chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Acute left ventricular failure, Acute respiratory failure, Cardiac failure congestive, Death, Dyspnoea
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 the patient's medical history, concurrent conditions, or concomitant medications. On or around 02-MAY-2016, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (date not further specified), the patient suffered acute respiratory failure, acute systolic congestive heart failure, shortness of breath, and pneumonia requiring admission into an intensive care unit. The patient was diagnosed with myocardial infarction, acute respiratory failure, acute systolic heart failure, and pneumonia. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 27-MAR-2017. As a direct and proximate result of ZOSTAVAX, the patient suffered serous and dangerous side effects, including death, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The cause of death was considered to be myocardial infarction, acute respiratory failure, acute systolic heart failure, and pneumonia. Causality assessment was related. Upon internal review, myocardial infarction, acute respiratory failure, acute systolic heart failure, and pneumonia were considered to be medically significant events. The lawyer considered myocardial infarction, acute respiratory failure, acute systolic heart failure, and pneumonia to be disabling. Additional information has been requested.; Reported Cause(s) of Death: acute respiratory failure; myocardial infarction; pneumonia; acute systolic heart failure.
Sex: M
Vaccine: VARZOS
Symptoms: Intensive care, Myocardial infarction, Pneumonia
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 the patient's medical history, concurrent conditions, or concomitant medications. On or around 02-MAY-2016, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (date not further specified), the patient suffered acute respiratory failure, acute systolic congestive heart failure, shortness of breath, and pneumonia requiring admission into an intensive care unit. The patient was diagnosed with myocardial infarction, acute respiratory failure, acute systolic heart failure, and pneumonia. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 27-MAR-2017. As a direct and proximate result of ZOSTAVAX, the patient suffered serous and dangerous side effects, including death, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The cause of death was considered to be myocardial infarction, acute respiratory failure, acute systolic heart failure, and pneumonia. Causality assessment was related. Upon internal review, myocardial infarction, acute respiratory failure, acute systolic heart failure, and pneumonia were considered to be medically significant events. The lawyer considered myocardial infarction, acute respiratory failure, acute systolic heart failure, and pneumonia to be disabling. Additional information has been requested.; Reported Cause(s) of Death: acute respiratory failure; myocardial infarction; pneumonia; acute systolic heart failure.
Sex: F
Vaccine: HPV9
Symptoms: Accidental exposure to product, Occupational exposure to product, Wound
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a female patient unknown age. No pertinent medical history, drug reactions or allergies or concurrent conditions were reported.    On unspecified date, an unspecified nurse cut her hand on a broken GARDASIL 9 pre-filled syringe (lot number: 1581027 with expiration date on: 03-JUN-2021) and experienced occupational exposure to product, accidental exposure to product and wound. The patient recovered from the events, and no medical intervention was provided. It was confirmed by the reporter that patient did not missed a dose. The causality assessment between GARDASIL 9 and the adverse event wound was unknown at the moment of the report.
Age: 0.33
Sex: U
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: This spontaneous report was received from a Nurse practitioner refers to a 4 month old patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-FEB-2019 (also reported as 21-FEB-2019) the patient was vaccinated with PNEUMOVAX 23 lot # R021045, 0.5 milliliter, intramuscular in the right thigh for prophylaxis accidentally instead of PREVNAR 13. The outcome of the events were reported as recovered.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 15-FEB-2019, the patient was vaccinated with one improperly stored dose of VARIVAX, lot # R023502, expiry date: 16-AUG-2020 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose of vaccine was reconstituted with improperly stored sterile diluent, lot # R034106, expiry date: 22-JUN-2021 (dose, route of administration, anatomical location and indication were not provided). The reporter did not know temperature and time frame of excursion. There was no previous temperature excursion. It was not reported if digital data logger was involved. No adverse effects were reported. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1903USA005458: US-009507513-1903USA005459: US-009507513-1902USA010800.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 20-FEB-2019, the patient was vaccinated with one improperly stored dose of VARIVAX, lot # R023502, expiry date: 16-AUG-2020 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose of vaccine was reconstituted with improperly stored sterile diluent, lot # R034106, expiry date: 22-JUN-2021 (dose, route of administration, anatomical location and indication were not provided). The reporter did not know temperature and time frame of excursion. There was no previous temperature excursion. It was not reported if digital data logger was involved. No adverse effects were reported. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1903USA005457; US-009507513-1903USA005459; US-009507513-1902USA010800.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 21-FEB-2019, the patient was vaccinated with one improperly stored dose of VARIVAX, lot # R023502, expiry date: 16-AUG-2020 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose of vaccine was reconstituted with improperly stored sterile diluent, lot # R034106, expiry date: 22-JUN-2021 (dose, route of administration, anatomical location and indication were not provided). The reporter did not know temperature and time frame of excursion. There was no previous temperature excursion. It was not reported if digital data logger was involved. No adverse effects were reported. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1903USA005458: US-009507513-1903USA005457: US-009507513-1902USA010800.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 70-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced allergic reaction and product supply issue. On an unknown date, the outcome of the allergic reaction and product supply issue were unknown. The reporter considered the allergic reaction to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of SHINGRIX. The case was reported by the patient's husband who informed that they were looking for the second dose of SHINGRIX since the first dose had been more than 6 months. No local sources claimed to have received it. The reporter inquired when his wife would get the second dose of SHINGRIX. The reporter stated that his wife had experienced an allergic reaction (facial) with the 1st dose of SHINGRIX and suspected a connection. This case was linked with the case US2019GSK044468, reported for patient's husband.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of myalgia upper extremities in a 78-year-old female patient who received SHINGRIX for prophylaxis.  On 11th February 2019, the patient received the 1st dose of SHINGRIX. On 11th February 2019, less than a day after receiving SHINGRIX, the patient experienced myalgia upper extremities. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the myalgia upper extremities was not recovered/not resolved. It was unknown if the reporter considered the myalgia upper extremities to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she received SHINGRIX and started having pain in the arm where she received the injection the same day she had the SHINGRIX shot and it has not improved. The patient said that it's like a muscle pain. About three days later, it even was worse. The patient said that she did not do a lot of things because of the pain. She has taken Aleve to treat it. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose in August 2018 at pharmacy) and SHINGRIX (received 2nd dose in October 2018 at his physician's office). In February 2019, the patient received the 3rd dose of SHINGRIX. In February 2019, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms and extra dose administered. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the extra dose administered was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX at an unknown deltoid. The patient got a call to get his 2nd dose from the pharmacy and got his 3rd dose of SHINGRIX in February 2019, which led to an extra dose administered. Later that night the patient experienced flu-like symptoms which resolved in about a day.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 68-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. In December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In December 2018, 6 hrs after receiving SHINGRIX, the patient experienced pain. The patient was treated with paracetamol (Tylenol). In 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, but could be 67 or 68 years. The batch number for SHINGRIX was not reported. Two and half months before the date of reporting, the patient received SHINGRIX on the right arm. The patient experienced soreness and lasted for 6 to 8 hours. The patient received Tylenol for the soreness. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature decreased, Diarrhoea, Diarrhoea haemorrhagic, Dysstasia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bloody diarrhea in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 6th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th November 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, extremities hot feeling of and swelling arm. On 9th November 2018, the patient experienced bloody diarrhea (serious criteria GSK medically significant), cramp, gut pain, diarrhea, body temperature decreased, cold and weakness. In November 2018, the patient experienced muscle soreness. On 9th November 2018, the outcome of the gut pain and diarrhea were recovered/resolved. On an unknown date, the outcome of the bloody diarrhea, erythema of extremities, extremities hot feeling of, swelling arm, muscle soreness, cramp, body temperature decreased, cold and weakness were recovered/resolved. It was unknown if the reporter considered the bloody diarrhea, erythema of extremities, extremities hot feeling of, swelling arm, muscle soreness, cramp, gut pain, diarrhea, body temperature decreased, cold and weakness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. After receiving SHINGRIX in the evening, the patient's arm was very red and warm and swollen. Redness went from her elbow to her shoulder. The redness and swelling gradually went away as the week went on. Less than a week after receiving SHINGRIX, the patient had normal soreness in the muscle. Three days after receiving SHINGRIX in the early evening on Friday, the patient started getting cramps and an hour later severe pain in her gut and diarrhea for an hour. She was in a lot of pain and could not stand up. She was too weak to get up and she stayed there for 45 minutes to an hour. She was able to walk a little bit and then half an hour later another incident of diarrhea which was a shorter duration but it had blood. She was still weak and her temperature was a degree under normal. She was cold. She was also somewhat sore from the incident in her intestines after the incident. The severe reaction she experienced resolved that night. The pain was so bad that she almost called 911. The patient already reported this information to the Food and Drug Administration. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling cold, Feeling hot, Gastrointestinal pain, Muscle spasms
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bloody diarrhea in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 6th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th November 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, extremities hot feeling of and swelling arm. On 9th November 2018, the patient experienced bloody diarrhea (serious criteria GSK medically significant), cramp, gut pain, diarrhea, body temperature decreased, cold and weakness. In November 2018, the patient experienced muscle soreness. On 9th November 2018, the outcome of the gut pain and diarrhea were recovered/resolved. On an unknown date, the outcome of the bloody diarrhea, erythema of extremities, extremities hot feeling of, swelling arm, muscle soreness, cramp, body temperature decreased, cold and weakness were recovered/resolved. It was unknown if the reporter considered the bloody diarrhea, erythema of extremities, extremities hot feeling of, swelling arm, muscle soreness, cramp, gut pain, diarrhea, body temperature decreased, cold and weakness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. After receiving SHINGRIX in the evening, the patient's arm was very red and warm and swollen. Redness went from her elbow to her shoulder. The redness and swelling gradually went away as the week went on. Less than a week after receiving SHINGRIX, the patient had normal soreness in the muscle. Three days after receiving SHINGRIX in the early evening on Friday, the patient started getting cramps and an hour later severe pain in her gut and diarrhea for an hour. She was in a lot of pain and could not stand up. She was too weak to get up and she stayed there for 45 minutes to an hour. She was able to walk a little bit and then half an hour later another incident of diarrhea which was a shorter duration but it had blood. She was still weak and her temperature was a degree under normal. She was cold. She was also somewhat sore from the incident in her intestines after the incident. The severe reaction she experienced resolved that night. The pain was so bad that she almost called 911. The patient already reported this information to the Food and Drug Administration. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bloody diarrhea in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 6th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th November 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, extremities hot feeling of and swelling arm. On 9th November 2018, the patient experienced bloody diarrhea (serious criteria GSK medically significant), cramp, gut pain, diarrhea, body temperature decreased, cold and weakness. In November 2018, the patient experienced muscle soreness. On 9th November 2018, the outcome of the gut pain and diarrhea were recovered/resolved. On an unknown date, the outcome of the bloody diarrhea, erythema of extremities, extremities hot feeling of, swelling arm, muscle soreness, cramp, body temperature decreased, cold and weakness were recovered/resolved. It was unknown if the reporter considered the bloody diarrhea, erythema of extremities, extremities hot feeling of, swelling arm, muscle soreness, cramp, gut pain, diarrhea, body temperature decreased, cold and weakness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. After receiving SHINGRIX in the evening, the patient's arm was very red and warm and swollen. Redness went from her elbow to her shoulder. The redness and swelling gradually went away as the week went on. Less than a week after receiving SHINGRIX, the patient had normal soreness in the muscle. Three days after receiving SHINGRIX in the early evening on Friday, the patient started getting cramps and an hour later severe pain in her gut and diarrhea for an hour. She was in a lot of pain and could not stand up. She was too weak to get up and she stayed there for 45 minutes to an hour. She was able to walk a little bit and then half an hour later another incident of diarrhea which was a shorter duration but it had blood. She was still weak and her temperature was a degree under normal. She was cold. She was also somewhat sore from the incident in her intestines after the incident. The severe reaction she experienced resolved that night. The pain was so bad that she almost called 911. The patient already reported this information to the Food and Drug Administration. The reporter consented to follow up.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 24 months old female patient who received only diluent from ACT-HIB batch number U6073AA (expiry date 14-Nov-2019) via unknown route in left thigh. And ACTHIB Powder lot number UI914AA (expiry date 28-Nov-2019). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A, VARICELLA VACCINE, MMR, PREVENAR 13 and DAPTACEL. It was a case of actual medication error due to inappropriate reconstitution technique. (It was reported that consumer only got the diluent from the ACTHIB box.) It was not reported that if any adverse reaction was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case involves a 4 months old patient (gender not reported) who was vaccinated with a 0.5 ml first and second dose of PENTACEL and ACT-HIB (Batch number: UI964AA and expiry date: 28-Jun-2020) in the left and right leg on 07-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included patient was vaccinated with PREVENAR. It was a case of actual medication error due to extra dose administered. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Gastrointestinal disorder, Influenza like illness
Clinical narrative: Initial information received on 06-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves elderly female patient who experienced flu-like symptom, feeling weak and gi issues, while she received vaccine FLUZONE HIGH DOSE and while treated with BOSUTINIB [BOSULIF]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included LEVOFLOXACIN (LEVOFLOXACIN); and BENZONATATE (BENZONATATE). On an unknown date, the patient started taking  in the OSULIF (BOSUTINIB) 100 mg (with an unknown batch number) for Product used for unknown indication. On 24-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported. The patient developed a non-serious flu-like symptom (influenza like illness) following the first dose intake and following the last dose intake of BOSUTINIB. The patient developed a non-serious feeling weak (asthenia) following the first dose intake and following the last dose intake of BOSUTINIB. The patient developed a non-serious gi issues (gastrointestinal tract irritation) following the first dose intake and following the last dose intake of BOSUTINIB.The patient developed a non-serious flu-like symptom (influenza like illness) 3 months 14 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient developed a non-serious feeling weak (asthenia) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient developed a non-serious gi issues (gastrointestinal tract irritation) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Final diagnosis was flu-like symptom, gi issues and feeling weak. BOSUTINIB (BOSULIF) was <<action taken blank>>. The patient was treated with AZITHROMYCIN (ZITHROMAX Z-PAK). The patient outcome is reported as Unknown for flu-like symptom, as Unknown for feeling weak and as Unknown for gi issues.
Sex: U
Vaccine: DTAPIPV, HEP, HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3.5 years old patient (gender not reported) who accidentally received QUADRACEL (lot- C5248AA, expiration date - 21-Aug-2019) via intramuscular route in the left thigh instead of DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (lot number and expiry date was not reported) on 08-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VAQTA; and RECOMBIVAX HB. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was not reported if 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: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (Office Staff). This case was linked with 2019SA067112 (same reporter reporting for twins). This case involves a 17 years old female patient who received vaccine MENACTRA in August 2018 (dosing details lot number was not reported) and again received a standard dose (0.5 ml) (lot-U6220AA, 31-May-2020) via intramuscular route in the left deltoid in 07-Mar-2019. 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 extra dose administered. It was reported that staff is checking on side effects to look for but states so far they haven't reported any. 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: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (Office Staff). This case was linked with 2019SA067108 (same reporter reporting for twins). This case involves a 17 years old female patient who received vaccine MENACTRA in August 2018 (dosing details lot number was not reported) and again received a standard dose (0.5 ml) (lot-U6220AA, 31-May-2020) via intramuscular route in the left deltoid in 07-Mar-2019. 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 extra dose administered. It was not reported if 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: DT
Symptoms: Allergy to vaccine, Pyrexia
Clinical narrative: Initial information received on 07-Mar-2019 regarding an unsolicited valid non-serious case received from Physician via other company (under the reference number-2019051602). This case involves a patient of unknown demographics who experienced high fever and allergy to Tetanus-Diphtheria Toxoid, while he/she received vaccine DIPHTHERIA AND TETANUS TOXOIDS. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patient experienced high fever (pyrexia) and allergy to vaccine. (Other relevant tests included no lab data). Final diagnosis was fever and allergy to vaccine. An unknown corrective treatment was received. The outcome of the events were unknown. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash, Rash pruritic, Skin discolouration
Clinical narrative: Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a female patient (age unknown) who experienced itchy rash that started at the injection site and then went down her arms to her hands and up to her neck and over to her chest, then the rash spread to the right arm and down to the right hand and gray spots on brown skin, while she received vaccine FLUZONE HIGH DOSE. The patient's past vaccination(s) included was INFLUENZA VACCINE. The patient's past medical history, medical treatment(s) and family history were not provided. On 08-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE batch number: U1994AB, expiration date: 30-Apr-2019 via intramuscular route in the left deltoid. On an unknown date, the patient experienced a non-serious itchy rash that started at the injection site and then went down her arms to her hands and up to her neck and over to her chest, then the rash spread to the right arm and down to the right hand (rash pruritic) (vaccination site reaction) and gray spots on brown skin (skin pigmentation), a couple of hours later following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab data.) Final diagnosis was gray spots on brown skin and itchy rash that started at the injection site and then went down her arms to her hands and up to her neck and over to her chest, then the rash spread to the right arm and down to the right hand. The patient was treated with 10mg PREDNISONE, 0.1percent TRIAMCINOLONE ACETONIDE and Tacrolimus 0.1% ointment. The patient outcome was not reported for all the events. List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Tenderness
Clinical narrative: Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves patient of an unknown demographics who experienced tenderness, while he/she received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious tenderness following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. (Other relevant tests included no lab data.). Final diagnosis was tenderness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for tenderness. Documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from a physician via other company (Pfizer). This case involves a patient (age and gender unknown) who experienced allergy to tetanus toxoids, while he/she received vaccine TETANUS TOXOID. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to tetanus toxoids (allergy to vaccine) with unknown latency following the administration of TETANUS TOXOID. Lab data was not provided. Final diagnosis was allergy to tetanus toxoids. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy to tetanus toxoids. List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine, Urticaria
Clinical narrative: Initial information received on 07-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional via other company (Pfizer). This case involves an unknown age and gender patient who experienced allergy to tetanus vaccines and toxoid, while he/she received vaccine TETANUS TOXOID. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to tetanus vaccines and toxoid (allergy to vaccine) with unknown latency following the administration of TETANUS TOXOID. On an unknown date, the patient developed a non-serious hives (urticaria) with unknown latency following the administration of TETANUS TOXOID. Lab data was not provided. Final diagnosis was allergy to tetanus vaccines and toxoid. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy to tetanus vaccines and toxoid and as Unknown for hives. List of documents held by sender- none.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Injection site pain. Pain through out right arm.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Influenza like illness, Pain
Clinical narrative: Woke up in the middle of the night. When I rolled over on my left arm, I was awakened by significant pain. Pain was significant, but subsided when I rolled off it. This morning, I have chills (T 101 F) and flu like aches and pains. My head and body feel exactly like when I've had the flu in the past. My mentation is foggy. I have no drug allergies and no significant PMH. I am a healthcare worker and have been vaccinated against the flu. First dose resulted in arm pain only. Pharmacist told me 2nd dose could have more side effects.
Age: 39.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Amnesia, Arthralgia, Fatigue, Gastrointestinal disorder, Headache
Clinical narrative: Fatigue, joint and nerve pain, muscle pain, headaches, memory loss, gastrointestinal issues, sleep apnea, insomnia, respiratory and neurological disorders, unexplained rashes or other dermatological signs or symptoms, allergic, neuropsychological signs.
Age: 39.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Hypersensitivity, Insomnia, Laboratory test, Myalgia, Nervous system disorder
Clinical narrative: Fatigue, joint and nerve pain, muscle pain, headaches, memory loss, gastrointestinal issues, sleep apnea, insomnia, respiratory and neurological disorders, unexplained rashes or other dermatological signs or symptoms, allergic, neuropsychological signs.
Age: 39.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Neuralgia, Neuropsychiatric symptoms, Rash, Respiratory disorder, Sleep apnoea syndrome
Clinical narrative: Fatigue, joint and nerve pain, muscle pain, headaches, memory loss, gastrointestinal issues, sleep apnea, insomnia, respiratory and neurological disorders, unexplained rashes or other dermatological signs or symptoms, allergic, neuropsychological signs.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: Chills, fever, stomach pain, muscle pain, headache, diarrhea. Took Advil every 4 hours. Effects lasted 24 hours.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, fever, stomach pain, muscle pain, headache, diarrhea. Took Advil every 4 hours. Effects lasted 24 hours.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Client did not suffer any ill effects nor have any complaints. It was discovered after given that adult formulation was used in error .
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Decreased appetite, Dyspnoea, Erythema, Fatigue
Clinical narrative: Tiny non- raised red spots covering both legs from knee down. Swelling and pain in joints especially hands and knees. General redness and mild itchyness throughout the body, fatigue, feeling winded and mild nausea, loss of appetite. Numbness and tingling crawling feeling in feet and hands. I had an appointment with my doctor 3 days after my vaccination and was told symptoms are transient. Symptoms started the day after my 2nd dose of hepatitis A vaccination and got worse the next three days. Symptoms are now slowly improving one week vaccination, but still present at the time I am writing report. Ice packs are extremely helpful in extremities. Keeping cool helpful.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Formication, Generalised erythema, Hypoaesthesia, Joint swelling, Nausea
Clinical narrative: Tiny non- raised red spots covering both legs from knee down. Swelling and pain in joints especially hands and knees. General redness and mild itchyness throughout the body, fatigue, feeling winded and mild nausea, loss of appetite. Numbness and tingling crawling feeling in feet and hands. I had an appointment with my doctor 3 days after my vaccination and was told symptoms are transient. Symptoms started the day after my 2nd dose of hepatitis A vaccination and got worse the next three days. Symptoms are now slowly improving one week vaccination, but still present at the time I am writing report. Ice packs are extremely helpful in extremities. Keeping cool helpful.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Paraesthesia, Pruritus generalised
Clinical narrative: Tiny non- raised red spots covering both legs from knee down. Swelling and pain in joints especially hands and knees. General redness and mild itchyness throughout the body, fatigue, feeling winded and mild nausea, loss of appetite. Numbness and tingling crawling feeling in feet and hands. I had an appointment with my doctor 3 days after my vaccination and was told symptoms are transient. Symptoms started the day after my 2nd dose of hepatitis A vaccination and got worse the next three days. Symptoms are now slowly improving one week vaccination, but still present at the time I am writing report. Ice packs are extremely helpful in extremities. Keeping cool helpful.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Contusion, Feeling of body temperature change, Headache, Muscle spasms, Nausea
Clinical narrative: Joint point, nervous system spasms on side of injection, bruising in the arm pit, fever, hot & cold sensations, nausea, headache. Was given the DTAP vaccine, but not sure which one.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Joint point, nervous system spasms on side of injection, bruising in the arm pit, fever, hot & cold sensations, nausea, headache. Was given the DTAP vaccine, but not sure which one.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Chills, muscle aches, and fatigue that lasted about 32 hours; additionally, these symptoms were accompanied for the initial 18 hours by headache and insomnia. Aspirin and fluids were the treatments. Lingering, mild body aches exist after about 34 hours. These symptoms were similar to the symptoms I experienced after my first SHINGRIX shot, which I received in early March of 2018, but at that time I recovered fully and resumed normal activities after less than 24 hours had passed. I have not yet resumed normal activities, but I plan to do so later this morning.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Chills, muscle aches, and fatigue that lasted about 32 hours; additionally, these symptoms were accompanied for the initial 18 hours by headache and insomnia. Aspirin and fluids were the treatments. Lingering, mild body aches exist after about 34 hours. These symptoms were similar to the symptoms I experienced after my first SHINGRIX shot, which I received in early March of 2018, but at that time I recovered fully and resumed normal activities after less than 24 hours had passed. I have not yet resumed normal activities, but I plan to do so later this morning.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia, Rash erythematous
Clinical narrative: Pain in large area where shot administered, red rash that increased in size over 5 day period, fever ranging from 99.6 to 102.2. Received prescription of doxycycline hyclate 100 mg, Tylenol, advil and warm and cold compresses.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Received vaccine at 1000 and broke out in hives on both arms at 1600. Took some Benadryl  with good results.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: I have had ringing in my ears ever since I received the shingles shot. This was the first round of the shot. I haven't informed the Doctor's office as of yet but I am going to do that next.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Biopsy artery, Blindness unilateral, Headache, Temporal arteritis
Clinical narrative: Autoimmune disease Temporal Arteritis diagnosed July 7, 2018 at Hospital after loss of vision in left eye and over a month of severe excruciating headaches.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Visual acuity reduced
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date, the patient was inoculated with ZOSTAVAX for routine health maintenance and for the prevention of shingles (dose, route, and lot # not provided). After receiving ZOSTAVAX (onset date not further specified), the patient developed vision loss and loss of visual acuity. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, 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. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The outcome of the events was not recovered. Causality assessment was related. The lawyer considered vision loss and loss of visual acuity to be disabling. Upon internal review, vision loss was considered to be a medically significant event. Additional information has been requested.