chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Symptoms were not directly observed at this facility. Symptoms were reported as erythema, inflammation and warmth over the entirety of the injection arm (shoulder to fingers). Treatment was uncertain from the patient but she stated she was discharged with instructions to use intermittent icing with ice packs/ice.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Symptoms were not directly observed at this facility. Symptoms were reported as erythema, inflammation and warmth over the entirety of the injection arm (shoulder to fingers). Treatment was uncertain from the patient but she stated she was discharged with instructions to use intermittent icing with ice packs/ice.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt. presented with  a large encircled area of right arm, just below the typical injection site for deltoid IM injections. The area was red, mildly swollen, slightly warm per pt.,  and itchy. She stated it begun recently, a few days after injection. She thinks it started Mon 07-23, the day after vaccine administration. She was instructed to report to doctor's office, and was told we would report the adverse event as well.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized redness and swelling around injection site in round shaped area of approximately 3x3 inches.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Pyrexia
Clinical narrative: Upset stomach and low grade fever (100 degrees F) -> same Sx on both 1st and 2nd vaccine in series.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Affective disorder, Crying, Depressed mood, Inappropriate affect, Incoherent
Clinical narrative: Excessive crying, picking/swatting at arm. Family left after 15 min observation period but returned 1h. later for increased sadness, babbling/incoherent speech and picking at arm. On reassessment, VSS, A+Ox3. Crying but would laugh when asked math problems. Remainder of exam normal, neuro normal. Mom advised to monitor closely for extreme sadness, mood lability. Patient denied wanting to hurt herself. Signs of seizure activity reviewed. Plan for family to go to ED if seizure activity developed overnight. Teen slept well and mom reported no problems the next morning.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Intentional self-injury, Neurological examination normal
Clinical narrative: Excessive crying, picking/swatting at arm. Family left after 15 min observation period but returned 1h. later for increased sadness, babbling/incoherent speech and picking at arm. On reassessment, VSS, A+Ox3. Crying but would laugh when asked math problems. Remainder of exam normal, neuro normal. Mom advised to monitor closely for extreme sadness, mood lability. Patient denied wanting to hurt herself. Signs of seizure activity reviewed. Plan for family to go to ED if seizure activity developed overnight. Teen slept well and mom reported no problems the next morning.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Erythema, Fatigue, Feeling abnormal
Clinical narrative: Side effects from SHINGRIX 500 mcg, Redness and swelling and muscle pain, headaches, fever, shivering, feeling tired and weak, felt so bad had to go to the doctor.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia, Swelling
Clinical narrative: Side effects from SHINGRIX 500 mcg, Redness and swelling and muscle pain, headaches, fever, shivering, feeling tired and weak, felt so bad had to go to the doctor.
Age: 17.0
Sex: F
Vaccine: IPV, MENB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: IPOL was given in error. 0.1ml into (L) forearm intradermal. Was supposed to receive 0.1ml TB intradermal test.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Eye pain, Facial pain, Headache, Injection site erythema
Clinical narrative: Received SHINGRIX 50 mcg vaccine at local pharmacy per PCP advice and Rx. Within 6 hours developed egg-size very painful knot at injection site. Proceeded to develop serious neck and back pain with moderate headache, all of which precluded sleep that night. Symptoms continued on Day 2 along with general malaise. Since cannot take NSAIDs due to GI sensitivity, took 2.5mg of hydrocodone on afternoon of Day 2 and managed to get a couple of hours sleep. Symptoms began to subside late Day 2, but injection site remained hard and mildly painful while becoming inflamed. Day 3 was better with only mild pain and redness at injection site, however during Day 3 overnight, developed episodes of significant face and eye pain during sleep. Not sure this was related to injection, but it was something I never experienced before. At this time (morning Day 4), no significant pain, although injection site remains swollen and slightly red. Hopefully this is the end. I am a 66YO male in good health and am reporting this because this is by far the worst reaction I've ever had to any vaccination and feel like I've wasted 2 days of my life. Further, there was absolutely no advance warning that this could happen, although a little research on the internet suggests that these side effects are common. Consumers should know what to expect so they can make an informed decision. I'm not sure whether I would have gone through with the vaccination, knowing what I know now and I will be talking with my PCP about the second dose, due in 2 months.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site inflammation, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Received SHINGRIX 50 mcg vaccine at local pharmacy per PCP advice and Rx. Within 6 hours developed egg-size very painful knot at injection site. Proceeded to develop serious neck and back pain with moderate headache, all of which precluded sleep that night. Symptoms continued on Day 2 along with general malaise. Since cannot take NSAIDs due to GI sensitivity, took 2.5mg of hydrocodone on afternoon of Day 2 and managed to get a couple of hours sleep. Symptoms began to subside late Day 2, but injection site remained hard and mildly painful while becoming inflamed. Day 3 was better with only mild pain and redness at injection site, however during Day 3 overnight, developed episodes of significant face and eye pain during sleep. Not sure this was related to injection, but it was something I never experienced before. At this time (morning Day 4), no significant pain, although injection site remains swollen and slightly red. Hopefully this is the end. I am a 66YO male in good health and am reporting this because this is by far the worst reaction I've ever had to any vaccination and feel like I've wasted 2 days of my life. Further, there was absolutely no advance warning that this could happen, although a little research on the internet suggests that these side effects are common. Consumers should know what to expect so they can make an informed decision. I'm not sure whether I would have gone through with the vaccination, knowing what I know now and I will be talking with my PCP about the second dose, due in 2 months.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Neck pain
Clinical narrative: Received SHINGRIX 50 mcg vaccine at local pharmacy per PCP advice and Rx. Within 6 hours developed egg-size very painful knot at injection site. Proceeded to develop serious neck and back pain with moderate headache, all of which precluded sleep that night. Symptoms continued on Day 2 along with general malaise. Since cannot take NSAIDs due to GI sensitivity, took 2.5mg of hydrocodone on afternoon of Day 2 and managed to get a couple of hours sleep. Symptoms began to subside late Day 2, but injection site remained hard and mildly painful while becoming inflamed. Day 3 was better with only mild pain and redness at injection site, however during Day 3 overnight, developed episodes of significant face and eye pain during sleep. Not sure this was related to injection, but it was something I never experienced before. At this time (morning Day 4), no significant pain, although injection site remains swollen and slightly red. Hopefully this is the end. I am a 66YO male in good health and am reporting this because this is by far the worst reaction I've ever had to any vaccination and feel like I've wasted 2 days of my life. Further, there was absolutely no advance warning that this could happen, although a little research on the internet suggests that these side effects are common. Consumers should know what to expect so they can make an informed decision. I'm not sure whether I would have gone through with the vaccination, knowing what I know now and I will be talking with my PCP about the second dose, due in 2 months.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Myalgia, Pain
Clinical narrative: Pt received the 2nd dose of the SHINGRIX on 7/23/18. Pt called on 7/24/18 to report she was having fatigue, aching, shivering, muscle pain, mild diarrhea and a low grade fever. This started the night of the vaccine. She did not have any of these side effects with the first shot in the series. I called Glaxo and was advised that these side effects have been reported more by patients after they receive the 2nd dose of the SHINGRIX.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt received the 2nd dose of the SHINGRIX on 7/23/18. Pt called on 7/24/18 to report she was having fatigue, aching, shivering, muscle pain, mild diarrhea and a low grade fever. This started the night of the vaccine. She did not have any of these side effects with the first shot in the series. I called Glaxo and was advised that these side effects have been reported more by patients after they receive the 2nd dose of the SHINGRIX.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Myalgia, Pyrexia
Clinical narrative: Pt received the 2nd dose of the SHINGRIX on 7/23/18. Pt called on 7/24/18 to report she was having fatigue, aching, shivering, muscle pain, mild diarrhea and a low grade fever. This started the night of the vaccine. She did not have any of these side effects with the first shot in the series. I called Glaxo and was advised that these side effects have been reported more by patients after they receive the 2nd dose of the SHINGRIX.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting projectile
Clinical narrative: When giving ROTATEQ vaccine child projectile vomited every time attempt was made to give vaccine.
Age: 17.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Contraindication to vaccination
Clinical narrative: Patient presented from their GI to have Hep B and VARIVAX repeated prior to planned HUMIRA therapy. Vaccine given and I then contacted Infectious Disease and they advised patient is mildly immunosuppressed and recommended post exposure prophylaxis with acyclovir 5 times/d x 2wk. She is on current acyclovir.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Blister, Burning sensation, Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling, itching, burning, blistering.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Entire deltoid area of left arm began to feel hot swollen and itchy greater than 2 hours after the injection. Patient presented back to office w/normal vitals and no resp. sx. Localized heat and swelling w/spreading wheal appearance was verified applied ice/gave 50 mg oral BENADRYL and 400 mg Ibuprofen w/good response. Tried to call, unable to reach; was improved when left office.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Local reaction
Clinical narrative: 7x7 cm local reaction - red.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of arm paralysis in a 77-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included knee arthritis (bilateral knee). On 16th April 2018, the patient received the 1st dose of SHINGRIX. On 16th April 2018, several hours after receiving SHINGRIX, the patient experienced arm paralysis (serious criteria GSK medically significant), injection site pain and abnormal sensation of limbs. On an unknown date, the outcome of the arm paralysis, injection site pain and abnormal sensation of limbs were recovered/resolved. It was unknown if the reporter considered the arm paralysis, injection site pain and abnormal sensation of limbs to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to the physician. The patient received SHINGRIX at mid-morning. The patient noted her arm feeling funny began around 5pm or 5:30 pm, exact time was not provided. The patient noted right arm pain began at approximately 6:30 pm. The arm feeling funny described as paralyzed and had to use left arm to lift the right arm. The patient visited the physician on Tuesday and was advised to follow up. The reporter noted arm feeling funny and arm pain completely resolved by Friday.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Monoplegia, Pain in extremity, Sensory disturbance
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of arm paralysis in a 77-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included knee arthritis (bilateral knee). On 16th April 2018, the patient received the 1st dose of SHINGRIX. On 16th April 2018, several hours after receiving SHINGRIX, the patient experienced arm paralysis (serious criteria GSK medically significant), injection site pain and abnormal sensation of limbs. On an unknown date, the outcome of the arm paralysis, injection site pain and abnormal sensation of limbs were recovered/resolved. It was unknown if the reporter considered the arm paralysis, injection site pain and abnormal sensation of limbs to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to the physician. The patient received SHINGRIX at mid-morning. The patient noted her arm feeling funny began around 5pm or 5:30 pm, exact time was not provided. The patient noted right arm pain began at approximately 6:30 pm. The arm feeling funny described as paralyzed and had to use left arm to lift the right arm. The patient visited the physician on Tuesday and was advised to follow up. The reporter noted arm feeling funny and arm pain completely resolved by Friday.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Blood test, Computerised tomogram, Dehydration, Wound infection
Clinical narrative: This case was reported by a consumer and described the occurrence of leg infection in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included leg injury (had a leg wound about a week before the patient received SHINGRIX). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced leg infection and unwell. The patient was treated with Antibiotics (Brand Names Not Known). On an unknown date, the outcome of the leg infection was not recovered/not resolved and the outcome of the unwell was unknown. It was unknown if the reporter considered the leg infection and unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's son. The age at vaccination was not reported. The patient had a leg wound about a week before she received one of SHINGRIX shots. It was healing and looking better. Two days after the patient received SHINGRIX shot, her leg was very infected. The reporter took the patient to the physician and the emergency room for treatment. As a result she was on two weeks antibiotics and did not feel well or act 100 percent. The reporter was very hesitant for her to get a second shot after the results from the first one.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: X-ray
Clinical narrative: This case was reported by a consumer and described the occurrence of leg infection in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included leg injury (had a leg wound about a week before the patient received SHINGRIX). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced leg infection and unwell. The patient was treated with Antibiotics (Brand Names Not Known). On an unknown date, the outcome of the leg infection was not recovered/not resolved and the outcome of the unwell was unknown. It was unknown if the reporter considered the leg infection and unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's son. The age at vaccination was not reported. The patient had a leg wound about a week before she received one of SHINGRIX shots. It was healing and looking better. Two days after the patient received SHINGRIX shot, her leg was very infected. The reporter took the patient to the physician and the emergency room for treatment. As a result she was on two weeks antibiotics and did not feel well or act 100 percent. The reporter was very hesitant for her to get a second shot after the results from the first one.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Localised infection, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of leg infection in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included leg injury (had a leg wound about a week before the patient received SHINGRIX). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced leg infection and unwell. The patient was treated with Antibiotics (Brand Names Not Known). On an unknown date, the outcome of the leg infection was not recovered/not resolved and the outcome of the unwell was unknown. It was unknown if the reporter considered the leg infection and unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's son. The age at vaccination was not reported. The patient had a leg wound about a week before she received one of SHINGRIX shots. It was healing and looking better. Two days after the patient received SHINGRIX shot, her leg was very infected. The reporter took the patient to the physician and the emergency room for treatment. As a result she was on two weeks antibiotics and did not feel well or act 100 percent. The reporter was very hesitant for her to get a second shot after the results from the first one.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye irritation, Herpes zoster, Hypoaesthesia, Ophthalmic herpes zoster, Skin irritation
Clinical narrative: Pt contracted shingles - sores as well as facial numbing - verified by dermatologist. Pt also had confirmed by ophthalmologist.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Skin ulcer
Clinical narrative: Pt contracted shingles - sores as well as facial numbing - verified by dermatologist. Pt also had confirmed by ophthalmologist.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient came to see me yesterday and showed me the 4 inches rash on her left arm. The rash was about 1 inch below the injection site. She said the rash was very bad on Friday after she was immunized got better every day. She took OTC BENADRYL for the rash to be better.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Decreased appetite, Pyrexia
Clinical narrative: Fever ranging from 99.4 degrees to 102 degrees. 99.4 degrees initially early on 7/23/18, increasing to 100.9 later that morning. CHILDREN'S TYLENOL given at 5mL periodically (4 times total since 7/23/18 morning to 7/24/18 evening) when temperatures reached near to or 101 degrees. First TYLENOL given late morning 7/23/18, second dose around 6pm on 7/23/18, third dose 5am 7/24/18, and fourth dose at 5:45pm on 7/24/18. Low energy and reduced appetite during peak of fever. No other symptoms of illness such as runny nose.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Vaccinated on 16 July in left upper arm. Following day area is red, swollen, and itching. Slight discomfort. No systemic sx. The next day area increased in size approx. 3x6 inches. Warm to touch. No problems with previous immunizations. Is taking acetaminophen and ibuprofen, and antihistamines. All symptoms resolved within a couple of days. Symptoms: Edema, unspecified, Pruritus, unspecified, Toxic erythema.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a medical assistant, and refers to three patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and concomitant medications was provided. On three separate dates after 07-NOV-2017, three separate patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # N012615 with an expiration date in 16-MAR-2018), for prophylaxis, that underwent a temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit during a time frame of 1 hour. Furthermore, it was also reported that an additional previous temperature excursion was registered from 15 degrees Fahrenheit to 46 degrees Fahrenheit during a time frame of 14 hours and 30 minutes. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT). It was unknown if sterile diluent (MERCK STERILE DILUENT) was properly stored. Digital data logger was involved. No adverse effects reported. This is a non-valid case due to lack of patients' identifiers. Upon receipt of follow-up information it was determined that this case is now valid because patient's identifiers were provided. Follow up information has been received from the medical assistant on 17-JUL-2018. The patient, who was 70 years old, received the improperly stored dose of ZOSTAVAX on 22-NOV-2017. No adverse events had been reported to date. This is one of three cases received from the same source.; Sender's Comments: US-009507513-1807USA010667: US-009507513-1807USA010666:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, previous drug reactions or concomitant medications. On unspecified dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot number N020015, with expiration date on 17-JUL-2019 and (Oka-Merck) PROQUAD lot number N014950, with expiration date on 11-NOV-2018 for prophylaxis (strength, doses, routes of administration, anatomical locations, lot numbers and expiration dates were not reported for any of the vaccines). The MERCK STERILE DILUENT used for the reconstitution of the vaccines was properly stored. The administered doses of the vaccines experienced a temperature excursion in the range between -14 to -10 degrees Celsius (°C) for 52 minutes, as recorded by a data logger. The vaccines had a previous temperature excursions in the range between -14°C to -10°C for 67 minutes, There was no adverse events reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Follow up information has been received from a nurse and stated that she did not have further information about patient details or dates of vaccination. Also, she stated that she was unsure where to find the information. Sender's Comments: US-009507513-1805USA009829.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4-month-old male patient. The patient had no pertinent medical history and drug reactions or allergies. There was no information about concomitant medications provided. On 11-APR-2018, the patient received the first dose of ROTATEQ administered orally (dose, lot# and expiration date were not provided) as rotavirus prevention. On 12-JUN-2018, the patient was vaccinated with the second dose of ROTATEQ 0.5 ml, administered orally, lot # N013992, expiration date 27-JAN-2019 as rotavirus prevention. On the same date, the patient also received haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (poliovirus vaccine inactivated (unspecified) and PREVNAR 13. On an unknown date in June 2018, the patient developed a rash over his entire body. He came to the physician office on 14-JUN-2018 and was given diphenhydramine hydrochloride (BENADRYL) for treatment. At the time of the reporting the outcome of the event of a rash over his entire body was not recovered (also reported as the patient still has a rash over his entire body, but it is dissipating). The relatedness between the event of rash and ROTATEQ and haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) was not reported.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Information was received from a physician concerning 4 year old male patient. The patient had no pertinent medical history, drug reactions/allergies or concomitant medications. On 29-JUN-2018 the patient was vaccinated with a Oka-Merck PROQUAD (dose unknown, batch/lot # N029879, expiration date 22-APR-2019) subcutaneously as general immunization and KINRIX (unknown dose, lot number and expiration date). The physician reported that "later that day when the patient was home he started to experience edema, and erythema at the injection site where the Oka-Merck PROQUAD was administered". The patient also started to experience "a fever". The physician reported that the "patient's mother took the patient to an unspecified Urgent Care where he was given cephalexin" (unknown lot number and expiration date). No lab diagnostics/studies was performed. The physician stated that the patient came to his office on 02-JUL-2018 for a "follow up" and the physician reported that the "symptoms are recovering but not fully recovered yet". The causal relationship between the vaccines and the events were unknown.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure before pregnancy, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and refers to an approximately 33 year old female patient. Concurrent conditions included anaemia. The patient had a previous pregnancy. Concomitant therapies included unspecified prenatal vitamins. Historical drugs were not reported. On 14-MAR-2018, the patient was vaccinated with a dose of VARIVAX Injection, lot # N017394, expiration date 07-JUN-2019, for prophylaxis (strength, dose, dose number, route and anatomical location were not reported). The dose was reconstituted with sterile diluent. The nurse informed that the patient became pregnant, with an estimated Last Menstrual Period (LMP) of 20-APR-2018, and an Estimated Due Date (EDD) of 25-JAN-2019. The patient had an unspecified pregnancy test on an unspecified date in 2018, and the pregnancy was confirmed with an ultrasound performed on 13-JUL-2018. The patient was 12 weeks and 0 days pregnant on that day. No treatment was given to the patient as a consequence of the exposure. At the moment of this report, the pregnancy outcome was pending and the fetal outcome was unknown.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to an adult patient of unknown age and gender. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The registered nurse informed that on an unknown date, the patient may have been vaccinated with a pediatric dose of VAQTA Injection, for prophylaxis (strength, dose, dose number, route, anatomical location, lot # and expiration date were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 28-JUL-2016, the patient was treated by a physician for vesicular outbreaks, 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 16-OCT-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated at a medical facility for a vesicular outbreak accompanied by weakened immune symptoms, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 21-JUL-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 29-JUL-2016, the patient was treated by a physician for a severe vesicular outbreak 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, 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-OCT-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 long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 10-DEC-2015, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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: 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 18-MAY-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a health care facility/office, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-AUG-2016, the patient was treated by a physician, at the health care facility/office for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was prescribed VALTREX 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 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 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 02-MAY-2013, the patient was inoculated with ZOSTAVAX at a healthcare facility/office/clinic as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated by a healthcare facility/office/clinic for the onset of a severe vesicular rash , which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated at a pharmacy with the ZOSTAVAX vaccine as recommended for routine adult health maintenance 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 condition of herpes zoster. In 2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated at an urgent care for a blistering vesicular outbreak 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 outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, 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 12-MAR-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 03-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as shingles. She was prescribed VALTREX and NORCO 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 of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored unspecified dose of GARDASIL 9 (route of administration and frequency were not reported) lot # N023952 (expiration date: 12-JUL-2020) for prophylaxis. No adverse effects were reported. Temperature and time frame: 0-1 Celsius degrees for 59 minutes and below 35 Fahrenheit degrees for 9 hours and 4 minutes. There were no previous temperature excursions. It was found because of a digital data logger.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Headache, Hyperhidrosis, Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 20 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 16-JUL-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R002354 with expiration date of 17-DEC-2019, intramuscularly to prevent pneumococcal disease (dose, route of administration and anatomical location were not reported). On 19-JUL-2018, the patient developed pain and warmth at the site of PNEUMOVAX 23 injection; the patient also felt dizzy, had a headache and had difficulty raising the arm that had received the PNEUMOVAX 23 injection. On 20-JUL-2018, the patient also developed sweating and a fever of 101.6 Fahrenheit degrees. On the same date, the patient sought medical attention at the emergency room. It was unknown if the patient received any treatment for the adverse events. The outcome of injection site pain, pyrexia, hyperhidrosis, injected limb mobility decreased, headache, dizziness and injection site warmth was reported as not recovered. The causal relationship between the aforementioned events and therapy with vaccine, PNEUMOVAX 23 was not provided.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 20 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 16-JUL-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R002354 with expiration date of 17-DEC-2019, intramuscularly to prevent pneumococcal disease (dose, route of administration and anatomical location were not reported). On 19-JUL-2018, the patient developed pain and warmth at the site of PNEUMOVAX 23 injection; the patient also felt dizzy, had a headache and had difficulty raising the arm that had received the PNEUMOVAX 23 injection. On 20-JUL-2018, the patient also developed sweating and a fever of 101.6 Fahrenheit degrees. On the same date, the patient sought medical attention at the emergency room. It was unknown if the patient received any treatment for the adverse events. The outcome of injection site pain, pyrexia, hyperhidrosis, injected limb mobility decreased, headache, dizziness and injection site warmth was reported as not recovered. The causal relationship between the aforementioned events and therapy with vaccine, PNEUMOVAX 23 was not provided.
Age: 75.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, and refers to a 75 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 30-NOV-2017, the patient was vaccinated with improperly stored ZOSTAVAX (lot # N012615 with an expiration date in 16-MAR-2018), for prophylaxis, that underwent a temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit during a time frame of 1 hour. Furthermore, it was also reported that an additional previous temperature excursion was registered from 15 degrees Fahrenheit to 46 degrees Fahrenheit during a time frame of 14 hours and 30 minutes. The vaccine was reconstituted with MERCK STERILE DILUENT. It was unknown if MERCK STERILE DILUENT was properly stored. Digital data logger was involved. No adverse effects were reported. This is one of three cases received from the same source. Sender's Comments: US-009507513-1803USA002223: US-009507513-1807USA010667.
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, and refers to a 52 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 08-FEB-2018, the patient was vaccinated with improperly stored ZOSTAVAX (lot # N012615 with an expiration date in 16-MAR-2018), for prophylaxis, that underwent a temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit during a time frame of 1 hour. Furthermore, it was also reported that an additional previous temperature excursion was registered from 15 degrees Fahrenheit to 46 degrees Fahrenheit during a time frame of 14 hours and 30 minutes. The vaccine was reconstituted with sterile diluent (MERCK). It was unknown if sterile diluent (MERCK) was properly stored. Digital data logger was involved. No adverse effects were reported. This is one of three cases received from the same source. Sender's Comments: US-009507513-1807USA010666: US-009507513-1803USA002223.
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of drug administration, Influenza like illness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a female patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO (received 1st dose 6 months prior to 1st dose). On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced influenza-like symptoms and drug dose administration interval too long. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. At the speaker program the reporter presented at last night, several nurses shared that they had attended a Immunization Conference and were told that BEXSERO should be given at 0 and 6 months so they had been administering BEXSERO on this schedule, which led to lengthening of the vaccination schedule. One of the nurse reported that her daughter experienced flu like symptoms with the second dose of BEXSERO. She did not seem overly concerned and reported that the symptoms resolved. The reporter did not agree to follow up from GlaxoSmithKline. This was 1 of 3 cases reported by the same reporter.