chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by health authority (VAERS ID: 683972) and concerns 74-years old female patient. The reporter reported past drug history of patient as codeine (reported as codine), morphine (reported as norphine), CIPRO and another drug starting with Z. The patient's concomitant medication included: gabapentin, RANEXA, carvedilol, spironolactone, potassium, Cyanocobalamin, Ergocalciferol, Sertraline hydrochloride, Pravastatin sodium, Pantoprazole, Warfarin. On 02-Feb-2017, AFLURIA QUADRIVALENT was administered (unknown dosage, route of administration: unknown, anatomical site: unknown, batch number: not reported). Indication not reported. On unspecified date after administration of AFLURIA QUADRIVALENT, the patient felt from elbow to shoulder of the right arm, he was not able to raise arm to the back of his head or try to reach something to the right without pain. Outcome of the events were not reported. The Health Authority considered the case as non-serious. The causality between the events and vaccine is not reported. Significant case correction received on 17-May-2017: The determined causality of the events was updated from related to unassessable.
Age: 58.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by other non-health professional via health authority (VAERS ID: 684314) and concerns a 58-years-old male patient. The patient's historical condition included diabetes. Administration of Company suspect drug: On 27-Feb-2017, the patient received AFLURIA QUADRIVALENT (dose: 1 DF, batch number: WT54807, expiry date: not reported) at right arm via intramuscular route. Indication not reported. Non-company suspect drug: On 27-Feb-2017, the patient also received PNEUMOVAX 23 (dose: 1 DF, batch number: M036161, expiry date: not reported) at right arm via intramuscular route. Indication not reported. Adverse reactions/events and outcomes: On 27-Feb-2017, after administration of influenza vaccine and pneumococcal vaccine, the patient's arm was red, swollen and tender to touch. Action taken with the suspect vaccine was not reported. The outcome of the events was recovered. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the influenza vaccine. This case was non-serious. Significant case correction follow up received on 18-May-2017; Added new event as drug administration error. The listedness of the events was changed from unlisted to listed and causality of the events was changed from not related to related.
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling, Rash, Tenderness
Clinical narrative: This spontaneous case, initially received on 05-May-2017, was reported by regulatory authority (vaccine adverse event reporting system: 684619) and concerns an 11-years-old male child patient. Administration of Company suspect drug: On 20-Jan-2017 the patient was administered with AFLURIA QUAD (batch number WT58508, dose: 0.5 ml, dose number: 10, via intramuscular route). Adverse reactions/events and outcomes: On 20-Jan-2017 after administration of AFLURIA QUADRIVALENT to 11 years old patient (Inappropriate age at vaccination), the patient experienced rash, swelling and tenderness in the right arm for 3 days The patient was treated with MOTRIN and continued icing. Action taken with AFLURIA QUAD was not reported and outcome of the events was reported as site area was improved and site swollen and tenderness was resolving and inappropriate age at vaccination was not reported. Reporter's Assessment: The Other Health Professional did not provide any causality assessment between the events and suspect vaccine. This case was non-serious. Case correction follow up received on 18-May-2017: The case comment was corrected.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Periarthritis
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 685598) and concerns a 55 years old male patient. The patient's medical history Included: Rheumatoid arthritis. The patient experienced frozen shoulder syndrome at the of 56 when administered by AFLURIA QUADRIVALENT. Patient's concomitant medication included: methotrexate. Administration of Company suspect drug: On 20-Sep-2016, patient was administered with AFLURIA QUADRIVALENT via intramuscular route of administration in right arm (dose: unknown) (batch number: WT55207A). Indication immunisation. Adverse reactions/events and outcomes: On 02-Mar-2017, after administration of AFLURIA QUADRIVALENT, the patient was diagnosed with frozen shoulder syndrome and believes that immunisation was the cause. Action taken with the suspect product was not reported. Outcome of the events was not reported. Reporter's Assessment: The reporter assessed the events as non-serious and the causality was not provided. This report was not serious.
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Muscle spasms, Neuralgia
Clinical narrative: This initial spontaneous case, was received on 15-Jun-2017, which was reported by other non-health professional via regulatory authority (VAERS ID: 685881) and concerning a 25-year-old female patient. On 21-Sep-2016, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 12849211A, expiry date: not reported). On an unspecified date, after administration of influenza vaccine, the patient experienced spasms and nerve pain in upper left arm and shoulders. At the time of this report outcome for the events was not reported. The reporter did not provide the causality between events and influenza vaccine. This report was not serious.
Age: 45.0
Sex: F
Vaccine: FLU4, HEP, TD
Symptoms: Asthenia, Fatigue, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This non-serious initial Spontaneous case, was received via regulatory authority (VAERS ID: 685952) on 15-Jun-2017 concerning a 45-year-old adult female patient. The patient's current condition included HX of cold sores, seasonal allergies and historical condition included GERD, allergic rhinitis and Bell's palsy (resolved). The patient's concomitant medications included VALTREX for HX of cold sores. BENADRYL, ZYRTEC, SINGULAIR, FLONASE and olopatadine hydrochloride. On 07-Mar-2017, the patient was administered with AFLURIA QUADRIVALENT (route of administration: intramuscular, anatomical location: right arm, batch number: WT58408, manufacturer: Seqirus, Inc, dose: not reported). On the same day, the patient was also administered with Hepatitis B vaccine (route of administration: intramuscular, anatomical location: left arm, batch number: C7EP5, dose: not reported) and Tetanus and diphtheria toxoids adsorbed (route of administration: intramuscular, anatomical location: left arm, batch number: U5526AA, dose: not reported). On the same day, after administration of vaccine the patient experienced weak, sick, nausea, fatigue, vertigo, eruptions of yellow, itchy papules and rash on right shoulder. At the time of this report, the outcome of the event was not reported. The reporter did not provide the causal relationship between the event and suspect product (AFLURIA QUADRIVALENT vaccine). The health authority assessed the report as non-serious. Case correction received on 27-Jun-2017: Description as reported for the events itchy rash, rash papular and injection site reaction was updated. The patient's historical condition Bell's palsy (resolved) was updated in the narrative.
Age: 45.0
Sex: F
Vaccine: FLU4, HEP, TD
Symptoms: Malaise, Nausea, Vertigo
Clinical narrative: This non-serious initial Spontaneous case, was received via regulatory authority (VAERS ID: 685952) on 15-Jun-2017 concerning a 45-year-old adult female patient. The patient's current condition included HX of cold sores, seasonal allergies and historical condition included GERD, allergic rhinitis and Bell's palsy (resolved). The patient's concomitant medications included VALTREX for HX of cold sores. BENADRYL, ZYRTEC, SINGULAIR, FLONASE and olopatadine hydrochloride. On 07-Mar-2017, the patient was administered with AFLURIA QUADRIVALENT (route of administration: intramuscular, anatomical location: right arm, batch number: WT58408, manufacturer: Seqirus, Inc, dose: not reported). On the same day, the patient was also administered with Hepatitis B vaccine (route of administration: intramuscular, anatomical location: left arm, batch number: C7EP5, dose: not reported) and Tetanus and diphtheria toxoids adsorbed (route of administration: intramuscular, anatomical location: left arm, batch number: U5526AA, dose: not reported). On the same day, after administration of vaccine the patient experienced weak, sick, nausea, fatigue, vertigo, eruptions of yellow, itchy papules and rash on right shoulder. At the time of this report, the outcome of the event was not reported. The reporter did not provide the causal relationship between the event and suspect product (AFLURIA QUADRIVALENT vaccine). The health authority assessed the report as non-serious. Case correction received on 27-Jun-2017: Description as reported for the events itchy rash, rash papular and injection site reaction was updated. The patient's historical condition Bell's palsy (resolved) was updated in the narrative.
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Pain, Pruritus, Swelling
Clinical narrative: This initial spontaneous case, was received on 15-Jun-2017, from other non-health professional via health authority (VAERS ID: 686480) and concerning a 10-year-old female patient. The patient neither had any illness at the time of vaccination nor any concomitant medications were taken at the time of vaccination. The patient did not have any medical history. On 17-Mar-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, lot number: WT58408, expiry date: not reported). On the same day, the patient developed swelling, redness, bruise (reported as bruising), throbbing pain and itching (reported as itchiness). At the time of this report, the patient recovered from all the events. The reporter did not provide any causality between the suspect vaccine and the events. This report was not serious.
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Periarthritis
Clinical narrative: This initial spontaneous case, was received from other non-health professional via health authority (VAERS Id: 686768) on 10-Jul-2017, concerning a of 55-year-old female patient. The patient concomitant medications included: Glucosamine, magnesium, Aspirin and fish oil. On 05-Oct-2016, the patient was administered with AFLURIA (dose: 0.5 ml, route of administration: Intramuscular, anatomical location: left arm, trade name, batch number, manufacturer: not reported). On the same day, after 2-3 hours of vaccination, the patient experienced left shoulder pain (same arm as flu shot) and continued to get increasingly worse. Limited motion resulted. On 21-Feb-2017, physician consulted and diagnosed with frozen shoulder (adhesive capsulitis). On 03-Mar-2017, the patient was administered with steroid injection and physical therapy begun on 13-Mar-2017. The outcome of the event was not reported. Reporter's comment: The health authority assessed the events as non-serious.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Blood glucose increased, Condition aggravated, Feeding disorder, Headache
Clinical narrative: Extreme headache, sore bones, overall ache and pain similar to severe flu symptoms. Loss of appetite or ability to eat. Significantly increased blood sugar results (diabetic). Lasted nearly 72 hours.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Extreme headache, sore bones, overall ache and pain similar to severe flu symptoms. Loss of appetite or ability to eat. Significantly increased blood sugar results (diabetic). Lasted nearly 72 hours.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood glucose increased, Bone pain, Decreased appetite, Feeding disorder, Headache
Clinical narrative: Extreme headache, sore bones, overall ache and pain similar to severe flu symptoms. Loss of appetite or ability to eat. Significantly increased blood sugar results (diabetic). Lasted nearly 72 hours.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza, Pain
Clinical narrative: Extreme headache, sore bones, overall ache and pain similar to severe flu symptoms. Loss of appetite or ability to eat. Significantly increased blood sugar results (diabetic). Lasted nearly 72 hours.
Age: 30.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Urticaria
Clinical narrative: The patient had urticaria on her torso and on both arms, a fever and itching. Duration of between five and six hours.
Age: 30.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: The patient had urticaria on her torso and on both arms, a fever and itching. Duration of between five and six hours.
Age: 32.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Patient reports high fever 12 hrs after vaccination. At the time of evaluation patient's right arm had localized redness within normal limits and no observable swelling. Site was not abnormally warm/hot to the touch. Patient reports 8/10 muscular pain that affects ROM. Pt denies having difficulty breathing, hives, or any other signs of allergic reaction at the time of evaluation. Evaluation took place 24hrs post vaccination. Advised patient to report to ER in anticipation of a delayed hypersensitivity reaction worsening within next 48 hrs.
Age: 32.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Erythema, Joint range of motion decreased, Myalgia, Pyrexia
Clinical narrative: Patient reports high fever 12 hrs after vaccination. At the time of evaluation patient's right arm had localized redness within normal limits and no observable swelling. Site was not abnormally warm/hot to the touch. Patient reports 8/10 muscular pain that affects ROM. Pt denies having difficulty breathing, hives, or any other signs of allergic reaction at the time of evaluation. Evaluation took place 24hrs post vaccination. Advised patient to report to ER in anticipation of a delayed hypersensitivity reaction worsening within next 48 hrs.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face, Urticaria
Clinical narrative: Hives every day, swelling of the face (06/16/18)-- couple of visits to Emergency room, couple of visits to doctor. Still have break out of hives daily 22 days after the vaccine while on 60 mg of prednisone daily and Benadryl.
Age: 35.0
Sex: F
Vaccine: TYP
Symptoms: Angiogram, Chest X-ray, Dizziness, Dyspnoea, Stress echocardiogram
Clinical narrative: Member returned to clinic on 6/8 to report the following: she was given a typhoid shot on 6/6 and started experiencing symptoms of facial swelling and shortness of breath that afternoon. She self-medicated and went to bed. Her symptoms were milder the next morning and began to escalate throughout the day. On 6/8 she returned to the clinic with symptoms at their worse to include lightheadedness, shortness of breath, and the sensation that her face was swelling. Member was seen at the clinic, EMS was called anf member was transported to hospital where she was evaluated and released 24 hrs later.
Age: 35.0
Sex: F
Vaccine: TYP
Symptoms: Swelling face
Clinical narrative: Member returned to clinic on 6/8 to report the following: she was given a typhoid shot on 6/6 and started experiencing symptoms of facial swelling and shortness of breath that afternoon. She self-medicated and went to bed. Her symptoms were milder the next morning and began to escalate throughout the day. On 6/8 she returned to the clinic with symptoms at their worse to include lightheadedness, shortness of breath, and the sensation that her face was swelling. Member was seen at the clinic, EMS was called anf member was transported to hospital where she was evaluated and released 24 hrs later.
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from the patient's mother, referring to a male patient of approximately 4 months old. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of ROTATEQ orally (strength, lot number and expiration date were not reported) for prophylaxis. The reporter stated that the patient went to the pediatrician for his 4 month well baby visit and was administered his second dose of ROTATEQ. The patient's mother stated that she did not recall having the initial dose administered during the patient's well baby visit at 2 months of age, although the pediatrician's records indicate that the initial dose was administered. No adverse reaction was reported.
Age: 37.0
Sex: M
Vaccine: VARZOS
Symptoms: Antibody test negative, Hepatitis A antibody negative, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician, and it refers to a 37 year old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 22-MAY-2018, the patient was inadvertently vaccinated with a dose of SHINGRIX for prophylaxis (dose, route of administration, lot number and expiration date were not reported) instead of Oka/Merck VARIVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported) (Wrong drug administered), from an unspecified pharmacy, also on 29-MAY-2018 the patient was vaccinated with one adult dose of Hepatitis A Vaccine, Inactivated (manufacturer unknown) 50/1 U/ml, for prophylaxis (dose, route of administration, lot number and expiration date were not reported) from the local health department. The vaccines were indicated for immigration purposes. On an unknown date, the patient was found to have low titers for varicella and hepatitis A (varicella titer was <135) (Antibody test abnormal), as a result of an unspecified test performed. The physician reported that the plan was to vaccinate the patient with varicella and hepatitis A. No adverse effects reported. No further information was provided. The outcome of the antibody test abnormal and the causal relationship between the event and therapy with VAQTA were not reported.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 24-year-old male patient. The pertinent medical history, drug reactions or allergies were not reported. The concomitant therapies included: vitamin B12, gabapentin and capsaicin cream. On 30-MAR-2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (lot #: N025428, expiration date: 19-JUN-2020, anatomical location, strength, dose and frequency were not provided) for prophylaxis (indication also reported as "what the doctor ordered"). On 03-APR-2018, the patient was vaccinated in right arm with second dose of GARDASIL 9 intramuscularly (lot #: N025428, expiration date: 19-JUN-2020, strength, dose, and frequency were not provided) for the same indication. On an unknown date, in approximately 2018, the patient developed numbness in his right arm, following the second dose of GARDASIL 9, where he was vaccinated with the second dose. The pharmacist did not specify where the patient was vaccinated with the first dose. The patient was seen in the emergency room and the patient was not admitted to the hospital. There were no lab diagnostics performed. There was unspecified treatment given for injection site numbness. The outcome of injection site numbness was reported as recovering. The relatedness between injection site numbness and GARDASIL 9 was not reported.
Sex: U
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUN-2018, the patient was vaccinated with ROTATEQ, orally lot # N028248, expiration date 01-MAY-2019 (formulation, strength, dose, frequency, were not reported) for prophylaxis. On an unknown date, the patient experienced vomiting. The outcome of vomiting and action taken with ROTATEQ was unknown. The causal relationship between the event and ROTATEQ was not provided.
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a 4 months and 24 days male patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 17-MAY-2018, the patient was vaccinated with a dose of ROTATEQ orally, for prophylaxis, with lot# N026686 and 30-MAR-2019 expiration date (strength and frequency were not reported) at 17 weeks with 5 days old, and was vaccinated again on 06-JUN-2018 with ROTATEQ orally, for prophylaxis with lot# N026663 and 23-FEB-2019 expiration date (strength and frequency were not reported). No adverse effect was reported. No product quality complain was present.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding an unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 30-OCT-2017 and on 21-FEB-2018, the patient received a dose of VAQTA intramuscular route for prophylaxis (strength, frequency, lot# and expiration date were not reported). No known adverse effects reported. No product quality complain was present.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-APR-2015, the patient was vaccinated with VARIVAX (formulation, strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported) for prophylaxis and on 16-MAR-2015 with M-M-R II for prophylaxis. On an unknown date, the patient experienced inappropriate schedule of drug administration. The outcome of the event and action taken with suspect vaccines was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 11-JUN-2018, the patient was vaccinated with an expired dose of VARIVAX lot # M027886 with expiration date 03-JUN-2018, subcutaneous for prophylaxis (dose was not reported). At the time of this report, there were no known adverse effects. No product quality complaint was involved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies. On 15-MAY-2018, the patient was vaccinated with M-M-R II lot # M017348 and expiration date on 06-APR-2018 for (dose and route of administration were not reported) prophylaxis. Concomitant therapies included sterile diluent (MRK). The reporter specified that, the expired dose was inadvertently administered and that the vaccine was properly stored. No adverse effect were reported.
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a female patient of unknown age, reporting on herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD for prophylaxis (route, lot # and expiration date were unknown); as an adult and outside of the prescribing information because it was required as part of her volunteer work at hospital to get vaccinated with PROQUAD or get titers taken to test for protection.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a office manager and a company representative and refers to a 74 year old female patient. The patient's medical history and concomitant therapies were not provided. There were no known allergies. On 11-JUN-2018, the patient was vaccinated with a properly stored PNEUMOVAX 23 1 injection, intramuscularly in the left deltoid, lot # R009408, expiration date on 07-MAR-2020 for prophylaxis. The reporter stated that on 13-JUN-2018, the patient noted that their left arm became swollen, warm and itchy with purple/red markings noted from the armpit down to the elbow. Therefore, the patient sought medical attention and visited the physician's office. The patient was treated with unspecified therapies. The outcome of feeling hot, peripheral swelling, erythema and pruritus was reported as recovering. The reporter did not provide causality assessment between the events and PNEUMOVAX 23.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 17-NOV-2009, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 05-JUL-2016, he was treated by a physician assistant for the onset of a vesicular rash, which was diagnosed as herpes zoster. The patient has been prescribed VALTREX for management of his painful symptoms and chronic pain. On or about 17-APR-2017, the patient sought subsequent treatment by a physician assistant for symptom of an ongoing and worsening vesicular rash, which was diagnosed as unresolved zoster. The patient was further prescribed VALTREX for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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. In 2012, the patient was inoculated with ZOSTAVAX, (lot# and route unknown), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 04-JUL-2015, the patient was treated at a medical center for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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. On or about 10-JUL-2014, the patient was inoculated with ZOSTAVAX, (lot# and route unknown), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at an urgent care health facility, for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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. In 2016, the patient was inoculated with ZOSTAVAX, (lot# and route unknown), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated by a physician, at a health facility/office, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-APR-2015, the patient was treated for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed VALTREX and PERCOCET for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 08-APR-2013, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) (by an unspecified healthcare professional) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2013, the patient was treated at a hospital (by an unspecified healthcare professional) for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Throat tightness
Clinical narrative: This spontaneous report was received from a 72 year old female patient (registered nurse) referring herself. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 injection in an unspecified arm (strength, dose, frequency, lot #, expiration date were not reported) for prophylaxis. On an unspecified date, the unspecified arm in which the vaccine was administered became swollen with associated redness, significant pain and throat tightness. Treatment was given to treat the adverse events. The patient seek medical attention and contacted the physician's office. The outcome of peripheral swelling, throat tightness, pain in extremity and erythema were reported as recovering/resolving. The relationship between the events peripheral swelling, throat tightness, pain in extremity, erythema and PNEUMOVAX 23 were not provided. There was no product quality complaint (PQC) reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 12-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N026075 with expiration date of 20-SEP-2018 (strength, dose, frequency, route, and anatomical location) for prophylaxis which was reconstituted with a properly stored sterile diluent (MERCK). The vaccine was exposed to a temperature range between 15°F to 46°F, during a time frame of 43 hours, which was called by a data logger. No previous excursions were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1806USA008265.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 12-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N026075 with expiration date of 20-SEP-2018 (strength, dose, frequency, route, and anatomical location) for prophylaxis which was reconstituted with a properly stored sterile diluent (MERCK). The vaccine was exposed to a temperature range between 15°F to 46°F, during a time frame of 43 hours, which was called by a data logger. No previous excursions were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1806USA008094.
Age: 1.5
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Incorrect vaccine given, should have been dtap.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Pallor, Posture abnormal
Clinical narrative: Patient became pale and slouched in chair for approximately 5 seconds. Aroused to name when called. CRNP made aware. Orange juice, peanut butter crackers given and tolerated well. Cool RA placed to forehead. Gave water to sip on and patient laid down. BP 103/63. Then 10 minutes later BP 108/70, P-100, R-24, and temp 36.4.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient stated that she was given the SHINGRIX vaccination in her left upper arm, at pharmacy, near the end of May. She states the day after the vaccination her arm at the site of the injection was red and painful. She states her symptoms have progressively become worse, and she can see where the needle entered her arm.
Age: 28.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Bursa disorder, Circumstance or information capable of leading to medication error, Injected limb mobility decreased, Injection site discomfort
Clinical narrative: I received my flu shot at work through a contracted company. At the time of administration, the technician/nurse was behind schedule and I felt very rushed. When I couldn't immediately remove my arm from my long sleeve shirt, he suggested I pull my collar over my shoulder and he administered the shot from above me. I clearly remember him mentioning that he would go above a tattoo on my upper shoulder, leaving the placement very high on my shoulder. I began experiencing significant and persistent pain in my left shoulder in the following weeks. This progressed and included weakness and limited range of motion. I first took a round of oral steroids 1-2 months following the injection, which only gave me temporary relief. I also attended physical therapy for several months. In June of 2018, I was still struggling with pain/discomfort in the same location. At that time I received an MRI and a steroid injection. I currently am still experiencing pain daily.
Age: 28.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Nuclear magnetic resonance imaging abnormal, Product administered at inappropriate site, X-ray
Clinical narrative: I received my flu shot at work through a contracted company. At the time of administration, the technician/nurse was behind schedule and I felt very rushed. When I couldn't immediately remove my arm from my long sleeve shirt, he suggested I pull my collar over my shoulder and he administered the shot from above me. I clearly remember him mentioning that he would go above a tattoo on my upper shoulder, leaving the placement very high on my shoulder. I began experiencing significant and persistent pain in my left shoulder in the following weeks. This progressed and included weakness and limited range of motion. I first took a round of oral steroids 1-2 months following the injection, which only gave me temporary relief. I also attended physical therapy for several months. In June of 2018, I was still struggling with pain/discomfort in the same location. At that time I received an MRI and a steroid injection. I currently am still experiencing pain daily.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Dehydration, Dizziness, Influenza like illness
Clinical narrative: After I got home, I took MOTRIN 800 mg. That night I started with shivers and fever and by morning could not get out of bed due to dehydration and dizziness and lightheadedness. My whole body ached. I couldn't go to work or do anything but stay in bed with the flu like symptoms. I got out of bed 30 hours later. Today I am just still aching in my back and sides but able to be at work.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: After I got home, I took MOTRIN 800 mg. That night I started with shivers and fever and by morning could not get out of bed due to dehydration and dizziness and lightheadedness. My whole body ached. I couldn't go to work or do anything but stay in bed with the flu like symptoms. I got out of bed 30 hours later. Today I am just still aching in my back and sides but able to be at work.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough
Clinical narrative: "Worst experience of my life" I will never take this vaccine again, severe chills, rigors, chronic lingering cough for weeks.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling
Clinical narrative: Bilateral eye swelling.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2017, the patient was inoculated with the ZOSTAVAX vaccine at a hospital as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On 07-JUL-2017, she was treated at a hospital for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, he was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2007, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On unknown dates during 2007 and in 2014, the patient was treated by a hospital for vesicular outbreaks, which were diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Neuralgia, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 04-AUG-2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 04-JAN-2009, the patient was treated by a licensed practical nurse for a vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. On or about 19-JAN-2009, the patient sought subsequent treatment from a licensed practical nurse for neuropathic pain secondary to zoster infections. The patient was prescribed LIDODERM to ease her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.