chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a 71-year-old male patient who received SHINGRIX. On 18th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 19th January 2018, the patient experienced chills, influenza like illness, general physical health deterioration and arthralgia. In January 2018, the outcome of the chills, influenza like illness, general physical health deterioration, arthralgia and injection site pain were recovered/resolved. The reporter considered the chills, influenza like illness, general physical health deterioration, arthralgia and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to manufacturer. This case was reported by the physician who himself was the patient. The patient experienced severe pain and tenderness at the injection site (right deltoid) which started the evening after the vaccination. The next day, the patient began to experience shaking chills, severe arthralgia, and stated that he felt extremely fluish, like he wanted to die and was totally laid up. The reporter gave permission to be contacted regarding his experience. He was unable to provide the lot number and expiration date for the product administered.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Adverse event, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report has been received from a medical assistant concerning a 16 year old female patient as a part of Child Protective Services intake. The patient's concurrent condition included depression. There was no information about drug reactions. Concomitant medication was unknown. Prior to administer the vaccine, the patient was given a urine test to determine pregnancy (date unspecified). It was then that the pregnancy test came back positive. The patient refused a blood test, but the patient's medical records indicated a last menstrual cycle as April 2016. On 17-JUN-2016, the patient was administered a first dose of GARDASIL 9 vaccine (lot# and dose not provided, Intramuscular) for prevention of human papillomavirus infection (HPV) (Exposure during pregnancy). On the same day, the patient experienced an adverse event. No treatment was given for the pregnancy.The outcome of the Exposure during pregnancy and adverse event was not reported. Causality assessment was not provided. Follow up information was received from the medical assistant on 29-JAN-2018. It was reported that, unfortunately they work for foster kids often do not have follow up. Report previously followed up with the case worker on this patient who was in the foster system. The case worker told the reporter, the girl had a baby (recovered) but case was closed in the foster system so there was no way to obtain additional information about the pregnancy, delivery or child that was born. No further information is available.
Age: 44.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a Nurse refers to a unspecified 44 year old patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 19-JAN-2018, the patient was vaccinated with received the pediatric dose of RECOMBIVAX HB from lot L016959 expiry date 12-MAR-2018 (drug administered to patient of inappropriate age)(incorrect dose administered) for prophylaxis. Nurse reports that dose was given mistakenly, by human error. No adverse effects reported. No additional information was provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 10-JAN-2018, the patient inadvertently received an expired dose of M-M-R II lot # L040960, expiration date 16-OCT-2017 for prophylaxis (route of administration was not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Coordination abnormal, 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. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 14-NOV-2015 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. On or about 09-DEC-2016, the patient was treated by a physician for the onset of a severe vesicular eruption 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, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 09-MAY-2016 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-AUG-2016, the patient was treated at a medical center and emergency department for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir and acetaminophen (+) hydrocodone for management of her painful symptoms. 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: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-FEB-2014, the patient was vaccinated at a hospital with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about  02-APR-2015, the patient was treated  for the onset of a severe vesicular eruption 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, and pain and suffering, and other damages. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Dyskinesia, Head titubation, Seizure, Syncope
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of seizure in a 19-year-old female patient who received BEXSERO (batch number 166901, expiry date 30th November 2018). Concomitant products included Tuberculin PPD. On 23rd January 2018, the patient received BEXSERO .5 ml. On 23rd January 2018, 2 min after receiving BEXSERO, the patient experienced seizure (serious criteria GSK medically significant), syncope, movements abnormal and nodding of head. On 23rd January 2018, the outcome of the seizure, syncope, movements abnormal and nodding of head were recovered/resolved. The reporter considered the seizure, syncope, movements abnormal and nodding of head to be related to BEXSERO. Additional details were provided as follows: On 23rd January 2018, the patient received Tuberculin purified protein derivative (PPD)  on left arm concomitantly before receiving BEXSERO. At 2:30 hours, the patient received BEXSERO on the left arm. The patient experienced head bopping and head movement. The reporter was not certain if it was syncope or possibly a seizure as the patient's eyes were closed during the event. It happened 30 minutes before the time of reporting and within 2 minutes following the administration of the vaccine. It resolved quickly on its own. The reporter believed that the events were caused by BEXSERO as the timing was closer to the administration of BEXSERO.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Disorientation, Dizziness, Nausea
Clinical narrative: Dizziness, feeling disoriented and nausea.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This initial spontaneous case was received on 23-Nov-2017 from a Pharmacist, concerns a 38-year-old male patient. On 09-Nov-2017, the patient was administered with influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported). On 09-Nov-2017, the patient experienced sore arm after receiving flu vaccine. On 12-Nov-2017, the patient recovered from the event. The reporter considered the case as non-serious.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site mass, Pain, Pain in extremity
Clinical narrative: PATIENT STATED ON 01/25/2018 THAT HER RIGHT ARM HAS BEEN HURTING FROM A PNEUMONIA VACCINATION THAT SHE HAS RECEIVED OVER A YEAR AGO. SHE SAID THERE IS A LUMP IN THE ARM WHERE THE INJECTION WAS GIVEN. SHE ALSO SAID THAT SHE CAN'T LIFT HER ARM ALL THE WAY AND IF SHE TRIES TO, IT HURTS REALLY BAD.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Otitis media, Pyrexia, Rash, Vaccination site vesicles
Clinical narrative: Patient received MMR, VARIVAX and Hep A vaccines on 01/18/2018. Parent notified the office of fever 101 and rash on 1/29/2018. Patient was seen in the office on 01/30/2018. Upon exam, redness and vesicles were noted on the site where the Varicella vaccine was administered. No pus, or warmth noted. Upon further exam it was noted that child has otitis media, which could also be a reason for the fever.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site reaction x6 days. Redness and swelling, soreness at injection site.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Biopsy skin abnormal, Contusion, Eosinophilic cellulitis, Erythema, Peripheral swelling
Clinical narrative: A week after the shot a bump appear on my son's leg. A few days after the bump appeared he show me to large, raised rings on his leg. The outer ring was red and raised while inside looked like a bruise. Over the next few days the two rings grew larger and another appeared on his other leg. We went to the pediatrician.  He prescribed two different antibiotics but there were no changes in the rash. We stopped the antibiotics because they were not doing anything. At this time we went out of town on vacation. From start to finish it took about 5 weeks for the rash to go away although the skin was discolored where it had been. In August the same thing happened starting with a bump and growing.  We went to a dermatologist.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Skin discolouration
Clinical narrative: A week after the shot a bump appear on my son's leg. A few days after the bump appeared he show me to large, raised rings on his leg. The outer ring was red and raised while inside looked like a bruise. Over the next few days the two rings grew larger and another appeared on his other leg. We went to the pediatrician.  He prescribed two different antibiotics but there were no changes in the rash. We stopped the antibiotics because they were not doing anything. At this time we went out of town on vacation. From start to finish it took about 5 weeks for the rash to go away although the skin was discolored where it had been. In August the same thing happened starting with a bump and growing.  We went to a dermatologist.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site pain, Pain in extremity
Clinical narrative: Intense right shoulder pain, radiating down arm to hand. Has had expected level of injection site discomfort on days 2-12, then unexpected onset of this pain.
Age: 67.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Injected limb mobility decreased, Injection site pain, Limb discomfort
Clinical narrative: Very painful, and limited movement in right arm from elbow joint to shoulder joint on day of vaccine. Right is swollen and red. Patient had shivering. Next day 1/30/18 patient able to move arm somewhat but still has discomfort.
Age: 67.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling
Clinical narrative: Very painful, and limited movement in right arm from elbow joint to shoulder joint on day of vaccine. Right is swollen and red. Patient had shivering. Next day 1/30/18 patient able to move arm somewhat but still has discomfort.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Ophthalmic herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received on 26-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 12-APR-2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, 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 22-FEB-2016, the patient was treated at an eye institute for herpes zoster keratitis, or herpes that had spread into the eyes. On or about 27-MAR-2017, the patient was also treated for new and worsening symptoms of blistering vesicular rashes, which were diagnosed as herpes zoster or shingles. On or about 12-DEC-2016, the patient sough subsequent treatment for continued and worsening symptoms of shingles pain, at which time she was diagnosed with post-herpetic neuralgia, a chronic condition of residual pain and nerve damage secondary to shingles. The patient has been prescribed gabapentin and gabapentin (NEURONTIN) for management of her extensive and lasting symptoms. 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. Upon internal review, herpes zoster keratitis/herpes that had spread into the eyes was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received on 26-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 12-APR-2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, 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 22-FEB-2016, the patient was treated at an eye institute for herpes zoster keratitis, or herpes that had spread into the eyes. On or about 27-MAR-2017, the patient was also treated for new and worsening symptoms of blistering vesicular rashes, which were diagnosed as herpes zoster or shingles. On or about 12-DEC-2016, the patient sough subsequent treatment for continued and worsening symptoms of shingles pain, at which time she was diagnosed with post-herpetic neuralgia, a chronic condition of residual pain and nerve damage secondary to shingles. The patient has been prescribed gabapentin and gabapentin (NEURONTIN) for management of her extensive and lasting symptoms. 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. Upon internal review, herpes zoster keratitis/herpes that had spread into the eyes was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours), 26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour); and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours), 25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 27-NOV-2017. This is one of several cases reported by the same reporter. Sender's Comments: US-009507513-1801USA006569: Original Case: 1801USA006569.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours),  26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour);  and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours),  25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 16-DEC-2017. This is one of several cases reported by the same reporter.; Sender's Comments: US-009507513-1801USA006569:Original Case : 1801USA006569.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours),  26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour);  and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours),  25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 22-DEC-2017. This is one of several cases reported by the same reporter.; Sender's Comments: US-009507513-1801USA006569:Original Case : 1801USA006569.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours), 26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour);  and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours), 25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 29-DEC-2017. This is one of several cases reported by the same reporter. Sender's Comments: US-009507513-1801USA006569: Original Case: 1801USA006569.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours), 26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour); and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours), 25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 02-JAN-2018. This is one of several cases reported by the same reporter. Sender's Comments: US-009507513-1801USA006569: Original Case: 1801USA006569.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours),  26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour);  and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours),  25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 02-JAN-2018. This is one of several cases reported by the same reporter.; Sender's Comments: US-009507513-1801USA006569:Original Case : 1801USA006569.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours), 26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour); and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours), 25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 03-JAN-2018. This is one of several cases reported by the same reporter. Sender's Comments: US-009507513-1801USA006569: Original Case: 1801USA006569.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours),  26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour);  and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours),  25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 05-JAN-2018. This is one of several cases reported by the same reporter.; Sender's Comments: US-009507513-1801USA006569:Original Case : 1801USA006569.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours),  26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour);  and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours),  25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 05-JAN-2018. This is one of several cases reported by the same reporter.; Sender's Comments: US-009507513-1801USA006569: Original Case : 1801USA006569.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours),  26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour);  and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours),  25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 08-JAN-2018. This is one of several cases reported by the same reporter.; Sender's Comments: US-009507513-1801USA006569:
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Tongue eruption
Clinical narrative: Initial unsolicited report received from a health care professional on 16-Jan-2018. This case involves a 47-year-old male patient who was vaccinated with a 0.5 ml dose of ADACEL injection once (batch number- U5810AA, expiration date, dose in series and site of administration were not reported), via intramuscular route on 12-Jan-2018. The patient medical history and concomitant medications were not reported. Also reported that the patient had no known drug allergies (NKDA) and chronic illness. On 13-Jan-2018, one day after the vaccination, the patient experienced bumps on both sides of his tongue while woke up. Laboratory data and corrective treatment were not reported. The outcome of the event was not recovered. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Biopsy site unspecified abnormal, Oral lichen planus
Clinical narrative: Initial unsolicited report received from a literature on 16-Jan-2018. This case is linked with 2018SA017671, 2018SA017679 and 2018SA017692 (Same literature). The following is the abstract from the article: Lichen planus is an inflammatory dermatosis with a prevalence of approximately 1%. Recent meta-analyses show that patients with hepatitis C virus have a 2.5- to 4.5-fold increased risk of developing lichen planus. Lichen planus has also followed vaccinations and has specifically been attributed to the hepatitis B vaccine, the influenza vaccine, and the tetanus-diphtheria-acellular pertussis vaccine. We describe a case of lichen planus in a hepatitis C virus-infected male occurring in temporal association with the administration of the tetanus-diphtheria-acellular pertussis vaccine. The patient's presentation was clinically consistent with lichen planus and confirmed by biopsy. It is likely that many cases of vaccine induced lichen planus have gone unpublished or unrecognized. In areas with high prevalence of hepatitis C virus infection, we may expect to see more cases of vaccine-induced lichen planus especially in light of the updated Centers for Disease Control and Prevention tetanus-diphtheria-acellular pertussis vaccination recommendations. This case serves to educate healthcare providers about vaccine-induced lichen planus and, in particular, the need to counsel hepatitis C virus-infected patients about a potential risk of developing lichen planus following vaccination. We also reflect on current theories suggesting the T-cell-mediated pathogenesis of lichen planus and the role that hepatitis C virus and toxoid or protein vaccines may play in initiating the disease. This case involves patient (Age and gender was not reported) who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, two weeks post vaccination patient had oral lichen planus. Laboratory investigation and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient has experienced redness, and continued warmth and swelling since vaccination has been given. Patient just reported to this office today (01/30/18). Patient away at school. Advised to seek treatment at Student Health.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Chromaturia, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Fever 102-103, chills, body aches, vertigo(accompanied by nausea), localized reaction at injection site 6 inches by 8 inches with redness, induration and heat, amber colored urine, despite drinking adequate fluids. These symptoms started 23-24 hours post injection and lasted 48+ hours. The localized reaction is still  there, but getting better today, which is 5 days later.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction, Nausea, Pain, Pyrexia, Urine analysis normal
Clinical narrative: Fever 102-103, chills, body aches, vertigo(accompanied by nausea), localized reaction at injection site 6 inches by 8 inches with redness, induration and heat, amber colored urine, despite drinking adequate fluids. These symptoms started 23-24 hours post injection and lasted 48+ hours. The localized reaction is still  there, but getting better today, which is 5 days later.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Vertigo
Clinical narrative: Fever 102-103, chills, body aches, vertigo(accompanied by nausea), localized reaction at injection site 6 inches by 8 inches with redness, induration and heat, amber colored urine, despite drinking adequate fluids. These symptoms started 23-24 hours post injection and lasted 48+ hours. The localized reaction is still  there, but getting better today, which is 5 days later.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Insomnia, Pain in extremity
Clinical narrative: PATIENT STATES THAT ARM IS VERY PAINFUL, NOT SWOLLEN NOR RED. PATIENT COULD NOT SLEEP BECAUSE OF THE PAIN. THE ARM APPEAR THE SAME BUT IS HURTING. PATIENT HAS AGREED TO WAIT ANOTHER DAY AND DETERMINE IF PAIN RESOLVES...
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt woke up on 1/16/18 with redness and swelling at the injection site. The redness was the size of 2 half dollars per mom. Nurse discussed signs/symptoms of infection. Advised to apply cold compress prn and call back with new/worsening symptoms.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose increased, Chest discomfort, Dysarthria, Dysgeusia, Feeling abnormal
Clinical narrative: A minute after injection, she got up and didn't feel good. I had her sit down and asked what her symptoms were. She felt a fullness in her chest, a regurgitation sensation with a bad taste, her face (rt side) felt numb & her speech was slurry for a minute or 2. Just felt off. We took her BP (pt & I) which was normal - she's a CMA in a hospital. I kept asking if she wanted paramedics called. Since she was not feeling better, paramedics were called. They checked her blood glucose at her request (high). She refused a trip to the ER, sat a while more and then left -- refused my escorting her to her car. She has experienced something similar once before 3-4 yrs ago w/pneumococcal injection, but has no issues with flu shots.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Regurgitation
Clinical narrative: A minute after injection, she got up and didn't feel good. I had her sit down and asked what her symptoms were. She felt a fullness in her chest, a regurgitation sensation with a bad taste, her face (rt side) felt numb & her speech was slurry for a minute or 2. Just felt off. We took her BP (pt & I) which was normal - she's a CMA in a hospital. I kept asking if she wanted paramedics called. Since she was not feeling better, paramedics were called. They checked her blood glucose at her request (high). She refused a trip to the ER, sat a while more and then left -- refused my escorting her to her car. She has experienced something similar once before 3-4 yrs ago w/pneumococcal injection, but has no issues with flu shots.
Age: 36.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pt's mother called the next day and stated that the pt needed to take 1/2 NORCO the night of the vaccine and the next morning due to severe pain and swelling. She was unable to lift her arm to get dressed. Pt was advised to go to the Emergency room.
Age: 36.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Swelling
Clinical narrative: Pt's mother called the next day and stated that the pt needed to take 1/2 NORCO the night of the vaccine and the next morning due to severe pain and swelling. She was unable to lift her arm to get dressed. Pt was advised to go to the Emergency room.
Age: 36.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain in extremity, Peripheral swelling
Clinical narrative: Pt's mother called the next day and stated that the pt needed to take 1/2 NORCO the night of the vaccine and the next morning due to severe pain and swelling. She was unable to lift her arm to get dressed. Pt was advised to go to the Emergency room.
Age: 36.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Pain, Swelling, Urticaria
Clinical narrative: Pt's mother called the next day and stated that the pt needed to take 1/2 NORCO the night of the vaccine and the next morning due to severe pain and swelling. She was unable to lift her arm to get dressed. Pt was advised to go to the Emergency room.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Arm is red and swollen at injection site. Advised to apply cold compresses, motrin, benadryl prn. Advised to call back with new/worsening symptoms.
Age: 1.17
Sex: F
Vaccine: FLU4
Symptoms: Dermatitis diaper
Clinical narrative: Pt developed mild diaper rash 1 week post flu vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Skin reaction, Urticaria
Clinical narrative: Painful red welt. About 2.5 x 1.5". Pt monitored and it resolved.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Dyspnoea, Erythema, Immediate post-injection reaction, Pruritus
Clinical narrative: Immediately following injection, shortness of breath, sneezing, coughing, itching, redness and hives - treated with BENADRYL- back to normal a few hours after injection.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Sneezing, Urticaria
Clinical narrative: Immediately following injection, shortness of breath, sneezing, coughing, itching, redness and hives - treated with BENADRYL- back to normal a few hours after injection.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash under injection site 1 day post vaccine administration. Advised to give motrin, benadryl prn, cold compresses. Advised to call back with new/worsening symptoms.