chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported radiating pain down her arm 6 consecutive days after receiving vaccine. The reporter agree for follow up contact.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Influenza virus test negative, Malaise, Night sweats
Clinical narrative: I had first shot of SHINGRIX at 9am. Took 2 ADVIL immediately. Felt perfectly healthy all day. 7pm I became extremely sick within half hour. Very high fever (no thermometer), chills, shivering, possible all over muscles spasms (or I couldn't stop moving because I was so cold nothing worked to warm me up). Fever finally broke 11pm. Then night sweats all night. Next day fever 100.4 went to doctor to make certain it wasn't flu (had flu shot October). Definitely not flu. No explanation given other than SHINGRIX side effects . Today, slight fever 99.0. I have never been so sick in my life, Ever. Vaccine from pharmacy. Side notes... I have had Plantar Fasciitis for 1 months. I woke up the next morning and it was gone. Secondary benefits or coincidence?
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Plantar fasciitis, Pyrexia
Clinical narrative: I had first shot of SHINGRIX at 9am. Took 2 ADVIL immediately. Felt perfectly healthy all day. 7pm I became extremely sick within half hour. Very high fever (no thermometer), chills, shivering, possible all over muscles spasms (or I couldn't stop moving because I was so cold nothing worked to warm me up). Fever finally broke 11pm. Then night sweats all night. Next day fever 100.4 went to doctor to make certain it wasn't flu (had flu shot October). Definitely not flu. No explanation given other than SHINGRIX side effects . Today, slight fever 99.0. I have never been so sick in my life, Ever. Vaccine from pharmacy. Side notes... I have had Plantar Fasciitis for 1 months. I woke up the next morning and it was gone. Secondary benefits or coincidence?
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced muscle pain, tiredness and chills. On an unknown date, the outcome of the muscle pain, tiredness and chills were recovered/resolved. It was unknown if the reporter considered the muscle pain, tiredness and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist had to end call due to time constraints, no further details were known.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site numbness in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site numbness and injection site tingling. On an unknown date, the outcome of the injection site numbness and injection site tingling were unknown. It was unknown if the reporter considered the injection site numbness and injection site tingling to be related to SHINGRIX. Additional details were provided as follows: This case was received via click to chat. The age at vaccination was not reported. No additional information was provided. The pharmacist would not give out demographic background and other information. This case has been linked to US2018GSK057093, reported by the same reporter for the patient who also experienced same adverse events.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh red and swollen warm to touch, indurated, 12 cm w x 10 cm long. Walking but with difficulty.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Local reaction to left arm that is red and warm to touch around the injection site of the DTaP vaccine.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Feeling hot, Flushing, Injection site pruritus, Paraesthesia
Clinical narrative: After administering vaccine, patient was advised to wait in office for any sudden symptoms. After 5 minutes, patient stated that she was feeling lightheaded. Doctor was notified, and patient was taken into a room for her to lay down. I followed up with the patient after another 5 minutes and she stated that she was feeling a tingling radiating from her left hand to her forearm, she was also feeling hot and looked flushed from her cheeks, and complained of feeling itchy at vaccine site. Left arm did not look swollen, no tenderness, or any form of rash at site. Patient was monitored for 20 minutes in which orthostatic blood pressure and pulse was checked during a period of 15 minutes.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Death
Clinical narrative: AE reported to pharmacy team member on 3-28-18 that patient is deceased as of 3-16-18. No additional details provided.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Eye swelling, Injection site swelling, Lip swelling, Rhinorrhoea
Clinical narrative: 03/31/18 6:30 pm: Patient has developed some swelling of her her periorbital skin and her lips. Has had some mild runny nose in the past few days, but no fever or hives rash. No labored breathing or vomiting. No new foods ingested and no exposure to new clothing or products. Just had her well visit yesterday and had a normal exam. Mom just also noticed that patient's entire left leg is swollen. She does not appear to be in any distress. No discoloration of the skin. Recommended that mom take pt to the ER or urgent care now for evaluation, given concern for worsening swelling of multiple parts of the body - allergic reaction. Mom agreed - will take her to be evaluated in ER now.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Hib was inadvertently given in a combination vaccine (PENtACEL) and given separately (PEDVAX HIB). I meant to give the PEDIARIX and PEDVAX HIB instead.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal pain, Peripheral swelling
Clinical narrative: Patient's arm became swollen at the shoulder and very painful. Patient could not lift arm on day 2 after the vaccine was given. Patient went to her family MD on day 2 after the vaccination, and was given a cortisone shot. It is much better today (3 days after vaccine).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Impaired work ability, Lethargy, Pain
Clinical narrative: Severe body aches, headache, chills, lethargy. (The New shingles vaccine is given twice. I had the same reaction both times.) My concern is I was told this new Shingles vaccine had no side effects. I have never had a reaction to any vaccine before. I had to call in sick to work which I never do.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Severe body aches, headache, chills, lethargy. (The New shingles vaccine is given twice. I had the same reaction both times.) My concern is I was told this new Shingles vaccine had no side effects. I have never had a reaction to any vaccine before. I had to call in sick to work which I never do.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: No adverse affects.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Insomnia, Joint range of motion decreased, Limb discomfort, Pain in extremity
Clinical narrative: Pt's wife reported that pt has been experiencing intense upper arm pain persistently since the injection. At first they thought it was normal muscle soreness but became concerned when the discomfort continued over a month after the injection. The sensation can be described as pain, burning, soreness, and reduced range of motion (cannot raise arm completely over head). Pt's wife is a physical therapist and has been performing physical therapy on the arm nightly, which helps temporarily but has not resolved the issue. Pt also takes ibuprofen at bedtime to help him sleep, which is minimally effective.  The injection site is still visible, but is not red or rashy in any way. The pt also reports that he had an itchy rash on the left side of his trunk shortly after the vaccine, which self-resolved. They did not provide dates. His injection was in his right deltoid. At this point they are considering pursuing further medical testing/imaging to determine an explanation for the pain and decide treatment options.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Rash pruritic
Clinical narrative: Pt's wife reported that pt has been experiencing intense upper arm pain persistently since the injection. At first they thought it was normal muscle soreness but became concerned when the discomfort continued over a month after the injection. The sensation can be described as pain, burning, soreness, and reduced range of motion (cannot raise arm completely over head). Pt's wife is a physical therapist and has been performing physical therapy on the arm nightly, which helps temporarily but has not resolved the issue. Pt also takes ibuprofen at bedtime to help him sleep, which is minimally effective.  The injection site is still visible, but is not red or rashy in any way. The pt also reports that he had an itchy rash on the left side of his trunk shortly after the vaccine, which self-resolved. They did not provide dates. His injection was in his right deltoid. At this point they are considering pursuing further medical testing/imaging to determine an explanation for the pain and decide treatment options.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Blood glucose normal, Eye movement disorder, Limb discomfort, Seizure
Clinical narrative: Patient came to the office to receive her second dose of Hepatitis A vaccine and MENACTRA vaccine.  She was given the Hep A in the Left arm and did ok, then when the CMA was giving the shot in the right arm, the patient stated that her left arm feels weird. She immediately laid back on the table, CMA asked if she was ok and pt stated NO and immediately started to have a seizure. She straightened her arms straight out and her eyes rolled to the back of her head and started to seize. This happened for about 1-2 minutes and she started to come around. An ambulance was called and they arrived in less than 10 minutes. The APRN in the office checked the patients BP at 90/62, pulse 56, 95% O2 and FSBS 91. The ambulance arrived and immediately took her to the emergency room.
Age: 0.25
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Urine analysis
Clinical narrative: He started a fever on the 9th of 100.6. Every day following he ran a low grade temperature between 99 and 100.1 for 22 days.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site numbness in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site numbness and injection site tingling. On an unknown date, the outcome of the injection site numbness and injection site tingling were unknown. It was unknown if the reporter considered the injection site numbness and injection site tingling to be related to SHINGRIX. Additional details were provided as follows: This case was received via click to chat. The age at vaccination was not reported. No additional information was provided. The pharmacist would not give out demographic background and other information. This case has been linked to US2018052256, reported by the same reporter for the patient who also experienced same adverse events.
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Skin indentation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of skin indentation in a male patient who received SHINGRIX. In March 2018, the patient received SHINGRIX. In March 2018, immediately after receiving SHINGRIX, the patient experienced skin indentation. On an unknown date, the outcome of the skin indentation was unknown. The reporter considered the skin indentation to be probably related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported to anyone. The patient received SHINGRIX on the left arm. The pharmacist reported that the patient experienced skin indented prior to the needle piercing the skin. The QA was ruled out. The registered pharmacist did follow the instructions for admixing and preparing.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Concussion, Dehydration, Dental implantation, Dizziness
Clinical narrative: At 3pm, I noticed pain at the site of the vaccine. Took ADVIL. Around 9:30 noticed again pain, so used ice pack and took ADVIL. Around 3:30 am, I woke with horrible pain in site where vaccine was given. Went to kitchen to get ADVIL to take and an ice pack, stopped at restroom and as I was sitting there, was overcome with an awful flu-like feeling. Felt bad, felt weak, felt dizzy - I recall thinking I needed to get back to bed. I woke on the kitchen tile floor in a puddle of blood, spitting up teeth. I went to counter to get paper towel to clean up blood and ADVIL and again woke on floor spitting more teeth. I believe I crawled to bedroom and woke my husband that I had fallen. He woke, got towels as I was bleeding bad on my chin. It was also hard for me to breathe in on the top part of my chest. Like I hit that too. He woke our EMS son and our daughter who worked in ER to check my blood pressure and vitals. All appeared to be ok. All agreed I needed stitches, but would be ok to wait until urgent care opened to go get them. At 8am, I called my regular doctor's office and was advised they do not do stitches and to go to the urgent care or an ER. We went to urgent care. Was treated by Drs. See attached medical report with diagnosis. I received ten stitches in my chin, had to stitch up all layers of skin as it was all the way to the bone, also received an IV full of antibiotics and fluid as I was severely dehydrated. I was then sent to the dentist for an emergency visit due to my teeth. He saw the chipped top left tooth - was actually broken in half. And the 3 chipped upper right side teeth. He sent us to an oral surgeon because I would likely need to have the tooth pulled and an implant put in. The next day we had the oral surgeon visit and were advised he did not want to work on it due to the probability of me having had a concussion due to my constant headache I had had since I fainted and he did not want to cause more issues and he wanted to let the stitches heal as well. He rescheduled me for the following Monday to come to the office and have oral surgery to remove the tooth. Was out of work the entire end of the week, as well as half of a day Monday, all day Tuesday and most of the day Wed. I have since had another dental visit to have 3 teeth repaired and the day after when I finally began to eat regular food, another lower left tooth chipped. It was likely already chipped die to the fainting issue. I will have continued dental visits due to this situation, as I am in the middle of receiving a dental implant where I lost the tooth. I have had nothing but doctor and dental visits since I received this vaccine. I was advised that this was a fast track vaccine and I am not quite understanding why, as IF this is being recommended for EVERYONE to replace the old vaccine, I feel its very important to do the full testing before trying it on anyone. Its my understanding that I am not the FIRST person with an adverse reaction.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Fall, Feeling abnormal, Full blood count, Haemorrhage
Clinical narrative: At 3pm, I noticed pain at the site of the vaccine. Took ADVIL. Around 9:30 noticed again pain, so used ice pack and took ADVIL. Around 3:30 am, I woke with horrible pain in site where vaccine was given. Went to kitchen to get ADVIL to take and an ice pack, stopped at restroom and as I was sitting there, was overcome with an awful flu-like feeling. Felt bad, felt weak, felt dizzy - I recall thinking I needed to get back to bed. I woke on the kitchen tile floor in a puddle of blood, spitting up teeth. I went to counter to get paper towel to clean up blood and ADVIL and again woke on floor spitting more teeth. I believe I crawled to bedroom and woke my husband that I had fallen. He woke, got towels as I was bleeding bad on my chin. It was also hard for me to breathe in on the top part of my chest. Like I hit that too. He woke our EMS son and our daughter who worked in ER to check my blood pressure and vitals. All appeared to be ok. All agreed I needed stitches, but would be ok to wait until urgent care opened to go get them. At 8am, I called my regular doctor's office and was advised they do not do stitches and to go to the urgent care or an ER. We went to urgent care. Was treated by Drs. See attached medical report with diagnosis. I received ten stitches in my chin, had to stitch up all layers of skin as it was all the way to the bone, also received an IV full of antibiotics and fluid as I was severely dehydrated. I was then sent to the dentist for an emergency visit due to my teeth. He saw the chipped top left tooth - was actually broken in half. And the 3 chipped upper right side teeth. He sent us to an oral surgeon because I would likely need to have the tooth pulled and an implant put in. The next day we had the oral surgeon visit and were advised he did not want to work on it due to the probability of me having had a concussion due to my constant headache I had had since I fainted and he did not want to cause more issues and he wanted to let the stitches heal as well. He rescheduled me for the following Monday to come to the office and have oral surgery to remove the tooth. Was out of work the entire end of the week, as well as half of a day Monday, all day Tuesday and most of the day Wed. I have since had another dental visit to have 3 teeth repaired and the day after when I finally began to eat regular food, another lower left tooth chipped. It was likely already chipped die to the fainting issue. I will have continued dental visits due to this situation, as I am in the middle of receiving a dental implant where I lost the tooth. I have had nothing but doctor and dental visits since I received this vaccine. I was advised that this was a fast track vaccine and I am not quite understanding why, as IF this is being recommended for EVERYONE to replace the old vaccine, I feel its very important to do the full testing before trying it on anyone. Its my understanding that I am not the FIRST person with an adverse reaction.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Impaired work ability, Influenza like illness, Laceration, Middle insomnia
Clinical narrative: At 3pm, I noticed pain at the site of the vaccine. Took ADVIL. Around 9:30 noticed again pain, so used ice pack and took ADVIL. Around 3:30 am, I woke with horrible pain in site where vaccine was given. Went to kitchen to get ADVIL to take and an ice pack, stopped at restroom and as I was sitting there, was overcome with an awful flu-like feeling. Felt bad, felt weak, felt dizzy - I recall thinking I needed to get back to bed. I woke on the kitchen tile floor in a puddle of blood, spitting up teeth. I went to counter to get paper towel to clean up blood and ADVIL and again woke on floor spitting more teeth. I believe I crawled to bedroom and woke my husband that I had fallen. He woke, got towels as I was bleeding bad on my chin. It was also hard for me to breathe in on the top part of my chest. Like I hit that too. He woke our EMS son and our daughter who worked in ER to check my blood pressure and vitals. All appeared to be ok. All agreed I needed stitches, but would be ok to wait until urgent care opened to go get them. At 8am, I called my regular doctor's office and was advised they do not do stitches and to go to the urgent care or an ER. We went to urgent care. Was treated by Drs. See attached medical report with diagnosis. I received ten stitches in my chin, had to stitch up all layers of skin as it was all the way to the bone, also received an IV full of antibiotics and fluid as I was severely dehydrated. I was then sent to the dentist for an emergency visit due to my teeth. He saw the chipped top left tooth - was actually broken in half. And the 3 chipped upper right side teeth. He sent us to an oral surgeon because I would likely need to have the tooth pulled and an implant put in. The next day we had the oral surgeon visit and were advised he did not want to work on it due to the probability of me having had a concussion due to my constant headache I had had since I fainted and he did not want to cause more issues and he wanted to let the stitches heal as well. He rescheduled me for the following Monday to come to the office and have oral surgery to remove the tooth. Was out of work the entire end of the week, as well as half of a day Monday, all day Tuesday and most of the day Wed. I have since had another dental visit to have 3 teeth repaired and the day after when I finally began to eat regular food, another lower left tooth chipped. It was likely already chipped die to the fainting issue. I will have continued dental visits due to this situation, as I am in the middle of receiving a dental implant where I lost the tooth. I have had nothing but doctor and dental visits since I received this vaccine. I was advised that this was a fast track vaccine and I am not quite understanding why, as IF this is being recommended for EVERYONE to replace the old vaccine, I feel its very important to do the full testing before trying it on anyone. Its my understanding that I am not the FIRST person with an adverse reaction.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Suture insertion, Syncope, Tooth fracture, Tooth loss, Tooth repair
Clinical narrative: At 3pm, I noticed pain at the site of the vaccine. Took ADVIL. Around 9:30 noticed again pain, so used ice pack and took ADVIL. Around 3:30 am, I woke with horrible pain in site where vaccine was given. Went to kitchen to get ADVIL to take and an ice pack, stopped at restroom and as I was sitting there, was overcome with an awful flu-like feeling. Felt bad, felt weak, felt dizzy - I recall thinking I needed to get back to bed. I woke on the kitchen tile floor in a puddle of blood, spitting up teeth. I went to counter to get paper towel to clean up blood and ADVIL and again woke on floor spitting more teeth. I believe I crawled to bedroom and woke my husband that I had fallen. He woke, got towels as I was bleeding bad on my chin. It was also hard for me to breathe in on the top part of my chest. Like I hit that too. He woke our EMS son and our daughter who worked in ER to check my blood pressure and vitals. All appeared to be ok. All agreed I needed stitches, but would be ok to wait until urgent care opened to go get them. At 8am, I called my regular doctor's office and was advised they do not do stitches and to go to the urgent care or an ER. We went to urgent care. Was treated by Drs. See attached medical report with diagnosis. I received ten stitches in my chin, had to stitch up all layers of skin as it was all the way to the bone, also received an IV full of antibiotics and fluid as I was severely dehydrated. I was then sent to the dentist for an emergency visit due to my teeth. He saw the chipped top left tooth - was actually broken in half. And the 3 chipped upper right side teeth. He sent us to an oral surgeon because I would likely need to have the tooth pulled and an implant put in. The next day we had the oral surgeon visit and were advised he did not want to work on it due to the probability of me having had a concussion due to my constant headache I had had since I fainted and he did not want to cause more issues and he wanted to let the stitches heal as well. He rescheduled me for the following Monday to come to the office and have oral surgery to remove the tooth. Was out of work the entire end of the week, as well as half of a day Monday, all day Tuesday and most of the day Wed. I have since had another dental visit to have 3 teeth repaired and the day after when I finally began to eat regular food, another lower left tooth chipped. It was likely already chipped die to the fainting issue. I will have continued dental visits due to this situation, as I am in the middle of receiving a dental implant where I lost the tooth. I have had nothing but doctor and dental visits since I received this vaccine. I was advised that this was a fast track vaccine and I am not quite understanding why, as IF this is being recommended for EVERYONE to replace the old vaccine, I feel its very important to do the full testing before trying it on anyone. Its my understanding that I am not the FIRST person with an adverse reaction.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination site pain
Clinical narrative: At 3pm, I noticed pain at the site of the vaccine. Took ADVIL. Around 9:30 noticed again pain, so used ice pack and took ADVIL. Around 3:30 am, I woke with horrible pain in site where vaccine was given. Went to kitchen to get ADVIL to take and an ice pack, stopped at restroom and as I was sitting there, was overcome with an awful flu-like feeling. Felt bad, felt weak, felt dizzy - I recall thinking I needed to get back to bed. I woke on the kitchen tile floor in a puddle of blood, spitting up teeth. I went to counter to get paper towel to clean up blood and ADVIL and again woke on floor spitting more teeth. I believe I crawled to bedroom and woke my husband that I had fallen. He woke, got towels as I was bleeding bad on my chin. It was also hard for me to breathe in on the top part of my chest. Like I hit that too. He woke our EMS son and our daughter who worked in ER to check my blood pressure and vitals. All appeared to be ok. All agreed I needed stitches, but would be ok to wait until urgent care opened to go get them. At 8am, I called my regular doctor's office and was advised they do not do stitches and to go to the urgent care or an ER. We went to urgent care. Was treated by Drs. See attached medical report with diagnosis. I received ten stitches in my chin, had to stitch up all layers of skin as it was all the way to the bone, also received an IV full of antibiotics and fluid as I was severely dehydrated. I was then sent to the dentist for an emergency visit due to my teeth. He saw the chipped top left tooth - was actually broken in half. And the 3 chipped upper right side teeth. He sent us to an oral surgeon because I would likely need to have the tooth pulled and an implant put in. The next day we had the oral surgeon visit and were advised he did not want to work on it due to the probability of me having had a concussion due to my constant headache I had had since I fainted and he did not want to cause more issues and he wanted to let the stitches heal as well. He rescheduled me for the following Monday to come to the office and have oral surgery to remove the tooth. Was out of work the entire end of the week, as well as half of a day Monday, all day Tuesday and most of the day Wed. I have since had another dental visit to have 3 teeth repaired and the day after when I finally began to eat regular food, another lower left tooth chipped. It was likely already chipped die to the fainting issue. I will have continued dental visits due to this situation, as I am in the middle of receiving a dental implant where I lost the tooth. I have had nothing but doctor and dental visits since I received this vaccine. I was advised that this was a fast track vaccine and I am not quite understanding why, as IF this is being recommended for EVERYONE to replace the old vaccine, I feel its very important to do the full testing before trying it on anyone. Its my understanding that I am not the FIRST person with an adverse reaction.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Dizziness, Erythema, Face injury, Influenza
Clinical narrative: At 3pm, I noticed pain at the site of the vaccine. Took ADVIL. Around 9:30 noticed again pain, so used ice pack and took ADVIL. Around 3:30 am, I woke with horrible pain in site where vaccine was given. Went to kitchen to get ADVIL to take and an ice pack, stopped at restroom and as I was sitting there, was overcome with an awful flu-like feeling. Felt bad, felt weak, felt dizzy - I recall thinking I needed to get back to bed. I woke on the kitchen tile floor in a puddle of blood, spitting up teeth. I went to counter to get paper towel to clean up blood and ADVIL and again woke on floor spitting more teeth. I believe I crawled to bedroom and woke my husband that I had fallen. He woke, got towels as I was bleeding bad on my chin. It was also hard for me to breathe in on the top part of my chest. Like I hit that too. He woke our EMS son and our daughter who worked in ER to check my blood pressure and vitals. All appeared to be ok. All agreed I needed stitches, but would be ok to wait until urgent care opened to go get them. At 8am, I called my regular doctor's office and was advised they do not do stitches and to go to the urgent care or an ER. We went to urgent care. Was treated by Drs. See attached medical report with diagnosis. I received ten stitches in my chin, had to stitch up all layers of skin as it was all the way to the bone, also received an IV full of antibiotics and fluid as I was severely dehydrated. I was then sent to the dentist for an emergency visit due to my teeth. He saw the chipped top left tooth - was actually broken in half. And the 3 chipped upper right side teeth. He sent us to an oral surgeon because I would likely need to have the tooth pulled and an implant put in. The next day we had the oral surgeon visit and were advised he did not want to work on it due to the probability of me having had a concussion due to my constant headache I had had since I fainted and he did not want to cause more issues and he wanted to let the stitches heal as well. He rescheduled me for the following Monday to come to the office and have oral surgery to remove the tooth. Was out of work the entire end of the week, as well as half of a day Monday, all day Tuesday and most of the day Wed. I have since had another dental visit to have 3 teeth repaired and the day after when I finally began to eat regular food, another lower left tooth chipped. It was likely already chipped die to the fainting issue. I will have continued dental visits due to this situation, as I am in the middle of receiving a dental implant where I lost the tooth. I have had nothing but doctor and dental visits since I received this vaccine. I was advised that this was a fast track vaccine and I am not quite understanding why, as IF this is being recommended for EVERYONE to replace the old vaccine, I feel its very important to do the full testing before trying it on anyone. Its my understanding that I am not the FIRST person with an adverse reaction.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Loose tooth, Loss of consciousness, Pain in extremity, Peripheral swelling
Clinical narrative: At 3pm, I noticed pain at the site of the vaccine. Took ADVIL. Around 9:30 noticed again pain, so used ice pack and took ADVIL. Around 3:30 am, I woke with horrible pain in site where vaccine was given. Went to kitchen to get ADVIL to take and an ice pack, stopped at restroom and as I was sitting there, was overcome with an awful flu-like feeling. Felt bad, felt weak, felt dizzy - I recall thinking I needed to get back to bed. I woke on the kitchen tile floor in a puddle of blood, spitting up teeth. I went to counter to get paper towel to clean up blood and ADVIL and again woke on floor spitting more teeth. I believe I crawled to bedroom and woke my husband that I had fallen. He woke, got towels as I was bleeding bad on my chin. It was also hard for me to breathe in on the top part of my chest. Like I hit that too. He woke our EMS son and our daughter who worked in ER to check my blood pressure and vitals. All appeared to be ok. All agreed I needed stitches, but would be ok to wait until urgent care opened to go get them. At 8am, I called my regular doctor's office and was advised they do not do stitches and to go to the urgent care or an ER. We went to urgent care. Was treated by Drs. See attached medical report with diagnosis. I received ten stitches in my chin, had to stitch up all layers of skin as it was all the way to the bone, also received an IV full of antibiotics and fluid as I was severely dehydrated. I was then sent to the dentist for an emergency visit due to my teeth. He saw the chipped top left tooth - was actually broken in half. And the 3 chipped upper right side teeth. He sent us to an oral surgeon because I would likely need to have the tooth pulled and an implant put in. The next day we had the oral surgeon visit and were advised he did not want to work on it due to the probability of me having had a concussion due to my constant headache I had had since I fainted and he did not want to cause more issues and he wanted to let the stitches heal as well. He rescheduled me for the following Monday to come to the office and have oral surgery to remove the tooth. Was out of work the entire end of the week, as well as half of a day Monday, all day Tuesday and most of the day Wed. I have since had another dental visit to have 3 teeth repaired and the day after when I finally began to eat regular food, another lower left tooth chipped. It was likely already chipped die to the fainting issue. I will have continued dental visits due to this situation, as I am in the middle of receiving a dental implant where I lost the tooth. I have had nothing but doctor and dental visits since I received this vaccine. I was advised that this was a fast track vaccine and I am not quite understanding why, as IF this is being recommended for EVERYONE to replace the old vaccine, I feel its very important to do the full testing before trying it on anyone. Its my understanding that I am not the FIRST person with an adverse reaction.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Suture insertion, Tooth extraction
Clinical narrative: At 3pm, I noticed pain at the site of the vaccine. Took ADVIL. Around 9:30 noticed again pain, so used ice pack and took ADVIL. Around 3:30 am, I woke with horrible pain in site where vaccine was given. Went to kitchen to get ADVIL to take and an ice pack, stopped at restroom and as I was sitting there, was overcome with an awful flu-like feeling. Felt bad, felt weak, felt dizzy - I recall thinking I needed to get back to bed. I woke on the kitchen tile floor in a puddle of blood, spitting up teeth. I went to counter to get paper towel to clean up blood and ADVIL and again woke on floor spitting more teeth. I believe I crawled to bedroom and woke my husband that I had fallen. He woke, got towels as I was bleeding bad on my chin. It was also hard for me to breathe in on the top part of my chest. Like I hit that too. He woke our EMS son and our daughter who worked in ER to check my blood pressure and vitals. All appeared to be ok. All agreed I needed stitches, but would be ok to wait until urgent care opened to go get them. At 8am, I called my regular doctor's office and was advised they do not do stitches and to go to the urgent care or an ER. We went to urgent care. Was treated by Drs. See attached medical report with diagnosis. I received ten stitches in my chin, had to stitch up all layers of skin as it was all the way to the bone, also received an IV full of antibiotics and fluid as I was severely dehydrated. I was then sent to the dentist for an emergency visit due to my teeth. He saw the chipped top left tooth - was actually broken in half. And the 3 chipped upper right side teeth. He sent us to an oral surgeon because I would likely need to have the tooth pulled and an implant put in. The next day we had the oral surgeon visit and were advised he did not want to work on it due to the probability of me having had a concussion due to my constant headache I had had since I fainted and he did not want to cause more issues and he wanted to let the stitches heal as well. He rescheduled me for the following Monday to come to the office and have oral surgery to remove the tooth. Was out of work the entire end of the week, as well as half of a day Monday, all day Tuesday and most of the day Wed. I have since had another dental visit to have 3 teeth repaired and the day after when I finally began to eat regular food, another lower left tooth chipped. It was likely already chipped die to the fainting issue. I will have continued dental visits due to this situation, as I am in the middle of receiving a dental implant where I lost the tooth. I have had nothing but doctor and dental visits since I received this vaccine. I was advised that this was a fast track vaccine and I am not quite understanding why, as IF this is being recommended for EVERYONE to replace the old vaccine, I feel its very important to do the full testing before trying it on anyone. Its my understanding that I am not the FIRST person with an adverse reaction.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness
Clinical narrative: Patient had problem several minutes after administering the vaccine. She felt that the trachea closed. We administered BENADRYL 25mg capsule.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Burning sensation, Discomfort, Erythema, Pruritus, Skin warm
Clinical narrative: Very hot to the touch, swollen, red, burning, heavy and itches.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: Very hot to the touch, swollen, red, burning, heavy and itches.
Age: 56.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Abdominal discomfort, Condition aggravated, Headache, Lyme disease, Pain
Clinical narrative: Stomach was "unsettled" starting day of vaccination. No fever, no N&V or diarrhea, no cramping. "I'm aware that my stomach is there". 1 - 1 1/2 weeks after vaccination c/o feeling like he did with previous cases of Lyme disease (aches, pains, headache). Saw MD, treated for Lyme with Doxy x 21 days (through 3/29/18). No Lyme test done. As of 4/4, still has "unsettled" stomach as described above.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV9, MENB, MNQ
Symptoms: Blood glucose normal, Electrocardiogram normal, Syncope
Clinical narrative: Patient fainted but was guided to the floor by medical assistants. Patient woke within a few seconds with ammonia. Patient was helped onto a bed from the closest exam room. Vitals were taken by doctor and oxygen was given to patient. EKG was done and Glucose was checked. Glucose was low and was given sweet snacks. Patient was later discharged in stable condition.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown demographics. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was reported. On an unknown date, the patient was vaccinated with two doses of PNEUMOVAX 23 injection, lot # N010109, expiration date 20-NOV-2018 (exact dose and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1803USA007661:
Age: 1.17
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Ear pruritus, Rash erythematous, Rash generalised
Clinical narrative: April 2nd pt received multiple vaccines: MMRV, varicella, DTaP, HIB, HEP A and PCV-13 and 2 days later on  4/4/2018 a generalized all over body rash-flat erythematous eruption occurred; mother states it started on feet and progressed upward to head. States child itching her ears; no signs of respiratory distress or poor feeding.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Pt with 3 inch radius ery, sl raised rash. No S/S of infection - not warm, tender or painful to the touch. + pruritis Pt given 25 mg of BENADRYL with good success, pt was checked at 1 hour intervals.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Fainted. Given pt juice and waited 10-15 mins and pt feel better and head to home.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Dizziness, Fatigue, Injection site bruising, Injection site erythema
Clinical narrative: Swelling, redness, bruising, 1 day after vaccination at injection site, also noticed lower back pain. Patient starting feeling tired and dizzy starting 1 day after vaccination.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Swelling, redness, bruising, 1 day after vaccination at injection site, also noticed lower back pain. Patient starting feeling tired and dizzy starting 1 day after vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling, erythema and induration at injection site 1 day after vaccine admin.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash on left upper arm, pt saw rash on 4/4/18.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Drug eruption, Rash
Clinical narrative: Rash on Back & Chest.
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Back pain, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: All symptoms manifest together within 12 hours. Quarter-sized, hard, sore lump in arm at injection site, + redness and swelling- 10 days to subside. Flu-like symptoms: muscle/joint pain, neck and back pain/stiffness, mild nausea- 10 days to subside entirely.
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Myalgia
Clinical narrative: All symptoms manifest together within 12 hours. Quarter-sized, hard, sore lump in arm at injection site, + redness and swelling- 10 days to subside. Flu-like symptoms: muscle/joint pain, neck and back pain/stiffness, mild nausea- 10 days to subside entirely.
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Nausea, Neck pain
Clinical narrative: All symptoms manifest together within 12 hours. Quarter-sized, hard, sore lump in arm at injection site, + redness and swelling- 10 days to subside. Flu-like symptoms: muscle/joint pain, neck and back pain/stiffness, mild nausea- 10 days to subside entirely.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: PATIENT DEVELOPED ERYTHEMA MULTIFORME 5 DAYS AFTER VACCINE WAS ADMINISTERED. WAS SEEN ON 04/02/2018 AT OUR OFFICE AND PRESCRIBED BENADRYL AND PREDNISOLONE.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Myalgia, Nausea
Clinical narrative: Sore arm with mild pain after getting SHINGRIX that lasted for 24 hours. General minor muscle pain, a mild headache, mild shivering, slight nausea w/ loss of appetite.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm with mild pain after getting SHINGRIX that lasted for 24 hours. General minor muscle pain, a mild headache, mild shivering, slight nausea w/ loss of appetite.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient had outbreak of Shingles (Rash according to patient which resembles shingles. Patient went physician and has been put on Valtrex 1g (1 tid x10).
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Employee complained of dizziness and nausea and then began vomiting. Employee states that she had only eaten a kolache and nutri-grain bar this morning. Employee states after reaction that she had donated plasma this morning and was told that she was dehydrated. This information was not disclosed prior to vaccination.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Redness and swelling (entire length of upper arm to elbow-larger than the size of a tennis ball); lots of pain; warmth.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, and itching of the left upper arm.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 4 year old female patient. The patient's concurrent condition included unspecified medical condition, which has a risk for pneumococcal disease. The patient's medical history, drug reactions, allergies and concomitant medications were not reported. On 12-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, units and frequency not reported) (lot# and expiration date not reported) intramuscularly because of an unspecified medical condition that places her at risk for pneumococcal disease. The reporter stated that, on 29-MAR-2018, 18 days after administered the first dose, the patient was inadvertently vaccinated with PNEUMOVAX 23 (Extra dose administered). The reporter confirmed that this was not due to product confusion. No product quality complaint was involved.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a 6 month old patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 02-APR-2018, the patients was vaccinated with an improperly stored dose of ROTATEQ per oral (Strength, dose, frequency, and anatomical location were unknown), with lot # N013992 and expiration date 27-JAN-2019 for prophylaxis. The administered doses of the vaccines experienced the temperature excursion of 9°C to 25°C Celsius degrees for 1 hour. There was a digital data logger involved, but there was no previous temperature excursion, and no adverse effects were reported.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Cyanosis, Dyspnoea, Electrocardiogram, Pyrexia
Clinical narrative: Fever, difficulty breathing for about 1 minute. Cyanosis.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Lethargy, Pyrexia
Clinical narrative: Mom reported "with one hour of vaccine given on 12/19/2017 the patient had a fever of 105 F. With TYLENOL the fever went down to 101.9 and stayed there for two days." The mom reported lethargy but no seizures or inconsolable crying. The PCP office has record of a telephone call on 12/20/18 from the mom stating the child is "running fever of 102." MD office advised mom give MOTRIN and to call back if fever did not improve. PCP office reports having a record of a phone call back to the parent on 12/20/2017 and indicates the parent stated "the child's temperature was down to 100 and seems better."
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Herpes zoster, Nausea, Pain in extremity
Clinical narrative: 3/20/2018 - Sore arm at 7PM. 3/21/2018 - Nausea, fatigue, headache upon awakening in the morning. 3/21/2018 - Headache better in the evening. 3/24/2018 - Noticed herpes rash on back of left leg.