chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: My eyes started to get itchy and ached all over. My skin started to get itchy and hurt. The following day I felt like I had the flu. I also had a slight fever. I was sick for several days.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Basal ganglia infarction, Cerebral infarction, Chills, Computerised tomogram head abnormal, Facial paralysis
Clinical narrative: Fever/Chills on the night of vaccine (11/16/2020). Ischemic stroke on 11/19/2020, which happened approximately 6:00 am EST, with stroke residual side effects (drooping left side of the face, limp leg/arm)setting in around 3:00 pm EST. Stroke side effects have worsened to a total loss of use of the left arm, unable to walk without assistance. Still in hospital from stroke as of 11/21/2020. Unknown if he will recover.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait inability, Ischaemic stroke, Magnetic resonance imaging brain abnormal, Musculoskeletal disorder, Pyrexia
Clinical narrative: Fever/Chills on the night of vaccine (11/16/2020). Ischemic stroke on 11/19/2020, which happened approximately 6:00 am EST, with stroke residual side effects (drooping left side of the face, limp leg/arm)setting in around 3:00 pm EST. Stroke side effects have worsened to a total loss of use of the left arm, unable to walk without assistance. Still in hospital from stroke as of 11/21/2020. Unknown if he will recover.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: REDNESS, SWELLING WITH A KNOT WITHIN 24 HOURS OF RECEIVING THE SHOT. RECOMMENDED ANTIHISTAMINE AND TYLENOL. THE PATIENT WILL BE SEEING BY PCP ON JANUARY 2021.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Feeling abnormal, Nausea, Pruritus
Clinical narrative: Patients daughter called about an hour after they left the pharmacy reporting that her mother was very nauseous and was beginning to itch.  She stated that there were no hives yet and she was not experiencing any problems breathing nor had shortness of breath.  Advised patient to take benedryl/diphenhydramine take an easy, informed daughter that if she got worse or had problems breathing to go to the ER, also assured patient that I would call in an hour to check on them.  When I called back and 1:52pm, patient had taken diphenhydramine and an ondansetron she had at home and was feeling much better.  Still felt foggy, but there was no more itching nor was she nauseous.  Advised her to take an easy for the rest of the day, and patient herself reported feeling much better.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Headache,  muscle pain, joint pain
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Head discomfort, Pain
Clinical narrative: Achy , tired, head heavy,
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye discharge, Eye pain, Skin sensitisation
Clinical narrative: shingles-like symptoms, sensitivity left side of face and scalp. weeping eye. pain left orbital. lasting a few days.
Age: 55.0
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: Patient received rabies vaccines 11/20/20. The next day developed nausea, vomiting,  diarrhea and headache.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Tetanus Vaccine was given to a qualified donor and he immediately felt dizzy, sweaty, and lightheaded. After a nurse provided comfort care (ice pack), oral fluids and  a snack, the donor felt much better. Donor's vitals remained stable and donor left the facility in good condition around 2:10pm.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: CSF protein increased, CSF white blood cell count increased, Meningitis aseptic, Mononuclear cell percentage, Polymerase chain reaction
Clinical narrative: Aseptic meningitis
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Nausea, severe pain all over body, particularly in joints, swelling and itching at shot site, severe headache, congestion, extreme fatigue, no appetite, fever of 100.9, Chills and sweats., swollen and painful lymph nodes on neck.  Popping feelings and then pain that spread.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: Nausea, severe pain all over body, particularly in joints, swelling and itching at shot site, severe headache, congestion, extreme fatigue, no appetite, fever of 100.9, Chills and sweats., swollen and painful lymph nodes on neck.  Popping feelings and then pain that spread.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Nausea, severe pain all over body, particularly in joints, swelling and itching at shot site, severe headache, congestion, extreme fatigue, no appetite, fever of 100.9, Chills and sweats., swollen and painful lymph nodes on neck.  Popping feelings and then pain that spread.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Headache, Myalgia
Clinical narrative: Headache,chills,sore joints, no energy, muscle pain
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Sinus disorder
Clinical narrative: Shivering for 3-4 hours, tiredness, muscle aches, sinus drainage
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Flushing, Hyperhidrosis, Injection site erythema, Injection site swelling
Clinical narrative: Flushing in the face, body aches, fatigue, headache, nasal congestion, swelling at injection site, itch at injection site, red circle at  injection (approximately 3" in diameter).  I took Advil ever 8 hours starting  at  4:00 pm on 11/20/20.  I also took one dose of Benedryl at 9 pm on 11/21/20.  I woke up at 3:00  am on 11/22/20 in a pool of sweat.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Nasal congestion, Pain
Clinical narrative: Flushing in the face, body aches, fatigue, headache, nasal congestion, swelling at injection site, itch at injection site, red circle at  injection (approximately 3" in diameter).  I took Advil ever 8 hours starting  at  4:00 pm on 11/20/20.  I also took one dose of Benedryl at 9 pm on 11/21/20.  I woke up at 3:00  am on 11/22/20 in a pool of sweat.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: Chills, feverish, joint pain, headache
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Skin sensitisation
Clinical narrative: Aches, skin sensitivity, sore arm, neck pain (2 days after injection)
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia
Clinical narrative: *Not sure exactly which Flu Vaccine was administered, but still having shoulder pain one month later.
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Blister, Nasal mucosal blistering
Clinical narrative: Patient is reporting that on the morning of 11/19/20 her nose both inside and outside broke out in blisters. She is attributing this to the Shingrix vaccine since she has had the "flu shot" before without incident. She said that prior to getting the vaccine she did feel like there were "bugs crawling around in her nose", but the blisters broke out after the vaccination.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration related reaction, Arthralgia, Limb discomfort, Movement disorder, Muscular weakness
Clinical narrative: Vaccine hurt more than other received vaccines in the past. Arm feels heavy and cannot lift/bear as much weight as previously able. Arm to wrist hurts (dull ache to sharp pains). Limited ability now with arm.
Age: 63.0
Sex: M
Vaccine: FLUR4, TDAP, VARZOS
Symptoms: Pain, Rash
Clinical narrative: Patient presented to pharmacy today (11/22) to inquire about next Shingrix vaccine. Patient stated they developed a truncal rash a few days after receiving immunizations accompanied by burning pain. The rash lasted a couple of days per patients. Patient did not receive any treatment.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Constipation, Flatulence, Pyrexia, Rash erythematous, Spinal fusion surgery
Clinical narrative: On 8th day Pt developed low grade fever 99-100 degrees F, fussy, gas, and constipation.  On day 10 developed an erythematous papular rash generalized on body excluding palms, soles and scalp.
Age: 55.0
Sex: F
Vaccine: FLUA3
Symptoms: Burning sensation, Diarrhoea, Dysgeusia, Gastric disorder, Headache
Clinical narrative: Half hour after shot  I got full Metallic taste in mouth. Then on 3/20 I got a full blown headache diarrhea and been sick with gastro issues, nerve pain, muscle weakness burning of nerves tingling and numbness in legacy and arms and neck.
Age: 55.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypoaesthesia, Muscular weakness, Neuralgia, Paraesthesia
Clinical narrative: Half hour after shot  I got full Metallic taste in mouth. Then on 3/20 I got a full blown headache diarrhea and been sick with gastro issues, nerve pain, muscle weakness burning of nerves tingling and numbness in legacy and arms and neck.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: I call patient to follow on his immunization.  Patient went to his PCP and doctor because of a rash that developed all over his body the next morning .  The doctor said that it's not life threatening and will resolve.  Patient said he was doing better.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Injection site pain, Pyrexia
Clinical narrative: Fever of 104.7 Chills,  Shivering all night, Sick to stomach and soreness at site
Age: 34.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient stated arm has been sore after both vaccines were administered.  Patient states arm is achy and is more painful with exertion.  States pain is 3 out of 10 when at rest and 7 out of 10 upon movement.  Difficult for patient to raise arm. Still, almost a month later, patient is still experiencing the same pain.  Patient continues to take ibuprofen or naproxen daily. He also uses muscle pain creams along with massage.   Instructed patient to contact PCP at this point but is currently uninsured
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness, redness in shoulder where vaccination occurred. Patient complained shoulder being swollen by ~1". Redness up to the lower arm. patient has taken over the counter ibuprofen.
Sex: U
Vaccine: MMR
Symptoms: Aggression, Intentional self-injury
Clinical narrative: Started to hit his face, no eye contact, extremely aggressive less than 24 hours after last does of MMR. He had to see a psychologist and still does has behavioral issues. Added to database.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Erythema, Fatigue, Heart rate increased
Clinical narrative: patient reports that they experienced rapid heart rate first night after vaccine is administered, which woke him. Pulse was 104, normally 74.  Also reported increase in blood pressure of144/94, normal 116/78. Both symptoms lasted 2 days. Arm became inflamed down almost to elbow, redness halfway around bicep, and pain as described by patient. Patient also reported chills and extreme fatigue for approximately 3 days. Some itching reported. Patient stated on 11/22/2020 at 955am that the arm is still red, looks like a sunburn, but pulse and bp are normal and fatigue is gone.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Inflammation, Pruritus
Clinical narrative: patient reports that they experienced rapid heart rate first night after vaccine is administered, which woke him. Pulse was 104, normally 74.  Also reported increase in blood pressure of144/94, normal 116/78. Both symptoms lasted 2 days. Arm became inflamed down almost to elbow, redness halfway around bicep, and pain as described by patient. Patient also reported chills and extreme fatigue for approximately 3 days. Some itching reported. Patient stated on 11/22/2020 at 955am that the arm is still red, looks like a sunburn, but pulse and bp are normal and fatigue is gone.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Ear pruritus, Eye pruritus, Injection site pruritus, Peripheral swelling, Pruritus genital
Clinical narrative: INTENSE itching, at site, swelling down to near elbow, hot to touch, itching eyes, ears, genital area, gradually lessening over three days.  Took Ibuprofen. Applied topical anti-itch cream. Did not want to take Benadryl as it would make me sleep. Stayed awake all night Friday as I have experienced Anaphylaxis following fire ant sting and wanted to be sure no swelling began in face, etc.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Skin warm, Sleep disorder
Clinical narrative: INTENSE itching, at site, swelling down to near elbow, hot to touch, itching eyes, ears, genital area, gradually lessening over three days.  Took Ibuprofen. Applied topical anti-itch cream. Did not want to take Benadryl as it would make me sleep. Stayed awake all night Friday as I have experienced Anaphylaxis following fire ant sting and wanted to be sure no swelling began in face, etc.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Cardiac stress test, Chest X-ray, Chest discomfort, Chills
Clinical narrative: My second vaccine of Shingrix produced the same effect as my first vaccine that I received on 8/11/2020 at drs office which 2 days later sent me to the hospital thinking I was having a heart attack.  All tests that were run at the hospital and through a cardiologist did not find anything wrong with my heart. I had the 2nd Shingrix vaccine administered on 11/17/20 at same dr office. Besides the usual side effects of nausea, mild headache and chills/low grade fever that I experienced the first time, again I experienced waking up the night of 11/1920 at 1:30 am with some heaviness on my chest. I was able to fall back to sleep but awoke again at 4:20am with such a heaviness that I could only takes shallow breaths and could no longer lie down.  I had to sit up the remainder of the night. The feeling was quite scary  but knowing this time it was not heart related, I was remained sitting up until the feeling eventually subsided.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Echocardiogram, Electrocardiogram, Fear, Headache, Hypopnoea
Clinical narrative: My second vaccine of Shingrix produced the same effect as my first vaccine that I received on 8/11/2020 at drs office which 2 days later sent me to the hospital thinking I was having a heart attack.  All tests that were run at the hospital and through a cardiologist did not find anything wrong with my heart. I had the 2nd Shingrix vaccine administered on 11/17/20 at same dr office. Besides the usual side effects of nausea, mild headache and chills/low grade fever that I experienced the first time, again I experienced waking up the night of 11/1920 at 1:30 am with some heaviness on my chest. I was able to fall back to sleep but awoke again at 4:20am with such a heaviness that I could only takes shallow breaths and could no longer lie down.  I had to sit up the remainder of the night. The feeling was quite scary  but knowing this time it was not heart related, I was remained sitting up until the feeling eventually subsided.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: My second vaccine of Shingrix produced the same effect as my first vaccine that I received on 8/11/2020 at drs office which 2 days later sent me to the hospital thinking I was having a heart attack.  All tests that were run at the hospital and through a cardiologist did not find anything wrong with my heart. I had the 2nd Shingrix vaccine administered on 11/17/20 at same dr office. Besides the usual side effects of nausea, mild headache and chills/low grade fever that I experienced the first time, again I experienced waking up the night of 11/1920 at 1:30 am with some heaviness on my chest. I was able to fall back to sleep but awoke again at 4:20am with such a heaviness that I could only takes shallow breaths and could no longer lie down.  I had to sit up the remainder of the night. The feeling was quite scary  but knowing this time it was not heart related, I was remained sitting up until the feeling eventually subsided.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fever, bilateral arm pain, fatigue
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Chapped lips, Fall, Headache, Stress
Clinical narrative: Patient looked stressed when the vaccine was administered, after few minutes he stood up and collapsed on the floor face down((syncope). He cracked his lower lip, and complained about headache 7 points from 1 to 10 scale ,Dad called 911 , EMT came in and took his vitals , patient was ok after that and walked home .called his home after 1 pm on 11/22/2020 , dad said he is ok.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient looked stressed when the vaccine was administered, after few minutes he stood up and collapsed on the floor face down((syncope). He cracked his lower lip, and complained about headache 7 points from 1 to 10 scale ,Dad called 911 , EMT came in and took his vitals , patient was ok after that and walked home .called his home after 1 pm on 11/22/2020 , dad said he is ok.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Dizziness, Fatigue
Clinical narrative: Headache; sever body ache all over especially back and joints; upset stomach; dizziness; fatigue.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: Headache; sever body ache all over especially back and joints; upset stomach; dizziness; fatigue.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Blood culture, C-reactive protein normal, Febrile convulsion, Full blood count, Influenza virus test negative
Clinical narrative: Patient initially developed fever 14 days after administration of vaccine. He was then fever free for 24 hours, but then developed additional fever on 11/21 that led to three generalized seizures (complex febrile seizure) requiring multiple doses of ativan as well as keppra load and then maintenance keppra. He required admission to the hospital for further monitoring and observation. He returned to baseline within 24 hours and did not have any additional seizures within that 24 hour observation period. He will continue on maintenance keppra until follow up with neurology.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Lymphocyte percentage, Magnetic resonance imaging brain normal, Metabolic function test normal, Monocyte percentage increased, Neutrophil percentage decreased
Clinical narrative: Patient initially developed fever 14 days after administration of vaccine. He was then fever free for 24 hours, but then developed additional fever on 11/21 that led to three generalized seizures (complex febrile seizure) requiring multiple doses of ativan as well as keppra load and then maintenance keppra. He required admission to the hospital for further monitoring and observation. He returned to baseline within 24 hours and did not have any additional seizures within that 24 hour observation period. He will continue on maintenance keppra until follow up with neurology.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Platelet count normal, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Seizure
Clinical narrative: Patient initially developed fever 14 days after administration of vaccine. He was then fever free for 24 hours, but then developed additional fever on 11/21 that led to three generalized seizures (complex febrile seizure) requiring multiple doses of ativan as well as keppra load and then maintenance keppra. He required admission to the hospital for further monitoring and observation. He returned to baseline within 24 hours and did not have any additional seizures within that 24 hour observation period. He will continue on maintenance keppra until follow up with neurology.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Urine analysis normal, White blood cell count decreased
Clinical narrative: Patient initially developed fever 14 days after administration of vaccine. He was then fever free for 24 hours, but then developed additional fever on 11/21 that led to three generalized seizures (complex febrile seizure) requiring multiple doses of ativan as well as keppra load and then maintenance keppra. He required admission to the hospital for further monitoring and observation. He returned to baseline within 24 hours and did not have any additional seizures within that 24 hour observation period. He will continue on maintenance keppra until follow up with neurology.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dysphemia, Dyspnoea, Feeling cold, Feeling hot
Clinical narrative: I administered a Shingrix vaccine to patient at 12:34 pm and had just finished giving her husband the same when she alerted us (myself and her husband) that she did not feel well. She was feeling hot, dizzy, and light headed. I had her sit in the chair with the arm rest and gave her a cool compress to put on her forehead.  After a few minutes, she (and I) noticed her speech pattern had changed (more of a stammer than a slurr).  Very shortly after that she complained that it was getting more difficult to breath.  I noticed it was becoming more difficult very quickly and could hear it in her breathing. I instructed tech to call a code white and tech to call 911.  I grabbed an epi pen and administered it at 12:41pm (epi 0.3mg, lot - 045J19AA, exp - 07/2021).  Her husband and I helped her lie down and her breathing began to go back to normal and continued to be normal even after the paramedics were finished with their evaluation.  The patient was feeling cold (most likely because she was on a cold floor) so she covered her torso up with her jacket and I laid a jacket we had in the pharmacy on her legs.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: I administered a Shingrix vaccine to patient at 12:34 pm and had just finished giving her husband the same when she alerted us (myself and her husband) that she did not feel well. She was feeling hot, dizzy, and light headed. I had her sit in the chair with the arm rest and gave her a cool compress to put on her forehead.  After a few minutes, she (and I) noticed her speech pattern had changed (more of a stammer than a slurr).  Very shortly after that she complained that it was getting more difficult to breath.  I noticed it was becoming more difficult very quickly and could hear it in her breathing. I instructed tech to call a code white and tech to call 911.  I grabbed an epi pen and administered it at 12:41pm (epi 0.3mg, lot - 045J19AA, exp - 07/2021).  Her husband and I helped her lie down and her breathing began to go back to normal and continued to be normal even after the paramedics were finished with their evaluation.  The patient was feeling cold (most likely because she was on a cold floor) so she covered her torso up with her jacket and I laid a jacket we had in the pharmacy on her legs.
Age: 79.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient came in with the intention of getting a Shingrix dose for her first shot, and ended up getting a high dose flu shot instead.  Patient had not had a flu shot prior so it wasn't a double dose, she didn't indicate which shot she wanted on the form, but was expecting a Shingrix shot.  The next day she was reviewing the paperwork and called me pretty upset because she didn't get what she had asked for.  She did not say anything about side effects or that she had already had the flu shot....she had asked the immunizing pharmacist if "it was the new shot" and the pharmacist thought she was asking if it was the high dose shot.  Patient was understandingly quite upset.
Age: 79.0
Sex: M
Vaccine: FLUA4, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Patient states they had a shingles outbreaks approx. 5 weeks after the vaccine. The disease has resolved but he now has post-herpetic neuralgia
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: PT HAD EXPERIENCE MILD TO MODERATE MUSCLE PAIN ON INJECTION SITE (LEFT ARM), IT HAD LASTED SINCE THE DATE SHE RECEIVED THE VACCINE TO NOW. THE PAIN INTENSIFIED MOSTLY IN THE MORNING AND EVENING.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Breast pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient called and was worried because her arm was sore and said that the pain had leaked into her breast. she had a hard time laying on the side. its now swollen but doesn't hurt
Age: 50.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain
Clinical narrative: Pt reported pain continuing at injection site and went to MD on 11/11/20 and was told possibly cellulitis and given keflex and ibuprofen
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Loss of consciousness, Muscular weakness
Clinical narrative: Patient reported that she commonly passes out with vaccination or piercing.  I advised patient to remain in counseling room seated after for observation.  After administering shot, she was fine for the next 30 seconds.  Within a minutes time she passed out and I held her head to prevent further injury as she lost muscle control.  She had difficulty breathing with mask so I instructed her to remove mask and to take deep breaths.  She regained consciousness after approximated a minute.  She reported dizziness but said feeling better and asked for water as that commonly helps her feel better.  I monitored patient for about 20 minutes and stayed behind her while in chair in the event to catch her if sycope occurs again.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Patient experienced shivering, chills, fever, and muscle aches that started about 11 hours after the vaccine was given and they lasted into the next day.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea
Clinical narrative: PATIENT DEVELOPED DIARRHEA THE FOLLOWING NIGHT AFTER RECEIVING FLU SHOT
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Limb discomfort, Peripheral swelling, Rash
Clinical narrative: Patient had a rash and discomfort on the arm the vaccine was given on later that day. 2 or 3 days later the patient had hives swelling on his legs and arms and pain at the injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hypotension, Restlessness, Syncope
Clinical narrative: 11 hours after vaccine started feeling chills, extreme fatigue, restless sleep at night, fainted next morning, and extremely low BP (58/38), normal 100/70. gradually came back to normal after drinking fluids and salt intake. symptoms resolved about 24 hours after immunization
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Heart rate increased
Clinical narrative: PATIENT STATES THAT THE DAY AFTER RECEIVING THE VACCINE HIS HEART RATE WAS ELEVATED CONSISTENTLY.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: Unknown amount of vaccine leaked out side of syringe due to a faulty syringe (needle not secure on barrel in manufacturing process), and unknown amount into patient. Will have to read minister vaccine.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Erythema, Pain
Clinical narrative: Bruising, redness, pain
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Arm pain that started night of vaccination. Was subtle that night but has progressively gotten worse, with range of motion affected. Had trouble sleeping last night due to pain, has been taking tylenol and ibuprofen for pain. Has scheduled doctors appt to take a look at arm and make possible diagnosis.
Age: 60.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: The evening after the shot (yesterday, Saturday), I had a very sore/tender arm from the injection site (more than the flu shot), and I felt a little bit chilled. The next day (today, Sunday), my arm was very sore, I felt more chilled and shivery, body aches, very fatigued, and all I wanted to do was sleep. I had a headache that grew in intensity until it was pounding, and I felt nauseated. Eventually, I vomited. After vomiting, I slept for another 1.5 hours or so and when I woke up, I felt a bit better, even the injection site didn't feel as painful. I took two ibuprofin. My stomach had settled and I was able to have some hot tea and eat a bit of food. I remained very tired and fatigued for the rest of the day, but no longer felt sick or nauseated. It took about 24 hours to get through the side effects.
Age: 60.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pain, Pain in extremity, Somnolence, Vomiting
Clinical narrative: The evening after the shot (yesterday, Saturday), I had a very sore/tender arm from the injection site (more than the flu shot), and I felt a little bit chilled. The next day (today, Sunday), my arm was very sore, I felt more chilled and shivery, body aches, very fatigued, and all I wanted to do was sleep. I had a headache that grew in intensity until it was pounding, and I felt nauseated. Eventually, I vomited. After vomiting, I slept for another 1.5 hours or so and when I woke up, I felt a bit better, even the injection site didn't feel as painful. I took two ibuprofin. My stomach had settled and I was able to have some hot tea and eat a bit of food. I remained very tired and fatigued for the rest of the day, but no longer felt sick or nauseated. It took about 24 hours to get through the side effects.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Fever of 102; severe shaking/chills; body aches; dizziness; fatigue; nausea; headache
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Fever of 102; severe shaking/chills; body aches; dizziness; fatigue; nausea; headache
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: PATIENT PRESENTS TO PHARMACY DEPARTMENT ON 11/17/20  STATING THAT HE RECEIVED A FLU VACCINE ABOUT 2 MONTHS AGO IN HIS RIGHT ARM AND IS CURRENTLY EXPERIENCING  PAIN IN THAT ARM AND HAS LIMITED RANGE OF MOTION. PATIENT STATES THE PAIN STARTED ABOUT A WEEK AFTER RECEIVING FLU VACCINE. PATIENT WAS  ADVISED TO FOLLOW-UP WITH HIS PRIMARY PHYSICIAN FOR FURTHER EVALUATION. AS OF 11/20/20 PATIENT STATES HE HAS NOT BEEN SEEN BY A MEDICAL DOCTOR FOR THIS ISSUE.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swollen, sore,red
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Chills, Cold sweat, Incorrect dose administered
Clinical narrative: PATIENT REC'D A 3RD SHINGRIX IN ERROR AT 11 AM ON 11/18/20.  HE VISITED THE ER AT 12:30 AM ON 11/19/20 WITH COMPLAINTS OF WEAKNESS, CHILLS AND CLAMMY SKIN
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test
Clinical narrative: PATIENT REC'D A 3RD SHINGRIX IN ERROR AT 11 AM ON 11/18/20.  HE VISITED THE ER AT 12:30 AM ON 11/19/20 WITH COMPLAINTS OF WEAKNESS, CHILLS AND CLAMMY SKIN
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received Prevnar 13 on 11/20/2018 and again on 11/20/2020. No adverse event(s) have been reported. The patient was instructed to contact the pharmacy and file a VAERS report in the event an adverse event occurs.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient states have muscle pain at injection site its been over a month
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Injection site erythema, Injection site swelling
Clinical narrative: L upper arm swelled, got red, developed large confluent raised hives below injection site over the upper arm. I had a tremendous amount of arm pain extending down to my L hand and upward into my neck muscles and shoulder.  This lasted for a week.  Cramps developed in medial upper arm into my lower forearm.   I had taken  two Tylenol arthritis tablets in the late day of the 27th but developed chills (no fever) by nightfall.  During the night, I felt restless, with diffuse muscle aches, and some nausea.  The next morning I was weak, dizzy, had chills and had to stay on the sofa all day.  The hives on my arm  were painful and slightly itchy.  The symptoms diminished over the third day. (Except for the arm pain).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Muscle spasms, Myalgia, Nausea, Pain
Clinical narrative: L upper arm swelled, got red, developed large confluent raised hives below injection site over the upper arm. I had a tremendous amount of arm pain extending down to my L hand and upward into my neck muscles and shoulder.  This lasted for a week.  Cramps developed in medial upper arm into my lower forearm.   I had taken  two Tylenol arthritis tablets in the late day of the 27th but developed chills (no fever) by nightfall.  During the night, I felt restless, with diffuse muscle aches, and some nausea.  The next morning I was weak, dizzy, had chills and had to stay on the sofa all day.  The hives on my arm  were painful and slightly itchy.  The symptoms diminished over the third day. (Except for the arm pain).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Restlessness
Clinical narrative: L upper arm swelled, got red, developed large confluent raised hives below injection site over the upper arm. I had a tremendous amount of arm pain extending down to my L hand and upward into my neck muscles and shoulder.  This lasted for a week.  Cramps developed in medial upper arm into my lower forearm.   I had taken  two Tylenol arthritis tablets in the late day of the 27th but developed chills (no fever) by nightfall.  During the night, I felt restless, with diffuse muscle aches, and some nausea.  The next morning I was weak, dizzy, had chills and had to stay on the sofa all day.  The hives on my arm  were painful and slightly itchy.  The symptoms diminished over the third day. (Except for the arm pain).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site movement impairment
Clinical narrative: patient received the vaccine at around 930am on 11/21/2020.  Patient came back to the pharmacy at around 230pm on the same day 11/21/2020.  The patient mentioned to me that she could not raise her left arm at all, where the vaccine was given.
Age: 68.0
Sex: M
Vaccine: FLUA3
Symptoms: Electrocardiogram normal, Headache, Myalgia, Neck pain, Sleep disorder
Clinical narrative: Could not lie down or sleep for five nights: severe pain in the neck muscles and head.  On sixth day I went to a Walk-in Clinic and was prescribed muscle relaxant (five day treatment) and pain killer.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient says the evening of his vaccine, he was unable to move his arm at all. He went to the MD was given a steroid shot. Pt was able to move arm, but still can't move part 90° at the shoulder. Still having pain.
Age: 76.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient couldn't move arm and states to have a torn ligament.
Age: 76.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Ligament rupture, Mobility decreased
Clinical narrative: Patient couldn't move arm and states to have a torn ligament.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal discomfort, Acne, Blister, Blister rupture, Decreased appetite
Clinical narrative: Blister; Blister on the left forearm that was red; Blister on the left forearm that was red and painful; Fluid discharge; This case was reported by a consumer via call center representative and described the occurrence of blister in a 61-year-old female patient who received Herpes zoster (Shingrix).    On 25th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th September 2020, 2 days after receiving Shingrix, the patient experienced blister, erythema and pain. On an unknown date, the patient experienced fluid discharge. On an unknown date, the outcome of the blister, erythema, pain and fluid discharge were not recovered/not resolved.   It was unknown if the reporter considered the blister, erythema, pain and fluid discharge to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. The female patient reported that she received the 1st dose of Shingrix vaccine on 25th september,2020     in left arm and om 27th September ,2020 she had one blister on the left forearm that was red and painful and is still ongoing currently. Patient reported the blister broke and filled back up with fluid. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Influenza like illness, Malaise, Nausea
Clinical narrative: Blister; Blister on the left forearm that was red; Blister on the left forearm that was red and painful; Fluid discharge; This case was reported by a consumer via call center representative and described the occurrence of blister in a 61-year-old female patient who received Herpes zoster (Shingrix).    On 25th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th September 2020, 2 days after receiving Shingrix, the patient experienced blister, erythema and pain. On an unknown date, the patient experienced fluid discharge. On an unknown date, the outcome of the blister, erythema, pain and fluid discharge were not recovered/not resolved.   It was unknown if the reporter considered the blister, erythema, pain and fluid discharge to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. The female patient reported that she received the 1st dose of Shingrix vaccine on 25th september,2020     in left arm and om 27th September ,2020 she had one blister on the left forearm that was red and painful and is still ongoing currently. Patient reported the blister broke and filled back up with fluid. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Blister; Blister on the left forearm that was red; Blister on the left forearm that was red and painful; Fluid discharge; This case was reported by a consumer via call center representative and described the occurrence of blister in a 61-year-old female patient who received Herpes zoster (Shingrix).    On 25th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th September 2020, 2 days after receiving Shingrix, the patient experienced blister, erythema and pain. On an unknown date, the patient experienced fluid discharge. On an unknown date, the outcome of the blister, erythema, pain and fluid discharge were not recovered/not resolved.   It was unknown if the reporter considered the blister, erythema, pain and fluid discharge to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. The female patient reported that she received the 1st dose of Shingrix vaccine on 25th september,2020     in left arm and om 27th September ,2020 she had one blister on the left forearm that was red and painful and is still ongoing currently. Patient reported the blister broke and filled back up with fluid. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Blister rupture, Erythema, Furuncle, Pain of skin
Clinical narrative: Blister; Blister on the left forearm that was red; Blister on the left forearm that was red and painful; Fluid discharge; This case was reported by a consumer via call center representative and described the occurrence of blister in a 61-year-old female patient who received Herpes zoster (Shingrix).    On 25th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th September 2020, 2 days after receiving Shingrix, the patient experienced blister, erythema and pain. On an unknown date, the patient experienced fluid discharge. On an unknown date, the outcome of the blister, erythema, pain and fluid discharge were not recovered/not resolved.   It was unknown if the reporter considered the blister, erythema, pain and fluid discharge to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. The female patient reported that she received the 1st dose of Shingrix vaccine on 25th september,2020     in left arm and om 27th September ,2020 she had one blister on the left forearm that was red and painful and is still ongoing currently. Patient reported the blister broke and filled back up with fluid. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Discharge, Erythema, Pain
Clinical narrative: Blister; Blister on the left forearm that was red; Blister on the left forearm that was red and painful; Fluid discharge; This case was reported by a consumer via call center representative and described the occurrence of blister in a 61-year-old female patient who received Herpes zoster (Shingrix).    On 25th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th September 2020, 2 days after receiving Shingrix, the patient experienced blister, erythema and pain. On an unknown date, the patient experienced fluid discharge. On an unknown date, the outcome of the blister, erythema, pain and fluid discharge were not recovered/not resolved.   It was unknown if the reporter considered the blister, erythema, pain and fluid discharge to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. The female patient reported that she received the 1st dose of Shingrix vaccine on 25th september,2020     in left arm and om 27th September ,2020 she had one blister on the left forearm that was red and painful and is still ongoing currently. Patient reported the blister broke and filled back up with fluid. The reporter consented to follow up.
Sex: U
Vaccine: HEP, HEP
Symptoms: Expired product administered
Clinical narrative: an expired Hepatitis B vaccine was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.        On 10-NOV-2020, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # R021370 with expiration date 07-NOV-2020; dose and route were not provided) for prophylaxis (expired vaccine used).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: RN reported a improperly stored PROQUAD administration; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. The pertinent medical history, concomitant therapies and drug allergy or reactions were not provided.  On 07-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number S035105 which has been verified to be valid, expiration date reported and validated as 03-MAY-2021, therapy type: rHA) for prophylaxis (formulation, strength, dose and route of administration were not reported). The vaccine administered was improperly stored at a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (11.8 degrees Fahrenheit) for a time frame of 31 hours, as recorded by a data logger. There was no previous temperature excursion reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error, Recalled product administered
Clinical narrative: patient was given PNEUMOVAX23 that was recalled; Incorrect Product Storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 22-OCT-2020, the patient was vaccinated with a recalled, improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # S036495 with expiration date 13-SEP-2021) via an unknown route for prophylaxis. No other adverse event information was given at this time. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: temperature excursion; This spontaneous report has been received from a medical assistant referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, lot # S022599 with expiration date of 25-FEB-2022 (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature of 1.8 °C during a time frame of 7 hours and 25 minutes.
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; Administration of GARDASIL 9 during the excursion; This spontaneous report was received from a health professional concerning a 10-year-old patient. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.  On 23-OCT-2020, the patient was vaccinated with a dose (during an excursion) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), (dose and frequency was not reported) (lot No. S022599 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 25-FEB-2022), 0.5 milliliter for prophylaxis.    On 23-OCT-2020 the patient experienced product storage error. No additional adverse events reported.  There was no previous temperature excursion. The call was made due to the data logger. The minimum temperature was 1.8°C with a time frame of 7 hours and 25 minutes. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Improperly stored administered PROQUAD vaccine; This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, drug reactions/allergies were not reported.   On 03-NOV-2020, the patient was administrated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot # T016990, expiration date: 11-NOV-2021) (strength, dose number, route and site of administration were not reported) for prophylaxis (product storage error).   The vaccine was exposed to a temperature range between -14 Celsius degrees to -10 Celsius degrees (-13.8 Celsius degrees) for 36 minutes; -14 Celsius degrees to -10 Celsius degrees (-13.4 Celsius degrees) for 42 minutes. The cumulative time frame was 4 hours and 32 minutes. There was an previous temperature excursion. Digital data logger was involved.