chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC13
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: nausea; vomiting; low grade temperature; This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for 2 patients. This is the 1st of 2 reports. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. Two days after vaccination the patient experienced nausea, vomiting and low grade temperature. The outcome of the reported events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020139838 same reporter/drug/event, different patient
Sex: U
Vaccine: PNC13
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: nausea; vomiting; low grade temperature; This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for 2 patients. This is the 2nd of 2 reports. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. Two days after vaccination the patient experienced nausea, vomiting and low grade temperature. The outcome of the reported events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020139308 same reporter/drug/event, different patient
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Acarodermatitis, Blister, Blood test normal, Dizziness, Headache
Clinical narrative: I am a 62 year old woman and I recently completed my two doses of the Shingrix vaccine. I wanted to inform you of my experience after I received the vaccine.   After my 1st dose of Shingrix on Sept. 21, 2019, I had a mild fever and increased levels of pain, headache and severe dizziness, which I considered just as extreme case of the possible documented reactions and side effects. This lasted for 3 days before it subsided. Until I received my vaccine, I have had no health related issues and have lead a normal, healthy life. Within 10 days, I developed a mild rash and hives which has persisted. I have also had severe headaches since then.   I had my 2nd dose on Jan, 13, 2020. Right after this, I had extensive shingles-like reactions all over my body and immediately met my primary care doctor.   ? The primary care physician diagnosed it as a staph infection, prescribed antibiotics and also recommended me to follow up with a dermatologist. There was no improvement to my condition even after completing the antibiotic treatment.  ? As the pain and blister-like reaction all over my body was still persistent even after 10 days, I could meet with a dermatologist who diagnosed it as scabies and prescribed medication for scabies.  ? After suffering for 2 more weeks, I could get an appointment with another dermatologist as I was suspicious and not convinced of the diagnosis of scabies. Also, the treatment prescribed for scabies did not work either. This time, the 2nd dermatologist did not have a diagnosis but prescribed a blood test for an auto-immune disorder. Blood tests were completed, with a negative result and there was no indication of an auto-immune issue. She also recommended a biopsy but the shingles?like blisters which turn into a scaly scab-like form, persist even today, are small and have not lent themselves to biopsy.   She also did mention that ?they are noticing some strange reactions to Shingrix?.   I wanted to let you know, that after many months of no clear diagnosis, I am still suffering with new blisters forming every few days and turning into scaly scabs.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain, Pyrexia, Rash vesicular, Scab
Clinical narrative: I am a 62 year old woman and I recently completed my two doses of the Shingrix vaccine. I wanted to inform you of my experience after I received the vaccine.   After my 1st dose of Shingrix on Sept. 21, 2019, I had a mild fever and increased levels of pain, headache and severe dizziness, which I considered just as extreme case of the possible documented reactions and side effects. This lasted for 3 days before it subsided. Until I received my vaccine, I have had no health related issues and have lead a normal, healthy life. Within 10 days, I developed a mild rash and hives which has persisted. I have also had severe headaches since then.   I had my 2nd dose on Jan, 13, 2020. Right after this, I had extensive shingles-like reactions all over my body and immediately met my primary care doctor.   ? The primary care physician diagnosed it as a staph infection, prescribed antibiotics and also recommended me to follow up with a dermatologist. There was no improvement to my condition even after completing the antibiotic treatment.  ? As the pain and blister-like reaction all over my body was still persistent even after 10 days, I could meet with a dermatologist who diagnosed it as scabies and prescribed medication for scabies.  ? After suffering for 2 more weeks, I could get an appointment with another dermatologist as I was suspicious and not convinced of the diagnosis of scabies. Also, the treatment prescribed for scabies did not work either. This time, the 2nd dermatologist did not have a diagnosis but prescribed a blood test for an auto-immune disorder. Blood tests were completed, with a negative result and there was no indication of an auto-immune issue. She also recommended a biopsy but the shingles?like blisters which turn into a scaly scab-like form, persist even today, are small and have not lent themselves to biopsy.   She also did mention that ?they are noticing some strange reactions to Shingrix?.   I wanted to let you know, that after many months of no clear diagnosis, I am still suffering with new blisters forming every few days and turning into scaly scabs.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation, Staphylococcal infection
Clinical narrative: I am a 62 year old woman and I recently completed my two doses of the Shingrix vaccine. I wanted to inform you of my experience after I received the vaccine.   After my 1st dose of Shingrix on Sept. 21, 2019, I had a mild fever and increased levels of pain, headache and severe dizziness, which I considered just as extreme case of the possible documented reactions and side effects. This lasted for 3 days before it subsided. Until I received my vaccine, I have had no health related issues and have lead a normal, healthy life. Within 10 days, I developed a mild rash and hives which has persisted. I have also had severe headaches since then.   I had my 2nd dose on Jan, 13, 2020. Right after this, I had extensive shingles-like reactions all over my body and immediately met my primary care doctor.   ? The primary care physician diagnosed it as a staph infection, prescribed antibiotics and also recommended me to follow up with a dermatologist. There was no improvement to my condition even after completing the antibiotic treatment.  ? As the pain and blister-like reaction all over my body was still persistent even after 10 days, I could meet with a dermatologist who diagnosed it as scabies and prescribed medication for scabies.  ? After suffering for 2 more weeks, I could get an appointment with another dermatologist as I was suspicious and not convinced of the diagnosis of scabies. Also, the treatment prescribed for scabies did not work either. This time, the 2nd dermatologist did not have a diagnosis but prescribed a blood test for an auto-immune disorder. Blood tests were completed, with a negative result and there was no indication of an auto-immune issue. She also recommended a biopsy but the shingles?like blisters which turn into a scaly scab-like form, persist even today, are small and have not lent themselves to biopsy.   She also did mention that ?they are noticing some strange reactions to Shingrix?.   I wanted to let you know, that after many months of no clear diagnosis, I am still suffering with new blisters forming every few days and turning into scaly scabs.
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, MMRV, PNC13, RV5
Symptoms: Cyanosis, Dyspnoea, Lethargy, Livedo reticularis, Pyrexia
Clinical narrative: So we just had a scary 45 minutes. The baby had vaccinations this morning. (VSD/PDA/PFO/PLSVC) 16 months). Came home went down for a nap woke up tremoring. I assumed fever and gave Tylenol. But then he started turning colors. Lethargic looking. Heart rate above 180. No fever on thermometer. Breathing labored. Nostrils flaring . Home health nurse witnessed it too. Purple toes and fingers, lips, mouth, etc. mottled skin. Took him outside to make sure he was actually turning colors. Call the pediatrician. Wait for virtual call takes forever. Pediatrician thinks it?s just a fever spiking that that?s mass by the tunnel I already gave so we?re monitoring him. His Color has returned. He?s shaking has stopped. His breathing is better. His oxygen has risen. He?s asleep now. His heart rate is 169 which is better than it was.
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, MMRV, PNC13, RV5
Symptoms: Skin discolouration, Tremor
Clinical narrative: So we just had a scary 45 minutes. The baby had vaccinations this morning. (VSD/PDA/PFO/PLSVC) 16 months). Came home went down for a nap woke up tremoring. I assumed fever and gave Tylenol. But then he started turning colors. Lethargic looking. Heart rate above 180. No fever on thermometer. Breathing labored. Nostrils flaring . Home health nurse witnessed it too. Purple toes and fingers, lips, mouth, etc. mottled skin. Took him outside to make sure he was actually turning colors. Call the pediatrician. Wait for virtual call takes forever. Pediatrician thinks it?s just a fever spiking that that?s mass by the tunnel I already gave so we?re monitoring him. His Color has returned. He?s shaking has stopped. His breathing is better. His oxygen has risen. He?s asleep now. His heart rate is 169 which is better than it was.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: herpes zoster; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In or around 28-FEB-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after vaccination, the pt suffered reoccurring rashes on her buttocks, face and chest; and was diagnosed with herpes zoster. As a direct and proximate result of the company's defective zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was reported as not resolved. The causal relationship of herpes zoster was reported as related to zoster vaccine live (ZOSTAVAX). The reporter considered herpes zoster to be a disabling event.
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Surgery
Clinical narrative: In surgery's
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Injection site rash, Injection site swelling, Rash, Rash erythematous
Clinical narrative: 17 hours after the shot I started to have red bumps with a white color fluid inside. First appeared on throat and chest, by 3pm the rash started to appear below the site of injection .  Also severe swelling approx. 6"w x 4"h at injection site. I have had many shots, but this is by far the worst I have ever experienced. I will not be going for the 2nd shot.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular
Clinical narrative: 17 hours after the shot I started to have red bumps with a white color fluid inside. First appeared on throat and chest, by 3pm the rash started to appear below the site of injection .  Also severe swelling approx. 6"w x 4"h at injection site. I have had many shots, but this is by far the worst I have ever experienced. I will not be going for the 2nd shot.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Dry skin, Eczema, Skin exfoliation
Clinical narrative: The next day I noticed a dry spot on the back of the right ear and a dry spot on the back of the right shoulder. When I reported it, via phone call, I was told that there is no way that can be from the vaccine.  Over a month or so it covered his arms and became a little more scaly. Then progressively traveled to both legs and varies in severity.  The doctor never noticed it in following visits and based on the phone conversation I didn?t feel comfortable bringing it up again. Then finally around 8 months I asked her how to help it and mentioned the vaccine again. She adamantly reported it is not possible to be caused by that and she told me it?s a result of bathing him too much. (He would sit in his little pool/tub -without soap, 4-5 nights a week before bed. 1 night a week I would use Baby Dove on his hair. ) She diagnosed it as eczema.   *****On my take home paper the only things written are: PEDIARIX and rotavirus.  I was unsure of which Rotavirus to pick, there were two options.
Age: 37.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Burning sensation, Pain, Pain in extremity, Pruritus, Rash
Clinical narrative: On Tuesday March 31st morning, vaccine was given by LVN. She told me MMR was given in right arm, assuming Varicella is given in left arm. Left arm started to become sore on Wednesday April 1st. Notice a rash, sore, burning, itchy. Took picture on Thursday, informed PCP. Took pictures again today 04/03/20 and notice rash gotten bigger, still sore, burning and itchy.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Fatigue, Headache, Mobility decreased
Clinical narrative: Swelling, redness, tender to touch, hot to touch, restricted movement, aching, some nausea, headache, weakness & fatigue
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: Swelling, redness, tender to touch, hot to touch, restricted movement, aching, some nausea, headache, weakness & fatigue
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site mass, Injection site pain, Musculoskeletal pain, X-ray limb
Clinical narrative: Lump and severe pain to left lower deltoid 2 days after injection. 4 months later continuing symptoms with progression of pain going up trapezius and shoulder blade.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Patient had red hard bumb on left posterior arm. Doctor note: "The symptoms began 3 days ago and generally last 3 days. She states the symptoms are acute."
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Endotracheal intubation, Gait inability, Gastrointestinal tube insertion, Guillain-Barre syndrome
Clinical narrative: As counsel, I completed this VAERS report without all the medical records. Prior to the subject event I am reliably informed the health of my client, was excellent.  On Wednesday, 2/6/2019 Patient received the pneumonoccal 13 vaccine, a.k.a. Prevnar 13, in Dr. office. On Wednesday, 2/13/2019 she visited hospital complaining of weakness, numbness and loss of sensation. She was seen by Dr. and sent home with anxiety medications and muscle relaxers. On Saturday, 2/16/2019 she visited Medical Center complaining of the same symptoms. She was admitted to the hospital for suspected Guillain-Barre syndrome (GBS). Many medical exams and tests followed....It is believed the GBS was caused by the 2/6/19 Prevnar 13 vaccination injection. Within the next week (medical records will provide exact dates) her respiratory system failed. She was intubated and placed on a ventilator for life support. She lost all consciousness and was kept sedated for many days while continuing to be supported only by the assistance of the ventilator which performed all her breathing. She was unable to come off the ventilator. She had a tracheotomy placed, a feeding tube placed and lost complete functionality in all body systems. In March of 2019, still hooked up to the ventilator and feeding tube, she was transferred from Medical Center to Hospital, where her daughter, a nurse, lives. Patient has since been placed in 4 facilities. To date she is still unable to walk and only has slight function in her upper extremities.   For efficiency Patient is in the process of requesting all her medical records from the relevant health providers attached to the required Certificate of Medical Records to be filed with our anticipated petition. From February 6, 2019 to date,  we will seek a.) medical records from Dr., Dr., Medical Center, ER, Hospital, Medicine Clinic, Hospital, School of Medicine,  and b.) her medical records from Hospital, Rehabilitation, Rehabilitation and Rehabilitation. Medical records will be compiled and attached as needed to further assist in answering any questions.  The daughter, holds her mother's Power of Attorney. Her mother's given email address and telephone number are those provded in Item # 1.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Hypoaesthesia, Life support, Loss of consciousness, Mechanical ventilation, Musculoskeletal disorder
Clinical narrative: As counsel, I completed this VAERS report without all the medical records. Prior to the subject event I am reliably informed the health of my client, was excellent.  On Wednesday, 2/6/2019 Patient received the pneumonoccal 13 vaccine, a.k.a. Prevnar 13, in Dr. office. On Wednesday, 2/13/2019 she visited hospital complaining of weakness, numbness and loss of sensation. She was seen by Dr. and sent home with anxiety medications and muscle relaxers. On Saturday, 2/16/2019 she visited Medical Center complaining of the same symptoms. She was admitted to the hospital for suspected Guillain-Barre syndrome (GBS). Many medical exams and tests followed....It is believed the GBS was caused by the 2/6/19 Prevnar 13 vaccination injection. Within the next week (medical records will provide exact dates) her respiratory system failed. She was intubated and placed on a ventilator for life support. She lost all consciousness and was kept sedated for many days while continuing to be supported only by the assistance of the ventilator which performed all her breathing. She was unable to come off the ventilator. She had a tracheotomy placed, a feeding tube placed and lost complete functionality in all body systems. In March of 2019, still hooked up to the ventilator and feeding tube, she was transferred from Medical Center to Hospital, where her daughter, a nurse, lives. Patient has since been placed in 4 facilities. To date she is still unable to walk and only has slight function in her upper extremities.   For efficiency Patient is in the process of requesting all her medical records from the relevant health providers attached to the required Certificate of Medical Records to be filed with our anticipated petition. From February 6, 2019 to date,  we will seek a.) medical records from Dr., Dr., Medical Center, ER, Hospital, Medicine Clinic, Hospital, School of Medicine,  and b.) her medical records from Hospital, Rehabilitation, Rehabilitation and Rehabilitation. Medical records will be compiled and attached as needed to further assist in answering any questions.  The daughter, holds her mother's Power of Attorney. Her mother's given email address and telephone number are those provded in Item # 1.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Respiratory failure, Sedation, Sensory loss, Tracheostomy
Clinical narrative: As counsel, I completed this VAERS report without all the medical records. Prior to the subject event I am reliably informed the health of my client, was excellent.  On Wednesday, 2/6/2019 Patient received the pneumonoccal 13 vaccine, a.k.a. Prevnar 13, in Dr. office. On Wednesday, 2/13/2019 she visited hospital complaining of weakness, numbness and loss of sensation. She was seen by Dr. and sent home with anxiety medications and muscle relaxers. On Saturday, 2/16/2019 she visited Medical Center complaining of the same symptoms. She was admitted to the hospital for suspected Guillain-Barre syndrome (GBS). Many medical exams and tests followed....It is believed the GBS was caused by the 2/6/19 Prevnar 13 vaccination injection. Within the next week (medical records will provide exact dates) her respiratory system failed. She was intubated and placed on a ventilator for life support. She lost all consciousness and was kept sedated for many days while continuing to be supported only by the assistance of the ventilator which performed all her breathing. She was unable to come off the ventilator. She had a tracheotomy placed, a feeding tube placed and lost complete functionality in all body systems. In March of 2019, still hooked up to the ventilator and feeding tube, she was transferred from Medical Center to Hospital, where her daughter, a nurse, lives. Patient has since been placed in 4 facilities. To date she is still unable to walk and only has slight function in her upper extremities.   For efficiency Patient is in the process of requesting all her medical records from the relevant health providers attached to the required Certificate of Medical Records to be filed with our anticipated petition. From February 6, 2019 to date,  we will seek a.) medical records from Dr., Dr., Medical Center, ER, Hospital, Medicine Clinic, Hospital, School of Medicine,  and b.) her medical records from Hospital, Rehabilitation, Rehabilitation and Rehabilitation. Medical records will be compiled and attached as needed to further assist in answering any questions.  The daughter, holds her mother's Power of Attorney. Her mother's given email address and telephone number are those provded in Item # 1.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Redness present about 2 in x 2in, minor swelling, and patient states soreness from deltoid area to bicep area of left arm. Patient placed cold compresses for 20 minutes at a time.
Age: 26.0
Sex: M
Vaccine: UNK
Symptoms: Insomnia, Lymphadenopathy, Odynophagia
Clinical narrative: Severely swollen lymph nodes. Very painful to swallow, difficult to sleep comfortably.
Age: 27.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient received three vaccines, upon completion of the third vaccine, the patient blacked out with no warning and fell to the ground, it is unknown if she hit her head or not. I (immunizer) immediately called for help and rolled the patient over an began to access the situation. After the patient regained consciousness (approx 30 seconds) I asked her her name, date, location.  At that time she refused an ambulance. She remained laying down for 5 minutes then sat up seated for some time. She was provided with a cool cloth, water, and crackers. She was observed  for around 30 minutes and left with the person who accompanied her to the store.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: UNSURE WHICH VACCINATION CAUSED REDNESS AND SWELLING WITH CELLULITIS WAS GIVEN BOTH MMR AND DTAP ON THURSDAY AND RED AREA NOTED IN LT THIGH AREA.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Culture, Herpes zoster
Clinical narrative: On Tuesday he developed Shingles
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: All are currently ongoing: Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering Upset stomach Warm but not running a fever
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Skin warm
Clinical narrative: All are currently ongoing: Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering Upset stomach Warm but not running a fever
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Biopsy, Lichen planus, Rash, Swelling face
Clinical narrative: Had the shot on October 1, 2019.  I woke up on Monday, October 7, 2019 with a rash and swelling in my face.  I went to the doctor that night and saw Dr.  Dr. observed the swelling and rash on my face.  He did not know what it was but he told me to take Benadryl.  On October 22, 2019 I saw Dr., my PCP, about the dark spots that had started to form on my face.  She did not know what it was and she told me to make an appointment with a dermatologist.  I made and appointment with Dr. of Dermatology.  My appointment was on October 28, 2019.  Dr. did not know what the issue was but he made a potential diagnosis of Lichen Planus vs sarcoidosis vs lupus vs connected tissue disorder. Dr did a biopsy on my face to find out definitely what the diagnosis should be.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Laboratory test abnormal, Pemphigoid
Clinical narrative: One month later started having  Bullous Pemphigold blisters.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Immediate pain and limited range of motion following shot, continued for 48 hours. Severity improved over the next week, however at 2 weeks post-shot, I still experience pain and stiffness in my left shoulder.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: Arm soreness when lifting arm; Occasional lightheadedness; Pain and redness and swelling at injection site; Pain and redness and swelling at injection site; Pain and redness and swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, pain in arm and light headedness. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were recovered/resolved and the outcome of the pain in arm and light headedness were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, pain in arm and light headedness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and experienced pain and redness and swelling at injection site that resolved after about three days; arm soreness when lifting arm that had persisted; and occasional lightheadedness that comes and goes.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Arm soreness when lifting arm; Occasional lightheadedness; Pain and redness and swelling at injection site; Pain and redness and swelling at injection site; Pain and redness and swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, pain in arm and light headedness. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were recovered/resolved and the outcome of the pain in arm and light headedness were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, pain in arm and light headedness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and experienced pain and redness and swelling at injection site that resolved after about three days; arm soreness when lifting arm that had persisted; and occasional lightheadedness that comes and goes.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Feeling hot, Hyperhidrosis, Migraine
Clinical narrative: Chills; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st March 2020, the patient received the 1st dose of Shingrix. On 31st March 2020, immediately after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: A pharmacist who was also a patient reported that shortly after receiving the Shingrix, experienced chills that lasted four hours. Consented to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Chills; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st March 2020, the patient received the 1st dose of Shingrix. On 31st March 2020, immediately after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: A pharmacist who was also a patient reported that shortly after receiving the Shingrix, experienced chills that lasted four hours. Consented to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills
Clinical narrative: Chills; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st March 2020, the patient received the 1st dose of Shingrix. On 31st March 2020, immediately after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: A pharmacist who was also a patient reported that shortly after receiving the Shingrix, experienced chills that lasted four hours. Consented to follow up.
Age: 70.0
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: Allergic reaction; Itchy; eruption kind of resembles a Shingles rash but not exactly; Eruption / has dozens on his legs, torso, back, and side of the arms / eruptions range from being the size of a dime to the size of a quarter / eruption is painful; This case was reported by a consumer via call center representative and described the occurrence of allergic skin reaction in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (received 1st dose in December 2019 and also had itchy rash which was not recovered, refer linked case US2020054996) and Shingles vaccine (single dose received 2-3 years ago before reporting).   In March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. In March 2020, less than a month after receiving Shingrix, the patient experienced vesicular rash and painful rash. On an unknown date, the patient experienced allergic skin reaction and itchy rash. On an unknown date, the outcome of the allergic skin reaction and vesicular rash were unknown and the outcome of the painful rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the allergic skin reaction, vesicular rash, painful rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix vaccine and that he developed the same eruption and that he had dozens on his legs, torso, back, and side of the arms.  Eruption was not on his face, hands or feet.  He said that the eruption kind of resembles a shingles rash but not exactly.  He said that the eruption is painful (the pain comes and goes), itchy and that he still had one area on the thigh that was 3 months old.  He stated on that one, he had tried using a band-aid as it was below the pocket area of his pants.  He stated the eruptions range from being the size of a dime to the size of a quarter and that he had used three types of cream including an antibacterial cream.  He said that the eruption from December 2019 did not completely clear up.  He said that his doctor thought it could be psoriasis and that he went to a dermatologist and that they took a sample of the eruption.  He stated that the results showed that it was an allergic reaction and that Shingrix was the only thing that had been recently introduced.
Age: 70.0
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dermatitis allergic, Rash, Rash pruritic, Rash vesicular, Skin test positive
Clinical narrative: Allergic reaction; Itchy; eruption kind of resembles a Shingles rash but not exactly; Eruption / has dozens on his legs, torso, back, and side of the arms / eruptions range from being the size of a dime to the size of a quarter / eruption is painful; This case was reported by a consumer via call center representative and described the occurrence of allergic skin reaction in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (received 1st dose in December 2019 and also had itchy rash which was not recovered, refer linked case US2020054996) and Shingles vaccine (single dose received 2-3 years ago before reporting).   In March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. In March 2020, less than a month after receiving Shingrix, the patient experienced vesicular rash and painful rash. On an unknown date, the patient experienced allergic skin reaction and itchy rash. On an unknown date, the outcome of the allergic skin reaction and vesicular rash were unknown and the outcome of the painful rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the allergic skin reaction, vesicular rash, painful rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix vaccine and that he developed the same eruption and that he had dozens on his legs, torso, back, and side of the arms.  Eruption was not on his face, hands or feet.  He said that the eruption kind of resembles a shingles rash but not exactly.  He said that the eruption is painful (the pain comes and goes), itchy and that he still had one area on the thigh that was 3 months old.  He stated on that one, he had tried using a band-aid as it was below the pocket area of his pants.  He stated the eruptions range from being the size of a dime to the size of a quarter and that he had used three types of cream including an antibacterial cream.  He said that the eruption from December 2019 did not completely clear up.  He said that his doctor thought it could be psoriasis and that he went to a dermatologist and that they took a sample of the eruption.  He stated that the results showed that it was an allergic reaction and that Shingrix was the only thing that had been recently introduced.
Sex: M
Vaccine: HPV4
Symptoms: Death, Product use in unapproved indication
Clinical narrative: HPV vaccine used for hands warts; Literature Report:.  This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 50 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, curettage and topical fluoracil (reported as 5-FU). The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for hands warts (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   The patient's immune status was reported as none. The patient was followed up for treatment for 2 months.  The authors informed that on an unspecified date, the patient died due to natural causes.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.  Follow-up information was received via telephone call on 02-APR-2020.  A request was made for patient identifiers, events experienced and causal relationships.; Sender's Comments:  US-009507513-1912USA001729:
Sex: F
Vaccine: HPV4
Symptoms: Product use in unapproved indication
Clinical narrative: HPV vaccine for fingers warts (peringual);   This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 32 year old female patient. The patient's pertinent medical history included therapy with liquid nitrogen, salicylic acid, candida albicans, sinecatechins ointment and curettage. The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for fingers warts (peringual) (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   The patient's immune status was reported as none. The patient was followed up for treatment for 9 months. There was no resolution of patient's condition.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.  Follow-up information was received via telephone call on 02-APR-2020.  A request was made for patient identifiers, events experienced and causal relationships.; Sender's Comments:  US-009507513-1912USA001729:
Sex: M
Vaccine: HPV4
Symptoms: Product use in unapproved indication
Clinical narrative: HPV vaccine for right palm verrucae vulgaris;    This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 78 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen and curettage. The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for right palm verrucae vulgaris (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  The patient's immune status was reported as none. The patient was followed up for treatment for 8 months. There was no resolution of patient's condition.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.  Follow-up information was received via telephone call on 02-APR-2020.  A request was made for patient identifiers, events experienced and causal relationships.; Sender's Comments:  US-009507513-1912USA001729:
Sex: M
Vaccine: HPV4
Symptoms: Drug effective for unapproved indication, Product use in unapproved indication
Clinical narrative: Fingers (peringual) warts resolved; HPV vaccine for fingers (peringual) warts;   This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 35 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, salicylic acid, candida albicans and curettage). The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for fingers (peringual) warts (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   On an unspecified date, the patient's fingers (peringual) warts resolved (drug effective for unapproved indication).   The patient's immune status was reported as none. The patient was followed up for treatment for 7 months.  The outcome of drug effective for unapproved indication was unknown.   The causal relationship between the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and drug effective for unapproved indication was considered as related, as the authors hypothesize that effectiveness of the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) in extragenital warts was due to the cross-protection of extragenital strains.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.  Follow-up information was received via telephone call on 02-APR-2020.  A request was made for patient identifiers, events experienced and causal relationships.; Sender's Comments:  US-009507513-1912USA001729:
Sex: M
Vaccine: HPV4
Symptoms: Product use in unapproved indication
Clinical narrative: HPV vaccine for bilateral hands warts;   This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 46 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, candida albicans and curettage. The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for bilateral hands warts (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   The patient's immune status was reported as none. The patient was followed up for treatment for 6 months. There was no resolution of patient's condition.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.  Follow-up information was received via telephone call on 02-APR-2020.  A request was made for patient identifiers, events experienced and causal relationships.; Sender's Comments:  US-009507513-1912USA001729:
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Insomnia, Limb discomfort, Local reaction, Product use in unapproved indication
Clinical narrative: several inches down there was a linear lymphatic irritation on the skin; patient had a local reaction at the injection site; Indication: asthma; patient had trouble sleeping; discomfort in her left arm; This spontaneous report was received from a retired physician who was also the patient's father referring to a 40 years old female patient. The patient's concomitant medication included unspecified asthma medications. The patient had no pertinent medical history and no drug reactions/ allergies.   On 16-MAR-2020 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, lot # and expiration date were not reported) via intramuscular in the left arm for prophylaxis (also reported as asthma) (product use in unapproved indication).         On 16-MAR-2020, the patient had trouble sleeping due to discomfort in her left arm. Whether treatment was given for the events was unknown. On 17-MAR-2020, the patient had a local reaction at the injection site and then several inches down there was a linear lymphatic irritation on the skin. It did not appear to be a cellulitis at this time. The patient was to monitor the site and used ice for discomfort. None lab diagnostics/studies were performed. The patient had sought medical attention.  Outcome of the events was not recovered. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.
Sex: F
Vaccine: PPV
Symptoms: Skin irritation
Clinical narrative: several inches down there was a linear lymphatic irritation on the skin; patient had a local reaction at the injection site; Indication: asthma; patient had trouble sleeping; discomfort in her left arm; This spontaneous report was received from a retired physician who was also the patient's father referring to a 40 years old female patient. The patient's concomitant medication included unspecified asthma medications. The patient had no pertinent medical history and no drug reactions/ allergies.   On 16-MAR-2020 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, lot # and expiration date were not reported) via intramuscular in the left arm for prophylaxis (also reported as asthma) (product use in unapproved indication).         On 16-MAR-2020, the patient had trouble sleeping due to discomfort in her left arm. Whether treatment was given for the events was unknown. On 17-MAR-2020, the patient had a local reaction at the injection site and then several inches down there was a linear lymphatic irritation on the skin. It did not appear to be a cellulitis at this time. The patient was to monitor the site and used ice for discomfort. None lab diagnostics/studies were performed. The patient had sought medical attention.  Outcome of the events was not recovered. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.