chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Blood pressure decreased, Cold sweat, Diarrhoea, Dizziness
Clinical narrative: Patient called 4 hours post vaccine to inquired about the soreness of her arm. Told her that up to 7% can have grade 3 pain and it can be painful at rest and limit daily activities. Advised her to use comfort measures and tylenol for pain relief and if she needed to seek additional help to go to the ER/Urgent care. Patient then stated that she started to feel lightheaded and nauseous and was going to try to eat something. She was very off balance. She then went to sit down only to find herself passed out on the floor. She called a neighbor who brought her to the ER. She was clammy, nauseous, and felt like diarrhea  and having trouble breathing. She told them she was having an allergic reaction and they took her back. She was at the ER for 1 hour before given steroids which helped immediately per patient. I follow up with the patient the next day 01/26 and she was still having significant arm pain. I informed her that could last for a few more days (possibly up to 1 week). Told her to follow up with MD and I will call her to submit the AE.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Laboratory test, Loss of consciousness, Nausea, Pain in extremity
Clinical narrative: Patient called 4 hours post vaccine to inquired about the soreness of her arm. Told her that up to 7% can have grade 3 pain and it can be painful at rest and limit daily activities. Advised her to use comfort measures and tylenol for pain relief and if she needed to seek additional help to go to the ER/Urgent care. Patient then stated that she started to feel lightheaded and nauseous and was going to try to eat something. She was very off balance. She then went to sit down only to find herself passed out on the floor. She called a neighbor who brought her to the ER. She was clammy, nauseous, and felt like diarrhea  and having trouble breathing. She told them she was having an allergic reaction and they took her back. She was at the ER for 1 hour before given steroids which helped immediately per patient. I follow up with the patient the next day 01/26 and she was still having significant arm pain. I informed her that could last for a few more days (possibly up to 1 week). Told her to follow up with MD and I will call her to submit the AE.
Age: 49.0
Sex: F
Vaccine: HEPA, MMR, TDAP
Symptoms: Abnormal behaviour, Anticonvulsant drug level, Blood glucose increased, Blood lactic acid increased, Breath sounds abnormal
Clinical narrative: Shortly after the vaccines were given, a discussion followed regarding the next visit for follow-up. The client was noted to briefly lean over to her right side; the attendant asked her if something was wrong. I could hear a subtle noise, like air was escaping; then she sat back up. She seemed different; she did not move, her eyes seem to flutter, she didn't look towards me when spoken to  and she didn't speak, right away. There was noted hand tremors. The client was incontinent of urine. When the client became more responsive, she was slightly diaphoretic, began to talk and complained of being dizzy. She became emotional over what had happened. A cool wash cloth was placed on her neck and a juice box given.
Age: 49.0
Sex: F
Vaccine: HEPA, MMR, TDAP
Symptoms: C-reactive protein increased, Dizziness, Emotional distress, Hyperhidrosis, Hyporesponsive to stimuli
Clinical narrative: Shortly after the vaccines were given, a discussion followed regarding the next visit for follow-up. The client was noted to briefly lean over to her right side; the attendant asked her if something was wrong. I could hear a subtle noise, like air was escaping; then she sat back up. She seemed different; she did not move, her eyes seem to flutter, she didn't look towards me when spoken to  and she didn't speak, right away. There was noted hand tremors. The client was incontinent of urine. When the client became more responsive, she was slightly diaphoretic, began to talk and complained of being dizzy. She became emotional over what had happened. A cool wash cloth was placed on her neck and a juice box given.
Age: 49.0
Sex: F
Vaccine: HEPA, MMR, TDAP
Symptoms: Posture abnormal, Tremor, Urinary incontinence, Urinary tract infection, Urine analysis abnormal
Clinical narrative: Shortly after the vaccines were given, a discussion followed regarding the next visit for follow-up. The client was noted to briefly lean over to her right side; the attendant asked her if something was wrong. I could hear a subtle noise, like air was escaping; then she sat back up. She seemed different; she did not move, her eyes seem to flutter, she didn't look towards me when spoken to  and she didn't speak, right away. There was noted hand tremors. The client was incontinent of urine. When the client became more responsive, she was slightly diaphoretic, began to talk and complained of being dizzy. She became emotional over what had happened. A cool wash cloth was placed on her neck and a juice box given.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Condition aggravated, Headache, Mobility decreased
Clinical narrative: She states every joint hurts and had trouble getting out of bed. Slight headache in the night. She has arthritis and was exacerbated by the shot takes pain meds anyway did use heating pad stayed on it all day.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Injection site erythema, Injection site pain, Mobility decreased, Paraesthesia
Clinical narrative: Patient stated that she experienced an adverse reaction a couple hours after leaving our office. Symptoms included paresthesia, had difficulty moving arm, severe pain, redness on (L) arm were immunization was given. States she did not go to Emergency Department. This was discussed on 1/18/19, when the patient came to our office because she was scheduled for her second dose of Meningococcal B.
Age: 24.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea onset 10 hours after vaccine followed by repeated vomiting (approximately 7 times over 8 hours) and diarrhea (lasting 48 hours).
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Bladder catheterisation, Blood urine present, Full blood count normal, Metabolic function test, Petechiae
Clinical narrative: Petechiae, started on legs, moved to trunk and arms.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Urinary tract procedural complication
Clinical narrative: Petechiae, started on legs, moved to trunk and arms.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Pyrexia, Rash pruritic
Clinical narrative: Patient report that 10 minutes after she receive the vaccination she developed a rash. Later that evening she complained of fever and sweats. She presented at pharmacy today (7 days after vaccination) and showed us circular rashes (itchy) on bilateral arms and bilateral legs.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Decreased appetite, Defaecation urgency, Dizziness, Fatigue
Clinical narrative: 6:00 am I experienced a minor Vasovagal episode. I felt my blood pressure drop, I went a little cold, I got a little dizzy, and my stomach gurgled. I lay down on the couch for only 1 minute. I suddenly felt the need to have another bowel movement (since I'd already had a healthy one about 30 minutes prior). I got up and went to the bathroom and had another BM, this time really soft, but a substantial amount. As soon as I got up from the toilet, I felt better. However, it is now 3:50 pm, and I have been a little tired all day. My muscles have been achy (especially the back of my neck), and I have had very little appetite. I have drunk 2 bottles of water, and I only ate half a PBJ for lunch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Gastric disorder, Myalgia, Presyncope
Clinical narrative: 6:00 am I experienced a minor Vasovagal episode. I felt my blood pressure drop, I went a little cold, I got a little dizzy, and my stomach gurgled. I lay down on the couch for only 1 minute. I suddenly felt the need to have another bowel movement (since I'd already had a healthy one about 30 minutes prior). I got up and went to the bathroom and had another BM, this time really soft, but a substantial amount. As soon as I got up from the toilet, I felt better. However, it is now 3:50 pm, and I have been a little tired all day. My muscles have been achy (especially the back of my neck), and I have had very little appetite. I have drunk 2 bottles of water, and I only ate half a PBJ for lunch.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity, Pyrexia
Clinical narrative: Very painful arm,100.5 fever for two days, sporadic joint pain.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site oedema, Injection site reaction, Pain, Weight bearing difficulty
Clinical narrative: 1 day following vaccination, patient presented to hospital with significant edema of the left thigh and difficulty bearing weight on left leg. Minimal erythema. 72 hours later, edema hardly detectable and pain has subsided.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Patient experienced cellulitis following ADACEL shot. Patient was treated with BACTRIM DS twice daily for 7 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Nausea, Swollen tongue, Throat tightness
Clinical narrative: Mild throat closing, tongue swelling, chills, sweats, and nausea all overnight. Self resolving. Pt did not seek medical attention.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: PATIENT HAD NO SYMPTOMS AT TIME OF SHOT, HOWEVER HE HAS BEEN BOTHERED EVER SINCE THE SHOT WITH MUSCLE SORENESS IN UPPER BODY, AND BOTH ARMS AS IF HE HAD WORKED OUT. PAIN IN RELIEVED WITH MOTRIN, BUT HAS NEVER FULLY GONE AWAY SINCE SHOT.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Pain
Clinical narrative: Patient describes feeling "very achy" for 3 days following shot. Able to go out to dinner, per wife and walk around. Per the patient, it was very uncomfortable to sleep on his back. Afebrile. TYLENOL taken and ineffective.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Biopsy skin, Blood pressure increased, Blood test, Contusion, Fatigue
Clinical narrative: Started to feel very tired, and unexplained bruising on thighs and buttock. Blood pressure went high and heart rate as well. Caught Molluscum contagiosum a week later as well. Almost two months later still dealing with weird side effects. In the past week broke out in a rash all over body which was biopsied and came back as a allergic reaction.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Heart rate increased, Hypersensitivity, Infection, Molluscum contagiosum, Rash generalised
Clinical narrative: Started to feel very tired, and unexplained bruising on thighs and buttock. Blood pressure went high and heart rate as well. Caught Molluscum contagiosum a week later as well. Almost two months later still dealing with weird side effects. In the past week broke out in a rash all over body which was biopsied and came back as a allergic reaction.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: White blood cell count increased
Clinical narrative: Started to feel very tired, and unexplained bruising on thighs and buttock. Blood pressure went high and heart rate as well. Caught Molluscum contagiosum a week later as well. Almost two months later still dealing with weird side effects. In the past week broke out in a rash all over body which was biopsied and came back as a allergic reaction.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Ear pain, Eye pain, Headache, Influenza virus test negative
Clinical narrative: Day after vaccine Body ache, temp 100.4, headache, nausea, stomach ache, felt like an elephant walked on me, ears and neck and head hurt really bad with stabbing pain in ears and felt like neck would break and eyeballs hurt to move them. 2nd day still have fever 99.4 and still some body aches, stomach hurts and felt very sluggish.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Pain, Pyrexia, Sluggishness
Clinical narrative: Day after vaccine Body ache, temp 100.4, headache, nausea, stomach ache, felt like an elephant walked on me, ears and neck and head hurt really bad with stabbing pain in ears and felt like neck would break and eyeballs hurt to move them. 2nd day still have fever 99.4 and still some body aches, stomach hurts and felt very sluggish.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Local reaction (swelling and redness). Treatment : Ice and Ibuprofen.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hypoacusis, Hypoaesthesia, Nausea, Peripheral swelling
Clinical narrative: Patient experienced dizziness, numbness  and fainted two days after vaccine. Complained of not being able to hear prior to fainting. Also experienced nausea and swelling in the arm. Also felt occasional numbness in leg 1/28 ( 3 days after).
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient experienced dizziness, numbness  and fainted two days after vaccine. Complained of not being able to hear prior to fainting. Also experienced nausea and swelling in the arm. Also felt occasional numbness in leg 1/28 ( 3 days after).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Influenza like illness
Clinical narrative: Chills, dizziness, flu like symptoms, achy joints, soreness at injection site, tired.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Chills, dizziness, flu like symptoms, achy joints, soreness at injection site, tired.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Pain at site of injection began immediate after administration. Pain moved down towards elbow, now it goes from 1/2 up from elbow to shoulder. It is a dull pain, and occasionally it is sharp pain. The pain gets worse when patient is exercising. There is no swelling or redness.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Upon checking out patient began to feel lightheaded. Dr. looked pale and he sat down on the waiting bench. Pharmacist went out to check on him and patient lost consciousness (about 5 seconds) called 911. Patient regained consciousness and was alert when the EMT arrived. Patient was awake and responsive, patient waited 20 minutes and left on his own.
Age: 23.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Full blood count, Headache, Metabolic function test, Nausea
Clinical narrative: Fever, Chills, Nausea, and Headache.
Age: 23.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever, Chills, Nausea, and Headache.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pityriasis rosea, Pruritus, Skin plaque
Clinical narrative: Patient has experienced itchy red plaques (suspected pityriasis rosea per Dr.) that started a few days after the vaccine and has not gone away.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Influenza virus test negative, Pyrexia
Clinical narrative: Patient developed a few days of low grade fever and then a prolonged febrile seizure (20 minutes in length per the family); the febrile seizure was 15 days after the vaccines. There were no other obvious signs of illness. Flu testing in the ED was negative.
Age: 0.58
Sex: M
Vaccine: FLUX
Symptoms: Injection site pruritus, Vomiting
Clinical narrative: Patient received seasonal influenza vaccine approximately 01:30pm. Began vomiting around 03:20. Had 4-5 episodes between that time and approximately 6pm and well as increased itchiness to injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Condition aggravated, Erythema, Joint stiffness
Clinical narrative: Developed fever of 101.7 two days following vaccination. Along with the fever I developed redness under my eyes (Rash) more marked on the right side. Other red splotches on my face. The fever subsided by the next day but the rash continues as of 27 January 2019. It becomes redder at sometimes than others. It is worse today than it was in the beginning, I have not sought medical attention, but am planning to. I kept thinking it would get better. I have felt that this vaccine has caused a flare up of my lupus. I have had increased general feeling of burning under my skin and joint stiffness. I have taken ibuprofen and meloxicam intermittently. My joint pain is improved but the rash does not improve.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash macular, Systemic lupus erythematosus
Clinical narrative: Developed fever of 101.7 two days following vaccination. Along with the fever I developed redness under my eyes (Rash) more marked on the right side. Other red splotches on my face. The fever subsided by the next day but the rash continues as of 27 January 2019. It becomes redder at sometimes than others. It is worse today than it was in the beginning, I have not sought medical attention, but am planning to. I kept thinking it would get better. I have felt that this vaccine has caused a flare up of my lupus. I have had increased general feeling of burning under my skin and joint stiffness. I have taken ibuprofen and meloxicam intermittently. My joint pain is improved but the rash does not improve.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Received vaccine to Left arm on 1/23/19 and felt sore the rest of the day. On 1/24/19 pt still C/O tenderness to arm and a large area of upper arm red and swollen about the size of grapefruit. By that same evening, Mother reported area at injection site appearing purple. Today, 1/25/19, arm is still a little sore and with an area of 3.25" in diameter of pink color. Area is not raised, or draining. Injection site a little sore.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Tenderness
Clinical narrative: Received vaccine to Left arm on 1/23/19 and felt sore the rest of the day. On 1/24/19 pt still C/O tenderness to arm and a large area of upper arm red and swollen about the size of grapefruit. By that same evening, Mother reported area at injection site appearing purple. Today, 1/25/19, arm is still a little sore and with an area of 3.25" in diameter of pink color. Area is not raised, or draining. Injection site a little sore.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: 10 cm pink, sore area, fever.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Cardiac stress test normal, Chest pain, Computerised tomogram thorax normal, Dyspnoea
Clinical narrative: Back pain, chest pain, neck discomfort. Seen in ER 10/25/18. Chest CT negative for dissection, pneumonia or blood clot. Ruled out for an MI. Treated with morphine and TORADOL and went home. She reports ongoing shortness of breast.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Echocardiogram, Musculoskeletal discomfort
Clinical narrative: Back pain, chest pain, neck discomfort. Seen in ER 10/25/18. Chest CT negative for dissection, pneumonia or blood clot. Ruled out for an MI. Treated with morphine and TORADOL and went home. She reports ongoing shortness of breast.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was administer by medical assistant. Vaccine not recommended for less than three years old, even though the manufacture describes on the box that it is for 6 months and up. Vaccine contains mercury.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia
Clinical narrative: Patient has experienced deep pain near the injection site since injection was given. Cannot sleep on left side as a result. Patient has past medical history of CLL. Pain was worse right away and has subsided somewhat but still cannot sleep on left side.
Age: 25.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: VARIVAX was given IM instead of SQ. No adverse event.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Pyrexia
Clinical narrative: Head pain and low grade fever x 24 hours. Resolved.
Age: 30.0
Sex: F
Vaccine: FLUC4, HEP, PPV, TYP
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 693498), concerns a 30-year-old, adult, female patient. The patient's current condition included type 1 diabetes mellitus (since an unspecified date). The concomitant medications were not reported. It was reported that, the patient using the insulin pump (since an unspecified date). On 07-Apr-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [1 as reported], route of administration: intramuscular, anatomical location: right arm, batch number: 185327 and expiry date: not reported), ENGERIX B (route of administration: intramuscular, anatomical location: left arm, batch number: EB993, dose and expiry date: not reported), PNEUMOVAX (route of administration: subcutaneous, anatomical location: right arm, batch number: M029680, dose and expiry date: not reported) and TYPHIM VI (route of administration: intramuscular, anatomical location: left arm, batch number: M01131, dose and expiry date: not reported). On the same day, after vaccination, the patient stated that, hepatitis vaccine hurt slightly more than all other given vaccines. Right arm pain resolved 3 days later. On 05-May-2017, the patient's left upper arm continued to be slight painful with adduction of arm and external rotation. The patient had no numbness. On an unspecified date, clinical examination was performed, and results were not reported. At the time of this report, the outcome of the events (pain, pain in extremity and injection site pain) was not reported. The reporter assessed this case as non-serious. Update 03-Jul-2018: Significant case correction was performed with IRD 19-May-2018: Verbatim of the event injection pain was updated from '[She stated] at time of administration vaccine hurt [slightly more than all other vaccines given]' to '[She stated] at time of administration vaccine hurt slightly more than all other vaccines given'. The company causality for the event injection site pain was changed from 'not related' to 'related'. Case comment was corrected accordingly. No changes were made in the narrative.
Age: 15.0
Sex: M
Vaccine: FLUC4, HPV4
Symptoms: Laboratory test, Loss of personal independence in daily activities, Specialist consultation
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 693652), concerns a 15-year-old adolescent male patient. The patient's current illness included migraine. The patient's concomitant medications included allergy shots and IMITREX. On 25-Aug-2016, the patient received FLUCELVAX QIV [dose: 0.5 ml (reported as 4 dose), anatomical location: left arm, batch number: 185286, route of administration and expiry date: not reported] and GARDASIL (dose: 1, anatomical location: right arm, batch number: M017983, route of administration and expiry date: not reported). On 13-Sep-2016, the patient had consulted many specialists and was advised to give up diving. The patient had missed lot of school days. The patient was receiving many medications and carrying out alternative methods. The lab tests were performed however those were not reported (reported as numerous to write down). It was reported that the patient was slowly improving. At the time of this report, the patient was recovering from the events loss of personal independence in daily activities. The reporter assessed this case as non-serious.
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 696500), concerns a 37-year-old, adult, male patient. On 12-Nov-2016, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 186685 and expiry date: not reported). On an unspecified date, after vaccination, the patient experienced pain (unspecified) from injection and received the unspecified treatment for the event. It was reported that, the patient's medications were filled and counselled him on their proper use. At the time of this report, the outcome of the event was unknown. The reporter assessed the event as non-serious and considered the causality of the event as related to the suspect vaccine. Update CRD 15-Jun-2018: Significant case correction was performed with IRD 19-May-2018: Company causality of the event pain was changed from unassessable to related. Case comment was amended accordingly. No changes were made in the narrative. Update 03-Jul-2018: Non-significant case correction performed with IRD 19-May-2018: 'On an unspecified date, after vaccination, the patient experienced pain (unspecified)' was changed to 'On an unspecified date, after vaccination, the patient experienced pain (unspecified) from injection'. Case comment was updated and narrative amended accordingly.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Electromyogram, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 696860), concerns a 62-year-old, adult, male patient. The patient's medical history was not reported, and the concomitant medications included PREVACID and Atorvastatin for an unknown indication. On 20-Sep-2016, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [1 as reported], anatomical location: right arm, route of administration, batch number and expiry date: not reported). On 30-Sep-2018, after 10 days of vaccination, the patient experienced severe pain in right shoulder blade, arm and hand which continued throughout morning. The patient went to emergency department [urgent care center as reported] and treated with ibuprofen, Cyclobenzaprine and ice packs. On an unspecified date, X-ray, nuclear magnetic resonance imaging (MRI) two times and electromyogram (EMG) two times were performed, and the results were not reported. After many visits with primary care physician, orthopaedic, orthopaedic specialist and neurologist, the patient was diagnosed with Parsonage Turner Syndrome and treated with multiple drugs and recommended physical therapy for pain. Currently, the patient treated with gabapentin 900 mg. At the time of this report, the outcome of the events (Parsonage-Turner Syndrome, shoulder blade pain and pain in extremity) was unknown. The reporter assessed the case as non-serious.
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Headache, Oculorespiratory syndrome
Clinical narrative: This is a non-serious spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 28-May-2018 by Seqirus from VAERS (VAERS ID: 705902), concerns an adult male patient of unspecified age. The patient's medical history included recurrent severe headaches accompanied by oculorespiratory syndrome following FLUVIRIN on an unspecified date in 2014. The patient had no current illness. The patient's allergies and concomitant medications were not reported. On an unspecified date in 2015, the patient was administered influenza vaccine (dose, batch number, route of administration, anatomical location, expiry date, manufacturer and trade name: not reported). On an unspecified date in 2015, after few hours of vaccination, the patient experienced recurrent severe headaches, accompanied with oculorespiratory syndrome. The outcome of the events was not reported. This case 201802129 was linked to case 201802128 reported by the same reporter. Update 12-Jul-2018: Significant case correction was performed with IRD 28-May-2018: The patient's medical history in the narrative was reframed as 'the patient's medical history included recurrent severe headaches accompanied by oculorespiratory syndrome following FLUVIRIN on an unspecified date in 2014'. Outcome of the events was changed from recovered to not reported in fields and in narrative. Information related to emergency room visit was removed from the narrative.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Axillary pain, Chest pain, Injection site pain
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 707467), concerns a 41-year-old, adult, female patient. The patient's current illness included joint pain and no known allergies. The patient's concomitant medication included diclofenac for an unknown indication. On 08-Aug-2017, the patient received FLUCELVAX QIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195214 and expiry date: not reported]. On the same day, the patient experienced pain that radiated from injection site towards her armpit and chest but no sign of chest pain. Possible heart attack was ruled out, but the patient was adamant that the pain resulted from vaccination since the onset of pain was after the vaccination. Pain continued the second day and the patient was recommended to take TYLENOL as she was already on diclofenac. At the time of report, the outcome of the events (axillary pain and injection site pain) was unknown. The reporter assessed this case as non-serious. Update on 18-Jun-2018: Case correction was performed with IRD 19-May-2018: Outcome of the events (axillary pain and injection site pain) was changed from not recovered to unknown. Amended narrative accordingly.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Chest pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 708079), concerns a 59-year-old, adult, female patient. It was reported that, the patient received flu shots in the past with no problems (as reported). The patient's historical procedure included stent placement (on an unspecified date in 2017) (reported as earlier in the year). The historical drug included nitroglycerine which was prescribed in February (as reported) for an unknown indication. The patient's current condition included penicillin allergy (since an unspecified date) and the concomitant medication included VICTOZA, metoprolol tartrate, vitamin D2, losartan potassium, levothyroxine sodium, Atorvastatin, LYRICA, isosorbide mononitrate, BRILINTA, bupropion (sustained release), spironolactone for an unknown indication (since an unspecified date). On 14-Aug-2017, at 11:40 AM, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number; 195214 and expiry date: not reported). On the same day (14-Aug-2017), within 10 minutes of vaccination, the patient experienced chest pain and back pain. The patient stated that, the back pain was more intense. The patient received nitroglycerine (0.4 mg. 1 tablet). It was reported that, the chest pain was slightly lessened and changes in the back pain. Later, the patient taken to the hospital. At the time of report, the outcome of the event (chest pain) was recovering and the patient had not recovered from the event (back pain). The reporter assessed the case as non-serious.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Staring
Clinical narrative: This spontaneous report was received from a registered nurse via Pfizer referring to a 2-months old female patient. The patient's medical history and concurrent conditions were not reported. Past drug included hepatitis B vaccine administered on 11-APR-2017. On 14-JUN-2017, the patient was vaccinated with first dose of ROTATEQ (lot: M035456; expiry date: 10-MAY-2018) orally. On the same date at 15:47, the patient was also vaccinated with first dose of PREVNAR 13 (lot: R48402; expiry date: 30-APR-2018) 0.5 ml intramuscularly in her right thigh. On the same day at an unspecified time she was also vaccinated with first dose of PENTACEL (lot: C5316AA; expiry date: 13-FEB-2018) intramuscularly in her left thigh. On 14-JUN-2017 at 16:15, the patient experienced intermittent episodes of gazing off and her mom was unable to break her stare. The starring episodes lasted for 2-3 hours. The reporter considered the event to be related to PREVNAR 13. No treatment was required for the event. Outcome of the event was unknown. Causality assessment for ROTATEQ was not reported.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 708370), concerns a 50-year-old, adult female patient. The patient's current condition included high blood pressure. The patient was allergic to CIPRO. The patient's concomitant medications included montelukast, lisinopril and hydrochlorothiazide. On 13-Aug-2017, the patient was administered FLUCELVAX QIV (dose: 0.5 ml [reported as 1], route of administration: intramuscular, anatomical location: right arm, batch number: 195214] and expiry date: not reported). On 14-Aug-2017, after 1 day of vaccination, the patient experienced swelling, redness and itchiness on the same arm where vaccine was administered. It was reported that, after 3 days after vaccination, the patient had recovered from swelling. At the time of this report, the patient had not recovered from the events- injection site redness and injection site warmth and had recovered from the event- injection site itching. The reporter assessed the events as non-serious. Update 18-Jun-2018: Case correction was performed 19-May-2018: The condition 'high blood pressure' was corrected from historical condition to current condition. The narrative was amended accordingly. Update 11-Jul-2018: Non-significant case correction received 19-May-2018: The case comment was corrected. No changes were done in the narrative.
Age: 54.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Back pain, Chest pain, Fatigue, Injection site pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 708939), concerns a 54-year-old, adult, male patient. The patient's current condition included shellfish allergy (since an unspecified date) and the concomitant medication included Fluoxetine. On 14-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [1 as reported], route of administration: intramuscular, anatomical location: left arm, batch number: 195214 and expiry date: not reported and non-company suspect product ZOSTAVAX (dose: 1 [as reported], route of administration: intramuscular, anatomical location: subcutaneous, batch number: N013278 and expiry date: not reported). On 15-Aug-2017, after 1 day of vaccination, the patient experienced pain and tenderness at injection site, the pain spreaded to back and chest for several days. The patient complained that pain and sensitivity on chest and the overall tiredness for 6 days post injection. At the time of this report, the patient had recovered from the event (fatigue) and the outcome of the events (chest pain, back pain, tenderness and injection site tenderness) was unknown. The reporter assessed the case as non-serious.
Age: 41.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 29-May-2018 by Seqirus from VAERS (VAERS ID: 709108), concerns a 41-year-old, adult female patient. The patient's historical condition included asthma. The patient's current condition included allergy to sulfa drugs. The patient's concomitant medication included omeprazole for an unknown indication, however, current illness was reported as none. On 19-Aug-2017, the patient was administered FLUCELVAX QIV (dose: 0.5 ml (1 DF), route of administration: intramuscular, anatomical location: left arm, batch number: 195220, expiry date: not reported). On the same day, the patient was administered PNEUMOVAX (dose: 1 DF, route of administration: intramuscular, anatomical location: left arm, batch number: N010105, expiry date: not reported) and ADACEL (dose: 1 DF, route of administration: intramuscular, anatomical location: right arm, batch number: U5521AA, expiry date: not reported). On 19-Aug-2017, the night after vaccination, the patient complained of pain (not soreness) in her left arm. On the same day, in evening, the injection site was found to be warm upon rubbing. At night, the patient experienced pain in the left arm. The following morning (on 20-Aug-2017), the patient noticed it was a bit swollen and slight redness. On 21-Aug-2017, the patient stopped by the pharmacy and her arm was more swollen and redness had spread all over the upper left arm. It was not hot to the touch. The patient was advised to consult a physician. At the time of this report, the outcome of the events was unknown. The reporter assessed the events as non-serious. Update 12-Jul-2018: Case correction was performed with IRD 19-May-2018: The verbatims for all the events were re-phrased and corrected. The onset date for the event skin warm was changed from 21-Aug-2017 to 20-Aug-2017. The sentences in the narrative were re-phrased. The narrative amended accordingly.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: This spontaneous case, reported by other non-health professional to VARES and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 709167), concerns a 09-year-old female child. The patient had no current illness and no concomitant medication was received. On 17-Aug-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195214, and expiry date: not reported). On the same day an hour after vaccination, the patient developed redness, hives, itching and swelling on right side of face and at the injection site. No lab test was done. At the time of this report, the patient had recovered from all the events (erythema, injection site erythema, injection site pruritus, injection site swelling, injection site urticaria, pruritus, swelling face and urticaria). The reporter assessed this case as non-serious.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: This spontaneous case, reported by other non-health professional to VARES and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 709167), concerns a 09-year-old female child. The patient had no current illness and no concomitant medication was received. On 17-Aug-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195214, and expiry date: not reported). On the same day an hour after vaccination, the patient developed redness, hives, itching and swelling on right side of face and at the injection site. No lab test was done. At the time of this report, the patient had recovered from all the events (erythema, injection site erythema, injection site pruritus, injection site swelling, injection site urticaria, pruritus, swelling face and urticaria). The reporter assessed this case as non-serious.
Age: 47.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Erythema, Injection site reaction, Local reaction, Skin warm
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 709169), concerns a 47-year-old adult male patient. The patient's current illness included diabetes, renal disease, hypertension and he was allergic to codeine and sulfasalazine (all reported as medical history). The patient's concomitant medications included Losartan, Pioglitazone, Atorvastatin, LANTUS and VICTOZA. On 20-Aug-2017, the patient received FLUCELVAX QIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195213, and expiry date: not reported] and PNEUMOVAX (route of administration: intramuscular, anatomical location: right arm, batch number: N003997, dose and expiry date: not reported). On 21-Aug-2017 the next day after vaccination, the patient's arm was red and warm to touch, a few inches below the vaccination site. It was reported that the arm was not painful and had no fever. The patient was administered both vaccines in the right arm as the patient insisted the pharmacist to do so. The patient walked in a clinic and was told that it was most likely a local site reaction and would be treated with methyl prednisone 6-day pack and cephalexin for the possible cellulitis. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious. Update 12-Jul-2018: Non-significant case correction performed 19-May-2018: For the current conditions in the narrative 'reported as medical history' as provided by health authority was mentioned. Upon internal review, it was observed that verbatims were not brief but comprehensive, so were updated. Amended narrative accordingly.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint swelling
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 709722), concerns a 60-year-old, adult, female patient. The patient's medical history and current conditions were not reported. On 19-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195214, expiry date: not reported). On 20-Aug-2017, 1 day after vaccination, the patient ankle had swollen up. At the time of this report, the patient had not recovered from the event. The reporter assessed the event as non-serious.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Injection site warmth, Nausea, Vomiting
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 710082), concerns a 46-year-old, adult, female patient. The patient's current conditions included mental health disorders, schizophrenia, allergy to primidone and morphine (since an unspecified date). The patient's concomitant medications included carbamazepine, citalopram, cyclobenzaprine, diazepam rectal gel, KEPPRA, ZOCOR, ATIVAN, ZYPREXA, SAPHRIS, ibuprofen and primidone for unknown indications. On 22-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [reported as 1 DF], route of administration: intramuscular, anatomical location: left arm, batch number: 1955210A, expiry date: not reported). On the same day, since vaccination, the patient experienced severe dizziness, nausea and vomiting. The patient also felt hot (warmth) at the site of injection, but there were no changes in the appearance of the injection site. On 27-Aug-2017, the symptoms got worsened. On an unspecified date, the patient visited the emergency room, but did not consult physician. It was reported that, the patient would follow-up with primary care physician in a month. At the time of the report, the patient had not yet recovered from the events. The reporter assessed this case as non-serious. Update 18-Jun-2018: Non-significant case correction received with IRD 19-May-2018: The current condition (schizophrenia) was added in narrative.
Age: 25.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 710273), concerns a 25-year-old, adult, male patient. The patient's current condition included diabetes (since an unspecified date). The patient's concomitant medication included HUMALOG (for an unknown indication). The patient had no allergies. On 29-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195214 and expiry date: not reported). On the same day, after vaccination, the patient passed out (loss of consciousness). No lab investigations were performed. On an unspecified date, the patient had recovered from the event. The reporter assessed the event as non-serious.
Age: 36.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Exposure during pregnancy, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 710545), concerns a 36-year-old, adult female pregnant patient. The patient's medical history and concomitant medications were not reported. On 10-Aug-2017, during third trimester of pregnancy, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as unknown), route of administration: intramuscular, anatomical location: left arm, batch number: 195214, expiry date: not reported). On the same day, the patient was also administered with BOOSTRIX (dose: unknown, route of administration: intramuscular, anatomical location: right arm, batch number FYYE3, expiry date: not reported). On 11-Aug-2017, the next day of vaccination with BOOSTRIX, the patient experienced soreness in the arm. As the days passed, the patient experienced pain while moving arm and felt difficulty in doing normal daily activities (due to pain upon movement). On an unspecified date, the patient visited the physician for consultation. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: HIV test negative, Hepatitis B virus test positive, Hepatitis C test negative, Hepatitis C virus test, Multiple use of single-use product
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 710659), concerns a 42-year-old, adult female patient. The patient had no medical history, concomitant medications or allergies. On 22-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: 195124, expiry date: not reported), which was used on another person. On an unspecified date, both patient's samples were sent for investigation to analyse cross-contamination, but the results were negative for Hepatitis C, Hepatitis B and HIV. The reporter assessed this case as non-serious.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 711573), concerns a 55-year-old, adult, female patient. The patient current conditions included cancer remission and hypertension. The patient had no known allergies. The patient's concomitant medication included Aspirin, Vitamin D3, CLARITIN, EFFEXOR and hydrochlorothiazide, lisinopril for an unknown indication. On 06-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [reported as 1] route of administration: intramuscular, anatomical location: left arm, batch number: 195215, expiry date: not reported). On the same day after vaccination, the patient experienced redness and oedema at the site of injection, which was warm to touch. The patient was advised to continue cool compresses and elevation of the affected limb. The patient was recommended for antibiotic therapy if reaction had worsened within 2 days. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious.