chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Balance disorder, Chills, Dizziness, Fatigue
Clinical narrative: Striking headache (3days; d), followed by intense nonstop shivering and shaking (2 d), w/ occasional overheating (flushed face; 1 d), malaise/fatigue (2d), dizzy/wobbly (2.5 d), intense nighttime sweating (1 night), nausea (2.5 d).  Totally sick.  No fever or respiratory trouble.  Muscle aching at injection site (2 d), but accustomed to that. Side effects were disabling.  Could not go out of house and do regular activities.  Totally sick, and worried how long it would last.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Flushing, Headache, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Striking headache (3days; d), followed by intense nonstop shivering and shaking (2 d), w/ occasional overheating (flushed face; 1 d), malaise/fatigue (2d), dizzy/wobbly (2.5 d), intense nighttime sweating (1 night), nausea (2.5 d).  Totally sick.  No fever or respiratory trouble.  Muscle aching at injection site (2 d), but accustomed to that. Side effects were disabling.  Could not go out of house and do regular activities.  Totally sick, and worried how long it would last.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Night sweats, Tremor
Clinical narrative: Striking headache (3days; d), followed by intense nonstop shivering and shaking (2 d), w/ occasional overheating (flushed face; 1 d), malaise/fatigue (2d), dizzy/wobbly (2.5 d), intense nighttime sweating (1 night), nausea (2.5 d).  Totally sick.  No fever or respiratory trouble.  Muscle aching at injection site (2 d), but accustomed to that. Side effects were disabling.  Could not go out of house and do regular activities.  Totally sick, and worried how long it would last.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Erythema, Swelling face
Clinical narrative: ? Friday afternoon on 7/24/20, around 12:30 she got the Hep B vaccine ? Friday night around 11:00 pm she noticed that her face was getting very red and starting to break out ? By 12:00am her face was very red, swollen, and she had difficulty breathing, especially out of her nose ? Around 1:00am she took Benadryl ? The redness and swelling had mostly gone down by 4:00am ? She woke up around 1:30pm Saturday afternoon, still slightly swollen   ? The swelling had completely subsided by 5:00pm Saturday
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Injection site pain, Nausea
Clinical narrative: After 11 hours post shot, extreme pain and sensitivity at injection site, inability to move arm without pain.  I took two extra strength acetaminophen.  14 hours post shot, I began shivering. Blankets did not help.  20 hours post shot, I  began feeling  general nausea and Loss of appetite until the evening, the day after the shot. I also felt like I was laying on a heating pad, a hot back, while my hands remained  ice cold. I also had a mild headache throughout the next day in my temples.  I had a fever that got up to 100.3 the evening of the next day after my shot. At that time I took two more extra strength Tylenol. Once that kicked in I felt totally back to normal.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: After 11 hours post shot, extreme pain and sensitivity at injection site, inability to move arm without pain.  I took two extra strength acetaminophen.  14 hours post shot, I began shivering. Blankets did not help.  20 hours post shot, I  began feeling  general nausea and Loss of appetite until the evening, the day after the shot. I also felt like I was laying on a heating pad, a hot back, while my hands remained  ice cold. I also had a mild headache throughout the next day in my temples.  I had a fever that got up to 100.3 the evening of the next day after my shot. At that time I took two more extra strength Tylenol. Once that kicked in I felt totally back to normal.
Age: 1.33
Sex: M
Vaccine: HIBV, IPV, PNC13
Symptoms: Erythema, Oedema peripheral, Peripheral swelling, Skin warm
Clinical narrative: Patient presented to office ~24 hours after vaccines with significant, bilateral hand and foot swelling.  Feet and hands were hot to the touch, read, and edematous, but improving per parent report. Advised parent to give benadryl and monitor. No further action taken.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Pain
Clinical narrative: Severe fatigue, body ache
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Sharp pain in upper arm that occurs on movement.  Pain has continued to present
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Dizziness, Nausea, Pain
Clinical narrative: Woke up in middle of night with chills, slight nausea, light-headedness that lasted an hour until Tylenol, warm milk, and slice of toast kicked in. After waking for the day at 8 am, chills, body aches, and light-headedness required more Tylenol. Body ache persisted for several hours, but chills subsided by afternoon.  Persistent dry cough started by late afternoon, but this is not a usual Shingrix symptom and may be due to something else going on.
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Echocardiogram, Electrocardiogram, Kawasaki's disease, Lymphadenopathy, Pyrexia
Clinical narrative: Infant received vaccine on 9/23/20 after a well child exam.  Infant returned to clinic on 9/28/20 with a low grade fever and enlarged lymph node on left side of neck. Infant was sent to ER on 9/28/20 for evaluation and treatment of symptoms and was discharged home on oral antibiotics,  Infant was seen in office on 9/30/20 for continuation of low grade fever and rash that developed over entire body.  Infant was sent back to ER for further evaluation of evaluation and treatment of symptoms. Infant was admitted to hospital from 9/30/20 to 10/4/20 for treatment of Kawasaki like illness. Infant was followed by cardiology and infectious disease during hospital stay.  The overall impression of  infectious disease MD was that Kawasaki like illness occurred secondary to hep b vaccination and recommended reporting vaccine in VAERS.
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Infant received vaccine on 9/23/20 after a well child exam.  Infant returned to clinic on 9/28/20 with a low grade fever and enlarged lymph node on left side of neck. Infant was sent to ER on 9/28/20 for evaluation and treatment of symptoms and was discharged home on oral antibiotics,  Infant was seen in office on 9/30/20 for continuation of low grade fever and rash that developed over entire body.  Infant was sent back to ER for further evaluation of evaluation and treatment of symptoms. Infant was admitted to hospital from 9/30/20 to 10/4/20 for treatment of Kawasaki like illness. Infant was followed by cardiology and infectious disease during hospital stay.  The overall impression of  infectious disease MD was that Kawasaki like illness occurred secondary to hep b vaccination and recommended reporting vaccine in VAERS.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Incorrect dose administered
Clinical narrative: patient came in to get a shingrix 2  shot series 9/29/20. unaware that she had recieved 2 shot series in 2018.  records not reviewed as patient claim never had vaccination. she completed 2 shot series 11/26/20.  in total she received 4 shots over 2 and 1/2 years. manufacture could not provide data on 4 vaccinations as there studies were limited to 3 vaccinations. manufacture informed us that any side effects would be similar to original series. (primarily injection site issues) patient made aware of error in receiving additional vaccinations. she has claimed that no adverse effects were noticed with additional vaccination. she will continue to monitor any effects, and follow up with pharmacy.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Impaired work ability, Pain in extremity
Clinical narrative: No pain for first 24 hours and then a sudden onset of severe arm pain, I used heat and mild massage.  The pain was a 10 on a scale of 1-10 and almost went to ER.  Heat was mildly helpful.  I waited a week and when the pain was the same I reported it to the Dr.  He advised to wait a little longer.  I have now waited more than a month and my arm is sore but at night or in the cold it gets extremely painful.  I am afraid this is a permanent injury from the vaccine and I do not know what kind of Dr. to go to.  I am a medical esthetician and massage therapist and use my arm for work.      I don't know if this is permanent or where to go and what to do for help!
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chest discomfort, Consciousness fluctuating, Disturbance in attention, Dizziness
Clinical narrative: First dose 10/14/2019: Approximately 3-4 hours after first dose vaccine I began feeling lightheaded, nauseated, and began getting a headache. The following day I was listless and no energy. I had trouble concentrating.  Second dose 12/17/2019: Approximately one hour after receiving  the second dose of the vaccine I began feeling like I did after the first vaccine, only more intense. I went to bed at 7:00 pm. The following morning I woke at 6:00 am but I couldn't move. I laid there for 3-5 minutes when I realized if I concentrated hard enough, I could move a little. After 20 minutes I was able to make it to the living room floor where I laid all day drifting in and out of consciousness. As I was drifting in and out throughout the day, I was sweating profusely. I couldn't take deep breaths as my chest felt very constricted as if there was an enormous weight on it. I seriously thought I was going to die. I did not have the need to go to the bathroom all day. At approximately 6:00 pm I had enough energy to make it to bed where I remained all night drifting in and out of consciousness. I didn't really know where I was. My chest still felt constricted until the following day. I woke at 5:30 am and was able to move easier than the previous day. My chest still felt constricted but not as much as the previous day
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Headache, Hyperhidrosis, Hypersomnia, Listless
Clinical narrative: First dose 10/14/2019: Approximately 3-4 hours after first dose vaccine I began feeling lightheaded, nauseated, and began getting a headache. The following day I was listless and no energy. I had trouble concentrating.  Second dose 12/17/2019: Approximately one hour after receiving  the second dose of the vaccine I began feeling like I did after the first vaccine, only more intense. I went to bed at 7:00 pm. The following morning I woke at 6:00 am but I couldn't move. I laid there for 3-5 minutes when I realized if I concentrated hard enough, I could move a little. After 20 minutes I was able to make it to the living room floor where I laid all day drifting in and out of consciousness. As I was drifting in and out throughout the day, I was sweating profusely. I couldn't take deep breaths as my chest felt very constricted as if there was an enormous weight on it. I seriously thought I was going to die. I did not have the need to go to the bathroom all day. At approximately 6:00 pm I had enough energy to make it to bed where I remained all night drifting in and out of consciousness. I didn't really know where I was. My chest still felt constricted until the following day. I woke at 5:30 am and was able to move easier than the previous day. My chest still felt constricted but not as much as the previous day
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Nausea
Clinical narrative: First dose 10/14/2019: Approximately 3-4 hours after first dose vaccine I began feeling lightheaded, nauseated, and began getting a headache. The following day I was listless and no energy. I had trouble concentrating.  Second dose 12/17/2019: Approximately one hour after receiving  the second dose of the vaccine I began feeling like I did after the first vaccine, only more intense. I went to bed at 7:00 pm. The following morning I woke at 6:00 am but I couldn't move. I laid there for 3-5 minutes when I realized if I concentrated hard enough, I could move a little. After 20 minutes I was able to make it to the living room floor where I laid all day drifting in and out of consciousness. As I was drifting in and out throughout the day, I was sweating profusely. I couldn't take deep breaths as my chest felt very constricted as if there was an enormous weight on it. I seriously thought I was going to die. I did not have the need to go to the bathroom all day. At approximately 6:00 pm I had enough energy to make it to bed where I remained all night drifting in and out of consciousness. I didn't really know where I was. My chest still felt constricted until the following day. I woke at 5:30 am and was able to move easier than the previous day. My chest still felt constricted but not as much as the previous day
Age: 54.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Headache, Paraesthesia oral, Peripheral swelling, Swollen tongue, Vomiting
Clinical narrative: In the evening after the vaccines, the patient's left arm became swollen up to her shoulder.   She had swelling in her tongue, multiple episodes of vomiting, and a severe headache.  By morning the swelling was starting to improve, her tongue was only tingling, the vomiting was less frequent, and her headache had improved.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Retinal detachment
Clinical narrative: pt called on 12/5/20. stated there was retina detachment after each vaccination (once in august once in november)
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives throughout Arms, legs, trunk, face.  Slight itching.  Denies trouble breathing, swelling, or any other symptoms.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Injection site pain
Clinical narrative: body ache, shivering, headache, finger joint pain, knee joint pain, felt like I had the flu but no nausea. Area of injection sensitive to pain.  My first injection of Shingrix on October 6, 2020 I had no side effects at all.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: body ache, shivering, headache, finger joint pain, knee joint pain, felt like I had the flu but no nausea. Area of injection sensitive to pain.  My first injection of Shingrix on October 6, 2020 I had no side effects at all.
Age: 76.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Decreased appetite, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Sensitive Skin, entire Body; Headache; sore or swollen throat; Muscle Ache; Lack of Energy; loss of appetite
Age: 76.0
Sex: M
Vaccine: UNK
Symptoms: Pharyngeal swelling, SARS-CoV-2 test negative, Sensitive skin
Clinical narrative: Sensitive Skin, entire Body; Headache; sore or swollen throat; Muscle Ache; Lack of Energy; loss of appetite
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Influenza like illness, Pyrexia, Sleep disorder, Tachycardia
Clinical narrative: Began to get severe chills about 9:30 PM, the same evening I received the vaccine.  Felt flu-like affects.  Went to bed with heavy layers of clothing and woke up at  @ 2 am with fever and tachycardia -heart rate @ 130 bpm.  Took a cold shower and went to bed sitting up with 2 pillow supporting me.  The tachycardia persisted until I finally fell back asleep. Woke up in the morning perfectly fine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, hot Fever, achy, nausea, fatigue for 3 days  I did not notice any issues with dose 1 on Sept 3rd 2020
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: Received injection at 4pm, lost vision at 6pm, regained vision seconds later
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Patient called stating she is having problems with the immunization from 10/27/20 stating the shot may have been administered too high on the arm.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Deep vein thrombosis, Erythema, Pain in extremity, Peripheral swelling, Ultrasound scan abnormal
Clinical narrative: Patient stated that he received the shingles vaccine  (Shingrix) in his left arm on Friday and presented to the emergency department with right arm swelling, redness and pain.  Ultrasound of the arm was done in the emergency department which confirmed a DVT in the right arm  as a possible ADR from the vaccine that he received on Friday.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Tardive dyskinesia
Clinical narrative: Patient specifically state that she experienced painful tardive dyskinesia for 6 to 7 hours that started in the evening day of vaccination. She also experienced a slight headache which was not as concerning to her.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Fever, swelling from shoulder to elbow, tender to touch, redness, unable to move arm.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: X-ray
Clinical narrative: Fever, swelling from shoulder to elbow, tender to touch, redness, unable to move arm.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Nausea, Pain, Rash papular
Clinical narrative: Rash developed on left arm about 3 inches away from the injection site which i noticed about 23 hours after the shot.   Rash was about the size of a quarter.  By night time it had tripled it's size.  By night on the 6th, it was about 3 inches down and about 5 inches across.  It is tender to the touch and raised.  It does not feel warm.  During the first 36hours after the shot I felt achy (no fever) and sore.  Slightly nauseous.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Rash developed on left arm about 3 inches away from the injection site which i noticed about 23 hours after the shot.   Rash was about the size of a quarter.  By night time it had tripled it's size.  By night on the 6th, it was about 3 inches down and about 5 inches across.  It is tender to the touch and raised.  It does not feel warm.  During the first 36hours after the shot I felt achy (no fever) and sore.  Slightly nauseous.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Dizziness, Heart rate increased, Muscle spasms, Muscle tightness, Muscle twitching
Clinical narrative: At 12am-1am that night, patient states suddent onset of tightness and spasms in the muscles of the neck, dizziness, and increased heart rate. The muscle spasms in the neck caused her head to continuously twitch. She states that these symptoms were reoccurring for "the remainder of the night". Patient called the pharmacy ~2pm on Sunday 12/06/20 to report reaction at which time she stated she is still experiencing soreness and tightness in the neck muscles. Patient did not seek medical attention or take any over-the-counter medications to treat her reaction. I recommended she reach out to her primary care provider to let them know of her reaction and to seek medical attention if severe symptoms come back.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Myalgia
Clinical narrative: At 12am-1am that night, patient states suddent onset of tightness and spasms in the muscles of the neck, dizziness, and increased heart rate. The muscle spasms in the neck caused her head to continuously twitch. She states that these symptoms were reoccurring for "the remainder of the night". Patient called the pharmacy ~2pm on Sunday 12/06/20 to report reaction at which time she stated she is still experiencing soreness and tightness in the neck muscles. Patient did not seek medical attention or take any over-the-counter medications to treat her reaction. I recommended she reach out to her primary care provider to let them know of her reaction and to seek medical attention if severe symptoms come back.
Age: 62.0
Sex: M
Vaccine: FLUR4
Symptoms: Arthralgia
Clinical narrative: Patient's right shoulder has been painful and sore since the immunization on 10/30/2020.  Patient has been taking ibuprofen OTC and using cold compresses to help with the pain.  Patient states that the shoulder is still sore and painful now.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Pruritus, Pyrexia, Swelling
Clinical narrative: Patient reported fever and headache after shot and then swelling and itching that was still present a few days after shot which led to her calling pharmacy. Patient stated she took some Benadryl and it helped and that she was going to follow up with a doctor on Monday (December 7).
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Injection site.  Swollen and red and at times itchy.   Bigger than a golf ball.   Low grade fever and some aches and chills
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Injection site.  Swollen and red and at times itchy.   Bigger than a golf ball.   Low grade fever and some aches and chills
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Chills - eventually ceased after one day Nausea - ceased after one day Headaches - ceased after two days Body aches
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Injection site pain, Vomiting
Clinical narrative: Severe chills Vomiting  Diarrhea  Pain at injection site for 7 days Fatigue
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain, Inflammation, Pain, Pain of skin, Rash macular
Clinical narrative: Intermittent, stabbing pain on right side of scalp and cheek began approximately 36 hours after receiving the Shingrix vaccination.  A quarter-size raised red spot just below the right earlobe approximately 60 hours after receiving the Shingrix vaccination.  Between 60 to 96 hours after receiving the Shingrix vaccination, more raised red patches have appeared on  the right side of  the face along the jawline and hairline.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Blood pressure increased, Malaise, Nasopharyngitis, Neck pain, Palpitations
Clinical narrative: manufacuer: seqirus hd for 65 yoa Swelling,  2r: 1 inch,  right a way as the needle out. After  around 10 minutes,  don't fell well- palpitation, cold and hurt around the neck.  Pharmacist give 2 tablets 25 mg ( 50 mg ) diphenhydramine by mouth.  Monitor blood pressure: 219/173 - 70 and 5 minutes after 186/97 - 70 . Patient ask to all 911
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash macular, Swelling
Clinical narrative: Redness, swelling  and itching. Red patch has migrated around arm as of 12-6-20 still present.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Lethargy
Clinical narrative: Extreme fatigue and  lethargy 22 hours post injection.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient says she has had arm pain since her vaccine, and says this happens each year after the flu vaccine. She says she has had pain since the vaccine. Pharmacist on duty recommended patient follow up with her PCP as she has already tried over the counter analgesics with no relief.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Severe hives on toro, back and arms
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Burning sensation, Herpes zoster, Injection site rash, Neuralgia
Clinical narrative: Initial reaction - rash emerged at injection site.  Started as red, then more raised/pronounced and itchy.  Spread above and then down injection site with blistering down to tips of fingers - left arm only.  Experienced pain that felt initially like electric shocks, then alternated with extreme burning sensations.   Saw dermatologist who confirmed SHINGLES.  Had  antiviral prescribed which lessened further blistering but the pain continued unabated.   Was prescribed Gabapentin to handle nerve pain - still taking .
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Initial reaction - rash emerged at injection site.  Started as red, then more raised/pronounced and itchy.  Spread above and then down injection site with blistering down to tips of fingers - left arm only.  Experienced pain that felt initially like electric shocks, then alternated with extreme burning sensations.   Saw dermatologist who confirmed SHINGLES.  Had  antiviral prescribed which lessened further blistering but the pain continued unabated.   Was prescribed Gabapentin to handle nerve pain - still taking .
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hangover
Clinical narrative: Patient experienced common side effects of vaccine but described it as very exaggerated. She felt extremely fatigued and had a "hangover" feeling. This lasted overnight. Although these side effects are common, the patient still wanted to file a report.
Age: 34.0
Sex: M
Vaccine: FLUR4
Symptoms: Dizziness, Pallor, Seizure
Clinical narrative: Patient developed dizziness, pallor, and had a mini-seizure about 15 mins after vaccine. No LOC.  911 called due to hx of epilepsy.  Patient recovered on his own after sitting and drinking some water. Escorted out by paramedics but did not go to hospital.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Vomiting
Clinical narrative: 10 MINUTES AFTER VACCINATION PATIENT COMPAINED ABOUT FULL BLOWN DIARREAR AND VOMITING AND FEELING WEAK.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain
Clinical narrative: The left arm had usual soreness at the injection site, more the second and third day.  The evening around 11pm began to have strong shivers as if from a fever.  More than likely had a fever, but did not take temperature.  Shivers continued until around 4am.  Took 2 Advil around 6am and felt like the possible fever was gone by 9am.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Injection site became red with a 3" circle of redness.  Injection site was extremely tender within an hour of receiving it.  About 3 hours after injection body aches began.  About 5 hours after injection, felt feverish but had not fever, body aches intensified, felt nauseous, and injection site so tender couldn't touch it.    19 hours after injection, took 2 Advil and they made me feel better.  Still felt ill, but not as severe.  28 hours after injection, all symptoms returned and more severe.  Felt as is I was sick with a virus ( body aches, joint aches, felt hot at times, but no fever, nauseous, headache, exhausted)  42 hours after injection still felt sick, but not as severe (headache, body aches, joint aches, tired, hot but no fever).  By 54 hours after injection I was less tired and less body aches.  Redness around injection site still there, but less tender.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain, Pyrexia, Skin warm
Clinical narrative: Injection site became red with a 3" circle of redness.  Injection site was extremely tender within an hour of receiving it.  About 3 hours after injection body aches began.  About 5 hours after injection, felt feverish but had not fever, body aches intensified, felt nauseous, and injection site so tender couldn't touch it.    19 hours after injection, took 2 Advil and they made me feel better.  Still felt ill, but not as severe.  28 hours after injection, all symptoms returned and more severe.  Felt as is I was sick with a virus ( body aches, joint aches, felt hot at times, but no fever, nauseous, headache, exhausted)  42 hours after injection still felt sick, but not as severe (headache, body aches, joint aches, tired, hot but no fever).  By 54 hours after injection I was less tired and less body aches.  Redness around injection site still there, but less tender.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint swelling, Peripheral swelling, Skin warm
Clinical narrative: Patient reported heat throughout entire arm swelling on wrist & hand on left arm same arm that was vaccinated. This was 2nd dose
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Death
Clinical narrative: passed away with a Questionable GBS; Initial information was received on 09-Nov-2017 regarding an unsolicited valid serious case from a nurse and consumer via medical representative.  This case involves a 65 year old male patient who passed away with a Questionable GBS (Guillain-Barre syndrome), while he received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, concomitant medications, past medical treatment(s), vaccination(s) and family history were not provided.   On 12-Oct-2017, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UI871AB) once via intramuscular route in unknown administration site for prophylactic vaccination.  On 20-Oct-2017, the patient passed away with a Questionable GBS (Guillain-Barre syndrome) 8 days (latency for GBS was unknown) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.   This event was assessed as medically significant.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment before death.  It was unknown if an autopsy was done. The cause of death was not reported.; Sender's Comments: This poorly documented case involves 65-year-old male patient who passed away with a possible Guillain-Barre syndrome after receiving FLUZONE HIGH DOSE. The time to onset is compatible. Additional information regarding medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed; Reported Cause(s) of Death: passed away with a Questionable GBS
Age: 68.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Throat tightness
Clinical narrative: Felt a lump in a her throat; Difficulty swallowing; Chest tightness; Her throat felt funny; Wheezing; Coughing; Difficulty breathing; She had shaking chills; Initial information regarding an unsolicited valid serious case was received from a Consumer/non-hcp (healthcare professional) via The Agency (Reference number- 00343761) and transmitted to Sanofi on 03-Nov-2020.  This case involves a 68 years old female patient who experienced a lump in a her throat (sensation of foreign body), difficulty swallowing (dysphagia), chest tightness (chest discomfort), her throat felt funny (throat irritation), wheezing (wheezing), coughing (cough), difficulty breathing (dyspnoea) and she had shaking chills (chills), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 25-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ482AB and expiration date: 30-Jun-2021) via unknown route in the upper right arm for prophylactic vaccination.  On 25-Sep-2020, the patient developed a non- a lump in a her throat (sensation of foreign body), difficulty swallowing (dysphagia), chest tightness (chest discomfort), her throat felt funny (throat irritation), wheezing, coughing (cough), difficulty breathing (dyspnoea) and she had shaking chills (chills), two hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The patient was treated with 50 mg DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  The patient was recovered from all events on an unknown date.
Age: 68.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Cough, Dysphagia, Dyspnoea, Sensation of foreign body
Clinical narrative: Felt a lump in a her throat; Difficulty swallowing; Chest tightness; Her throat felt funny; Wheezing; Coughing; Difficulty breathing; She had shaking chills; Initial information regarding an unsolicited valid serious case was received from a Consumer/non-hcp (healthcare professional) via The Agency (Reference number- 00343761) and transmitted to Sanofi on 03-Nov-2020.  This case involves a 68 years old female patient who experienced a lump in a her throat (sensation of foreign body), difficulty swallowing (dysphagia), chest tightness (chest discomfort), her throat felt funny (throat irritation), wheezing (wheezing), coughing (cough), difficulty breathing (dyspnoea) and she had shaking chills (chills), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 25-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ482AB and expiration date: 30-Jun-2021) via unknown route in the upper right arm for prophylactic vaccination.  On 25-Sep-2020, the patient developed a non- a lump in a her throat (sensation of foreign body), difficulty swallowing (dysphagia), chest tightness (chest discomfort), her throat felt funny (throat irritation), wheezing, coughing (cough), difficulty breathing (dyspnoea) and she had shaking chills (chills), two hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The patient was treated with 50 mg DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  The patient was recovered from all events on an unknown date.
Age: 68.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Throat irritation, Wheezing
Clinical narrative: Felt a lump in a her throat; Difficulty swallowing; Chest tightness; Her throat felt funny; Wheezing; Coughing; Difficulty breathing; She had shaking chills; Initial information regarding an unsolicited valid serious case was received from a Consumer/non-hcp (healthcare professional) via The Agency (Reference number- 00343761) and transmitted to Sanofi on 03-Nov-2020.  This case involves a 68 years old female patient who experienced a lump in a her throat (sensation of foreign body), difficulty swallowing (dysphagia), chest tightness (chest discomfort), her throat felt funny (throat irritation), wheezing (wheezing), coughing (cough), difficulty breathing (dyspnoea) and she had shaking chills (chills), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 25-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ482AB and expiration date: 30-Jun-2021) via unknown route in the upper right arm for prophylactic vaccination.  On 25-Sep-2020, the patient developed a non- a lump in a her throat (sensation of foreign body), difficulty swallowing (dysphagia), chest tightness (chest discomfort), her throat felt funny (throat irritation), wheezing, coughing (cough), difficulty breathing (dyspnoea) and she had shaking chills (chills), two hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The patient was treated with 50 mg DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  The patient was recovered from all events on an unknown date.
Age: 2.0
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Computerised tomogram, Dyspnoea, Endotracheal intubation, Laboratory test, Pneumothorax
Clinical narrative: catatonic state for 48hrs; oxygen saturation was worse (ranging in 70s); wheezing in the morning; Initial information regarding an unsolicited valid serious case was received from the Other Health Care Professional via Medical Information (Reference number- 00377582) and transmitted to Sanofi on 01-Dec-2020.  This case involves a 2 year old male patient who's oxygen saturation was worse (ranging in 70s) (Oxygen saturation decreased), was in catatonic state for 48 hours (Catatonia) and wheezing in the morning (Wheezing), while he received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On 04-Nov-2020, the patient received a fourth dose of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) once (lot number: UJ351AA Expiration date: 09-Aug-2021) at a dose of 0.5 mL via intramuscular route in the left thigh for prophylactic vaccination.  On 07-Nov-2020, three days after administration of the suspect vaccine the patient had wheezing in the morning (Wheezing).   On 07-Nov-2020 at night, patient was retracting and went to the emergency room. Patent received chest x-ray and at that time they were not able to determine if it was collapsed lung or pneumonia.   On same date, Oxygen saturation was in limit of upper 80 saturation to lower 90 saturation. Nebulizer treatments were given, but this treatment were not working.  On 08-Nov-2020, four days following vaccination oxygen saturation was worse ranging in 70 saturation level (Oxygen saturation decreased) and patient was admitted to intensive care unit and was intubated for 48 hours.   Patient was extubated and then went into catatonic state for 48 hours (Catatonia). Patient was hospitalized for a total of six days.  Other relevant test were not reported.    It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for all the events.  Result of Reporter causality Assessment- Related; Sender's Comments: Sanofi company comment dated 03-Dec-2020: This case concerns 2 year old male patient who was presented oxygen saturation was worse (ranging in 70s) (Oxygen saturation decreased), catatonic state for 48 hours (Catatonia) and wheezing in the morning (Wheezing) with HIB (PRP/T) VACCINE [ACT-HIB]. The time to onset for all event was not compatible. Laboratory tests included oxygen saturation resulted in 70 saturation. However, patient's medical condition and concomitant medications were ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 2.0
Sex: M
Vaccine: HIBV, HIBV
Symptoms: X-ray
Clinical narrative: catatonic state for 48hrs; oxygen saturation was worse (ranging in 70s); wheezing in the morning; Initial information regarding an unsolicited valid serious case was received from the Other Health Care Professional via Medical Information (Reference number- 00377582) and transmitted to Sanofi on 01-Dec-2020.  This case involves a 2 year old male patient who's oxygen saturation was worse (ranging in 70s) (Oxygen saturation decreased), was in catatonic state for 48 hours (Catatonia) and wheezing in the morning (Wheezing), while he received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On 04-Nov-2020, the patient received a fourth dose of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) once (lot number: UJ351AA Expiration date: 09-Aug-2021) at a dose of 0.5 mL via intramuscular route in the left thigh for prophylactic vaccination.  On 07-Nov-2020, three days after administration of the suspect vaccine the patient had wheezing in the morning (Wheezing).   On 07-Nov-2020 at night, patient was retracting and went to the emergency room. Patent received chest x-ray and at that time they were not able to determine if it was collapsed lung or pneumonia.   On same date, Oxygen saturation was in limit of upper 80 saturation to lower 90 saturation. Nebulizer treatments were given, but this treatment were not working.  On 08-Nov-2020, four days following vaccination oxygen saturation was worse ranging in 70 saturation level (Oxygen saturation decreased) and patient was admitted to intensive care unit and was intubated for 48 hours.   Patient was extubated and then went into catatonic state for 48 hours (Catatonia). Patient was hospitalized for a total of six days.  Other relevant test were not reported.    It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for all the events.  Result of Reporter causality Assessment- Related; Sender's Comments: Sanofi company comment dated 03-Dec-2020: This case concerns 2 year old male patient who was presented oxygen saturation was worse (ranging in 70s) (Oxygen saturation decreased), catatonic state for 48 hours (Catatonia) and wheezing in the morning (Wheezing) with HIB (PRP/T) VACCINE [ACT-HIB]. The time to onset for all event was not compatible. Laboratory tests included oxygen saturation resulted in 70 saturation. However, patient's medical condition and concomitant medications were ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 2.0
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Catatonia, Chest X-ray abnormal, Endotracheal intubation, Intensive care, Oxygen saturation decreased
Clinical narrative: catatonic state for 48hrs; oxygen saturation was worse (ranging in 70s); wheezing in the morning; Initial information regarding an unsolicited valid serious case was received from the Other Health Care Professional via Medical Information (Reference number- 00377582) and transmitted to Sanofi on 01-Dec-2020.  This case involves a 2 year old male patient who's oxygen saturation was worse (ranging in 70s) (Oxygen saturation decreased), was in catatonic state for 48 hours (Catatonia) and wheezing in the morning (Wheezing), while he received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On 04-Nov-2020, the patient received a fourth dose of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) once (lot number: UJ351AA Expiration date: 09-Aug-2021) at a dose of 0.5 mL via intramuscular route in the left thigh for prophylactic vaccination.  On 07-Nov-2020, three days after administration of the suspect vaccine the patient had wheezing in the morning (Wheezing).   On 07-Nov-2020 at night, patient was retracting and went to the emergency room. Patent received chest x-ray and at that time they were not able to determine if it was collapsed lung or pneumonia.   On same date, Oxygen saturation was in limit of upper 80 saturation to lower 90 saturation. Nebulizer treatments were given, but this treatment were not working.  On 08-Nov-2020, four days following vaccination oxygen saturation was worse ranging in 70 saturation level (Oxygen saturation decreased) and patient was admitted to intensive care unit and was intubated for 48 hours.   Patient was extubated and then went into catatonic state for 48 hours (Catatonia). Patient was hospitalized for a total of six days.  Other relevant test were not reported.    It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for all the events.  Result of Reporter causality Assessment- Related; Sender's Comments: Sanofi company comment dated 03-Dec-2020: This case concerns 2 year old male patient who was presented oxygen saturation was worse (ranging in 70s) (Oxygen saturation decreased), catatonic state for 48 hours (Catatonia) and wheezing in the morning (Wheezing) with HIB (PRP/T) VACCINE [ACT-HIB]. The time to onset for all event was not compatible. Laboratory tests included oxygen saturation resulted in 70 saturation. However, patient's medical condition and concomitant medications were ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 2.0
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Use of accessory respiratory muscles, Wheezing
Clinical narrative: catatonic state for 48hrs; oxygen saturation was worse (ranging in 70s); wheezing in the morning; Initial information regarding an unsolicited valid serious case was received from the Other Health Care Professional via Medical Information (Reference number- 00377582) and transmitted to Sanofi on 01-Dec-2020.  This case involves a 2 year old male patient who's oxygen saturation was worse (ranging in 70s) (Oxygen saturation decreased), was in catatonic state for 48 hours (Catatonia) and wheezing in the morning (Wheezing), while he received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On 04-Nov-2020, the patient received a fourth dose of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) once (lot number: UJ351AA Expiration date: 09-Aug-2021) at a dose of 0.5 mL via intramuscular route in the left thigh for prophylactic vaccination.  On 07-Nov-2020, three days after administration of the suspect vaccine the patient had wheezing in the morning (Wheezing).   On 07-Nov-2020 at night, patient was retracting and went to the emergency room. Patent received chest x-ray and at that time they were not able to determine if it was collapsed lung or pneumonia.   On same date, Oxygen saturation was in limit of upper 80 saturation to lower 90 saturation. Nebulizer treatments were given, but this treatment were not working.  On 08-Nov-2020, four days following vaccination oxygen saturation was worse ranging in 70 saturation level (Oxygen saturation decreased) and patient was admitted to intensive care unit and was intubated for 48 hours.   Patient was extubated and then went into catatonic state for 48 hours (Catatonia). Patient was hospitalized for a total of six days.  Other relevant test were not reported.    It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for all the events.  Result of Reporter causality Assessment- Related; Sender's Comments: Sanofi company comment dated 03-Dec-2020: This case concerns 2 year old male patient who was presented oxygen saturation was worse (ranging in 70s) (Oxygen saturation decreased), catatonic state for 48 hours (Catatonia) and wheezing in the morning (Wheezing) with HIB (PRP/T) VACCINE [ACT-HIB]. The time to onset for all event was not compatible. Laboratory tests included oxygen saturation resulted in 70 saturation. However, patient's medical condition and concomitant medications were ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: As with my first vaccination of Shingrix, I developed flu like symptoms. All joints ache, lymph nodes at neck on left side are swollen and tender, massive headache, and swelling and pain at the injection site. The first time this resolved in about 24-36 hours from onset (except for the swelling and pain at injection site - that lasted at least a week). This second round was just yesterday, so none of the reactions have resolved yet.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy, Vaccine positive rechallenge
Clinical narrative: As with my first vaccination of Shingrix, I developed flu like symptoms. All joints ache, lymph nodes at neck on left side are swollen and tender, massive headache, and swelling and pain at the injection site. The first time this resolved in about 24-36 hours from onset (except for the swelling and pain at injection site - that lasted at least a week). This second round was just yesterday, so none of the reactions have resolved yet.