chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Started to become tired around 3:00 pm. The site of the injection was sore. At 8:00 pm I started feeling cold and that went right into the chills where I could not warm up. Went to bed at 10 pm with extra blankets. No fever. At 12:15 am I woke up very hot. I had a fever of 100.7. I researched online and took (3) 200 mg of ibuprofen at 12:45 am. Within 15 minutes I started feeling slightly better.  Went to bed and woke up at 7 am back to normal.
Age: 0.5
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX, ROTATEQ (oral administration), and VAQTA, all administered for prophylaxis. The doses of VARIVAX was reconstituted with properly stored sterile diluent, and was stored between -14 Celsius degrees and -10 Celsius degrees for 48 hours. The doses of ROTATEQ and VAQTA were stored below 0 Celsius degrees (-0.56) for 24 hours. There were no previous temperature excursions. The temperature excursions were detected by a data logger. No adverse effects were reported. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. Follow up information was received from an other unspecified reporter on 11-JUL-2018. This report concerned a 6 month old patient of unknown gender. Pre-existing allergies, birth defects, medical condition and illness at the time of vaccination was reported as none. Patient's birth weight was reported as 6 lb12 oz. Previously, on 25-JAN-2017 and 18-JAN-2018, the patient was vaccinated with 2 doses of ROTATEQ, PREVNAR, DTAP, hib conj vaccine (unspecified carrier)(HIB) and poliovirus vaccine inactivated (unspecified)(IPV). On 17-MAR-2018, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # N005078, expiry date 22-NOV-2018) dose 3, orally for prophylaxis. On 17-MAR-2018, the patient was also vaccinated with improperly stored doses of PREVNAR (via intramuscular route), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(DTAP) (lot# C5157AA, via intramuscular route), hib conj vaccine (unspecified carrier)(HIB) (lot# 41787AA, via intramuscular route) and poliovirus vaccine inactivated (unspecified)(IPV) (lot# m1453, via intramuscular route). No adverse event was reported. On 28-FEB-2018, the temperature excursion occurred in the refrigerator, and it was not known if the temperature excursion occurred as result of a reading from a digital data logger.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster
Clinical narrative: This spontaneous report was received from a company representative while attending a digital marketing training from internet website containing information about a female patient between 55 to 64 years old. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-FEB-2008, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) for prophylaxis. Subsequently, on 14-FEB-2018, the patient experienced shingles and joint pain and was given an unspecified treatment. At the time of reporting, the patient's outcome was unknown. The patient sought medical attention through an office visit. No further information was provided.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 2 month old patient. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The medical assistant informed that on 28-JUN-2018, the patient was vaccinated with two doses of PEDVAXHIB Injection, lot # N034410, expiration date 01-FEB-2020, intramuscularly for prophylaxis (incorrect dose administered). No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via field representative refers to a 68 year old female patient. The patient's relevant medical history and concurrent condition were not reported. The patient's concomitant medication included momordica chairanta topical ointment. On an unknown date in 2015, the patient was vaccinated with one dose of ZOSTAVAX vial 19400 plaque-forming unit (PFU), for prevention of shingles (lot#, expiry date, route and frequency were not reported). On 03-JUL-2018, the patient developed shingles. It was reported that some of the shingles were around the patient's eyes. The patient visited physician. As of 12-JUL-2018 (reported as currently), the patient was taking "VALTREX 1 gram three times daily" to treat the shingles. No product quality complaint (PQC) was involved. The patient did not recover from the event. The reporter did not provide any causality assessment.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse referring to an adult patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. On 06-JUL-2018, the patient was vaccinated with a pediatric dose of VAQTA for prophylaxis (specific dose, route of administration, lot number and expiration date were not reported). The reporter specified that there were no adverse effects.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In approximately 2014, the patient was inoculated with the ZOSTAVAX vaccine at physician office as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On 11-MAY-2015, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. On 11-MAY-2015, the patient was prescribed famciclovir for the management of her zoster-related symptoms. On 11-AUG-2016, she was again treated by a physician for shingles and was prescribed famciclovir for the management of her zoster related symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In approximately January 2016, the patient was inoculated by a pharmacist or physician with the ZOSTAVAX vaccine at drug store as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In approximately February 2016, the patient was treated at a physician office for the onset of a rash, which was diagnosed as herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In or around 2013, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with the ZOSTAVAX vaccine by a pharmacist or physician at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2013, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 2013, the patient was inoculated with the ZOSTAVAX vaccine by a pharmacist and/or physician at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In or around June 2013, the patient was treated for the onset of a vesicular rash, which was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or about 2013, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 2013, the patient was treated for the onset of a severe vesicular rash accompanied, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report was received from a physician via field representative refers to a 12 year old female patient. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patient was vaccinated with 2 doses of GARDASIL 9 injection, intramuscularly as routine vaccination for human papillomavirus (HPV), (lot#, expiry date and dosage details were not reported). On an unknown date, the patient experienced topical warts on the patient's fingers. The patient did not receive any treatment for the event. On an unknown date, within five months of receiving GARDASIL 9, the topical warts on the patient's fingers went away. No product quality complaint (PQC) was involved. The reporter did not provide any causality assessment.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a physician assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unspecified date in 2014, the patient started GARDASIL (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On 17-JUL-2018, the patient received GARDASIL 9 (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. No adverse effects were reported. No product quality compliant (PQC) involved.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 55-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included lisinopril. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was recovered/resolved. The reporter considered the dizziness to be related to SHINGRIX. Additional details were provided as follows: The patient had the SHINGRIX vaccine 5:00 PM in the left arm, approximately 2.5 months ago before the time of reporting on a Friday. The patient reported experiencing some dizziness the following day and throughout the weekend. It resolved by Monday.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Presyncope
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vasovagal attack in a 16-year-old female patient who received BEXSERO for prophylaxis. On 2nd April 2018, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced vasovagal attack. On an unknown date, the outcome of the vasovagal attack was unknown. It was unknown if the reporter considered the vasovagal attack to be related to BEXSERO. Additional details were provided as follows: After receiving the SHINGRIX, the patient experienced vaso vagal response.
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer via other and described the occurrence of allergic reaction in a male patient who received SHINGRIX for prophylaxis. On 18th May 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. It was reported that, the patient sustained an allergic reaction after receiving the SHINGRIX vaccine.
Sex: M
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist. A male patient of an unspecified age received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at an unknown date, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction to the vaccine on an unspecified date. The outcome of the event, allergic reaction was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: U
Vaccine: DTAP
Symptoms: Incomplete course of vaccination
Clinical narrative: Initial information received on 05-Jul-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 7 years old patient who missed DAPTACEL vaccination, while he/she received vaccine DAPTACEL. The patients past medical history, medical treatment, vaccination and family history were not provided. On an unknown date, the patient missed a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported and he wanted to know if he should just give him the PENTACEL instead. It was a case of actual medication error due to drug dose missed. It was unknown if patient experienced any adverse event post vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Pain at injection site, fatigue, nausea, headache, muscle aches, minor itching. On day two still experiencing weakness and pain.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pruritus
Clinical narrative: Pain at injection site, fatigue, nausea, headache, muscle aches, minor itching. On day two still experiencing weakness and pain.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pyrexia, Rash
Clinical narrative: Flu like symptoms. Rash on back, low grade fever. Felt terrible for about 24 hours starting the next morning after shot. I also received the booster hoping it wouldn't be as bad the next day but it was. The day after the booster I was sick to my stomach and vomited and had flu like symptoms again.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscles aches, flu like symptoms for 12 hours.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Blindness transient, Dizziness, Headache, Heart rate increased, Injection site pain
Clinical narrative: Weakness in arms and legs, severe pain in injection site, temporary vision loss, fever of 102, rapid pulse, dizzy, severe headache.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: Weakness in arms and legs, severe pain in injection site, temporary vision loss, fever of 102, rapid pulse, dizzy, severe headache.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Warm to touch, sore, swollen at injection site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient presented in office with redness, swelling, heat, and "stinging" on left arm for two days. Site where vaccines were given. Patient states "all symptoms were improving" Dr.'s treatment plan is to continue to allow it to resolve on it's own.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased, Dizziness, Fall, Flushing, Muscular weakness
Clinical narrative: Pre-syncopal epsiode this morning. Felt flushed when he was standing at a breakfast spot waiting for his sandwich. Reports he sat down. Got up to get sandwich when his name was called. His legs felt rubbery, slow crumple to the ground. Reports did not lose consciousness. Pt reports he stood up without assistance quickly after "popping up". Felt okay afterwards, slighlty lightheaded. Staff at restaurant gave him a bottled water and called the EMS. Vitals: BP 98/70, Pulse 98, Fasting blood sugar: 169. No other suspected factors that contributed.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Presyncope
Clinical narrative: Pre-syncopal epsiode this morning. Felt flushed when he was standing at a breakfast spot waiting for his sandwich. Reports he sat down. Got up to get sandwich when his name was called. His legs felt rubbery, slow crumple to the ground. Reports did not lose consciousness. Pt reports he stood up without assistance quickly after "popping up". Felt okay afterwards, slighlty lightheaded. Staff at restaurant gave him a bottled water and called the EMS. Vitals: BP 98/70, Pulse 98, Fasting blood sugar: 169. No other suspected factors that contributed.
Age: 38.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Injection site pain, Injection site paraesthesia, Joint range of motion decreased
Clinical narrative: Unsure of exact immunizations (they were given at Clinic) c/o right shoulder tingling pain at time of injection, soreness x few days, but now with decreased range of motion and pain right shoulder after receiving Tdap and typhoid immunization in right arm.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Lingering sore arm/shoulder, pain when swimming, lifting arm overhead.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This was 2nd shot. First one, felt a little flu like but not serious, no fever. After 2nd shot, in addition to expected sore arm, started feeling chilled the night after shot. Felt okay in the morning, so went for morning jog. After the run, chills came on pretty quick and fever went to 102 by lunch time where it stayed all day. Finally took an ALKA SELTZER to sleep that night and fever broke about 1am. No fever the next day, some muscle soreness. Next day, felt fine. Suspended daily runs until that next Tuesday.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Red, swollen, hard, warm, size of a softball on both arms. Started after getting injections.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea, Paraesthesia
Clinical narrative: Headache, nausea, vomiting, redness and swelling at injection site, low grade fever, paresthesia in lower arms. (Symptoms for 5 hours nausea vomiting, headache paresthesia), redness and swelling 5 days. Naproxen taken 200 mg.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headache, nausea, vomiting, redness and swelling at injection site, low grade fever, paresthesia in lower arms. (Symptoms for 5 hours nausea vomiting, headache paresthesia), redness and swelling 5 days. Naproxen taken 200 mg.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Feeling cold, shivering at night after the vaccination (we couldn't measure the temperature). Two days after the vaccination: stiff neck and headache, three days after: stiff neck and pain: nearly unable to get in or out the bed due to the stiff neck or doing anything, immense headache and immense neck pain. Pain pills (high dosage ibuprofen) reduced pain but not as long as expected (Patient hasn't taken any painkiller within years before this). Severe stiff neck pain and headache on day four, five and six after the vaccination. Seven days after vaccination: slightly better, less neck pain and headache but still there, still taken Ibuprofen
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: Feeling cold, shivering at night after the vaccination (we couldn't measure the temperature). Two days after the vaccination: stiff neck and headache, three days after: stiff neck and pain: nearly unable to get in or out the bed due to the stiff neck or doing anything, immense headache and immense neck pain. Pain pills (high dosage ibuprofen) reduced pain but not as long as expected (Patient hasn't taken any painkiller within years before this). Severe stiff neck pain and headache on day four, five and six after the vaccination. Seven days after vaccination: slightly better, less neck pain and headache but still there, still taken Ibuprofen
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Injection site swelling, Pain, Pyrexia
Clinical narrative: Pain, swelling at injection site, then flu like syndrome with low fever about 100 F, aching knee joints for only one day on 7/18/2018.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Started with swelling on the thigh. Mother described the area as red, swollen and purple. Swelling of the thigh was started at the middle thigh and reached to the knee.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Excessive swelling, Paint redness, heat rise at injection site, spread from shoulder to elbow of right arm. On-set 3+ hours after admin. -Patient returned next day given antihistamine (cetirizine) cold pack therapy recommended, counseled on more severe symptoms to go to ER.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: CSF test normal, Computerised tomogram head normal, Electroencephalogram, Endotracheal intubation, Laboratory test normal
Clinical narrative: Lethargy after administration, 5 hours later seizure lasting 45 minutes, aborted with ATIVAN and fosphenytoin, 2nd seizure in ED <5 min, intubated, extubated overnight. Infectious work-up including CSF studies and RPP negative. CT head without contrast WNL, EEG pending.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: Lethargy, Seizure
Clinical narrative: Lethargy after administration, 5 hours later seizure lasting 45 minutes, aborted with ATIVAN and fosphenytoin, 2nd seizure in ED <5 min, intubated, extubated overnight. Infectious work-up including CSF studies and RPP negative. CT head without contrast WNL, EEG pending.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: Computerised tomogram normal, Endotracheal intubation, Intensive care, Lumbar puncture normal, Seizure
Clinical narrative: Lethargy after administration, 5 hours later seizure lasting 45 minutes, aborted with ATIVAN and fosphenytoin, 2nd seizure in ED <5 min, intubated, extubated overnight. Infectious work-up including CSF studies and RPP negative. CT head without contrast WNL, EEG pending.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: Febrile convulsion
Clinical narrative: Lethargy after administration, 5 hours later seizure lasting 45 minutes, aborted with ATIVAN and fosphenytoin, 2nd seizure in ED <5 min, intubated, extubated overnight. Infectious work-up including CSF studies and RPP negative. CT head without contrast WNL, EEG pending.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Muscular weakness, Myalgia, Nausea
Clinical narrative: At first my arm was only slightly sore, but as the day went on it became extremely sore and weak. I did not want to lift anything heavy. By bedtime I seemed sore all over and could not sleep well. I became nauseous and had a headache. This morning I could not eat because my stomach still felt nauseous and the headache and muscle soreness are still there. After being awake for a few hours I ate dry cereal and have been drinking a lot of water. I also took aspirin.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Poor quality sleep, Weight bearing difficulty
Clinical narrative: At first my arm was only slightly sore, but as the day went on it became extremely sore and weak. I did not want to lift anything heavy. By bedtime I seemed sore all over and could not sleep well. I became nauseous and had a headache. This morning I could not eat because my stomach still felt nauseous and the headache and muscle soreness are still there. After being awake for a few hours I ate dry cereal and have been drinking a lot of water. I also took aspirin.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Decreased activity, Diet refusal, Fatigue, Flushing, Irritability
Clinical narrative: Day vaccines given - very tired and less active. Mom had to wake baby to feed. Day 2 - Very fussy, flushed, fever - mom did not take temp but reported fever to doctor, decreased urine output, fighting bottle and not wanting to eat. No vomiting or diarrhea. Day 3 - baby seen in clinic and fully recovered. Eating well and happy.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Urine output decreased
Clinical narrative: Day vaccines given - very tired and less active. Mom had to wake baby to feed. Day 2 - Very fussy, flushed, fever - mom did not take temp but reported fever to doctor, decreased urine output, fighting bottle and not wanting to eat. No vomiting or diarrhea. Day 3 - baby seen in clinic and fully recovered. Eating well and happy.
Age: 88.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash papular, Rash pruritic, Scab
Clinical narrative: Pt received immunization at pharmacy and they requested that we do a VAERS. Patient is here with complaints of a rash on his LEFT arm s/p SHINGRIX vaccine. He states he received the SHINGRIX vaccine approximately 2 weeks ago. He states after the injection he noticed a rash on his posterior LEFT arm from his deltoid area to his wrist. He reports the rash extended to his LEFT forearm. He denies the rash is painful. He states it is itchy. He scratched the area and a few of the papules opened and scabbed. He denies the papules drained fluid. He denies a change in soaps, lotions or detergents. He states he went to the pharmacy where he had the injection and they told him to notify his PCP. He states the rash is resolving. He continues to have an area of papules on his posterior upper arm. He has not used any OTC medications. The rash was located on his LEFT arm only.
Age: 88.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Papule, Pruritus, Rash, Rash papular
Clinical narrative: Pt received immunization at pharmacy and they requested that we do a VAERS. Patient is here with complaints of a rash on his LEFT arm s/p SHINGRIX vaccine. He states he received the SHINGRIX vaccine approximately 2 weeks ago. He states after the injection he noticed a rash on his posterior LEFT arm from his deltoid area to his wrist. He reports the rash extended to his LEFT forearm. He denies the rash is painful. He states it is itchy. He scratched the area and a few of the papules opened and scabbed. He denies the papules drained fluid. He denies a change in soaps, lotions or detergents. He states he went to the pharmacy where he had the injection and they told him to notify his PCP. He states the rash is resolving. He continues to have an area of papules on his posterior upper arm. He has not used any OTC medications. The rash was located on his LEFT arm only.
Age: 88.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Scab
Clinical narrative: Pt received immunization at pharmacy and they requested that we do a VAERS. Patient is here with complaints of a rash on his LEFT arm s/p SHINGRIX vaccine. He states he received the SHINGRIX vaccine approximately 2 weeks ago. He states after the injection he noticed a rash on his posterior LEFT arm from his deltoid area to his wrist. He reports the rash extended to his LEFT forearm. He denies the rash is painful. He states it is itchy. He scratched the area and a few of the papules opened and scabbed. He denies the papules drained fluid. He denies a change in soaps, lotions or detergents. He states he went to the pharmacy where he had the injection and they told him to notify his PCP. He states the rash is resolving. He continues to have an area of papules on his posterior upper arm. He has not used any OTC medications. The rash was located on his LEFT arm only.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash erythematous, Vomiting
Clinical narrative: Was informed that pt. developed red rash about 20 minutes after receiving immunizations. Episode lasted for about 1 and 1/2 hours. Pt vomited x 1 after arriving home.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Body temperature increased, Chills, Decreased appetite
Clinical narrative: Reactions began 4-5 hours after receiving vaccine. Severe joint aches, nausea, severe arm pain to left upper arm into shoulder, chills/shakes, headache, temperature 101, body aches, fatigue, loss of appetite, general weakness. This lasted approximately 48 hours after injection. Continue to have malaise and slight headache.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Malaise, Nausea
Clinical narrative: Reactions began 4-5 hours after receiving vaccine. Severe joint aches, nausea, severe arm pain to left upper arm into shoulder, chills/shakes, headache, temperature 101, body aches, fatigue, loss of appetite, general weakness. This lasted approximately 48 hours after injection. Continue to have malaise and slight headache.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Tremor
Clinical narrative: Reactions began 4-5 hours after receiving vaccine. Severe joint aches, nausea, severe arm pain to left upper arm into shoulder, chills/shakes, headache, temperature 101, body aches, fatigue, loss of appetite, general weakness. This lasted approximately 48 hours after injection. Continue to have malaise and slight headache.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh where MENACTRA and MEN B were given=red, warm, swollen, hard, -gold ball size.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Client fainted and fell to floor. Assisted client to chair. Cool washcloth applied to back of neck and forehead and fanned. Peanut butter crackers and Sprite given. Observed client for 40 minutes. Client was stable and released.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cognitive disorder, Eye pruritus, Injection site rash, Injection site warmth, Muscular weakness
Clinical narrative: Rash with fever at injection site, muscle weakness, itchy red eyes, cognitive "slowness".
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Ocular hyperaemia
Clinical narrative: Rash with fever at injection site, muscle weakness, itchy red eyes, cognitive "slowness".
Age: 64.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Asthenia, Blood alkaline phosphatase increased, Blood lactic acid normal, Chest X-ray normal, Chills
Clinical narrative: Fever 101 Chills weakness Nausea Headache patient went to ER.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Eosinophil count decreased, Full blood count, Headache, Lymphocyte percentage decreased, Metabolic function test normal
Clinical narrative: Fever 101 Chills weakness Nausea Headache patient went to ER.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Nausea, Neutrophil count increased, Neutrophil percentage increased, Pyrexia, Red cell distribution width increased
Clinical narrative: Fever 101 Chills weakness Nausea Headache patient went to ER.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: White blood cell count increased
Clinical narrative: Fever 101 Chills weakness Nausea Headache patient went to ER.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Patient has had pain since SHINGRIX vaccine administered 3/9/18 left deltoid, Patient has limited range of motion.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Tdap-Left thigh-red, swollen, warm, painful.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies were not reported. The patient's concomitant medications included Diluent Mrk Inj which was used for the reconstitution of VARIVAX. On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose, units and frequency not reported) (lot # N030410 and expiration date: 30-OCT-2019) subcutaneously. The administered VARIVAX was stored at a temperature from -14 degree Celsius (C) to -10 C (-11.2) for 24 hours as recorded by data logger. There was no previous temperature excursion for the VARIVAX. No adverse effects were reported. No product quality complaint was involved.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Crying, Drug administered to patient of inappropriate age, Enema administration, Intestinal operation, Intussusception
Clinical narrative: This spontaneous case was received from a physician via a company representative regarding a 6 month old (also reported as 11-month-old) male patient. The patient did not have any pertinent medical history, drug allergies/reactions and was not taking any concomitant medications. On 23-OCT-2017, the patient received the first dose of ROTATEQ (dose, unit not reported) (lot# N003978, expiration date: 11-NOV-2018) orally and on 26-DEC-2017, the patient received second dose of ROTATEQ (dose, unit not reported) (lot# N009963, expiration date: 17-NOV-2018) orally for vaccination (immunization). On 26-FEB-2018, the patient received the third dose of ROTATEQ (dose, unit not reported) (lot# N009963, expiration date: 17-NOV-2018) orally for vaccination (immunization) (Drug administered to patient of inappropriate age). On 05-JUL-2018, the patient was brought to hospital because the patient was crying and vomiting. The patient sought medical attention. The patient was treated with an unspecified enema and with air, via tube and was discharged. On 06-JUL-2018, the patient returned to hospital and was operated for intussusception. On an unknown date in July 2018, The patient recovered and the patient was discharged. On 11-JUL-2018, the patient had follow-up visit with the physician and the patient was fully recovered. No lab diagnostics/studies were performed. The causality assessment of the events to the suspect therapy was not reported. The event was considered to be life threatening. No product quality complaint (PQC) was involved. Upon internal review, the event intussusception was determined to be medically significant. This is one of the two reports from the same source. Sender's Comments: US-009507513-1807USA008541.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous case was received from a physician via a company representative regarding a 6 month old (also reported as 11-month-old) male patient. The patient did not have any pertinent medical history, drug allergies/reactions and was not taking any concomitant medications. On 23-OCT-2017, the patient received the first dose of ROTATEQ (dose, unit not reported) (lot# N003978, expiration date: 11-NOV-2018) orally and on 26-DEC-2017, the patient received second dose of ROTATEQ (dose, unit not reported) (lot# N009963, expiration date: 17-NOV-2018) orally for vaccination (immunization). On 26-FEB-2018, the patient received the third dose of ROTATEQ (dose, unit not reported) (lot# N009963, expiration date: 17-NOV-2018) orally for vaccination (immunization) (Drug administered to patient of inappropriate age). On 05-JUL-2018, the patient was brought to hospital because the patient was crying and vomiting. The patient sought medical attention. The patient was treated with an unspecified enema and with air, via tube and was discharged. On 06-JUL-2018, the patient returned to hospital and was operated for intussusception. On an unknown date in July 2018, The patient recovered and the patient was discharged. On 11-JUL-2018, the patient had follow-up visit with the physician and the patient was fully recovered. No lab diagnostics/studies were performed. The causality assessment of the events to the suspect therapy was not reported. The event was considered to be life threatening. No product quality complaint (PQC) was involved. Upon internal review, the event intussusception was determined to be medically significant. This is one of the two reports from the same source. Sender's Comments: US-009507513-1807USA008541.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 2013, the patient was inoculated with the ZOSTAVAX vaccine at a Medical Center as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about February 2015, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX, ibuprofen and TYLENOL for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-AUG-2011, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 17-AUG-2013, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 18-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician at a physician's office for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Hot flush, Loss of consciousness, Myalgia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 18-year-old male patient received TRUMENBA on 13Jul2018 in the evening, at single dose for immunization in left deltoid. The patient medical history and concomitant medications were not reported. The patient experienced episode of passing out, high fever, chills, vomiting, headache, muscle pain, hot flashes on an unknown date in Jul2018. The day after, in the morning, the patient had to go to urgent care due to the events and in the afternoon he was better.All the events are serious as medically significant.The final outcome of the event was recovering.Causality between TRUMENBA and all the events was reported as related.Information on the batch number has been requested. Sender's Comments: Based on the information currently available, the known adverse event profile of the suspect vaccine and the pathophysiology of the events, the Company cannot completely exclude that the suspect drug contributed to the development of the reported events.