chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that an 85-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (trade name and manufacturer were not reported), with route of administration and therapy dates unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had allergies with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The outcome of the event was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. An 87-year-old female patient received PREVNAR 13, lot number and expiration date unknown, via an unspecified route of administration on 28Dec2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that on an unspecified date, the patient experienced swelling at injection site the 'size of a baseball', no fever, warm to the touch. Condition persists as of 06Jan2019. The patient had not recovered from the events. Information on the lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: After two hrs of getting vaccine pt complained of severe pain in arm from shoulder to elbow. Stated arm was swollen and red and very painful to the touch. Pt. was instructed by Dr. to apply cold compress a few times a day and to watch for fever, vomiting or cold chills and to c/b if this happens. After 48 hrs I called pt to see how he was and he stated arm felt better.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Blood glucose normal, Dizziness, Haemoglobin normal, Loss of consciousness, Pallor
Clinical narrative: Patient was given an HPV #2 IM right deltoid. Upon MA administering the HPV patient stated that he was feeling dizzy. He put his head back turned pale and passed out for about 15 seconds, he did not fully lose consciousness but patient stated he was still dizzy. Provider was called. BP, blood sugar, hemoglobin was taken and patient was monitored until provider gave the ok to let him go. Upon pts. departure from the clinic patient stated that he was feeling much better. Water was also given. Vasovagal syncope.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Syncope
Clinical narrative: Patient was given an HPV #2 IM right deltoid. Upon MA administering the HPV patient stated that he was feeling dizzy. He put his head back turned pale and passed out for about 15 seconds, he did not fully lose consciousness but patient stated he was still dizzy. Provider was called. BP, blood sugar, hemoglobin was taken and patient was monitored until provider gave the ok to let him go. Upon pts. departure from the clinic patient stated that he was feeling much better. Water was also given. Vasovagal syncope.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Limb discomfort, Pain in extremity
Clinical narrative: Pt states she got the vaccine and felt some discomfort that day but did not think anything about it, she states then that the pain was dull and in her left arm. She felt her arm heavy and just sore, then she felt some pain...but still thought nothing of it but simply a flu shot. She says the dull pain is still there and has not gone away since oct 3, and that at time she feels like it radiates down her arm. But patient never went to see a MD regarding her pain.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: On 1/10/19, patient's spouse a Dr. called and reported patient had some pretty bad reactions starting about bedtime. She experienced fever (102 F), chills, headache, shivering, myalgia, arthralgia, insomnia. He reported that the temperature had come down but she still felt pretty weak and fatigued.  After reinforcing that these were possible side effects of the vaccine, I asked him to let me know when she started feeling better and of course to call me if it did not get better. On 1/15/19 I called him back.  He reported that the worst of it lasted about 2 and 1/2 days but she was better now. He said she does still a bit tired and her arm is still sore.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: On 1/10/19, patient's spouse a Dr. called and reported patient had some pretty bad reactions starting about bedtime. She experienced fever (102 F), chills, headache, shivering, myalgia, arthralgia, insomnia. He reported that the temperature had come down but she still felt pretty weak and fatigued.  After reinforcing that these were possible side effects of the vaccine, I asked him to let me know when she started feeling better and of course to call me if it did not get better. On 1/15/19 I called him back.  He reported that the worst of it lasted about 2 and 1/2 days but she was better now. He said she does still a bit tired and her arm is still sore.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Discomfort, Hypersensitivity, Limb discomfort, Urticaria
Clinical narrative: I ended up having a delayed allergic reaction to the second dose of the vaccine, which was also split in half based off of my reaction to the first vaccine. The reaction was hives (located on the inside of my knees). I also had some leg discomfort. This was not pain- but it was more of a heavy feeling or like the feeling of when a limb is asleep. To treat the hives I took benedryal and the following day claratin.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Patient was vaccinated at @1:30pm on 1/2/19 and by @6pm that evening she said she developed a severe headache and started having chills. Her fever was 102 F when she checked it that evening.  She felt severe fatigue all over similar to flu she said this did not resolve until lunchtime on Friday 1/4/19. Her arm was also swollen, red and very itchy at injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Patient was vaccinated at @1:30pm on 1/2/19 and by @6pm that evening she said she developed a severe headache and started having chills. Her fever was 102 F when she checked it that evening.  She felt severe fatigue all over similar to flu she said this did not resolve until lunchtime on Friday 1/4/19. Her arm was also swollen, red and very itchy at injection site.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Injection site pain, Pain, Sciatica
Clinical narrative: I received the SHINGRIX 50 mcg vaccine on 1/08/2019. Initially experienced a sore arm at the injection site, which I understand is somewhat common. However, after 3 days, I experienced the onset of sciatica on the same side as the injection. This included moderate pain in the left, lower back and radiating pain to the knee area. It continues to date, and will require medical intervention if it doesn't ease up. I never had this issue before and I believe may be related to the vaccine.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site pain
Clinical narrative: I got the SHINGRIX vaccine the afternoon of January 9th. The following morning January 10th, I began having heart rate of 104 +. Today is January 11th, and I'm still having heart rate above 100 in the morning. I do not have a fever, though the injection site is extremely sore (left upper arm).
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product container issue
Clinical narrative: A medical assistant was giving a pre filled injection the vial broke in her hand. Patient nor medical assistant were harmed when this happened.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait inability, Muscle spasms, Myalgia, Sciatica
Clinical narrative: Sciatic pain, Muscle aches in the legs, Foot cramping. Inability to walk.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient was given a Tdap instead of a Hepatitis B.
Age: 21.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Erythema 41mm by 43mm and itching at site. Warm upon palpation. Tender upon palpation. PT noted discomfort at approximately 1000 that morning and setup appointment 1230. HCP provided BENADRYL.
Sex: M
Vaccine: HPV9
Symptoms: Encephalitis, Malaise, Myalgia, Post viral fatigue syndrome
Clinical narrative: This spontaneous report was received from a physician via a field representative and refers to a 15 year old male patient. No information was provided regarding the patient's medical history, concomitant medications or drug reactions/ allergies. The patient concurrent condition included myalgic encephalitis. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient was diagnosed with "myalgic encephalitis (encephalitis), and felt more sick." It was unknown if the patient sought medical attention, if received treatment for the event or if laboratory diagnostics or studies were performed. The outcome of the events was reported as not recovered. The causal relationship between the events and therapy with GARDASIL 9 was not reported. Upon internal review the event encephalitis was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 17-MAY-2007, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 22-MAY-2009, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 2007, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about May 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse and refers to a 34-year-old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 06-NOV-2018, the patient was vaccinated with a child dose of PROQUAD (albumin status: rHA) lot # R006217, expiration date 28-AUG-2019 (exact dose, dose # and route of administration were not report) for prophylaxis. No adverse effects were reported.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Abdominal pain upper, Fatigue, Skin warm
Clinical narrative: Extreme fatigue, stomach ache, unknown temperature but parents report pt feels warm.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hyperhidrosis, Nausea, Pregnancy test positive
Clinical narrative: Employee received influenza vaccine at ~1340 on 09-21-2018. Returned to work location and began to experience sudden headache, diaphoresis, and nausea. No shortness of breath. Escorted to the ED.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count normal, Heart rate increased, Pyrexia
Clinical narrative: High fever 101.5 degree, high heart rate 144 bpm next day 7:17am, sustained at 100 for 3 hours, went to ER via ambulance.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Erythema, Fatigue, Headache, Myalgia
Clinical narrative: My arm swelled up and was red about 2.5 inches. Swollen axillary LN left arm, and mildly sore inguinal LNs. I had severe headache, it was an unusual headache, muscle pains shooting through my body, feet hurt, nausea, extreme fatigue, diarrhea. This lasted for almost 3 days. The arm swelling last for 4 days. I am scared to get the booster.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: My arm swelled up and was red about 2.5 inches. Swollen axillary LN left arm, and mildly sore inguinal LNs. I had severe headache, it was an unusual headache, muscle pains shooting through my body, feet hurt, nausea, extreme fatigue, diarrhea. This lasted for almost 3 days. The arm swelling last for 4 days. I am scared to get the booster.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: My arm swelled up and was red about 2.5 inches. Swollen axillary LN left arm, and mildly sore inguinal LNs. I had severe headache, it was an unusual headache, muscle pains shooting through my body, feet hurt, nausea, extreme fatigue, diarrhea. This lasted for almost 3 days. The arm swelling last for 4 days. I am scared to get the booster.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: My arm swelled up and was red about 2.5 inches. Swollen axillary LN left arm, and mildly sore inguinal LNs. I had severe headache, it was an unusual headache, muscle pains shooting through my body, feet hurt, nausea, extreme fatigue, diarrhea. This lasted for almost 3 days. The arm swelling last for 4 days. I am scared to get the booster.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site pain, Malaise, Vomiting
Clinical narrative: Approximately 12 hours after receiving the second SHINGRIX vaccine, I became quite ill.  My temperature was 101.5 degrees F and I threw up repeatedly. I tried to control the vomiting by taking ondansetron (Zofran) by mouth, but I promptly threw it up. The vomiting subsided only after I rectally inserted a second ondansetron tablet and it had time to dissolve, be absorbed, and take effect about 6 hours after the vomiting began. I had received the first dose of SHINGRIX vaccine on September 15, 2018. Following that vaccination, I had a little soreness at the injection site but no other adverse effects.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient reported to pharmacy with complaints of prolonged arm soreness and reduced range of motion one month after receiving vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Neck pain, Pain in extremity, X-ray
Clinical narrative: Patient called in on 1/4/19 stating that her vaccine was administered too high in her arm and has caused her severe pain. She states that the pain went from her arm to her neck and she did not have this reaction with the first injection in the series. She said that she went to the ER where they did x-rays and stated to her that it looks that it was administered too high. Patient states that she cannot move her arm and that it is in a sling. She was given a prescription for the pain/muscle and is to follow up with her primary care provider. The administering pharmacist recount of the event of the vaccination. Prior to administering the vaccination I informed the patient that redness and pain near the injection site is common following this vaccination and reviewed the screening questionnaire for immunization and consent and asked the patient if she had any questions about the vaccine. I asked the patient to lift her right arm and palpated to feel for the deltoid muscle. I then advised the patient to put her arm down and relax her arm as much as possible. I then cleansed the injection site with an alcohol swab and administered the vaccine intramuscularly in the patients right deltoid per Meijer vaccination protocol and covered the injection site with a Band-Aid. The patient's arm was thin, but nothing else was atypical or of note when the vaccine was given. We reviewed how to find the deltoid muscle and then where in the deltoid muscle to make the injection.
Age: 24.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Extreme diarrhea and stomach pain, at the point where the patient was not able to leave the house for fear of being stuck somewhere without access to a bathroom due to lack of notice and abrupt need.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 30-JAN-2015, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about October 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. In 2016, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Myocardial infarction
Clinical narrative: Information has been received on 14-JAN-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for the prevention of shingles. Instead, in June 2017, the vaccine caused the patient to suffer a heart attack. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. As a direct and proximate result of ZOSTAVAX the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. The patient has paid and has become liable to pay for medical aid, treatment, and medications and will necessarily incur further expenses of a similar nature in the future. The outcome of the events is not recovered. The causality of the events is related. Upon internal review, heart attack was considered to be medically significant. Heart attack was considered to be disabling. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 2 months old female patient who received dose of vaccine QUADRACEL (lot number and Expiry date unknown) via unknown route in the right thigh on Jan 2018. The patient's past vaccination(s) not reported. Patient received DTAP, IPOL Polio  Vaccine and PENTACEL at the age of 4 months and 7 months. It was a case of actual medication error due to inappropriate age at vaccine administration. (It was reported that QUADRACEL administered to a 2 months old female just discovered during a review of her record at a 10 months visit.) No reaction reported at the time of vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none. Addendum 15-Jan-2019.
Sex: U
Vaccine: TYP
Symptoms: Syringe issue
Clinical narrative: Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist and also additional information was received on 09-Jan-2019 from a Pharmacist. This case involves a 37 years old patient of unknown gender who received vaccine TYPHIM VI (batch number: N1K811M, expiry date: 19-Oct-2019) (dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of Syringe issue as she went to screw on the needle the plastic part of the syringe fell off. It was also reported that she thinks the end cap was rubber and she twisted it off and still has the syringe and cap to return. It was not reported if vaccine was administered or not. List of documents held by sender- none.
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 months old male patient who was vaccinated with the fourth dose of 0.1 ml IPOL (lot number: P1A242M, expiry date 26 April 2020 via unknown route in the left arm) instead of TUBERSOL batch number, expiry date, route and site of administration were not reported on 08-Jan-2019. It was reported that, patient had already received the 3 full doses of IPOL previously. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE and PREVNAR for Immunisation. It was an actual medication error due to extra dose administered and wrong product administered as accidentally grabbed an IPOL vial instead of the TUBERSOL vial and administered 0.1mL ID of the IPOL. The patient had already received the 3 full doses of IPOL previously. Patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Product use in unapproved indication
Clinical narrative: Initial information received on 08-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old patient with an unknown vaccination history if he has a completed his catch series for Diptheria, Pertussis and Tetanus who received vaccine ADACEL (lot number not reported) on 19-Jun-2017, via unknown route in unknown administration site. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Inappropriate schedule of vaccine administered and product use in unapproved indication. The patient had a TD vaccine on 02-Oct-2017. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old male patient who was vaccinated with an expired dose of vaccine ACT-HIB (lot UI821AA and Exp. Date 19-NOV-2018) via unknown route in unknown administration site on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to expired vaccine used. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, MMRV, PNC13
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old female patient who received vaccine FLUZONE QUADRIVALENT. The patients past medical history and family history were not provided. Concomitant medications included PEDIARIX, PREVNAR, HEPATITIS A and MMRV. On 08-Jan-2019, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AB, expiry date 30-Jun-2019 via intramuscular route in the right thigh. It was an actual medication error due to overdose. It was reported that FLUZONE QUADRIVALENT, 0.5 ml was given to 15m old patient. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves 32 years old male patient who received a 0.5 mL dose of vaccine FLUZONE HIGH DOSE batch number UJ000AA (expiry date 28-Mar-2019) via unknown route in left deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patients' medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was not reported that if any adverse reaction was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Induration, Mass, Pain in extremity, Tenderness
Clinical narrative: Patient reports a soft, tender lump that became hard along with arm pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Injection site pain, Nausea, Pain in extremity
Clinical narrative: Agonizing pain in right arm and shoulder, nausea, Teeth chattering, chills, weakness.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Patient claims that he is suffering from flulike symptoms after getting the vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Severe pain and swelling at injection site within hour, much more than comparable tetanus shot, necessitating Extra-Strength Tylenol throughout the night. By 10:00 am following day (01/15/2019), started experiencing chills, headache, nausea, neck pain, low back pain, buttock pain, leg aches, fatigue. Necessitated going to bed and continuation of Extra-Strength Tylenol. As of 05:30 pm, symptoms continue.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Musculoskeletal pain, Nausea, Neck pain, Pain in extremity
Clinical narrative: Severe pain and swelling at injection site within hour, much more than comparable tetanus shot, necessitating Extra-Strength Tylenol throughout the night. By 10:00 am following day (01/15/2019), started experiencing chills, headache, nausea, neck pain, low back pain, buttock pain, leg aches, fatigue. Necessitated going to bed and continuation of Extra-Strength Tylenol. As of 05:30 pm, symptoms continue.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Patient reports severe arm pain radiating up to her neck.
Sex: U
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Irritation and redness to the injection site approximately  2" x 4" area.
Age: 1.08
Sex: F
Vaccine: FLU4
Symptoms: Nodule
Clinical narrative: Foster parent states client has a not on her buttock area from previous vaccination. She states not sure when it happened had vaccination previously on 12/05/2018 then later on 12/18/2019.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Burning sensation, Dizziness, Electromyogram, Feeling abnormal
Clinical narrative: Same day felt loopy and weak. Day 2, 3, 4 and 5, I felt heavier, loopier, body aches and dizzy and could just hang out in my pajamas and was extremely thirsty. Day 6 in the evening is when the worst hit. Sitting in a recliner acute pain and numbness with pins and needles started in my feet and traveled up my legs. It went up to my butt. By morning it was in my breast and by November 22nd it traveled up to the left side of face with numbness. I could not think or talk my brain wouldn't work. Everything was spinning and the acute pain and the pins and needles covered my entire body but worse on the left side due to the pinched nerves. I went to the Emergency Room. My muscles and tissues throughout my body had cramps and shooting pains and my body wouldn't and couldn't move because the tissues felt inflamed and pulsing and throbbing with electrical pains. I felt like I was burning up but didn't have a fever. I couldn't tell the difference between hot or cold. I'd try to move and my body was stuck even my fingers and wrists and I was so thirsty. My body shut down from normal feeling. Clothes hurt, tried to soak my feet and the water touching my ankle hurt. I couldn't touch my own skin because it would send shocks and pins and needles then pain.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperaesthesia, Hypoaesthesia, Inflammation, Laboratory test, Mental impairment
Clinical narrative: Same day felt loopy and weak. Day 2, 3, 4 and 5, I felt heavier, loopier, body aches and dizzy and could just hang out in my pajamas and was extremely thirsty. Day 6 in the evening is when the worst hit. Sitting in a recliner acute pain and numbness with pins and needles started in my feet and traveled up my legs. It went up to my butt. By morning it was in my breast and by November 22nd it traveled up to the left side of face with numbness. I could not think or talk my brain wouldn't work. Everything was spinning and the acute pain and the pins and needles covered my entire body but worse on the left side due to the pinched nerves. I went to the Emergency Room. My muscles and tissues throughout my body had cramps and shooting pains and my body wouldn't and couldn't move because the tissues felt inflamed and pulsing and throbbing with electrical pains. I felt like I was burning up but didn't have a fever. I couldn't tell the difference between hot or cold. I'd try to move and my body was stuck even my fingers and wrists and I was so thirsty. My body shut down from normal feeling. Clothes hurt, tried to soak my feet and the water touching my ankle hurt. I couldn't touch my own skin because it would send shocks and pins and needles then pain.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Nerve compression, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Pain
Clinical narrative: Same day felt loopy and weak. Day 2, 3, 4 and 5, I felt heavier, loopier, body aches and dizzy and could just hang out in my pajamas and was extremely thirsty. Day 6 in the evening is when the worst hit. Sitting in a recliner acute pain and numbness with pins and needles started in my feet and traveled up my legs. It went up to my butt. By morning it was in my breast and by November 22nd it traveled up to the left side of face with numbness. I could not think or talk my brain wouldn't work. Everything was spinning and the acute pain and the pins and needles covered my entire body but worse on the left side due to the pinched nerves. I went to the Emergency Room. My muscles and tissues throughout my body had cramps and shooting pains and my body wouldn't and couldn't move because the tissues felt inflamed and pulsing and throbbing with electrical pains. I felt like I was burning up but didn't have a fever. I couldn't tell the difference between hot or cold. I'd try to move and my body was stuck even my fingers and wrists and I was so thirsty. My body shut down from normal feeling. Clothes hurt, tried to soak my feet and the water touching my ankle hurt. I couldn't touch my own skin because it would send shocks and pins and needles then pain.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia, Speech disorder, Thirst, Vertigo
Clinical narrative: Same day felt loopy and weak. Day 2, 3, 4 and 5, I felt heavier, loopier, body aches and dizzy and could just hang out in my pajamas and was extremely thirsty. Day 6 in the evening is when the worst hit. Sitting in a recliner acute pain and numbness with pins and needles started in my feet and traveled up my legs. It went up to my butt. By morning it was in my breast and by November 22nd it traveled up to the left side of face with numbness. I could not think or talk my brain wouldn't work. Everything was spinning and the acute pain and the pins and needles covered my entire body but worse on the left side due to the pinched nerves. I went to the Emergency Room. My muscles and tissues throughout my body had cramps and shooting pains and my body wouldn't and couldn't move because the tissues felt inflamed and pulsing and throbbing with electrical pains. I felt like I was burning up but didn't have a fever. I couldn't tell the difference between hot or cold. I'd try to move and my body was stuck even my fingers and wrists and I was so thirsty. My body shut down from normal feeling. Clothes hurt, tried to soak my feet and the water touching my ankle hurt. I couldn't touch my own skin because it would send shocks and pins and needles then pain.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: Same day felt loopy and weak. Day 2, 3, 4 and 5, I felt heavier, loopier, body aches and dizzy and could just hang out in my pajamas and was extremely thirsty. Day 6 in the evening is when the worst hit. Sitting in a recliner acute pain and numbness with pins and needles started in my feet and traveled up my legs. It went up to my butt. By morning it was in my breast and by November 22nd it traveled up to the left side of face with numbness. I could not think or talk my brain wouldn't work. Everything was spinning and the acute pain and the pins and needles covered my entire body but worse on the left side due to the pinched nerves. I went to the Emergency Room. My muscles and tissues throughout my body had cramps and shooting pains and my body wouldn't and couldn't move because the tissues felt inflamed and pulsing and throbbing with electrical pains. I felt like I was burning up but didn't have a fever. I couldn't tell the difference between hot or cold. I'd try to move and my body was stuck even my fingers and wrists and I was so thirsty. My body shut down from normal feeling. Clothes hurt, tried to soak my feet and the water touching my ankle hurt. I couldn't touch my own skin because it would send shocks and pins and needles then pain.
Age: 29.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Human chorionic gonadotropin positive, Maternal exposure before pregnancy
Clinical narrative: Pt received Anthrax vaccination on 16OCT2018 and 04DEC2018 and Smallpox vaccination on 04DEC2018. Pt did not believe that she was pregnant at either of those visits. At that time it was discussed to avoid becoming pregnant for at least the next four weeks due to potential harm to unborn child. Pt realized on 15DEC that she had not had her menstrual cycle yet that month which usually occurs on 10DEC. Pt took a home pregnancy test on 15DEC which was positive but waited to discuss pregnancy with providers until 08JAN due to work related commitments. She had her initial OB/GYN visit on 14JAN where she was estimated to be at around 8 weeks gestational age and has a 10 week visit on 30JAN. Unit physician met with pt on 14JAN to discuss potential complications or outcomes of becoming pregnant after receiving Smallpox vaccination. Handout from website on the subject of pregnancy after smallpox vaccination was given to and reviewed with the pt. Pt self registered with the registry on 14JAN.
Age: 1.08
Sex: U
Vaccine: FLU4, HIBV, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: The varicella vaccine was given on January 7th, 2019 in my son's left upper arm. On January 13th, a red spot appeared in the area where the vaccine was given. It was a red spot slightly bigger than the size of the quarter. The next day the spot became a lump and was hot to the touch. The spot has been like this for two days and I am still monitoring it at this time.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Axillary pain, Injection site erythema, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pt reported on 01/08/19 (approx. 27 days post vaccination) fever of 101.3, vaccine site redness, hot to touch, swelling and pain radiating to left axillary/shoulder. Pt denies chest pain or breathing difficulty. Pt informed she had no vaccine complications prior to 01/08/19. Pt denies prior vaccine reactions.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Vaccination site warmth
Clinical narrative: Pt reported on 01/08/19 (approx. 27 days post vaccination) fever of 101.3, vaccine site redness, hot to touch, swelling and pain radiating to left axillary/shoulder. Pt denies chest pain or breathing difficulty. Pt informed she had no vaccine complications prior to 01/08/19. Pt denies prior vaccine reactions.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Blood test normal, Chest X-ray normal, Feeling abnormal, Flushing
Clinical narrative: It began yesterday at 3:30. I came home from having the TD shot and  had a massive headache. It went from that to left arm feeling tingly. A few hours later my head still hurts right shoulder started hurting. When I went to bed I experienced nausea, back pain, flushing. My left arm felt oddly sick as it felt the shots contents surging thru it for hours. It felt sick... and then my left leg felt ill too, oddly like flu but only on left side of my body. Felt swollen and odd, but it really didnt look swollen. I tried to sleep but couldn't due to feeling ill. And the pain. Today it went up to face tingly, left side only, eye tingly and continued arm. Leg seems ok. Headache still present.