chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: U
Vaccine: DTAP, HEP, IPV, PPV, RV1
Symptoms: Aphasia, Death, Hypokinesia, Social avoidant behaviour
Clinical narrative: This case was reported by a non-health professional via local affiliate and described the occurrence of speech loss in a 4-month-old patient who received DTaP vaccine. Co-suspect products included Rotavirus vaccine, Hepatitis B vaccine, Poliomyelitis vaccine (IPV) and Pneumococcal vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose, Rotavirus vaccine at an unknown dose, Hepatitis B vaccine at an unknown dose, IPV at an unknown dose and Pneumococcal Vaccine at an unknown dose. On an unknown date, less than a day after receiving DTaP vaccine, Rotavirus vaccine and Hepatitis B vaccine, the patient experienced speech loss (serious criteria death), movements reduced (serious criteria death) and withdrawn (serious criteria death). On an unknown date, the outcome of the speech loss, movements reduced and withdrawn were fatal. The reported cause of death was speech loss, movements reduced and withdrawn. The reporter considered the speech loss, movements reduced and withdrawn to be related to DTaP vaccine, Rotavirus vaccine and Hepatitis B vaccine. Additional details were reported as follows: This report was found in a debate article published in a newspaper (there was no information about the source of the information and no contact information to the author of the debate article). The Vaccination Court believed it was proven that the patient died of vaccines. The parents visited their pediatrician with their baby vaccinated with five different vaccines. According to the court documents, the patient's physician described in his journal at the physician's visit that, the patient was healthy, cooperative, well-fed and babbling. After the physician's visit, in the afternoon, the parents noticed that the patient was no longer babbling, the patient was instead withdrawn, silent and moved less than before. Less than 24 hours later, the patient died. It was unknown if an autopsy was performed or not. The reporter considered the speech loss, movements reduced and withdrawn to be related to Poliomyelitis vaccine (IPV) and Pneumococcal vaccine as well.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX. Concurrent medical conditions included arthritis. Concomitant products included Oral Contraceptives. On 5th February 2018, the patient received SHINGRIX. On 5th February 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain was unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient had no medical history except for arthritis. The patient received oral contraceptives as concomitant medications. The patient experienced soreness in site of SHINGRIX administration shortly after receiving vaccine. No medical intervention had been taken except for ibuprofen at night. The pharmacist reported that this was definitely related to vaccine administration and that soreness was about the same since two days ago. No other reported medical history except for arthritis and only reported medication is oral contraceptives.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Inflammation, Insomnia, Pain
Clinical narrative: The patient stated a few hours after receiving the vaccination, her arm was red, sore and inflamed. The soreness and inflammation covered the front and under her arm (opposite the deltoid muscle). It was painful for her to move her arm. She was unable to sleep the first night due to the discomfort. Each day, it has gotten a little bit better. She did not take any medication or apply any topical preparations to ease the discomfort. She will contact her doctor to follow up with them on Monday 2/12/18.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: The patient stated a few hours after receiving the vaccination, her arm was red, sore and inflamed. The soreness and inflammation covered the front and under her arm (opposite the deltoid muscle). It was painful for her to move her arm. She was unable to sleep the first night due to the discomfort. Each day, it has gotten a little bit better. She did not take any medication or apply any topical preparations to ease the discomfort. She will contact her doctor to follow up with them on Monday 2/12/18.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: Pruritus.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a 68 years old female consumer regarding herself. The patient's current conditions included  osteopenia (not medicated), betadine allergy and acid reflux drug allergy. On an unknown date in 2010, the patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (lot # not reported). Concomitant medication included lovastatin. On an unknown date in June 2012, the patient  was diagnosed with Shingles. The patient still had  nerve pain and was currently seeing a pain specialist. She first thought she had pancreatitis. Antiviral and nerve pain medicine was given as treatment. The patient also received several pain procedures. A blood work was performed (result not reported). The outcome of nerve pain and shingles was reported as not recovered. The relatedness for nerve pain and shingles was unknown for ZOSTAVAX. It has been determined that case #US-009507513-1210USA002203 is a duplicate of case #US-009507513-1207USA005328. Therefore, case #US-009507513-1210USA2203 is being deleted from our files and the cases are consolidated into case #US-009507513-1207USA005328.; Sender's Comments: MERCK 1210USA002203:Mfr number.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received on 09-FEB-2018 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 20-MAY-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-MAY-2015, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. On or about 11-JUN-2015, the patient sought subsequent treatment at a medical center for ongoing and worsening symptoms of shingles and post-herpetic neuralgia, a chronic condition of nerve damage and residual pain secondary to zoster infections. On or about 24-JUN-2015, the patient was also treated for continued and worsening neuralgia symptoms. The patient has been prescribed Valacyclovir, Gabapentin, VICODIN and LYRICA for management of his painful condition. 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 further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Injected limb mobility decreased, Injection site inflammation, Injection site joint pain, Limb injury, X-ray limb abnormal
Clinical narrative: Right Rotator Cuff pain began ~12 hours post administration, unable to touch, lift, move, turn or twist shoulder ~24 hours post administration. No redness at site. Pain level became 9/10 at this time, called Urgent care. Appointment 10/16/2017 ICD-10 diagnosis of SIRVA given, at risk for Frozen Shoulder. Physical Therapy ordered and advised. Topical and oral pain meds given, advised to not go into work, drive, etc until okay by provider.
Age: 39.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Blood pressure increased, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: Right Rotator Cuff pain began ~12 hours post administration, unable to touch, lift, move, turn or twist shoulder ~24 hours post administration. No redness at site. Pain level became 9/10 at this time, called Urgent care. Appointment 10/16/2017 ICD-10 diagnosis of SIRVA given, at risk for Frozen Shoulder. Physical Therapy ordered and advised. Topical and oral pain meds given, advised to not go into work, drive, etc until okay by provider.
Age: 23.0
Sex: M
Vaccine: VARCEL, HEP, VARCEL
Symptoms: Blister, Erythema, Rash
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 23 year old male patient. The patient did not have pertinent medical history drug reactions or allergies. The patient's concurrent conditions were not reported. On 24-JAN-2018, the patient was vaccinated with one dose of VARIVAX lot # M038225, expiration date 07-SEP-2018, subcutaneously in the left arm (strength was not provided) for prevention of varicella. He also was concomitantly vaccinated with ENGERIX-B via the intramuscular route in the deltoid region of the patient's right arm. The patient concomitant therapies included NUVIGIL. On the same date, the patient experienced a rash and blistering at the injection site in the left arm. The patient visited the physician's office for medical attention. There were not laboratory test performed, and neither any treatment was given for the adverse events. The reporter also stated there was not reaction noted in the patient's right arm. At the time of reporting, the events had not resolved. The reporter did not provided the causality assessment between the events of injection site rash and injection site vesicles and VARIVAX.
Age: 23.0
Sex: M
Vaccine: VARCEL, HEP, VARCEL
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 23 year old male patient. The patient did not have pertinent medical history drug reactions or allergies. The patient's concurrent conditions were not reported. On 24-JAN-2018, the patient was vaccinated with one dose of VARIVAX lot # M038225, expiration date 07-SEP-2018, subcutaneously in the left arm (strength was not provided) for prevention of varicella. He also was concomitantly vaccinated with ENGERIX-B via the intramuscular route in the deltoid region of the patient's right arm. The patient concomitant therapies included NUVIGIL. On the same date, the patient experienced a rash and blistering at the injection site in the left arm. The patient visited the physician's office for medical attention. There were not laboratory test performed, and neither any treatment was given for the adverse events. The reporter also stated there was not reaction noted in the patient's right arm. At the time of reporting, the events had not resolved. The reporter did not provided the causality assessment between the events of injection site rash and injection site vesicles and VARIVAX.
Sex: M
Vaccine: YF, YF
Symptoms: Deafness neurosensory, Deafness unilateral, Ear pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a physician on 02-Feb-2018. This case involves a five-year-old (reported as five-year, eleven month) male patient who was vaccinated with a dose of YF-VAX (Batch number, Expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date when patient was traveling with family on 3/8. Medical history was not reported. Patient had no known allergies as of 24-Jan (date unknown). Concomitant medications were not reported. On an unknown date, one day following vaccination, patient had developed tactile fever and was complaining of an earache at school and was taken to a pediatrician who noted some fluid in the ear, patient then reported he could not hear out of his left ear, and was seen by ENT who confirmed sensorineural hearing loss in his left ear. Other Lab tests were not reported. A corrective treatment, pediatrician suggested to try allergy medications to help with ear pain. Patient was placed on steroids and acyclovir and had an MRI and specialist appointment with an otologist scheduled. Outcome of the event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event: Sensorineural hearing loss. List of documents held by sender: none.; Sender's Comments: Patient Experienced Sensorineural hearing loss after vaccination. Time to onset is compatible. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the given information the role of the vaccine cannot be assessed.
Sex: M
Vaccine: YF, YF
Symptoms: Deafness neurosensory, Deafness unilateral, Ear pain, Middle ear effusion, Pyrexia
Clinical narrative: Initial unsolicited report received from a physician on 02-Feb-2018. This case involves a five-year-old (reported as five-year, eleven month) male patient who was vaccinated with a dose of YF-VAX (Batch number, Expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date when patient was traveling with family on 3/8. Medical history was not reported. Patient had no known allergies as of 24-Jan (date unknown). Concomitant medications were not reported. On an unknown date, one day following vaccination, patient had developed tactile fever and was complaining of an earache at school and was taken to a pediatrician who noted some fluid in the ear, patient then reported he could not hear out of his left ear, and was seen by ENT who confirmed sensorineural hearing loss in his left ear. Other Lab tests were not reported. A corrective treatment, pediatrician suggested to try allergy medications to help with ear pain. Patient was placed on steroids and acyclovir and had an MRI and specialist appointment with an otologist scheduled. Outcome of the event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event: Sensorineural hearing loss. List of documents held by sender: none.; Sender's Comments: Patient Experienced Sensorineural hearing loss after vaccination. Time to onset is compatible. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the given information the role of the vaccine cannot be assessed.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 68-year-old male patient who received SHINGRIX. Concomitant products included CYMBALTA, gabapentin and vitamins. On 1st February 2018, the patient received SHINGRIX. On 1st February 2018, 3 hrs 35 min after receiving SHINGRIX, the patient experienced pruritus, pain, erythema and raised rash. On an unknown date, the outcome of the pruritus and pain were recovered/resolved and the outcome of the erythema was recovering/resolving and the outcome of the raised rash was unknown. The reporter considered the pruritus, pain and erythema to be related to SHINGRIX. It was unknown if the reporter considered the raised rash to be related to SHINGRIX. Additional details were provided as follows: At 1:25 hours, the patient received SHINGRIX in right arm. The patient reported normal pain at the time of injection that subsided. At 5:00 or 6:00 that evening he experienced itching on the right inner forearm near the elbow. Two red stripes presented in the same area measuring 2 and half inches long by one fourth inch wide. The stripes had faded but not were completely gone. There were raises in the skin in the stripes. The upper most stripe was almost gone but the lower one was still obvious. The patient requested follow up with him after speaking with his doctor. He wanted to know what safety discussed with his doctor.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Pruritus, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 68-year-old male patient who received SHINGRIX. Concomitant products included CYMBALTA, gabapentin and vitamins. On 1st February 2018, the patient received SHINGRIX. On 1st February 2018, 3 hrs 35 min after receiving SHINGRIX, the patient experienced pruritus, pain, erythema and raised rash. On an unknown date, the outcome of the pruritus and pain were recovered/resolved and the outcome of the erythema was recovering/resolving and the outcome of the raised rash was unknown. The reporter considered the pruritus, pain and erythema to be related to SHINGRIX. It was unknown if the reporter considered the raised rash to be related to SHINGRIX. Additional details were provided as follows: At 1:25 hours, the patient received SHINGRIX in right arm. The patient reported normal pain at the time of injection that subsided. At 5:00 or 6:00 that evening he experienced itching on the right inner forearm near the elbow. Two red stripes presented in the same area measuring 2 and half inches long by one fourth inch wide. The stripes had faded but not were completely gone. There were raises in the skin in the stripes. The upper most stripe was almost gone but the lower one was still obvious. The patient requested follow up with him after speaking with his doctor. He wanted to know what safety discussed with his doctor.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Anti-transglutaminase antibody, Anxiety, Blood thyroid stimulating hormone, C-reactive protein, Ceruloplasmin
Clinical narrative: Patient developed diarrhea and sore throat about 15 days after vaccination. This turned into severe anxiety, chronic fatigue and then depression with weight loss. He missed a lot of school. He is still very anxious and has trouble with daily activities.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Culture stool, Depression, Diarrhoea, Epstein-Barr virus antibody, Fatigue
Clinical narrative: Patient developed diarrhea and sore throat about 15 days after vaccination. This turned into severe anxiety, chronic fatigue and then depression with weight loss. He missed a lot of school. He is still very anxious and has trouble with daily activities.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Full blood count, Loss of personal independence in daily activities, Metabolic function test, Nuclear magnetic resonance imaging brain, Oropharyngeal pain
Clinical narrative: Patient developed diarrhea and sore throat about 15 days after vaccination. This turned into severe anxiety, chronic fatigue and then depression with weight loss. He missed a lot of school. He is still very anxious and has trouble with daily activities.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Parasite stool test, Red blood cell sedimentation rate, Streptococcus test, Thyroxine, Weight decreased
Clinical narrative: Patient developed diarrhea and sore throat about 15 days after vaccination. This turned into severe anxiety, chronic fatigue and then depression with weight loss. He missed a lot of school. He is still very anxious and has trouble with daily activities.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patient. On an unknown date, the patient was vaccinated with M-M-R II lot number N009172, expiration date 20-MAR-2019, therapy type rHA; lot number reported as N029919 with expiration date 13-JUN-2018 for prophylaxis or ROTATEQ lot number N005619, expiration date 29-OCT-2018 that were improperly stored. The vaccines underwent a temperature excursion of 47 to 77 degrees Fahrenheit for 1 hour and 10 minutes. There was no previous temperature excursion. Data logger was involved. No adverse event was reported. Lot number N029919 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Follow-up information was received from a nurse on 07-FEB-2018. On unknown dates, multiple additional unspecified patients were administered improperly stored doses of M-M-R II (lot N029919, expiration date: 13-JUN-2018; lot N009172, expiration date: 20-MAR-2019) or ROTATEQ (lot N005619, expiration date: 29-OCT-2018). The vaccine was reconstituted with sterile diluent (MRK INJ) (lot# N026286, expiration date: 06-FEB-2020). The vaccines underwent a temperature excursion of 47 to 77 degrees Fahrenheit for 2 hours and 8 minutes. Previous temperature excursion included 47 to 77 degrees Fahrenheit for 1 hour and 10 minutes. No adverse effect reported. There was no product quality complaint involved.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 15-JAN-2018 (also reported as "yesterday"), the patient received a dose of VARIVAX lot # N014631, expiration date on 11-MAY-2019, for prophylaxis; as well as a dose of PROQUAD Non-valid lot #N037010, for prophylaxis. Both vaccines were reconstituted with a sterile diluent (MERCK) (strengths and routes of administration were not provided). No adverse effect was reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not provided. In November 2015, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (route of administration, lot# and expiration date were not reported). In November 2017, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (route of administration, lot# and expiration date were not reported). No adverse effects were reported. Follow-up information was received from the reporter on 01-FEB-2018. She confirmed the requested information. She also stated that this information guided the office to revise their policy/procedure addressing inappropriate schedule dose. She was thankful for the "preferred "administration recommendations. She provided the following additional information regarding the case at the time of call: She declined to give patient specific information, such as name or date of birth. She only stated that patient was a female. Firstly, she corrected that the first dose administered on 23-NOV-2015 was GARDASIL (Lot number K016966, expiration date: 10-MAY-2017). This was incorrectly recorded originally as GARDASIL 9. The dose was given by another specified provider. On 15-NOV-2017, patient presented to office as a new patient. She was administered GARDASIL 9 (lot number N009801, expiration date: 20-NOV-2019). Lastly, she shared that patient is scheduled to return to office for another dose in the near future. No additional information was provided at time of call.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a Licensed Practical Nurse regarding multiple unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided. The patients were vaccinate on multiple unspecified dates between 14-JAN-2018 and 24-JAN-2018 with improperly stored doses of ROTATEQ, (lot # N013504, expiry date 08-DEC-2018 and N011647 expiry date 17-NOV-2018) for prophylaxis (dosage schedule, route and anatomical location were not reported); and improperly stored doses of LIQUID PEDVAXHIB, (lot # N022167 expiry date 08-FEB-2020 and N012119 expiry date 06-FEB-2020) for prophylaxis (dosage schedule, route and anatomical location were not reported). The temperature excursion for the vaccines were reported as 47 Fahrenheit degrees  to 77 Fahrenheit degrees during a time frame of 1 hour and 10 minutes. No previous temperature excursions were reported and the call was made because a data logger. No adverse effects were reported.
Sex: U
Vaccine: MMR, MMRV, RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified patients of unknown ages and genders who on an unknown date, might have received an improperly stored dose of one of the following vaccines (she was not sure which lot the patient received): M-M-R II, (rHA, lot #s N013295, expiry date 28-APR-2019; N009172, expiry date 20-MAR-2019; M040558, expiry date 03-OCT-2018). ROTATEQ, (lot #s N013884, expiry date 05-DEC-2018; N000193, expiry date 20-OCT-2018). PROQUAD, (lot #s N023969, expiry date 19-MAY-2019; N020007, expiry date 13-JAN-2019) or VARIVAX, (lot #s M049125, expiry date 15-DEC-2018; N025931, expiry date 19-SEP-2019). The temperature excursion for the vaccines were of 9°C to 25°C during a time frame of 112 hours (also reported as 44 minutes in refrigerator and 35 minutes in freezer). There were not previous temperature excursions and it was called because of a data logger. No adverse effects were reported. Later the Medical Assistant also update details only for VARIVAX and PROQUAD, she stated that were administered to unspecified patients after being improperly stored. Total time in the range was 9 C to 25 C. Time frame was 112 hours, for this two vaccines no previous temperature excursion was reported and the call because of a data logger as well. All the information regarding the other products remained the same.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On unknown dates, the patient was vaccinated with VARIVAX lot N022995, expiry 23-AUG-2019, lot N012619, expiry 21-APR-2019, for prophylaxis and PROQUAD lot N023965, expiry 28-FEB-2019), lot N015625, expiry 15-NOV-2018 for prophylaxis. (routes of administration were not reported for any of the aforementioned vaccines). The sterile diluent (MERCK) used for reconstitution was properly stored (lot number and expiry date unknown). No adverse effects were reported. On unknown dates, the doses of VARIVAX and PROQUAD underwent temperature excursions of 6 degrees Fahrenheit (°F) to 14 °F (6.1°F) for 16 minutes. Previous temperature excursions were reported as follows: 6 °F to 14 °F (9.7°F) for 30 minutes, 6 °F to 14 °F (6.3°F) for 15 minutes and 6 °F to 14 °F (6.8°F) for 8 minutes. Total cumulative: 6 °F to 14 °F for 69 minutes. This is one of several cases received from the same reporter. Sender's Comments: US009507513-1802USA005899: US-009507513-1802USA005900: US-009507513-1802USA005898.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 15 month old female patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions, and allergies were not reported. On 29-JAN-2018, the patient received her 4th dose of RECOMBIVAX HB 5/0.5 microgram/milliliter (lot # M037248 and expiration date of 21-FEB-2019) intramuscularly for prophylaxis. No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX vial dose 1, 1 DF, (lot# N025704, Exp date: 16-DEC-2018, route, frequency were not provided) for prophylaxis which was stored at a temperature of 6.6 degree Fahrenheit at a time frame of 40 minutes and there was no previous temperature excursion and call was because of digital data logger and no adverse symptoms were reported. No product quality compliant (PQC) was present. Lot# N025704 has been verified to be a valid lot number for zoster vaccine live.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to a 5-year-old male patient. The patient's medical history was not reported. On 08-JAN-2018, the patient was vaccinated with improperly stored PROQUAD therapy type RHA, lot # N023001, expiration date 19-FEB-2019 or lot # N019249, expiration date 20-DEC-2018 for prophylaxis (dose, route and site of administration were not reported). The vaccine underwent a temperature excursion of 20 degrees Fahrenheit for 1 hour and 42 minutes. Other temperature excursions were: 6 degrees Fahrenheit for 48 minutes, 18 degrees Fahrenheit for 1 hour and 5 minutes and 8 degrees Fahrenheit for 1 minute. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA013248: US-009507513-1802USA005175: US-009507513-1802USA005176: US-009507513-1802USA005177: US-009507513-1802USA005178: US-009507513-1802USA005179.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to a 4-year-old male patient. The patient's medical history was not reported. On 10-JAN-2018, the patient was vaccinated with improperly stored PROQUAD therapy type RHA, lot # N023001, expiration date 19-FEB-2019 or lot # N019249, expiration date 20-DEC-2018 for prophylaxis (dose, route and site of administration were not reported). The vaccine underwent a temperature excursion of 20 degrees Fahrenheit for 1 hour and 42 minutes. Other temperature excursions were: 6 degrees Fahrenheit for 48 minutes, 18 degrees Fahrenheit for 1 hour and 5 minutes and 8 degrees Fahrenheit for 1 minute. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA013248: US-009507513-1802USA005174: US-009507513-1802USA005176: US-009507513-1802USA005177: US-009507513-1802USA005178: US-009507513-1802USA005179.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to a 3-year-old male patient. The patient's medical history was not reported. On 19-JAN-2018, the patient was vaccinated with improperly stored PROQUAD therapy type RHA, lot # N023001, expiration date 19-FEB-2019 or lot # N019249, expiration date 20-DEC-2018 for prophylaxis (dose, route and site of administration were not reported). The vaccine underwent a temperature excursion of 20 degrees Fahrenheit for 1 hour and 42 minutes. Other temperature excursions were: 6 degrees Fahrenheit for 48 minutes, 18 degrees Fahrenheit for 1 hour and 5 minutes and 8 degrees Fahrenheit for 1 minute. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA013248: US-009507513-1802USA005174: US-009507513-1802USA005175: US-009507513-1802USA005177: US-009507513-1802USA005178: US-009507513-1802USA005179.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine cooridnator refers to a 13-year-old male patient. The patient's medical history was not reported. On 11-JAN-2018, the patient was vaccinated with improperly stored VARIVAX lot # N021315, expiration date 07-AUG-2019 for prophylaxis (dose, route and site of administration were not reported). The vaccine underwent a temperature excursion of 20 degrees Fahrenheit for 1 hour and 42 minutes. Other temperature excursions were: 6 degrees Fahrenheit for 48 minutes, 18 degrees Fahrenheit for 1 hour and 5 minutes and 8 degrees Fahrenheit for 1 minute. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA013248: US-009507513-1802USA005174: US-009507513-1802USA005175:  US-009507513-1802USA005176: US-009507513-1802USA005178: US-009507513-1802USA005179:
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to a 15-year-old female patient. The patient's medical history was not reported. On 17-JAN-2018, the patient was vaccinated with improperly stored VARIVAX lot # N021315, expiration date 07-AUG-2019 for prophylaxis (dose, route and site of administration were not reported). The vaccine underwent a temperature excursion of 20 degrees Fahrenheit for 1 hour and 42 minutes. Other temperature excursions were: 6 degrees Fahrenheit for 48 minutes, 18 degrees Fahrenheit for 1 hour and 5 minutes and 8 degrees Fahrenheit for 1 minute. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA013248: US-009507513-1802USA005174: US-009507513-1802USA005175: US-009507513-1802USA005176: US-009507513-1802USA005177: US-009507513-1802USA005179.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to an 8-year-old female patient. The patient's medical history was not reported. On 23-JAN-2018, the patient was vaccinated with improperly stored VARIVAX lot # N021315, expiration date 07-AUG-2019 for prophylaxis (dose, route and site of administration were not reported). The vaccine underwent a temperature excursion of 20 degrees Fahrenheit for 1 hour and 42 minutes. Other temperature excursions were: 6 degrees Fahrenheit for 48 minutes, 18 degrees Fahrenheit for 1 hour and 5 minutes and 8 degrees Fahrenheit for 1 minute. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA013248: US-009507513-1802USA005174: US-009507513-1802USA005175: US-009507513-1802USA005176: US-009507513-1802USA005177: US-009507513-1802USA005178.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified patient of unknown age and gender. The patient's concomitant medication included a sterile diluent (manufacturer unknown) (lot number M037018, expiry date 01-MAY-2019) that was properly stored. The patient's concurrent conditions, historical conditions and drug allergies/reactions were not reported. On 31-JAN-2018, the patient was vaccinated with a dose of improperly stored PROQUAD (lot number: N000336 and expiry date: 30-JUL-2018) (dose, strength, frequency and route not reported) for prophylaxis. It was reported that the PROQUAD vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. It was reported that this call was made because of a data logger. No adverse effects were reported. No additional information was provided. There was no product quality complaint present.
Sex: F
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 female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. On 19-DEC-2012 the patient was vaccinated with ZOSTAVAX, 1 DF, (route unknown), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 27-JUN-2016 the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, 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 further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
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 female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unspecified date in 2016 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-AUG-2016, the patient was treated at a medical facility, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, 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 further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On an unspecified date, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. The patient was treated by a physician for the onset of a rash, 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 further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On unknown dates, the patient was vaccinated with VARIVAX lot N022995, expiry 23-AUG-2019, lot N012619, expiry 21-APR-2019, for prophylaxis and PROQUAD lot N023965, expiry 28-FEB-2019), lot N015625, expiry 15-NOV-2018 for prophylaxis. (routes of administration were not reported for any of the aforementioned vaccines). The sterile diluent (MERCK) used for reconstitution was properly stored (lot number and expiry date unknown). No adverse effects were reported. On unknown dates, the doses of VARIVAX and PROQUAD underwent temperature excursions of 6 degrees Fahrenheit (°F) to 14 °F (6.1°F) for 16 minutes. Previous temperature excursions were reported as follows: 6 °F to 14 °F (9.7°F) for 30 minutes, 6 °F to 14 °F (6.3°F) for 15 minutes and 6 °F to 14 °F (6.8°F) for 8 minutes. Total cumulative: 6 °F to 14 °F for 69 minutes. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1802USA005899: US-009507513-1802USA005900: US-009507513-1801USA010912.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On unknown dates, the patient was vaccinated with VARIVAX lot N022995, expiry 23-AUG-2019, lot N012619, expiry 21-APR-2019, for prophylaxis and PROQUAD lot N023965, expiry 28-FEB-2019), lot N015625, expiry 15-NOV-2018 for prophylaxis. (routes of administration were not reported for any of the aforementioned vaccines). The sterile diluent (MERCK) used for reconstitution was properly stored (lot number and expiry date unknown). No adverse effects were reported. On unknown dates, the doses of VARIVAX and PROQUAD underwent temperature excursions of 6 degrees Fahrenheit (°F) to 14 °F (6.1°F) for 16 minutes. Previous temperature excursions were reported as follows: 6 °F to 14 °F (9.7°F) for 30 minutes, 6 °F to 14 °F (6.3°F) for 15 minutes and 6 °F to 14 °F (6.8°F) for 8 minutes. Total cumulative: 6 °F to 14 °F for 69 minutes. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1801USA010912: US-009507513-1802USA005900: US-009507513-1802USA005898.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On unknown dates, the patient was vaccinated with VARIVAX lot N022995, expiry 23-AUG-2019, lot N012619, expiry 21-APR-2019, for prophylaxis and PROQUAD lot N023965, expiry 28-FEB-2019, lot N015625, expiry 15-NOV-2018 for prophylaxis. (routes of administration were not reported for any of the aforementioned vaccines). The sterile diluent (MERCK) used for reconstitution was properly stored (lot number and expiry date unknown). No adverse effects were reported. On unknown dates, the doses of VARIVAX and PROQUAD underwent temperature excursions of 6 degrees Fahrenheit (°F) to 14 °F (6.1°F) for 16 minutes. Previous temperature excursions were reported as follows: 6 °F to 14 °F (9.7°F) for 30 minutes, 6 °F to 14 °F (6.3°F) for 15 minutes and 6 °F to 14 °F (6.8°F) for 8 minutes. Total cumulative: 6 °F to 14 °F for 69 minutes. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1802USA005899: US-009507513-1801USA010912: US-009507513-1802USA005898.
Age: 66.0
Sex: F
Vaccine: DTAP, FLUR3
Symptoms: Abdominal discomfort, Aphonia, Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: Had dtap plus strong flu shot for seniors same time. Was told no flu or whooping cough will result from these. I have fever, sore throat, bad cough, upset stomach, no voice.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Not feeling well a few hours post vaccination, face turned red and right arm is painful and swollen.
Age: 65.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Back pain, Dysstasia, Injection site pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: Within a minute or two, extreme pain in lower back, on scale of 1-10, a 20. Then the pain jumped to my shoulders, not traveling, while my back pain increased. I tried standing but could not move my legs. The administrator, called 911. By the time they came, I was able to stand, and the pain was subsiding, but never went away totally. Today, about three weeks later, the lower back pain has not totally rescinded. It's effecting me 24/7. The shoulder pain has subsided.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient at clinic 2/8/18 with raised, red, hot itching area approximately 3/4 down right arm from deltoid down X2 days. Patient reports it was circling around the back of arm on 2/7/18. Had fever of 102 on 2/7/18. Redness is resolving but itching and heat continues. Instructed to try BENADRYL if can tolerate, cool compress. If symptoms do not resolve contact PCP.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Received vaccine on 1-24-18 and tolerated them well. Through the night, his arm began to get edematous and erythematous. He showed this to the school nurse 1-26-18 and she called his parents.  Started on BENADRYL and prednisone with warm compresses to affected area. Seen again in office on 1-29-18 with area showing much improvement.
Age: 33.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Diarrhoea, Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: Muscle aches, joint aches, numbness/tingling on left side of face & watery stools.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody positive
Clinical narrative: Information has been received from a registered nurse referring to an unspecified patient of unknown age and gender. Patient's concurrent conditions included developmental issues. Information regarding patient's medical history and concomitant medications were not reported. On unknown dates, in 2011 (two separate unspecified dates), the patient was vaccinated with two doses of M-M-R II, (dosage schedule, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT), (dosage schedule, route, anatomical location, lot number and expiration date were not reported). In approximately 2018 (reporting as "7 years after receiving M-M-R II"), the patient was seen in the physician office were labs were performed, demonstrating elevated measles titers. No other side effects were reported. No treatment was given for the event. The patient's outcome was not recovered. No causality assessment between the event and the vaccine was provided by the nurse.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of an unknown demographics. Information on patient's pertinent medical history and drug reactions/allergies were not reported. On 05-FEB-2018, the patient was vaccinated with properly stored expired VAQTA (strength, dose and frequency were not reported) (lot # M18767, expiration date: 01-FEB-2018) for prophylaxis (Expired product administered). No adverse events were reported. There was no product quality complaint (PQC) reported.