chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
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 male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 19-NOV-2008 and 02-FEB-2009, the patient was inoculated with ZOSTAVAX (lot numbers, dosages and routes of administration not provided) 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 23-SEP-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed gabapentin for management of his 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: 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. On or about 08-NOV-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), 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 19-APR-2016, the patient was treated by a nurse practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. She was prescribed lidocaine, topical film, and acetaminophen/hydrocodone bitartrate for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On or about 25-OCT-2014, the patient was inoculated with ZOSTAVAX at a hospital as recommended for routine 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 23-DEC-2015, the patient was treated at the same hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: F
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 female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-OCT-2015, the patient was vaccinated at a pharmacy 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 23-FEB-2017, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 20-FEB-2009, the patient was inoculated with ZOSTAVAX at a grocery store pharmacy for routine 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 12-FEB-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received on 09-FEB-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 19-SEP-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-MAR-2017, the patient was treated in an emergency department for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster and post-herpetic neuralgia. The patient has been prescribed prednisone, FAMVIR and DILAUDID for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
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 female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-OCT-2011, the patient was vaccinated at a pharmacy 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 15-JUN-2015, the patient was treated for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. 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: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Neuralgia, Pain, Rash vesicular
Clinical narrative: Information has been received on 09-FEB-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 11-MAR-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-FEB-2016, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster with neuropathic pain. The patient has been prescribed valacyclovir and gabapentin 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: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 23-JUN-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-MAY-2015, the patient was treated at an urgent care for the onset of severe rash symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir for management of his symptoms and pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), 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. The patient was treated for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles (onset unknown). As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site rash, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Mother of child called on 2/9 stating that child's left leg was limp and he has been complaining of pain right below the knee. She stated symptoms started after immunizations were given on 2/7 and child was carried out to the car. She states he screams if anyone tries to touch his left leg and does not move it. Child is fine in sitting position. Child will move his right leg like normal; had tried alternating TYLENOL with MOTRIN and giving child a bath. States left thigh where immunizations were given has a small spot but denies any swelling. Encouraged MOC to call Dr. to follow-up. Both the nurse administering and another nurse witnessed the child walking around after the immunizations were given. Spoke with MOC on 2/12/18. She stated that child is doing much better. States she spoke with the dr. office on 2/9 and they think it was an injury; states that child possibly pulled away or flinched wrong when getting immunizations. She stated child has been walking on it; leg more stiff in the morning but gets better as the day goes on.
Age: 52.0
Sex: F
Vaccine: FLUR3
Symptoms: Pruritus, Rash
Clinical narrative: Approximately 5 minutes after giving influenza vaccine IM in left deltoid pt. reports itching and rash to this arm. No wheezing or respiratory symptoms. No lip or facial swelling. No other area of rash. BENADRYL 25 mg PO x1 given in office and pt. reports resolved symptoms. Instructed to monitor for any further symptoms.
Age: 75.0
Sex: U
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Redness, Lump, itching at site of Injection.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Patient returned w/palpable masses tender to palpate site of injection. No erythema, swelling, fluctuance. Positive induration. No fevers, chills, N/V or other systemic signs of infection. Resp stable. Rx given for Ibuprofen and KEFLEX.  Return in 3 days for follow-up. Addendum: Injection site on left thigh.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Dysstasia, Gait inability, Injection site reaction, Syncope, Weight bearing difficulty
Clinical narrative: 02/13/2018: Adverse event was reported verbally by child's parent. Child received a single dose of PCV13 on 02/09/2018 in right thigh without incident. The child was given Tylenol immediately after vaccination for potential fever and pain. No noticeable problems. On 02/12/18 the child was walking and the child " collapsed". No other problems noted. " He did not seem to be in and pain but he could not support his body weight with his legs." The parent noted that he could move his legs but could not walk or stand and that both legs were affected. The parent walked the child around the house supporting him for about one hour. After about one hour the child could stand on one leg. The parent was not sure which leg. The parent gave him a bath and put him to bed. In the morning the child was able to take 3 steps and then he collapsed. The parent took the child to Hospital ER. An X-ray was done on the child's left leg and the parent reported the x-ray was normal. The parent was told to observe the child for 3-5 days and to come back to ER if child's condition worsens. Parent was also instructed to follow-up with Primary Care MD. was notified and spoke with parent and all questions were answered.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: X-ray limb normal
Clinical narrative: 02/13/2018: Adverse event was reported verbally by child's parent. Child received a single dose of PCV13 on 02/09/2018 in right thigh without incident. The child was given Tylenol immediately after vaccination for potential fever and pain. No noticeable problems. On 02/12/18 the child was walking and the child " collapsed". No other problems noted. " He did not seem to be in and pain but he could not support his body weight with his legs." The parent noted that he could move his legs but could not walk or stand and that both legs were affected. The parent walked the child around the house supporting him for about one hour. After about one hour the child could stand on one leg. The parent was not sure which leg. The parent gave him a bath and put him to bed. In the morning the child was able to take 3 steps and then he collapsed. The parent took the child to Hospital ER. An X-ray was done on the child's left leg and the parent reported the x-ray was normal. The parent was told to observe the child for 3-5 days and to come back to ER if child's condition worsens. Parent was also instructed to follow-up with Primary Care MD. was notified and spoke with parent and all questions were answered.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Swelling face
Clinical narrative: Mom called and reports patient came home from school on 2-9-18 with a red face and some face swelling at approx 4pm.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Patient said that she started to develop redness in both arms on Friday, the 9th after the vaccines but the next day she had "hives" on the left arm, which she received the SHINGRIX vaccine. I questioned her about what the hives looked like and she said it was like little pimples so it sounds more like a rash and not hives. I advised that unless she was very concerned that she should take Benadryl and just keep an eye on it but to see a doctor if it got worse or if she was very worried about it. Today, after calling to check up on her she said it is improving but is still warm and red, which I again explained can be a normal side effect of the vaccines. She wants this reported but I am leary about saying that it is a true allergic reaction or whether it is a normal reaction. She didn't want to go in to be seen by the doctor if she didn't have to since influenza is so rampant right now and she didn't want to be exposed.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: Left axillary lymph node swelling and tenderness, left deltoid muscle tenderness, symptoms started 48 hours after injection and already improved after another 24 hours.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: PATIENT HAS HAD TO MAKE SEVERAL TRIPS TO THE DOCTOR'S OFFICE DUE TO MUSCLE WEAKNESS.
Age: 17.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: Client did not experience an adverse event upon receiving the vaccine on 1/9/18; client's parent informed immunization nurse at appointment for MMR/VZV Dose #2 that client was pregnant and was due July 2018. Client nor family knew of the pregnancy until 2/5/18 when UCG was resulted positive and therefore did not know of pregnancy when MMR/VZV Dose #1 was administered on 1/9/18. This VAER is for information purposes, as client has not experienced an adverse event to date.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Fatigue, Screaming, Seizure, Speech disorder
Clinical narrative: Screaming for hours, fatigue, seizure activity (hear turning from side to side repeatedly for 5-10 seconds), loss of vocalization (cooing) for one week.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Electroencephalogram, Erythema, Fatigue, Mass, Screaming
Clinical narrative: Screaming for hours, fatigue, large red lump for over a week, seizure activity (head going back and forth repeatedly for 10 seconds), lost speech ability for 18 months (had been babbling a lot with consonant-vowel-consonant sounds), staring spells which last up to 30 seconds for 5 months afterwards.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Seizure, Speech disorder, Staring
Clinical narrative: Screaming for hours, fatigue, large red lump for over a week, seizure activity (head going back and forth repeatedly for 10 seconds), lost speech ability for 18 months (had been babbling a lot with consonant-vowel-consonant sounds), staring spells which last up to 30 seconds for 5 months afterwards.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting about 1 hour after receiving immunization.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Feeling abnormal, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: While at school, the patient complained of painful/swollen lymph nodes of his right neck at approximately 8:15AM the morning after being given the meningococcal vaccine. He went to the school nurse who took his temperature (which was normal at that time). The patient had no other complaints of not feeling well. The school nurse administered IB profin to the patient. The patient returned to class. Approximately 90 minutes later, the patient returned to the school nurse with complaints of feeling dizzy, light headed and "weird." The patient also complained of a bad headache and also felt his throat hurt. The nurse took his temperature which at that point was 100.7, even after being give the fever reducing meds 90 minutes prior. The patient was brought home from school. Patient has been given alternating doses every three hours of IB profin and acetaminophen. Patient complained of continuous headache throughout the day. Patient was seen by Dr. at his primary care. Dr. explained symptoms were "normal". Patient's mother explained her concern for the dizziness/lightheadedness and fever.  Dr. said she would not report as an allergic reaction. Dr. wanted to test for flu and strep which patient's mother declined, the patient having just been at the dr 14 hours before with no symptoms and the symptoms came on quite suddenly. Dr. suggested fluids and meds.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: While at school, the patient complained of painful/swollen lymph nodes of his right neck at approximately 8:15AM the morning after being given the meningococcal vaccine. He went to the school nurse who took his temperature (which was normal at that time). The patient had no other complaints of not feeling well. The school nurse administered IB profin to the patient. The patient returned to class. Approximately 90 minutes later, the patient returned to the school nurse with complaints of feeling dizzy, light headed and "weird." The patient also complained of a bad headache and also felt his throat hurt. The nurse took his temperature which at that point was 100.7, even after being give the fever reducing meds 90 minutes prior. The patient was brought home from school. Patient has been given alternating doses every three hours of IB profin and acetaminophen. Patient complained of continuous headache throughout the day. Patient was seen by Dr. at his primary care. Dr. explained symptoms were "normal". Patient's mother explained her concern for the dizziness/lightheadedness and fever.  Dr. said she would not report as an allergic reaction. Dr. wanted to test for flu and strep which patient's mother declined, the patient having just been at the dr 14 hours before with no symptoms and the symptoms came on quite suddenly. Dr. suggested fluids and meds.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase, Full blood count, Metabolic function test, Mobility decreased, Pain in extremity
Clinical narrative: Approximately 3 days after the immunization, the patient developed severe lower extremity pain, from level of hips to knees, including anterior thigh. No associated numbness, tingling, weakness, bowel or bladder problems, or back pain. He insists that the pain began proximally and then proceeded distally. His pain was bad enough that he spent about 2 days in bed, only rising to use the bathroom. On the third day his symptoms resolved spontaneously. He is now back at work and asymptomatic. He has had prior flu immunizations without any adverse reactions, he reports.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: Fever, generalized body aches, chills and malaise. Self resolved without intervention.
Age: 42.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Type III immune complex mediated reaction, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Within 24 hours of vaccine patient noted redness, swelling, warmth and mild tenderness at vaccination site in left upper extremity. By 11 Feb, redness, swelling, induration and warmth had extended to triceps near elbow - see photo (please email me and I will attach photo of reaction without patient identifiers). No systemic symptoms. Assessed to be arthus reaction.
Age: 42.0
Sex: M
Vaccine: MNQ
Symptoms: Vaccination site warmth
Clinical narrative: Within 24 hours of vaccine patient noted redness, swelling, warmth and mild tenderness at vaccination site in left upper extremity. By 11 Feb, redness, swelling, induration and warmth had extended to triceps near elbow - see photo (please email me and I will attach photo of reaction without patient identifiers). No systemic symptoms. Assessed to be arthus reaction.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, SWOLLEN AND HOT IN THE INJECTION SITE. BENADRYL AND IBUPROFEN. PATIENT ALSO HAD TO SEE A DOCTOR AND GOT STEROID SHOT.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Musculoskeletal stiffness, Nausea, Pain in extremity
Clinical narrative: Patient received vaccination. That night he woke up with nausea, shaking, and felt faint and weak. His arm was sore and stiff into the next day.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Patient received vaccination. That night he woke up with nausea, shaking, and felt faint and weak. His arm was sore and stiff into the next day.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Altered state of consciousness, Asthenia, Nausea, Pruritus, Urticaria
Clinical narrative: A few minutes after the injection (maybe 5 minutes), I felt very weak and like I was going to vomit or pass out. The nurse had me lay down. Then maybe 5  minutes after laying down, I started to feel itchy on my shoulders, abdomen and inner thighs. I started to see small hives on my abdomen and arm. The nurse gave me benadryl.
Age: 86.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Alanine aminotransferase normal, Anion gap decreased, Aspartate aminotransferase normal, Basophil percentage, Bilirubin conjugated normal
Clinical narrative: Right upper arm large erythematous rash at the site of PCV 13 injection, no discharge, no bleeding.
Age: 86.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood chloride normal, Blood cholesterol normal
Clinical narrative: Right upper arm large erythematous rash at the site of PCV 13 injection, no discharge, no bleeding.
Age: 86.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Blood creatinine normal, Blood glucose normal, Blood lactate dehydrogenase normal, Blood potassium normal, Blood sodium normal
Clinical narrative: Right upper arm large erythematous rash at the site of PCV 13 injection, no discharge, no bleeding.
Age: 86.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Blood triglycerides normal, Blood urea normal, Blood urine absent, Carbon dioxide normal, Eosinophil percentage
Clinical narrative: Right upper arm large erythematous rash at the site of PCV 13 injection, no discharge, no bleeding.
Age: 86.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Gamma-glutamyltransferase normal, Glomerular filtration rate normal, Glucose urine absent, Glycosylated haemoglobin increased, Haematocrit normal
Clinical narrative: Right upper arm large erythematous rash at the site of PCV 13 injection, no discharge, no bleeding.
Age: 86.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Haemoglobin normal, High density lipoprotein normal, Injection site reaction, Low density lipoprotein normal, Lymphocyte percentage
Clinical narrative: Right upper arm large erythematous rash at the site of PCV 13 injection, no discharge, no bleeding.
Age: 86.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte percentage, Neutrophil percentage
Clinical narrative: Right upper arm large erythematous rash at the site of PCV 13 injection, no discharge, no bleeding.
Age: 86.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Nitrite urine absent, Platelet count normal, Protein total, Protein urine absent, Rash erythematous
Clinical narrative: Right upper arm large erythematous rash at the site of PCV 13 injection, no discharge, no bleeding.
Age: 86.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Red blood cell count normal, Red cell distribution width normal, Specific gravity urine normal, Urine bilirubin decreased, Urine ketone body absent
Clinical narrative: Right upper arm large erythematous rash at the site of PCV 13 injection, no discharge, no bleeding.
Age: 86.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Urine leukocyte esterase, Urobilinogen urine, White blood cell count normal, pH urine normal
Clinical narrative: Right upper arm large erythematous rash at the site of PCV 13 injection, no discharge, no bleeding.
Sex: U
Vaccine: FLUA3, FLUA3
Symptoms: Injection site pain
Clinical narrative: Customer called pharmacy on 2-13-18 reporting muscle pain at injection site that started 1 or 2 days after administration of vaccine.
Age: 1.5
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given 3+ yr Influenza dose of vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Tension
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 65-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date January 2019). On 30th January 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: It was reported that the patient received SHINGRIX and it bothered her. The reporter thought it was maybe soreness but was uncertain. The reporter stated that the patient's tenseness might had contributed to adverse event. The case was linked with the case US2018019800, reported by the same reporter for spouse.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Asthma, Erythema, Inflammation, Influenza like illness, Rash
Clinical narrative: This case was reported by a nurse and described the occurrence of asthma in a 11-year-old female patient who received MENVEO (batch number M17031, expiry date 31st March 2019). On 23rd March 2016, the patient received the 1st dose of MENVEO .5 ml. On 24th March 2016, 1 days after receiving MENVEO, the patient experienced asthma, erythema of extremities, rash, inflammation and influenza-like symptoms. On an unknown date, the outcome of the asthma, erythema of extremities, rash, inflammation and influenza-like symptoms were unknown. It was unknown if the reported considered the asthma, erythema of extremities, rash, inflammation and influenza-like symptoms to be related to MENVEO. Additional details were provided as follows: The patient received MENVEO on left upper arm. The next day after vaccination, the patient appeared with the erythema on her arm, rash, internal inflammation, and very flu like symptoms and asthma. The reporter did not agree to follow up.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Nausea, Vaccination site erythema, Vaccination site induration, Vaccination site mass
Clinical narrative: 9 x 9 cm area of erythema, warmth, induration, almost baseball size, palpable at site of vaccination reaction, chills, vomiting x 1, nausea.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site swelling, Vaccination site warmth, Vomiting
Clinical narrative: 9 x 9 cm area of erythema, warmth, induration, almost baseball size, palpable at site of vaccination reaction, chills, vomiting x 1, nausea.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia, Rash erythematous
Clinical narrative: 2-7-18 rash on lower abd. x 3 days. Red but not warm. 2-9-18 raised red hard area at injection site 4.5cm x 3cm area and fever treated with Cephalexin. 2-12-18 improved no redness.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dysphagia, Eye irritation, Headache, Ocular hyperaemia
Clinical narrative: 1 hour, 45 min after vaccine: Difficulty swallowing. Tightness in chest noticed: symptoms worsening, eyes scratchy and blood shot. Dr.'s office said go to ER 3:00 pm (2 1/2 hr later) vomiting continuously. I was given BENADRYL IV, NaCl 0.9%, ZOFRAN. Stopped vomiting (approximately 3 1/2 - 4 hours) later. Throat symptoms reduced but didn't go away for 10 hours from onset. Tightness in chest reduced approximately 5 hours from onset. Headache 2 days continued from onset of reaction. Blood shot eyes and scratchy eyes cont. 2 days from onset. I was seen by MD at ER.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: 1 hour, 45 min after vaccine: Difficulty swallowing. Tightness in chest noticed: symptoms worsening, eyes scratchy and blood shot. Dr.'s office said go to ER 3:00 pm (2 1/2 hr later) vomiting continuously. I was given BENADRYL IV, NaCl 0.9%, ZOFRAN. Stopped vomiting (approximately 3 1/2 - 4 hours) later. Throat symptoms reduced but didn't go away for 10 hours from onset. Tightness in chest reduced approximately 5 hours from onset. Headache 2 days continued from onset of reaction. Blood shot eyes and scratchy eyes cont. 2 days from onset. I was seen by MD at ER.
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a female consumer of unknown age referring to herself. The patient's medical history included pneumonia. In September 2017, the patient had an unspecified "flu shot". The patient was on other regular medications but did to provide details. The patient's drug reactions or allergies were not reported. On an unspecified date (reported as "Sunday afternoon"), the patient was vaccinated inside the deltoid towards the inner part of the shoulder with PNEUMOVAX 23 lot number: N030849 (expiration date: 09-JUN-2019), one shot once, for prophylaxis (reported as "she did not want to get pneumonia again") (strength and route were not reported). The reporter informed that no other vaccines were given concomitantly. On an unspecified date, almost immediately after vaccination, the patient felt pain and the injection site became red and itchy. By evening, the whole patient's arm was swollen from the shoulder to the elbow and she had difficulty sleeping (insomnia). By the next morning, her whole arm kept swollen. In addition, she was unable to bend her arm (injected limb mobility decreased) and it was excruciatingly painful, red and hot. On an unspecified date (reported as "9am on Monday"), the patient went to see her physician who told her that it looked like cellulitis and gave her cephalexin (KEFLEX). The patient described to the physician how the vaccine was administered and the physician said that it was given improperly. On the next night (unspecified date), the patient was unable to sleep and had trouble dressing. The patient tried to use icepacks on her arm but it was too painful. After that, on an unspecified date, the patient saw her gastroenterologist on an unspecified date who also said the vaccine was improperly administered and it could have hit a vessel  (vascular injury). At the time of the report the patient was getting better and recovering from injected limb mobility decreased and cellulitis, as she was able to move the arm; however, the outcome of insomnia and vascular injury was unknown. The reporter did not assess the relatedness between PNEUMOVAX 23 with cellulitis, injected limb mobility decreased, insomnia, and vascular injury. Upon internal review, cellulitis was determined to be a medically significant event.
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site pruritus, Insomnia
Clinical narrative: This spontaneous report was received from a female consumer of unknown age referring to herself. The patient's medical history included pneumonia. In September 2017, the patient had an unspecified "flu shot". The patient was on other regular medications but did to provide details. The patient's drug reactions or allergies were not reported. On an unspecified date (reported as "Sunday afternoon"), the patient was vaccinated inside the deltoid towards the inner part of the shoulder with PNEUMOVAX 23 lot number: N030849 (expiration date: 09-JUN-2019), one shot once, for prophylaxis (reported as "she did not want to get pneumonia again") (strength and route were not reported). The reporter informed that no other vaccines were given concomitantly. On an unspecified date, almost immediately after vaccination, the patient felt pain and the injection site became red and itchy. By evening, the whole patient's arm was swollen from the shoulder to the elbow and she had difficulty sleeping (insomnia). By the next morning, her whole arm kept swollen. In addition, she was unable to bend her arm (injected limb mobility decreased) and it was excruciatingly painful, red and hot. On an unspecified date (reported as "9am on Monday"), the patient went to see her physician who told her that it looked like cellulitis and gave her cephalexin (KEFLEX). The patient described to the physician how the vaccine was administered and the physician said that it was given improperly. On the next night (unspecified date), the patient was unable to sleep and had trouble dressing. The patient tried to use icepacks on her arm but it was too painful. After that, on an unspecified date, the patient saw her gastroenterologist on an unspecified date who also said the vaccine was improperly administered and it could have hit a vessel  (vascular injury). At the time of the report the patient was getting better and recovering from injected limb mobility decreased and cellulitis, as she was able to move the arm; however, the outcome of insomnia and vascular injury was unknown. The reporter did not assess the relatedness between PNEUMOVAX 23 with cellulitis, injected limb mobility decreased, insomnia, and vascular injury. Upon internal review, cellulitis was determined to be a medically significant event.
Sex: F
Vaccine: PPV, PPV
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a female consumer of unknown age referring to herself. The patient's medical history included pneumonia. In September 2017, the patient had an unspecified "flu shot". The patient was on other regular medications but did to provide details. The patient's drug reactions or allergies were not reported. On an unspecified date (reported as "Sunday afternoon"), the patient was vaccinated inside the deltoid towards the inner part of the shoulder with PNEUMOVAX 23 lot number: N030849 (expiration date: 09-JUN-2019), one shot once, for prophylaxis (reported as "she did not want to get pneumonia again") (strength and route were not reported). The reporter informed that no other vaccines were given concomitantly. On an unspecified date, almost immediately after vaccination, the patient felt pain and the injection site became red and itchy. By evening, the whole patient's arm was swollen from the shoulder to the elbow and she had difficulty sleeping (insomnia). By the next morning, her whole arm kept swollen. In addition, she was unable to bend her arm (injected limb mobility decreased) and it was excruciatingly painful, red and hot. On an unspecified date (reported as "9am on Monday"), the patient went to see her physician who told her that it looked like cellulitis and gave her cephalexin (KEFLEX). The patient described to the physician how the vaccine was administered and the physician said that it was given improperly. On the next night (unspecified date), the patient was unable to sleep and had trouble dressing. The patient tried to use icepacks on her arm but it was too painful. After that, on an unspecified date, the patient saw her gastroenterologist on an unspecified date who also said the vaccine was improperly administered and it could have hit a vessel  (vascular injury). At the time of the report the patient was getting better and recovering from injected limb mobility decreased and cellulitis, as she was able to move the arm; however, the outcome of insomnia and vascular injury was unknown. The reporter did not assess the relatedness between PNEUMOVAX 23 with cellulitis, injected limb mobility decreased, insomnia, and vascular injury. Upon internal review, cellulitis was determined to be a medically significant event.
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin warm
Clinical narrative: This spontaneous report was received from a female consumer of unknown age referring to herself. The patient's medical history included pneumonia. In September 2017, the patient had an unspecified "flu shot". The patient was on other regular medications but did to provide details. The patient's drug reactions or allergies were not reported. On an unspecified date (reported as "Sunday afternoon"), the patient was vaccinated inside the deltoid towards the inner part of the shoulder with PNEUMOVAX 23 lot number: N030849 (expiration date: 09-JUN-2019), one shot once, for prophylaxis (reported as "she did not want to get pneumonia again") (strength and route were not reported). The reporter informed that no other vaccines were given concomitantly. On an unspecified date, almost immediately after vaccination, the patient felt pain and the injection site became red and itchy. By evening, the whole patient's arm was swollen from the shoulder to the elbow and she had difficulty sleeping (insomnia). By the next morning, her whole arm kept swollen. In addition, she was unable to bend her arm (injected limb mobility decreased) and it was excruciatingly painful, red and hot. On an unspecified date (reported as "9am on Monday"), the patient went to see her physician who told her that it looked like cellulitis and gave her cephalexin (KEFLEX). The patient described to the physician how the vaccine was administered and the physician said that it was given improperly. On the next night (unspecified date), the patient was unable to sleep and had trouble dressing. The patient tried to use icepacks on her arm but it was too painful. After that, on an unspecified date, the patient saw her gastroenterologist on an unspecified date who also said the vaccine was improperly administered and it could have hit a vessel  (vascular injury). At the time of the report the patient was getting better and recovering from injected limb mobility decreased and cellulitis, as she was able to move the arm; however, the outcome of insomnia and vascular injury was unknown. The reporter did not assess the relatedness between PNEUMOVAX 23 with cellulitis, injected limb mobility decreased, insomnia, and vascular injury. Upon internal review, cellulitis was determined to be a medically significant event.
Sex: F
Vaccine: HIBV, HIBV, MNQ
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-FEB-2018, the patient was vaccinated with PEDVAXHIB intramuscular (lot # N003536, Expiry date: 02-NOV-2019) for prophylaxis. Other suspect therapies included MENACTRA (unspecified lot number and expiration date). On 02-FEB-2018, the patient received a dose of PEDVAXHIB instead of MENACTRA which was ordered. The reporting nurse noticed this while she was reconciling her vaccine count on 09-FEB-2018. No adverse event reported. No product quality complaint involved.
Sex: F
Vaccine: HIBV, HIBV, MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-FEB-2018, the patient was vaccinated with PEDVAXHIB intramuscular (lot # N003536, Expiry date: 02-NOV-2019) for prophylaxis. Other suspect therapies included MENACTRA (unspecified lot number and expiration date). On 02-FEB-2018, the patient received a dose of PEDVAXHIB instead of MENACTRA which was ordered. The reporting nurse noticed this while she was reconciling her vaccine count on 09-FEB-2018. No adverse event reported. No product quality complaint involved.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: At about 72 hours post vaccine, rash has developed, rash still bothersome 2/13/2018 a week later, burning itching raised area about 3 x 3" upper left arm. Called Dr on advice of (physically revisiting) pharmacist, no other action taken. Wondering if second dose is advisable. Spoke with PC, advised I should come for office visit. No insurance.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: At about 72 hours post vaccine, rash has developed, rash still bothersome 2/13/2018 a week later, burning itching raised area about 3 x 3" upper left arm. Called Dr on advice of (physically revisiting) pharmacist, no other action taken. Wondering if second dose is advisable. Spoke with PC, advised I should come for office visit. No insurance.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pruritus
Clinical narrative: Itching at injection site started approximately 24 hours after injection.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Myalgias, chills, headache, stiff neck, very sore arm at injection site.
Age: 1.17
Sex: F
Vaccine: MMR, PNC13
Symptoms: Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: 3.5 x 6.5 red oval lesion with an area protruding to 7 cm on left upper thigh. Not tender to palpation.
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report was received from an office manager via a company representative and refers to a 13 year old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 21-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot # and expiration date were not reported) for prophylaxis. Immediately after receiving the GARDASIL 9, the patient fainted. On an unspecified date, the patient recovered with no complications. On an unknown date, the patient received her second dose of GARDASIL 9 with no adverse reactions.    The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.