chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Fatigue, Gingival swelling, Malaise, Pyrexia
Clinical narrative: Fever up to 102 degrees Fahrenheit, swollen gums, malaise, fatigue, loss of appetite.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site nodule, Injection site warmth, Peripheral swelling, Pyrexia
Clinical narrative: Flu-like symptoms for 2 days, fever of 101.3 (hard to bring down with OTC IBU/APAP-- took several doses), arm swelling and tenderness, small knot in arm at site of injection, warmth at site of injection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Flu-like symptoms for 2 days, fever of 101.3 (hard to bring down with OTC IBU/APAP-- took several doses), arm swelling and tenderness, small knot in arm at site of injection, warmth at site of injection.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Rash pustular
Clinical narrative: Nonpruritic, nonpainful outbreak of tiny pustules across shoulders and upper back, one day after receiving MENACTRA in left deltoid.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: One large blister that is not with injection site. Just on same deltoid that injection was given, rash and swelling. Treatment with BACTRIM DS and steroid shot.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Influenza like illness, Injection site swelling, Pyrexia
Clinical narrative: Patient had flu-like symptoms with a low-grade fever. Patient also had mild swelling to injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Patient had inflammation and redness around the injection site and for up to 4 inches around the site. She also experienced a little pain as well.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache, Nausea, Paraesthesia
Clinical narrative: Severe headache, chills, nausea, very tired, tingling, fever (max 100.9).
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Severe headache, chills, nausea, very tired, tingling, fever (max 100.9).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Muscular weakness, Myalgia
Clinical narrative: Patient stated she had a sore deltoid for about 2 weeks and was counseled that is a common side effect. After several days the pain transitioned to her elbow. She has weakness in her elbow since the time of vaccination (~2 months). She has taken ibuprofen and TYLENOL to help treat.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site pain
Clinical narrative: Right arm pain at injection site and temp 100.3. No redness, no edema.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Pain
Clinical narrative: Sweats, chills and aches, ibuprofen.
Age: 29.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Muscle spasms, Somnolence
Clinical narrative: I took the second does of this vaccine about 11pm at night after eating around 9 PM and having 2 beers. I went to sleep at 2 am. I woke the next morning around 10 am. I felt groggy and also was experiencing muscle cramping in my lower abdomen and lower back. I took 400mg of ibuprofen to relieve the cramping and I went back to sleep. I slept until 5 pm that day, and still felt groggy and sleepy. I went to sleep around 1 am. The next day I felt a little sluggish, but overall much better.  However, I have been experiencing loose, runny stools (diarrhea) still, even though I have finished the course of taking this vaccine. I am writing only to report that I experienced side effects, not an adverse reaction. I was able to manage these symptoms at home and I did not require any other medical care. Thus the side effects I experienced were abdominal muscle cramping, extreme fatigue, and diarrhea following day 2 of the vaccine. I believe that I followed the instructions for the vaccine appropriately by keeping it refrigerated and taking the vaccine on any empty stomach with water.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Expired product administered, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had right leg swelling and erythema with reports of itching and pain. Significant circumferential swelling but no signs of taut skin or signs of compartment syndrome. Patient with fever as well. Developed over the last 10 hours prior to presentation in the ED. Patient's mother had been called today as well and told that one of the vaccines of the 3 he received (polio, MMRV, and DTAP) was expired, but she wasn't told which one.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Patient had right leg swelling and erythema with reports of itching and pain. Significant circumferential swelling but no signs of taut skin or signs of compartment syndrome. Patient with fever as well. Developed over the last 10 hours prior to presentation in the ED. Patient's mother had been called today as well and told that one of the vaccines of the 3 he received (polio, MMRV, and DTAP) was expired, but she wasn't told which one.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Abdominal pain upper, Altered state of consciousness, Lethargy, Oropharyngeal discomfort, Pallor
Clinical narrative: Pt. felt like passing out, pale, nondiaphoretic, throat sensation discomfort, stomach ache....lethargy 3pm- pt was sat on chair, O2sat 90, P 60 O2sat=90, P=60 ammonia inhaled, oxygen placed at 3L, BENADRYL 12.5mg/5ml-10ml given slowly, 1 small sip of apple juice. 3:13-laid on table w/ feet elevation BP 100/60, bp=100/60 - pt awake, answered name, mom's name when asked, but appeared somewhat lethargic 3:20 bp=100/60 3:24 O2=98 p=60- 3L O2 3:30 O2=97 p=60- 3L O2- mom accepts transfer to hospital-911 called, 3:40-paramedics arrived-taken hospital- at 3:45 pm.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Induration, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Per MOC about 24 hour post vaccinations she noticed child's arm appeared red, swollen, warm and hard. When asked about itchiness, patient admitted to having some this morning. Patient seen in clinic at 2:30 pm. on 7/10/18. Swelling and redness measuring approx. 100 mm by 80 mm. 25 mg of BENADRYL Suspension given. Assessed 35 minutes post administration and redness measuring the same. However, the swelling had resolved. Prednisone 30 mg oral tablet prescribed. Give 1 tablet PO twice a day for 5 days. Spoke to mother of child on 7/17/18. Patient completed course of medication. MOC states on 7/11/18 the site showed no signs as the previous day (7/10) documented above. Patient has been asymptomatic since.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash pruritic, Respiration abnormal
Clinical narrative: Patient returned to clinic next day post vaccination complaining of itchy rash and stated she felt that her breathing was a little bit off last night several hours after getting zoster vaccine. She has rash at the injection site that extends to her neck. Patient denies breathing difficulty today and no signs of distress noted upon assessment. Vital signs are within normal limits.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient did not have a reaction after vaccination in office. Parents were informed of possible adverse reactions. If she had more fever than usual with vaccines that does not break with TYLENOL or MOTRIN, severe rash. She should return to clinic or go to nearest emergency room.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: Passed out a few minutes after immunization walking in lobby and again sitting in triage chair.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint noise, Vaccination site reaction
Clinical narrative: Loud clicking noise in arm at site of vaccine starting on Saturday following vaccine.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Myalgia, Nausea
Clinical narrative: Muscle pain achille tendon joint pain - knees, hips ankles nausea (L) arm pain at injection site - fingers numb.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Tendon pain
Clinical narrative: Muscle pain achille tendon joint pain - knees, hips ankles nausea (L) arm pain at injection site - fingers numb.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX (batch number C523T, expiry date unknown) for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm and arm discomfort. On an unknown date, the outcome of the pain in arm and arm discomfort were recovering/resolving. The reporter considered the pain in arm and arm discomfort to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. The reporter stated that her pharmacist called several days ago and also reported the events however, no duplicate case was found for this patient. The age at vaccination was not reported. The patient experienced sore and painful arm approximately 5 inches from the injection site. The patient reported that this pain woke her up the 1st night post dose and for the next 3 days her arm was uncomfortable and sore. Less than a week after receiving SHINGRIX, the patient experienced arm discomfort. The reporter stated that at the time of reporting, 2 weeks later the soreness was still there but had improved some. Follow up information received from physician on 11th July 2018: The patient allowed to contact the physician. The primary reporter details were updated. The patient's demographic details were reported. The batch number of SHINGRIX was provided. On 12th April 2018, the patient received the 1st dose of SHINGRIX 0.5 ml, intramuscularly. On 12th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and in April 2018, less than a week after receiving SHINGRIX, the patient experienced arm discomfort. The patient did not contact office with any side effects. The VAERS details were updated. Sender's Comments: US2018GSK074579: Previous VAERS submission in paper format.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX (batch number C523T, expiry date unknown) for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm and arm discomfort. On an unknown date, the outcome of the pain in arm and arm discomfort were recovering/resolving. The reporter considered the pain in arm and arm discomfort to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. The reporter stated that her pharmacist called several days ago and also reported the events however, no duplicate case was found for this patient. The age at vaccination was not reported. The patient experienced sore and painful arm approximately 5 inches from the injection site. The patient reported that this pain woke her up the 1st night post dose and for the next 3 days her arm was uncomfortable and sore. Less than a week after receiving SHINGRIX, the patient experienced arm discomfort. The reporter stated that at the time of reporting, 2 weeks later the soreness was still there but had improved some. Follow up information received from physician on 11th July 2018: The patient allowed to contact the physician. The primary reporter details were updated. The patient's demographic details were reported. The batch number of SHINGRIX was provided. On 12th April 2018, the patient received the 1st dose of SHINGRIX 0.5 ml, intramuscularly. On 12th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and in April 2018, less than a week after receiving SHINGRIX, the patient experienced arm discomfort. The patient did not contact office with any side effects. The VAERS details were updated. Sender's Comments: US2018GSK074579: Previous VAERS submission in paper format.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal disorder, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. In April 2018, 4 days after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the doctor. The age at vaccination was not reported, but the patient could be 77 or 78 years old. The patient received dose of SHINGRIX on left arm. The patient reported that after four or five days after SHINGRIX injection, she started to have great pain in her left arm. The pain ran down her arm and caused something like paralysis of the arm she said. The patient was unable to use her left arm at all. The patient could not bend or lift the arm and had very limited movement of the arm without having severe pain. The patient's physician recommended physical therapy to regain movement of the arm. The patient had been going to therapy ever since the end of April 2018 or first of May 2018, three times a week. The patient had been making strides with therapy and gaining more range of movement as time went by and lessening the pain she felt. The therapist was impressed about how the patient was progressing with the movement. The therapist would take measurements of the arm recording how much the patient was able to move her arm. With the last two or three sessions, the patient did not have any pain. The therapist and the patient both agreed that she was doing well enough that she was fine without therapy. The patient could pick up her purse and could wash her back in the shower. Over past weekend of the reporting date, the patient started to experience pain again in the arm in the muscles. For example, the patient said that she was in church on Sunday and the pain was so bad that she had to leave. The patient was no longer able to sleep on her left side because of the pain. The patient thought that a pharmacist might have contacted the company but she was not certain. The patient was advised to call and report the experience with the company. The patient did not provide any names of physicians because there were multiples in the practice that she had seen, however she would give the form that she would receive with her letter to someone in the office.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal disorder, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. In April 2018, 4 days after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the doctor. The age at vaccination was not reported, but the patient could be 77 or 78 years old. The patient received dose of SHINGRIX on left arm. The patient reported that after four or five days after SHINGRIX injection, she started to have great pain in her left arm. The pain ran down her arm and caused something like paralysis of the arm she said. The patient was unable to use her left arm at all. The patient could not bend or lift the arm and had very limited movement of the arm without having severe pain. The patient's physician recommended physical therapy to regain movement of the arm. The patient had been going to therapy ever since the end of April 2018 or first of May 2018, three times a week. The patient had been making strides with therapy and gaining more range of movement as time went by and lessening the pain she felt. The therapist was impressed about how the patient was progressing with the movement. The therapist would take measurements of the arm recording how much the patient was able to move her arm. With the last two or three sessions, the patient did not have any pain. The therapist and the patient both agreed that she was doing well enough that she was fine without therapy. The patient could pick up her purse and could wash her back in the shower. Over past weekend of the reporting date, the patient started to experience pain again in the arm in the muscles. For example, the patient said that she was in church on Sunday and the pain was so bad that she had to leave. The patient was no longer able to sleep on her left side because of the pain. The patient thought that a pharmacist might have contacted the company but she was not certain. The patient was advised to call and report the experience with the company. The patient did not provide any names of physicians because there were multiples in the practice that she had seen, however she would give the form that she would receive with her letter to someone in the office.
Age: 89.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of skin ulcer in a 89-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 6th June 2018, the patient received the 1st dose of SHINGRIX. On 7th June 2018, 1 days after receiving SHINGRIX, the patient experienced rash. In June 2018, the patient experienced skin ulcer, feeling miserable and erythema. On an unknown date, the outcome of the skin ulcer, feeling miserable, rash and erythema were not recovered/not resolved. It was unknown if the reporter considered the skin ulcer, feeling miserable, rash and erythema to be related to SHINGRIX. Additional details were provided as follows: This case was received as a voicemail in after hours. The patient received a dose of SHINGRIX and 1 to 2 days later, developed sores and a rash which was mostly on the back, but might be spreading. The patient had seen several doctors and taken several medications, but had no effect. The pharmacy was called and the partner was spoken with but the partner was not as familiar with the situation so was only able to provide limited information. The batch number reported for SHINGRIX (326R4) did not exist and was updated to 32GR4 as per sales database.
Age: 89.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling abnormal, Rash, Skin ulcer
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of skin ulcer in a 89-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 6th June 2018, the patient received the 1st dose of SHINGRIX. On 7th June 2018, 1 days after receiving SHINGRIX, the patient experienced rash. In June 2018, the patient experienced skin ulcer, feeling miserable and erythema. On an unknown date, the outcome of the skin ulcer, feeling miserable, rash and erythema were not recovered/not resolved. It was unknown if the reporter considered the skin ulcer, feeling miserable, rash and erythema to be related to SHINGRIX. Additional details were provided as follows: This case was received as a voicemail in after hours. The patient received a dose of SHINGRIX and 1 to 2 days later, developed sores and a rash which was mostly on the back, but might be spreading. The patient had seen several doctors and taken several medications, but had no effect. The pharmacy was called and the partner was spoken with but the partner was not as familiar with the situation so was only able to provide limited information. The batch number reported for SHINGRIX (326R4) did not exist and was updated to 32GR4 as per sales database.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Rash, Varicella
Clinical narrative: This case was reported by a other health professional via out of hour services and described the occurrence of chickenpox in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (at the age of 7 years). On 5th July 2018, the patient received SHINGRIX. In July 2018, 3 days after receiving SHINGIRX, the patient experienced chickenpox and papular rash. On an unknown date, the outcome of the chickenpox and papular rash were unknown.  The reporter considered the chickenpox and papular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Three days after receiving SHINGRIX, the patient experienced little papules starting popping up, two at a time. The patient went to a clinic yesterday and it was confirmed that she has chickenpox. The patient stated that the vaccine has given her a case of the chickenpox. The patient would visit her private doctor today and they would report the adverse event to the state board of health and from there, the state board of health would contact the CDC. The patient stated that she was health care professional and had to cancel all of her patients due to the chickenpox. The caller did not clarify what type of health care professional the patient was. No additional details were provided on the voicemail.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Hypersensitivity, Inflammation, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: This case was reported by a other health professional via out of hour services and described the occurrence of chickenpox in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (at the age of 7 years). On 5th July 2018, the patient received SHINGRIX. In July 2018, 3 days after receiving SHINGIRX, the patient experienced chickenpox and papular rash. On an unknown date, the outcome of the chickenpox and papular rash were unknown.  The reporter considered the chickenpox and papular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Three days after receiving SHINGRIX, the patient experienced little papules starting popping up, two at a time. The patient went to a clinic yesterday and it was confirmed that she has chickenpox. The patient stated that the vaccine has given her a case of the chickenpox. The patient would visit her private doctor today and they would report the adverse event to the state board of health and from there, the state board of health would contact the CDC. The patient stated that she was health care professional and had to cancel all of her patients due to the chickenpox. The caller did not clarify what type of health care professional the patient was. No additional details were provided on the voicemail.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: This case was reported by a other health professional via out of hour services and described the occurrence of chickenpox in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (at the age of 7 years). On 5th July 2018, the patient received SHINGRIX. In July 2018, 3 days after receiving SHINGIRX, the patient experienced chickenpox and papular rash. On an unknown date, the outcome of the chickenpox and papular rash were unknown.  The reporter considered the chickenpox and papular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Three days after receiving SHINGRIX, the patient experienced little papules starting popping up, two at a time. The patient went to a clinic yesterday and it was confirmed that she has chickenpox. The patient stated that the vaccine has given her a case of the chickenpox. The patient would visit her private doctor today and they would report the adverse event to the state board of health and from there, the state board of health would contact the CDC. The patient stated that she was health care professional and had to cancel all of her patients due to the chickenpox. The caller did not clarify what type of health care professional the patient was. No additional details were provided on the voicemail.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Rash papular, Varicella
Clinical narrative: This case was reported by a other health professional via out of hour services and described the occurrence of chickenpox in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (at the age of 7 years). On 5th July 2018, the patient received SHINGRIX. In July 2018, 3 days after receiving SHINGIRX, the patient experienced chickenpox and papular rash. On an unknown date, the outcome of the chickenpox and papular rash were unknown.  The reporter considered the chickenpox and papular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Three days after receiving SHINGRIX, the patient experienced little papules starting popping up, two at a time. The patient went to a clinic yesterday and it was confirmed that she has chickenpox. The patient stated that the vaccine has given her a case of the chickenpox. The patient would visit her private doctor today and they would report the adverse event to the state board of health and from there, the state board of health would contact the CDC. The patient stated that she was health care professional and had to cancel all of her patients due to the chickenpox. The caller did not clarify what type of health care professional the patient was. No additional details were provided on the voicemail.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Contusion, Fatigue, Injection site erythema
Clinical narrative: Sore muscles and joints started in right arm and shoulder went to hip then went to left arm and shoulder and left hip. Still have it on my left side.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Loss of personal independence in daily activities, Myalgia, Pain, Pain in extremity
Clinical narrative: Sore muscles and joints started in right arm and shoulder went to hip then went to left arm and shoulder and left hip. Still have it on my left side.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Skin haemorrhage
Clinical narrative: Sore muscles and joints started in right arm and shoulder went to hip then went to left arm and shoulder and left hip. Still have it on my left side.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Sore muscles and joints started in right arm and shoulder went to hip then went to left arm and shoulder and left hip. Still have it on my left side.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Sore muscles and joints started in right arm and shoulder went to hip then went to left arm and shoulder and left hip. Still have it on my left side.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Impaired work ability, Injected limb mobility decreased
Clinical narrative: Minimal pain at time of injection (8pm 7/17/2018). Worsening pain over the next 3 hours. The pain radiated down the injection arm into her wrist, around the circumference of her arm, and up into her shoulder and neck. At 11pm 7/17/2018, pt had extreme myalgia over entire body and weakness (she described as way more severe pain than she ever got while sick with the flu). In the morning her pain was as severe and she had become extremely weak. She couldn't lift her arms and had severe fatigue after only 5 minutes exertion. She was unable to go to work (fitness trainer). She called us at 3 pm. We told her the pain and weakness is a normal reaction especially for her age group but it was our opinion that the degree of her pain and weakness may have exceeded a norml outcome. We attempted to reach her Primary care physician but he was on vacation. Patient also called Dr. We encouraged her that if the pain were to worsen more, her weakness progress further, or she has problems breathing, she should immediately call 911. I followed up with the patient tonight and she said the pain had improved slightly but she was still as weak. She reports no systemic fever and no local redness, warmth or swelling at the sight of the injection.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: Minimal pain at time of injection (8pm 7/17/2018). Worsening pain over the next 3 hours. The pain radiated down the injection arm into her wrist, around the circumference of her arm, and up into her shoulder and neck. At 11pm 7/17/2018, pt had extreme myalgia over entire body and weakness (she described as way more severe pain than she ever got while sick with the flu). In the morning her pain was as severe and she had become extremely weak. She couldn't lift her arms and had severe fatigue after only 5 minutes exertion. She was unable to go to work (fitness trainer). She called us at 3 pm. We told her the pain and weakness is a normal reaction especially for her age group but it was our opinion that the degree of her pain and weakness may have exceeded a norml outcome. We attempted to reach her Primary care physician but he was on vacation. Patient also called Dr. We encouraged her that if the pain were to worsen more, her weakness progress further, or she has problems breathing, she should immediately call 911. I followed up with the patient tonight and she said the pain had improved slightly but she was still as weak. She reports no systemic fever and no local redness, warmth or swelling at the sight of the injection.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site reaction, Urticaria
Clinical narrative: Patient experienced a headache and a raised welt that formed around the site of injection. Patient feels fatigued.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Autism spectrum disorder, Developmental regression, Mental impairment
Clinical narrative: Ceased and regressed in all developmental milestones including speech, walking, toilet training and showed obvious signs of lacking simple comprehension. Advised by healthcare provider that original records of 2nd dose administration were lost and that receiving a third posed no risk to the child.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 7 month old female patient. There were no illnesses at the time of vaccination. Medical history, historical or concomitant drugs were not reported. The reporter informed that on 26-JUN-2018, the patient was vaccinated with improperly stored doses of PEDVAXHIB Injection, dose 3, intramuscular in the left thigh, lot # R000877, expiration date 24-SEP-2020; ROTATEQ liquid, dose 3, oral, lot # N024294, expiration date 26-FEB-2019; PEDIARIX dose 2, intramuscular in the left thigh, lot # 33P194 (expiration date not reported); and PREVENAR 13 dose 3, intramuscular in the right thigh, lot # T81219 (expiration date not reported); all for prophylaxis. The nurse stated that the refrigerator door was left slightly open. The doses were exposed to a temperature of 52.1 F for 1 hour and 25 minutes. There was no previous temperature excursion, and this call was not made because of a digital data logger.
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant concerning a female patient of unknown age. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 09-JUL-2018, the patient was vaccinated with a dose of improperly stored (wistar ra 27-3) -M-R II lot # R002930 and expiration date of 30-JAN-2019, subcutaneously (anatomical location was not reported) for prophylaxis, which was stored in the range of 73.9 Fahrenheit degrees for 17.5 hours. The vaccine was reconstituted with properly stored sterile diluent(manufacturer unknown) (lot # unknown). No previous temperature excursion was reported.  No adverse effects were reported. Digital data logger was involved.
Sex: U
Vaccine: HPV9
Symptoms: Device leakage, Drug dose omission, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not reported. On an unknown date, the patient was going to be vaccinated with the first dose of GARDASIL 9 lot # reported as M03548 with expiration date 31-MAY-2020, for prophylaxis (frequency and route were not reported), but its vial was leaking from the rubber stopper so the medical assistant attempted to draw the solution but it was not enough for a 0.5 ml dose. Consequently, the patient missed the first dose of GARDASIL 9. No adverse effects were reported. Lot number M03548 is an invalid lot number for GARDASIL 9.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product use issue
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On multiple unspecified dates, the patients were vaccinated with recalled GARDASIL 9 lot # N029069 and expiration date 17-MAY-2020 for prophylaxis (dose, strength, frequency, and route of administration were unknown). It was reported that the patients did not experience any adverse effects.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a 12 month old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an adult dose of VAQTA 50/1.0 U/ml (1 unspecified dose, route, lot# and expiration date unknown) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2015, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 10-FEB-2015, the patient was treated at a physician office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term 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, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 05-JAN-2016, the patient was inoculated with the ZOSTAVAX vaccine at a clinic as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 30-JAN-2016, the patient was treated at a clinic for a rash diagnosed as herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term 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, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with a dose of the improperly stored GARDASIL 9 (lot # N021475) (expiry date: 31-JAN-2020), intramuscularly for prophylaxis (dosage details were not reported) (incorrect product storage). This vaccine underwent a temperature excursion of 29 degree Fahrenheit (F) for a time frame of 168 hours. There was a previous temperature excursion of 47 degree F to 77 degree F for a time frame of 21.5 hours. No known adverse effects were reported. A data logger was involved. No product quality complaint (PQC) was involved.
Age: 87.0
Sex: F
Vaccine: FLUX
Symptoms: Blood potassium decreased, Chest X-ray normal, Cholecystitis, Cholecystitis infective, Computerised tomogram head normal
Clinical narrative: Initial solicited report received on 18 September 2017 and follow up information received on 19 September 2017 from an investigator participating in the below mentioned study. This case involves an 87-year-old female subject who had seizure secondary to low potassium during the study participation. It was reported that there was no medical history to report. Subject received concomitant therapies of paracetamol (Tylenol) orally for osteoarthritis from 2015 (ongoing),  levofloxacin (Levaquin) orally for inflamed gall bladder from 17 September 2017 to an unknown date and metronidazole (Flagyl) orally for inflamed gall bladder from 17 September 2017 to an unknown date. On 17 September 2017, 09 days after receiving a first intramuscular dose of blinded therapy in the right arm (upper) on 08 September 2017, the subject had seizure secondary to low potassium. The event appeared after visit 01. As per subject report, subject experienced a seizure shortly after hospitalization for gallbladder infection. She was told her potassium was low at discharge and was advised to eat bananas, which she had been doing. She felt flat on her back during the seizure and hit her head. Records have not yet been received for this event. Maximum intensity considering the entire AE duration was reported as Grade 03. The subject's weight was 145.0 lb (65.77kg). Lab investigation included subject underwent cat scan of head which was negative for abnormalities, right elbow x-ray, also negative, and negative chest x-ray, initial labs showed mild hyponatremia, otherwise unremarkable. The subject's corrective treatment details were not reported. The event seizure secondary to low potassium was resolved on 17 September 2017. The subject was discharged from the hospital on 19 September 2017. According to the investigator, the event was not related to concomitant therapy, study vaccine or trial procedures. Relationship to investigational product according to company: not reportable. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow up information received on 26 April 2018. Concomitant medication was updated. Sae narrative was updated. Lab data was updated. Corrective treatment was updated. Discharge date was updated. (previously reported as 17 September 2017). Follow-up information received on 16 May 2018; Database lock: Study unblinded on 16 May 2018: INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (TIV-HD2).; Sender's Comments: Follow-up information received on 26 April 2018 does not change the previous medical assessment. An 87-year-old female subject had seizure secondary to low potassium, nine days after receiving a dose of study product. Based on available information, the sponsor assesses the event as not related to study product or trial procedure, in agreement with the investigator.
Age: 87.0
Sex: F
Vaccine: FLUX
Symptoms: Fall, Head injury, Hyponatraemia, Seizure, X-ray limb normal
Clinical narrative: Initial solicited report received on 18 September 2017 and follow up information received on 19 September 2017 from an investigator participating in the below mentioned study. This case involves an 87-year-old female subject who had seizure secondary to low potassium during the study participation. It was reported that there was no medical history to report. Subject received concomitant therapies of paracetamol (Tylenol) orally for osteoarthritis from 2015 (ongoing),  levofloxacin (Levaquin) orally for inflamed gall bladder from 17 September 2017 to an unknown date and metronidazole (Flagyl) orally for inflamed gall bladder from 17 September 2017 to an unknown date. On 17 September 2017, 09 days after receiving a first intramuscular dose of blinded therapy in the right arm (upper) on 08 September 2017, the subject had seizure secondary to low potassium. The event appeared after visit 01. As per subject report, subject experienced a seizure shortly after hospitalization for gallbladder infection. She was told her potassium was low at discharge and was advised to eat bananas, which she had been doing. She felt flat on her back during the seizure and hit her head. Records have not yet been received for this event. Maximum intensity considering the entire AE duration was reported as Grade 03. The subject's weight was 145.0 lb (65.77kg). Lab investigation included subject underwent cat scan of head which was negative for abnormalities, right elbow x-ray, also negative, and negative chest x-ray, initial labs showed mild hyponatremia, otherwise unremarkable. The subject's corrective treatment details were not reported. The event seizure secondary to low potassium was resolved on 17 September 2017. The subject was discharged from the hospital on 19 September 2017. According to the investigator, the event was not related to concomitant therapy, study vaccine or trial procedures. Relationship to investigational product according to company: not reportable. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow up information received on 26 April 2018. Concomitant medication was updated. Sae narrative was updated. Lab data was updated. Corrective treatment was updated. Discharge date was updated. (previously reported as 17 September 2017). Follow-up information received on 16 May 2018; Database lock: Study unblinded on 16 May 2018: INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (TIV-HD2).; Sender's Comments: Follow-up information received on 26 April 2018 does not change the previous medical assessment. An 87-year-old female subject had seizure secondary to low potassium, nine days after receiving a dose of study product. Based on available information, the sponsor assesses the event as not related to study product or trial procedure, in agreement with the investigator.
Age: 0.42
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Mass
Clinical narrative: Red lump about quarter sized. Still has lump under skin (6 days later today).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Myalgia, Nausea, Tenderness
Clinical narrative: Severe shivering, sweats, nausea, muscle aches and skin hurts to touch.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Depressed level of consciousness, Flushing
Clinical narrative: Patient turned flushed and was about to pass out.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Warm redness on chest and front of torso. This was the 2nd of the 2-shot series. I experience this reaction both times.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood pressure increased, Body temperature decreased, Diarrhoea, Gait disturbance
Clinical narrative: In order- severe diarrhea, weakness, needed help of another to walk, tremor due to body temperature decrease to 97.0 degrees, BP increase to 168/80, HR increase to 90. Events from 3PM to 7PM
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Tremor
Clinical narrative: In order- severe diarrhea, weakness, needed help of another to walk, tremor due to body temperature decrease to 97.0 degrees, BP increase to 168/80, HR increase to 90. Events from 3PM to 7PM
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-JAN-2014, the patient was inoculated with the ZOSTAVAX vaccine at a health department as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On 13-JUN-2016, the patient was treated by a physician for the onset herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term 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, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.