chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Catheterisation cardiac, Chest pain, Decreased appetite, Dry mouth, Dysgeusia
Clinical narrative: Severe joint pain to the point I couldn't care for myself. Developed Polymyalgia Rheumatica. I have to take Prednisone for a long period of time to keep pain down-which has bad side effects for me.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Gait disturbance, Influenza like illness, Limb discomfort, Loss of personal independence in daily activities, Mental impairment
Clinical narrative: Severe joint pain to the point I couldn't care for myself. Developed Polymyalgia Rheumatica. I have to take Prednisone for a long period of time to keep pain down-which has bad side effects for me.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Nausea, Taste disorder, Weight decreased
Clinical narrative: Severe joint pain to the point I couldn't care for myself. Developed Polymyalgia Rheumatica. I have to take Prednisone for a long period of time to keep pain down-which has bad side effects for me.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Feeling cold, Headache, Pain
Clinical narrative: I got a headache around 6:00 PM the day of the vaccine which did not go away. I got cold during the night and felt discomfort in my abdomen. By the next morning, I was tired and achy all over. I still had the headache which was about 6 on a 1-10 scale. I didn't start to feel relief until around 4:00 PM on Wednesday, the day after the vaccine. By evening I felt fine.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Swelling reported to left upper arm, red "whelps" left upper arm; reported to health department after school the day following vaccinations.
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Quadracel was used in place of Pediarix because they were out and it doesnt include Hep. B; a 4 month old patient was given Quadracel vaccine is only intended for ages 4-6 yr; Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a four months old male patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of PEDIARIX (lot C5222AA and Exp. Date 20-JUN-2019) via unknown route in the left thigh on an unspecified date.  The patient's medical history not reported and concomitant medications included HIB VACCINE CONJ (OMPC) (PEDVAXHIB) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered.  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.
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 provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 20-JUN-2012, a healthcare provider administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2017, 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 vaccine, and suffered serious physical, emotional, and economic damages as a result of her 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 (dates unknown), 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 (unspecified); 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 provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In November 2013, a healthcare provider at a clinic administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). In December 2013, 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 vaccine, and suffered serious physical, emotional, and economic damages as a result of her 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 (dates unknown), 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 (unspecified); 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: 0.75
Sex: U
Vaccine: DTAP, FLU4, HIBV, IPV, PPV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9 months old patient of unknown gender who received an expired dose of vaccine IPOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal Vaccine; TDAP; ACTHIB; and FLUZONE QUADRIVALENT. On 10-Jan-2019, the patient received a single 0.5 ml dose of suspect IPV (VERO), lot UI859AAA via unknown route in the right thigh. It was a case of actual medication error due to expired vaccine used. (expiry date: 09-Jan-2019). It was unknown whether adverse event occurred. 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: 18.0
Sex: F
Vaccine: FLUX, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case is linked to case 2019SA010565 (same reporter). This case involves a 18 years old female patient who was vaccinated with an 0.5 ml expired dose of MENACTRA (Batch number: U5746AC and expiry date: 14-Oct-2018) (dose in series and route of administration were not reported) in the right arm on 10-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included patient was received flu vaccine on an unspecified date. It was a case of actual medication error due to expired vaccine used. No reported symptoms. 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. Documents held by the sender: none.
Sex: F
Vaccine: FLUX, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2019SA010556 (same reporter). This case involves a 24 years old female patient who received vaccine MENACTRA. Expiry date: 14-Oct-2018 (lot number U5746AC) via unknown route in in the right arm, on 10-Jan-2019. The patients past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included INFLUENZA VACCIN. It was a case of actual medication error due to expired product administered. ( It was reported that expired doses of MENACTRA were administered) No reported symptoms. 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: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blood creatine phosphokinase normal, Blood culture negative, C-reactive protein increased, Cellulitis, Culture wound negative
Clinical narrative: Seen at clinic on 1/14/19 for febrile illness with onset of fever on 1/13/19 and onset of redness at site of VARIVAX injection at right thigh on 1/12/19. Started on Clindamycin by mouth for myositis. Returned to clinic on 1/15/19 for increased redness at affected area. Had labs done to include CBC, CPK, ESR, CRP, and blood culture on 1/15/19. Labs came back with elevated CRP and ESR. Admitted to hospital on 1/15/19 for cellulitis with concern of abscess formation and started IV Clindamycin. Had incision and drainage of area on 1/16/19 in OR by surgeon. Findings on I&D procedure per report by surgeon: Indurated subcutaneous tissue; no evidence of purulent fluid.  Report of area of erythema at right thigh improving on 1/17/19. Plan possible discharge home on 1/18/19 per note from hospitalist and surgeon.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Haematocrit normal, Haemoglobin normal, Incisional drainage, Induration, Injection site erythema
Clinical narrative: Seen at clinic on 1/14/19 for febrile illness with onset of fever on 1/13/19 and onset of redness at site of VARIVAX injection at right thigh on 1/12/19. Started on Clindamycin by mouth for myositis. Returned to clinic on 1/15/19 for increased redness at affected area. Had labs done to include CBC, CPK, ESR, CRP, and blood culture on 1/15/19. Labs came back with elevated CRP and ESR. Admitted to hospital on 1/15/19 for cellulitis with concern of abscess formation and started IV Clindamycin. Had incision and drainage of area on 1/16/19 in OR by surgeon. Findings on I&D procedure per report by surgeon: Indurated subcutaneous tissue; no evidence of purulent fluid.  Report of area of erythema at right thigh improving on 1/17/19. Plan possible discharge home on 1/18/19 per note from hospitalist and surgeon.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Myositis, Platelet count normal, Pyrexia, Red blood cell sedimentation rate increased, White blood cell count normal
Clinical narrative: Seen at clinic on 1/14/19 for febrile illness with onset of fever on 1/13/19 and onset of redness at site of VARIVAX injection at right thigh on 1/12/19. Started on Clindamycin by mouth for myositis. Returned to clinic on 1/15/19 for increased redness at affected area. Had labs done to include CBC, CPK, ESR, CRP, and blood culture on 1/15/19. Labs came back with elevated CRP and ESR. Admitted to hospital on 1/15/19 for cellulitis with concern of abscess formation and started IV Clindamycin. Had incision and drainage of area on 1/16/19 in OR by surgeon. Findings on I&D procedure per report by surgeon: Indurated subcutaneous tissue; no evidence of purulent fluid.  Report of area of erythema at right thigh improving on 1/17/19. Plan possible discharge home on 1/18/19 per note from hospitalist and surgeon.
Age: 14.0
Sex: M
Vaccine: IPV
Symptoms: Headache, Migraine, Pain
Clinical narrative: Within 30 minutes of the 4th polio vaccine patient started getting a dull headache. Within 60 minutes he had a full blown migraine. He needed to take 3 ADVIL and a rescue medication. Within 1 hour the pain subsided from what he said an 8 to a 3 and remained at a 3 for 24 hours.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Blood test abnormal, Chest X-ray normal, Computerised tomogram head normal, Eye movement disorder, Fall
Clinical narrative: WE WERE AT OUR LOCAL STORE GETTING ITEMS AND PATIENT STATED THAT HE WAS FEELING FUNNY-HIS EYES WERE MOVING RAPIDLY BACK AND FORTH AND WITHIN MINUTES HE FELL BACKWARDS AND WAS CAUGHT BY AN OFFICER WORKING AT THE FRONT AND HAD A SEIZURE - CALLED 9-1-1 -- AMBULANCE TOOK HIM TO THE ER AND WAS TOLD HE DID HAVE A SEIZURE AND HAD BLOOD WORK/CT SCAN OF HEAD AND CHEST XRAY -- ALL CAME BACK CLEAR.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Feeling abnormal, Seizure
Clinical narrative: WE WERE AT OUR LOCAL STORE GETTING ITEMS AND PATIENT STATED THAT HE WAS FEELING FUNNY-HIS EYES WERE MOVING RAPIDLY BACK AND FORTH AND WITHIN MINUTES HE FELL BACKWARDS AND WAS CAUGHT BY AN OFFICER WORKING AT THE FRONT AND HAD A SEIZURE - CALLED 9-1-1 -- AMBULANCE TOOK HIM TO THE ER AND WAS TOLD HE DID HAVE A SEIZURE AND HAD BLOOD WORK/CT SCAN OF HEAD AND CHEST XRAY -- ALL CAME BACK CLEAR.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Rash, Rash vesicular, Vaccination complication
Clinical narrative: Approximately 3 weeks after receiving vaccine client noticed vesicular rash on her chest and back. On December 20th, came into the clinic for second Varicella, but it was not given due to rash. Client stated rash was still developing. Denied fever, but felt tired. Was seen by physician at Urgent Care Clinic and was diagnosed with probable vaccine reaction.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Oropharyngeal pain, Sneezing
Clinical narrative: States that he came into the office today and received both vaccines and in the last hour cannot stop sneezing. Mild sore throat. Denies rash, dyspnea, throat closure/swelling, fever, malaise, chills. No hx of vaccine reaction.
Age: 19.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Blister, Viral test, Vulval ulceration
Clinical narrative: Assuming from smallpox inoculation, patient developed vesicules and ulcerations of vulva. Viral cultures are pending, but I believe this is from autoinoculation from vaccinia wound. She had unprotected intercourse and reports that her partner is asymptomatic.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Hepatobiliary scan, Laboratory test normal, Loss of consciousness, Malaise, Muscle spasms
Clinical narrative: Patient called today and said after her second HBV on 09/14/2018 she and her family had a stomach bug or she thought she did, then after her 3rd dose on 12/17/2018 that she became ill again and has had cramping, vomiting and hurting to the extent that she passed out on 12/24/2018 and went to ER and then again on 12/26/2018. She had had a HIDA scan and gallbladder test and all have come back ok, still gets sick when she eats a few bites.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Vomiting
Clinical narrative: Patient called today and said after her second HBV on 09/14/2018 she and her family had a stomach bug or she thought she did, then after her 3rd dose on 12/17/2018 that she became ill again and has had cramping, vomiting and hurting to the extent that she passed out on 12/24/2018 and went to ER and then again on 12/26/2018. She had had a HIDA scan and gallbladder test and all have come back ok, still gets sick when she eats a few bites.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Arthritis, Eye inflammation, Gait disturbance, Joint range of motion decreased
Clinical narrative: 4 days after receiving vaccine every joint in my body flared up to the extent that walking/any range of motion was difficult. Significant swelling in knees and ankles/feet. Excruciating pain in all joints, difficulty lifting left leg to get into shower or car. Eye inflammation.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Joint swelling, Laboratory test, Mobility decreased, Peripheral swelling
Clinical narrative: 4 days after receiving vaccine every joint in my body flared up to the extent that walking/any range of motion was difficult. Significant swelling in knees and ankles/feet. Excruciating pain in all joints, difficulty lifting left leg to get into shower or car. Eye inflammation.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: VERY SORE ARM BELOW INJECTION SITE. SOME SWELLING NO REDNESS.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 04-SEP-2012, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 01-FEB-2017, the patient was treated by a physician provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. 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 include 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. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2016, a pharmacist at a pharmacy administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2018, 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 vaccine, 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 (dates unknown), 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 (unspecified); 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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a physician administered zoster vaccine live ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2017, 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 vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. 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 include 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received on 10-JAN-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 10-FEB-2017 and 23-FEB-2017, the patient was treated by a family nurse practitioner at a medical center for shingles and post herpetic neuralgia. The patient was diagnosed with shingles and post herpetic neuralgia 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, 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 include 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 is not recovered. The causality of the events is related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
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 provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 22-DEC-2008, a healthcare provider at a medical group administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 25-MAY-2016 and 09-JUN-2016, the patient was treated by a healthcare provider at a medical group for shingles and post-herpetic neuralgia. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: HEP, HEPA, IPV, TD
Symptoms: Expired product administered
Clinical narrative: Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves an eight-years-old patient who received an expired dose of vaccine TENIVAC (lot number: U5280AA, expiry date: 16-Mar-2018) via unknown route in the left deltoid on 10-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunisation; HEPATITIS B VACCINE for Immunisation; and IPOL POLIO VACCINE for Immunisation. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event occurred or not following the 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.
Sex: M
Vaccine: HPVX, MENB, MNQ, TDAP
Symptoms: Back pain, Swelling
Clinical narrative: Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves 19 years old male patient who experienced reporting a bump on the head and back pain., while he received vaccines MENACTRA, ADACEL,  TRUMENBA and  HPV VACCINE, The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jan-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6207AA and suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE via intramuscular route in the right arm. On 09-Jan-2019, the patient received a dose of suspect HPV VACCINE and TRUMENBA (lot number and Expiry date unknown) via unknown route in the left arm. On 10-Jan-2019, the patient developed a non-serious reporting back pain. (back pain) and bump on his head (peripheral swelling) one day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, HPV VACCINE and TRUMENBA. (Other relevant tests included No lab data.) Final diagnosis was bump on his head and back pain. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown. List of documents held by sender: none
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case involves a 5 years old male patient who was inadvertently vaccinated with a 0.25 ml dose of FLUZONE QUADRIVALENT (Batch number: UT6315SA and expiry date: 30-Jun-2019) via intramuscular route in left vastus lateralis on 11-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were not reported. It was a case of actual medication error due to vaccine underdose because the patient was vaccinated with 0.25 ml instead of 0.5 ml. It was unknown if any adverse event was occurred or not following the vaccination. 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. Documents held by the sender: none.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt received PNEUMOVAX 23 L arm on 1/15/19 at 2pm. At 9pm site became tender. When pt awoke 1/16/19 site was red, slightly swollen, itchy, and burning. Pt returned to office 1/17/19 and was advised to apply cool compressed.
Age: 91.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt received PNEUMOVAX 23 R delt on 1/15/19 at 1:30pm. At 8 pm site became tender, red, slightly swollen, and very warm to touch. Pt returned to office 1/16/19 and was advised to apply cool compressed and prednisone taper ordered. Pt contacted 1/17/19 and reports improvement in symptoms.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Antinuclear antibody negative, Blood test normal, Musculoskeletal pain, Neck pain, Rheumatoid factor increased
Clinical narrative: About 6 hours post vac had moderate pain in Rt. shoulder. This continued for several days. Both shoulders and neck sore at times. Now 2 months post vacc shoulders are still sore especially Rt side. Hard to do normal activities with Rt. arm. Have seen doctors 3 or 4 times PT 3 times and do exercises regularly. Never any fever. Injection site was never swollen or sore. Have taken oral steroids and they are effective for a short time. Slow pain returned in about 5-7 days after steroid treatment finished. 4 mg Dexameth prior to oral surgery Nov. 29th and prednisone tapered treatment starting 12-22.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Urine analysis normal
Clinical narrative: About 6 hours post vac had moderate pain in Rt. shoulder. This continued for several days. Both shoulders and neck sore at times. Now 2 months post vacc shoulders are still sore especially Rt side. Hard to do normal activities with Rt. arm. Have seen doctors 3 or 4 times PT 3 times and do exercises regularly. Never any fever. Injection site was never swollen or sore. Have taken oral steroids and they are effective for a short time. Slow pain returned in about 5-7 days after steroid treatment finished. 4 mg Dexameth prior to oral surgery Nov. 29th and prednisone tapered treatment starting 12-22.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Feeling abnormal, Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: SHINGRIX injection around 3:30 PM on 12/28/2018. Sore arm later in the evening. Pain increased and during the night arm was very hot from the shoulder to the elbow. Pain worsened and was not able to sleep. Tossing and turning. By morning I felt as if I was in a fog and could not function. Very weak and just wanted to lay down. Around 3 PM in the afternoon the fog was starting to lift and had something to eat. Never, never had an adverse reaction to ANY injection I ever had. This was a terrible experience and not sure if I should receive the 2nd injection. Have an appointment with my primary doctor to discuss this horrible experience.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: SHINGRIX injection around 3:30 PM on 12/28/2018. Sore arm later in the evening. Pain increased and during the night arm was very hot from the shoulder to the elbow. Pain worsened and was not able to sleep. Tossing and turning. By morning I felt as if I was in a fog and could not function. Very weak and just wanted to lay down. Around 3 PM in the afternoon the fog was starting to lift and had something to eat. Never, never had an adverse reaction to ANY injection I ever had. This was a terrible experience and not sure if I should receive the 2nd injection. Have an appointment with my primary doctor to discuss this horrible experience.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Disorientation, Injection site pain, Injection site warmth, Insomnia
Clinical narrative: SHINGRIX injection around 3:30 PM on 12/28/2018. Sore arm later in the evening. Pain increased and during the night arm was very hot from the shoulder to the elbow. Pain worsened and was not able to sleep. Tossing and turning. By morning I felt as if I was in a fog and could not function. Very weak and just wanted to lay down. Around 3 PM in the afternoon the fog was starting to lift and had something to eat. Never, never had an adverse reaction to ANY injection I ever had. This was a terrible experience and not sure if I should receive the 2nd injection. Have an appointment with my primary doctor to discuss this horrible experience.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This is spontaneous case, initially received on 23-Apr-2018, reported by a pharmacist and concerns a 22-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On 20-Oct-2017, the patient received FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, batch number: 179904P, expiry date: 31-May-2018). On 16-Dec-2017, the patient was inadvertently administered with FLUVIRIN (dose 0.5ml, route of administration: intramuscular, batch number and expiry date were not reported) as the pharmacist did not know that the patient had already received the flu shot for the season (inappropriate schedule of vaccine administered). And also, the second vaccination was not done at the same pharmacy where the first vaccine was received. The patient did not experience any adverse effects.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills
Clinical narrative: Patient complained of having feelings of weakness and chills shortly after receiving the vaccine. He did not report this reaction until after receiving the second dose on 1/14/19. He stated that he had the same reaction when he had received the first dose on 10/20/18. He stated that the weakness and chills started "a little while" after receiving the vaccine and lasted for about one day and then resolved.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: WHEN I WAS GETTING INJECTION RIGHT UPPER ARM I FELT NUMBNESS AND TINGLING GOING ALL THE WAY DOWN MY ARM TO FINGERS, LIKE A BOLT OF ELECTRICITY, I STILL HAVE PAIN FROM SHOULDER TO ELBOW AND SOMETIMES DOWN TO FINGERS ACHES AND THROBS WAKES ME UP AT NIGHT SOMETIMES OR WHEN I REACH FOR SOMETHING WITH RIGHT HAND I HAVE PAIN.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: WHEN I WAS GETTING INJECTION RIGHT UPPER ARM I FELT NUMBNESS AND TINGLING GOING ALL THE WAY DOWN MY ARM TO FINGERS, LIKE A BOLT OF ELECTRICITY, I STILL HAVE PAIN FROM SHOULDER TO ELBOW AND SOMETIMES DOWN TO FINGERS ACHES AND THROBS WAKES ME UP AT NIGHT SOMETIMES OR WHEN I REACH FOR SOMETHING WITH RIGHT HAND I HAVE PAIN.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills
Clinical narrative: Patient complained of having feelings of weakness and chills shortly after receiving his vaccine. He states that he had a similar reaction when he received his first vaccine on 10/20/18. He stated that the weakness and chills started "a little while" after receiving the vaccine and lasted for about one day and then they resolved.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Rash
Clinical narrative: Swelling, erythema, pain to right upper arm, Rash noted to upper arm, shoulder and face. Patient took BENADRYL with improvement. Symptoms improved each day.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Overnight  fever of 101, soreness and pain in the injection area with a duration of 2-3 days.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Headache, Pain
Clinical narrative: Chills, fever, headache, upset stomach, body aches, joint pain.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, fever, headache, upset stomach, body aches, joint pain.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Diarrhoea, Erythema, Nausea, Nodule, Pain in extremity
Clinical narrative: Soreness / knot on arm, red, warm; also nausea, vomiting, diarrhea, fever up to 102.8 x36 hours.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia, Skin warm, Vomiting
Clinical narrative: Soreness / knot on arm, red, warm; also nausea, vomiting, diarrhea, fever up to 102.8 x36 hours.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site haemorrhage, Injection site pain, Moaning, Pain
Clinical narrative: Per hospital records: In the ED: Given IV toradol and morphine. PO acetaminophen given and topical lidocaine patch was placed. Pt reported no significant change in pain. Hospitalist Initial H&P: moaning, writhing in pain; there is a very tiny area of ecchymoses in the right upper biceps at the site of recent vaccine injection. Discharge summary: "... severe arm pain started almost immediately after receiving shingles vaccine. Shingles vaccine was given superiorly in the right arm very near the AC joint. The pain was described as a shooting pain down her arm, however passive range of motion was intact without really increasing the pain but it did hurt with palpation overlying the injection site. Given that she had no passive range of motion, swelling, or erythema around the site I felt septic joint was very unlikely and we had better reason for her fevers which improved with treatment of her UTI. Given the neurologic component of the pain I prescribed her 100 mg of gabapentin 3 times daily which controlled the pain very well and about an hour after the first dose she was able to actively move her arm with minimally increasing the pain. Again this favors against the diagnosis of septic joint. Her pain was well-controlled on gabapentin and overall improving, I will give her a seven-day course of gabapentin 100mg TID and counseled her extensively that this should not be a chronic medication as I would expect inflammation from the vaccine to decrease over the course of the next 7 days. She agrees with this plan and has stated that she does not want to be on gabapentin chronically for this." PCP note for f/u visit indicates that it took 3 days to find and agent that helped with pain.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Per hospital records: In the ED: Given IV toradol and morphine. PO acetaminophen given and topical lidocaine patch was placed. Pt reported no significant change in pain. Hospitalist Initial H&P: moaning, writhing in pain; there is a very tiny area of ecchymoses in the right upper biceps at the site of recent vaccine injection. Discharge summary: "... severe arm pain started almost immediately after receiving shingles vaccine. Shingles vaccine was given superiorly in the right arm very near the AC joint. The pain was described as a shooting pain down her arm, however passive range of motion was intact without really increasing the pain but it did hurt with palpation overlying the injection site. Given that she had no passive range of motion, swelling, or erythema around the site I felt septic joint was very unlikely and we had better reason for her fevers which improved with treatment of her UTI. Given the neurologic component of the pain I prescribed her 100 mg of gabapentin 3 times daily which controlled the pain very well and about an hour after the first dose she was able to actively move her arm with minimally increasing the pain. Again this favors against the diagnosis of septic joint. Her pain was well-controlled on gabapentin and overall improving, I will give her a seven-day course of gabapentin 100mg TID and counseled her extensively that this should not be a chronic medication as I would expect inflammation from the vaccine to decrease over the course of the next 7 days. She agrees with this plan and has stated that she does not want to be on gabapentin chronically for this." PCP note for f/u visit indicates that it took 3 days to find and agent that helped with pain.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain, X-ray normal
Clinical narrative: Per the patient report, she experienced ongoing pain with limited range of motion after one week of receiving the flu vaccination at her employment through a work clinic. Patient reported pain was worse at night.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 08-NOV-2012, a healthcare provider at a family clinic administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 28-DEC-2015, the patient was treated by a physician at the family clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, 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 (unspecified); 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.