still reporting pain and swelling at the injection site at the time of reporting. The pharmacist refused to provide further information.
Sex: F
Vaccine: MENB
Symptoms: Injection site urticaria, Injection site vesicles
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site wheal in a 20-year-old female patient who received BEXSERO. On 15th June 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site wheal and injection site blisters. BEXSERO was continued with no change. On an unknown date, the outcome of the injection wheal and injection site blisters were recovered/resolved. The reporter considered the injection site wheal and injection site blisters to be probably related to BEXSERO. Additional details provided as follows: The age at vaccination was not reported. The patient experienced a 1 inch welt with blisters at the injection site after receiving BEXSERO. The welt lasted for about 1 month. The patient received the 2nd dose of BEXSERO and did not have pain at the injection site. No other vaccines were administered.
Age: 54.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Pruritus, Swelling, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 54-year-old female patient who received MENVEO (batch number M16096, expiry date 31st March 2018). On 23rd May 2017, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On 24th May 2017, 1 days after receiving MENVEO, the patient experienced pain, hives, pruritus and swelling. The patient was treated with Steroid Cream. On an unknown date, the outcome of the pain, hives, pruritus and swelling were not recovered/not resolved. It was unknown if the reporter considered the pain, hives, pruritus and swelling to be related to MENVEO. Additional details were provided as follows: The patient received MENVEO on right deltoid. The pharmacist reported that the patient returned to physician's office on 25th May 2017 after receiving vaccine. The noted symptoms had worsened requiring a physician visit and a topical steroid cream was being prescribed. The pharmacist noted the patient did take other medications but those were not provided. It was unknown at the time of reporting about continuing with this vaccine in the future.
Sex: U
Vaccine: HEP
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nausea in a adult patient who received ENGERIX B (batch number XM59T, expiry date unknown). In May 2017, the patient received ENGERIX B. In May 2017, less than a day receiving ENGERIX B, the patient experienced nausea, vomiting and rash to be related to ENGERIX B. Additional details were reported as follows: The case was received from a medical distributor. The age at vaccination was not reported. This case was 4 of the 5 cases, reported by same reporter.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received BEXSERO. Concomitant products included MENVEO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were recovering/resolving. The reporter considered the injection site pain to be related to BEXSERO. It was unknown if the reporter considered the injection site swelling to be related to BEXSERO. Additional details were reported as follows: The reporter reported that his daughter was administered BEXSERO in his office and experienced the events. The field rep wasn't sure if it was the physician himself or a staff member, who administered the vaccine to the patient. The field representative was not certain about the concomitant vaccine but thought it was MENVEO. It was reported that the onset date was not known but field representative said it was recently occurred. The events were better but not completely gone.
Sex: U
Vaccine: HEP
Symptoms: Injection site pruritus, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of general body pain in a adult patient who received ENGERIX B (batch number XM59T, expiry date unknown). In May 2017, the patient received ENGERIX B. In May 2017, less than a month after receiving ENGERIX B, the patient experienced general body pain, sore throat, injection site itching and fever. On an unknown date, the outcome of the general body pain, sore throat, injection site itching and fever were unknown. It was unknown if the reporter considered the general body pain, sore throat, injection site itching and fever to be related to ENGERIX B. Additional details were reported as follows: This case was reported by a medical distributor. The age at vaccination was not reported. This case was one of the 5 cases, reported by same reporter.
Sex: U
Vaccine: HEP
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a physician and described the occurrence of adverse reaction in a unspecified number of patients who received ENGERIX B adult. On 15th March 2017, the patients received ENGERIX B adult. On an unknown date, less than a year after receiving ENGERIX B adult, the patients experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to ENGERIX B adult. Additional details were provided as follows: It was reported that all the patients who were vaccinated on 15th March 2017, were called with adverse event. This case has been linked with case US2017040276, reported by the same reporter.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Hypersensitivity, Oropharyngeal pain, Purpura, Pyrexia, Rash generalised
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of hypersensitivity reaction in a 16-year-old male patient who received MENVEO. On 15th May 2017, the patient received the 1st dose of MENVEO. On 15th May 2017, less than a day after receiving MENVEO, the patient experienced hypersensitivity reaction, purpuric rash, sore throat, fever and vasculitic rash. On an unknown date, the outcome of the hypersensitivity reaction, purpuric rash, sore throat, fever and vasculitic rash were unknown. It was unknown if the reporter considered the hypersensitivity reaction, purpuric rash, sore throat, fever and vasculitic rash to be related to MENVEO. Additional details were provided as follows: The physician reported that the patient experienced a rash that started on his feet and moved his way up his entire body within an hour of 2 after the injection and rash spread to his legs, arms, neck. The physician reported that it was a purpuric rash or vasculitic type rash. On 18th May 2017, the physician observed the patient and the rash had started to get better from when the patient first experienced the rash, but the rash was still there somewhat. The physician reported that the rash spread very quickly. No further information was provided.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Vasculitic rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of hypersensitivity reaction in a 16-year-old male patient who received MENVEO. On 15th May 2017, the patient received the 1st dose of MENVEO. On 15th May 2017, less than a day after receiving MENVEO, the patient experienced hypersensitivity reaction, purpuric rash, sore throat, fever and vasculitic rash. On an unknown date, the outcome of the hypersensitivity reaction, purpuric rash, sore throat, fever and vasculitic rash were unknown. It was unknown if the reporter considered the hypersensitivity reaction, purpuric rash, sore throat, fever and vasculitic rash to be related to MENVEO. Additional details were provided as follows: The physician reported that the patient experienced a rash that started on his feet and moved his way up his entire body within an hour of 2 after the injection and rash spread to his legs, arms, neck. The physician reported that it was a purpuric rash or vasculitic type rash. On 18th May 2017, the physician observed the patient and the rash had started to get better from when the patient first experienced the rash, but the rash was still there somewhat. The physician reported that the rash spread very quickly. No further information was provided.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Bursitis, Drug administered at inappropriate site
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of vaccine administered at inappropriate site in a 18-year-old female patient who received BEXSERO (batch number 158401, expiry date unknown). On 13th April 2017, the patient received BEXSERO. On 13th April 2017, unknown after receiving BEXSERO, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown. Additional details were reported as follows: The patient received a dose of BEXSERO inadvertently into the joint capsule of the left shoulder, which led to vaccine administered at inappropriate site. Follow up information was received from a physician on 25th May 2017: The patient's demographic details were updated. The patient received 1st dose of BEXSERO 0.5 ml intramuscularly. In 2017, less than a year after vaccination with BEXSERO, the patient experienced bursitis. At the time of reporting, bursitis was completely resolved. It was unknown if the reporter considered the bursitis to be related to BEXSERO. The VAERS details were updated.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Eyelid oedema, Pruritus, Urticaria
Clinical narrative: Patient developed hives, swelling around her eyes, itching several hours after receiving meningococcal B vaccine.
Sex: M
Vaccine: MENB
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO 0.5 ml. On an unknown date, less than a day after receiving BEXSERO, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. The reporter considered the injection site swelling to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to manufacturer. This case was reported by Certified Medical Assistant (CMA). The age at vaccination was not reported. The CMA reported to the field employee that she observed a male patient receiving the suspect vaccine in the arm (which arm not specified), along with multiple unspecified vaccines on the same day, date unspecified, and the patient experienced significant are swelling at the injection site of the BEXSERO after receiving the dose. No additional information was provided to the filed employee for this report.  The patient had denied permission to contact their physician.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Electrocardiogram, Electroencephalogram, Gait disturbance, Increased upper airway secretion, Irritability
Clinical narrative: Yesterday evening just after 7 PM parents called me; Was in for his 4 month well visit today, and received his 4 month vaccines (DTaP-IPV-HIB, PCV-13 and RV-5) - about 6 hours prior. Just then they had given him a bath; after the bath he became very fussy, then started screaming, his eyes opened and closed, and he became very pale. He was afebrile. He was now asleep, his color was normal again - but he had red blotches on his shins. I suggested: Let him sleep a while - then try to feed him (his last bottle was about 1 1/2 hours ago). Call me back if he refuses to feed; becomes febrile; or deviates in any other way from normal. I already discussed with his parents that this is possibly a reaction to the DTaP vaccine - rare, but "serious". Mom tells me now that he slept almost 4 hours after this episode. Reviewing the history again, after the bath mom put on his pajamas - "like a switch, nothing we've heard before, he started screaming". He screamed for 3 minutes (red while screaming) - mom eventually put him down in his crib - he became pale, and his eyes kept opening and closing. No limb movements, no stiffness - just limp. Then - after a few minutes - his color came back, he made some grumbling noises, took his pacifier and fell asleep. Mom has seen him "almost hold his breath" in the past - but "this wasn't like it". He woke up at midnight, took 6 oz, by bottle and went right back to sleep. He was up every hour because he lost his pacifier, went straight back to sleep. Mom doesn't want to be looking for things - but he is making some throat noises, like throwing up in his mouth, and has already taken two naps this morning; but he is making eye contact, smiling, had had wet diapers.