chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. In 2012, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) at a medical facility/office, (by an unspecified health care professional), for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. During 2013, the patient was treated at the medical facility/office (by an unspecified healthcare professional), for a vesicular outbreak, which was diagnosed as shingles and Ramsey Hunt Syndrome, a neurological disorder secondary to zoster infections. As a direct and proximate result of the 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, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Upon internal review, Ramsey Hunt Syndrome was determined to be a medically significant event. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site erythema in a 73-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included acetylsalicylic acid (Baby Aspirin). On 22nd May 2018, the patient received the 1st dose of SHINGRIX. On 22nd May 2018, several hours after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling, injection site itching, injection site lump, influenza-like symptoms, feeling unwell and chills. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling, influenza-like symptoms, feeling unwell and chills were recovered/resolved and the outcome of the injection site itching and injection site lump were recovering/resolving. The reporter considered the injection site erythema, injection site pain, injection site swelling, injection site itching, injection site lump, influenza-like symptoms, feeling unwell and chills to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient and was not reported to anyone previously. The patient received OTC probiotics as concomitant medication. The patient experienced injection site reactions consisting of redness, pain, and swelling. The patient also experienced flu like symptoms described as not feeling well, and chills. The symptoms began on the same day, a few hours after receiving the SHINGRIX vaccine and lasted for about 10 days. The patient stated that, the injection site still itches and had a lump under the site.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Malaise
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site erythema in a 73-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included acetylsalicylic acid (Baby Aspirin). On 22nd May 2018, the patient received the 1st dose of SHINGRIX. On 22nd May 2018, several hours after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling, injection site itching, injection site lump, influenza-like symptoms, feeling unwell and chills. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling, influenza-like symptoms, feeling unwell and chills were recovered/resolved and the outcome of the injection site itching and injection site lump were recovering/resolving. The reporter considered the injection site erythema, injection site pain, injection site swelling, injection site itching, injection site lump, influenza-like symptoms, feeling unwell and chills to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient and was not reported to anyone previously. The patient received OTC probiotics as concomitant medication. The patient experienced injection site reactions consisting of redness, pain, and swelling. The patient also experienced flu like symptoms described as not feeling well, and chills. The symptoms began on the same day, a few hours after receiving the SHINGRIX vaccine and lasted for about 10 days. The patient stated that, the injection site still itches and had a lump under the site.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 1st June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd June 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms and feeling bad. On 4th June 2018, the outcome of the influenza-like symptoms and feeling bad were recovered/resolved. The reporter considered the influenza-like symptoms and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient woke up on Saturday morning feeling bad.
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Underdose
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult female patient who received HAV (HAVRIX pediatric) (batch number 39Y4G, expiry date 29th October 2018) for prophylaxis. On an unknown date, the patient received HAVRIX pediatric. On an unknown date, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown. Additional details were provided as follows: The age at vaccination was not reported. An adult patient was given a pediatric dose of HAVRIX which led to underdose and adult use of a child product. This case has been linked with case US2018100653, reported by the same reporter for the same event.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 61-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. Concurrent medical conditions included hashimoto's disease. Concomitant products included calcium salt (Calcium), vitamin d and levothyroxine sodium (Synthroid). On 4th June 2018 09:31, the patient received the 1st dose of SHINGRIX. On 5th June 2018, 1 days after receiving SHINGRIX, the patient experienced fever, nausea, injection site pain, chills, tremor, headache and muscle pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, nausea, injection site pain, chills, tremor, headache and muscle pain were recovering/resolving. The reporter considered the fever, nausea, injection site pain, chills, tremor, headache and muscle pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by office manager. The patient received Shingrix vaccine on left arm. The health care professional reported that a patient received her first dose of SHINGRIX and the following day developed fever, chills, headache, shaking, nausea, muscle aches and pains, and injection site pain. The patient took Tylenol which helped alleviate symptoms.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 61-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. Concurrent medical conditions included hashimoto's disease. Concomitant products included calcium salt (Calcium), vitamin d and levothyroxine sodium (Synthroid). On 4th June 2018 09:31, the patient received the 1st dose of SHINGRIX. On 5th June 2018, 1 days after receiving SHINGRIX, the patient experienced fever, nausea, injection site pain, chills, tremor, headache and muscle pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, nausea, injection site pain, chills, tremor, headache and muscle pain were recovering/resolving. The reporter considered the fever, nausea, injection site pain, chills, tremor, headache and muscle pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by office manager. The patient received Shingrix vaccine on left arm. The health care professional reported that a patient received her first dose of SHINGRIX and the following day developed fever, chills, headache, shaking, nausea, muscle aches and pains, and injection site pain. The patient took Tylenol which helped alleviate symptoms.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. On 20th May 2018, the patient received SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, mobility decreased and neck pain. On an unknown date, the outcome of the pain in arm, mobility decreased and neck pain were not recovered/not resolved. The reporter considered the pain in arm, mobility decreased and neck pain to be related to SHINGRIX. Additional details were provided as follows: At 13:05 hours, the patient received SHINGRIX on right arm. Sometimes later, the patient developed pain going up her arm and radiating into her neck, with some loss of movement in the arm. The patient was instructed to ice the area, and also used heat which did not help.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 6th April 2018, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced an episode of shingles. The patient was asking if she should receive 2nd dose of SHINGRIX to help protect her against future additional episodes.
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Flatulence, Laboratory test, Limb discomfort, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for herself. This 67-year-old female patient received PREVNAR 13 about two months before reporting, at single dose at right arm  for immunization. Medical history includes ongoing diabetes. Concomitant medication includes insulin aspart (NOVOLOG). Past vaccination history includes pneumococcal vaccine, about 13 years before.  After the injection, she has experienced right arm pain, arm had not got well at all yet, had pain, swelling comes and goes and arm on the right side is not right, mean it doesn't feel good, had kind of sick at stomach, had a lot of gas. Pain went all around, all over my back, around arm and back on the right side. She underwent lab work, on an unknown date and results were unknown. The outcome of the events was not recovered. The information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for herself. This 67-year-old female patient received PREVNAR 13 about two months before reporting, at single dose at right arm  for immunization. Medical history includes ongoing diabetes. Concomitant medication includes insulin aspart (NOVOLOG). Past vaccination history includes pneumococcal vaccine, about 13 years before.  After the injection, she has experienced right arm pain, arm had not got well at all yet, had pain, swelling comes and goes and arm on the right side is not right, mean it doesn't feel good, had kind of sick at stomach, had a lot of gas. Pain went all around, all over my back, around arm and back on the right side. She underwent lab work, on an unknown date and results were unknown. The outcome of the events was not recovered. The information on the batch number has been requested.
Sex: M
Vaccine: MENB
Symptoms: Disturbance in attention, Dyspepsia, Fatigue, Feeding disorder, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her son. A 17-year-old male patient received TRUMENBA, (lot number and expiration date were unknown) via an unspecified route of administration in the arm on 05Jun2018 at a single dose for immunization.  The patient medical history was not reported. There were no concomitant medications. The reporter stated "he received the shot yesterday (on 05Jun2018) and when he received the shot he complaint about not feeling well, last night he went to bed I guess kind of hauntable without of it but he came home today from school he had two tests to take and he said how he was not able to focus and his stomach was burning, like he had a burning sensation in his stomach, he was unable to eat lunch today. The arm in which he received the shot, it's still aching and he is sleeping right now, he is just really been fatigued. It stayed with him all of the day, with this headache he was feeling, he was not able to concentrate and is again not been able to eat for lunch time because his stomach was like burning." All the events occurred on an unspecified date in Jun2018. The reporter stated that the patient was a healthy boy. The outcome of the events was unknown. The information on the batch number has been requested.
Sex: M
Vaccine: MENB
Symptoms: Malaise, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her son. A 17-year-old male patient received TRUMENBA, (lot number and expiration date were unknown) via an unspecified route of administration in the arm on 05Jun2018 at a single dose for immunization.  The patient medical history was not reported. There were no concomitant medications. The reporter stated "he received the shot yesterday (on 05Jun2018) and when he received the shot he complaint about not feeling well, last night he went to bed I guess kind of hauntable without of it but he came home today from school he had two tests to take and he said how he was not able to focus and his stomach was burning, like he had a burning sensation in his stomach, he was unable to eat lunch today. The arm in which he received the shot, it's still aching and he is sleeping right now, he is just really been fatigued. It stayed with him all of the day, with this headache he was feeling, he was not able to concentrate and is again not been able to eat for lunch time because his stomach was like burning." All the events occurred on an unspecified date in Jun2018. The reporter stated that the patient was a healthy boy. The outcome of the events was unknown. The information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13 (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness at injection site on an unspecified date. It was reported that event took place after use of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). The outcome of the event was unknown. The following information on the batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Swelling face
Clinical narrative: This is a spontaneous report from a contactable other HCP received via a Pfizer sales representative. A female patient of an unspecified age receive TRUMENBA, (batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the young lady had facial swelling after she had vaccine 1 year ago, didn't know if allergic reaction. The outcome of the events was unknown. The information on the batch/lot number and expiration date has been requested.
Sex: U
Vaccine: MNQ
Symptoms: Device connection issue, Underdose
Clinical narrative: Initial unsolicited report received from a Nurse on 25-May-2018. This case involves a patient (age and gender not reported) who have not received all of the dose of MENACTRA (Batch number, expiry date, dose, dose in series, route and side of administration were not reported) as the needle came off the syringe on an unknown date. Patient's medical history and concomitant medication were not reported. It was a case of actual medication error due to vaccine underdose, occupational exposure to product and needle issue. It was unknown whether adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Adverse reaction, Expired product administered
Clinical narrative: Initial unsolicited report received from Health care professional on 29-May-2018. This case involves female patient (age also reported as less than 1 year as 2m, 4m) who was vaccinated with an 0.5 ml once expired dose of MENACTRA (batch number- U54642AA, expiration date, dose, dose in series, route of administration was not reported) in right deltoid on an unknown date. Medical history were not reported. No other vaccines used. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Adverse reaction, Expired product administered
Clinical narrative: Initial unsolicited report received from Health care professional on 29-May-2018. This case involves female patient (age not reported) who was vaccinated with an expired dose of MENACTRA (batch number, expiration date, dose, dose in series, route, site of administration was not reported) on an unknown date. Medical history was not reported. Concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Two hours after receiving vaccine, pt. began having chills, fever (102.5) and body aches.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Shows up to clinic 7 days after injection with redness, warmth and induration at site of injection (40mm x 40mm).
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Musculoskeletal pain
Clinical narrative: Redness about 5 inches around site of injection, heat, pain in shoulder lasting 6 days after injection treatment: ibuprofen, BENADRYL.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Dyspnoea, Rash, Respiratory distress, Stridor
Clinical narrative: 15 month old male with no significant medical history received Hib and DTap immunizations in clinic on 6/6 and subsequently developed difficulty breathing, stridor and rash approximately 1 hour administration. Was transported to ED via ambulance where he received IM Epinephrine, IV Benadryl, IV MPS, IV Famotidine. Respiratory distress improved after medication administration and patient was discharged home after a 4 hour monitoring period.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Seizure
Clinical narrative: Mom reported patient was having seizures 3 hours after 12 month vaccines.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Redness, swelling, bumps that lasted about 3 weeks.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Hypoaesthesia, Limb mass, Mobility decreased, Myalgia
Clinical narrative: Swelling in arm, large lump, lose of use of arm (unable to raise arm), muscular aches, pain, numbness in arm, pain in elbow. 6 weeks still with symptoms. Started with Tylenol, aspirin, cool compress. Prescribed Naproxen (no results with Naproxen). Back to Dr. and was given Prednisone to relieve pain.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Peripheral swelling
Clinical narrative: Swelling in arm, large lump, lose of use of arm (unable to raise arm), muscular aches, pain, numbness in arm, pain in elbow. 6 weeks still with symptoms. Started with Tylenol, aspirin, cool compress. Prescribed Naproxen (no results with Naproxen). Back to Dr. and was given Prednisone to relieve pain.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Condition aggravated, Herpes zoster, Pain in extremity, Rash
Clinical narrative: Patient states she had four eruptions on her right buttocks after receiving SHINGRIX immunization.  One area of involvement had a "big blister". Doctor was visited 6/12/18 and patient was diagnosed with Shingles. This is an unconfirmed patient report. Patient also had the expected arm pain which persisted for 3 to 4 days.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site mass, Lymphadenopathy, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Patient states she had four eruptions on her right buttocks after receiving SHINGRIX immunization.  One area of involvement had a "big blister". Doctor was visited 6/12/18 and patient was diagnosed with Shingles. This is an unconfirmed patient report. Patient also had the expected arm pain which persisted for 3 to 4 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pain, Painful respiration
Clinical narrative: Pts husband called since his wife was not feeling well starting this morning 6/12. No swelling or redness or pain at injection site but overall feelings of fatigue/pain/sick, pain with breathing this morning but not anymore. Instructed pt to call MD. No swelling in face/throat or vomiting or rash and patient feels better than she did this morning but still feels sick.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Crying, Feeling abnormal, Feeling cold, Laboratory test
Clinical narrative: Mom was in the room with patient and she reported that she didn't feel well so she laid on the table. Per mom, she became unresponsive and her arms became tense. Mom called for help, employee arrived in the room just ahead of me. As employee entered she saw that patient was stiff and shaking. As I entered, she had urinary incontinence (probably within one minute of the seizure like activity). She was pale, eyes were open, pupils dilated. Neck arched back, elbows flexed with arms crossed over chest with stiffness of her entire body. This lasted for about 2 minutes, 911 was called but cancelled as she recovered quickly. She cried uncontrollably for several minutes and was only able to say  "I feel weird". She did not have a post ictal period. She was cold and shakey, resolved with juice. When I entered the room, she was coherent but feeling weak. Discussed action plan in the event she felt dizzy with walking. I called Dr to discuss her seizure like acitivity given her urinary incontinence She feels this can still be consistent with and increase in vagal tone and emotional output and essentially be a reflexive type of seizure. They will arrange to see her in their office.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Malaise, Musculoskeletal stiffness, Mydriasis, Pallor, Seizure like phenomena
Clinical narrative: Mom was in the room with patient and she reported that she didn't feel well so she laid on the table. Per mom, she became unresponsive and her arms became tense. Mom called for help, employee arrived in the room just ahead of me. As employee entered she saw that patient was stiff and shaking. As I entered, she had urinary incontinence (probably within one minute of the seizure like activity). She was pale, eyes were open, pupils dilated. Neck arched back, elbows flexed with arms crossed over chest with stiffness of her entire body. This lasted for about 2 minutes, 911 was called but cancelled as she recovered quickly. She cried uncontrollably for several minutes and was only able to say  "I feel weird". She did not have a post ictal period. She was cold and shakey, resolved with juice. When I entered the room, she was coherent but feeling weak. Discussed action plan in the event she felt dizzy with walking. I called Dr to discuss her seizure like acitivity given her urinary incontinence She feels this can still be consistent with and increase in vagal tone and emotional output and essentially be a reflexive type of seizure. They will arrange to see her in their office.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Tremor, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Mom was in the room with patient and she reported that she didn't feel well so she laid on the table. Per mom, she became unresponsive and her arms became tense. Mom called for help, employee arrived in the room just ahead of me. As employee entered she saw that patient was stiff and shaking. As I entered, she had urinary incontinence (probably within one minute of the seizure like activity). She was pale, eyes were open, pupils dilated. Neck arched back, elbows flexed with arms crossed over chest with stiffness of her entire body. This lasted for about 2 minutes, 911 was called but cancelled as she recovered quickly. She cried uncontrollably for several minutes and was only able to say  "I feel weird". She did not have a post ictal period. She was cold and shakey, resolved with juice. When I entered the room, she was coherent but feeling weak. Discussed action plan in the event she felt dizzy with walking. I called Dr to discuss her seizure like acitivity given her urinary incontinence She feels this can still be consistent with and increase in vagal tone and emotional output and essentially be a reflexive type of seizure. They will arrange to see her in their office.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Fatigue, Headache, Injection site discomfort
Clinical narrative: Onset of fever and injection site pain following vaccine administration. Then shaking chills during the evening with headache, extreme fatigue and prostration lasting 48 hours. Also experienced severe bone pain (all extremities in addition to muscle pain). I only experienced injection site discomfort after the first SHINGRIX on 2/20/2018 Lot 79N59. Of note I received ZOSTAVAX 10/11/2012. I had chickenpox as a child and have not had shingles. I am a retired pediatrician.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pyrexia, Tremor
Clinical narrative: Onset of fever and injection site pain following vaccine administration. Then shaking chills during the evening with headache, extreme fatigue and prostration lasting 48 hours. Also experienced severe bone pain (all extremities in addition to muscle pain). I only experienced injection site discomfort after the first SHINGRIX on 2/20/2018 Lot 79N59. Of note I received ZOSTAVAX 10/11/2012. I had chickenpox as a child and have not had shingles. I am a retired pediatrician.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Attention deficit/hyperactivity disorder, Disturbance in attention, Insomnia, Irritability
Clinical narrative: During the first year after receiving the vaccines, I began experiencing anxiety (moderate to severe). I also began having serious trouble sleeping, restlessness, irritability, major trouble concentrating and staying focused. During my last year in high school I was having trouble, even though I had always been a good student. When I began college in 2009, I was having serious issues with staying focused on my work. It was in/around 2012/2013 that the dept counselor/school doctor referred me to see a doctor for my lack of concentration. They diagnosed me with ADHD and also informed me it was odd that I did not have these troubles as a child or a teen. Each issue I have experienced took place after I was vaccinated for HPV. I received all 3 vaccines in the series.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Restlessness
Clinical narrative: During the first year after receiving the vaccines, I began experiencing anxiety (moderate to severe). I also began having serious trouble sleeping, restlessness, irritability, major trouble concentrating and staying focused. During my last year in high school I was having trouble, even though I had always been a good student. When I began college in 2009, I was having serious issues with staying focused on my work. It was in/around 2012/2013 that the dept counselor/school doctor referred me to see a doctor for my lack of concentration. They diagnosed me with ADHD and also informed me it was odd that I did not have these troubles as a child or a teen. Each issue I have experienced took place after I was vaccinated for HPV. I received all 3 vaccines in the series.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Pain in extremity
Clinical narrative: Patient reported numbness, tingling and pain all the way down her left arm to her fingers.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Patient reported numbness, tingling and pain all the way down her left arm to her fingers.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse regarding an 12 months old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 02-JUN-2018, the patient was inadvertently vaccinated with PROQUAD lot # N024562 and 06-MAR-2019 expiration date for prophylaxis (dose, strength, frequency and route of administration were not reported) instead of M-M-R II for prophylaxis (dose, strength, frequency, lot#, expiration date and route of administration were not reported). No adverse effects were reported. No product quality complain was present.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During January of 2011, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), at a clinic (by an unspecified healthcare professional), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-JUN-2016, the patient was treated at a medical center (by an unspecified healthcare professional) for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. 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 27-SEP-2012, the patient was inoculated with ZOSTAVAX at the department of health as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated by a physician for a persistent and severe vesicular 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 15-AUG-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy 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. During 2015, the patient was treated by a physician at an internal medicine office for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has 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.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-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 January 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy 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 July 2016, the patient was treated at a family medicine office for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has 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.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-DEC-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 30-APR-2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient has been prescribed valacyclovir (VALTREX) and mupirocin (BACTROBAN)  for management of her painful symptoms and chronic pain. As a direct and proximate result of the 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 is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 22-SEP-2012, the patient was inoculated with  ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-JUL-2013, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient has been prescribed valacyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the 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 is unknown. Additional information has been requested.
Age: 0.42
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a public health nurse and refers to a currently 6 month old female patient. There was no information about patient's concurrent conditions, medical history or concomitant medications. Two instances of a temperature excursion took place. The first excursion occurred on an unspecified date in March 2018. Following which, it was reported that approval was provided from the manufacturer for the effected vaccinations to be administered. On 08-MAY-2018, the patient, at an approximate age of 5 months, was vaccinated with improperly stored ROTATEQ orally, lot # N012757 with expiration date of 27-JAN-219 for prophylaxis. Dosing details were not reported. The first temperature excursion occurred in a range at or above 32 Fahrenheit (°F) degrees to 35°F for 19 hours and 30 minutes. The second excursion occurred on 15-MAY-2018; the details of which were not reported. Following the second temperature excursion, there have been no doses of the vaccination ROTATEQ administered. No adverse effects were reported. A previous temperature excursion was reported to have occurred on an unknown date in a range at or above 32°F to 35°F for 4 hours. A digital data logger was involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1803USA011860: US-009507513-1806USA004705:
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Eye irritation, Herpes ophthalmic, Herpes virus infection, Vision blurred
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of herpes ophthalmic in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ACE inhibitors with an associated reaction of anaphylactic reaction. Concurrent medical conditions included implantable defibrillator insertion (in 2005), supraventricular tachycardia and allergy (Penicillin). Concomitant products included Aspirin, Probiotics), vitamin B complex, vitamin D, Calcium, Coreg, Crestor, hydrochlorothiazide, Dyazide, glucosamine, omeprazole, Co Q 10 and verapamil. On 4th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, less than a year after receiving SHINGRIX, the patient experienced blurred vision. On 20th May 2018, the patient experienced herpes ophthalmic (serious criteria GSK medically significant) and eye irritation. On an unknown date, the outcome of the herpes ophthalmic was not recovered/not resolved and the outcome of the eye irritation and blurred vision were unknown. The reporter considered the herpes ophthalmic to be related to SHINGRIX. It was unknown if the reporter considered the eye irritation and blurred vision to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Concomitant medication included multivitamins. After 16 days of vaccination, the patient reported that the she experienced irritation in the right eye while on vaccination and upon return to home, she was seen by ophthalmologist and diagnosed with herpetic infection in that eye. The patient reported that she experienced irritation and blurry vision in the eye, at the time of reporting, as a result as an infection and that it had not responded to antiviral eye drops. The patient reported that the vision had gotten worse since diagnosis. The reporter unable to provide full demographics for the pharmacy or her ophthalmologist. The representative researched the data to saw if there was any similar report. There were no reports. The call center representative taken patient's physician contact for further information, so that he could contact them.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blindness unilateral
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of herpes ophthalmic in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ACE inhibitors with an associated reaction of anaphylactic reaction. Concurrent medical conditions included implantable defibrillator insertion (in 2005), supraventricular tachycardia and allergy (Penicillin). Concomitant products included Aspirin, Probiotics), vitamin B complex, vitamin D, Calcium, Coreg, Crestor, hydrochlorothiazide, Dyazide, glucosamine, omeprazole, Co Q 10 and verapamil. On 4th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, less than a year after receiving SHINGRIX, the patient experienced blurred vision. On 20th May 2018, the patient experienced herpes ophthalmic (serious criteria GSK medically significant) and eye irritation. On an unknown date, the outcome of the herpes ophthalmic was not recovered/not resolved and the outcome of the eye irritation and blurred vision were unknown. The reporter considered the herpes ophthalmic to be related to SHINGRIX. It was unknown if the reporter considered the eye irritation and blurred vision to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Concomitant medication included multivitamins. After 16 days of vaccination, the patient reported that the she experienced irritation in the right eye while on vaccination and upon return to home, she was seen by ophthalmologist and diagnosed with herpetic infection in that eye. The patient reported that she experienced irritation and blurry vision in the eye, at the time of reporting, as a result as an infection and that it had not responded to antiviral eye drops. The patient reported that the vision had gotten worse since diagnosis. The reporter unable to provide full demographics for the pharmacy or her ophthalmologist. The representative researched the data to saw if there was any similar report. There were no reports. The call center representative taken patient's physician contact for further information, so that he could contact them.