chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13, PNC13
Symptoms: No adverse event
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity started to receive PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatigue, and also some myalgia, some muscle pain on an unspecified date. She said she got the shot on the night and she said it seems like it was getting worst. She guess, muscle and joint pain actually. The outcome was not recovered.
Age: 18.0
Sex: F
Vaccine: HPVX, MENB
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable unspecified Healthcare professional via a Pfizer sales representative. A 18-year-old female patient of unknown age and race/ethnicity received approximately a month before this report (unspecified date in 2018) a single dose of TRUMENBA, lot S58877, expiration date 28feb2019) for immunization. Medical history was not reported. Concomitant medication administered in the same date included hpv vaccine (manufacturer unknown) for immunization. Patient had a severe headache the evening of the vaccines given. Patient almost went to ER. Parent called the provider and she told her to take ADVIL. Patient did and the headache went away by morning. Headache lasted approximately 12 hours and resolved on an unspecified date in 2018.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: Patient was light headed and nauseous after 911 call paramedics arrived no treatment was administered/she got better after a drink of orange juice and some rest.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Sweating, nausea, dizziness.
Age: 8.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Development of fever and localized rash within one day of vaccination, progressing to full body rash and joint pain in hands, feet, knees and hips by 2/17/16. Painful gait. Pain unrelieved by TYLENOL. Doctor's office visit on 2/20/16; advised to switch from TYLENOL to ibuprofen for joint pain and ongoing fever. Advised to return for course of Prednisone if not resolved within one week. Pain and fever resolved without follow up visit.
Age: 8.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Development of fever and localized rash within one day of vaccination, progressing to full body rash and joint pain in hands, feet, knees and hips by 2/17/16. Painful gait. Pain unrelieved by TYLENOL. Doctor's office visit on 2/20/16; advised to switch from TYLENOL to ibuprofen for joint pain and ongoing fever. Advised to return for course of Prednisone if not resolved within one week. Pain and fever resolved without follow up visit.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Severe soreness in arm at injection site. Soreness on movement and at contact.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypersensitivity, Injection site pain, Urticaria
Clinical narrative: Intense muscle pain in an area 6 inches around vaccination site. I was warned about this and expected it. However, I also woke up with hives all over my body the next morning. I self treated with oral BENADRYL and topical CORTIZONE (I used several tubes) and the hives went away. However, they have reoccurred multiple times in various areas in the last 32 hours, especially while I sleep, sit still or wear tight clothing. Glaxo didn't seem interested in much of the details of the hives or sharing any information they may have of similar reactions. They just kept referring me to the package insert, which I didn't have. I was given the CDC Vaccine info statement dated 2-12-18 which warns of hives as a sign of a severe allergic reaction. The Glaxo rep claimed their product info didn't mention hives at all.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Urticaria
Clinical narrative: Intense muscle pain in an area 6 inches around vaccination site. I was warned about this and expected it. However, I also woke up with hives all over my body the next morning. I self treated with oral BENADRYL and topical CORTIZONE (I used several tubes) and the hives went away. However, they have reoccurred multiple times in various areas in the last 32 hours, especially while I sleep, sit still or wear tight clothing. Glaxo didn't seem interested in much of the details of the hives or sharing any information they may have of similar reactions. They just kept referring me to the package insert, which I didn't have. I was given the CDC Vaccine info statement dated 2-12-18 which warns of hives as a sign of a severe allergic reaction. The Glaxo rep claimed their product info didn't mention hives at all.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Intense muscle pain in an area 6 inches around vaccination site. I was warned about this and expected it. However, I also woke up with hives all over my body the next morning. I self treated with oral BENADRYL and topical CORTIZONE (I used several tubes) and the hives went away. However, they have reoccurred multiple times in various areas in the last 32 hours, especially while I sleep, sit still or wear tight clothing. Glaxo didn't seem interested in much of the details of the hives or sharing any information they may have of similar reactions. They just kept referring me to the package insert, which I didn't have. I was given the CDC Vaccine info statement dated 2-12-18 which warns of hives as a sign of a severe allergic reaction. The Glaxo rep claimed their product info didn't mention hives at all.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Having a local reaction. Slightly swollen, raised, red and painful area at the injection site. Its probably 4 inches long and egg shaped. Applying warm packs and taking TYLENOL helps. Tired and had some chills.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: Having a local reaction. Slightly swollen, raised, red and painful area at the injection site. Its probably 4 inches long and egg shaped. Applying warm packs and taking TYLENOL helps. Tired and had some chills.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, tender, small bump for 2 days at injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Several hours after administration, patient reported that her arm was red, warm and seemed swollen and hard in area around injections site. In the first 24 hours this reaction continued extending to area near elbow. In the first 24 hours it seemed the worst, sensitive to pressure, and hot to touch. Began to resolve after 24 hours, but continued thru 48 hours.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial pain, Rash pustular, Rash vesicular
Clinical narrative: Shingle like rash/pain from top right center of forehead to above the right eye with pustules lasting over 10 days.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Shingle like rash/pain from top right center of forehead to above the right eye with pustules lasting over 10 days.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: Waited 15 min. after shot in office, felt fine so went home. Started feeling itching B/L hips and spread down thighs. Saw hives. Took BENADRYL x1 dose, most of it went away. No sob/swelling. No other new exposures.
Age: 0.0
Sex: M
Vaccine: HIBV
Symptoms: Drug administration error, No adverse event
Clinical narrative: There was no adverse effect as a result of this vaccine administration error and no harm to the patient. After the error happened, we consulted with our Chief of Pediatrics/ID specialist and he said it would be best to enter it in VAERS. The parent was notified and a physician discussed the error with mom and answered all of her questions/concerns and assured her there was no harm to the patient's health.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Chest pain, Painful respiration
Clinical narrative: Pain in chest, intensified on inhale.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself. No information was provided regarding the patient's medical, drug and allergy history or concurrent conditions. On 06-MAR-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (dose number, route, location of administration, lot number and expiration date were not reported). On 07-MAR-2018, the patient woke up with "pain, severe swelling, and redness at the injection site". She also reported that the area was "hot to touch". The area affected was from "the shoulder all the way down to the elbow". No treatment was given to treat the events. The outcome of the aforementioned events was not recovered. The causality assessment between the events and PNEUMOVAX 23 was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 27-AUG-2015, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended. On or about 19-APR-2016, the patient was treated for the onset of a rash which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2014, the patient was inoculated by a physician with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated by a physician and diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2008, the patient was inoculated at medical center with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated and diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2008, the patient was inoculated by a physician with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the female patient was treated by a physician (optometrist) at an eye care facility and was diagnosed with Herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 23-MAR-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 14-DEC-2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 23-MAR-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 22-SEP-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 05-JAN-2016, the patient was treated and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-SEP-2009, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster.  In or about May 2016, the patient was treated at the same clinic and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-APR-2016, the patient was inoculated with ZOSTAVAX at a medical clinic as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended. In or about May 2016, the patient was treated by a physician and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Chills, Headache, Pallor, Seizure like phenomena
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age, race, ethnicity and gender received TRUMENBA at single dose via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient had sudden seizure type event, felt weak and had headache for number of days following vaccine administration, was pale and had chills. Outcome was unknown. The information on the batch number has been requested. Sender's Comments: This case is poorly documented. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 0.25
Sex: M
Vaccine: PNC13
Symptoms: Infantile apnoea
Clinical narrative: This is a spontaneous report from a contactable nurse. A 12-week-old male patient of an unspecified ethnicity received PREVNAR 13 (NDC number 0005197102, Lot# S15257, Expiry date: 01Sep2018), intramuscular on 11Dec2017 at 0.5 ml, single for child immunization schedules. Medical history were none. Concomitant medication included VITAMIN D Drops as supplement. The patient experienced brief resolved unexplained events in an infant, basically stopped breathing on 12Dec2017. He was given the vaccine on 11Dec2017 and then the following day, the patient went to the ER for basically stopped breathing. It just happened that one time. No treatment received. He had not received any additional doses of pneumococcal 13-val conj vac (dipht crm197 protein). The outcome was recovered.
Age: 29.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Arthralgia
Clinical narrative: Patient had painful shoulder joint for over 3 weeks.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: L deltoid 6 cm red tender swelling at site.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Breath holding, Cyanosis, Dyspnoea, Pallor, Presyncope
Clinical narrative: It appeared to be more of a vasovagal event. After receiving vaccines she was crying and then started to gag on her post nasal drip. She was gasping for air and turned very pale. The breath holding was x 3 for about 5 seconds each. No angioedema no retractions. Paleness lasted about 10 minutes. Nursed on mom and O2 stayed at 96-98% within 10 minutes of event.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Retching, Upper-airway cough syndrome
Clinical narrative: It appeared to be more of a vasovagal event. After receiving vaccines she was crying and then started to gag on her post nasal drip. She was gasping for air and turned very pale. The breath holding was x 3 for about 5 seconds each. No angioedema no retractions. Paleness lasted about 10 minutes. Nursed on mom and O2 stayed at 96-98% within 10 minutes of event.
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, PNC13, DTAPHEPBIP, FLU4, HEPA, PNC13
Symptoms: Acute respiratory failure, Ataxia, Endotracheal intubation, Paralysis
Clinical narrative: Ataxia, acute flaccid paralysis requiring intubation, acute respiratory failure.
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, PNC13, DTAPHEPBIP, FLU4, HEPA, PNC13
Symptoms: Feeding tube user, Gastrostomy, Immobile, Immunoglobulin therapy, Mechanical ventilation
Clinical narrative: Ataxia, acute flaccid paralysis requiring intubation, acute respiratory failure.
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, PNC13, DTAPHEPBIP, FLU4, HEPA, PNC13
Symptoms: Mobility decreased, Neurological examination, Peripheral sensorimotor neuropathy, Tracheostomy
Clinical narrative: Ataxia, acute flaccid paralysis requiring intubation, acute respiratory failure.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Headache, Insomnia, Myalgia
Clinical narrative: Sore muscles and joints, headache, red face, difficulty sleeping - no redness or swelling to injection site.
Age: 29.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: PATIENT SCREENED FOR VACCINATIONS. MARKED "NO" TO ARE YOU PREGNANT OR PLAN ON  BECOMING PREGNANT IN THE NEXT THREE MONTHS. AFTER IMMUNIZATION WAS COMPLETED  PATIENT HAD AN APPOINTMENT FOR OVERSEAS SCREENING A PREGNANCY TEST CAME OUT POSTIVE. PATIENT WITH LMP OF 16JAN18 NEG. PREGNANCY TEST 09FEB18/13FEB18. HAD NEXPLANON PLACED 13FEB18. ON MARCH 23, 2018 NEXPLANON REMOVED.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red spots that appeared around left ear on 3/23/18 and have since spread to face neck abdomen and back, spots itch.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient received vaccination on 3/23 and began to have hives during the early morning of 3/26. Patient insists that they there are no other factors that could have contributed to this reaction. Patient was advised to take BENADRYL and go to her PCP where she was prescribed prednisone.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Induration, Local reaction, Skin warm
Clinical narrative: Preferred route IM. Was given SQ in error. Patient with local reaction, 2 cm warm indurated.
Age: 27.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Altered state of consciousness, Confusional state, Dizziness, Fatigue, Hypertonia
Clinical narrative: Patient received initial vaccinations for both Anthrax and Typhoid. While waiting at a post-vaccine documentation station a few yards away, patient complained of nausea and light-headedness. A chair was produced and patient was assisted into the chair. On the scene assisting him were two medical professionals, and myself, a physician assistant. Suddenly patient expressed increased tone in bilateral upper extremity. This was followed by an alteration of consciousness, with tonic-clonic movements of upper extremity. Suspected seizure-like activity lasted resolved under 15 seconds. There was a post-ictal period of confusion and fatigue. An ambulance was called.
Age: 27.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Nausea, Postictal state, Seizure like phenomena, Tonic clonic movements
Clinical narrative: Patient received initial vaccinations for both Anthrax and Typhoid. While waiting at a post-vaccine documentation station a few yards away, patient complained of nausea and light-headedness. A chair was produced and patient was assisted into the chair. On the scene assisting him were two medical professionals, and myself, a physician assistant. Suddenly patient expressed increased tone in bilateral upper extremity. This was followed by an alteration of consciousness, with tonic-clonic movements of upper extremity. Suspected seizure-like activity lasted resolved under 15 seconds. There was a post-ictal period of confusion and fatigue. An ambulance was called.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Per patient: Dr. - I had a pretty bad reaction to the SHINGRIX vaccination I got at your office last Monday. I had muscle aches all over, a pounding headache and I think a fever for several hours. I had these for about 24 hours. I understand that this is a fairly common reaction to this vaccine but the paper I was given after the shot said it should be reported to agency.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Rash, Rash erythematous, Rash pruritic, Rash pustular
Clinical narrative: PATIENT HAS BEEN OBSERVING RED SPOTS COME UP ALONG HER ARM, IT WOULD APPEAR AND PUSS OVER AND CAUSE A BRUISE. PATIENT DOES SAY IT IS ITCHY, BUT IT'S NOT IN CLUSTERS. AND IT'S ONLY OCCURING ON THE LEFT SIDE OF HER BODY WHERE SHE GOT THE INJECTION.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Injection site erythema, Rash pustular, Scab
Clinical narrative: PATIENT HAS BEEN OBSERVING RED SPOTS COME UP ALONG HER ARM, IT WOULD APPEAR AND PUSS OVER AND CAUSE A BRUISE. PATIENT DOES SAY IT IS ITCHY, BUT IT'S NOT IN CLUSTERS. AND IT'S ONLY OCCURING ON THE LEFT SIDE OF HER BODY WHERE SHE GOT THE INJECTION.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Fever (up to 104F), malaise, muscle aches, took 48-72 hours to resolve.
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: C-reactive protein, Full blood count, Mobility decreased, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: Extreme arm pain, unable to move entire shoulder.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Patient reported nausea, vomiting, and fever beginning about 12 hours after receiving the vaccine and lasting for about 3 hours.
Age: 33.0
Sex: F
Vaccine: DTAPHEPBIP, HPV9, IPV, MMR
Symptoms: Back pain, Haemorrhage, Headache, Laboratory test, Menorrhagia
Clinical narrative: Headaches, ovarian cyst, I'm losing my right ovary due to cysts, heavy periods, backache, fatigue. I wrote all this in the wrong section. Cyst ruptured almost bled to death.
Age: 33.0
Sex: F
Vaccine: DTAPHEPBIP, HPV9, IPV, MMR
Symptoms: Nuclear magnetic resonance imaging, Ovarian cyst, Ovarian cyst ruptured, Ultrasound scan
Clinical narrative: Headaches, ovarian cyst, I'm losing my right ovary due to cysts, heavy periods, backache, fatigue. I wrote all this in the wrong section. Cyst ruptured almost bled to death.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain, Peripheral swelling
Clinical narrative: Body ache, swollen arm, red, bruising, pain.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal X-ray, Abdominal pain upper, Back pain, Blood test normal, Chest X-ray normal
Clinical narrative: Patient's main symptom is constant, severe chest pain. He also suffers from dizziness, fatigue, lack of appetite, and intermittent pain in his stomach, side, and back. He has been sick since Monday, Feb 26th 2018. At office, he has seen 4 different doctors (two PCPs, 1 pediatrician, 1 pediatric GI specialist). He is yet undiagnosed.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Decreased appetite, Dizziness, Electrocardiogram normal, Fatigue
Clinical narrative: Patient's main symptom is constant, severe chest pain. He also suffers from dizziness, fatigue, lack of appetite, and intermittent pain in his stomach, side, and back. He has been sick since Monday, Feb 26th 2018. At office, he has seen 4 different doctors (two PCPs, 1 pediatrician, 1 pediatric GI specialist). He is yet undiagnosed.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Flank pain, Malaise, Stool analysis normal
Clinical narrative: Patient's main symptom is constant, severe chest pain. He also suffers from dizziness, fatigue, lack of appetite, and intermittent pain in his stomach, side, and back. He has been sick since Monday, Feb 26th 2018. At office, he has seen 4 different doctors (two PCPs, 1 pediatrician, 1 pediatric GI specialist). He is yet undiagnosed.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Tendonitis, X-ray normal
Clinical narrative: Seeing Dr on 3/28/18 for (D) shoulder bursitis/tendonitis with H/O T.O.S. Did not report this until 3/15/18. Still with sx.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Injection site pain, Pneumonia, Pyrexia, Respiratory symptom
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 65-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 8th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 8th March 2018, less than a day after receiving SHINGRIX, the patient experienced fever (serious criteria disability) and injection site pain (serious criteria disability). In March 2018, the patient experienced inability to work, pneumonia (serious criteria disability and GSK medically significant) and respiratory symptom (serious criteria disability). On an unknown date, the outcome of the fever, injection site pain, inability to work, pneumonia and respiratory symptom were unknown. It was unknown if the reporter considered the fever, injection site pain, inability to work, pneumonia and respiratory symptom to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the left deltoid. The patient experienced soreness at the injection site. Couple days after vaccination with SHINGRIX, the patient complained that he had pneumonia and respiratory symptoms. Less than a week after vaccination, the patient went to see the doctor and also missed 1 week of work due to these symptoms.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Febrile convulsion, Seizure, Vaccination complication
Clinical narrative: Per mother at 4 AM 3/23/2018 pt had a seizure call 911, pt was evaluated by paramedics was told reaction from immunizations, febrile seizure. This is the 1st episode of seizure.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia, Rash generalised, Rash maculo-papular
Clinical narrative: Rash - Sat 3/24. Rash all over body. Fever started 24 hours after vaccines (100) lasted 4 days. Generalized med sized papules and macules - All over including  palms and soles, no weeping, no warm to touch.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 1 week after shot was given, patient noticed area of injection swell to size of golf ball. Looked red and inflamed with heat per patient. Patient took TYLENOL and BENADRYL and iced area. Also was prescribed steroids by MD.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Anti-thyroid antibody positive, Blood cholesterol abnormal, Blood thyroid stimulating hormone increased, Inflammation, Pruritus
Clinical narrative: This spontaneous case, initially received on 10-Dec-2017, from health authority (VAERS ID: 697639) via other health professional, concerns a 66-year-old female patient. The patient's historical condition included breast cancer for which radiation treatments and ARIMIDEX for 5 years from an unspecified date in 2010 to an unspecified date in Oct-2015. The historical drug included, ALLEGRA and unspecified vaccines for unknown indications. The current illness included abnormal blood cholesterol, blood pressure and hole in heart (cardiac septal defect). The concomitant medication included Losartan for blood pressure, fish oil and niacin for abnormal blood cholesterol, aspirin for hole in heart. On 01-Nov-2015, the patient was administered with INN Flu Vaccine Seasonal (anatomical location: arm, dose, route of administration, batch no and expiry date, trade name and manufacturer: not reported). On the same day, the patient was administered with PREVENAR 13 vaccine, anatomical location: arm, dose: single dose (as reported), route of administration, batch no and expiry date: not reported). On an unspecified date in Nov-2015, after vaccination, the patient experienced hives on her legs, which spread to her whole body. On an unspecified date in Nov-2015, she experienced itching and the patient received unspecified treatment. On an unknown date, the patient consulted endocrinologist. The lab test of the patient included TSH (thyroid stimulating hormone) which showed inflammation and the antibodies to thyroid antibodies were positive. The patient was prescribed with levothyroxine. It was reported that the patient was on levothyroxine for a month and from Apr-2016, she was on levothyroxine 75 mcg. The outcome of the event hives was reported as not recovered. The outcome of the other events was not recovered. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Urticaria
Clinical narrative: This spontaneous case, initially received on 10-Dec-2017, from health authority (VAERS ID: 697639) via other health professional, concerns a 66-year-old female patient. The patient's historical condition included breast cancer for which radiation treatments and ARIMIDEX for 5 years from an unspecified date in 2010 to an unspecified date in Oct-2015. The historical drug included, ALLEGRA and unspecified vaccines for unknown indications. The current illness included abnormal blood cholesterol, blood pressure and hole in heart (cardiac septal defect). The concomitant medication included Losartan for blood pressure, fish oil and niacin for abnormal blood cholesterol, aspirin for hole in heart. On 01-Nov-2015, the patient was administered with INN Flu Vaccine Seasonal (anatomical location: arm, dose, route of administration, batch no and expiry date, trade name and manufacturer: not reported). On the same day, the patient was administered with PREVENAR 13 vaccine, anatomical location: arm, dose: single dose (as reported), route of administration, batch no and expiry date: not reported). On an unspecified date in Nov-2015, after vaccination, the patient experienced hives on her legs, which spread to her whole body. On an unspecified date in Nov-2015, she experienced itching and the patient received unspecified treatment. On an unknown date, the patient consulted endocrinologist. The lab test of the patient included TSH (thyroid stimulating hormone) which showed inflammation and the antibodies to thyroid antibodies were positive. The patient was prescribed with levothyroxine. It was reported that the patient was on levothyroxine for a month and from Apr-2016, she was on levothyroxine 75 mcg. The outcome of the event hives was reported as not recovered. The outcome of the other events was not recovered. The reporter assessed this case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain
Clinical narrative: This initial spontaneous case, was received from health authority (VAERS ID: 699848) (health authority was reported by other health professional) on 10-Dec-2017, concerning a 63-year-old adult female patient. The patient current condition included pneumonia, for which she was hospitalized. On 21-Feb-2017, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number and expiry date: not reported). On the same day, the patient was administered with pneumococcal vaccine polyvalent, (dose, route of administration, anatomical location, batch number and expiry date: not reported). On 01-Mar-2017, 8 days after vaccination, the patient experienced a continual pain in his right upper arm where the pneumonia shot was administered. At the time of this, report the patient was not recovered from the event. The reporter considered this case as non-serious.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site joint pain, Pain
Clinical narrative: This spontaneous case, initially received on 10-Dec-2017 from regulatory authority (reported to regulatory authority by other non-health professional) (VAERS ID: 699966), concerning a 20-year-old, adult female patient. On 24-Oct-2016, the patient was administered with influenza vaccine, (route of administration: injection (reported as SYR), dose, batch number, anatomical location, expiry date, manufacture and trade name: not reported). On the same day, after the administration of vaccine, the patient was unable to move her shoulder and noticed a pain in her rotator cuff which was extreme. It was reported that, after a flu shot the patient's limb was immobilized for a few weeks. On 20-Nov-2016, the patient went to hospital where she was treated with a round of steroids (as reported) and Ibuprofen. It was reported that, as the symptoms did not subside, the patient went for physical therapy in February and after a few sessions, she was able to rebuild the muscle in her shoulder so that she could move her arm above and head again. It was reported that, the patient still experiences limited discomfort while using her arm. At the time of this report, the patient recovered from the events injected limb mobility decreased, pain upon movement, injection site pain and she was still recovering from the event arm discomfort. The reporter assessed the events as non-serious. Case correction received with IRD 10-Dec-2017: The outcome of the event arm discomfort was changed from recovered to recovering (in event tab). Route of administration was changed from "SYR" to injection. The narrative was amended accordingly.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Cough, Decreased appetite, Influenza like illness, Oral discomfort
Clinical narrative: This spontaneous case, initially received on 10-Dec-2017, from a consumer, via health authority (VAERS ID: 700227), concerning a 35-year-old adult female patient. The patient had no medical history, birth defects or allergy. The patient had no illness at the time of the vaccination. The patient had not taken any vaccines 4 weeks prior to the influenza vaccination. On 17-Apr-2017, the patient was administered with influenza vaccine, (route of administration: intramuscular, dose, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient was administered with non-company product Tuberculin, PPD (route of administration: intramuscular, dose: dose in series (as reported), anatomical location, batch number, expiry date: not reported). On 18-Apr-2017, after 2 days of vaccination, the patient developed cough, weakness and flu like symptoms. The patient was treated with ALEVE 2 times and CORICIDIN (reported as Corocidin) for one week. On an unspecified date, the patient developed burning in her mouth and throat, had no appetite after receiving the treatment medications ALEVE and CORICIDIN. The patient had been to emergency room 4 times and visited the physician for 5 times in that week. Laboratory investigations were not reported. The patient felt that the treatment medications were not effective. The patient consulted a primary care physician who advised her to continue the follow-up recommendations. At the time of the report, the patient had not recovered from the event. The reporter assessed the events as non-serious.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Throat irritation
Clinical narrative: This spontaneous case, initially received on 10-Dec-2017, from a consumer, via health authority (VAERS ID: 700227), concerning a 35-year-old adult female patient. The patient had no medical history, birth defects or allergy. The patient had no illness at the time of the vaccination. The patient had not taken any vaccines 4 weeks prior to the influenza vaccination. On 17-Apr-2017, the patient was administered with influenza vaccine, (route of administration: intramuscular, dose, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient was administered with non-company product Tuberculin, PPD (route of administration: intramuscular, dose: dose in series (as reported), anatomical location, batch number, expiry date: not reported). On 18-Apr-2017, after 2 days of vaccination, the patient developed cough, weakness and flu like symptoms. The patient was treated with ALEVE 2 times and CORICIDIN (reported as Corocidin) for one week. On an unspecified date, the patient developed burning in her mouth and throat, had no appetite after receiving the treatment medications ALEVE and CORICIDIN. The patient had been to emergency room 4 times and visited the physician for 5 times in that week. Laboratory investigations were not reported. The patient felt that the treatment medications were not effective. The patient consulted a primary care physician who advised her to continue the follow-up recommendations. At the time of the report, the patient had not recovered from the event. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous case, initially received on 10-Dec-2017, from health authority (reported to health authority by a physician) (VAERS ID: 700228) concerning a female patient of unspecified age. The patient's relevant medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, following the vaccination, the patient developed allergies to influenza vaccine. The patient's laboratory data and corrective treatment was not reported. At the time of this report, the outcome of the event allergy to vaccine was not reported. The reporter assessed the event allergy to vaccine as non-serious. Significant case correction received on 10-Dec-2017: The IRD of the initial version was changed form 10-Oct-2017 to 10-Dec-2017.
Sex: F
Vaccine: FLUX
Symptoms: Disturbance in attention, Fatigue, Middle insomnia, Pain, Pain in extremity
Clinical narrative: This non-serious Initial spontaneous case, was received from other health professional via health authority (VAERS ID: 700290) on 10-Dec-2017, concerning a 45-year-old, adult female patient. The patient's historical drug included: Influenza (seasonal) and had pain in left arm with no movement. On 21-Dec-2016, the patient was administered with INN Flu Vaccine Seasonal (route of administration: intramuscular, anatomical location: left arm, dose, batch number, expiry date, trade name, manufacture: not reported). On the same day, the patient complained of pain when lifting or rotating her left arm and reaching arm across front or stretching back. The patient could wake up in the nights when moving arm unintentionally. She was tired and lacked concentration. At the time of this report, the outcome of the events was not recovered. The reporter assessed the events as non-serious.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This initial spontaneous case, was received on 10-Dec-2017, from a pharmacist, via health authority (VAERS ID: 700413), concerning 67-year-old, elderly, male patient. The patient's relevant medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, following the vaccination, the patient was diagnosed with Guillain-Barre syndrome. Lab investigations were not reported. The patient received unspecified treatment for the event. It was reported that, the patient was advised by another physician that never to get a flu vaccine again. On an unspecified date, the patient recovered from the event.
Sex: M
Vaccine: FLUX, HEP, HEPA, HPVX, IPV, MENB, TDAP
Symptoms: Injection site rash
Clinical narrative: This spontaneous case, initially received from regulatory authority (VAERS ID: 700505) (reported to HA by other health professional) on 10-Dec-2017 and concerns a 19-year-old, adult, male patient. The patient had no medical history, current condition and concomitant medication. On the 17-May-2017, the patient was administered with influenza vaccine (dose: 5 (as reported), route of administration: intramuscular, anatomical location: arm, trade name, manufacturer, batch number and expiry date: not reported). On the same day, the patient was administered with Hepatitis A vaccine (dose: 2 (as reported), route of administration: intramuscular, anatomical location: arm, trade name, manufacturer, batch number and expiry date: not reported). On the same date, the patient was administered with Hepatitis B vaccine (dose: 1 (as reported), route of administration: intramuscular, anatomical location: arm, trade name, manufacturer, batch number and expiry date: not reported). On the same date, the patient was administered with human papilloma vaccine (dose: 1 (as reported), route of administration: intramuscular, anatomical location: arm, trade name, manufacturer, batch number and expiry date: not reported). On the same day, the patient was administered with BEXSERO (dose: 1 (as reported), route of administration: intramuscular, anatomical location: arm, manufacturer: Novartis vaccine and diagnostics , batch number and expiry date: not reported). On the same day, the patient was administered with Polio Vaccine (dose: 3 (as reported), route of administration: intramuscular, anatomical location: arm, trade name, manufacturer, batch number and expiry date: not reported). On the same day, the patient was administered with ADACEL (dose: 2 (as reported), route of administration: intramuscular, anatomical location: arm, trade name, manufacturer, batch number and expiry date: not reported). On 18-May-2017, after 2 days of vaccination, the patient had many small firm fairly bumps near the injection site which was persist to the present. At the time of this report, the patient had recovered from the event. The reporter assessed this case as non-serious.