chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: Site reaction that is warm to touch, possible cellulitis.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling, Pain in extremity, Rash
Clinical narrative: Patient reports on telephone that later on the evening  of 12/7/17, she began having swelling and rash develop on upper arm of injection site; pt reports 2 days later, the rash spread to lower arm and also developed pain in the arm. Patient reports some improvement today.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Right shoulder swollen, red rash over whole shoulder, cannot lift arm, painful to touch - started day after immunization; two days after IMZ using icepacks, BENADRYL, and ibuprofen for 5 hours now, hasn't gotten any worse.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Vein disorder
Clinical narrative: Pt calls pharmacy and complains of a high level of pain in right arm. She says skin is of normal coloration and doesn't note anything abnormal. She points out her vein, running the entire length of the arm is swollen, discolored of a red/purple tinge, and throbbing. She has tried ibuprofen for past few days with no relief. Advised pt to seek medical attention.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Full blood count normal, Headache, Immediate post-injection reaction, Metabolic function test normal
Clinical narrative: Patient received AFLUIRA at her workplace (administered by worker from Pharmacy) on October 6, 2017. Patient developed significant left arm pain immediately following the injection. On October 7, 2017, she developed significant aches/myalgia's (neck/upper back), headache and low grade fever (99.4 degrees) that persisted for more than a month (last contact with patient). Patient had never received this particular type of Flu shot before and attributed her symptoms to the AFLURIA.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Patient received AFLUIRA at her workplace (administered by worker from Pharmacy) on October 6, 2017. Patient developed significant left arm pain immediately following the injection. On October 7, 2017, she developed significant aches/myalgia's (neck/upper back), headache and low grade fever (99.4 degrees) that persisted for more than a month (last contact with patient). Patient had never received this particular type of Flu shot before and attributed her symptoms to the AFLURIA.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Feeding disorder, Fluid intake reduced, Nerve injury, Peripheral swelling
Clinical narrative: This Initial spontaneous case was received on 28-Nov-2017, from a consumer, concerning a 34-year-old, adult, male patient. It was reported that, the patient was good and very active. On an unspecified date in 2014 (September or October, 3 years ago), the patient was administered with Influenza virus vaccine polyvalent,  route  of administration: intramuscular, anatomical location: left arm, dose, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2014 (between November and December), the patient developed diabetes. The patient also felt  tired,  could not drink or eat anything, was throwing up and legs were swelling. The patient consulted a physician and was diagnosed with type 2 Diabetes, he was suggested to take unspecified diabetes pills.  Later, the patient was  diagnosed with type 1 diabetes and the medication was changed to NOVOLOG  and LEVEMIR.  The patient also reported that, he had some nerve damage, right above the feet. The patient was admitted for the first time in hospital, on an unspecified date in November or  December 2015 and second time on an unspecified date in July or August 2016. At the time of this report, the patient  had not recovered from the event type 1 diabetes and nerve damage. The reporter considered the events as serious due to hospitalization and assessed the causality as related to the suspect vaccine.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Type 1 diabetes mellitus, Type 2 diabetes mellitus, Vomiting
Clinical narrative: This Initial spontaneous case was received on 28-Nov-2017, from a consumer, concerning a 34-year-old, adult, male patient. It was reported that, the patient was good and very active. On an unspecified date in 2014 (September or October, 3 years ago), the patient was administered with Influenza virus vaccine polyvalent,  route  of administration: intramuscular, anatomical location: left arm, dose, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2014 (between November and December), the patient developed diabetes. The patient also felt  tired,  could not drink or eat anything, was throwing up and legs were swelling. The patient consulted a physician and was diagnosed with type 2 Diabetes, he was suggested to take unspecified diabetes pills.  Later, the patient was  diagnosed with type 1 diabetes and the medication was changed to NOVOLOG  and LEVEMIR.  The patient also reported that, he had some nerve damage, right above the feet. The patient was admitted for the first time in hospital, on an unspecified date in November or  December 2015 and second time on an unspecified date in July or August 2016. At the time of this report, the patient  had not recovered from the event type 1 diabetes and nerve damage. The reporter considered the events as serious due to hospitalization and assessed the causality as related to the suspect vaccine.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Biopsy skin, Blood test, Chills, Keratosis pilaris, Pain of skin
Clinical narrative: This initial spontaneous case, initially received on 10-Nov-2017 was reported by other health professional (pharmacist), concerns a 75-year-old, elderly, female patient. It was reported that, the patient had no allergies, current condition included high blood  pressure and the concomitant medications included losartan for high blood pressure. On 15-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 179303, expiry date: not reported). On 19-Oct-2017, the patient felt like sunburn on her skin and developed a very bad rash all over the body, high fever, chills. On an unspecified date, a couple of blood tests and a skin biopsy was performed. The patient was hospitalized on 24-Nov-2017 and discharged on 25-Nov-2017. The results of the tests would be known on 06-Dec-2017. It was reported that, the patient was diagnosed with keratosis pilaris rubra by the physician. The patient still thought that, it was because of the vaccine, so she went to another hospital for a new diagnosis. The patient had a shot of KENALOG but it did not help. At the time of this report, the patient had not recovered from the event. The reporter assessed the causality as related to the  suspect vaccine. The reporter assessed the case as serious. Follow-up report received on 28-Nov-2017: Indication for concomitant medication (losartan) was updated as high blood pressure and current condition was updated as high blood pressure. Seriousness criteria "hospitalization" was added. Hospitalization dates (admission and discharge date) were added. On an unspecified date, a couple of blood tests (unspecified) and a skin biopsy was performed, the results of which would be known on 06-Dec-2017. It was reported that, the patient was diagnosed with keratosis pilaris rubra. The patient still thought that, it was because of the vaccine, so she went to another hospital for a new diagnosis. The patient had a shot of KENALOG but it did not work. Amended narrative accordingly.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: This initial spontaneous case, initially received on 10-Nov-2017 was reported by other health professional (pharmacist), concerns a 75-year-old, elderly, female patient. It was reported that, the patient had no allergies, current condition included high blood  pressure and the concomitant medications included losartan for high blood pressure. On 15-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 179303, expiry date: not reported). On 19-Oct-2017, the patient felt like sunburn on her skin and developed a very bad rash all over the body, high fever, chills. On an unspecified date, a couple of blood tests and a skin biopsy was performed. The patient was hospitalized on 24-Nov-2017 and discharged on 25-Nov-2017. The results of the tests would be known on 06-Dec-2017. It was reported that, the patient was diagnosed with keratosis pilaris rubra by the physician. The patient still thought that, it was because of the vaccine, so she went to another hospital for a new diagnosis. The patient had a shot of KENALOG but it did not help. At the time of this report, the patient had not recovered from the event. The reporter assessed the causality as related to the  suspect vaccine. The reporter assessed the case as serious. Follow-up report received on 28-Nov-2017: Indication for concomitant medication (losartan) was updated as high blood pressure and current condition was updated as high blood pressure. Seriousness criteria "hospitalization" was added. Hospitalization dates (admission and discharge date) were added. On an unspecified date, a couple of blood tests (unspecified) and a skin biopsy was performed, the results of which would be known on 06-Dec-2017. It was reported that, the patient was diagnosed with keratosis pilaris rubra. The patient still thought that, it was because of the vaccine, so she went to another hospital for a new diagnosis. The patient had a shot of KENALOG but it did not work. Amended narrative accordingly.
Age: 0.42
Sex: M
Vaccine: FLUX
Symptoms: Drug administered to patient of inappropriate age, Febrile convulsion
Clinical narrative: This initial literature case was received on 27-Nov-2017, from a physician, concerning an infant of unspecified age and gender. The main objective of the study was to estimate the febrile seizure risk from the time of vaccination through the following day associated with vaccines administered to children aged one through five months. This report was a cohort study in which patients (one to five months of age) prone to febrile seizure risk after vaccination were involved. In the present study, 15 febrile seizure cases were reported after 585,342 vaccination visits. The patients had received a median of four (range two to six) vaccines simultaneously. The patients were grouped from emergency department visits and inpatient admissions associated with International Classification of Diseases (ninth revision ICD-9, "convulsion" code 780.3, 780.31, 780.32, or 780.39 which included only febrile seizure and not epilepsy) from 01-Jul-2006 to 30-Jun-2011. They defined the day of vaccination as "day 0" and only included convulsion visits that occurred on days zero to one or 14 to 20 following the administration of one or more vaccines of any type. The patient's concomitant vaccination included DTaP, hepatitis B (with doses recommended at birth and at one to two months of age), Hib, IPV and rotavirus vaccine pentavalent (live attenuated) (doses recommended at two and four months of age), monovalent pandemic 2009 H1N1 inactivated influenza vaccine. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after administration of the suspect vaccine, the patient had febrile seizure (probable). The characteristics of the possible or probable febrile seizure followed by vaccination was determined by medical record abstraction. It was reported that, the vaccine was received by the patient at the age of five months, which was less than the minimum recommended age of six months (explicitly coded as inappropriate age at vaccine administration). The outcome of the event was not reported. The causality of the event febrile seizure was related (probable as reported) to the suspect vaccine. The author stated that the timing of fever and febrile seizure after vaccination depends on whether the vaccine contains a live attenuated virus, which requires several days to replicate before inducing a febrile response, or contains inactivated components, which may elicit a febrile response within the first 24 hours.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Paralysis
Clinical narrative: Per another pharmacist - pt paralyzed for 12 hours. Tried to call pt on 12/10/17 for more details. No answer.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Dizziness, Headache, Vision blurred
Clinical narrative: Minutes after - dizziness, blurred vision, headache.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Immediate post-injection reaction, Injection site pain, Rash, Rash pruritic, Swelling
Clinical narrative: Immediate burning at injection site. Baseball sized swelling developed itchy rash area was painful but did not bruise. BENADRYL/Hydrocortisone provided some relief. Swelling is decreasing.
Age: 49.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Dyspnoea, Swelling, Urticaria
Clinical narrative: Immediate itching upon being given the vaccine, reported to physician. Arm began to swell. Developed a rash along with the swelling and painful to touch. Around 1230 p.m. developed hives, took 25 mg Benadryl. By approximately 1245 p.m. difficulty breathing, began to worsen, unable to breathe, HR 168 at times too fast to count. Co-worker called 911. Was taken to Hospital via Advanced Life Support services. Was given IV Benadryl in the ambulance. In the ER was given Solumedrol IV. BP and Pulse Ox were monitored. Developed chest pain, still had difficulty swallowing. After several hours ER physician said he felt it was okay for me to leave despite the chest tightness. Instructed me to try Prednisone and Benadryl if needed, Ativan if necessary for anxiety related to the event. Stated that I could go to the ER nearest my home if I had additional issues. Reported event to my physician's office.
Age: 49.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Anxiety, Chest discomfort, Chest pain, Dysphagia, Dyspnoea
Clinical narrative: Immediate itching upon being given the vaccine, reported to physician. Arm began to swell. Developed a rash along with the swelling and painful to touch. Around 1230 p.m. developed hives, took 25 mg Benadryl. By approximately 1245 p.m. difficulty breathing, began to worsen, unable to breathe, HR 168 at times too fast to count. Co-worker called 911. Was taken to Hospital via Advanced Life Support services. Was given IV Benadryl in the ambulance. In the ER was given Solumedrol IV. BP and Pulse Ox were monitored. Developed chest pain, still had difficulty swallowing. After several hours ER physician said he felt it was okay for me to leave despite the chest tightness. Instructed me to try Prednisone and Benadryl if needed, Ativan if necessary for anxiety related to the event. Stated that I could go to the ER nearest my home if I had additional issues. Reported event to my physician's office.
Age: 49.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Heart rate increased, Immediate post-injection reaction, Peripheral swelling, Pruritus, Rash
Clinical narrative: Immediate itching upon being given the vaccine, reported to physician. Arm began to swell. Developed a rash along with the swelling and painful to touch. Around 1230 p.m. developed hives, took 25 mg Benadryl. By approximately 1245 p.m. difficulty breathing, began to worsen, unable to breathe, HR 168 at times too fast to count. Co-worker called 911. Was taken to Hospital via Advanced Life Support services. Was given IV Benadryl in the ambulance. In the ER was given Solumedrol IV. BP and Pulse Ox were monitored. Developed chest pain, still had difficulty swallowing. After several hours ER physician said he felt it was okay for me to leave despite the chest tightness. Instructed me to try Prednisone and Benadryl if needed, Ativan if necessary for anxiety related to the event. Stated that I could go to the ER nearest my home if I had additional issues. Reported event to my physician's office.
Age: 49.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Tenderness, Urticaria
Clinical narrative: Immediate itching upon being given the vaccine, reported to physician. Arm began to swell. Developed a rash along with the swelling and painful to touch. Around 1230 p.m. developed hives, took 25 mg Benadryl. By approximately 1245 p.m. difficulty breathing, began to worsen, unable to breathe, HR 168 at times too fast to count. Co-worker called 911. Was taken to Hospital via Advanced Life Support services. Was given IV Benadryl in the ambulance. In the ER was given Solumedrol IV. BP and Pulse Ox were monitored. Developed chest pain, still had difficulty swallowing. After several hours ER physician said he felt it was okay for me to leave despite the chest tightness. Instructed me to try Prednisone and Benadryl if needed, Ativan if necessary for anxiety related to the event. Stated that I could go to the ER nearest my home if I had additional issues. Reported event to my physician's office.
Age: 60.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Generalised erythema, Injection site discolouration, Injection site swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  A 60-year-old female patient of an unspecified race received PREVNAR 13 (Lot Number: T08483), intramuscular on 15Nov2017 at 0.5 ml, single dose for pneumonia prevention. Medical history was not reported. The patient was on unspecified concomitant medications. On 20Nov2017, the patient experienced cutaneous reaction and fever. The cutaneous skin reaction was reported as serious for being medically significant. The clinical outcome of the events, cutaneous reaction and fever, was recovering as at the time of the report, the patient stated that the events were mostly resolved. The patient was instructed to follow-up with a medical professional if the symptoms worsen.; Sender's Comments: A possible causal association between administration of PREVNAR 13 and the onset of cutaneous reaction cannot be excluded, considering a plausible temporal association. More information such as the details on the unspecified skin reaction including the location and nature are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pyrexia, Skin reaction
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  A 60-year-old female patient of an unspecified race received PREVNAR 13 (Lot Number: T08483), intramuscular on 15Nov2017 at 0.5 ml, single dose for pneumonia prevention. Medical history was not reported. The patient was on unspecified concomitant medications. On 20Nov2017, the patient experienced cutaneous reaction and fever. The cutaneous skin reaction was reported as serious for being medically significant. The clinical outcome of the events, cutaneous reaction and fever, was recovering as at the time of the report, the patient stated that the events were mostly resolved. The patient was instructed to follow-up with a medical professional if the symptoms worsen.; Sender's Comments: A possible causal association between administration of PREVNAR 13 and the onset of cutaneous reaction cannot be excluded, considering a plausible temporal association. More information such as the details on the unspecified skin reaction including the location and nature are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Disturbance in attention, Dizziness, Dysphagia, Electroencephalogram, Feeling abnormal
Clinical narrative: I received a mandatory flu vaccination through the hospital I work for. % hours later my hands and feet felt like they were vibrating for 15 minutes. About 10 hours later I woke up with my arms and legs feeling very heavy and weak. I have had symptoms ever since receiving the vaccination which include limb heaviness and weakness, difficulty walking, fogginess and dizziness, difficulty concentrating, speaking, and swallowing. I have been to the ER and Neurologist 2 times. I had 2 MRI's and an EEG. The Neurologist believes it is a mild case of Guillain-Barre Syndrome from the flu vaccination.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Gait disturbance, Guillain-Barre syndrome, Laboratory test, Limb discomfort, Muscular weakness
Clinical narrative: I received a mandatory flu vaccination through the hospital I work for. % hours later my hands and feet felt like they were vibrating for 15 minutes. About 10 hours later I woke up with my arms and legs feeling very heavy and weak. I have had symptoms ever since receiving the vaccination which include limb heaviness and weakness, difficulty walking, fogginess and dizziness, difficulty concentrating, speaking, and swallowing. I have been to the ER and Neurologist 2 times. I had 2 MRI's and an EEG. The Neurologist believes it is a mild case of Guillain-Barre Syndrome from the flu vaccination.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Nuclear magnetic resonance imaging, Speech disorder
Clinical narrative: I received a mandatory flu vaccination through the hospital I work for. % hours later my hands and feet felt like they were vibrating for 15 minutes. About 10 hours later I woke up with my arms and legs feeling very heavy and weak. I have had symptoms ever since receiving the vaccination which include limb heaviness and weakness, difficulty walking, fogginess and dizziness, difficulty concentrating, speaking, and swallowing. I have been to the ER and Neurologist 2 times. I had 2 MRI's and an EEG. The Neurologist believes it is a mild case of Guillain-Barre Syndrome from the flu vaccination.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Nausea, Urticaria, Vomiting
Clinical narrative: Within 90 minutes vomiting, increased temperature, weakness, nausea and hives. Vomited several times within next 1 hours. Contacted clinic that administered vaccine. Rested and took diphenhydramine by mouth once able to keep small amounts liquid down.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This non-valid spontaneous report as received from a medical assistant refers to the patient of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On 23-OCT-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # M013156, expiration date: 15-OCT-2017, dose and route of administration were not reported) for prophylaxis. The patient did not experience any adverse events. Product quality complaint was not involved. Follow-up information has been received from the medical assistant on 28-NOV-2017. Information about the patient updated from an unspecified patient to a 63 year old male patient. Information about the vaccine administration had been updated.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance and refers to a 2-month-old patient of unknown gander. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 08-NOV-2017, the patient was vaccinated with one dose of expired ROTATEQ, orally, lot # M025568, expiration date 07-NOV-2017, for prophylaxis. No adverse effects were reported.
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 12 month old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 20-NOV-2017, the patient was inadvertently administered a dose of VARIVAX (0.5 ml) subcutaneous (dose, frequency and anatomical location  were unknown) with lot # M047662 and expiration date 02-DEC-2018, and a dose of PROQUAD (dose, frequency and anatomical location date were unknown) with lot # N009774 and expiration date 20-SEP-2018 reconstituted with sterile diluent (MERCK STERILE DILUENT) for prophylaxis. No adverse effects reported.
Age: 23.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 23 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 17-NOV-2017, the patient was administered a dose of ZOSTAVAX left arm, subcutaneous (dose, dose number and frequency  were unknown) with lot # N025386 and expiration date 08-DEC-2018, instead of VARIVAX (lot # and expiration date were unknown) by another unspecified pharmacist reconstituted with a sterile diluent (MERCK STERILE DILUENT) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 13-NOV-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (route, dose, frequency and anatomical location were unknown) with lot # N011867 and expiration date 8-NOV-2017 for prophylaxis. No adverse effects reported. Sender's Comments: US-009507513-1712USA004581.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a license practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). On 21-NOV-2017, the patient was inadvertently vaccinated with a dose of PROQUAD Lot # N012491, expiration date on 17-OCT-2018, for prophylaxis (strength and route of administration were not reported), instead of an intended dose of M-M-R II for prophylaxis (strength, dose, route, Lot # and expiration date were not reported). The PROQUAD vaccine was administered simultaneously with an intended dose of VARIVAX for prophylaxis (strength, route, Lot # and expiration date were not reported). The nurse confirmed that she did not confuse PROQUAD with M-M-R II but simply grabbed the wrong vaccine and did not realize her error until she went to document in the patient's chart. No adverse effects were reported. The dose of M-M-R II was not administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 20-NOV-2017, the patient received inadvertently a dose of ZOSTAVAX non-valid Lot #M038864, expiration date on 12-DEC-2017, for prophylaxis (strength was not reported) that was administered intramuscularly instead of subcutaneously. The vaccine was administered with a sterile diluent (MERCK STERILE DILUENT) Lot #M046369, expiration date on 07-JUL-2019 (strength was not reported). No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a medical assistant via a company representative referring to an adult patient of unknown gender and age. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 22-NOV-2017, the patient was vaccinated with a pediatric dose of the VAQTA 25/0.5 (unit unknown) (route, lot# and expiration date were unknown) for prophylaxis (Incorrect dose administered and drug administered to patient of inappropriate age). No adverse effects were reported. No product quality complaints (PQC) involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical technical assistance referring to a patient of unknown age and gender. Information about concurrent condition, drug reactions/allergies and medical history was not provided. Concomitant therapies included sterile diluent (manufacturer unknown). On 27-NOV-2017 (also reported as 20-NOV-2017), the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022981 with expiration date on 23-AUG-2017, strength and route unknown) for prophylaxis. No adverse effects reported. The vaccines had been exposed under temperature 6 Fahrenheit (F) to 14 F for 30 minutes, 15 F to 46 F for 64 hours and 47 to 77 F for 3 hours and 30 minutes. A data logger was used. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1712USA004729.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Ophthalmic 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 condition, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 29-NOV-2015 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 shingles. On or about 17-DEC-2015, the patient was treated by a physician for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles with ocular involvement. The patient was prescribed tramadol (ULTRAM) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review, herpes zoster/shingles with ocular involvement was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Loss of employment, Pain, Rash vesicular
Clinical narrative: Information has been received on 06-DEC-2017 from a lawyer regarding a case in litigation concerning a female patient. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 13-MAR-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration are 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 contact a persistent strain of shingles. On or about 09-AUG-2013, the patient was treated by a physician, for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient experienced persistent symptoms that afflicted her so severely she lost her employment because of her condition. The patient has been prescribed valacyclovir hydrochloride (VALTREX) and acetaminophen, hydrocodone bitartrate (VICODIN) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages. Severe herpes zoster/persistent strain of shingles was considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patients medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 15-NOV-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (route, dose, frequency and anatomical location were unknown) with lot # N011867 and expiration date 8-NOV-2017 for prophylaxis. No adverse effects reported.; Sender's Comments:  US-009507513-1711USA009458:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chest X-ray normal, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. This nurse reported on behalf of physician. A 17-year-old female patient received, on 27Nov2017 at 14:54, TRUMENBA (Lot. S56023, Expiration date: 28Feb2019) intramuscularly, in the right deltoid, at 0.5 ml, single dose, for immunization. Relevant medical history included attention deficit/hyperactivity disorder (ADHD), ongoing food allergy (allergy to tree nuts), allergy, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient previously received, on 09Oct2017, influenza vaccine (FLU) for immunization and amoxicillin from 23Jan2005 (ongoing) for an unspecified indication. The patient experienced allergy due to amoxicillin. Family history included asthma and thyroid disease for father. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 25 mg, for ADHD and epinephrine injection 0.3 mg, as needed, for hypersensitivity (allergy to amoxicillin and tree nuts). On 27Nov2017, the patient developed generalized weakness, discomfort pain over the sternum (started at night), irritation, and she felt sick and didn't go to school. On 28Nov2017, the patient experienced also shortness of breath, palpitations, chest tightness, headache with allergic reaction and she felt a tinge down her right arm. Sinus tachycardia was detected with electrocardiogram (EKG). No evidence of local site infection or significant reaction. The patient's parent called the office and reported the patient was seen in the emergency room, the day after the vaccination, on 28Nov2017. Hospitalization was not required. Relevant laboratory tests, performed on 28Nov2017, were the following: Chest X-ray unremarkable, EKG showed sinus tachycardia, full blood count (CBC) with platelets unremarkable, basic metabolic panel unremarkable and troponin normal. Clinical outcome of the events was unknown at time of this report. The events, palpitations, generalized weakness, shortness of breath, chest tightness, paraesthesia, discomfort pain over the sternum, were assessed as serious (Medically Significant); while the other events were considered non-serious.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Electrocardiogram abnormal, Full blood count normal, Headache, Hypersensitivity, Irritability
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. This nurse reported on behalf of physician. A 17-year-old female patient received, on 27Nov2017 at 14:54, TRUMENBA (Lot. S56023, Expiration date: 28Feb2019) intramuscularly, in the right deltoid, at 0.5 ml, single dose, for immunization. Relevant medical history included attention deficit/hyperactivity disorder (ADHD), ongoing food allergy (allergy to tree nuts), allergy, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient previously received, on 09Oct2017, influenza vaccine (FLU) for immunization and amoxicillin from 23Jan2005 (ongoing) for an unspecified indication. The patient experienced allergy due to amoxicillin. Family history included asthma and thyroid disease for father. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 25 mg, for ADHD and epinephrine injection 0.3 mg, as needed, for hypersensitivity (allergy to amoxicillin and tree nuts). On 27Nov2017, the patient developed generalized weakness, discomfort pain over the sternum (started at night), irritation, and she felt sick and didn't go to school. On 28Nov2017, the patient experienced also shortness of breath, palpitations, chest tightness, headache with allergic reaction and she felt a tinge down her right arm. Sinus tachycardia was detected with electrocardiogram (EKG). No evidence of local site infection or significant reaction. The patient's parent called the office and reported the patient was seen in the emergency room, the day after the vaccination, on 28Nov2017. Hospitalization was not required. Relevant laboratory tests, performed on 28Nov2017, were the following: Chest X-ray unremarkable, EKG showed sinus tachycardia, full blood count (CBC) with platelets unremarkable, basic metabolic panel unremarkable and troponin normal. Clinical outcome of the events was unknown at time of this report. The events, palpitations, generalized weakness, shortness of breath, chest tightness, paraesthesia, discomfort pain over the sternum, were assessed as serious (Medically Significant); while the other events were considered non-serious.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Loss of personal independence in daily activities, Malaise, Metabolic function test normal, Palpitations, Paraesthesia
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. This nurse reported on behalf of physician. A 17-year-old female patient received, on 27Nov2017 at 14:54, TRUMENBA (Lot. S56023, Expiration date: 28Feb2019) intramuscularly, in the right deltoid, at 0.5 ml, single dose, for immunization. Relevant medical history included attention deficit/hyperactivity disorder (ADHD), ongoing food allergy (allergy to tree nuts), allergy, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient previously received, on 09Oct2017, influenza vaccine (FLU) for immunization and amoxicillin from 23Jan2005 (ongoing) for an unspecified indication. The patient experienced allergy due to amoxicillin. Family history included asthma and thyroid disease for father. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 25 mg, for ADHD and epinephrine injection 0.3 mg, as needed, for hypersensitivity (allergy to amoxicillin and tree nuts). On 27Nov2017, the patient developed generalized weakness, discomfort pain over the sternum (started at night), irritation, and she felt sick and didn't go to school. On 28Nov2017, the patient experienced also shortness of breath, palpitations, chest tightness, headache with allergic reaction and she felt a tinge down her right arm. Sinus tachycardia was detected with electrocardiogram (EKG). No evidence of local site infection or significant reaction. The patient's parent called the office and reported the patient was seen in the emergency room, the day after the vaccination, on 28Nov2017. Hospitalization was not required. Relevant laboratory tests, performed on 28Nov2017, were the following: Chest X-ray unremarkable, EKG showed sinus tachycardia, full blood count (CBC) with platelets unremarkable, basic metabolic panel unremarkable and troponin normal. Clinical outcome of the events was unknown at time of this report. The events, palpitations, generalized weakness, shortness of breath, chest tightness, paraesthesia, discomfort pain over the sternum, were assessed as serious (Medically Significant); while the other events were considered non-serious.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Platelet count normal, Sinus tachycardia, Troponin normal
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. This nurse reported on behalf of physician. A 17-year-old female patient received, on 27Nov2017 at 14:54, TRUMENBA (Lot. S56023, Expiration date: 28Feb2019) intramuscularly, in the right deltoid, at 0.5 ml, single dose, for immunization. Relevant medical history included attention deficit/hyperactivity disorder (ADHD), ongoing food allergy (allergy to tree nuts), allergy, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient previously received, on 09Oct2017, influenza vaccine (FLU) for immunization and amoxicillin from 23Jan2005 (ongoing) for an unspecified indication. The patient experienced allergy due to amoxicillin. Family history included asthma and thyroid disease for father. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 25 mg, for ADHD and epinephrine injection 0.3 mg, as needed, for hypersensitivity (allergy to amoxicillin and tree nuts). On 27Nov2017, the patient developed generalized weakness, discomfort pain over the sternum (started at night), irritation, and she felt sick and didn't go to school. On 28Nov2017, the patient experienced also shortness of breath, palpitations, chest tightness, headache with allergic reaction and she felt a tinge down her right arm. Sinus tachycardia was detected with electrocardiogram (EKG). No evidence of local site infection or significant reaction. The patient's parent called the office and reported the patient was seen in the emergency room, the day after the vaccination, on 28Nov2017. Hospitalization was not required. Relevant laboratory tests, performed on 28Nov2017, were the following: Chest X-ray unremarkable, EKG showed sinus tachycardia, full blood count (CBC) with platelets unremarkable, basic metabolic panel unremarkable and troponin normal. Clinical outcome of the events was unknown at time of this report. The events, palpitations, generalized weakness, shortness of breath, chest tightness, paraesthesia, discomfort pain over the sternum, were assessed as serious (Medically Significant); while the other events were considered non-serious.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Sex: U
Vaccine: PNC13
Symptoms: Arthralgia, Pain in extremity, Spinal pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age, ethnicity, and gender received PREVNAR 13 via an unspecified route of administration in the left arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported  getting the pneumonia shot on late Monday night at a pharmacy and the next day, on an unspecified date, experienced joint pain in hips and in lower spine and in the left hand where the shot was given, was very tender. It had gotten worse and it was not going away and the patient was wondering how long  the reaction was going to be. The patient stated that they gave the shot and did not give anything else. The patient clarified that the injection was in the left arm but it was the hand that got very sore. The outcome of the events was unknown.  Follow-up information on lot number, batch numbers, and expiration date has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This is a spontaneous report received from a contactable healthcare professional. An elderly patient (reported as older than 65-year-old) of an unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history was and concomitant medications were not reported. On an unspecified date, it was reported that the patient has an arm that is sore with red circle 4 inches from the shot and is hot to touch. The outcome of the events was not recovered. Information regarding the batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (Age: 17; Unit: Unknown) and ethnicity received the first dose of TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history included bee stings. There were no concomitant medications. The patient previously took flu vaccine for immunization and experienced skin reactions. On an unspecified date, 3 hours post injection, patient experienced pain at site, fatigue and fever. On the second day, patient experienced fatigue, pain and swollen red with the size of baseball at injection site, fever and body aches. The patient took ibuprofen (ADVIL) for pain and fever. The outcome of the events was unknown.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abnormal dreams, Asthenia, Discomfort, Oropharyngeal pain, Pain
Clinical narrative: Within 24 hours of injection patient experienced body aches, local vaccine site pain and "vivid dreams' That disturbed sleep. She also had a very sore throat - these symptoms persisted for 5 days and she came in to be seen 11/14/17 - her strep test was negative. I viral illness combined with post-vaccine discomfort was suspected. Patient returned 11/30/17 with a rash consistent with pityriasis rosea, and again with the sore throat - she had been feeling weak tired and achey since 11/10/17. I told the mother I would submit a VAERS form however I personally felt the events all signified a viral illness.