chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Headache, Heart rate increased, Hypotension
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 29th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th October 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site itching and injection site hives. On 30th October 2018, the patient experienced fever, chills, erythema, headache, pain and nausea. On 31st October 2018, the patient experienced low blood pressure, heart rate increased and tremor. The patient was treated with naproxen (Aleve) and benadryl (nos) (Benadryl). On 1st November 2018, the outcome of the injection site itching, injection site hives, fever, chills, erythema, headache, low blood pressure and tremor were recovered/resolved. In November 2018, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the heart rate increased was recovered/resolved and the outcome of the nausea was unknown. It was unknown if the reporter considered the injection site itching, injection site hives, fever, chills, erythema, headache, pain, low blood pressure, heart rate increased, tremor and nausea to be related to SHINGRIX. Additional details were provided as follows: About 4 hours later the patient noticed hives around the site of injection with 3 inches in diameter circle. Next day she experienced low grade fever of 99.8, chills, nausea, redness, headache, and pain. She took alleve and Benadryl as a treatment at night. She visited her physician on 31st October 2018. During her visit her heart rate was 86 and blood pressure was 90/60. She was also shaky, and nauseated during the visit. She recovered from all the side effects on 1st November 2018 except the pain which lasted for about a week. The reporter did not gave consent for follow up. No further details were provided. The reporter stated that the nurse from her doctor office might have already reported this but she was not 100% sure.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site urticaria, Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 29th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th October 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site itching and injection site hives. On 30th October 2018, the patient experienced fever, chills, erythema, headache, pain and nausea. On 31st October 2018, the patient experienced low blood pressure, heart rate increased and tremor. The patient was treated with naproxen (Aleve) and benadryl (nos) (Benadryl). On 1st November 2018, the outcome of the injection site itching, injection site hives, fever, chills, erythema, headache, low blood pressure and tremor were recovered/resolved. In November 2018, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the heart rate increased was recovered/resolved and the outcome of the nausea was unknown. It was unknown if the reporter considered the injection site itching, injection site hives, fever, chills, erythema, headache, pain, low blood pressure, heart rate increased, tremor and nausea to be related to SHINGRIX. Additional details were provided as follows: About 4 hours later the patient noticed hives around the site of injection with 3 inches in diameter circle. Next day she experienced low grade fever of 99.8, chills, nausea, redness, headache, and pain. She took alleve and Benadryl as a treatment at night. She visited her physician on 31st October 2018. During her visit her heart rate was 86 and blood pressure was 90/60. She was also shaky, and nauseated during the visit. She recovered from all the side effects on 1st November 2018 except the pain which lasted for about a week. The reporter did not gave consent for follow up. No further details were provided. The reporter stated that the nurse from her doctor office might have already reported this but she was not 100% sure.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 29th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th October 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site itching and injection site hives. On 30th October 2018, the patient experienced fever, chills, erythema, headache, pain and nausea. On 31st October 2018, the patient experienced low blood pressure, heart rate increased and tremor. The patient was treated with naproxen (Aleve) and benadryl (nos) (Benadryl). On 1st November 2018, the outcome of the injection site itching, injection site hives, fever, chills, erythema, headache, low blood pressure and tremor were recovered/resolved. In November 2018, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the heart rate increased was recovered/resolved and the outcome of the nausea was unknown. It was unknown if the reporter considered the injection site itching, injection site hives, fever, chills, erythema, headache, pain, low blood pressure, heart rate increased, tremor and nausea to be related to SHINGRIX. Additional details were provided as follows: About 4 hours later the patient noticed hives around the site of injection with 3 inches in diameter circle. Next day she experienced low grade fever of 99.8, chills, nausea, redness, headache, and pain. She took alleve and Benadryl as a treatment at night. She visited her physician on 31st October 2018. During her visit her heart rate was 86 and blood pressure was 90/60. She was also shaky, and nauseated during the visit. She recovered from all the side effects on 1st November 2018 except the pain which lasted for about a week. The reporter did not gave consent for follow up. No further details were provided. The reporter stated that the nurse from her doctor office might have already reported this but she was not 100% sure.
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Blood glucose normal, Headache, Skin laceration, Suture insertion, Syncope
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A female patient of an unspecified age received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation, MENACTRA Prefilled syringe, via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient experienced passed out and hit head on something on an unspecified date. Outcome of event was unknown. Sender's Comments: Current limited information does not allow a full medically meaningful assessment, especially lack of medical history, concomitant medications, concurrent illness and event details description including time lag between the onset of the event and vaccination date. Given that syncope is the known adverse reaction for TRUMENBA, a causal relationship between the serious event passed out and TRUMENBA cannot be completely ruled out considering the information available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Head injury, Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A female patient of an unspecified age received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation, MENACTRA Prefilled syringe, via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient experienced passed out and hit head on something on an unspecified date. Outcome of event was unknown. Sender's Comments: Current limited information does not allow a full medically meaningful assessment, especially lack of medical history, concomitant medications, concurrent illness and event details description including time lag between the onset of the event and vaccination date. Given that syncope is the known adverse reaction for TRUMENBA, a causal relationship between the serious event passed out and TRUMENBA cannot be completely ruled out considering the information available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received SHINGRIX for prophylaxis. On 8th December 2018, the patient received the 2nd dose of SHINGRIX. On 8th December 2018, less than a day after receiving SHINGRIX, the patient experienced pain. On 21st December 2018, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced extreme achy pain and soreness following the second dose of SHINGRIX in left arm.  The pain began on the day of vaccination and had lasted approximately 2 weeks. The patient did not provided any further details.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received SHINGRIX for prophylaxis. On 8th December 2018, the patient received the 2nd dose of SHINGRIX. On 8th December 2018, less than a day after receiving SHINGRIX, the patient experienced pain. On 21st December 2018, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced extreme achy pain and soreness following the second dose of SHINGRIX in left arm.  The pain began on the day of vaccination and had lasted approximately 2 weeks. The patient did not provided any further details.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received SHINGRIX for prophylaxis. On 8th December 2018, the patient received the 2nd dose of SHINGRIX. On 8th December 2018, less than a day after receiving SHINGRIX, the patient experienced pain. On 21st December 2018, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced extreme achy pain and soreness following the second dose of SHINGRIX in left arm.  The pain began on the day of vaccination and had lasted approximately 2 weeks. The patient did not provided any further details.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Dry skin, Injection site erythema, Injection site reaction
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received PREVNAR 13 (Batch/lot number X13847, Expiry date Jul2020, NDC number 00005197101), intramuscular at 0.5 ml single on 12Dec2018 for immunisation. Medical history none. Concomitant medications included unspecified drugs. On 19Dec2018, the patient had a rash after receiving a PREVNAR shot with outcome of not recovered. No treatment required.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received PREVNAR 13 (Batch/lot number X13847, Expiry date Jul2020, NDC number 00005197101), intramuscular at 0.5 ml single on 12Dec2018 for immunisation. Medical history none. Concomitant medications included unspecified drugs. On 19Dec2018, the patient had a rash after receiving a PREVNAR shot with outcome of not recovered. No treatment required.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: PATIENT WAS ADMINISTERED TWO INJECTIONS BY A FLOATER PHARMACIST ON 10/15/2108: FLUAD AND PNEUMOVAX 23. PATIENT HAD NO PROBLEMS WITH THE PNEUOMOVAX INJECTION, BUT, EXPERIENCED ALOT OF PAIN AS THE FLUAD INJECTION WAS ADMINSTERED. PATIENT SAID THAT SHE COULD NOT LIFT HER RIGHT ARM, AND VISITED HER PRIMARY CARE PHYSICIAN ON 10/31 AND HIS ASSOCIATE ON 11/7. DR PRESCRIBED DICLOFENAC GEL AND DR PRESCRIBED AMOXICILLIN. BOTH WERE INEFFECTIVE. PATIENT VISITED AN ORTHOPEDIC SPECIALIST, AND ACCORDING TO PATIENT WAS ADMINISTERED TRAMCINOLONE INJECTION WHICH HAS HELPED. PATIENT STATED DR  CONCLUDED THAT THE INJECTION WAS ADMINISTERED TOO HIGH RESULTING IN INJURY.
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: This spontaneous prospective pregnancy report was received from a 41 year old female patient referring herself. Concomitant therapy included low dose aspirin. The patient had no medical history or drug reactions/allergies. On 12-NOV-2018, the patient was accidently vaccinated with GARDASIL 9 injection (strength, dose, route of administration, lot # and expiry date were not reported) in upper arm instead of a flu vaccine (unspecified) for prophylaxis (wrong product administered, exposure during pregnancy). The patient became pregnant with last menstrual period (LMP) of 13-AUG-2018 (reported as 17 weeks) and estimated due date (EDD) of 20-MAY-2019. Initial exposure to GARDASIL 9 was at 13 week(s). The pregnancy outcome was outcome pending. No lab diagnostics/studies was performed. The patient sought medical attention and spoke with physician. No treatment was given. The patient was not hospitalized. There was no product quality complaint (PQC) reported.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella virus test negative
Clinical narrative: Information has been received from a nurse, referring to an unknown age female patient whos was her daughter. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date in 1998 (reported as "20 years ago"), the patient was vaccinated with VARIVAX injection to prophylaxis (strength, dose, frequency, route of administration, anatomical injection site, lot number and expiration date were no reported). Also, as a suspect therapy, was reported the Sterile Diluent (strength, dose, frequency, route of administration, anatomical injection site, lot number and expiration date were no reported). On an unknown date, the nurse reported that the patient had titer drawn which were negative for immunity to varicella (varicella virus test negative). At the time of the report, outcome of the event and the causality assessment between VARIVAX and varicella virus test negative were not reported.
Sex: U
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a medical assistant calling on behalf of physician regarding a 18 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications and drug/allergies were not reported. On 31-MAY-2018, the patient was vaccinated with GARDASIL 9 lot # N020138, expiry date: 14-FEB-2020, dose 1 for prophylaxis. On 31-MAY-2018, after 20 minutes of administration of the first dose of the GARDASIL 9 the patient developed temperature of 103 Fahrenheit (F) (pyrexia). On 07-AUG-2018, the patient was vaccinated GARDASIL 9 lot # N028567, expiry date: 17-MAY-2020 (route not reported) dose 2 for prophylaxis. On 07-AUG-2018, after 20 minutes of administration of the second dose of the GARDASIL 9 patient developed temperature of 105.7 Fahrenheit (F) (pyrexia). Outcome of pyrexia was unknown. Causality assessment was not reported.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant regarding a 2 years-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 17-DEC-2018, the patient was vaccinated with improperly stored VARIVAX injection, lot number R017768 with expiration date in 21-JUN-2020, which was reconstituted with properly stored sterile diluent (DILUENT MRK) (strength, dose, route of administration and anatomical location not reported), for prophylaxis. The VARIVAX was stored at a temperature range of -9 degrees Celsius (°C) to 8°C for the time frame of 70 hours and 45 minutes, and another range of 9°C to 25°C (17.7C) for the time frame of 34 hours and 30 minutes . There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.
Sex: U
Vaccine: HEP, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from an administrator referring to unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (intramuscular, newborn, 2month, 6month; strength, dose, batch/lot # and expiration date were not reported), ROTATEQ (oral, 2month, 4month, 6month; strength, dose, batch/lot # and expiration date were not reported) and GARDASIL 9 (intramuscular, two doses, six months apart; strength, dose, batch/lot # and expiration date were not reported) for prophylaxis. These vaccines were exposed to temperature excursion of 8.11 degrees Celsius to 9.09 degrees Celsius for unspecified duration. It was unspecified if there were previous excursions or not. It was unspecified if the call was because of a data logger. No adverse effect was reported.
Sex: F
Vaccine: HPV9
Symptoms: Encephalitis
Clinical narrative: This spontaneous report as received from a consumer refers to herself a 46-year-old female patient. The patient's medical history, concurrent condition, concomitant medication was not reported. On an unknown date in November 2017, the patient was vaccinated with GARDASIL 9 (Lot#, Expiry date: not reported) for prophylaxis. On an unknown date in November 2017 (reported as one day after the vaccination), the patient experienced encephalitis for which the patient had to visit the emergency room and was treated at an unspecified hospital and was diagnosed with encephalitis. The outcome of encephalitis was reported as not recovered. The causality of the adverse event encephalitis with the suspect GARDASIL 9 was unknown. Upon internal review the adverse event encephalitis was considered medically significant.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site discomfort, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report was received from the patient's mother referring to a 21 year old female patient. The patient had no medical history, concurrent conditions, drug reactions, allergies nor concomitant medication. On 03-OCT-2018, the patient was vaccinated with 1 injection of GARDASIL 9 in the upper arm, lot number R008163 and expiration date of 18-NOV-2020 for prophylaxis (dose and route of administration were not reported). In approximately November 2018, (reported as "a month after vaccination") the patient experienced injection site hardness under the skin (injection site induration), swelling, and discomfort that lasted for a little more than a week and it went away on its own without treatment. The patient called the clinician, nevertheless there were no laboratory diagnostics or studies performed. The reporter did not provide causality assessment between the events and vaccination with injection of GARDASIL 9.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a nurse refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On unknown date, the patient was inadvertently vaccinated with one dose of VAQTA (lot # R013859, expiry date: 14-JUN-2019) via unspecified route for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral, Eyelid function disorder, Eyelid ptosis, Facial paralysis, Facial paresis
Clinical narrative: Information has been received regarding a case from a lawyer, spouse, and a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 15-FEB-2018, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On approximately 17-FEB-2018 [reported as approximately 3 days after receiving the ZOSTAVAX vaccine], the patient began to experience left-sided facial numbness, right-sided weakness, droopy right eye, and was diagnosed with Bell's Palsy. As a result, the patient also suffered from right-sided hearing issues shortly after being diagnosed with Bell's Palsy and continued to suffer from right-sided facial paralysis. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, Bell's palsy was determined to be medically significant. Bell's palsy and right-sided hearing issues were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Hemiparesis, Hypoaesthesia, Quality of life decreased
Clinical narrative: Information has been received regarding a case from a lawyer, spouse, and a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 15-FEB-2018, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On approximately 17-FEB-2018 [reported as approximately 3 days after receiving the ZOSTAVAX vaccine], the patient began to experience left-sided facial numbness, right-sided weakness, droopy right eye, and was diagnosed with Bell's Palsy. As a result, the patient also suffered from right-sided hearing issues shortly after being diagnosed with Bell's Palsy and continued to suffer from right-sided facial paralysis. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, Bell's palsy was determined to be medically significant. Bell's palsy and right-sided hearing issues were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Herpes zoster, Lower respiratory tract congestion, Pneumonia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age with chronic obstructive pulmonary disease (COPD). In or around 08-NOV-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date [reported as shortly after receiving the ZOSTAVAX], the patient suffered rashes on her left upper shoulder and in between her thighs for months. Additionally, the patient suffered from persistent chest congestion and wheezing. The patient was diagnosed with herpes zoster, pneumonia, and COPD exacerbation. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, pneumonia was determined to be medically significant. Pneumonia, herpes zoster, and COPD exacerbation were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Quality of life decreased, Rash, Wheezing
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age with chronic obstructive pulmonary disease (COPD). In or around 08-NOV-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date [reported as shortly after receiving the ZOSTAVAX], the patient suffered rashes on her left upper shoulder and in between her thighs for months. Additionally, the patient suffered from persistent chest congestion and wheezing. The patient was diagnosed with herpes zoster, pneumonia, and COPD exacerbation. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, pneumonia was determined to be medically significant. Pneumonia, herpes zoster, and COPD exacerbation were considered to be disabling. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLUR4
Symptoms: Headache, Oropharyngeal pain, Pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Initial unsolicited report received from a pharmacist on 28-Nov-2017. This case involves a 13-year-old male patient, who was vaccinated with 0.5 ml dose of FLUBLOK QUADRIVALENT batch number: QFAA1703 expiry date: 26-Mar-2018 (dose in series was not reported) via intramuscular route in left deltoid on 25-Nov-2017. Patient medical history and concomitant medications were not reported. On 27-Nov-2017, two days following the vaccination, the patient experienced general body pain, fever, headache and sore throat. It was an actual medication error due to Inappropriate age at vaccine administration. A 13-year-old male patient was administered FLUBLOK. Lab data was not reported. No corrective treatment was given. Outcome of the events was unknown for all the events at the time of reporting. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Follow up information received from a pharmacist on 23-Dec-2018. Event updated. List of documents held by sender: none.
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Chills, Decreased appetite, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Initial unsolicited report received from a healthcare professional via health authority (under reference number: 730388) on 03-Apr-2018. This case involves a 66-year-old female patient who was vaccinated with a dose of FLUBLOK QIV in the right arm and PNEUMOVAX in the left arm (batch number, expiry date, dose, dose in series and route of administration were not reported for both the vaccines) on 01-Dec-2017 at night. The patient was vaccinated with a dose of FLU SHOT on an unknown date of Oct-1987 and also with STEROID SHOT on an unknown date (three weeks and one day before PREVENAR 13) for back pain. Patient had a medical history of fibromyalgia and back pain on an unknown date. Concomitant medications was not reported. On 01-Dec-2017, on the same day following the vaccination, the patient experienced that her left arm from the almost top of the arm to her elbow was red, hot, swollen and I couldn't lift it, had chills-did not eat supper for two days-felt queasy. Patient's Lab data was reported as none. Patient received BENADRYL to take about a week for all the red to go away, CALCIUM, VITAMINS, PANTOPRAZOLE and ADVIL as a corrective treatment. On an unknown date, the patient was recovered/resolved from all the events. List of documents held by the sender: None. Addendum 28 Dec 2018: Amendment: Upon second medical examination of the case during internal review, a significant correction was performed on 28-Dec-2018 to amendment product code of suspect product from FLUBLOK TIV 528 to FLUBLOK QIV 529.
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Injection site warmth, Nausea
Clinical narrative: Initial unsolicited report received from a healthcare professional via health authority (under reference number: 730388) on 03-Apr-2018. This case involves a 66-year-old female patient who was vaccinated with a dose of FLUBLOK QIV in the right arm and PNEUMOVAX in the left arm (batch number, expiry date, dose, dose in series and route of administration were not reported for both the vaccines) on 01-Dec-2017 at night. The patient was vaccinated with a dose of FLU SHOT on an unknown date of Oct-1987 and also with STEROID SHOT on an unknown date (three weeks and one day before PREVENAR 13) for back pain. Patient had a medical history of fibromyalgia and back pain on an unknown date. Concomitant medications was not reported. On 01-Dec-2017, on the same day following the vaccination, the patient experienced that her left arm from the almost top of the arm to her elbow was red, hot, swollen and I couldn't lift it, had chills-did not eat supper for two days-felt queasy. Patient's Lab data was reported as none. Patient received BENADRYL to take about a week for all the red to go away, CALCIUM, VITAMINS, PANTOPRAZOLE and ADVIL as a corrective treatment. On an unknown date, the patient was recovered/resolved from all the events. List of documents held by the sender: None. Addendum 28 Dec 2018: Amendment: Upon second medical examination of the case during internal review, a significant correction was performed on 28-Dec-2018 to amendment product code of suspect product from FLUBLOK TIV 528 to FLUBLOK QIV 529.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB, RV1
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from an other non healthcare professional (consumer). This case involves a 2 months old patient of unknown age who received only the liquid portion of 0.5 ml of first dose of vaccine PENTACEL (batch number: C5545AA, expiry date: 10-Jun-2019) (route not reported) in the right thigh on 02-Dec-2018.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication include ROTARIX (Rotavirus vaccine). It was case of actual medication error due to Inappropriate reconstitution technique. It was not reported if any adverse event was experienced or not. 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: TD
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult pregnant female patient who was vaccinated with TENIVAC (lot number and Expiry date unknown) via unknown route in unknown administration site instead of ADACEL. The date of last menstrual period, estimated due date and gestation period was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due wrong vaccine administered. (It was reported that pregnant female that had been given a TENIVAC instead of ADACEL). It was also a case of vaccine exposure during pregnancy. 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.
Sex: U
Vaccine: DT
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an adult patient of unknown age and gender who received the pediatric vaccine DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer lot number not reported via unknown route in unknown administration site on an unknown date instead of the adult dose of the Td. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse manager. This case involves an unknown age three patients who received vaccine FLUZONE QUADRIVALENT. The patients' past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number, expiry date not reported via nasal route. It was an actual medication error due to inappropriate route of vaccination. It was reported that another nurse in their practice administered the FLUZONE QUADRIVALENT as a mist instead of intramuscular. Caller stated that she has 3 employees that received a FLUZONE QUADRIVALENT as a Flu Mist through their nasal cavity. It was unknown whether patients experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 26-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an eight-years-old patient of unknown gender who received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On an unknown date, the patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported by mother that her 2 children got vaccinated 3 or 4 days ago out of the same "package" - one was 18 and one was 8 years of age. She wasn't sure if the shot given was FLUBLOK or FLUZONE QUADRIVALENT. 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: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Tinnitus
Clinical narrative: Initial information received on 26-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP (nursing student). This case involves a 32 years old female patient who experienced Tinnitus and little achy, while she received vaccine FLUZONE QUADRIVALENT. Reporter stated that this is the first time she received FLUZONE QUADRIVALENT. The patient's past vaccination(s) included Tdap vaccine 2 months before. The patient's past medical history, medical treatment(s) and family history were not provided. No concomitant therapy was taken. On 17-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the left arm. On 18-Oct-2018, the patient experiencing ringing in the ears 1 day following the administration and on an unknown date, patient was a little achy (latency not reported) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient saw an ENT because of the ringing in her ears that hadn't gone away and the ENT told her to call manufacturer and also her PCP told her that ringing in the ears can be a side effect of the flu. No lab test was reported. Final diagnosis was Tinnitus and little achy. It was not reported if the patient received a corrective treatment. The patient did not recover from ringing in the ears (reported as hadn't gone away) at the time of report and outcome of little achy was not reported. List of document held: none.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Contusion, Dizziness, Eye swelling
Clinical narrative: Common side effects within about 14 hours including pain, redness, slight swelling near injection site, shivering (major shaking) and about 24 hours after injection lightheaded feeling followed by loss of consciousness. When I "passed out" on my way to lie down, I fell into the bedroom door frame which resulted in a cut over my right eye (approx. 1" long) significant bleeding and eventually swelling and discoloration of tissue surrounding eye. Other bruising on my face was minor. Bruised right knee from contact with door frame or from falling to the floor-not serious, just sore for the past 2 days. I expect it will take some time for cut over eye to heal, and for resulting dark discoloration to disappear. I did not seek medical help because after lying down for about 2 hours, the "lightheadedness" did not return. I suspect a temporary drop in blood pressure may have caused me to faint, even though it is not listed as a "most common side effect".
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Haemorrhage, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Common side effects within about 14 hours including pain, redness, slight swelling near injection site, shivering (major shaking) and about 24 hours after injection lightheaded feeling followed by loss of consciousness. When I "passed out" on my way to lie down, I fell into the bedroom door frame which resulted in a cut over my right eye (approx. 1" long) significant bleeding and eventually swelling and discoloration of tissue surrounding eye. Other bruising on my face was minor. Bruised right knee from contact with door frame or from falling to the floor-not serious, just sore for the past 2 days. I expect it will take some time for cut over eye to heal, and for resulting dark discoloration to disappear. I did not seek medical help because after lying down for about 2 hours, the "lightheadedness" did not return. I suspect a temporary drop in blood pressure may have caused me to faint, even though it is not listed as a "most common side effect".
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Skin discolouration, Skin laceration, Syncope, Tremor
Clinical narrative: Common side effects within about 14 hours including pain, redness, slight swelling near injection site, shivering (major shaking) and about 24 hours after injection lightheaded feeling followed by loss of consciousness. When I "passed out" on my way to lie down, I fell into the bedroom door frame which resulted in a cut over my right eye (approx. 1" long) significant bleeding and eventually swelling and discoloration of tissue surrounding eye. Other bruising on my face was minor. Bruised right knee from contact with door frame or from falling to the floor-not serious, just sore for the past 2 days. I expect it will take some time for cut over eye to heal, and for resulting dark discoloration to disappear. I did not seek medical help because after lying down for about 2 hours, the "lightheadedness" did not return. I suspect a temporary drop in blood pressure may have caused me to faint, even though it is not listed as a "most common side effect".
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling and warmth around injection site 4 inches x 1 1/2 inches.