chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Burning sensation, Chills, Fatigue, Hypoaesthesia
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 51 years old male patient who experienced nodule in his arm pit that was extremely painful, fatigue, brachial neuritis, pain in arm, vaccination site erythema, fever, chills, burning sensation, painful arm, numbness and tingling, could not perform daily activities while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Diabetes mellitus. On 04-Sep-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported) via intramuscular route in the right arm. The patient developed a non-serious he noticed a nodule in his arm pit that was extremely painful, (granuloma), feeling fatigue, brachial neuritis, my arm was sore, there was a round, red, 5 cm, 2 inch spot, weakness, feeling fever, feeling chills, sharp, burning pain from my arm pit to elbow almost daily, burning sensation, feeling similar numbness and tingling, feeling similar numbness and tingling, could not perform daily activities because of weakness and the activity would aggravate his right arm(Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. (Other relevant tests included No lab data.) Final diagnosis was nodule in his arm pit that was extremely painful, fatigue, brachial neuritis, pain in arm, vaccination site erythema, fever, chills, burning sensation, painful arm, numbness and tingling, could not perform daily activities because of weakness and the activity would aggravate his right arm. It was not reported if the patient received a corrective treatment. On an unknown date, the patient outcome was reported as Unknown for all the events. List of documents held by sender: None.
Sex: M
Vaccine: TDAP
Symptoms: Loss of personal independence in daily activities, Nodule, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 51 years old male patient who experienced nodule in his arm pit that was extremely painful, fatigue, brachial neuritis, pain in arm, vaccination site erythema, fever, chills, burning sensation, painful arm, numbness and tingling, could not perform daily activities while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Diabetes mellitus. On 04-Sep-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported) via intramuscular route in the right arm. The patient developed a non-serious he noticed a nodule in his arm pit that was extremely painful, (granuloma), feeling fatigue, brachial neuritis, my arm was sore, there was a round, red, 5 cm, 2 inch spot, weakness, feeling fever, feeling chills, sharp, burning pain from my arm pit to elbow almost daily, burning sensation, feeling similar numbness and tingling, feeling similar numbness and tingling, could not perform daily activities because of weakness and the activity would aggravate his right arm(Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. (Other relevant tests included No lab data.) Final diagnosis was nodule in his arm pit that was extremely painful, fatigue, brachial neuritis, pain in arm, vaccination site erythema, fever, chills, burning sensation, painful arm, numbness and tingling, could not perform daily activities because of weakness and the activity would aggravate his right arm. It was not reported if the patient received a corrective treatment. On an unknown date, the patient outcome was reported as Unknown for all the events. List of documents held by sender: None.
Sex: M
Vaccine: TDAP
Symptoms: Radiculitis brachial, Vaccination site erythema
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 51 years old male patient who experienced nodule in his arm pit that was extremely painful, fatigue, brachial neuritis, pain in arm, vaccination site erythema, fever, chills, burning sensation, painful arm, numbness and tingling, could not perform daily activities while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Diabetes mellitus. On 04-Sep-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported) via intramuscular route in the right arm. The patient developed a non-serious he noticed a nodule in his arm pit that was extremely painful, (granuloma), feeling fatigue, brachial neuritis, my arm was sore, there was a round, red, 5 cm, 2 inch spot, weakness, feeling fever, feeling chills, sharp, burning pain from my arm pit to elbow almost daily, burning sensation, feeling similar numbness and tingling, feeling similar numbness and tingling, could not perform daily activities because of weakness and the activity would aggravate his right arm(Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. (Other relevant tests included No lab data.) Final diagnosis was nodule in his arm pit that was extremely painful, fatigue, brachial neuritis, pain in arm, vaccination site erythema, fever, chills, burning sensation, painful arm, numbness and tingling, could not perform daily activities because of weakness and the activity would aggravate his right arm. It was not reported if the patient received a corrective treatment. On an unknown date, the patient outcome was reported as Unknown for all the events. List of documents held by sender: None.
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Rash erythematous, Skin burning sensation, Urticaria
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 52 years old female patient who experienced worsening hives on her neck, chest, face, hairline and down her back/a very sensitive sunburn, painful just from contact with clothing, red raised hives and pain at the injection site, while she received vaccine FLUBLOK QIV. The patient's past vaccination(s) included FLUBLOK several times in the past and did not experience hives just injection site pain. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing food allergy (egg allergy). The patient had no concomitant medications reported. On 02-Nov-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1814 in the left arm. On an unknown date, the patient developed a non-serious had worsening hives on her neck, chest, face, hairline and down her back/a very sensitive sunburn, painful just from contact with clothing, red raised hives and pain at the injection site, following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. The patient denies shortness of breath and facial/tongue swelling. (Other relevant tests included No lab data reported.) Final diagnosis was pain at the injection site and had worsening hives on her neck, chest, face, hairline and down her back/a very sensitive sunburn, painful just from contact with clothing, red raised hives. The patient was treated with BENADRYL. The patient outcome is reported as Unknown for pain at the injection site and as Unknown for had worsening hives on her neck, chest, face, hairline and down her back/a very sensitive sunburn, painful just from contact with clothing.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 17 years old female patient who received 0.25 ml dose instead of 0.5 ml dose of vaccine FLUZONE QUADRIVALENT by accident. The patient's past medical history and concomitant medication were not provided. On 07-Nov-2018, the patient received a 0.25 ml single dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via intramuscular route in the right deltoid. It was a case of actual medication error due to vaccine underdose. Physician's nurse reported later that they had the low dose pediatric for 6 months-35 months flu vaccine in the fridge. It was unknown whether patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 71 years old male patient who received vaccines INFLUENZA VACCINE (FLU SHOT) and FLUZONE HIGH DOSE. The patient's past medical history, concomitant medication and family history were not provided. On 07-Nov-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ044AB, expiry date 04-Jun-2019 via unknown route in the left arm. On 07-Sep-2018, the patient received a 0.5ml dose of suspect INFLUENZA VACCINE (FLU SHOT) produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. It was an actual medication error due to extra dose administered. It was reported that Patient received flu shot on 07-Sep-2018 and received FLUZONE HD on 07-Nov-2018. The pharmacist states that may be the patient has dementia. He states that he would verify it with the doctor but he has no idea who the doctor is. It was unknown whether patient 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: FLU4, MNQ, TDAP, VARCEL
Symptoms: Expired product administered
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA310640 (same patient). This case involves 19 years old patient (gender not reported) who was vaccinated with 0.5 ml expired dose of MENACTRA (Batch number: 05712AA, expiration date: 11 Oct 2018, dose, route and site of administration was not reported) on 07 Nov 2018. The patient's medical history was not reported. Concomitant medications included FLUZONE QUADRIVALENT for Immunisation; ADACEL for Immunisation; and VARICELLA VACCINE for Immunisation. It was an actual medication error due to expired product administered. It was unknown if patient had 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, IPV, MNQ, VARCEL
Symptoms: Expired product administered
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA310637 same reporter. This case involves a 20 years old patient who received 0.5 mL dose of suspect vaccine MENACTRA lot 05712AA, expiry date: 11-Oct-2018 via unknown route in the right deltoid on 07 Nov 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included IPOL for Immunisation; FLUZONE QUADRIVALENT for Immunisation; and VARICELLA VACCINE for Immunisation. It was actual medication error due to Expired vaccine used. It was reported that the patient who received an expired MENACTRA vaccine. It was unknown if any adverse event was 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 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.
Sex: M
Vaccine: YF
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, C-reactive protein increased, Immunoglobulin therapy
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 70 years old male patient who experienced testicular pain, weakness, fever, night sweats, while he received vaccine YELLOW FEVER VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date (11 days prior to October 30th), the patient received a 0.5 ml once dose of suspect YELLOW FEVER VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, patient developed a non-serious weakness (asthenia) following the administration of YELLOW FEVER VACCINE. On an unknown date, patient developed a non-serious fever (pyrexia) following the administration of YELLOW FEVER VACCINE. On an unknown date, patient developed a non-serious night sweats following the administration of YELLOW FEVER VACCINE. On an unknown date, patient developed a non-serious testicular pain following the administration of YELLOW FEVER VACCINE. Patient admitted to emergency room on 30-Oct-2018. It was also reported There were no sign of neurological deficit, kidney failure or encephalopathy. Relevant tests included he had elevated ALT and AST, high sed rate and CRP and positive PCR. Final diagnosis was testicular pain, night sweats, fever and weakness. The patient was treated with IVIGLOB-EX (also reported as IVIG). The outcome of all event was not reported. List of documents held by sender- none.
Sex: M
Vaccine: YF
Symptoms: Night sweats, Polymerase chain reaction positive, Pyrexia, Red blood cell sedimentation rate increased, Testicular pain
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 70 years old male patient who experienced testicular pain, weakness, fever, night sweats, while he received vaccine YELLOW FEVER VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date (11 days prior to October 30th), the patient received a 0.5 ml once dose of suspect YELLOW FEVER VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, patient developed a non-serious weakness (asthenia) following the administration of YELLOW FEVER VACCINE. On an unknown date, patient developed a non-serious fever (pyrexia) following the administration of YELLOW FEVER VACCINE. On an unknown date, patient developed a non-serious night sweats following the administration of YELLOW FEVER VACCINE. On an unknown date, patient developed a non-serious testicular pain following the administration of YELLOW FEVER VACCINE. Patient admitted to emergency room on 30-Oct-2018. It was also reported There were no sign of neurological deficit, kidney failure or encephalopathy. Relevant tests included he had elevated ALT and AST, high sed rate and CRP and positive PCR. Final diagnosis was testicular pain, night sweats, fever and weakness. The patient was treated with IVIGLOB-EX (also reported as IVIG). The outcome of all event was not reported. List of documents held by sender- none.
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient who was vaccinated with a dose of FLUZONE HIGH DOSE (lot number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. 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 vaccine underdose. It was also a case of syringe issue since the vaccine leak out of the end of the needle. It was unknown whether the patient experienced any adverse events. 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 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: Product storage error
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a patient who may vaccinated with a dose of FLUZONE (Batch number: UJ005AF, expiration date: 30-Jun-2019, dose, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was a actual medication error due to incorrect product storage (FLUZONE QUAD excursion stored at 49.5 F for 2 hours and 20 minutes). It was unknown whether patient experienced any adverse event following 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. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an female patient (age was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT on an unknown date. It was reported that the patient received vaccination by her employer. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Details of concomitant medication was not provided. It was a case of actual medication error due to incorrect product storage. It was unknown whether the patient experienced any adverse events. The patient enquired whether she can be revaccinated 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 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: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 22 years old female patient who experienced redness, allergic reaction, hives and itching, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Nov-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number) not reported via intramuscular route in the right arm. On an unknown date, the patient developed a non-serious bright redness 3 days after, received a flu shot from this company and had an allergic reaction to it, hives all down the backs of my legs and itching (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data.) Final diagnosis was redness, allergic reaction, hives and itching. The patient was treated with BENADRYL ALLERGY/COLD and HYDROCORTISONE. On an unknown date, the event outcome was unknown for all the events. List of document held by sender: None.
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Back pain, Extra dose administered
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid serious case received from a nurse. This case involves an 88 years old male patient who experienced back pain, while he received vaccines FLUZONE QUADRIVALENT and FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as no other vaccines were administered. On 10-Sep-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the outpatient. On 07-Nov-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the inpatient. On an unknown date, the patient developed a serious back pain following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient was hospitalized for this event. (It was reported that the patient was admitted for back pain but will be discharged back to his nursing home where he resides). It was also a case of actual medication error due to Extra dose administered as patient received FLUZONE QUAD in an outpatient clinic on 10Sep2018 and then received FLUZONE HD as an inpatient today. (Other relevant tests included No lab data). Final diagnosis was back pain. It was not reported if the patient received a corrective treatment. The patient as Unknown for back pain. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none. Sender's Comments: Patient experienced vomiting after vaccination. Exact time to onset is unknown. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Sex: M
Vaccine: FLU3
Symptoms: Needle issue, Underdose
Clinical narrative: Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 71 years old male patient who was administered a 0.5 ml 2/3rd dose from the physician and needle was too tight and came off during injection of FLUZONE HD, while he received vaccine FLUZONE HIGH DOSE (Batch number: UJ029AA, expiration date: 02-May-2019, site of administration was right deltoid and route was unknown) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to underdose (physician administered 2/3rd of FLUZONE HD) and needle issue (needle was too tight and came off during injection of FLUZONE HD). It was unknown whether patient experienced any adverse event following 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. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, Exposure via skin contact, Syringe issue
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a female patient who experienced vaccine got on her hand/felt wetness on my hand and leaking prefilled syringes, while using vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was exposed to dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6258MA. It was a case of actual medication error due exposure via skin contact, accidental exposure to product and Syringe issue. It was unknown if any 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.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 9 months old male patient who received a 0.5 ml dose of FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. No concomitant vaccinations were given. On 07-Nov-2018, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6375NA and expiry date: 30-Jun-2019) (dose in series, route of administration was not reported) in left vastus lateralis. It was a case of actual medication error due to overdose. It was unknown 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 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: FLU4
Symptoms: Erythema, Swelling face
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 11 years old female patient who had her face was red and swollen, while she received vaccine FLUZONE QUADRIVALENT. 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 INFLUENZA QUADRIVAL A-B VACCINE (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 redness facial and swelling face. (Other relevant tests included no lab data.) Final diagnosis was her face was red and swollen. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown for both events. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 41 years old male patient who received less than 0.5 mL dose of vaccine FLUZONE QUADRIVALENT lot UJ070AB, expiry date: 30-Jun-2019 via unknown route in the left arm on 07-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to vaccine underdose. It was also the case of syringe issue. It was reported that administering a prefilled syringe of FLUZONE QUADRIVALENT 0.5ml, when some of the vaccine leaked from the plunger stopper and 3/4ths of the vaccine go through, but some of it came out from the back of the syringe from the plunger. No reported symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Pain in entire left arm, inability to lift arm without pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Tremor
Clinical narrative: Profound chills/shivering/shaking - uncontrolled; headache, whole body pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Injection site pain, Injection site warmth, Pain
Clinical narrative: Left upper arm, is feverish, pain to touch, day after I ached all over, bones hurt. Took TYLENOL and ibuprofen. Approximately 12 hours later aching stopped but started again this morning.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Osteomyelitis, Pyrexia, Skin warm, Weight bearing difficulty, White blood cell count increased
Clinical narrative: On Oct 29, 2018, pt began complaining of pain in her left leg. She continued to play and baby the leg slightly. We looked at it to see if there was a bump, bruise or mark, but we did not see anything. The next day, Oct 30th, 2018, pt woke up in pain, saying her knee/leg hurt. She had a lot of trouble putting weight on it and I noticed she was hot, so I took her temp and she had a low fever. I gave her Tylenol, and within 30 min she was walking normally and her fever had gone down. She went to school, because there were no signs of any congestion, cough, sore throat, or anything respiratory- besides the leg pain and very low fever (100.1-100.3). I picked her up from school that day and the teach told me she had been fine all day - playing and acting normal, until she woke up from her nap (2:15 end of the day). I walked in and she was on the floor, telling me she couldn't walk. I asked her where it hurt and she said her leg. So I picked her up and carried her out. When we got home her fever was higher than before - 101.5-101.8. I gave her Tylenol once again and about an hour later her pain was gone and so was the fever. She was walking around and playing like normal. She went to bed and woke the next morning (Oct 31st) and has some pain and low fever (100.1-100.4), but was walking. She went to play at the museum in town, had lunch and went down for a nap. When she woke up around 3pm she was in  a lot of pain. We decided to take her into Urgent Care because it was day 3 and did not seem to be getting any better. They sent us to the local hospital and we were seen right away. The began an IV and took blood. They saw elevated white blood cell counts and told us it was indicative of an infection somewhere in the body. They gave her Tylenol and transferred us to Hospital. We checked into the ER and were seen by several doctors - they too took blood and confirmed the high white blood cell count and elevated CRP levels in her blood - indicating infection. They decided to keep her overnight to watch her. The next day, Nov. 1st they began running blood tests for bacterial infection and an infectious disease doctor and Oncologist came in to assess pt and sort of get the history of what had been happening with her. The next day, Nov. 2nd, we began IV antibiotics. We continued on the antibiotics and are still currently on them via PICC line. Over the next days Nov 3-9, we did two MRI's, a CT scan, bone marrow biopsy, PICC line insertion and the only thing they could find was that the bone marrow appeared to be darkened on the MRI - in the same place on both MRI's. There was no abscess, or "highlighted" areas on the scans to indicate "infection", however they would treat this as Osteomyelitis, since the antibiotics did seem to space her fever out further, and make the pain go almost completely away as well. We left on 11/11/18 with the PICC line and order of IV of antibiotics to complete at home over the next 3 weeks. We go for our follow up visit today, 11/15/18 to read further blood test results, etc.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Patient was given SHINGRIX #2 on 11/12/2018, that evening she developed fever and chills and left arm was very sore and warm to the touch. She was seen in clinic on 11/14/2018 with possible cellulitis left upper arm. She was placed on KEFLEX.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Extensive swelling of vaccinated limb, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Immediate onset of pain within the left deltoid. This progressed to swelling of the entire left arm with a welt approximately 5 cm in diameter by that evening. Joint pain in the hips, shoulders, elbows and back the following day with frontal headache. The swelling lasted 7 days and the joint pain lasted 4 days. The day following injection it was examined by both provider and chief medical director (MD) with prescription of BENADRYL and steroid.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Immediate onset of pain within the left deltoid. This progressed to swelling of the entire left arm with a welt approximately 5 cm in diameter by that evening. Joint pain in the hips, shoulders, elbows and back the following day with frontal headache. The swelling lasted 7 days and the joint pain lasted 4 days. The day following injection it was examined by both provider and chief medical director (MD) with prescription of BENADRYL and steroid.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Musculoskeletal stiffness, Myalgia, Nausea, Vomiting
Clinical narrative: Muscle pain, stiffness, nausea. Started about 2 hours after the vaccine was administered. Went to basketball practice and became nauseated, legs stiffened up, pain in joints, ended up throwing up.  Still nauseous today. Did not have any of these symptoms prior to the vaccine. No signs of stomach flu, no fever prior or after.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Red rash on upper arm above and wrapping around shoulder on arm of injection site. Rash was raised and slightly itchy. Rash was there for only a couple of days after it appeared which was about 2 days after vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pruritus, Injection site rash, Pharyngitis streptococcal, Pyrexia, Streptococcus test positive
Clinical narrative: Rash on right arm from QUADRACEL and or PROQUAD. Developed fever 2 days ago after receiving QUADRACEL and PROQUAD on 11/8/18. Fever was 103. Seen in ED and diagnosed with strep throat. Presribed amoxicillin. This morning mom noted rash on the upper arm where he received vaccines. Patient complains that the area is itchy. No fever since starting amoxicillin. No other rash noted.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dry mouth, Headache, Pain
Clinical narrative: Got chills on the evening of my vaccination, woke up during the night with a very painful headache, dry mouth, achy, weak. Drank water. Same symptoms when I got up in the morning except feeling even worse. Drank a bunch of water, took 3 aspirins, regular strength, headache began to fade approx. 7:30 AM, strength mostly back to normal by 9 AM.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Head injury, Pallor, Syncope, Vomiting
Clinical narrative: Upon leaving from well exam pt. had vasovagal syncope, hit forehead on wall, pale, spit-up, HR 46 - pulse Ox 98%, B/P - 82/58, brought into exam room to lie down, water and lollipop given, color returned, HR - 72-80, BP - 92/64, after 20 minutes resolved and discharged home. Called later that night and doing well, called 11/13/18 - and completely fine.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Arrhythmia, Condition aggravated, Dizziness, Fatigue
Clinical narrative: The shot was quadrivalent preservative free which I don't see on the list above. Within 20 minutes of the shot I felt a warm flush come over my body and I felt light headed and swimmy in my head.  I have had panic attacks before and this felt much different. I was not nervous in the Dr office and do not mind shots. I was very tired after I drove home feeling like this after the reaction. I noticed anxiety after the reaction seemed much worse than usual. I had heart arrhythmia event on October 18th. After the initial reaction on October 2, I called primary care Dr and cardiologist. After about 6 weeks, anxiety and exhaustion are improving a little. It all started within about 20 minutes of getting the shot.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Hot flush
Clinical narrative: The shot was quadrivalent preservative free which I don't see on the list above. Within 20 minutes of the shot I felt a warm flush come over my body and I felt light headed and swimmy in my head.  I have had panic attacks before and this felt much different. I was not nervous in the Dr office and do not mind shots. I was very tired after I drove home feeling like this after the reaction. I noticed anxiety after the reaction seemed much worse than usual. I had heart arrhythmia event on October 18th. After the initial reaction on October 2, I called primary care Dr and cardiologist. After about 6 weeks, anxiety and exhaustion are improving a little. It all started within about 20 minutes of getting the shot.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Received shot approx between 11:00 to 11:30 am on 11/12/2018. Felt tired took a nap at 1:00 pm did not get up until 4:00 pm which was very unusual. Had severe sore throat, (lower part of throat).  Was afraid of throat closing. Gargled with salt water. Various aches and pains with the sore throat. Gradually getting better as of 11/15/2018.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Dad states that left thigh developed a "rash" the day after receiving immunizations. The site on left thigh was red and somewhat hard but not hot. Denies pain or itching or fever. The reddened area was approx. 1.5 inches in diameter. Dad states he is acting normal.
Age: 0.92
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 11 month old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 29-OCT-2018 the patient was vaccinated with VAQTA, VARIVAX and M-M-R II (inappropriate schedule of vaccine administered). All three vaccines were indicated for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported). No adverse effect was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Drug ineffective, Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant therapies were not provided. On 15-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided) for prophylaxis (reported as: to prevent the shingles illness from infecting her). On an unknown date, the patient said that ZOSTAVAX gave her shingles. It was considered as special situation - lack of effect. The outcome of the events was unknown. The reporter considered shingles to be related to ZOSTAVAX. The causality assessment between lack of effect and ZOSTAVAX was not provided.
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a 78 year old male patient. Information about pertinent medical history, concomitant medication and drug reactions/allergies were unknown. On 17-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 (frequency, dose detail, route, lot # and expiration date were unknown) and a dose of FLUAD (frequency, dose detail, route, lot # and expiration date were unknown) for prophylaxis. In 2018, after vaccination, the patient experienced cellulitis with swollen arm, the patient went to the Emergency Room and was prescribed with "steroids and antibiotics" (dosage and formulation unknown) for the event. Treatment was given for the event. It was unknown if lab diagnostics/studies were performed for the event. The outcome of cellulitis with peripheral swelling was unknown. The causality assessment was not provided by the reporter. Upon internal review, cellulitis was determined to be medically significant.
Age: 0.92
Sex: U
Vaccine: MENB
Symptoms: Erythema, Fatigue, Induration, Ocular hyperaemia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse (patient's mother) via a Pfizer sales representative. An 11-month-old patient of unspecified gender received the second dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose on the right arm for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of meningococcal group b rlp2086 for immunization on an unspecified date. It was reported that the patient had fever 102 (highest) for 2 days and fatigue for 3 days. The patient also experienced redness, swelling and was hard to touch on the right arm 3 inches below injection site and eye redness. Outcome of the events fever and fatigue was recovered on an unspecified date while unknown for the events redness, swelling and was hard to touch on the right arm 3 inches below injection site and eye redness.
Age: 0.92
Sex: U
Vaccine: MENB
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse (patient's mother) via a Pfizer sales representative. An 11-month-old patient of unspecified gender received the second dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose on the right arm for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of meningococcal group b rlp2086 for immunization on an unspecified date. It was reported that the patient had fever 102 (highest) for 2 days and fatigue for 3 days. The patient also experienced redness, swelling and was hard to touch on the right arm 3 inches below injection site and eye redness. Outcome of the events fever and fatigue was recovered on an unspecified date while unknown for the events redness, swelling and was hard to touch on the right arm 3 inches below injection site and eye redness.
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A female patient of an unspecified age (reported over 65) received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. Three days after vaccination, the patient reported redness that would not go away. The patient was treated with antibiotics. The outcome of the event was recovered on an unspecified date. Information on the batch number has been requested.