chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: I ORIGINALLY FILLED OUT THIS FORM ON 12/26/17 WHEN THE PATIENT ORIGINALLY CAME TO THE PHARMACY TO COMPLAIN OF THE PAIN IN HER ARM. I DID NOT FILL IN MY EMAIL OR ADDRESS AND THE FORM COULD NOT BE COMPLETED, SO WHEN I CALLED, I WAS ADVISED TO FILL OUT AGAIN SO THAT THE TWO FORMS COULD BE LINKED. Patient came in on 12/26/2017 complaining of pain in her arm that she believed was due to her pneumonia shot that she received on 8/28/2017. She said her Dr has been treating her with NSAIDS but the pain has not gotten better and she was going to go for an MRI. I asked her if her Dr believed it was due to her vaccine and she did not say yes or no. I let her know to follow up with me if her Dr decided that the vaccine was the cause and we could go from there. As of this report on 3/21/18 I have not heard either way about the official diagnosis either but I do know that she is still experiencing pain in her arm.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Fatigue, Neuropathy peripheral
Clinical narrative: Customer experience extremely fatigue and tiredness, out of breath and very light headed, neuropathy getting worse.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Pain and redness at injection site, low-grade fever, "flu-like symptoms" for approximately 72 hours.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Myalgia, Peripheral swelling, Pyrexia, Ultrasound scan
Clinical narrative: Extreme pain in leg muscles, swelling of calves and feet, fever of 100.2. Pain relief with TYLENOL 500 mg 3xD. Very slowly getting better.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Bursitis, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: I got the second dose of the HPV vaccine injected in my right arm in October, 2017. The nurse informed me that the injection site may be sore for up to a week. I experienced pain at the injection site immediately after the injection, but I expected that and thought nothing of it. After one week had passed, my arm was still very sore but and painful but I thought that was normal. The pain continued to worsen and become more intense as time passed. Two weeks after the injection I decided to go get my arm checked out because the pain had never subsided and was quite intense. It was difficult and painful to move my right arm, and this worsened by the day. Despite this, the provider who examined my arm at Brown University Health Services on Nov. 16, 2017 said that my pain was probably unrelated to the shot and should resolve on its own. After a couple of more weeks, my arm was extremely painful and preventing me from sleeping (I sleep on my right side), it was very difficult to lift things with my right arm, and my range of motion was even more limited. I decided to go see a physical therapist (PT) to see if my symptoms could be relieved. After examining me and collecting my history, my physical therapist felt very strongly that the HPV injection had somehow irritated my shoulder and was causing my symptoms. I have been going to PT weekly since Nov. 26, 2017 to address the injury associated with the vaccination. PT has helped to improve my symptoms; the pain in my right shoulder is less severe than before, and I have regained most of my range of motion in my right arm. However, the issue has not been completely resolved, and the pain in my shoulder still limits me in some activities and household chores. After having been in PT for about three and a half months and still not resolving my symptoms completely. My PT referred me to an orthopedist for an evaluation. I saw the orthopedist on March 16, 2018; the doctor diagnosed me with bursitis in the right shoulder and felt very confident that the vaccination I received in October, 2017 was the cause. The orthopedist gave me a cortisone injection in my right shoulder to try to alleviate the bursitis and my symptoms and instructed me to follow-up in four weeks. As of today, March 21, 2018 I am still experiencing pain in my right shoulder.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: I got the second dose of the HPV vaccine injected in my right arm in October, 2017. The nurse informed me that the injection site may be sore for up to a week. I experienced pain at the injection site immediately after the injection, but I expected that and thought nothing of it. After one week had passed, my arm was still very sore but and painful but I thought that was normal. The pain continued to worsen and become more intense as time passed. Two weeks after the injection I decided to go get my arm checked out because the pain had never subsided and was quite intense. It was difficult and painful to move my right arm, and this worsened by the day. Despite this, the provider who examined my arm at Brown University Health Services on Nov. 16, 2017 said that my pain was probably unrelated to the shot and should resolve on its own. After a couple of more weeks, my arm was extremely painful and preventing me from sleeping (I sleep on my right side), it was very difficult to lift things with my right arm, and my range of motion was even more limited. I decided to go see a physical therapist (PT) to see if my symptoms could be relieved. After examining me and collecting my history, my physical therapist felt very strongly that the HPV injection had somehow irritated my shoulder and was causing my symptoms. I have been going to PT weekly since Nov. 26, 2017 to address the injury associated with the vaccination. PT has helped to improve my symptoms; the pain in my right shoulder is less severe than before, and I have regained most of my range of motion in my right arm. However, the issue has not been completely resolved, and the pain in my shoulder still limits me in some activities and household chores. After having been in PT for about three and a half months and still not resolving my symptoms completely. My PT referred me to an orthopedist for an evaluation. I saw the orthopedist on March 16, 2018; the doctor diagnosed me with bursitis in the right shoulder and felt very confident that the vaccination I received in October, 2017 was the cause. The orthopedist gave me a cortisone injection in my right shoulder to try to alleviate the bursitis and my symptoms and instructed me to follow-up in four weeks. As of today, March 21, 2018 I am still experiencing pain in my right shoulder.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Gout, Pain in extremity, Peripheral swelling
Clinical narrative: SWOLLEN AND PAINFUL LEFT THUMB JOINT. PATIENT WENT TO DOCTOR & WAS DIAGNOSED WITH GOUT IN THAT JOINT.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient picked up cephalexin yesterday from the pharmacy. He stated that his hand had been swollen since he received the vaccine. I spoke to him and his wife a few times after the vaccine was given, and that was the first time his hand being swollen was ever mentioned.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Red, swollen, painful infection sight reaction within 24 hours. Hives on upper body and neck within 48 hours lasting greater than one week.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Patient stated she developed a headache the morning after vaccination on 3/20/18. According to the patient, this progressed to body aches and fever of 102 degrees F. Fever broke the morning of 3/21/18.
Age: 28.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test negative
Clinical narrative: Pregnancy test negative at time of administration, recently found out pregnant. EDD 12NOV2018. No specific adverse event. Needs to be added to registry for Anthrax and Smallpox vaccination in a pregnant patient.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site rash, Myalgia, Pyrexia, Tenderness
Clinical narrative: Patient had a rash starting at the site of the injection down at the elbow area, fever, muscle pain and tenderness by the collar bone.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a rash starting at the site of the injection down at the elbow area, fever, muscle pain and tenderness by the collar bone.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Lymph node pain, Rash erythematous, Rash macular, Rash vesicular
Clinical narrative: Patient had a rash starting at the site of the injection down at the elbow area, fever, muscle pain and tenderness by the collar bone.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site indentation, Injection site pain, Injection site reaction, Muscular weakness, Myalgia
Clinical narrative: Patient states approximately 1 month following vaccination she is still having muscle pain/soreness/weakness in her deltoid and has a small indention where the vaccine was administered.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Balance disorder, Deafness unilateral, Fatigue
Clinical narrative: Area of inflammation in upper left arm, where vaccination was given, oval in shape measuring 6 cm x 8 cm of about 1 cm in height. Severe myalgia throughout my body for the duration of the day into the night. Severe malaise. Severe fatigue. Mild weakness. Mild abdominal pain. Mild disequilibrium. In short I felt like I was coming down with the flu. There was a short lived low grade fever of 99.9 F for about 4 hours of same day. I woke in the morning of 03-21-18 with hearing loss in my right ear with exacerbated tinnitus. All symptoms except inflammation at injection sight and exacerbation of tinnitus resolved by late afternoon of 03-21-18.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Myalgia, Pyrexia, Tinnitus
Clinical narrative: Area of inflammation in upper left arm, where vaccination was given, oval in shape measuring 6 cm x 8 cm of about 1 cm in height. Severe myalgia throughout my body for the duration of the day into the night. Severe malaise. Severe fatigue. Mild weakness. Mild abdominal pain. Mild disequilibrium. In short I felt like I was coming down with the flu. There was a short lived low grade fever of 99.9 F for about 4 hours of same day. I woke in the morning of 03-21-18 with hearing loss in my right ear with exacerbated tinnitus. All symptoms except inflammation at injection sight and exacerbation of tinnitus resolved by late afternoon of 03-21-18.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site inflammation
Clinical narrative: Area of inflammation in upper left arm, where vaccination was given, oval in shape measuring 6 cm x 8 cm of about 1 cm in height. Severe myalgia throughout my body for the duration of the day into the night. Severe malaise. Severe fatigue. Mild weakness. Mild abdominal pain. Mild disequilibrium. In short I felt like I was coming down with the flu. There was a short lived low grade fever of 99.9 F for about 4 hours of same day. I woke in the morning of 03-21-18 with hearing loss in my right ear with exacerbated tinnitus. All symptoms except inflammation at injection sight and exacerbation of tinnitus resolved by late afternoon of 03-21-18.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Fatigue, Headache, Malaise
Clinical narrative: Severe sore throat, chills, cough, severe mucus, aches, headache, fatigue 11/4/2017 for about a week. Milder symptoms about 1/20/2018 for about a week: main complaint is severe sore throat for about a week. Been ill again starting 3/7/2018 and continue to be ill today: main complaint is bad cough.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Secretion discharge
Clinical narrative: Severe sore throat, chills, cough, severe mucus, aches, headache, fatigue 11/4/2017 for about a week. Milder symptoms about 1/20/2018 for about a week: main complaint is severe sore throat for about a week. Been ill again starting 3/7/2018 and continue to be ill today: main complaint is bad cough.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: fever, body aches, head ache, nausea.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The patient called approximately 24 hours after receiving the vaccination complaining of moderate pain, redness, and warmth at and around the injection site. The patient also complained of headache. Patient denied signs/symptoms of anaphylaxis upon further questioning by the pharmacist. The Pharmacist recommended using a cold compress and taking TYLENOL for the pain and discomfort.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: Immediately after vaccine administration, pt. broke out in hives on face, abdomen, back, legs. Stayed in office for 30 min. after the vaccines given, hives began to dissipate.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Swelling
Clinical narrative: Started swelling Wednesday night 3-14-18 got worse until 3/20 started getting better. She thought it was a normal side effect - had chills and HA.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Folliculitis, Rash papular, Rash pruritic, Urticaria
Clinical narrative: Patient developed urticaria within a few hours of getting the 2nd TRUMENBA vaccine. The urticaria resolved after a few days. The patient then developed an itchy papular rash that looks like folliculitis.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt presented 03/20/18, with reports of a reaction to PCV 13 vaccine, given 03/14/18 reports has been getting worse, site: left deltoid, red, warm and raised to about the size of a baseball, soft. Doxycycline 100 mg for 14 days prescribed, Ibuprofen 600 mg three times a day for pain, also recommended, application of ice pack off and on every 2 hours for 24 hours, pt to return in 1 week for re-evaluation.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash maculo-papular
Clinical narrative: X1 day macular popular lesions, mild erythema, no itching, no CP no SOB.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Device breakage, Haemorrhage, Immediate post-injection reaction, Laceration, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hemorrhage in a 23-year-old female patient who received MENVEO (batch number M17002, expiry date October 2018) and (batch number X17002, expiry date January 2020). On 13th March 2018, the patient received MENVEO. On an unknown date, the dose was an unknown dose. On 13th March 2018, immediately after receiving MENVEO, the patient experienced hemorrhage (serious criteria GSK medically significant), laceration and pain. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the hemorrhage was recovered/resolved and the outcome of the laceration and pain were not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown. The reporter considered the hemorrhage, laceration and pain to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The call was transferred from the GSK Vaccine Service Center. A nurse from the physician office reports that yesterday on 13th March 2018 a different nurse who was experienced with MENVEO was preparing the product for administration. When that nurse attempted to withdraw the MenCYW-135 liquid conjugate component from its vial, she was unable to withdraw any product into the tuberculin syringe with 5/8ths by 25 inch needle. She then looked to realize there was no product to withdraw because the vial's bottom was broken. She also realized she was bleeding and that her left hand's middle upper finger had been cut by the vial. She removed a little piece of glass out of the cut too. The physician examined her finger to see if it needed stitches because it would not stop bleeding, and the physician decided the cut did not require stitches. Pressure was applied to the cut and it was elevated for about 15 or 20 minutes and then a band-aid was applied. She did not know exactly when it stopped bleeding. She removed the Band-Aid about 9 o'clock last night. The band aid was full of blood, but the cut had stopped bleeding by that time. The cut was today covered with a Band-Aid and was still painful upon touch. She had not required any pain medication for the pain. There were pieces of broken glass in the bottom of the box, so the reporter said that the vial had broken inside its product box. Looking from the top, the vial had first appeared normal. But it was spiky near where part of the bottom had broken off. The product as well as the glass inside the product box was discarded already into the sharps container. The product was not administered. It was stored in the refrigerator. The reporter also provided a lot number of X17002 and expiration date of 01/2020 from one of the other MenCYW-135 component vials within the box. Related QA notes continued: Credit for one dose status pending callback from reporter. The physician examined the cut. The lot number above was from the product box.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Product quality issue, Tenderness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hemorrhage in a 23-year-old female patient who received MENVEO (batch number M17002, expiry date October 2018) and (batch number X17002, expiry date January 2020). On 13th March 2018, the patient received MENVEO. On an unknown date, the dose was an unknown dose. On 13th March 2018, immediately after receiving MENVEO, the patient experienced hemorrhage (serious criteria GSK medically significant), laceration and pain. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the hemorrhage was recovered/resolved and the outcome of the laceration and pain were not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown. The reporter considered the hemorrhage, laceration and pain to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The call was transferred from the GSK Vaccine Service Center. A nurse from the physician office reports that yesterday on 13th March 2018 a different nurse who was experienced with MENVEO was preparing the product for administration. When that nurse attempted to withdraw the MenCYW-135 liquid conjugate component from its vial, she was unable to withdraw any product into the tuberculin syringe with 5/8ths by 25 inch needle. She then looked to realize there was no product to withdraw because the vial's bottom was broken. She also realized she was bleeding and that her left hand's middle upper finger had been cut by the vial. She removed a little piece of glass out of the cut too. The physician examined her finger to see if it needed stitches because it would not stop bleeding, and the physician decided the cut did not require stitches. Pressure was applied to the cut and it was elevated for about 15 or 20 minutes and then a band-aid was applied. She did not know exactly when it stopped bleeding. She removed the Band-Aid about 9 o'clock last night. The band aid was full of blood, but the cut had stopped bleeding by that time. The cut was today covered with a Band-Aid and was still painful upon touch. She had not required any pain medication for the pain. There were pieces of broken glass in the bottom of the box, so the reporter said that the vial had broken inside its product box. Looking from the top, the vial had first appeared normal. But it was spiky near where part of the bottom had broken off. The product as well as the glass inside the product box was discarded already into the sharps container. The product was not administered. It was stored in the refrigerator. The reporter also provided a lot number of X17002 and expiration date of 01/2020 from one of the other MenCYW-135 component vials within the box. Related QA notes continued: Credit for one dose status pending callback from reporter. The physician examined the cut. The lot number above was from the product box.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Headache, Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site induration in a 71-year-old female patient who received SHINGRIX. The patient's past medical history included biopsy (showed Grover's lichenoid dermatitis). Previously administered products included CHLOR-TRIMETON (did not tolerate BENADRYL). Concurrent medical conditions included rash (a chronic waxing and waning rash), mast cell activation syndrome, dermatitis lichenoid, drug hypersensitivity (allergy to CELEBREX, CIPRO, sulfa) and bee sting. On 7th March 2018, the patient received SHINGRIX. On 7th March 2018, 5 hrs after receiving SHINGRIX, the patient experienced headache and nausea. In March 2018, less than a week after receiving SHINGRIX, the patient experienced injection site induration, injection site erythema, injection site pain, injection site inflammation and emotional distress. On an unknown date, the outcome of the injection site induration, injection site erythema, injection site pain, injection site inflammation and emotional distress were unknown and the outcome of the headache and nausea were recovered/resolved. It was unknown if the reporter considered the injection site induration, injection site erythema, injection site pain, injection site inflammation, headache, nausea and emotional distress to be related to SHINGRIX. Additional details were provided as follows: This information was submitted to afterhours via web form. The patient had bad headache and nausea in evening on the day of vaccination (that were better next morning), and pain and erythema and induration (2 by 4 cm) surrounding the injection site. It looked minor to physician, but the patient found with the inflammation badly painful and very upsetting. The patient was on a number of medications. The patient's tryptase was abnormal, then normalized. The physician suggested the patient to take alternate ice and local heat. The physician saw a historical conditions and local rash were in the label as common adverse effects. The physician considered it minor and unremarkable, but the patient considered it as painful and a problem. The patient wanted to proceed with the 2nd shot, as she was very afraid of developing shingles. The physician advised her to wait the full 6 months, in part for there to be more clinical experience with SHINGRIX. GlaxoSmithKline was yet to speak with healthcare professional. The office was called, but it was closed. Follow up would be done and the report would be updated.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Tryptase
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site induration in a 71-year-old female patient who received SHINGRIX. The patient's past medical history included biopsy (showed Grover's lichenoid dermatitis). Previously administered products included CHLOR-TRIMETON (did not tolerate BENADRYL). Concurrent medical conditions included rash (a chronic waxing and waning rash), mast cell activation syndrome, dermatitis lichenoid, drug hypersensitivity (allergy to CELEBREX, CIPRO, sulfa) and bee sting. On 7th March 2018, the patient received SHINGRIX. On 7th March 2018, 5 hrs after receiving SHINGRIX, the patient experienced headache and nausea. In March 2018, less than a week after receiving SHINGRIX, the patient experienced injection site induration, injection site erythema, injection site pain, injection site inflammation and emotional distress. On an unknown date, the outcome of the injection site induration, injection site erythema, injection site pain, injection site inflammation and emotional distress were unknown and the outcome of the headache and nausea were recovered/resolved. It was unknown if the reporter considered the injection site induration, injection site erythema, injection site pain, injection site inflammation, headache, nausea and emotional distress to be related to SHINGRIX. Additional details were provided as follows: This information was submitted to afterhours via web form. The patient had bad headache and nausea in evening on the day of vaccination (that were better next morning), and pain and erythema and induration (2 by 4 cm) surrounding the injection site. It looked minor to physician, but the patient found with the inflammation badly painful and very upsetting. The patient was on a number of medications. The patient's tryptase was abnormal, then normalized. The physician suggested the patient to take alternate ice and local heat. The physician saw a historical conditions and local rash were in the label as common adverse effects. The physician considered it minor and unremarkable, but the patient considered it as painful and a problem. The patient wanted to proceed with the 2nd shot, as she was very afraid of developing shingles. The physician advised her to wait the full 6 months, in part for there to be more clinical experience with SHINGRIX. GlaxoSmithKline was yet to speak with healthcare professional. The office was called, but it was closed. Follow up would be done and the report would be updated.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Influenza virus test negative, Pain, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a 66 year old female patient referring to herself. The patient did not have any known pertinent medical history, allergies or reactions. Concomitant medications included tamoxifen, clonazepam and acyclovir. On 14-FEB-2018 at 16:30 hours, the patient was vaccinated with PNEUMOVAX 23 via intramuscular or subcutaneous route in the Left deltoid for prophylaxis (lot # reported as 24385, expiration date 31-MAY-2019) (dosage schedule was not reported). Less than 24 hours after vaccination, the patient stated that the "left deltoid" started becoming "redden" and "got swollen measuring 5 inches to 5 1/2 inches from the elbow to shoulder" (vaccination site erythema and vaccination site swelling). The patient started using BENADRYL roughly 24 hours after seeing the previously reported reactions. On 15-FEB-2018 at 01:00 hours, the patient experienced chills, pain and "flu like symptoms" and could not go back to sleep. The patient stated she had a "low fever never going over 101 degrees and would fluctuate with TYLENOL". Additionally, in February 2018, the patient experienced a "knot" under the injection site of her "left deltoid". On 16-FEB-2018, the patient still had, "flu like symptoms" but by night of the same day, the patient "was feeling better". By the morning of 17-FEB-2018, the patient stated that, "all symptoms minus the redness of the arm were gone". Also, the patient visited the doctor in February 2018 and they did a "nose swab for the flu", the results came back negative on 19-FEB-2018. The outcome of vaccination site erythema and injection site nodule was reported as not recovered. The outcome of vaccination site swelling was reported as recovered. The outcome of insomnia and influenza like illness was reported as recovered. The causal relationship between the events and therapy with PNEUMOVAX 23 was not reported. Lot number 24385 is an invalid lot number for PNEUMOVAX 23.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a 66 year old female patient referring to herself. The patient did not have any known pertinent medical history, allergies or reactions. Concomitant medications included tamoxifen, clonazepam and acyclovir. On 14-FEB-2018 at 16:30 hours, the patient was vaccinated with PNEUMOVAX 23 via intramuscular or subcutaneous route in the Left deltoid for prophylaxis (lot # reported as 24385, expiration date 31-MAY-2019) (dosage schedule was not reported). Less than 24 hours after vaccination, the patient stated that the "left deltoid" started becoming "redden" and "got swollen measuring 5 inches to 5 1/2 inches from the elbow to shoulder" (vaccination site erythema and vaccination site swelling). The patient started using BENADRYL roughly 24 hours after seeing the previously reported reactions. On 15-FEB-2018 at 01:00 hours, the patient experienced chills, pain and "flu like symptoms" and could not go back to sleep. The patient stated she had a "low fever never going over 101 degrees and would fluctuate with TYLENOL". Additionally, in February 2018, the patient experienced a "knot" under the injection site of her "left deltoid". On 16-FEB-2018, the patient still had, "flu like symptoms" but by night of the same day, the patient "was feeling better". By the morning of 17-FEB-2018, the patient stated that, "all symptoms minus the redness of the arm were gone". Also, the patient visited the doctor in February 2018 and they did a "nose swab for the flu", the results came back negative on 19-FEB-2018. The outcome of vaccination site erythema and injection site nodule was reported as not recovered. The outcome of vaccination site swelling was reported as recovered. The outcome of insomnia and influenza like illness was reported as recovered. The causal relationship between the events and therapy with PNEUMOVAX 23 was not reported. Lot number 24385 is an invalid lot number for PNEUMOVAX 23.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Influenza like illness, Influenza virus test negative, Injection site erythema, Injection site nodule
Clinical narrative: This spontaneous report was received from a 66 year old female patient referring to herself. The patient did not have any known pertinent medical history, allergies or reactions. Concomitant medications included tamoxifen, clonazepam and acyclovir. On 14-FEB-2018 at 16:30 hours, the patient was vaccinated with PNEUMOVAX 23 via intramuscular or subcutaneous route in the Left deltoid for prophylaxis (lot # reported as 24385, expiration date 31-MAY-2019) (dosage schedule was not reported). Less than 24 hours after vaccination, the patient stated that the "left deltoid" started becoming "redden" and "got swollen measuring 5 inches to 5 1/2 inches from the elbow to shoulder" (vaccination site erythema and vaccination site swelling). The patient started using BENADRYL roughly 24 hours after seeing the previously reported reactions. On 15-FEB-2018 at 01:00 hours, the patient experienced chills, pain and "flu like symptoms" and could not go back to sleep. The patient stated she had a "low fever never going over 101 degrees and would fluctuate with TYLENOL". Additionally, in February 2018, the patient experienced a "knot" under the injection site of her "left deltoid". On 16-FEB-2018, the patient still had, "flu like symptoms" but by night of the same day, the patient "was feeling better". By the morning of 17-FEB-2018, the patient stated that, "all symptoms minus the redness of the arm were gone". Also, the patient visited the doctor in February 2018 and they did a "nose swab for the flu", the results came back negative on 19-FEB-2018. The outcome of vaccination site erythema and injection site nodule was reported as not recovered. The outcome of vaccination site swelling was reported as recovered. The outcome of insomnia and influenza like illness was reported as recovered. The causal relationship between the events and therapy with PNEUMOVAX 23 was not reported. Lot number 24385 is an invalid lot number for PNEUMOVAX 23.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a 66 year old female patient referring to herself. The patient did not have any known pertinent medical history, allergies or reactions. Concomitant medications included tamoxifen, clonazepam and acyclovir. On 14-FEB-2018 at 16:30 hours, the patient was vaccinated with PNEUMOVAX 23 via intramuscular or subcutaneous route in the Left deltoid for prophylaxis (lot # reported as 24385, expiration date 31-MAY-2019) (dosage schedule was not reported). Less than 24 hours after vaccination, the patient stated that the "left deltoid" started becoming "redden" and "got swollen measuring 5 inches to 5 1/2 inches from the elbow to shoulder" (vaccination site erythema and vaccination site swelling). The patient started using BENADRYL roughly 24 hours after seeing the previously reported reactions. On 15-FEB-2018 at 01:00 hours, the patient experienced chills, pain and "flu like symptoms" and could not go back to sleep. The patient stated she had a "low fever never going over 101 degrees and would fluctuate with TYLENOL". Additionally, in February 2018, the patient experienced a "knot" under the injection site of her "left deltoid". On 16-FEB-2018, the patient still had, "flu like symptoms" but by night of the same day, the patient "was feeling better". By the morning of 17-FEB-2018, the patient stated that, "all symptoms minus the redness of the arm were gone". Also, the patient visited the doctor in February 2018 and they did a "nose swab for the flu", the results came back negative on 19-FEB-2018. The outcome of vaccination site erythema and injection site nodule was reported as not recovered. The outcome of vaccination site swelling was reported as recovered. The outcome of insomnia and influenza like illness was reported as recovered. The causal relationship between the events and therapy with PNEUMOVAX 23 was not reported. Lot number 24385 is an invalid lot number for PNEUMOVAX 23.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Influenza virus test negative, Pyrexia, Vomiting
Clinical narrative: Patient got SHINGRIX vaccine and six hours post vaccine was running a fever of 103 degrees and started to vomit without being able to stop. Patient went to emergency room and received fluids.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site rash, Myalgia, Pyrexia, Tenderness
Clinical narrative: Very painful, red, hot swollen arm on the site of injection, but more on the front of my arm. Red, swollen, and blotchy rash with almost a blister appearing on the front of the affected arm extending to my elbow. Other symptoms included painful nodes in axilla and collar bone area and a flu-like feeling of illness. Symptoms appearing to begin subsiding on day three, but rash and swelling still evident, although less. FYI I also received PNEUMOVAX 23 in the same arm at the same time. Never had any adverse reactions to any vaccine in my life.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Very painful, red, hot swollen arm on the site of injection, but more on the front of my arm. Red, swollen, and blotchy rash with almost a blister appearing on the front of the affected arm extending to my elbow. Other symptoms included painful nodes in axilla and collar bone area and a flu-like feeling of illness. Symptoms appearing to begin subsiding on day three, but rash and swelling still evident, although less. FYI I also received PNEUMOVAX 23 in the same arm at the same time. Never had any adverse reactions to any vaccine in my life.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Lymph node pain, Rash erythematous, Rash macular, Rash vesicular
Clinical narrative: Very painful, red, hot swollen arm on the site of injection, but more on the front of my arm. Red, swollen, and blotchy rash with almost a blister appearing on the front of the affected arm extending to my elbow. Other symptoms included painful nodes in axilla and collar bone area and a flu-like feeling of illness. Symptoms appearing to begin subsiding on day three, but rash and swelling still evident, although less. FYI I also received PNEUMOVAX 23 in the same arm at the same time. Never had any adverse reactions to any vaccine in my life.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR
Symptoms: Aphasia
Clinical narrative: I received the DTaP a week before the MMR immunization. Before these immunizations I could say Mama, Dada, "dawbry dink", "I wuv u" whilst looking at my family and spending time snuggling and playing with them. Within a week after the MMR immunization, I became a blank slate. I looked only at the ground and never spoke to people other than to echo what they would say. We believe I developed encephalitis from these vaccines. I needed years of therapy to improve my speech.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Immediate post-injection reaction, Injection site pain
Clinical narrative: Chills, tiredness, injection site pain, dizziness. The injection site pain started immediately after the injection. The chills, dizziness, and tiredness happened the next morning.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Drug ineffective, Muscular weakness, Pyrexia
Clinical narrative: This spontaneous report was received from a male patient of unknown age regarding him. Historical drug, medical history, concurrent conditions, concomitant medication, drug reactions and allergies were not provided. On an unspecified date, the patient received a "brand new" Zoster Vaccine Live (manufacturer unknown) (dose, strength, frequency, lot number and expiration date were not reported) for prophylaxis. A couple of years ago (date unspecified), after receiving the original Zoster Vaccine Live (manufacturer unknown), the patient stated that he found out it was "only 50 percent effective", and that the new one that was "95 percent effective". The patient reported that he had with high fever, chills, and weak legs and weakness after receiving the new Zoster Vaccine Live (manufacturer unknown); due to the events he was bedridden all the weekend. Despite the aforementioned reactions, the patient did not regret for receiving the vaccine. The patient emphasized that vaccine was "very important", and that it was recommended for anyone 50+, and also shingles was a very painful virus. Additionally, he said that his doctor administered the vaccine to about 10 people so far, and that no one had a reaction, but that the literature said it was possible to have a reaction. He also mentioned that his dad got shingles in his face, and that was just "awful". Furthermore he mentioned that most people did not have reaction and that there was no way to abate the reaction; he took aspirin to mitigate the pain. The outcome of drug ineffective, pyrexia, asthenia, pain, muscular weakness and chills was unknown. The patient attributed to the new Zoster Vaccine Live (manufacturer unknown) to be the cause of the high fever, chills and weakness he experienced. The causal relationship between the drug ineffective, pain, and the muscular weakness with the suspect vaccine was not provided.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 15 month old male patient. The patient's pertinent medical history, drug reactions and allergies were not reported. On 13-MAR-2018, the patient was vaccinated with an expired (wistar ra 27-3) M-M-R II lot # M008588 with an expiration date 16-FEB-2018 for prophylaxis (route of administration and anatomical location were not reported). It was confirmed that sterile diluent (unknown lot number and expiration date), used for reconstitution of (wistar ra 27-3) M-M-R II was properly stored. The expired (wistar ra 27-3) M-M-R II had no temperature excursions prior to being administered. No adverse effects reported. Product quality complaint was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 09-FEB-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD with lot # N023967 (expiration date unknown)(Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis, reconstituted with MERCK STERILE DILUENT that was properly stored. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 6°F to 14°F degrees Fahrenheit for 158 hours 39 minutes and 15°F to 46°F degrees Fahrenheit for 343 hours 29 minutes. There was a digital data logger involved, but there was no previous temperature excursion. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA006483.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 16-FEB-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD with lot # N023967 (expiration date unknown)(Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis reconstituted with MERCK STERILE DILUENT that was properly stored. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 6°F to 14°F degrees Fahrenheit for 158 hours 39 minutes and 15°F to 46°F degrees Fahrenheit for 343 hours 29 minutes. There was a digital data logger involved, but there was no previous temperature excursion. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA006483.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 28-FEB-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD with lot # N023967 (expiration date unknown) (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis, reconstituted with MERCK STERILE DILUENT that was properly stored. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 6°F to 14°F degrees Fahrenheit for 158 hours 39 minutes and 15°F to 46°F degrees Fahrenheit for 343 hours 29 minutes. There was a digital data logger involved, but there was no previous temperature excursion. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistance referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided. On 14-MAR-2018, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # M036458 with expiration date of 02-MAR-2018, 0.5 ml by intramuscular route (strength and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via company representative and refers to a female patient in her 20's. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 19-MAR-2018, the patient was vaccinated with an expired dose of (wistar ra 27-3) M-M-R II lot number M011666 with expiration date on 08-MAR-2018, it was stated that the dose dose was expired by 9 days (strength , dose, route of administration and anatomical location were not reported) for prophylaxis. Additionally, it was reported that on 19-MAR-2018, the patient received a tuberculin skin test, no results were provided and no adverse effects were reported.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Mobility decreased, Motor dysfunction
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 67 year old male patient with diabetes mellitus, chronic obstructive pulmonary disease, anxiety and depression. Concomitant therapies included amlodipine, atorvastatin, alprazolam and quetiapine fumarate (SEROQUEL). The patient had a history of drug reaction or allergies to aspirin, nonsteroidal anti-inflammatory drug (NSAIDS) and lisinopril (manufacturer unknown) (MARRS# 1803USA008407). On 10-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 (strength and dosage schedule were not reported), intramuscularly, for prophylaxis (lot number: N004564, expiration date: 22-OCT-2018). On an unspecified date in 2018, the patient's whole body was immobilized (immobile) and had to get help to get up from couch since lost muscle control (motor dysfunction) and strength (asthenia) for 3 days. The patient did not seek medical attention or receive treatment. No laboratories or diagnostic tests were carried out. The outcome of immobile, asthenia and motor dysfunction was reported as recovered on an unspecified date in 2018. The reporter did not assess the relatedness between PNEUMOVAX 23 and the adverse events. Upon internal review, immobile was determined to be a medically significant event.; Sender's Comments: US-009507513-1803USA008407:
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 02-MAR-2018, the patient received a dose of Oka/Merck VARIVAX subcutaneously, for prophylaxis (strength, lot # and expiration date were not reported). On 20-MAR-2018, two weeks and 4 days after first dose, the patient was vaccinated with another dose of Oka/Merck VARIVAX subcutaneously, for prophylaxis (strength, lot # and expiration date were not reported). No adverse effects were reported in the patient.
Age: 60.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Impaired work ability, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Upon administration of HAVRIX to the left mid-deltoid, patient c/o significant pain. Then c/o tingling feeling in left 4th & 5th fingers. Injection site without redness, swelling. Ice applied to injection site.  After several minutes patient stated that arm felt better. Had full range of motion of arm, hand, and fingers. The patient filed a workman's comp claim the next day stating that her arm hurt so bad that she could not work. She was seen by an NP in a clinic who advised her to increase use and movement of the arm and to take OTC analgesics has needed.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Inflammation, Vaccination complication
Clinical narrative: Adverse effect of vaccine, initial encounter. Vaccine reaction; suspect allergic/inflammatory and less likely infection given improving spontaneously. Area of reaction outlined with marker; call if extending beyond margins or if any worsening symptoms like increased redness, swelling, pain, or fevers. Apply cool compress or ice pack (not directly to skin) for 15-20 minutes several times/day BENADRYL 25-50 mg every 4-6 hours x 24 hours, then prn. Off work today F/u if symptoms worsen or do not improve as expected.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Migraine, Nausea, Vomiting
Clinical narrative: Dibilitating Migraine with nausea and vomiting.