chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.  Sender's Comments: US-009507513-1804USA005153.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.  Sender's Comments: US-009507513-1804USA005153.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 18 year old patients of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 4 year old patient of unknown gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 31-MAR-2018, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # N027002 and expiration date: 28-SEP-2019), (strength, dose and route were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiry date were not reported). It was reported that the vaccine was stored in 13 degrees Fahrenheit (F) for 100 hours. There was previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the many reports from the same source. Sender's Comments: US-009507513-1804USA008748: US-009507513-1809USA007363.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 4 year old patient of unknown gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 31-MAR-2018, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # N027002 and expiration date: 28-SEP-2019), (strength, dose and route were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiry date were not reported). It was reported that the vaccine was stored in 13 degrees Fahrenheit (F) for 100 hours. There was previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the many reports from the same source. Sender's Comments: US-009507513-1804USA008748: US-009507513-1809USA007362.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Burns second degree, Burns third degree, Contusion, Fall, Haemorrhage
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (and light headedness after receiving 1st dose on 2nd July 2018, refer case US2018GSK167116). Concomitant products included fish oil. On 4th September 2018, the patient received the 2nd dose of SHINGRIX. On 5th September 2018, 1 days after receiving SHINGRIX, the patient experienced loss of consciousness (serious criteria GSK medically significant) and fainting. On an unknown date, the outcome of the loss of consciousness and fainting were recovered/resolved. It was unknown if the reporter considered the loss of consciousness and fainting to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. The patient queried if there was any fainting issues as a side effect following the 2nd dosage after waiting for 2 months. The day after the second dose, the patient blacked out twice within a 20 minute time period. He was unconscious for about 2 seconds but the second time he fainted, he fell and hit his head and had bleeding on the back of his head. He had been preparing hot tea and dropped it on his stomach and had 2nd and 3rd degree burns. He also hit his hip and had a bruise.The primary care provider and other physician details were provided.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Head injury, Loss of consciousness, Syncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (and light headedness after receiving 1st dose on 2nd July 2018, refer case US2018GSK167116). Concomitant products included fish oil. On 4th September 2018, the patient received the 2nd dose of SHINGRIX. On 5th September 2018, 1 days after receiving SHINGRIX, the patient experienced loss of consciousness (serious criteria GSK medically significant) and fainting. On an unknown date, the outcome of the loss of consciousness and fainting were recovered/resolved. It was unknown if the reporter considered the loss of consciousness and fainting to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. The patient queried if there was any fainting issues as a side effect following the 2nd dosage after waiting for 2 months. The day after the second dose, the patient blacked out twice within a 20 minute time period. He was unconscious for about 2 seconds but the second time he fainted, he fell and hit his head and had bleeding on the back of his head. He had been preparing hot tea and dropped it on his stomach and had 2nd and 3rd degree burns. He also hit his hip and had a bruise.The primary care provider and other physician details were provided.
Sex: M
Vaccine: FLUX
Symptoms: Condition aggravated, Genital herpes
Clinical narrative: This case was reported by a consumer and described the occurrence of genital herpes in a male patient who received Influenza vaccine for prophylaxis. The patient's past medical history included genital herpes and chickenpox. Concurrent medical conditions included blood pressure high and benign prostatic hyperplasia. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced genital herpes and condition aggravated. On an unknown date, the outcome of the genital herpes and condition aggravated were unknown. It was unknown if the reporter considered the genital herpes and condition aggravated to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient's herpes genitalis flared up after receiving anti-flu vaccine. This case has been linked with US2018GSK119866, reported for the same patient for SHINGRIX vaccine.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Rash generalised, Rash papular
Clinical narrative: Initial information received on 03-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 months old male patient who experienced papular rash on his inner thigh, and it spread to the rest of his side, while he received vaccines PREVNAR 13 and PENTACEL. The patient's past medical history included Rash with At 7 weeks old, a generalized rash on his face and neck then arms, legs, and chest and back. It was itchy, and had finer papules than this rash. Pinpoint size papules, they changed the mother's diet and it got better over the course of few days.. The patient's past vaccination(s) included PENTACEL at 2 months, rotavirus vaccine at 2 months, PREVNAR 13 at 3 months with first dose of the PREVNAR 13 vaccine and PENTACEL at 4 months with 2nd PENTACEL dose, 1mm to 2mm size papules, with white heads. The patient's past medical treatment(s) and family history were not provided. Concomitant medication was not reported. On 14-Jun-2018, the patient received a  dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot T94430 in the right thigh. On 17-May-2018, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5439AA. The patient developed a non-serious papular rash on his inner thigh, and it spread to the rest of his side (rash papular) <<Unknown latency>> following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and <<Unknown latency>> following the administration of PREVNAR 13. Final diagnosis was papular rash on his inner thigh, and it spread to the rest of his side. The patient was treated with PHENETICILLIN POTASSIUM (PENICILLIN B) for Immunisation. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for papular rash on his inner thigh, and it spread to the rest of his side.
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 49 years old female patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant.therapies taken. On 13-Sep-2018, the patient received 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ006AA (expiry date: 14-Apr-2019) in the right deltoid. It was a case of actual medication error due to Inappropriate age at vaccine administration. It was unknown whether any adverse event occurred or not. 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.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacy intern (other health professional). This case involves a 43 years old female patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. On 10-Sep-2018, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI994AB in the left deltoid. It waa a case of actual medication error due to Inappropriate age at vaccine administration. It was unknown whether adverse event occurred or not. 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.
Age: 1.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient received KINRIX, supposed to have been Hep A. Dr has been notified of error and will be contacting parents.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Fatigue, Injection site pain, Myalgia
Clinical narrative: I'm writing this on Wednesday, had the injection Monday night (this is the third day). Extreme fatigue several hours after injection, ongoing. Ran a fever that night which has continued, highest was 101 degrees, currently 99.6. Mild nausea the day after vaccine, subsided. Mild diarrhea the day after vaccine, ongoing. Joint and muscle pain the day after vaccine, improving. Severe pain starting in big toe, spreading to foot, then up lower leg to knee, began and ended the day after vaccine. Extremely painful at injection site since a few hours after, ongoing. Treated with ibuprofen, fluids, rest. Confined to bed most of the day after vaccine. Today the muscle/joint pains are much better, fever is lower, still very fatigued and have mild diarrhea.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: I'm writing this on Wednesday, had the injection Monday night (this is the third day). Extreme fatigue several hours after injection, ongoing. Ran a fever that night which has continued, highest was 101 degrees, currently 99.6. Mild nausea the day after vaccine, subsided. Mild diarrhea the day after vaccine, ongoing. Joint and muscle pain the day after vaccine, improving. Severe pain starting in big toe, spreading to foot, then up lower leg to knee, began and ended the day after vaccine. Extremely painful at injection site since a few hours after, ongoing. Treated with ibuprofen, fluids, rest. Confined to bed most of the day after vaccine. Today the muscle/joint pains are much better, fever is lower, still very fatigued and have mild diarrhea.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Fall
Clinical narrative: The child walked out of the office after receiving the shots then fell on the floor in the hallway. She denied hitting her head. She also reported that she did not lose any consciousness. Answered the questions coherently. Stated that she just felt dizzy after receiving the shots. A pouch of juice and a pack of crackers were given. Legs were elevated. Stood up with assistance after 10 minutes,  walked with a steady gait and claimed that she's "fine". Sent home, accompanied by parents.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Gastrointestinal disorder, Nausea
Clinical narrative: Pt states very loose bowel movements, diarrhea, nausea, general GI problems.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Incorrect dose administered, Incorrect route of product administration, Wrong product administered
Clinical narrative: I came in there to have my right ankle sprain checked. They don't have x-ray so I'm going to Ortho till the next day and I said can I just have a flu shot. RN practitioner injected me with a tuberculin shot intramuscular on the left arm .5 mL instead of flu shot. CDC and poison control were called. They said no harm but that's supposedly intradermal. She has an intern with us in the room doing the computer work. She then proceeded with injecting flu shot on R arm. She gave me a post visit summary with a handwritten note at the bottom that stated she gave me an overdosed tuberculin shot. The next day Monday, 9/17/18, I went to Dr., my primary MD and Dr., my Ortho. I also called Advocate patient portal and spoke with RN but they don't know anything and referred me back to talk to pharmacy. I asked for another written report from clinic in pharmacy of my medical records Tuesday. I can't drive because of my R post tib tendon rupture per Ortho on Monday so I asked my husband to pick it up and there was no record of her giving the tuberculin injection to me. The mere fact that the wrong medication, wrong dose, and not documenting properly, as well as not following up is unacceptable. I am so enraged and at the same time very worried that I'm going to be positive for TB in the future. I'm a physical therapist and every year at work, we have a physical exam which includes TB testing which I am negative. I am so mad that she is incompetent.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Myalgia, Nightmare
Clinical narrative: Patient had severe headache the evening of shot and it has continued. Patient also experienced nightmares, extreme sweating and migrating muscular pain.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Peripheral swelling
Clinical narrative: Pt was seen in office on 09/19/18 with c/o red and swollen left arm. She received PNEUMOVAX 9/18/18. Site was red, warm to touch and tender. Seen by Dr, dx with vaccine reaction. Instructed to put cool compress on site and call if worsens in 24 hours. Pt verbalized an understanding of instructions.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vaccination complication
Clinical narrative: Pt was seen in office on 09/19/18 with c/o red and swollen left arm. She received PNEUMOVAX 9/18/18. Site was red, warm to touch and tender. Seen by Dr, dx with vaccine reaction. Instructed to put cool compress on site and call if worsens in 24 hours. Pt verbalized an understanding of instructions.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Nodule, Pain, Skin warm
Clinical narrative: Hot knot, bruised, 3.5 to 4 inches, throbs, - took 2-3 days for hot knot to go away, and 5 days for the everything else to subside.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Injection site erythema, Injection site swelling, Palpitations
Clinical narrative: Red, swollen area at injection site; Dizziness/Lightheadedness; Headache; Wheezing; Palpitations.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Red, swollen area at injection site; Dizziness/Lightheadedness; Headache; Wheezing; Palpitations.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza virus test negative, Pyrexia
Clinical narrative: Pt medicated with TYLENOL in office with successful fever reduction. Rapid flu test negative.  Rapid onset of fever the evening after vaccination for influenza. T max 103.3 po.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Injection site erythema, Injection site pain
Clinical narrative: Day One: chills, headache, site arm pain; Day Two: chills, aches, site arm pain, fatigue; Day Three: chills, aches, site arm pain, fatigue; Day Four: arm pain, redness at injection site, slight swelling at injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain
Clinical narrative: Day One: chills, headache, site arm pain; Day Two: chills, aches, site arm pain, fatigue; Day Three: chills, aches, site arm pain, fatigue; Day Four: arm pain, redness at injection site, slight swelling at injection site.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site nodule, Injection site rash, Injection site warmth
Clinical narrative: Hot to the touch, rash surrounding the site, firm knot, and bruising. Call patient to check on her- bruising still apparent but rash, firm knot went away, and still a little warm.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Body temperature, Cough, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Cough-three Weeks, Fatigue, temperature, arm swelled (have pictures), aches, loss of appetite, breathing problems.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Pain, Peripheral swelling
Clinical narrative: Cough-three Weeks, Fatigue, temperature, arm swelled (have pictures), aches, loss of appetite, breathing problems.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Asthenia, Cough, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Cough-three Weeks, Fatigue, temperature, arm swelled (have pictures), aches, loss of appetite, breathing problems.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Headache, Pyrexia, Weight decreased
Clinical narrative: Cough-three Weeks, Fatigue, temperature, arm swelled (have pictures), aches, loss of appetite, breathing problems.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Pyrexia
Clinical narrative: Cough-three Weeks, Fatigue, temperature, arm swelled (have pictures), aches, loss of appetite, breathing problems.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Weight decreased
Clinical narrative: Cough-three Weeks, Fatigue, temperature, arm swelled (have pictures), aches, loss of appetite, breathing problems.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Nausea, Pyrexia, Vomiting
Clinical narrative: 12 hours post vaccination: Fever, chills, nausea, vomiting; resolved within 1 day.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Bed rest, Chills, Gait disturbance, Headache, Loss of personal independence in daily activities
Clinical narrative: Received shot in left arm on Monday night. The following day, was extremely achy and was in bed most of the day. Muscles were extremely fatigued and had trouble walking. Severity of symptoms prevented me from doing daily activities. Also had chills and bad headache on Tuesday and Tuesday night. On Wednesday, developed hives and red rash on stomach, legs and left arm. Felt better on Wednesday afternoon and was able to walk, but hives are still present. Taking BENADRYL but still not 100%.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle fatigue, Pain, Rash erythematous, Urticaria
Clinical narrative: Received shot in left arm on Monday night. The following day, was extremely achy and was in bed most of the day. Muscles were extremely fatigued and had trouble walking. Severity of symptoms prevented me from doing daily activities. Also had chills and bad headache on Tuesday and Tuesday night. On Wednesday, developed hives and red rash on stomach, legs and left arm. Felt better on Wednesday afternoon and was able to walk, but hives are still present. Taking BENADRYL but still not 100%.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities
Clinical narrative: I received the flu shot at 13:26 in right upper arm and then woke up at 4am with severe right shoulder pain and limited ROM. I took MOTRIN 800mg, applied cold and heat however the pain persists and the limited ROM persists, I could not even open a door today, carry my purse, brush my teeth with my right arm. I am a APRN and I did alert my PCP, we will continue to monitor and if needed I will go see her. Thank you. Place which I work for provided education to staff today with the CDC hand out - know the site, get it right, reviewed what SIRVA is and how to prevent it, and also provided staff the links for the online program.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 101 to 102 degrees for 29 hours.
Age: 44.0
Sex: F
Vaccine: FLU4, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Got vaccines 9-17-18. Patient said she spiked a fever 9-18. Next morning (today 9-19), her upper right arm (deltoid) was red, swollen, and she said she's in pain. Tried ibuprofen, acetaminophen. Tried diphenhydramine cream, even though there was no itching. She is heading to urgent care/clinic.
Age: 44.0
Sex: F
Vaccine: FLU4, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Fatigue, Headache, Injection site pain, Malaise, Pain
Clinical narrative: Got vaccines 9-17-18. Patient said she spiked a fever 9-18. Next morning (today 9-19), her upper right arm (deltoid) was red, swollen, and she said she's in pain. Tried ibuprofen, acetaminophen. Tried diphenhydramine cream, even though there was no itching. She is heading to urgent care/clinic.
Age: 44.0
Sex: F
Vaccine: FLU4, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Got vaccines 9-17-18. Patient said she spiked a fever 9-18. Next morning (today 9-19), her upper right arm (deltoid) was red, swollen, and she said she's in pain. Tried ibuprofen, acetaminophen. Tried diphenhydramine cream, even though there was no itching. She is heading to urgent care/clinic.
Age: 44.0
Sex: F
Vaccine: FLU4, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient received PNEUMOVAX and flu vaccines in R arm and TdaP in L arm at noon on Monday September 17, 2018. She started feeling generalized malaise including fatigue, headache, body aches, fever, and pain at the injection approximately 2 hours later. This morning, September 19, 2018 she woke up with a rash on her right shoulder where the flu and PNEUMOVAX injections had been given. She returned to the pharmacy where she had received vaccines and was told to come to this clinic to be evaluated for an allergic reaction and then return to the pharmacy so they could follow up on the adverse event. The patient was prescribed hydrocortisone 2.5% topical cream to apply directly to the affected area and instructed to take BENADRYL 50mg every 6 hours along with ibuprofen 600mg every 6 hours alternated with TYLENOL 1000mg every 6 hours to control pain and fever. She was further instructed to follow up with her PCP tomorrow if there was no improvement in symptoms and to go to nearest ER immediately for any shortness of breath, difficulty breathing, or swelling of the mouth and face.
Age: 44.0
Sex: F
Vaccine: FLU4, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Fatigue, Headache, Injection site pain, Malaise, Pain
Clinical narrative: Patient received PNEUMOVAX and flu vaccines in R arm and TdaP in L arm at noon on Monday September 17, 2018. She started feeling generalized malaise including fatigue, headache, body aches, fever, and pain at the injection approximately 2 hours later. This morning, September 19, 2018 she woke up with a rash on her right shoulder where the flu and PNEUMOVAX injections had been given. She returned to the pharmacy where she had received vaccines and was told to come to this clinic to be evaluated for an allergic reaction and then return to the pharmacy so they could follow up on the adverse event. The patient was prescribed hydrocortisone 2.5% topical cream to apply directly to the affected area and instructed to take BENADRYL 50mg every 6 hours along with ibuprofen 600mg every 6 hours alternated with TYLENOL 1000mg every 6 hours to control pain and fever. She was further instructed to follow up with her PCP tomorrow if there was no improvement in symptoms and to go to nearest ER immediately for any shortness of breath, difficulty breathing, or swelling of the mouth and face.
Age: 44.0
Sex: F
Vaccine: FLU4, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Patient received PNEUMOVAX and flu vaccines in R arm and TdaP in L arm at noon on Monday September 17, 2018. She started feeling generalized malaise including fatigue, headache, body aches, fever, and pain at the injection approximately 2 hours later. This morning, September 19, 2018 she woke up with a rash on her right shoulder where the flu and PNEUMOVAX injections had been given. She returned to the pharmacy where she had received vaccines and was told to come to this clinic to be evaluated for an allergic reaction and then return to the pharmacy so they could follow up on the adverse event. The patient was prescribed hydrocortisone 2.5% topical cream to apply directly to the affected area and instructed to take BENADRYL 50mg every 6 hours along with ibuprofen 600mg every 6 hours alternated with TYLENOL 1000mg every 6 hours to control pain and fever. She was further instructed to follow up with her PCP tomorrow if there was no improvement in symptoms and to go to nearest ER immediately for any shortness of breath, difficulty breathing, or swelling of the mouth and face.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction, Urticaria
Clinical narrative: Localized hives along with a typical local reaction to Tdap 15 Aug 2016 in the setting of a URI. The question of hives raises the concern for anaphylaxis. Was this anaphylaxis? Not likely. Anaphylaxis to tetanus containing vaccines is extremely rare. Her reaction does not fit the definition of a generalized reaction, however, an abundance of caution is used in healthcare, and proceeding in a cautious way with further Tdap/Td immunizations is recommended.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Pt reports that deltoid is still swollen and sore. It is not red, however.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Pt reported fever and chills the morning after the injection. PT also reported injection site reaction of redness and swelling. Pt symptoms worsened over the next few days and more flu like symptoms occurred. She became very tired and lethargic on Monday and Tuesday and had to leave work early.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pyrexia
Clinical narrative: Pt reported fever and chills the morning after the injection. PT also reported injection site reaction of redness and swelling. Pt symptoms worsened over the next few days and more flu like symptoms occurred. She became very tired and lethargic on Monday and Tuesday and had to leave work early.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. Information on patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 19-MAR-2018, multiple unspecified patients were vaccinated with improperly stored dose of VARIVAX (lot # N027002 and expiration date: 28-SEP-2019), (strength, dose and route were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiry date were not reported). The vaccine was stored in 13 degrees Fahrenheit (F) for 100 hours. There was previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is a non-valid case due to lack of patient identifiers. Follow up information was received from the medical assistant on 14-SEP-2018. This spontaneous report concerns a 4 year old patient of unknown gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 19-MAR-2018, the patient was vaccinated with a dose of improperly stored dose of VARIVAX (lot # N027002 and expiration date: 28-SEP-2019), (strength, dose and route were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiry date were not reported). It was reported that the vaccine was stored in 13 degrees Fahrenheit (F) for 100 hours. There was previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the many reports from the same source.; Sender's Comments: US-009507513-1809USA007362: US-009507513-1809USA007363:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 4 year old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. The reporter stated that, on 06-SEP-2018, the patient was vaccinated with ROTATEQ, oral, lot # N030476, expiration date 17-JUN-2019 (dose was not reported) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported. Lot number N030476 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. On 09-JUN-2015 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles at a clinic. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 27-APR-2016, the patient was treated at a clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. On or about 22-MAY-2012 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles at a pharmacy. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 14-JUN-2016 the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was treated with acyclovir, prednisone, LYRICA, and ZOFRAN. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Injection site mass, Injection site pain
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 43 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-AUG-2018, the patient was vaccinated with M-M-R II, lot number N027779, expiration date 08-AUG-2019, subcutaneously in the left arm for prophylaxis also reported as "vaccination of measles, mumps and rubella" (dose and strength were not reported); administered in combination with sterile diluent (manufacturer unknown). On the same administration date, the patient experienced a lump and tenderness at the injection site, no laboratory diagnostic studies were performed, the patient did not seek medical attention and no treatment was given for the event. Product quality complaint (PQC) was not reported. At the reporting time, the patient had not recovered from the reported events. The reporter did not provide causality assesssment between vaccination with M-M-R II and the reported events.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly male patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced fever and malaise. On an unknown date, the outcome of the fever and malaise were recovered/resolved. It was unknown if the reporter considered the fever and malaise to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the right arm. The patient experienced a low grade fever and malaise which started the next day after receiving Shingrix. These events lasted for total of 2 days. The patient gave permission to contact his physician. No further details were provided.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 76-year-old female patient who received Shingrix for prophylaxis. On 10th July 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In July 2018, 1 day after receiving Shingrix, the patient experienced erythema, pain, swelling, skin warm and pruritus. On an unknown date, the outcome of the erythema, pain, swelling, skin warm and pruritus were recovered/resolved. It was unknown if the reporter considered the erythema, pain, swelling, skin warm and pruritus to be related to Shingrix. Additional details were reported as follows: The reporter was the patient. She did report this to her pharmacist. The date of vaccination in left arm  was an estimate. She knew it was about 2 months before the date of reporting and could not provide a specific date. The day after the vaccination, a red, hot, itchy patch that was slightly swollen appeared about 3 inches down from the injection site. It was circular and about 3 inches in diameter. Less than a year vaccination, The patient also had some soreness and pain. It lasted about a week and a half to two weeks but had now resolved.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody positive, Autoimmune disorder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of antinuclear antibody positive in a 65-year-old female patient who received Shingrix for prophylaxis. Concurrent medical conditions included fibromyalgia (had a long standing history of fibromyalgia that the patient believed was diagnosed incorrectly 15 years before the date of reporting). Concomitant products included prednisone. In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced antinuclear antibody positive. On 11th September 2018, the outcome of the antinuclear antibody positive was recovered/resolved. The reporter considered the antinuclear antibody positive to be unrelated to Shingrix. Additional information was reported as follows: The reporting pharmacist was the patient herself, she was a retired pharmacist. The batch number and expiry date for Shingrix was not reported. The patient used to work in a safety department so she understood she had to report the events experienced by her. On the date of reporting, after vaccination with Shingrix, the patient received her lab results, that showed positive results for antinuclear antibody (an autoimmune disorder). At the time of reporting, the patient was prescribed Prednisone for a period of about 12 days. The pharmacist believed that the event experienced by the patient was not related to Shingrix. The pharmacist also stated that if the lab test samples were withdrawn prior to vaccination with Shingrix, they would still had shown positive results. The pharmacist believed that the events experienced by her were not due to the vaccine as she had a long-standing history.