chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Loss of consciousness, Pain, Vaccine positive rechallenge
Clinical narrative: light headed and passed out aprox 3 hrs. after vaccine. Achy and very fatigued until following evening.  Had the same reaction with the first of the 2 shots 3 months prior to this one. That time it took aprox 12-14 hrs before passing out.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Rash erythematous, Rash maculo-papular
Clinical narrative: Classic post MMR rash -  maculopapular rash on trunk and head  that started 8 days after MMR vaccine.  It started first around umbilicus and then spread to rest of trunk. Cheeks also became red. Bumpy red spots also spread to head.  Temp max 99.8 at home.  Full recovery is anticipated.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Oropharyngeal discomfort, Peripheral swelling, Pruritus
Clinical narrative: Swollen arm, redness, itchiness, and scratchy throat
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Malaise, Pyrexia, Wheezing
Clinical narrative: After 6 hours of receiving vaccine, patient experienced wheezing,chills,malaise,tiredness and fever equal or more than 101
Age: 40.0
Sex: M
Vaccine: FLUR4
Symptoms: Fall, Skin laceration, Syncope
Clinical narrative: pt fainted after receiving vaccine.  He did say he had fainted in the past.  When he fell face down, he cut his eyebrow on his glasses.  Another pt called 911 immediately, but pt refused to go to hospital with them.  His wife came to pick him up and they did say they would go to hospital to possibly get a couple stitches and make sure everything else was okay
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 7cm itchy, red, warm to touch and swollen patch around the injection site within 24 hours. Has been present since date of injection on 10/01/2020. No treatment currently.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient received flu shot and proceeded to go in line to hand paperwork to RPh to sign. While in line patient fainted, was passed out for no more than a minute. Patient reported no adverse reactions and no other injuries. Campus police was called.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at site of injection. Blue bruises underneath of arm (not at the site of injection but bruises on the skin underneath). Symptoms last for 5 days. Patient took Ibuprofen with little improvement
Age: 34.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Myalgia, Vomiting
Clinical narrative: Muscle aches and vomiting developing into joint pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Blood test, Furuncle, Rash
Clinical narrative: Boil type rash  Appeared 3 days later   Very painful
Age: 53.0
Sex: F
Vaccine: FLU4, UNK, UNK
Symptoms: Asthenia, Decreased appetite, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Fever for three days averaging 100 degrees. Extremely bad body aches,  weakness.  Swelling , redness and hot to the touch at the injection sit Nasea  No appetite
Age: 53.0
Sex: F
Vaccine: FLU4, UNK, UNK
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever for three days averaging 100 degrees. Extremely bad body aches,  weakness.  Swelling , redness and hot to the touch at the injection sit Nasea  No appetite
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Influenza like illness, Injection site swelling, Pain, Pyrexia
Clinical narrative: FEVER, FLU LIKE SYMPTOMS, ACHES PAINS, TIREDNESS AND SWELLING AT SITE OF INJECTION.
Age: 74.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Discomfort, Malaise, Rash, Vaccination complication
Clinical narrative: About 40 minute from receiving a flu vaccine, the patient's husband contacted the pharmacy to informed us that the patient was experiencing a reaction to the vaccine. Some of her symptoms include: rash all over her body, disconfort, malase, weakness. The husband took her to the emergency department, were she stayed overnight.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Patient received Fluzone Quad without Consent. No adverse event reported or mentioned by parents.
Age: 88.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site pain, Pain
Clinical narrative: Painful injection site, unable to move arm, pain radiating to back bruised and tender to the touch
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Sleep disorder
Clinical narrative: Painful injection that felt like it hit bone. Soon after injection I was unable to move my shoulder/arm due to pain and have had trouble sleeping due to discomfort. Three weeks later I am still unable to use my right arm for any amount of weight or upward movement. I have been taking 600mg of Ibuprofen three times a day per my doctor's instructions, with only temporary pain relief and still unable to use arm.
Age: 67.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Diarrhoea, Nausea
Clinical narrative: Patient reported two bouts of diarrhea and nausea since receiving her two vaccinations.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Fatigue, Headache, Injection site pruritus, Injection site warmth
Clinical narrative: patient reports: swelling of area, headaches, asthma issues, extreme fatigue, hot and itchy at imz location   Apply a cold compress to the site for approximately 15 minutes if the patient has any inflammation/swelling/or soreness. Recommend an analgesic such as acetaminophen or non-steroid anti-inflammatory drug. An anti-histamine can be used for any swelling make sure to observe and discuss with the patient signs of generalized anaphylaxis. Patient symptoms have gradually improved to date.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: patient reports: swelling of area, headaches, asthma issues, extreme fatigue, hot and itchy at imz location   Apply a cold compress to the site for approximately 15 minutes if the patient has any inflammation/swelling/or soreness. Recommend an analgesic such as acetaminophen or non-steroid anti-inflammatory drug. An anti-histamine can be used for any swelling make sure to observe and discuss with the patient signs of generalized anaphylaxis. Patient symptoms have gradually improved to date.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Erythema, Pruritus, Swelling
Clinical narrative: swalling  /Redness/Burning/ Itching
Age: 71.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Patient reported swelling, red tenderness that moved down her arm for about 4 days following the administration of the shot.
Age: 59.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: patient got prevnar 13 and later on that day she experience redness in the arm and the following day when she woke up it swollen and then the day after even more swollen
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall
Clinical narrative: Patient felt dizzy and fell after Fluzone Quard shot
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia, Urticaria, Vomiting
Clinical narrative: pt received flu and shingrix on 10/3/20. pt's family member stated the site of the injection is swollen on 10/4/20. and today on 10/5/20 pt woke up vomiting with hives on face and a fever. pt went to er and dr prescribed cimetidine, benadryl and prednisone.
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presented with injection site reaction of redness, swelling, and itching.  Advised patient to take Benadryl and if it doesn't improve see physician.
Age: 32.0
Sex: M
Vaccine: FLUR4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Vaccine administered around 3:15 pm.  Around 3:25 pm in front of the pharmacy, patient became dizzy and extremely nauseated.  He was given a trash receptacle and started vomiting.  He was moved into the semi-private counseling area where he proceeded to continue vomiting on and off for about an hour.  He was given a sanitized ice pack.  He and his wife refused 2 offers of calling paramedics.  Wife took him home around 4:15 pm.  Pharmacist called to check his status and wife said he was feeling "much better".
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cold sweat, Dizziness
Clinical narrative: Patient fainted approximately 2 minutes after receiving the vaccine. Her skin became clammy and EMS responded. All vital signs returned to normal and she was transported home by her husband.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Syncope
Clinical narrative: Patient fainted approximately 2 minutes after receiving the vaccine. Her skin became clammy and EMS responded. All vital signs returned to normal and she was transported home by her husband.
Age: 56.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Acoustic stimulation tests, Blood test normal, Deafness unilateral, Ear discomfort, Magnetic resonance imaging brain normal
Clinical narrative: Approximately 6 hours after getting vaccines I began to get a fullness feeling in my left ear and within an hour I had lost all hearing in my left ear and had associated tinnitus. I saw the audiologist & ENT on 8/24, 9/1, 9/8 and 9/24/2020 (to date) and I still have profound / severe hearing loss. On 8/24/2020 ENT prescribed a high dose steroid (60 mg/day prednisone for a week tapered off over the next six days) and an anti-viral (1 g / 3X day of valacyclovir for a week). ENT did three intratympanic injections of dexamethasone on 8/24, 9/1 & 9/24/2020. Nothing has returned hearing or stopped tinnitus.  I have never had issues with the yearly flu vaccine so this is almost certainly Shingrix related.
Age: 56.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Scan with contrast normal, Tinnitus
Clinical narrative: Approximately 6 hours after getting vaccines I began to get a fullness feeling in my left ear and within an hour I had lost all hearing in my left ear and had associated tinnitus. I saw the audiologist & ENT on 8/24, 9/1, 9/8 and 9/24/2020 (to date) and I still have profound / severe hearing loss. On 8/24/2020 ENT prescribed a high dose steroid (60 mg/day prednisone for a week tapered off over the next six days) and an anti-viral (1 g / 3X day of valacyclovir for a week). ENT did three intratympanic injections of dexamethasone on 8/24, 9/1 & 9/24/2020. Nothing has returned hearing or stopped tinnitus.  I have never had issues with the yearly flu vaccine so this is almost certainly Shingrix related.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin exfoliation
Clinical narrative: soreness, swelling, redness, scalyness of area around site of injection
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Syncope
Clinical narrative: PATIENT LEFT THE PHARMACY AFTER STATING SHE FELT FINE TO THE IMMUNIZER. SHE LATER FAINTED IN THE PARKING LOT AND THE CLINIC NURSE WAS CALLED AND CHECKED ON HER. WE DID NOT FIND OUT UNTIL HER HUSBAND BROUGHT IN A RX FOR HER THAT ANYTHING OUT OF THE ORDINARY HAD HAPPENED. HE SAID SHE WAS FEELING BETTER BUT STILL NAUSOUS AND THAT SHE HAS A FEAR OF NEEDLES.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Influenza like illness, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: patient reported flu like symptoms that started the next day after getting the shingrix shot. she was in bed for 2 days, drowsy, dizzy and can't function. Patient was planning to go to E.R., but with pandemic, decided to stay home. patient is feeling better now, almost a week later but not fully recovered. she still gets tired after doing some tasks. also patient had swelling around sight of injection that spread, but now is getting better.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: patient reported flu like symptoms that started the next day after getting the shingrix shot. she was in bed for 2 days, drowsy, dizzy and can't function. Patient was planning to go to E.R., but with pandemic, decided to stay home. patient is feeling better now, almost a week later but not fully recovered. she still gets tired after doing some tasks. also patient had swelling around sight of injection that spread, but now is getting better.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, JEV1, PNC13, RV5
Symptoms: Erythema, Injection site reaction, Rash, Skin discolouration
Clinical narrative: PATIENT IS A 4MOS OLD WHO PRESENTS FOR 4 MOS VACCINATIONS. PARENTS OPTED TO RECEIVE JEV ALONG WITH ROUTINE 4 MONTH VACCINES. ABOUT 2 -3 MINUTES POST VACCINATION, PARENTS WERE IN THE WAITING ROOM AND BROUGHT INFANT BACK TO ROOM STATING REDNESS AND PURPLE RASH.  RN ASSESSED AND GENERALIZED RASH TO BILATERAL LOWER EXTREMITIES; NOT RAISED. NO DYSPNEA NOTED. PATIENT WAS ESCORTED TO THE ACUTE CARE CLINIC FOR FURTHER ASSESSMENT BY PROVIDER.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Fatigue, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: patient reported flu like symptoms that started the next day after getting the shingrix shot. He was bedridden also like his wife (they both got the 2nd shingrix dose together on 9/29/2020) and could not function. he felt tired, worn out but his symptoms were less harsher then his wife. she had it worst. He feels better now and can do errands, but gets easily tired afterwards.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Rash
Clinical narrative: Rash on chest, neck, arms, back, feet.  Severe itching. Upper left arm swollen and red.
Age: 71.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complained of lot of pain and that she could not lift her arm. She si doing better now but still complianing of pain
Age: 71.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Bursitis, Fear, Injected limb mobility decreased, Injection site reaction, Injection site swelling
Clinical narrative: Patient complained of lot of pain and that she could not lift her arm. She si doing better now but still complianing of pain
Age: 71.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site, Swelling
Clinical narrative: Patient complained of lot of pain and that she could not lift her arm. She si doing better now but still complianing of pain
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Blister, Erythema, Injection site pustule, Pain, Skin exfoliation
Clinical narrative: I now have blisters on my left arm. My arm has pus at the injection site. A little peeling skin on my left arm. It feels hot . It's very red and sore. Now I'm applying antibacterial cream.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Skin warm
Clinical narrative: I now have blisters on my left arm. My arm has pus at the injection site. A little peeling skin on my left arm. It feels hot . It's very red and sore. Now I'm applying antibacterial cream.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Itchy and hot red skin on upper arm at injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Pain
Clinical narrative: Chills, body aches, severe arm pain at injection site and down to elbow in triceps.  Altrhough not quite as painful as it was on the day of injection, I still have triceps pain.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Mobility decreased, Pain, Swelling
Clinical narrative: Localized erythema, swelling, pain, limitation in movement of arm.
Age: 34.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Abdominal discomfort, Abdominal pain upper, Blood test normal, Computerised tomogram normal, Dizziness
Clinical narrative: 2 weeks after the second dose, patient started having muscular pain on both sides of her back, light headaches and pressure on both sides of her ribs. Patient had constant dizziness sometimes characterized by a strong spinning sensation. Patient had the need to urinate frequently.  8 weeks later, on May 14th, 2020 the level of pain increased. Patient had stabbing pain around her ribs and upper abdomen. Patient felt inflammation around her upper abdomen. She went to urgent care that night. 2 days later on May 16th, patient went to the ER because pain was severe and her legs were very week. ER conducted a CT scan, blood test, X-ray; doctors did not find ?anything serious?. After this week patient suffered from insomnia. Patient felt organs were heavy causing discomfort and pain when she laid down. Patient had to sleep sitting up in her bed. Patient had muscle spasms around her abdomen.  On June, patient?s headaches were much stronger. Patient started taking muscle relaxants (cyclobenzaprine, 5 mg - 3 tablets per day) which helped decreasing the upper abdominal pain and headaches; Vitamin B (B-Complex 1 tablet per day) and B-12 (3,000 mcg 1 tablet per day). However, patient still had pain around her ribs.  At the end of July patient?s abdominal pain increased. Patient felt inflammation on her upper abdominal area. She could not stand up straight because of her pain in her abdomen.  Patient saw a Neurologist in late July who ordered an MRI of her thoracic spine; the results were normal. Patient saw a neurologist who specializes in chronic virus infections of the nervous system and virus latency in early August. Doctor prescribed Vitamin D, 2000 IU and Valacyclovir 1 g 3 times per day for 14 days in case the Varicella virus was active due to the vaccine. Doctor ordered blood tests of immune function and virology of varicella while patient was taking Valacyclovir. Tests results were normal.  In September, patient saw another neurologist who ordered another blood tests and MRI of her brain and cervical spine. Results were normal.  Patient started to recover in late September. In late December patient saw another Neurologist who specializes in Neuroimmunology. Doctor indicated that symptoms coincided with a condition called transverse myelitis. He indicated that MRIs might look normal with this condition. The way to identify an inflammation of the spinal cord would be through a lumbar puncture and test the spinal cord fluid. Patient was feeling better at that time and did not want to get tested.  Patient recovered by the end of December 9 months after the first symptoms started.
Age: 34.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Gastritis, Headache, Immunology test normal, Insomnia, Magnetic resonance imaging brain normal
Clinical narrative: 2 weeks after the second dose, patient started having muscular pain on both sides of her back, light headaches and pressure on both sides of her ribs. Patient had constant dizziness sometimes characterized by a strong spinning sensation. Patient had the need to urinate frequently.  8 weeks later, on May 14th, 2020 the level of pain increased. Patient had stabbing pain around her ribs and upper abdomen. Patient felt inflammation around her upper abdomen. She went to urgent care that night. 2 days later on May 16th, patient went to the ER because pain was severe and her legs were very week. ER conducted a CT scan, blood test, X-ray; doctors did not find ?anything serious?. After this week patient suffered from insomnia. Patient felt organs were heavy causing discomfort and pain when she laid down. Patient had to sleep sitting up in her bed. Patient had muscle spasms around her abdomen.  On June, patient?s headaches were much stronger. Patient started taking muscle relaxants (cyclobenzaprine, 5 mg - 3 tablets per day) which helped decreasing the upper abdominal pain and headaches; Vitamin B (B-Complex 1 tablet per day) and B-12 (3,000 mcg 1 tablet per day). However, patient still had pain around her ribs.  At the end of July patient?s abdominal pain increased. Patient felt inflammation on her upper abdominal area. She could not stand up straight because of her pain in her abdomen.  Patient saw a Neurologist in late July who ordered an MRI of her thoracic spine; the results were normal. Patient saw a neurologist who specializes in chronic virus infections of the nervous system and virus latency in early August. Doctor prescribed Vitamin D, 2000 IU and Valacyclovir 1 g 3 times per day for 14 days in case the Varicella virus was active due to the vaccine. Doctor ordered blood tests of immune function and virology of varicella while patient was taking Valacyclovir. Tests results were normal.  In September, patient saw another neurologist who ordered another blood tests and MRI of her brain and cervical spine. Results were normal.  Patient started to recover in late September. In late December patient saw another Neurologist who specializes in Neuroimmunology. Doctor indicated that symptoms coincided with a condition called transverse myelitis. He indicated that MRIs might look normal with this condition. The way to identify an inflammation of the spinal cord would be through a lumbar puncture and test the spinal cord fluid. Patient was feeling better at that time and did not want to get tested.  Patient recovered by the end of December 9 months after the first symptoms started.
Age: 34.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Magnetic resonance imaging spinal normal, Magnetic resonance imaging thoracic normal, Muscle spasms, Muscular weakness, Musculoskeletal chest pain
Clinical narrative: 2 weeks after the second dose, patient started having muscular pain on both sides of her back, light headaches and pressure on both sides of her ribs. Patient had constant dizziness sometimes characterized by a strong spinning sensation. Patient had the need to urinate frequently.  8 weeks later, on May 14th, 2020 the level of pain increased. Patient had stabbing pain around her ribs and upper abdomen. Patient felt inflammation around her upper abdomen. She went to urgent care that night. 2 days later on May 16th, patient went to the ER because pain was severe and her legs were very week. ER conducted a CT scan, blood test, X-ray; doctors did not find ?anything serious?. After this week patient suffered from insomnia. Patient felt organs were heavy causing discomfort and pain when she laid down. Patient had to sleep sitting up in her bed. Patient had muscle spasms around her abdomen.  On June, patient?s headaches were much stronger. Patient started taking muscle relaxants (cyclobenzaprine, 5 mg - 3 tablets per day) which helped decreasing the upper abdominal pain and headaches; Vitamin B (B-Complex 1 tablet per day) and B-12 (3,000 mcg 1 tablet per day). However, patient still had pain around her ribs.  At the end of July patient?s abdominal pain increased. Patient felt inflammation on her upper abdominal area. She could not stand up straight because of her pain in her abdomen.  Patient saw a Neurologist in late July who ordered an MRI of her thoracic spine; the results were normal. Patient saw a neurologist who specializes in chronic virus infections of the nervous system and virus latency in early August. Doctor prescribed Vitamin D, 2000 IU and Valacyclovir 1 g 3 times per day for 14 days in case the Varicella virus was active due to the vaccine. Doctor ordered blood tests of immune function and virology of varicella while patient was taking Valacyclovir. Tests results were normal.  In September, patient saw another neurologist who ordered another blood tests and MRI of her brain and cervical spine. Results were normal.  Patient started to recover in late September. In late December patient saw another Neurologist who specializes in Neuroimmunology. Doctor indicated that symptoms coincided with a condition called transverse myelitis. He indicated that MRIs might look normal with this condition. The way to identify an inflammation of the spinal cord would be through a lumbar puncture and test the spinal cord fluid. Patient was feeling better at that time and did not want to get tested.  Patient recovered by the end of December 9 months after the first symptoms started.
Age: 34.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Myalgia, Myelitis transverse, Pollakiuria, Posture abnormal, Sleep disorder
Clinical narrative: 2 weeks after the second dose, patient started having muscular pain on both sides of her back, light headaches and pressure on both sides of her ribs. Patient had constant dizziness sometimes characterized by a strong spinning sensation. Patient had the need to urinate frequently.  8 weeks later, on May 14th, 2020 the level of pain increased. Patient had stabbing pain around her ribs and upper abdomen. Patient felt inflammation around her upper abdomen. She went to urgent care that night. 2 days later on May 16th, patient went to the ER because pain was severe and her legs were very week. ER conducted a CT scan, blood test, X-ray; doctors did not find ?anything serious?. After this week patient suffered from insomnia. Patient felt organs were heavy causing discomfort and pain when she laid down. Patient had to sleep sitting up in her bed. Patient had muscle spasms around her abdomen.  On June, patient?s headaches were much stronger. Patient started taking muscle relaxants (cyclobenzaprine, 5 mg - 3 tablets per day) which helped decreasing the upper abdominal pain and headaches; Vitamin B (B-Complex 1 tablet per day) and B-12 (3,000 mcg 1 tablet per day). However, patient still had pain around her ribs.  At the end of July patient?s abdominal pain increased. Patient felt inflammation on her upper abdominal area. She could not stand up straight because of her pain in her abdomen.  Patient saw a Neurologist in late July who ordered an MRI of her thoracic spine; the results were normal. Patient saw a neurologist who specializes in chronic virus infections of the nervous system and virus latency in early August. Doctor prescribed Vitamin D, 2000 IU and Valacyclovir 1 g 3 times per day for 14 days in case the Varicella virus was active due to the vaccine. Doctor ordered blood tests of immune function and virology of varicella while patient was taking Valacyclovir. Tests results were normal.  In September, patient saw another neurologist who ordered another blood tests and MRI of her brain and cervical spine. Results were normal.  Patient started to recover in late September. In late December patient saw another Neurologist who specializes in Neuroimmunology. Doctor indicated that symptoms coincided with a condition called transverse myelitis. He indicated that MRIs might look normal with this condition. The way to identify an inflammation of the spinal cord would be through a lumbar puncture and test the spinal cord fluid. Patient was feeling better at that time and did not want to get tested.  Patient recovered by the end of December 9 months after the first symptoms started.
Age: 34.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Vertigo
Clinical narrative: 2 weeks after the second dose, patient started having muscular pain on both sides of her back, light headaches and pressure on both sides of her ribs. Patient had constant dizziness sometimes characterized by a strong spinning sensation. Patient had the need to urinate frequently.  8 weeks later, on May 14th, 2020 the level of pain increased. Patient had stabbing pain around her ribs and upper abdomen. Patient felt inflammation around her upper abdomen. She went to urgent care that night. 2 days later on May 16th, patient went to the ER because pain was severe and her legs were very week. ER conducted a CT scan, blood test, X-ray; doctors did not find ?anything serious?. After this week patient suffered from insomnia. Patient felt organs were heavy causing discomfort and pain when she laid down. Patient had to sleep sitting up in her bed. Patient had muscle spasms around her abdomen.  On June, patient?s headaches were much stronger. Patient started taking muscle relaxants (cyclobenzaprine, 5 mg - 3 tablets per day) which helped decreasing the upper abdominal pain and headaches; Vitamin B (B-Complex 1 tablet per day) and B-12 (3,000 mcg 1 tablet per day). However, patient still had pain around her ribs.  At the end of July patient?s abdominal pain increased. Patient felt inflammation on her upper abdominal area. She could not stand up straight because of her pain in her abdomen.  Patient saw a Neurologist in late July who ordered an MRI of her thoracic spine; the results were normal. Patient saw a neurologist who specializes in chronic virus infections of the nervous system and virus latency in early August. Doctor prescribed Vitamin D, 2000 IU and Valacyclovir 1 g 3 times per day for 14 days in case the Varicella virus was active due to the vaccine. Doctor ordered blood tests of immune function and virology of varicella while patient was taking Valacyclovir. Tests results were normal.  In September, patient saw another neurologist who ordered another blood tests and MRI of her brain and cervical spine. Results were normal.  Patient started to recover in late September. In late December patient saw another Neurologist who specializes in Neuroimmunology. Doctor indicated that symptoms coincided with a condition called transverse myelitis. He indicated that MRIs might look normal with this condition. The way to identify an inflammation of the spinal cord would be through a lumbar puncture and test the spinal cord fluid. Patient was feeling better at that time and did not want to get tested.  Patient recovered by the end of December 9 months after the first symptoms started.
Age: 62.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Starting the morning after the vaccine, patient developed a red rash around the injection site and says she has pain from the rash, came into the pharmacy today (Monday), two days after the injections and says rash has become worse.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Contusion, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Patient had high fever 103, body aches and swollen arm and bruise.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Mobility decreased
Clinical narrative: the patient had inflammation redness from shoulder to elbow. it was difficult to move. pt said it started the afternoon/evening of imz.  she did not call us until today. she had a planned office visit with her md the friday after the imz , and it was better by that time. the imz was given 9-26-2020 and the office visit was 10-2-2020. the md stated that he felt it was due to the imz given in the same arm.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Syncope
Clinical narrative: Patient had a fainting episode and felt faint after receiving flu vaccine and walking for a short distance.  Patient was then laid on the floor and the legs were elevated.  He had a fear of needles but had not fainted before after receiving any other vaccinations.  Only one other fainting episode had occurred before after giving blood.  Patient then laid on the ground for around 10 minutes or so and sat for another 10.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain, Pruritus, Swelling, Urticaria
Clinical narrative: swelling, hives, redness, pain, itching.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Rash, Swelling
Clinical narrative: RASH, SWELLING AND PAIN
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: PT CAME IN ON 10/2 STATING THAT HER RIGHT ARM WAS STILL HURTING. AT INSPECTION OF THE INJECTION SITE, ARM WAS VERY RED. PT SAID IT HURTS AND WANTED TO COME BY THE PHARMACY TO CONSULT IF THERE WAS SOMETHING SHE COULD TAKE OVER THE COUNTER.  PT STATES SITE WAS WARM AND HAS BEEN LIKE THAT AFTER ADMINSTRATION AND ALMOST A WEEK AFTER
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Hypotension, Loss of consciousness, Syncope
Clinical narrative: Suspected syncope/pass out soon after administering shot, called 911, paramedics said she had low blood pressure, they thought she was good to go and she left
Age: 66.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Chills, Headache, Injection site pain, Lethargy, Micturition urgency
Clinical narrative: Beginning around 1 to 2 hours after the injections, my left shoulder became very sore and felt weak. Painful to the slightest touch or pressure. At bedtime, I was unable to lie on my side (left or right, although left was much more sore). I awoke after about one hour of sleep with a powerful urge to urinate, and then four more times through the night at approximate one hour intervals. Chills and nearly uncontrollable shivering. I felt lethargic and feverish starting that night and for the next 2 days. Also headache and body aches. Fever of 99.4 degrees on Saturday. Symptoms subsided by Sunday afternoon.
Age: 66.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Muscular weakness, Pain, Pollakiuria, Pyrexia
Clinical narrative: Beginning around 1 to 2 hours after the injections, my left shoulder became very sore and felt weak. Painful to the slightest touch or pressure. At bedtime, I was unable to lie on my side (left or right, although left was much more sore). I awoke after about one hour of sleep with a powerful urge to urinate, and then four more times through the night at approximate one hour intervals. Chills and nearly uncontrollable shivering. I felt lethargic and feverish starting that night and for the next 2 days. Also headache and body aches. Fever of 99.4 degrees on Saturday. Symptoms subsided by Sunday afternoon.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Chills, Malaise, Myalgia
Clinical narrative: 4 days of symptoms and counting. Chills, fever, malaise, weakness, joint pain, overall body pain. Chills and fever started four hours after shot was administered. Next day, muscle/joint pain, continued high fever and chills. . My wife, same age, got the same Fluzone Highdose 10 minutes before me at the same location and no symptoms.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: 4 days of symptoms and counting. Chills, fever, malaise, weakness, joint pain, overall body pain. Chills and fever started four hours after shot was administered. Next day, muscle/joint pain, continued high fever and chills. . My wife, same age, got the same Fluzone Highdose 10 minutes before me at the same location and no symptoms.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: Myalgia, Product administered to patient of inappropriate age, Swelling
Clinical narrative: Patient received flu shot (Flublock) that is indicated for those 18 years of age and older. Patient is 17 years old. Patient's father called tonight approximately 4 hours after the shot was given, and his son's chief complaint is muscle pain and swelling.
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: patient received Fluzone HD. waited for wife in pharmacy and was feeling fine. However about 15 minutes after they left patient felt light headed and passed out. Patient is doing well and following up w/cardiologist.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Kinrix was given. Emailed state. "Does not need to be repeated but considered off label and vaccine adminstration error."
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: PATIENT CAME INTO THE PHARMACY ON 10-4-20 AND SHOWED THE PHARMACIST ON DUTY HER ARM. FROM THE UPPER ARM STARTING NEAR INJECTION SITE TO PATIENTS ELBOW IS BRUSED IN APPERANCE. PATIENT ALSO REPORTS SORENESS/STIFFNESS IN INJECTION ARM. NO OTHER SYMPTOMS PRESENT IN REVEIWING PATIENT PROFILE PATIENT IS TAKING ELIQUIS 2.5MG. WILL CALL DR TO REPORT REACTION
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Patient had a big bruise on her left arm covering about half the length of the upper arm. It looked to be more on the front side of the bicep and with the edge of the bruise being by the injection site. She came in to the pharmacy on 10/5 wanted me to take a look at it.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA4
Symptoms: Urticaria
Clinical narrative: Patient reported mild case of hives following her immunization. Patient is treating with Benadryl and has mostly resolve after 2 days.
Age: 0.92
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Discomfort, Rash, Rash papular
Clinical narrative: Rash over left leg and a little on right that are very uncomfortable. Rash started the day after the vaccine.The week prior, patient had a papular rash around her mouth, which mom thinks was due to eating figs, it is persisting and fading now.Rash Description : left knee and lower leg/ pretibial region with area of diffuse erythematous, raised papules. Scant papules on contralateral outer thigh. No macules. no target lesions or blisters or sloughing. nontender.  Uncertain Etiology , possible Vaccine reaction , possible other dermatitis. Zyrtec Allergy 1mg/mL oral solution - Take 2.5 mg every day by oral route for 10 days.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Patient called the pharmacy on 10/03/2020, more than 5 weeks after getting immunized to speak to the pharmacist. According to the patient she was still experiencing pain on the injection site. She also stated that her left arm was getting numb and tingly at times. Patient did not report having any soreness, erythema, or swelling around the injection site but attributes her pain to the vaccination since she claims she wasn't feeling like that prior to getting vaccinated. Pharmacist recommended using OTC analgesics for pain and to follow up with her primary care provider to rule out other possible etiologies.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pt got flu shot on 9/29/2020 around 10:50am. Overnight (in the early morning hours) of 10/1/2020 the patient woke up with pain in her left hand. Over the course of Thursday, the pain continued to worsen and the patient treated symptoms with ibuprofen. Friday the had continued to hurt and was visibly swollen and painful to use so the patient treated with ibuprofen. Saturday, 10/3/2020 the hand was improving and has gotten better since. The patient called their physician 10/5/20 and the MD assumed it was a reaction to the flu vaccine. The patient reported the adverse event 10/5/2020 at930am.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Erythema, Local reaction, Pain, Pruritus, Skin tightness
Clinical narrative: localized redness, itching, pain and skin tightness;
Age: 86.0
Sex: M
Vaccine: FLU4
Symptoms: Incontinence, Loss of consciousness
Clinical narrative: passed out for approx. 1 hr. lost control of bodily functions
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injected limb mobility decreased, Pain
Clinical narrative: patient report pain, no edema, erythema, difficult to elevate arm since the injection given, only pain has been the only complaint, short course of prednisone given with out any result, no improvement no worsening, will send MRI deltoid area, since inspection is normal
Age: 40.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: PT. CALLED TO C/O SHOULDER PAIN & FEELS A NERVE WAS HIT DURING GARDASIL INJECTION
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Ageusia, Anxiety, Arthralgia, Arthropathy, Chest pain
Clinical narrative: Joint pain, stuffiness, muscle pain, increased fatigue unable to sleep, No taste, Rash on face + arms, chills, skin crawling, joint sensitivity - worse lasting 5 days. then 2 wks for most to subside Chest pain + anxiety Have taken flu vaccine for many years, No reaction until this HD  Have had flu in the 1970s + 1990's - this was worse than the flu, but I'm older. Talked with State Immunization Dictor (we are cousins) She state Immunity Response, a Super one. I'm public Health ARNP about 43 years and would agree a Super Response, But Im real sure thats my last flu shot. This was not fun.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Formication, Insomnia, Myalgia
Clinical narrative: Joint pain, stuffiness, muscle pain, increased fatigue unable to sleep, No taste, Rash on face + arms, chills, skin crawling, joint sensitivity - worse lasting 5 days. then 2 wks for most to subside Chest pain + anxiety Have taken flu vaccine for many years, No reaction until this HD  Have had flu in the 1970s + 1990's - this was worse than the flu, but I'm older. Talked with State Immunization Dictor (we are cousins) She state Immunity Response, a Super one. I'm public Health ARNP about 43 years and would agree a Super Response, But Im real sure thats my last flu shot. This was not fun.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Nasal congestion, Rash
Clinical narrative: Joint pain, stuffiness, muscle pain, increased fatigue unable to sleep, No taste, Rash on face + arms, chills, skin crawling, joint sensitivity - worse lasting 5 days. then 2 wks for most to subside Chest pain + anxiety Have taken flu vaccine for many years, No reaction until this HD  Have had flu in the 1970s + 1990's - this was worse than the flu, but I'm older. Talked with State Immunization Dictor (we are cousins) She state Immunity Response, a Super one. I'm public Health ARNP about 43 years and would agree a Super Response, But Im real sure thats my last flu shot. This was not fun.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Moderate swelling of left deltoid with mild erythema tender to touch palpation hypopigmented area to upper arms
Age: 82.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Erythema, Induration, Mass, Pain
Clinical narrative: pt's case manager reported that pt feeling light headed. She can't walk back to her room after vaccination. She sat for about 30 minutes and felt a little better. She went to her room and took a nap. Felt better after the nap. Report soreness, red, and hard lump below the injection site for a couple days.
Age: 82.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Gait disturbance, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: pt's case manager reported that pt feeling light headed. She can't walk back to her room after vaccination. She sat for about 30 minutes and felt a little better. She went to her room and took a nap. Felt better after the nap. Report soreness, red, and hard lump below the injection site for a couple days.
Age: 82.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site swelling
Clinical narrative: pt's case manager reported that pt feeling light headed. She can't walk back to her room after vaccination. She sat for about 30 minutes and felt a little better. She went to her room and took a nap. Felt better after the nap. Report soreness, red, and hard lump below the injection site for a couple days.
Age: 69.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Discomfort, Injection site swelling, Peripheral swelling, Tenderness
Clinical narrative: I vaccinated one of our patients on Friday 09/18/2020 (Fluad and Pneumovax), both vaccines on the left upper arm. Patient came in on 09/20/2020 Sunday and was saying that her arm was swollen, painful to touch and was in a lot of discomfort. I noticed that the swelling was mostly little away from the injection site, extending down the upper arm towards the elbow, but not on the elbow. Followed up with patient on Monday 09/21/2020 around 5pm and she said there was not much improvement. Followed up another call to patient on Wednesday 09/23/2020 - had to leave message on voice mail - no reply from patient. S/W STAFF @ MD's OFFICE & NOTIFIED (9/30/20) PT. CAME IN STORE DRIVE THRU ON 10/2/20 & SAID SHE WAS DOING WELL & NO MORE SWELLING!
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Aspiration joint, Culture negative, Injection site joint effusion
Clinical narrative: (L) Shoulder jt effusion asp 30 cc 9/6/20 re asp 9/8/20 30 cc + injection steroids  C+S neg
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: L. forearm swelling pain
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Medication error
Clinical narrative: A patient received an expired dose of Fluzone Quadrivalent /No AE; Initial information was received on 17-Sep-2020 regarding an unsolicited valid non-serious case from a consumer (Practice manager).  This case is linked to cases 2020SA256509, 2020SA256508, 2020SA256507, 2020SA256510 and 2020SA256506.  This case involves a 20 years old female patient who was administered with an expired 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot number: UJ295AA, expiration date: 30-Jun-2020) via intramuscular route at an left deltoid on 16-Sep-2020 for prophylactic vaccination (expired product administered).  Medical history, past medical treatments, past vaccination and family history were not provided.  Concomitant: None.  This was an actual medication error case due to expired vaccine used (latency on the same day).  Symptoms: None reported.  Reported asked do they need to revaccinate the patient and would like to know what needs to be done next.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: U
Vaccine: FLUR4
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: a 13 years old patient was inadvertently given a dose of FLUBLOK QUADRIVALENT, No AE; Initial information was received on 28-Sep-2020 regarding this unsolicited valid non-serious case from a pharmacist via phone.  This case was linked to case 2020SA267028 (same reporter).  This case involved a 13-years-old patient who was inadvertently given a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]  (lot QFAA2003 and expiration date: 19-May-2021) via an unknown route and administration site on 26-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency was same day).   Reporter wanted to know if any data available on use of Flublok quadrivalent for pediatric patients and whether the patient needed additional flu vaccines this season.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.