chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Product administered to patient of inappropriate age
Clinical narrative: His arm is red [and swollen/very swollen arm]; [His arm is red and] swollen/very swollen arm; 28 months old child was received Flucelvax Quadrivalent vaccine; This is spontaneous case, initially received from other health professional (nurse) via Company (reference number: SEQ19-04031, SEQ19-04534) on 07-Oct-2019 with additional information received on 11-Oct-2019 (being processed together), concerning a 2.5-year-old, male patient.  The patient had no medical history and concomitant medications.  On 06-Oct-2019, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular (IM), anatomical location: right arm, batch number: 261220, expiration date: 30-Jun-2020] for influenza prophylaxis (explicitly coded as Inappropriate age at vaccine administration').  On the same day, after vaccination, the patient's arm was red and swollen. The patient's parents monitored him, and his mother reported that the patient was fine, except a very swollen arm.   As reported, a week, to a week and a half after vaccination, the patient recovered.  The reporter assessed the case as non-serious and did not provide causality assessment.  Follow up received from other health professional (nurse) via Company (reference number: SEQ19-04936) on 17-Oct-2019: Age at vaccination added. The outcome for swollen arm was provided and changed from resolving to resolved. Stop date was added. Event of arm red was added. Narrative was amended accordingly.  Company comment: The patient experienced erythema and peripheral swelling after Flucelvax QIV administration to patient of inappropriate age. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Product administered to patient of inappropriate age is assessed as not related per company conventions. Considering all the above mentioned, causal role of the suspect product is assessed as related.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthma, Condition aggravated, Throat tightness
Clinical narrative: Asthma attack; This is a spontaneous case, initially reported by other health professional via Med Communications (reference number: SEQ19-05194) on 26-Jul-2019, concerning a 52-year-old, female patient.  The patient's relevant medical history included a history of asthma.  The patient did not have concomitant medications.    On 18-Oct-2019, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 259814 and expiry date: 30-Jun-2020] for influenza prophylaxis.  On the same day of vaccination, later that evening, the patient experienced an asthma attack and same thing happened the next morning as well. The patient reported  she was feeling  like her throat was 'closing up' and had to use her inhaler and take Benadryl.  On 19-Oct-2019 the outcome of the event was considered resolved.  The reporter assessed the case as non-serious.  Company comment: The patient experienced asthma (reported as asthmatic attack) on the same day of vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. The patient was previously diagnosed with asthma and the disease itself is characterised with numerous attacks that can be provoked with multiple factors. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.; Sender's Comments: The patient experienced asthma (reported as asthmatic attack) on the same day of vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. The patient was previously diagnosed with asthma and the disease itself is characterised with numerous attacks that can be provoked with multiple factors. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Headache
Clinical narrative: Tightness in chest; Headache; This is a spontaneous case, reported by other non-healthcare professional to Med Communications [reference number: SEQ19-06089] and initially received on 04-Nov-2019, concerning a 15-year-old, male patient.  The patient's medical history was not reported. The patient's concomitant medications were not provided.  On 30-Sep-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number and expiry date: not reported] for prevention of seasonal influenza.  On the same day, after vaccination, the patient experienced tightness in chest and headache. No further details were provided.  At the time of initial reporting, the outcome of the events was not reported.  This case was assessed as non-serious.   The reporter did not provide the causality assessment.  This case is linked to cases: 201905875, 201905876 and 201905878 (same reporter).  Company comment: The patient experienced chest discomfort and headache after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced chest discomfort and headache after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Headache
Clinical narrative: Headache; Coughing; This is a spontaneous case, reported by other non-healthcare professional to agency [reference number: SEQ19-06089] and initially received on 04-Nov-2019, concerning a 7-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications were not provided.  On 30-Sep-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose, route of administration, anatomical location, batch number and expiry date: not reported] for prevention of seasonal influenza.  On the same day, after vaccination, the patient experienced headache and coughing. No corrective treatment was given for the events.  At the time of initial reporting, the outcome of the events was not reported.  This case was assessed as non-serious.   The reporter did not provide the causality assessment.  This case is linked to cases: 201905875, 201905876 and 201905877 (same reporter).  Company Comment: The events of 'headache' and 'coughing' are considered related to Afluria Quadrivalent.; Sender's Comments: The events of 'headache' and 'coughing' are considered related to Afluria Quadrivalent.
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Allergy to vaccine, Dizziness, Hypersensitivity, Nausea, Peripheral swelling
Clinical narrative: She was feeling light headed/dizzy; The patient was nauseous; Hives; It was an allergic reaction to the flu shot; Injected arm started swelling; This is a spontaneous case, reported by other non health professional via agency (reference number: SEQ19-06611) on 13-Nov-2019, concerning a 19- year-old, female patient.  The patient's medical history included removal of tonsils and surgical removal of swallowed quarters. The patient was not taking any concomitant medication.  On 08-Nov-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular (IM), anatomical location: deltoid, batch number and expiry date: not reported] for influenza prophylaxis.  On the same day, within 5 minutes after vaccination, the patient's injected arm started swelling.  On 09-Nov-2019, one day after vaccination, the patient developed hives.  On an unspecified date, the patient used Benadryl (diphenhydramine hydrochloride) and prednisone, but it did not help. The patient went to emergency room (ER) and this event was confirmed to be an allergic reaction to the flu shot.  On 13-Nov-2019, five days after vaccination, the patient was feeling light-headed/dizzy and she was also nauseous.  On 27-Nov-2019, the patient recovered from all events.  This case was assessed as non-serious.  The reporter did not provide the causality assessment to Flucelvax Quadrivalent.  Follow up received from other non health professional (consumer) on 12-Dec-2019: It was confirmed that injected arm was swollen. The outcomes and stop dates for all events were provided. Narrative amended accordingly.  Company comment: The patient experienced peripheral swelling five minutes after administration of suspect product, Flucelvax Quadrivalent. The patient also developed urticaria one day post vaccination. Allergy to vaccine was confirmed. The patient developed nausea and dizziness, five days after vaccination. Chronology is plausible and causal role of the suspect product is assessed as possible.; Sender's Comments: The patient experienced peripheral swelling five minutes after administration of suspect product, Flucelvax Quadrivalent. The patient also developed urticaria one day post vaccination. Allergy to vaccine was confirmed. The patient developed nausea and dizziness, five days after vaccination. Chronology is plausible and causal role of the suspect product is assessed as possible.
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: She was feeling light headed/dizzy; The patient was nauseous; Hives; It was an allergic reaction to the flu shot; Injected arm started swelling; This is a spontaneous case, reported by other non health professional via agency (reference number: SEQ19-06611) on 13-Nov-2019, concerning a 19- year-old, female patient.  The patient's medical history included removal of tonsils and surgical removal of swallowed quarters. The patient was not taking any concomitant medication.  On 08-Nov-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular (IM), anatomical location: deltoid, batch number and expiry date: not reported] for influenza prophylaxis.  On the same day, within 5 minutes after vaccination, the patient's injected arm started swelling.  On 09-Nov-2019, one day after vaccination, the patient developed hives.  On an unspecified date, the patient used Benadryl (diphenhydramine hydrochloride) and prednisone, but it did not help. The patient went to emergency room (ER) and this event was confirmed to be an allergic reaction to the flu shot.  On 13-Nov-2019, five days after vaccination, the patient was feeling light-headed/dizzy and she was also nauseous.  On 27-Nov-2019, the patient recovered from all events.  This case was assessed as non-serious.  The reporter did not provide the causality assessment to Flucelvax Quadrivalent.  Follow up received from other non health professional (consumer) on 12-Dec-2019: It was confirmed that injected arm was swollen. The outcomes and stop dates for all events were provided. Narrative amended accordingly.  Company comment: The patient experienced peripheral swelling five minutes after administration of suspect product, Flucelvax Quadrivalent. The patient also developed urticaria one day post vaccination. Allergy to vaccine was confirmed. The patient developed nausea and dizziness, five days after vaccination. Chronology is plausible and causal role of the suspect product is assessed as possible.; Sender's Comments: The patient experienced peripheral swelling five minutes after administration of suspect product, Flucelvax Quadrivalent. The patient also developed urticaria one day post vaccination. Allergy to vaccine was confirmed. The patient developed nausea and dizziness, five days after vaccination. Chronology is plausible and causal role of the suspect product is assessed as possible.
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Limited movement of left arm; Muscle pain; Pain in her arm; This is a spontaneous case reported by a pharmacist to agency (reference number: SEQ20-00421) and initially received on 28-Jan-2020, concerning an 80-year-old, female patient   The patient's medical history included thyroid issue.  The patient did not take any concomitant medications.  On 11-Dec-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 262311 and expiration date: 30-Jun-2020] for influenza prophylaxis.  On 12-Dec-2019, the day after receiving the vaccine, the patient developed pain in her arm. The patient called her health care provider (HCP) and he advised her to wait to see if the pain resolved.  On an unknown date, reported as after injection, the patient complained about muscle pain and the muscle pain that had not gone away. It was reported that the patient had limited movement of left arm.  On 15-Jan-2020, four days after vaccination, the patient was seen by her HCP for muscle pain and limited movement of left arm. It was reported that the magnetic resonance imaging (MRI) had been scheduled and that tretament measures associated with the events included medication no name known by reporter.  At the time of the report, the patient had not recovered from the events of muscle pain and mobility decreased, while the outcome of the event pain in arm was not reported.  The case seriousness and causality assessment were not provided.  Company comment: The patient experienced mobility decreased, pain in extremity and myalgia after vaccination with the suspect product, Fluad (TIV). Medical history of thyroid issue may have contributed to development of the events. No concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as related.; Sender's Comments: The patient experienced mobility decreased, pain in extremity and myalgia after vaccination with the suspect product, Fluad (TIV). Medical history of thyroid issue may have contributed to development of the events. No concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as related.
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Exposure during pregnancy, Insomnia, Mental disorder
Clinical narrative: Anxiety; Insomnia; Psychiatric issues; Vaccine exposure during pregnancy; This is a spontaneous case initially received from other non-health professional (consumer) via Company (reference number: SEQW20-00043) on 03-Mar-2020, concerning an adult, female, pregnant patient.  The patient's medical history included pregnancy with advanced maternal age.   The patient's concomitant medications were not reported.  The patient's obstetrical history was not provided.   The patient's last menstrual period (LMP) date, estimated delivery date (EDD), corrected estimated date of delivery (CEDD) and type of pregnancy were not reported.  On an unknown date in Sep-2016, during the end of her first trimester of pregnancy, the patient was administered unspecified flu vaccine, reported as Afluria (unknown if TIV or QIV) [Influenza virus vaccine polyvalent; dose, route of administration, anatomical location, batch number and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for protection against seasonal influenza. It was her first and only vaccine she had ever received.   On an unknown day in Oct-2016, about one month later, the patient developed some psychiatric issues, such as severe insomnia and anxiety.   The patient stated that her pregnancy was uneventful, and she soon returned to her normal self.  At the time of this report, the outcome of all events was resolved.  The reporter assessed the case as non-serious.   The reporter did not provide causality assessment.  Company comment:The pregnant patient developed anxiety, insomnia and mental disorder, about one month after vaccination with the suspect product, Afluria. (explicitly coded as Vaccine exposure during pregnancy'). Chronology is unsuggestive. No information about concomitant medications was provided. Based on provided information, causal relationship between the suspect product and the events of anxiety, insomnia and mental disorder is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes), while for vaccine exposure during pregnancy as not related per company conventions.; Sender's Comments: The pregnant patient developed anxiety, insomnia and mental disorder, about one month after vaccination with the suspect product, Afluria. (explicitly coded as Vaccine exposure during pregnancy'). Chronology is unsuggestive. No information about concomitant medications was provided. Based on provided information, causal relationship between the suspect product and the events of anxiety, insomnia and mental disorder is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes), while for vaccine exposure during pregnancy as not related per company conventions.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Rash macular, Skin warm, Swelling
Clinical narrative: Quarter-sized red bump and itchy on May 21. Also, hot and itchy.  May 22: Spread to two inches and blochy red. Bump and itching are gone. No meds  only benydryl cream
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Amenorrhoea, Cervix injury, Fallopian tube disorder, Headache, Nausea
Clinical narrative: Secondary amenorrhea; Damage to cervix, uterus, and fallopian tubes; Primary ovarian insufficiency (POI)/Premature ovarian failure (POF); Nausea; Head and body aches
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Ovarian failure, Pain, Premature menopause, Uterine injury
Clinical narrative: Secondary amenorrhea; Damage to cervix, uterus, and fallopian tubes; Primary ovarian insufficiency (POI)/Premature ovarian failure (POF); Nausea; Head and body aches
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Fatigue, Headache, Injection site erythema, Injection site warmth
Clinical narrative: Patient reported that she experienced atrial fibrillations, headaches, vertigo and extreme tiredness beginning the day after date of vaccine administration. Area of injection appeared pink and patient reported that the area of injection was warm to the touch. Patient also reported that these effects were lessening at time of report.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Patient reported that she experienced atrial fibrillations, headaches, vertigo and extreme tiredness beginning the day after date of vaccine administration. Area of injection appeared pink and patient reported that the area of injection was warm to the touch. Patient also reported that these effects were lessening at time of report.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patients did no experienced any symptoms; Unspecified number of patients received unspecified doses of PEDVAXHIB; This spontaneous report was received from medical assistant, concerning an unspecified number of patients. The patient's pertinent medical history, concomitant medications, concurrent conditions, and past drug allergies or reactions were not reported.   Since May 2019, the patients were vaccinated with unspecified doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (strength, dose, route of administration, and anatomical site of injection were not reported), lot number R0121083 with an expiration date on 13-JUL-2021 and lot number R014261 with expiration date on 25-MAR-2021. The patient did not experience any symptoms and nor product quality complain involved. The administrated doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature of 14 degrees Celsius for 12 hours with a previous temperature excursion of 17 degrees Celsius for 12.5 hours (product storage error).  Follow-up information was received from a medical assistant on 21-MAY-2020.  The reporter confirmed that no further information was available regarding the patient identifiers and the date of vaccination.  This case is non-valid due to the lack of patient identifiers.
Sex: F
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Cough, Dyspnoea, Hypoxia, Pneumonia
Clinical narrative: right lower lobe pneumonia; COPD with hypoxia; COPD with hypoxia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 27-JUL-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequently, the patient suffered shortness of breath, chronic cough with yellowish to brown sputum. The patient was hospitalized and diagnosed with right lower lobe pneumonia and chronic obstructive pulmonary disease (COPD) with hypoxia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient symptoms have resulted in physical limitations not present prior to using this product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were determined to be disabling by the reporter. Upon internal review, the events of hypoxia and right lower lobe pneumonia were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Sputum discoloured
Clinical narrative: right lower lobe pneumonia; COPD with hypoxia; COPD with hypoxia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 27-JUL-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequently, the patient suffered shortness of breath, chronic cough with yellowish to brown sputum. The patient was hospitalized and diagnosed with right lower lobe pneumonia and chronic obstructive pulmonary disease (COPD) with hypoxia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient symptoms have resulted in physical limitations not present prior to using this product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were determined to be disabling by the reporter. Upon internal review, the events of hypoxia and right lower lobe pneumonia were considered to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered an expired dose of VARIVAX which had a temperature excursion.; No additional adverse effect reported.; patient was administered an expired dose of VARIVAX which had a temperature excursion.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 19-MAY-2020, the patient was vaccinated with an improper stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # R013566 with expiration date of 13-MAY-2020, for prophylaxis (route of administration and frequency were not reported), the varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with proper storage sterile diluent(STERILE DILUENT MRK).     No adverse effects were reported.  It was stated that the vaccines underwent a temperature excursion of 6°F (degrees Fahrenheit) to 14°F (8.24F) for 35 minutes. No previous temperature excursion was done. The call was because of a "data logger".
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Off label use, Secretion discharge, Vaccination failure
Clinical narrative: Vaccination failure; Type A Influenza; Dark mucus; Off label use; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a 66-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included fluticasone furoate, vilanterol trifenatate (Breo Ellipta) unknown for asthma and chronic obstructive pulmonary disease.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose. In February 2020, the patient started Breo Ellipta at an unknown dose and frequency. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2019-2020 season and not applicable after starting Breo Ellipta, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza a virus infection, mucus discharge and off label use. On an unknown date, the outcome of the vaccination failure, influenza a virus infection, mucus discharge and off label use were unknown.   It was unknown if the reporter considered the vaccination failure, influenza a virus infection and mucus discharge to be related to Influenza vaccine Quadrivalent 2019-2020 season. It was unknown if the reporter considered the influenza a virus infection and mucus discharge to be related to Breo Ellipta.  Additional case details were reported as follows: The patient was dentist. The age at vaccination was not reported. The patient stated that started Breo Ellipta for 14 days in February and then developed Type A Influenza. The patient did not take any more Breo Ellipta after those 14 days, but just resumed it last week before reporting date. The patient had taken about 5-6 days so far of Breo Ellipta (filled a 30 day supply) and as he was reading about it became concerned about the risk for developing COVID-19 due to any possible immunosuppression. The patient would stop taking it because he does not have asthma or COPD, the doctor was prescribing it short-term only for some chronic congestion, which led to off label use. The patient also had dark mucus. This case was considered as suspected vaccination failure, as time to onset and laboratoty test were unknown at the time of reporting. The patient consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Will be due to the pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown. This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that she dose not have any patients who have missed the 6 month time frame but will be due to the pandemic. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: child, not previously vaccinated, received a dose of Quadracel, no AE; Initial information received on 12-May-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4 years 8 months 6 days old male patient who was not previously vaccinated, received a first 0.5 mL dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number C5635AA, expiration date: 18-June-2021; via intramuscular route in the right deltoid) on 31-May-2019 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for prophylactic vaccination.  It was an actual medication error case due to inappropriate schedule of vaccine administered. Quadracel is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series.  The patient also received two additional doses of GSKs DTAP VACCINE / IPV (lot numbers and other dosing details not reported) on 10-Mar-2020 and 29-Apr-2020 respectively.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: U
Vaccine: DTAPIPVHIB
Symptoms: Crying, Erythema, Local reaction, Rash, Swelling
Clinical narrative: redness; rash; swollen; Baby is crying a lot; Localized reaction; Initial information received on 15-May-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an infant patient who experienced redness (erythema), rash (rash), swollen (swelling), baby is crying a lot (crying) and localized reaction (local reaction), while he/she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ190AAA expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed redness (erythema), rash (rash), swollen (swelling), baby is crying a lot (crying) and localized reaction (local reaction) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  No relevant laboratory tests were reported.  Final diagnosis was local reaction, crying, swelling, rash and erythema.    It was not reported if the patient received a corrective treatment.  The patient outcome was reported unknown for all the events.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: little arm soreness; pregnant woman (13 week of pregnancy) received ADACEL vaccine; Initial information was received on 14-May-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional.  This case involves a 38 years old pregnant female patient who experienced little arm soreness (pain in extremity) while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  Events occurred at 13 week of pregnancy.  The date of last menstrual period was reported as 08-Feb-2020.  The estimated due date was reported as 16-Nov-2020.  The patient's medical history included Limb injury (cut her finger).  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The Concomitant medications were not reported (no other vaccines given at the same visit)   On 13-May-2020, the patient received a standard dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via unknown route in the right deltoid for prophylactic vaccination.  On 14-May-2020, the patient developed a non-serious little arm soreness (pain in extremity) one day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also the case of vaccine exposure during pregnancy. The patient was 13 weeks pregnant while she received vaccine.  No laboratory data was reported.  Final diagnosis was pain in extremity.   It was not reported if the patient received a corrective treatment.  Pregnancy outcome was unknown at the time of report.  The outcome was unknown for the event of pain in extremity.  There will be no information available on the batch number for this case.  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: 23.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given an expired IPOL to a patient/ No AE; Initial information was received on 15-May-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 23 years old female patient who received an expired dose of vaccine IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication was not reported.  On 14-May-2020, the patient received a 0.5 mL fourth dose of suspect IPV (VERO) (lot P1A251M and expiry date 02-May-2020) via unknown route in the right deltoid for prophylactic vaccination.   It was an actual medication error case due to expired vaccine used.   At a time of reporting no adverse event 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.
Sex: F
Vaccine: RAB
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product dose omission, Product preparation issue
Clinical narrative: due to no enough diulent for complete reconsititution big chunk observered which did not dissolved into diluent/No AE; patient had sent home without receiving vaccine/No AE; Initial information was received on 15-May-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 22-years-old female patient who did not received RABIES (HDC) VACCINE [IMOVAX RABIES] due to no enough diluent used for complete reconstitution and big chunk observed which did not dissolve into diluent (product dose omission and Package quantity incorrect).  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the vaccination was scheduled of suspect RABIES (HDC) VACCINE [vial lot: R1C85, Diluent lot: N1L47, Box lot: R1C854M and expiry date: 14-May-2021] for prophylactic vaccination for the patient.  It was a case of potential medication error due to product dose omission and Package quantity incorrect.   At the time of report, 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.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Pyrexia, Rash, Rash macular, Rash pruritic
Clinical narrative: Infant developed a rash starting on face and spreading down body, then arms and legs. Had MMR 3/8/20 Rash was itchy. Low grade fever pink macular eruptions over body Eruptions are more confluent on face and upper chest, with scratch marks * Rash started on 3/18/2020 televisit done 3/19/2020 toddler visited clinic 3/20/2020 - Pt had been on amoxicillin for bilateral otitis media course completed on 3/19/2020. Eruptions continued to spread after amoxicillin was complete. Advised parent that eruptions mostly likely vaccine reaction with Rubella like rash. The rash will be self-limiting. Televisit done on 3/30/20 - Eruptions resolved.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Scratch, Vaccination complication
Clinical narrative: Infant developed a rash starting on face and spreading down body, then arms and legs. Had MMR 3/8/20 Rash was itchy. Low grade fever pink macular eruptions over body Eruptions are more confluent on face and upper chest, with scratch marks * Rash started on 3/18/2020 televisit done 3/19/2020 toddler visited clinic 3/20/2020 - Pt had been on amoxicillin for bilateral otitis media course completed on 3/19/2020. Eruptions continued to spread after amoxicillin was complete. Advised parent that eruptions mostly likely vaccine reaction with Rubella like rash. The rash will be self-limiting. Televisit done on 3/30/20 - Eruptions resolved.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site reaction, Pallor, Rash, Rash maculo-papular
Clinical narrative: gradual onset of blanching, non urticarial maculopapular rash on thighs and lower abdomen/lower back within 18 hours after vaccine given, started to slightly improve 2 days after but present. No other symptoms.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Pain in extremity, Pruritus
Clinical narrative: Patient experience severe itching, pain, and large bruising expanding from elbow to shoulder.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin disorder
Clinical narrative: zoster -related skin conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), for the long term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated by a healthcare-provider for zoster-related skin conditions. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives that spread from injection site down to below elbow. Special needs and unsure if he was also having trouble breathing which is why an emergency visit was warranted.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Lot was expired, expired 3/10/2020 and provider ordered Hepatitis B vaccine.  Called patient to inform, no tenderness or other s/s noted.  Will provide Hepatitis B vaccination next week.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Developmental regression, Erythema, Fatigue, Injection site swelling, Pyrexia
Clinical narrative: He was given mmr in addition to a few more shots. He was visibly tired and the next five days had a fever of 103-104. He had swollen legs and red skin.  He also regressed his speech and stopped talking.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Speech disorder
Clinical narrative: He was given mmr in addition to a few more shots. He was visibly tired and the next five days had a fever of 103-104. He had swollen legs and red skin.  He also regressed his speech and stopped talking.
Age: 1.25
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Hyporesponsive to stimuli, Pyrexia, Rash, Rash erythematous
Clinical narrative: received vaccines on 5/12/20 5/20/20 @ 3am started with fever around 11pm child started "convulsing" and vomited x 1 also had red bumpy rash around mouth, seemed tired and less responsive parents called EMS who advised Tylenol, parents declined to be taken to ER Parents ended up taking him to ER --was examined and told it was a febrile seizure
Age: 1.25
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Seizure, Vomiting
Clinical narrative: received vaccines on 5/12/20 5/20/20 @ 3am started with fever around 11pm child started "convulsing" and vomited x 1 also had red bumpy rash around mouth, seemed tired and less responsive parents called EMS who advised Tylenol, parents declined to be taken to ER Parents ended up taking him to ER --was examined and told it was a febrile seizure
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hypersomnia, Injection site erythema, Injection site pain
Clinical narrative: I woke up in the middle of the night with the shakes, jagged headache pain, a small amount of body pain, and a general feeling of not quite well.  I got back to sleep after about an hour.  When I woke up the next morning I felt like I had been hit by a mack truck.  I was fatigued, had a headache and other bodily ache that included most specifically in shoulders, hips, fingers, and lower legs.  I slept most of that day due to the fatigue.  I felt somewhat better the next day, and was pretty much back to normal by the third day.  I had pain and redness at the shot site in my arm starting the day of the shot.  Over the next several days it was very sore and the redness spread out in about a 2 and 1/2 inch circle on my arm.  By the fourth day after the shot the pain was mostly gone.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Middle insomnia, Pain, Tremor
Clinical narrative: I woke up in the middle of the night with the shakes, jagged headache pain, a small amount of body pain, and a general feeling of not quite well.  I got back to sleep after about an hour.  When I woke up the next morning I felt like I had been hit by a mack truck.  I was fatigued, had a headache and other bodily ache that included most specifically in shoulders, hips, fingers, and lower legs.  I slept most of that day due to the fatigue.  I felt somewhat better the next day, and was pretty much back to normal by the third day.  I had pain and redness at the shot site in my arm starting the day of the shot.  Over the next several days it was very sore and the redness spread out in about a 2 and 1/2 inch circle on my arm.  By the fourth day after the shot the pain was mostly gone.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: B-cell lymphoma
Clinical narrative: B-Cell Lymphoma developed within 2 weeks
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Injection site pain, Malaise, Pyrexia
Clinical narrative: Aching beyond injection site, fever, fatigue, loss  of appetite, malaise
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia
Clinical narrative: Patient has her one-year appointment on Tuesday May 12, 2020 at 12:30. She was healthy and had vaccines. Tuesday evening she started having a fever. It was around 101-102 tympanic most of the evening and through the night, with a high of 102.9 but it broke several times with Tylenol. She continued to have a fever yesterday, but with Tylenol also had some normal readings.    This morning (Thursday) she has a 104.1 tympanic fever at 7am and mom called into the triage line, and sent message to provider.   Tylenol and a cool bath given and it cam down to 100.9 by 7:30.  Pt recovered without  further fevers or need for OV>
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Eye irritation, Pain, Pyrexia
Clinical narrative: low fever 100.2, achy body, burning eyes, tightness in chest