chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Neutrophil count normal, Neutrophil percentage increased, Pain in extremity, Platelet count normal, Protein total normal
Clinical narrative: Reporting pain in both shoulders, hips, lower extremities. He has a difficult time lifting his arms overhead or donning his jacket. His legs feel heavy. He denies any specific areas of weakness or numbness. He has a history of joint pain and stiffness, not to this degree. ROS: Musculoskeletal: Nonantalgic gait. Wide based, slow to move. Muscle strength and tone appear normal. Negative Homans sign. Varicose veins bilateral lower extremities. Decreased range of motion of the shoulders, tenderness over the bursa on the shoulders and hips. Lumbar range of motion is affected with endpoint flexion and extension. He has some difficulty with balance with toe raises. There is no swelling of the joints. There is chronic deformity of the joints in the hands. AFTER treatment with prednisone: Significant improvement after starting the prednisone.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Red blood cell count normal, Red blood cell sedimentation rate normal, Red cell distribution width normal, Reticulocyte percentage increased, Rheumatoid factor negative
Clinical narrative: Reporting pain in both shoulders, hips, lower extremities. He has a difficult time lifting his arms overhead or donning his jacket. His legs feel heavy. He denies any specific areas of weakness or numbness. He has a history of joint pain and stiffness, not to this degree. ROS: Musculoskeletal: Nonantalgic gait. Wide based, slow to move. Muscle strength and tone appear normal. Negative Homans sign. Varicose veins bilateral lower extremities. Decreased range of motion of the shoulders, tenderness over the bursa on the shoulders and hips. Lumbar range of motion is affected with endpoint flexion and extension. He has some difficulty with balance with toe raises. There is no swelling of the joints. There is chronic deformity of the joints in the hands. AFTER treatment with prednisone: Significant improvement after starting the prednisone.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness, Thyroxine free decreased, Tri-iodothyronine normal, Varicose vein, White blood cell count decreased
Clinical narrative: Reporting pain in both shoulders, hips, lower extremities. He has a difficult time lifting his arms overhead or donning his jacket. His legs feel heavy. He denies any specific areas of weakness or numbness. He has a history of joint pain and stiffness, not to this degree. ROS: Musculoskeletal: Nonantalgic gait. Wide based, slow to move. Muscle strength and tone appear normal. Negative Homans sign. Varicose veins bilateral lower extremities. Decreased range of motion of the shoulders, tenderness over the bursa on the shoulders and hips. Lumbar range of motion is affected with endpoint flexion and extension. He has some difficulty with balance with toe raises. There is no swelling of the joints. There is chronic deformity of the joints in the hands. AFTER treatment with prednisone: Significant improvement after starting the prednisone.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: 5/3/2018 pt notified office very sick the following day tired, nauseated, just felt sick - then noticed increasing redness and swelling at injection site. States site is golf ball sized today, and very red, sore to touch. Acetaminophen.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: 5/3/2018 pt notified office very sick the following day tired, nauseated, just felt sick - then noticed increasing redness and swelling at injection site. States site is golf ball sized today, and very red, sore to touch. Acetaminophen.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Decreased appetite, Fatigue
Clinical narrative: I had noticeable but trivial side effects to the first vaccine of the series on March 2, 2018 (sore arm at injection site, mild headache, tiredness for a day or two, very mild stomach upset). I was just a little 'off' for 2-3 days. Essentially nothing of note other than to make sure to avoid getting the second vaccination if I had something important on my calendar. I expected similar or no reaction to the second shot. However the second shot produced a severe reaction. For the first 11 hours post-injection I felt absolutely great, other than a sore arm at the injection site. At 11 p.m. I began to fell shivery and feverish, as if I was coming down with the flu. By midnight, I was headachy, shivery, felt like I had a fever (though I didn't seem to) but even worse various muscles in my upper body kept intermittently twitching (this has NEVER happened before). I was frightened enough to consider going to an Urgent Care center, but I honestly felt too exhausted and sick to go. The symptoms continued for the next 3 hours (I was unable to sleep), peaked at 2 a.m., and then slowly abated over the next 6-8 hours. I had bouts of nausea and gi distress, though never vomited. I spent all of Saturday exhausted and dozing in bed (again, as if I had the flu). The headache was there, but mild.  (I rarely get any headaches). By late afternoon, I could get up, though had no energy or appetite. By Sunday morning, I was still extremely tired and 'off' (mild headache, exhaustion, little appetite). By dinner on Sunday, I was able to eat a normal meal and by 8 p.m. I felt fantastic again. All symptoms just ended. So it was a very frightening experience, even though I assumed it was a reaction to the vaccine. All of my symptoms were listed as potential side effects, other than the twitching muscles in my arms and back which was very scary. It was completely unexpected, given my mild reaction to the previous vaccine in the series a little over 2 months earlier. My underlying health at the time was great (other than seasonal allergies), and I returned to feeling that way after 2-3 days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Insomnia, Malaise
Clinical narrative: I had noticeable but trivial side effects to the first vaccine of the series on March 2, 2018 (sore arm at injection site, mild headache, tiredness for a day or two, very mild stomach upset). I was just a little 'off' for 2-3 days. Essentially nothing of note other than to make sure to avoid getting the second vaccination if I had something important on my calendar. I expected similar or no reaction to the second shot. However the second shot produced a severe reaction. For the first 11 hours post-injection I felt absolutely great, other than a sore arm at the injection site. At 11 p.m. I began to fell shivery and feverish, as if I was coming down with the flu. By midnight, I was headachy, shivery, felt like I had a fever (though I didn't seem to) but even worse various muscles in my upper body kept intermittently twitching (this has NEVER happened before). I was frightened enough to consider going to an Urgent Care center, but I honestly felt too exhausted and sick to go. The symptoms continued for the next 3 hours (I was unable to sleep), peaked at 2 a.m., and then slowly abated over the next 6-8 hours. I had bouts of nausea and gi distress, though never vomited. I spent all of Saturday exhausted and dozing in bed (again, as if I had the flu). The headache was there, but mild.  (I rarely get any headaches). By late afternoon, I could get up, though had no energy or appetite. By Sunday morning, I was still extremely tired and 'off' (mild headache, exhaustion, little appetite). By dinner on Sunday, I was able to eat a normal meal and by 8 p.m. I felt fantastic again. All symptoms just ended. So it was a very frightening experience, even though I assumed it was a reaction to the vaccine. All of my symptoms were listed as potential side effects, other than the twitching muscles in my arms and back which was very scary. It was completely unexpected, given my mild reaction to the previous vaccine in the series a little over 2 months earlier. My underlying health at the time was great (other than seasonal allergies), and I returned to feeling that way after 2-3 days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle twitching, Nausea, Pyrexia
Clinical narrative: I had noticeable but trivial side effects to the first vaccine of the series on March 2, 2018 (sore arm at injection site, mild headache, tiredness for a day or two, very mild stomach upset). I was just a little 'off' for 2-3 days. Essentially nothing of note other than to make sure to avoid getting the second vaccination if I had something important on my calendar. I expected similar or no reaction to the second shot. However the second shot produced a severe reaction. For the first 11 hours post-injection I felt absolutely great, other than a sore arm at the injection site. At 11 p.m. I began to fell shivery and feverish, as if I was coming down with the flu. By midnight, I was headachy, shivery, felt like I had a fever (though I didn't seem to) but even worse various muscles in my upper body kept intermittently twitching (this has NEVER happened before). I was frightened enough to consider going to an Urgent Care center, but I honestly felt too exhausted and sick to go. The symptoms continued for the next 3 hours (I was unable to sleep), peaked at 2 a.m., and then slowly abated over the next 6-8 hours. I had bouts of nausea and gi distress, though never vomited. I spent all of Saturday exhausted and dozing in bed (again, as if I had the flu). The headache was there, but mild.  (I rarely get any headaches). By late afternoon, I could get up, though had no energy or appetite. By Sunday morning, I was still extremely tired and 'off' (mild headache, exhaustion, little appetite). By dinner on Sunday, I was able to eat a normal meal and by 8 p.m. I felt fantastic again. All symptoms just ended. So it was a very frightening experience, even though I assumed it was a reaction to the vaccine. All of my symptoms were listed as potential side effects, other than the twitching muscles in my arms and back which was very scary. It was completely unexpected, given my mild reaction to the previous vaccine in the series a little over 2 months earlier. My underlying health at the time was great (other than seasonal allergies), and I returned to feeling that way after 2-3 days.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Dehydration, Lethargy, Nausea, Night sweats, Pertussis
Clinical narrative: Lethargy, Fever of 101 degrees, Night Sweats, Nausea, Congestion, Cough, Feeling Dehydrated; Eventually Diagnosed with Pertussis (Whooping Cough).
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Lethargy, Fever of 101 degrees, Night Sweats, Nausea, Congestion, Cough, Feeling Dehydrated; Eventually Diagnosed with Pertussis (Whooping Cough).
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Cough, Discomfort, Skin lesion, Urticaria
Clinical narrative: Same day as receiving shot patient experienced hives all over trunk, open lesions around pant line, cough, discomfort. MOC is a provider and stated she had never seen anything like that as a reaction. She gave him ZYRTEC. Lesions healed by day 5.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Alanine aminotransferase, Aspartate aminotransferase, Computerised tomogram abdomen, Hypersensitivity
Clinical narrative: Severe pain in left arm, shoulder, redness/hot, swelling. Pain in stomach, nausea. Severe rash on face, neck, chest, upper torso, arms, stomach, back, legs. In ER on 6/1/18 given Fentanyl. In Hospital 6/2-6/4/18 given injections of prednisone and benadryl; upon release given a 3 day course of oral prednisone. Rash appeared on 6/2/18 and lasted through 6/8/18.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Lipase abnormal
Clinical narrative: Severe pain in left arm, shoulder, redness/hot, swelling. Pain in stomach, nausea. Severe rash on face, neck, chest, upper torso, arms, stomach, back, legs. In ER on 6/1/18 given Fentanyl. In Hospital 6/2-6/4/18 given injections of prednisone and benadryl; upon release given a 3 day course of oral prednisone. Rash appeared on 6/2/18 and lasted through 6/8/18.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance cholangiopancreatography, Nausea, Pain in extremity, Rash, Scan with contrast
Clinical narrative: Severe pain in left arm, shoulder, redness/hot, swelling. Pain in stomach, nausea. Severe rash on face, neck, chest, upper torso, arms, stomach, back, legs. In ER on 6/1/18 given Fentanyl. In Hospital 6/2-6/4/18 given injections of prednisone and benadryl; upon release given a 3 day course of oral prednisone. Rash appeared on 6/2/18 and lasted through 6/8/18.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme, Swelling
Clinical narrative: Erythema multiform and swelling 2 days after vaccine administered.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme, Swelling
Clinical narrative: Erythema Multiforme and swelling.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Pain, Pyrexia
Clinical narrative: Chills, fever, vomitting, tiredness, pain, redness & swelling.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Vomiting
Clinical narrative: Chills, fever, vomitting, tiredness, pain, redness & swelling.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test abnormal, Contusion, Lymphadenopathy, Transfusion
Clinical narrative: According to his wife, patient began bruising all over, including on his feet, and developed a swollen gland on right side throat the next morning.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Hyperhidrosis, Influenza virus test negative
Clinical narrative: About 12 hrs after the vaccine was administered, I became extremely fatigued (about 6 a.m. on 5/30/18). As the morning progressed, I became more fatigued, the muscles of my extremities began to ache, then I developed chills. I felt miserable. During the lunch break, I had the staff check a quick flu test on me, I was negative. (I am a pediatrician and did not want to expose my pts if I had the flu). I then read the CDC site & figured the Sx were due to the SHINGRIX. I took ibuprofen & acetaminophen. About an hour later, I started sweating (x ~30 minutes). Later I felt better intermittently. By 11:00 p.m, I only had mild fatigue. The entire next day (05/31/2018), I just felt mild to moderate fatigue. On 06/01/2018, I felt mild fatigue.
Sex: U
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial unsolicited report received from office person medical assistant on 24-May-2018. This case involves a 15-month-old patient (gender was not reported) who was vaccinated with a dose of ADACEL (batch number, expiry date, dose, route and site of administration were not reported) instead of DAPTACEL (batch number and expiry date were not reported) on an unknown date. It was a case of actual medication error due to wrong vaccine administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Initial unsolicited report received from office person medical assistant on 25 May 2018. This case involves 14-month-old patient (gender not reported) who was vaccinated with a dose of QUADRACEL instead of DAPTACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial unsolicited case received from a nurse on 25 May 2018. This case involves a patient (age and gender not reported) who received only DTaP/IPV component of PENTACEL (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unspecified date. Without the ACTHIB component of PENTACEL. Patient's medical history and concomitant medications were not reported. It was of actual medication error due to inappropriate reconstitution technique. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation error
Clinical narrative: Initial unsolicited report received from a Nurse (LPN) on 25-May-2018. This case involves a patient (age and gender was not reported), who was vaccinated with a dose of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to inappropriate reconstitution technique because patient inadvertently received ACTHIB component of PENTACEL reconstituted with QUADRACEL vaccine instead of the DTaP/IPV component of PENTACEL. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial unsolicited report received from a Nurse on 25-May-2018. This case involves 2-year-old patient (gender was reported as unknown), who was vaccinated with QUADRACEL (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. It was a case of actual medication error due to inappropriate age at vaccine administration as QUADRACEL is approved for use in children 4 through 6 years of age. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm, Swelling
Clinical narrative: Initial unsolicited case received from a nurse on 25 May 2018. This case involves a female patient (age not reported) who received a dose of QUADRACEL (Batch number: C5248AA, expiry date, dose, dose in series, route and site of administration was not reported) via subcutaneous route on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, post vaccination, the patient presented with redness, hot and swelling at the left arm, the itchy bumpy was which was 3 inches in diameter. Lab tests and corrective treatment were not reported. Outcome of the events was not reported. List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm, Swelling
Clinical narrative: Initial unsolicited report received from a nurse on 25 May 2018. This case involves a male child (age not reported) patient who was vaccinated with QUADRACEL (batch number C5248AA, expiry date, route and site of administration were not reported) were not reported on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, post vaccination patient experienced left arm hot red swollen more than 3 inches diameter bumpy itchy. Relevant lab investigations and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Initial unsolicited report received from a Nurse on 25-May-2018. This case involves female patient (gender was not reported), who was vaccinated with QUADRACEL (batch number- C5248AA, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. Medical history and concomitant medication was not reported. On an unknown date, following vaccination patient had hot red swollen more than 3 in in diameter itchy bumpy. Lab data and corrective treatment were not reported. Outcome of the events were not reported. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation error
Clinical narrative: Initial unsolicited report received from office person medical assistant on 30-May-2018. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of PENTACEL (Batch number: C4976AA, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was case of an actual medication error due to inappropriate reconstitution technique. It was not reported whether the patient experienced any adverse events or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Pain in extremity, Pruritus, Scratch
Clinical narrative: Patient reports (R) arm itching on 5/30/18 late evening, states she scratched her arm; arm started hurting - pain level 7 on scale 1-10; did not take pain meds or put anything on the site; states never had chickenpox; redness noted to site measuring 5 inches x 3 inches - completely resolved on 6/5/18.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pt LMP 4-23-18 was given varicella vaccine 5-4-2018. (positive) Preg test 6-4-2018.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Appro 5 min after getting GARDASIL pt passed out. Was placed in a laying post and monitored for 30 min.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Injection site pain, Lymph node pain, Pruritus
Clinical narrative: 5 days after injection, patient then developed erythema, overlying skin rash, TTP, pruritus, TTP at site. Denies fever, nausea, vomiting. No previous episodes or allergic reactions to vaccine. Exam significant for Left arm with local reaction at previous vaccine injection site. + Erythema, overlying macularpapular rash, area of induration. + TTP. + Axillary lymph nodes. No edema, discharge.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash maculo-papular, Tenderness
Clinical narrative: 5 days after injection, patient then developed erythema, overlying skin rash, TTP, pruritus, TTP at site. Denies fever, nausea, vomiting. No previous episodes or allergic reactions to vaccine. Exam significant for Left arm with local reaction at previous vaccine injection site. + Erythema, overlying macularpapular rash, area of induration. + TTP. + Axillary lymph nodes. No edema, discharge.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: High fever, nausea, site pain within 12 hours of vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: EXTREME REDNESS, SWOLLEN, AND HOT TO THE TOUCH
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Muscle pain, chills, fever up to 101, nausea.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Muscle pain, chills, fever up to 101, nausea.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Retching
Clinical narrative: Muscle pain, chills, fever up to 101, nausea.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: EXTREMELY SWOLLEN, RED, AND HOT TO THE TOUCH.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: Insomnia - unable to sleep the entire night following the vaccination, 06/01/2018 11:00 pm - 06/02/2018 07:00 am. Insomnia not related to pain or other discernable cause. Resolved after one night of insomnia.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Approx 5 min. after getting GARDASIL pt passed out for 1-3 min. Pt was moved to a laying pos and monitored for 30 min.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Approx 5 min after getting GARDASIL pt passed out for 1-3 min. Pt was moved to a laying post. and monitored for 30 min.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Erythema, swelling. Acetaminophen.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were reported as follows: This case was reported for reporter's son. The age at vaccination was not reported. The reporter indicated that the adverse events experienced by her son and coworkers were reported to the health department where they received the vaccination. The reporter would not provide additional information. This case was 1 of the 3 linked cases.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administrated by other route in a 74-year-old male patient who received SHINGRIX. Concomitant products included digoxin, vitamin D, Warfarin, dofetilide and metoprolol. On 26th April 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 26th April 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The concomitant product include multivitamin. The SHINGRIX was administered to the patient subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. The reporter gave permission to be contacted for further information. All questions were asked, reporter provided limited information. Follow up information was received by a pharmacist via call center representative on 30th May 2018: The patient's demographic details were updated. The patient may have been received SHINGRIX subcutaneously instead of intramuscular route. Less than a year after receiving SHINGRIX, the patient experienced injection site pain and arm swelling for about a week. The reporter's details and VAERS details were updated.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Local reaction, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received SHINGRIX. Previously administered products included Shingles vaccine (In 2016). On 17th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced muscle soreness, influenza like illness and malaise. On 17th May 2018, the patient experienced injection site erythema and injection site swelling. The patient was treated with Aspirin (Baby), CRESTOR and SYNTHROID. On an unknown date, the outcome of the injection site erythema, injection site swelling, muscle soreness, influenza like illness and malaise were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, muscle soreness, influenza like illness and malaise to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The local injection site reaction started within a few hours of administration. The flu, malaise, etc started several hours later and lasted approximately 48 hours. The local injection site reactions lasted for 5 days. The picture of patients arm was taken on day 4 since I was concerned it hadn't gone away. The patient was not hospitalized. This case has been linked with US2018GSK102763, reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received SHINGRIX. Previously administered products included Shingles vaccine (In 2016). On 17th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced muscle soreness, influenza like illness and malaise. On 17th May 2018, the patient experienced injection site erythema and injection site swelling. The patient was treated with Aspirin (Baby), CRESTOR and SYNTHROID. On an unknown date, the outcome of the injection site erythema, injection site swelling, muscle soreness, influenza like illness and malaise were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, muscle soreness, influenza like illness and malaise to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The local injection site reaction started within a few hours of administration. The flu, malaise, etc started several hours later and lasted approximately 48 hours. The local injection site reactions lasted for 5 days. The picture of patients arm was taken on day 4 since I was concerned it hadn't gone away. The patient was not hospitalized. This case has been linked with US2018GSK102763, reported by the same reporter.
Age: 71.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Local reaction, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old male patient who received SHINGRIX. Co-suspect products included PNEUMONIA VACCINE. Previously administered products included shingles vaccine with an associated reaction of herpes zoster. On 17th May 2018, the patient received the 1st dose of SHINGRIX and the 1st dose of pneumonia vaccine. In May 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and muscle soreness. On an unknown date, the patient experienced influenza like illness and malaise. The patient was treated with Aspirin (baby), NIASPAN and vitamin. On an unknown date, the outcome of the injection site erythema, injection site swelling, muscle soreness, influenza like illness and malaise were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, muscle soreness, influenza like illness and malaise to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. Both of them had received the SHINGRIX vaccine and experienced similar reactions. The patient's local reaction was not as bad like what his wife experienced and only last about 2 days with muscle soreness, redness. The patient was not hospitalized. This case has been linked with US2018GSK095562, reported by the same reporter.
Age: 71.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old male patient who received SHINGRIX. Co-suspect products included PNEUMONIA VACCINE. Previously administered products included shingles vaccine with an associated reaction of herpes zoster. On 17th May 2018, the patient received the 1st dose of SHINGRIX and the 1st dose of pneumonia vaccine. In May 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and muscle soreness. On an unknown date, the patient experienced influenza like illness and malaise. The patient was treated with Aspirin (baby), NIASPAN and vitamin. On an unknown date, the outcome of the injection site erythema, injection site swelling, muscle soreness, influenza like illness and malaise were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, muscle soreness, influenza like illness and malaise to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. Both of them had received the SHINGRIX vaccine and experienced similar reactions. The patient's local reaction was not as bad like what his wife experienced and only last about 2 days with muscle soreness, redness. The patient was not hospitalized. This case has been linked with US2018GSK095562, reported by the same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site bruising, Injection site pain, Injection site urticaria, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 64-year-old female patient who received SHINGRIX. Concurrent medical conditions included multiple sclerosis (Diagnosed prior to receiving the vaccine), supraventricular tachycardia (Diagnosed prior to receiving the vaccine), osteoporosis (diagnosed prior to receiving the vaccine) and bladder infection (Diagnosed prior to receiving the vaccine). Concomitant products included atenolol, gabapentin, trimethoprim, Vitamin B12, vitamin d, ZYRTEC, Calcium Plus S, CELEXA, Cranberry, ESTRACE cream, Glucosamine and chondroitin, Preservision, PROLIA, Red yeast rice and XANAX. On 24th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced localized erythema, injection site bruising, vaccine administered at inappropriate site, leg pain, injection site pain, swelling, injection site wheal and skin warm. On an unknown date, the outcome of the localized erythema, injection site bruising, vaccine administered at inappropriate site, swelling, injection site wheal and skin warm were unknown and the outcome of the leg pain and injection site pain were recovering/resolving. It was unknown if the reporter considered the localized erythema, injection site bruising, leg pain, injection site pain, swelling, injection site wheal and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received OCREVUS infusion as concomitant medication. The patient received SHINGRIX on right buttock due to MS and past injections. The consumer reported that as soon a s she got home, she experienced red, raised spot larger than a silver dollar with a deep bruise as well. The patient had a really huge welt at the injection site that was about the size of a moon pie and it really, really hurt. The patient stated that when she rolled over, her leg on that same side would ache as well. The patient stated that the redness and heat started going away and at the date of reporting it was flat and pink, but there was still a bruise about the size of a silver dollar. The caller had reaction to vaccine at injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site, Skin warm, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 64-year-old female patient who received SHINGRIX. Concurrent medical conditions included multiple sclerosis (Diagnosed prior to receiving the vaccine), supraventricular tachycardia (Diagnosed prior to receiving the vaccine), osteoporosis (diagnosed prior to receiving the vaccine) and bladder infection (Diagnosed prior to receiving the vaccine). Concomitant products included atenolol, gabapentin, trimethoprim, Vitamin B12, vitamin d, ZYRTEC, Calcium Plus S, CELEXA, Cranberry, ESTRACE cream, Glucosamine and chondroitin, Preservision, PROLIA, Red yeast rice and XANAX. On 24th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced localized erythema, injection site bruising, vaccine administered at inappropriate site, leg pain, injection site pain, swelling, injection site wheal and skin warm. On an unknown date, the outcome of the localized erythema, injection site bruising, vaccine administered at inappropriate site, swelling, injection site wheal and skin warm were unknown and the outcome of the leg pain and injection site pain were recovering/resolving. It was unknown if the reporter considered the localized erythema, injection site bruising, leg pain, injection site pain, swelling, injection site wheal and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received OCREVUS infusion as concomitant medication. The patient received SHINGRIX on right buttock due to MS and past injections. The consumer reported that as soon a s she got home, she experienced red, raised spot larger than a silver dollar with a deep bruise as well. The patient had a really huge welt at the injection site that was about the size of a moon pie and it really, really hurt. The patient stated that when she rolled over, her leg on that same side would ache as well. The patient stated that the redness and heat started going away and at the date of reporting it was flat and pink, but there was still a bruise about the size of a silver dollar. The caller had reaction to vaccine at injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness and vomiting. On an unknown date, the outcome of the sickness and vomiting were unknown. It was unknown if the reporter considered the sickness and vomiting to be related to SHINGRIX. Additional details were reported as follows: This case was reported for one of the coworker who was sick and experienced vomiting as well. The age at vaccination was not reported. The reporter reported that all coworkers and her son got sick. The reporter indicated that the adverse events experienced by her son and coworkers were reported to the health department where they received the vaccination. The reporter would not provide additional information. This is 1 of 3 cases, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray, Computerised tomogram, Emphysema, Loss of personal independence in daily activities, Pain
Clinical narrative: Pain - felt like my lungs were going to explode. Rx RX ZITHROMAX 250mg, 250 mg - VENTOLIN HFA. Outcome 3 mos later 12-12-2017 panlobar Panlobular emphysema. Now have daily near syncope making it difficult to perform daily ADL's. ADLs. I have scheduled appn't with a cardiologist.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Presyncope, Pulmonary function test, Pulmonary pain
Clinical narrative: Pain - felt like my lungs were going to explode. Rx RX ZITHROMAX 250mg, 250 mg - VENTOLIN HFA. Outcome 3 mos later 12-12-2017 panlobar Panlobular emphysema. Now have daily near syncope making it difficult to perform daily ADL's. ADLs. I have scheduled appn't with a cardiologist.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Headache, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult female patient who received SHINGRIX (batch number 4492P, expiry date April 2020). Concomitant products included Atorvastatin, Baby Aspirin, PAXIL, Ranitidine, glucosamine, estradiol and glipizide. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, rash, injection site erythema and injected limb mobility decreased. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, rash, injection site erythema and injected limb mobility decreased were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, rash and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient received SHINGRIX in the right arm. Immediately after receiving SHINGRIX, the patient had headache. The patient's right arm was sore and swollen from her elbow (extensive swelling of vaccinated limb) and was red hot. The swelling was so much that she could hardly bend her elbow (injected limb mobility decreased). The patient also experienced a butterfly shaped rash. This side effects lasted 6 weeks and then resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult female patient who received SHINGRIX (batch number 4492P, expiry date April 2020). Concomitant products included Atorvastatin, Baby Aspirin, PAXIL, Ranitidine, glucosamine, estradiol and glipizide. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, rash, injection site erythema and injected limb mobility decreased. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, rash, injection site erythema and injected limb mobility decreased were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, rash and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient received SHINGRIX in the right arm. Immediately after receiving SHINGRIX, the patient had headache. The patient's right arm was sore and swollen from her elbow (extensive swelling of vaccinated limb) and was red hot. The swelling was so much that she could hardly bend her elbow (injected limb mobility decreased). The patient also experienced a butterfly shaped rash. This side effects lasted 6 weeks and then resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX, at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The consumer reported that her aunt received SHINGRIX and the pain was awful. No consent for follow up and no additional information available.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: After 1-2 hr. Became very drowsy. By 8:30PM -so sleepy I went to bed and fell asleep. A ok next day. I never go to bed that early.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Rash, Rash vesicular
Clinical narrative: Left forearm rash. Left wrist vesicular rash eventually to cellulitis. Left chest vesicular rash.