chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: C-reactive protein increased, Chest discomfort, Chest pain, Dyspnoea, Gastrooesophageal reflux disease
Clinical narrative: On the evening of 2/1/2016 he developed mild chest pain that worsened (5/10) through the night making him call in to his midnight shift.  It became severe, 9/10, and he sought care at 0600 at Sick Call and then at the ED where he was admitted for four days.  He describes the chest pain and SOB as "if someone was sitting on my chest"; aggravated by deep breath and walking around.  Also, associated palpitations.  He was evaluated for cardiac conditions and diagnosed with myopericarditis. Later dx of GERD and OSA.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Myocardial necrosis marker increased, Myocarditis, Pain, Painful respiration, Palpitations
Clinical narrative: On the evening of 2/1/2016 he developed mild chest pain that worsened (5/10) through the night making him call in to his midnight shift.  It became severe, 9/10, and he sought care at 0600 at Sick Call and then at the ED where he was admitted for four days.  He describes the chest pain and SOB as "if someone was sitting on my chest"; aggravated by deep breath and walking around.  Also, associated palpitations.  He was evaluated for cardiac conditions and diagnosed with myopericarditis. Later dx of GERD and OSA.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Red blood cell sedimentation rate increased, Sleep apnoea syndrome
Clinical narrative: On the evening of 2/1/2016 he developed mild chest pain that worsened (5/10) through the night making him call in to his midnight shift.  It became severe, 9/10, and he sought care at 0600 at Sick Call and then at the ED where he was admitted for four days.  He describes the chest pain and SOB as "if someone was sitting on my chest"; aggravated by deep breath and walking around.  Also, associated palpitations.  He was evaluated for cardiac conditions and diagnosed with myopericarditis. Later dx of GERD and OSA.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's current conditions, historical conditions and concomitant medications were not provided. On 12-NOV-2018, the patient was vaccinated with an expired dose of VAQTA (lot # N026997 with an expiration date 10-NOV-2018)(dose and frequency were not reported), via intramuscular, for prophylaxis. No adverse effect was reported.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Painful, swelling and itching with reddened large hard bump entire deltoid area of right arm. Treatment with ice and Ibuprofen. Resolution of symptoms in 24h.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Around noon left arm became sore around injection site; at 9 p.m. 11/27/18 I felt suddenly nauseated, my scalp was sensitive, I had chills and a fever of 100.4. My hands were cold and fairly stiff.  Stretching them out required special effort. Felt dizzy at 2 a.m. 11/28/18 temperature was 100.6, all other symptoms remain except the scalp sensitivity. Slight headache.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain of skin, Peripheral coldness, Pyrexia
Clinical narrative: Around noon left arm became sore around injection site; at 9 p.m. 11/27/18 I felt suddenly nauseated, my scalp was sensitive, I had chills and a fever of 100.4. My hands were cold and fairly stiff.  Stretching them out required special effort. Felt dizzy at 2 a.m. 11/28/18 temperature was 100.6, all other symptoms remain except the scalp sensitivity. Slight headache.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling of body temperature change, Hyperhidrosis
Clinical narrative: Shivering, hot and cold, body aches, body sweats, low fever 99.5 max., weakness/tired from 6am until approx. 4am the next day when I went to sleep.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Shivering, hot and cold, body aches, body sweats, low fever 99.5 max., weakness/tired from 6am until approx. 4am the next day when I went to sleep.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 11/26 - left arm noticable red larger than 2 inches around shot site, normal soreness and warmth to touch. 11/27 - redness spread from shoulder to elbow and starting to wrap around arm; hot to touch arm noticeable swollen. 11/28 - entire upper arm red from elbow to shoulder and all they way around upper arm; hot to touch, swollen even more, less than double its original size.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: PT arrived escorted by parent at 4:00pm. 4 year old received Dtap as well as the Flu vaccine. Mother was inform and instructed to wait 15 minutes in waiting room. Parent was informed she will receive a call from the supervisor within 24- 48 hours. No adverse reaction at the time of administration.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever, chills, shaking, shivering, debilitating headache, nausea from 1am til about 7pm, then slight fever and headache, then just headach now 36 hours later.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Fever, chills, shaking, shivering, debilitating headache, nausea from 1am til about 7pm, then slight fever and headache, then just headach now 36 hours later.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patients were vaccinated with improperly stored doses of either ZOSTAVAX (lot# and expiration date unknown) or VARIVAX lot# N030407 and expiration date 30-OCT-2019. Both vaccines were used for prophylaxis. Dose, strength, frequency, and route of administration were unknown. No adverse effects were reported. It was reported that the vaccines had a temperature excursion of 6 degrees Fahrenheit (F) to 14F for 30 minutes and 15F to 46F for 15 minutes. No previous temperature excursions were reported. Data logger was involved. As of 02-NOV-2018, all telephone attempts to obtain follow up information have been unsuccessful.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. Information about concomitant medication, concurrent condition and medical history was not provided. On 29-OCT-2018, the patient was vaccinated with an improperly stored PNEUMOVAX 23 intramuscularly, lot # R022249, expiration date 16-APR-2020 for prophylaxis (strength, dose detail and anatomical location were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 47 Fahrenheit (F) and 77 F (average 70 F) for a time frame of 1 hour without previous temperature excursion. Data logger was not involved.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Injection site erythema, Injection site rash, Myalgia, Palpitations
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a 70 year old female patient. Information about medical history and concurrent conditions was unknown.  On 10-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (expiration date 06-APR-2020, lot# R018741; dose detail and route were not reported) for prevention of pneumonia and concomitantly with HIGH DOSE of FLUZONE (high dose; route, lot # and expiration date were not reported) in the left arm for prophylaxis. On 12-OCT-2018, the patient experienced a rash, large grapefruit-sized red patch at injection site, high fever, heart palpitations, muscle aches, and weakness. No treatment given for the events and the patient did not seek medical attention. The causality assessments and the outcome of events were not reported.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a 70 year old female patient. Information about medical history and concurrent conditions was unknown.  On 10-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (expiration date 06-APR-2020, lot# R018741; dose detail and route were not reported) for prevention of pneumonia and concomitantly with HIGH DOSE of FLUZONE (high dose; route, lot # and expiration date were not reported) in the left arm for prophylaxis. On 12-OCT-2018, the patient experienced a rash, large grapefruit-sized red patch at injection site, high fever, heart palpitations, muscle aches, and weakness. No treatment given for the events and the patient did not seek medical attention. The causality assessments and the outcome of events were not reported.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner, and refers to a 15 month old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 27-SEP-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # M034189, expiration date 23-MAY-2019, for prophylaxis. No adverse effects reported. The temperature excursions were as follows: 32.8°F during 10 hours, 14°C during 12 hours, and 8.1°C during 30 minutes. Digital data logger involved.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 25 year old patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On 24-NOV-2017, the patient was vaccinated with the first dose of GARDASIL 9 (Strength, dose, anatomical location, lot # and expiry date were not reported) intramuscularly for prophylaxis. On 14-OCT-2018, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly for prophylaxis (Inappropriate schedule of product administration). On 15-NOV-2018, the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly for prophylaxis. There were no adverse reactions reported. There was no product quality complaint associated with this report.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a Nurse, referring to a male patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were unknown by reporter. In approximately 2016 (reported as "one or two years ago"), the patient was vaccinated with a dose of GARDASIL 9 (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. After an unspecified amount of time in the office, the patient experienced syncope, and no treatment or medical intervention was performed. The patient was reported to be "ok after a few minutes" on an unspecified date in 2016. The Nurse did not mention the causality assessment between the event and therapy with GARDASIL 9. Upon internal review syncope was determined to be a medically significant event.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with VARIVAX injection (dose and frequency were not reported) (lot # R018141, expiry date: 25-JUN-2020) intramuscularly instead of subcutaneous (incorrect route of product administration) for prophylaxis. No adverse effects were reported. No product quality compliant was involved. Lot number [R018141] has been verified to be a valid lot number for VARIVAX.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in November 2018, between 02-NOV-2018 and 16-NOV-2018, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) subcutaneously (dose was not provided, lot# R018144, expiration date 25-JUN-2020) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effect. The digital data logger was involed. The vaccine experienced temperature excursion between 15 degrees Fahrenheit to 46 degrees Fahrenheit (15.1 degrees Fahrenheit) for 1 hour. There were no previous temperature excursions. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1811USA009261: US-009507513-1811USA009257: US-009507513-1811USA009258: US-009507513-1811USA009259: US-009507513-1811USA009260: US-009507513-1811USA009255: US-009507513-1811USA009256: US-009507513-1811USA009254:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 21-NOV-2018 the patient was vaccinated with properly stored but expired dose of M-M-R II (therapy type rHA) (lot # M045394 with expiry date of 14-NOV-2018) for prophylaxis. No adverse effects reported. No product quality complaint was filed.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. the patient's medical history, concurrent conditions and concomitant medications were not provided. On 26-NOV-2018, the patient was vaccinated with an expired dose of VAQTA 25/0.5 (unit not provided), lot # N026997 with expiration date 10-NOV-2018 (dose, frequency, route and anatomical location were not provided) for prophylaxis. No symptoms reported.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test negative
Clinical narrative: This is a spontaneous report from a contactable physician via a company representative. A child patient of unspecified age and gender received PREVNAR 13, lot no and expiration date unknown, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The physician stated they have a child patient with low pneumo titers after 4 pcv13. Outcome of the event was unknown. Information on the batch number has been requested.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Dyspnoea, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves female patient who experienced short of breath, allergic reaction, hives on her back and jaw, burns and itches, while she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Nov-2018, the patient received a dose of suspect INFLUENZA 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 short of breath, allergic reaction, hives on her back and jaw, burns and itches and burns and itches, following the administration of INFLUENZA VACCINE. (Other relevant tests included No lab data.) Final diagnosis was burns and itches, hives on her back and jaw, allergic reaction and short of breath. It was not reported if the patient received a corrective treatment. On an unknown date, the patient outcome for all the events was not reported. List of document held by sender: None. Follow up information recieved from consumer on 19-Nov-2018. No additional information recieved.
Age: 13.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 13 years old patient (gender not reported) who received MENACTRA (lot number and Exp. Date not reported) twice on 06-Aug-2012 and then again on 23-Apr-2014. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due extra dose administered. It was unknown whether the patient had any adverse reactions. 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: MNQ
Symptoms: Accidental exposure to product, Needle issue
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA322127 (same reporter). This case involves female patient who got splashed in the face and eyes with the MENACTRA vaccine due to needle cracked and sprayed the vaccine on them, while she received vaccine MENACTRA. 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 exposed with dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine, lot U6016AA, expiry date- 09-Oct-2019 via eyes and face. It was a case of actual medication error due to Occupational exposure while administering product. It was also a case of needle 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.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a five-months old female patient who was vaccinated with a dose of PENTACEL lot UI952AAA in the left thigh on an unknown date. The patient's past vaccination(s) included PREVNAR on 22-AUG-2018 with at 2 months, ROTAVIRUS VACCINE on 22-AUG-2018 with at 2 months, HEPATITIS B VACCINE on 22-AUG-2018 with at 2 months, PENTACEL on 22-AUG-2018 with at 2 months, HIB on 24-OCT-2018 with at 4 months old and Ipol on 24-OCT-2018 with at 4 months old. The patient's past medical history, medical treatment(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. No reported side effects. 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: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a Other Health care professional (pharmacy intern). This case involves patient who had vaccine for which syringe was placed back into the fridge, and the dose was then given 2 days later, while he/she received vaccine FLUZONE HIGH DOSE. 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 INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route. It was also a case of actual medication error due to incorrect product storage. 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: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60 years old male patient who received a dose of vaccine FLUZONE HIGH DOSE (lot UI981AA and expiration date 16-Mar-2019) via unknown route in the right arm on 19-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccine included PNEUMOVAX for Immunization. It was a case of actual medication error due to inappropriate age at vaccine administration and accidental overdose. 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.
Age: 17.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HIBV, IPV, MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 years old female patient who received an 0.5ml, standard immunization of invalid ipol today/excursion was 53.6 degrees f. x 38 minutes, while she received vaccine ACT-HIB, PENTACEL, MENACTRA, FLUZONE QUADRIVALENT, ADACEL and IPOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given. On an unknown date, the patient received a dose of suspect ACT-HIB lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect IPOL lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose  of suspect FLUZONE QUADRIVALENT lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect MENACTRA lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect PENTACEL lot number not reported via unknown route in unknown administration site. On 20-Nov-2018, the patient received a 0.5 ml dose 4 of suspect IPOL lot N1F931Mecp date: 05-Jul-2019 via unknown route in the right deltoid. On an unknown date she also received a dose 3, dose 2 and dose 1 of the same vaccine lot N1F931M via unknown route in unknown administration site. The patient an 0.5ml, standard immunization of invalid IPOL today which was excursion was 53.6 degrees f. x 38 minutes (product storage error). There were no side effects and no treatments. This case was an actual medication error due to incorrect product storage (of IPOL vaccine). This case was potential medication error due to incorrect product storage of unopened ACT-HIB, PENTACEL, MENACTRA, FLUZONE QUADRIVALENT, ADACEL. As it was not reported whether the patient received these vaccine or not. Lab data was not reported. 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 Good 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: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 19 years old male patient and reports that received expired MENACTRA, while he received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 20-Nov-2018, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine (lot number: U5751AA and expiry date: 12-Nov-2018) (dose and dose in series was not reported) via intramuscular route in the right deltoid. It was a case of actual medication error due to expired product used. 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: M
Vaccine: FLUX
Symptoms: Diarrhoea, Fatigue, Fibromyalgia, Gastrooesophageal reflux disease, Injection site pain
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 55 years old male patient who had chronic fatigue syndrome, fibromyalgia, muscle aches, injection site pain, acid reflux and diarrhea, while he received vaccine Influenza Vaccine. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 19-Nov-2018, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, expiry date, dose, dose in series and route was not reported) in the right arm. On an unknown date, following the vaccination the patient experienced fatigue, fibromyalgia, muscle ache, injection site pain, acid reflux and diarrhea. (Other relevant tests included IgGs are low). Final diagnosis was diarrhea, acid reflux, injection site pain, muscle aches, fibromyalgia and chronic fatigue syndrome. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown for all events. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 55 years old male patient who had chronic fatigue syndrome, fibromyalgia, muscle aches, injection site pain, acid reflux and diarrhea, while he received vaccine Influenza Vaccine. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 19-Nov-2018, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, expiry date, dose, dose in series and route was not reported) in the right arm. On an unknown date, following the vaccination the patient experienced fatigue, fibromyalgia, muscle ache, injection site pain, acid reflux and diarrhea. (Other relevant tests included IgGs are low). Final diagnosis was diarrhea, acid reflux, injection site pain, muscle aches, fibromyalgia and chronic fatigue syndrome. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown for all events. List of documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 48 years old female patient who received expired 0.5 ml dose of vaccine IMOVAX RABIES (lot number not reported) via intramuscular route in unknown administration site on 12-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No Concomitant vaccines were given. It was a case of actual medication error due to expired vaccine used. 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.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 40 years old male patient who received expired 0.5 ml single vaccine ADACEL (lot U5459AB and expiry date 05-Oct-2018) via unknown route in the left deltoid on an unknown date (reported as today). 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 expired vaccine used. 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: TDAP
Symptoms: Manufacturing product shipping issue
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves 5-10 patients (specified number not reported, age and gender not reported) who received vaccine ADACEL that was too long in transit. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. No concomitant vaccine administered. On 19-Nov-2018 and on 20-Nov-2018 the patients received a dose of 0.5 ml suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6103AA expiry date: 25-OCT-2020) via intramuscular route in the deltoid nos. It was a case of actual medication error due to incorrect product storage. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an eight-year-old male patient who received third dose of vaccine DAPTACEL (Suspension for injection) (batch number, expiry date, route and site of administration were not reported) on an unknown date as child was "missing those vaccines" referring to DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, and states they used DAPTACEL for his catch-up series. The patient's past medical history and concomitant medication were not provided. It was a case of actual medication error due to inappropriate schedule of vaccine administered as 8 year old child was "missing those vaccines" referring to DTaP, and states they used DAPTACEL for his catch-up series. Caller states this child was 8.5 years old when he received his third dose of DAPTACEL, and will need his fourth dose in 6 months, when he's 9 years old. It was unknown if adverse event was received or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six months old female patient who was vaccinated with 0.5 ml expired dose of PENTACEL (lot C5439AA and Exp. Date 30-OCT-2018) via unknown route in the left thigh on 21-Nov-2018.  The patient's medical history was not reported and concomitant medications included PNEUMOVAX 13; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunization. It was an actual medication error due to expired vaccine used. The patient did not experienced any symptom. 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: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue, Underdose
Clinical narrative: Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old patient who did not get the full dose of first dose of vaccine PENTACEL (batch number, expiry date, dose, route and site of administration were not reported) as they got the liquid but not the powder on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to Vaccine under dose and Inappropriate reconstitution technique. It was not reported if the vaccine was administered or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient of unknown demography who received an expired dose of vaccine FLUZONE HIGH DOSE (lot UJ031AA and expiry date 01-May-2018) via intramuscular route in the right deltoid on 18-Oct-2018. 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 expired vaccine used. 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.
Age: 23.0
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 23 years old patient who received vaccine FLUZONE HIGH DOSE lot number not reported via unknown route in unknown administration site 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 inappropriate age at vaccine administration and overdose. 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: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 75 years old male patient who was vaccinated with a 0.5 ml dose of vaccine FLUZONE HIGH DOSE (lot number UI9811AB or UJ9811AB and Exp. Date 16 March 2019) via intramuscular route in the left deltoid on 05-Nov-2018. And that vaccine experienced temperature excursion for 3 hours at (-3) degrees Celsius. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Nausea
Clinical narrative: I was showering, felt like throwing up, then found myself sitting in the tub with the shower running. I believe I passed out. I did not my head or hurt myself.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Immediate post-injection reaction, Injection site pain, Joint range of motion decreased
Clinical narrative: 10/19/18 received vaccine "high" left deltoid with sharp immediate pain, but OK. Every day since then worse pain at site, no obvious swelling, bruising, couldn't visualize injection site but tender high deltoid, then self-limiting range of motion related to pain. No fever, no rash. Initial arm pain eval in Employee Health on 11/08/2018, diagnosed with sub-deltoid bursa inflammation and referred to PT for further eval and treatment. 11/27/18 Pain ongoing, PT ongoing.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain, Pain in extremity
Clinical narrative: Patient describes that pain in right arm started the day vaccine given, and at times it was so painful that when he bent his arm in a certain position - it would "stop me in my tracks".  Client feels that a nerve was "hit". He states that he pain/discomfort lasted over two months. He did not seek medical care for this pain/discomfort.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On 09-NOV-2018, the patient was vaccinated with an expired dose of M-M-R II albumin status RHA, lot # M039914, expiration date 26-SEP-2018 (exact dose and route of administration were not reported) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies were provided. On unknown date, the patient was vaccinated with GARDASIL 9 (lot number, expiration date, strength, dose number, route of administration and anatomical location were not provided) for human papilloma virus (HPV) prophylaxis. On unknown date, the patient experienced hives on an unspecified area of the body. The outcome of the event was reported as recovered. The causality assessment between the event and suspected therapy was not provided.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, PPV, TDAP
Symptoms: Laboratory test, Ultrasound scan, Urticaria
Clinical narrative: Pt was given GARDISIL, 9, MENVEO, and PNEUMOVAX 23 on 10-18-18. Mother state she didn't notice the adverse reaction until the next following day. Pt end up with hive. Mother took pt to emergency room - where they end up giving pt some antibiotics.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Rash, Unevaluable event
Clinical narrative: Developed rash 15 mins after Hep B was administered above lip (2 pea sized lesions). Pt did not have resp. distress clear lungs and was happy and smiling. Mom stated pt. had 2 eggs reaction, one in the morning and the first.
Age: 34.0
Sex: F
Vaccine: FLUN4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: 3 skin rashes, baseball size. Treated with BENADRYL, no effect. Lasted 2 weeks-itchy at times. Red rash- 2 patches on legs, 1 patch on back. No exposure to poison ivy.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Low fever of 99.8° F, achy body, particularly sore at injection site. Took some aspirin. Fever resolved after 24 hrs. Injection site soreness gone after 3-4 days.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Areflexia, Asthenia, Balance disorder, Computerised tomogram normal, Diplopia
Clinical narrative: On 11/10 woke up with diplopia, felt very wobbly/ weak when standing. Called sister, to take to Urgency Room. Cat scan was able to rule out stroke/ aneurysm/tumor. Sent to Hospital Emergency Department - EKG and MRI - no abnormalities. Sent home and recommended Ophthalmology and Neurology. Appt for Ophthalmology - on 11/12 seen sinus pressure on MRI. Sent to ENT, ENT - seen same day at 2PM - wanted to drain sinus pressure but did not do Sent to Neurology - labs drawn, no infection seen with CBC. Admitted to hospital 11/12 admitted to Hospital - many tests done including CT/ MRI/ Spinal Tap on 11/15 diagnosed with Miller Fischer Syndrome and started treatment IVIG for 5 days. Sent home, residual symptoms - instability had improved, close up vision improving, soft palate function improving. Deep tendon reflexes continued to be absent. Follow up apt 11/30 with Neurology.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Electrocardiogram normal, Full blood count normal, Immunoglobulin therapy, Lumbar puncture, Miller Fisher syndrome
Clinical narrative: On 11/10 woke up with diplopia, felt very wobbly/ weak when standing. Called sister, to take to Urgency Room. Cat scan was able to rule out stroke/ aneurysm/tumor. Sent to Hospital Emergency Department - EKG and MRI - no abnormalities. Sent home and recommended Ophthalmology and Neurology. Appt for Ophthalmology - on 11/12 seen sinus pressure on MRI. Sent to ENT, ENT - seen same day at 2PM - wanted to drain sinus pressure but did not do Sent to Neurology - labs drawn, no infection seen with CBC. Admitted to hospital 11/12 admitted to Hospital - many tests done including CT/ MRI/ Spinal Tap on 11/15 diagnosed with Miller Fischer Syndrome and started treatment IVIG for 5 days. Sent home, residual symptoms - instability had improved, close up vision improving, soft palate function improving. Deep tendon reflexes continued to be absent. Follow up apt 11/30 with Neurology.