chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Night sweats
Clinical narrative: Weakness; Loss of appetite; Sweating through the night; Chills; Not feeling well; Thumb, index finger, little bit of other finger tips and entire left hand was numb; This is a spontaneous case from  initially received from other non-health professional on 31-Oct-2018, concerning a 58-year-old, adult, female patient.   The patient's concomitant medications included Zocor (simvastatin), lisinopril and levothyroxine (levothyroxine sodium) for unknown indications.  On 25-Oct-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, batch number: 02844611A, expiry date: 25-Jun-2019, dose, route of administration, anatomical location: not reported] for unknown indication. It was reported that, the patient received the vaccine through in-house at her job.   On 27-Oct-2018 (reported as Saturday), 2 days after vaccination, the patient was not feeling well.   On 28-Oct-2018 (reported as Sunday), at the night, she started having chills, weakness, loss of appetite, sweating through the night. On 29-Oct-2018, the patient woke up feeling better.   On an unspecified, the patient reported that her thumb, index finger, little bit of other finger tips and entire left hand was numb. It was reported that the patient tried to get blood circulation, but the numbness persisted. Also, the patient reported that she hasn't had any excursing and thought it was because of new bra but realized it was not.   At the time of this report, the patient was recovering from the event (weakness, sweating, chills, loss of appetite and not feeling well) and had recovered from the event numbness in hand.  The reporter assessed the case as non-serious.  Significant case amendment (31-Oct-2018): The lowest level term (LLT) for the event 'sweating through the night' was changed from 'sweating' to 'night sweat' in the event tab. No changes were made in narrative.  Follow up received from reporter on 15-Jan-2019: It was reported that, one attempt had been made on 12-Dec-2018 in order to obtain additional information regarding this case, with no success. Hence this case was considered as lost to follow up. Med Info number (SEQ18-07356) was added in the additional information tab. Hence, no changes were made in the narrative.; Reporter's Comments: A 58-year-old, female patient experienced malaise two days after and weakness, loss of appetite, night sweat, chills three days after and numbness in hand on an unspecified date, after vaccination with Afluria quadrivalent. The company assessed the causality of the events as related to the suspect vaccine due to the plausible temporal relationship between events and suspect vaccine.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Pain and soreness in shoulder; Vaccine was administered in shoulder joint; This is a spontaneous case, initially received from pharmacist on 02-Nov-2018, concerning a female patient of unspecified age.  On an unspecified date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: shoulder joint as reported (explicitly coded as vaccine administered at inappropriate site), batch number and expiry date: not reported] for an influenza prophylaxis.  On an unspecified date, after vaccination, the patient experienced pain and soreness in the shoulder. The patient was doing physical therapy.  The outcome of the events was not reported.  The reporter assessed the case as non-serious.  Significant case amendment (02-Nov-2018): The 'treatment received' of the event musculoskeletal pain was changed from 'UNK' to 'Yes' in the event tab. No changes were made in the narrative.; Reporter's Comments: A female patient of unspecified age administered the Afluria Quadrivalent vaccine in the shoulder joint (vaccine administered at inappropriate site) and developed shoulder pain on an unspecified period of time after vaccination. The company assessed the causality of the event (shoulder pain) as related to suspect vaccine, considering the anatomical site specific reaction and the causality of the event (vaccine administered at inappropriate site) as not related to the suspect vaccine due to accidental nature of the event (medication error).
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash on scapula and shoulder area/trunk of arm/ rash over whole body and bottom of feet; This is a non-serious spontaneous case from initially received from a pharmacist on 05-Nov-2018, concerning a 20-year-old, adult female patient.  On 24-Sep-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, batch number: YF38607, expiry date: 30-Jun-2019, dose, route of administration and anatomical location: not reported) for an unknown indication.  On an unspecified date in Sep-2018, after vaccination, the patient developed rash on her scapula and shoulder area which had spread to her trunk of her arm.  On 26-Sep-2018, the patient was advised to seek care with her primary care physician and was prescribed a Medrol (methylprednisolone) dose pack. The patient was still having rash all over whole body and bottom of feet.  At the time of this report, the patient had not recovered from the event.  Non-significant case amendment (05-Nov-2018): The onset latency in the case comment was changed from 'on an unspecified date' to 'within two days' in the analysis tab. No changes were made in narrative.  Non-significant follow-up received on 22-Jan-2019: This case was considered as lost to follow up as the reporter could not be contacted to gather further information. Added Med Info Number (SEQ18-07541) in the additional information tab. No amendment done in narrative.; Reporter's Comments: A 20-year-old, female patient developed rash all over within two days of administration of Afluria Quadrivalent. The company assessed the causality of the event as related to the suspect vaccine due to plausible temporal relationship between the events and the suspect vaccine.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Injection site erythema, Injection site swelling
Clinical narrative: Swelling [and redness] on the injection site; Redness on the injection site; Patient had 1 ml dose administered/gave a 1 ml vaccine mistakenly to a patient instead of 0.5ml; This is a spontaneous case initially received from other non-health professional on 13-Nov-2018, concerning a 77-year-old, elderly, female patient.  The patient's current conditions included arthritis, hypertension, hyperlipidemia, gastroesophageal reflux, hypothyroidism, and psoriasis. The patient's concomitant medications included levothyroxine (levothyroxine sodium), furosemide (furosemide sodium), Metoprolol ER (metoprolol tartrate), simvastatin, dapsone, Amlodipine (amlodipine besilate), calcipotriene (calcipotriol), Zyrtec (cetirizine hydrochloride) and acetaminophen.  On 13-Nov-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 1 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 02944611A, expiry date: 28-Jun-2019] for active immunization against influenza. The patient was administered 1 ml vaccine mistakenly instead of 0.5ml (explicitly coded as overdose). It was reported that, there was no problem during administration of vaccine.  On the same day, after administration of vaccine, the patient experienced swelling and redness on the injection site. The patient did not require any treatment for the events.  On 15-Nov-2018, the patient recovered from the events swelling and redness at the injection site. The outcome of the event overdose was unknown.  The reporter considered the case as non-serious.  Non-significant follow up received on 26-Dec-2018: Non-significant follow up received on 26-Dec-2018: Added reference number (Info Number: SEQ18-07584) in the additional information tab. No changes were made in the narrative.  Significant case amendment (13-Nov-2018): Deleted classification 'special case with no AE', in the general tab. Added new events swelling and redness at the injection site. The patient did not require any treatment for the events. On 15-Nov-2018, the patient recovered from the events swelling and redness at the injection site. Amended narrative accordingly.  Non-significant case amendment (13-Nov-2018): The verbiage for an unknown indication' was removed for concomitant medications in the narrative.; Reporter's Comments: A 77-year-old female patient was administered Afluria QIV mistakenly 1 ml instead of 0.5 ml (overdose) and experienced swelling and redness at the injection site on the same day after administration.The company assessed causality of the events swelling and redness at the injection site as related due to plausible temporal relationship between the events and suspect vaccine and due to the vaccination site-specific reaction. The company assessed the causality of the event overdose as not related due to accidental nature of the event (medication error).
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Right arm and had difficulty moving and lifting her arm up after the injection; Pain in her right arm; This spontaneous case from, initially received from other health professional (pharmacist) on 14-Nov-2018, concerns a 59-year-old, adult female patient.   The patient had no relevant medical history. The patient did not receive any concomitant medications.  On 16-Oct-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: YF43409 and expiry date: 30-Jun-2019) for protection against seasonal influenza.  On the same day, after the vaccination, the patient developed pain in right arm and had difficulty in moving and lifting arm up after the injection. It was reported that these adverse reactions were persistent at the time of the report. The patient didn't receive any treatment.  At the time of the report, the patient had not recovered from the events.The reporter assessed the causality of the events as related (adverse reaction) to suspect vaccine.  The reporter assessed the case as non-serious.  Non-significant follow-up received on 02-Jan-2019: Two attempts were made to contact the patient but were unsuccessful. Hence, the case was considered lost to follow up. No changes were made in the narrative.  Non-significant case correction performed on 25-Nov-2019: Reference number SEQ19-06946 deleted from narrative and additional information.; Reporter's Comments: A 59-year-old female patient developed pain in right arm and had difficulty in moving and lifting arm up after receiving Afluria Quadrivalent. The company assessed the causality of the events as related to the suspect vaccine, considering the plausible temporal relationship.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm, Type III immune complex mediated reaction
Clinical narrative: Halfway down the elbow appeared a huge [red hot] swollen reaction; Halfway down the elbow appeared a huge [red] hot [swollen] reaction; Halfway down the elbow appeared a huge red [hot swollen] reaction; Halfway down the elbow appeared a huge [red hot swollen] reaction with itching; This is a spontaneous case, initially received from other health professional (Nurse) on 26-Nov-2018, concerning a 50-year-old, adult female patient.  The patient had no medical history and concomitant medications.  On 16-Oct-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF37005 and expiry date: 17-May-2018] for active immunization against influenza.  On the same day, within an hour or two after the administration of the vaccine, the patient had a reaction. It was reported that halfway down to the elbow, a huge red, hot, swollen reaction with itching was appeared with no pain. It affected above the elbow, a halfway up the arm but not the deltoid. There was no swelling of the airways. The patient was treated with anti-histamines and she got better. It was reported that, the patient was not hospitalized, and it looked like an Arthus-type reaction, but the patient did not receive any tetanus or diphtheria vaccines, received only the Afluria Quadrivalent vaccine.  The outcome of the events was recovered on 18-Oct-2018.  The reporter assessed this case as non-serious and the causality of the events as related to suspect vaccine.  Non-significant follow up received from the reporter (med comm) on 18-Feb-2019: It was reported that, it was tried to reach the reporter on 18-Jan-2019 but were unable to obtain the requested information. The Med info number (SEQ19-00376) was added in additional information tab. No changes were made in the narrative.  Significant case amendment (26-Nov-2018): The description to be coded for the event verbatim "Halfway down the elbow appeared a huge [red hot] swollen reaction" was changed from 'swelling of elbow' to 'swelling arm' in the event tab. The case comment was amended accordingly.; Reporter's Comments: A 50-year-old female patient experienced swelling arm, localized feeling of warmth, redness and itching, within an hour or two after the administration of the suspect vaccine Afluria Quadrivalent. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship between the suspect vaccine and the events.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Influenza, Influenza virus test, Vaccination failure
Clinical narrative: Vaccination failure; Energy still low; Flu; This is a serious spontaneous case, initially received from other health professional on 21-Nov-2018, concerning a 16-year-old, male, adolescent patient.    On 16-Oct-2018, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell culture derived, batch number: 252664, dose, route of administration, anatomical location and expiry date: not reported) for an unknown indication.  On 21-Nov-2018, 1 month and 5 days after vaccination, the patient experienced low energy and was diagnosed with flu (considered as vaccination failure). A nasal swab test was performed. It was reported that, there was an error in sampling and testing and the diagnosis was determined on the basis of patient's symptoms. The patient was prescribed with Tamiflu (oseltamivir phosphate).  At the time of this report, the patient had not recovered from the event low energy and outcome of the event influenza was not reported.  Follow up received from the reporter on 16-Jan-2019: New reporter was added in the general tab. No changes were made in the narrative.  Non-significant follow-up received on 01-Mar-2019: Reference number (Med Info Number: SEQ19-00552) was added in the additional information tab. It was reported that unsuccessful attempt to follow-up was made on 31-Jan-2019. No new information received. Hence, no changes were made in the narrative.; Reporter's Comments: A 16-year-old male patient was diagnosed with influenza, 1 month and 5 days after receipt of Flucelvax QIVc on the basis of symptoms. Although a nasal swab test was performed, results were unavailable, time to onset is plausible following vaccination with the reported Influenza and vaccination failure events. Hence, company assessed the events as possibly related to suspect vaccine. The company assessed the events (influenza and vaccination failure) assessed as serious (medically significant).
Sex: F
Vaccine: FLU4
Symptoms: Product quality issue, Skin laceration, Syringe issue
Clinical narrative: Glass shattered and broke off cutting other hand; Glass shattered and broke off; This is a spontaneous case initially received from a pharmacist on 26-Nov-2018 (follow-up 2 received on 28-Nov-2018, processed together), concerning a female patient (pharmacist) of an unspecified age.  On an unspecified date in Nov-2018, the pharmacist when went to administer Afluria Quadrivalent (influenza vaccine) to a patient, she depressed the plunger and the glass shattered and broke off (explicitly coded as syringe broken) cutting her other hand (explicitly coded as device induced injury).  No adverse events were reported.  This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was PR608951. As per the QA investigation report, due to the ambiguity of this complaint and due to the limited information provided, there was no assignable root cause. There were no CAPAs (corrective action and preventive action), therefore an effectiveness check is not required.  Non-significant follow-up received from the pharmacist on 09-Jan-2019: This case was considered as lost to follow up as the reporter could not be contacted to gather further information. Added reference number (Info Number: SEQ19-00182 and SEQ19-00018) in the additional information tab. No changes were made in the narrative.  Follow up received from the QA (Quality assurance) department on 06-Feb-2019: As per the QA investigation report, due to the limited information provided, there was no assignable root cause. There were no CAPAs, therefore an effectiveness check is not required. The narrative was amended accordingly.; Reporter's Comments: A female pharmacist of an unspecified age experienced device induced injury after the glass shattered and broke off the syringe of Afluria Quadrivalent (syringe broken and device induced injury). The company assessed the causality of the events as not related considering the incidental nature of the event syringe broken and the accidental nature of the event device induced injury.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cough, Dizziness, Expired product administered, Urticaria
Clinical narrative: Dizziness; Cough; Hives on the face/ hives on her chest,neck and back; Expired vaccine used; This is a spontaneous case initially received from a pharmacist on 03-Dec-2018, concerning a 34-year-old, adult female patient.  On an unspecified date in the past, the patient had received an unspecified vaccine as immunization for an unknown indication and had got queasy and blackout. It was reported that the patient was fine after some time of receiving vaccine. The patient's current condition included allergic rhinitis due to pollen (reported as medical history). The patient did not receive any concomitant medications.  On 11-Oct-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF38807 and expiry date: 30-Jun-2018) (explicitly coded as expired vaccine used) for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. On the same day, the patient was administered a non-company suspect vaccine pneumococcal vaccine (reported as pneumonia vaccine) (pneumococcal vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported) for an unknown indication.  On the same day, 2 hours after vaccination, the patient experienced dizziness and cough. The patient also experienced hives on the face 8 hours after vaccination. Between 10 and 11 hours after vaccination, the patient experienced hives on her face, chest, neck and back. The patient was treated with Benadryl by doctor's indication. The next day, she was feeling better.  The outcome of the events was recovered on 12-Oct-2018.  The reporter assessed the case as non-serious and the events as related to the suspect vaccine.  Non-significant follow up received from the reporter on 04-Feb-2019: The Info reference number (SEQ19-00079) was added in the additional information tab. no changes were made in the narrative.; Reporter's Comments: A 34-year-old, female patient experienced dizziness, cough, and hives on the same day after vaccination with the expired suspect vaccine Afluria Quadrivalent (coded as expired vaccine used) and non-company suspect vaccine pneumococcal vaccine. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship between events and suspect vaccine. The company assessed the causality of the event expired vaccine used as not related to the suspect vaccine due to accidental nature of the event.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node pumped up on the side of the neck; This is a spontaneous case initially received from nurse on 03-Dec-2018, concerning a 51-year-old, adult, female patient.  On an unknown date in past, the patient was administered Tdap vaccination and had exact same reaction (lymph node pumped up on the side of the neck). The patient was not taking any concomitant medications.  On 30-Nov-2018, the patient was administered Afluria TIV [Influenza vaccine, dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YT38006, expiry date: 30-Nov-2019) for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  On 01-Dec-2018, 1 day after vaccination, the patient's lymph node pumped up on the side of neck. The patient did not receive any treatment of the event. The patient was better after 2-3 weeks as the major swelling decreased significantly. As of 09-Jan-2019, the patient felt better, but still had minor swelling of the lymph node.  The outcome of the event was recovering.  The reporter assessed the events as non-serious.  Follow up information was received by a other health professional (nurse) on 09-Jan-2019: Secondary reporter details were added in the general tab. It was confirmed that the reporter did not give permission to contact the patient, hence no patient contact information was available. The outcome of the event (lymph node pumped up on the side of the neck) was changed from not recovered to recovering. The narrative was amended accordingly.  Non-significant follow-up received from other heath professional (nurse) on 12-Feb-2019: It was reported that T-dap was not a concomitant medication and no further information was available regarding the T-Dap vaccine. Reference number (info number:SEQ19-00703) was added in the additional information tab. No changes were made in the narrative.  Case re-opened for completion of full data entry: 12-Feb-2019.; Reporter's Comments: A 51-year-old female patient experienced lymph node enlargement one day after administration of Afluria TIV. The company assessed the causality of the event as related to the suspect vaccine, due to plausible temporal relationship between event and suspect vaccine.
Age: 30.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: Soreness at the site of injection; Redness at the site of injection; Fluad was given to under the age of 65; This is a non-serious spontaneous case, initially received from pharmacist on 05-Dec-2018, concerning a 30-year-old, adult, female patient.  On 25-Oct-2018, the patient (under 65 years) 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: deltoid, batch number: 250794 and expiry date: 30-Apr-2019] for active immunization against influenza (explicitly coded as inappropriate age at vaccine administration).  On the same day, after vaccination, the patient experienced soreness and redness at the injection site for 5 days. It was reported that no treatment was required.  The outcome of the events was recovered on 30-Oct-2018.  This case is linked to 201804954 due to same reporter.  Follow up report received from the pharmacist on 07-Jan-2019: The reporter did not give the permission to contact the patient and hence no patient information was provided. Added reference number (Med info number: SEQ19-00117) in the additional information section. No changes were made in the narrative.; Reporter's Comments: A 30-year-old female patient (under 65 years) was administered Fluad (TIV) (as inappropriate age at vaccine administration) and developed pain injection site and injection site redness on the same day after vaccination. The company assessed the causality of the events (pain injection site and injection site redness) as related to suspect vaccine due to plausible temporal relationship between the events and suspect vaccine and the causality of the event (inappropriate age at vaccine administration) as not related to suspect vaccine due to accidental nature of the event.
Age: 33.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Sore arm; Fluad was given to under the age of 65; This is a non-serious spontaneous case, initially received from a pharmacist on 05-Dec-2018, concerning a 33-year-old adult female patient.  On 25-Oct-2018, the patient (under 65 years) 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: deltoid, batch number: 250794 and expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration) for active immunization against influenza.  On the same day, after vaccination, the patient experienced sore arm for 2 days. It was reported that no treatment was required.  The outcome of the event was recovered on 27-Oct-2018.  This case is linked to 201804954 (same reporter).  Non-significant follow up was received from the pharmacist on 02-Jan-2018: Reporting pharmacist's county was provided. It was confirmed that the pharmacist did not give permission to contact the patient so no patient contact information could be provided. No changes were done in the narrative.; Reporter's Comments: A 33-year-old female patient (under 65 years) was administered Fluad (TIV) (inappropriate age at vaccine administration) and developed painful arm on the same day after vaccination. The company assessed the causality of the event painful arm as related to suspect vaccine due to plausible temporal relationship between the event and suspect vaccine and the causality of the event inappropriate age at vaccine administration as not related to suspect vaccine due to accidental nature of the event.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Sore arm; Fluad was given to under the age of 65; This is a non-serious spontaneous case, initially received from pharmacist on 05-Dec-2018, concerning a 62-year-old adult female patient.  On 25-Oct-2018, the patient (under 65 years) 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: deltoid, batch number: 250794 and expiry date: 30-Apr-2019] for active immunization against influenza (explicitly coded as inappropriate age at vaccine administration).  On the same day, after vaccination, the patient experienced sore arm for 2 days. It was reported that no treatment was required.  The outcome of the event was recovered on 27-Oct-2018.  This case is linked to 201804954 due to same reporter.  Non-significant follow-up received from the pharmacist on 07-Jan-2019: The reporter's county (Bristol) was updated in the reporter tab. The reporter did not give permission to contact the patient. No changes were made in the narrative. Med info number (SEQ19-00121) was updated in the additional information section.; Reporter's Comments: A 62-year-old female patient (under 65 years) was administered Fluad (TIV) (as inappropriate age at vaccine administration) and developed painful arm on the same day after vaccination. The company assessed the causality of the event (painful arm) as related to suspect vaccine due to plausible temporal relationship between the event and suspect vaccine and the causality of the event (inappropriate age at vaccine administration) as not related to suspect vaccine due to accidental nature of the event.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Slightly sore arm; Fluad was given to under the age of 65; This is a non-serious spontaneous case, initially received from a pharmacist on 05-Dec-2018, concerning a 61-year-old adult female patient.  On 25-Oct-2018, the patient (under 65 years) 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: deltoid, batch number: 250794 and expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration) for active immunization against influenza.  On the same day, after vaccination, the patient experienced slightly sore arm. It was reported that no treatment was required.   The outcome of the event was recovered on the same day (25-Oct-2018).  This case is linked to 201804954 (same reporter).  Non-significant follow-up received on 02-Jan-2019: The reporter's county was added in the general tab. The reporter did not give permission to contact the patient. Med info number SEQ19-00015 was added in the additional information tab. No changes were made in the narrative.; Reporter's Comments: A 61-year-old female patient (under 65 years) was administered Fluad (TIV) (inappropriate age at vaccine administration) and developed painful arm on the same day after vaccination. The company assessed the causality of the event painful arm as related to suspect vaccine due to plausible temporal relationship between the event and suspect vaccine and the causality of the event inappropriate age at vaccine administration as not related to suspect vaccine due to accidental nature of the event.
Age: 43.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Sore arm; Fluad was given to under the age of 65; This is a non-serious spontaneous case, initially received from a pharmacist on 05-Dec-2018, concerning a 43-year-old adult female patient.  On 25-Oct-2018, the patient (under 65 years) 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: deltoid, batch number: 250794 and expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration) for active immunization against influenza.  On the same day, after vaccination, the patient experienced sore arm for 2 days. It was reported that no treatment was required for the event.  The outcome of the event was recovered on 27-Oct-2018.  This case is linked to 201804954 (same reporter).  Non-significant follow up report received from the pharmacist on 07-Jan-2019: The county of the reporter was updated in general tab. Pharmacist confirmed that the reporter had not given permission to contact the patient; hence no patient information was obtained. Added reference number (Med-info number: SEQ19-00119) in the additional information tab. No changes were made in the narrative.; Reporter's Comments: A 43-year-old female (under 65 years) patient was administered Fluad (TIV) (inappropriate age at vaccine administration) and developed painful arm on the same day after vaccination. The company assessed the causality of the event (painful arm) as related to the suspect vaccine due to plausible temporal relationship between the event and suspect vaccine and the causality of the event (inappropriate age at vaccine administration) as not related to suspect vaccine due to accidental nature of the event.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Grip strength decreased, Headache, Pain in extremity
Clinical narrative: Dizziness/lightheadedness; Pain to the right arm; Trouble holding on to things; Headaches; This is a non-serious spontaneous case initially received from other non-health professional on 04-Dec-2018, concerning a female patient of an unspecified age.  On 02-Oct-2018, the patient was administered Afluria (TIV) [influenza vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication.  On an unspecified day in 2018, after vaccination, the patient experienced pain to the right arm, dizziness, headaches, light-headedness and had trouble holding on to things.  The outcome of the events was not reported.  Non-significant follow-up information received on 26-Feb-2019: The Info number (SEQ19-00043) was added in the additional information. No changes were done in the narrative.; Reporter's Comments: A female patient of an unspecified age experienced pain to the right arm, dizziness, headaches, light-headedness and had trouble holding on to things, unspecified days after the administration of Afluria (TIV). The causality of the events was unassessable due to lack of information regarding onset latency.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Hypersensitivity, Lymphadenopathy
Clinical narrative: Enlarged lymph nodes; Cough; Allergies; This is a spontaneous case initially received from a pharmacist on 10-Dec-2018, concerning a 60-year-old, adult female patient.  The patient had no relevant medical history and did not receive any concomitant medications.  On 06-Dec-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF43309 and expiry date: 30-Jun-2019) for influenza prophylaxis.  On 07-Dec-2018, 1 day after vaccination, the patient experienced enlarged lymph nodes, cough and allergies. The patient was treated with ice pack to the area.  The outcome of the event enlarged lymph nodes was not recovered and the outcome of the events cough and allergies was not reported.  The reporter assessed the case as non-serious.  Non-significant follow up received from the pharmacist on 07-Jan-2019: The pharmacist reported that, no new information was obtained from the patient.; Reporter's Comments: A 60-year-old, female patient experienced enlarged lymph nodes, cough and allergies, 1 day after vaccination with Afluria Quadrivalent. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship between events and suspect vaccine.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Small patch of red [bumps] at the injection site and just north of the site; Small patch of [red] bumps at the injection site and just north of the site; This is a spontaneous case, initially received from other non-health professional on 15-Dec-2018, concerning a 66-year-old, elderly, female patient.   On an unspecified date in 2018, 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: deltoid, batch number and expiry date: not reported) for influenza prophylaxis.  It was reported that, it was patient's first influenza vaccination.  On the same day, after vaccination, the patient developed a small patch of red bumps at the injection site, which was at north of the site. The patient did not receive any treatment.  At the time of this report, the patient had not yet recovered from the events.  The reporter assessed this case as non-serious.  Non-significant follow-up received from other non-health professional on 09-Jan-2019: It was reported that, the phone provided by the consumer was from one of the Seqirus' locations. Therefore, the consumer could not be followed up. Med info number (SEQ19-0068) was added in the additional information tab. No changes were made in the narrative.  Significant case amendment (receipt date: 15-Dec-2018): Description to be coded and preferred term of the verbatim' Small patch of [red] bumps at the injection site and just north of the site' was changed from 'Injection site swelling to Injection site rash' in event tab. The case comment was amended accordingly.; Reporter's Comments: A 66-year-old, female patient developed injection site redness and rash, on the same day after receiving Fluad (TIV). The company assessed the causality of the events as related to the suspect vaccine due to the plausible temporal relationship between the events and suspect vaccine.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: Rash between neck and chest; Pain [and swelling] at the injection site; Swelling at the injection site; This is a spontaneous case initially received from other non-health professional (consumer) on 14-Dec-2018, concerning a 65-year-old elderly male patient.  The current condition of the patient included high blood pressure (reported as for many years). Patient's concomitant medication included enalapril, that the patient was taking for years for high blood pressure.  On 08-Dec-2018, 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: deltoid, batch number and expiry date: not reported] for influenza prophylaxis.   On the same day after vaccination, the patient experienced pain and swelling at the injection site that went away in a couple of days. On 14-Dec-18, 6 days after vaccination, patient started having rash, not at the injection site, but between the neck and chest.  It was reported that, the patient was not hospitalized.  The patient had recovered from the events.  The reporter assessed this case as non-serious.  Follow up received from other non-health professional (consumer) on 10-Jan-2019: Added concomitant drug details (enalapril) in product tab, updated outcome of the event rash from not recovered to recovered. The narrative was amended accordingly.  Non-significant case amendment (10-Jan-2019): The follow-up sentence in the narrative was corrected from Added concomitant drug details (enalapril) in patient tab' to Added concomitant drug details (enalapril) in product tab'.; Reporter's Comments: A 65-year-old male patient experienced pain and swelling at the injection site on the same day and rash six days after administration of Fluad (TIV). The company assessed the causality of the events (pain and swelling at the injection site) as related to the suspect vaccine due to plausible temporal relationship between the suspect vaccine and the events and site specificity. The company assessed the causality of the event (rash) as related to the suspect vaccine due to plausible temporal relationship between the suspect vaccine and the event.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Malaise, Pain, Rhinorrhoea, Sneezing
Clinical narrative: Sneezing; Coughing; Runny nose; Felt sick; Body aches; This is a spontaneous case, initially received from other non-health professional on 18-Dec-2018, concerning a 79-year-old, elderly, female patient.  The patient did not have any relevant medical history. The concomitant medications of the patient were not provided.   On 10-Dec-2018, the patient was administered Fluad (TIV) (Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, anatomical location: left deltoid, batch number: 250800, expiry date: 31-May-2019 and route of administration: intramuscular) for protection against seasonal influenza.  On 11-Dec-2018, 1 day after vaccination, the patient experienced body aches and felt sick. On 12-Dec-2018, 2 days after vaccination, the patient experienced coughing, sneezing, and a runny nose. The patient did not receive any treatment for the events.   On an unknown date (reported as in a couple of days), all the events were resolved.   The reporter assessed the case as non-serious and causality of the events as related (adverse reactions).; Reporter's Comments: A 79-year-old female patient experienced ache and sickness one day after the administration of the suspect vaccine Fluad (TIV) and coughing, sneezing, runny nose two days after the administration of the suspect vaccine. The company assessed the causality as related due to plausible temporal relationship between the suspect vaccine and the events.
Sex: F
Vaccine: UNK
Symptoms: Cough, Malaise, Pain, Rhinorrhoea, Sneezing
Clinical narrative: Body aches; Coughing; Sneezing; Runny nose; Felt sick; This is a non-serious spontaneous case  initially received from other non-health professional (consumer) on 18-Dec-2018, concerning a female patient of unspecified age.  On an unspecified date, the patient was administered was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose, route anatomical location, batch number and expiry date: not reported] for an unknown indication.   On an unspecified date, the patient experienced body ache, coughing, sneezing, runny nose and felt sick. It was reported that the events experienced by the patient was a lot worse than her friend.  The outcome of the events was not reported.  This case is linked to 201806211 (due to same reporter).; Reporter's Comments: A female patient of unspecified age experienced body ache, coughing, sneezing, runny nose and felt sick on unspecified date after administration of Fluad (TIV). The company assessed the causality of the events as unassessable to the suspect vaccine due to lack of information regarding the onset latency of the events.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Pain in extremity, Paraesthesia, Rhinorrhoea, Sinusitis
Clinical narrative: Sudden sneezing; Runny nose; Soreness in arm; Headache; Tingling in sinuses; This is a spontaneous case, initially received from other non-health professional (consumer) on 18-Dec-2018, concerning a 75-year-old, elderly, female patient.  The patient's historical conditions included emphysema and arthritis (on an unspecified date). The current conditions included diabetes type 2, high blood pressure, high cholesterol and glaucoma (since an unspecified date). The patient's concomitant medications included Humalog, Enalapril, Lovastatin, Glipizide, Alphagan p (brimonidine tartrate), Travatan, Advair (fluticasone propionate, salmeterol xinafoate) for Victoza (liraglutide) for unknown indications.  On 10-Dec-2018, 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: deltoid, batch number: 250800 and expiry date: 31-May-2019] for influenza prophylaxis.  On 11-Dec-2018, the patient experienced tingling in her sinuses, runny nose and headache. The patient had sudden sneezing about 20 times in 2 hours. The patient also experienced little soreness in her arm. The patient went to primary care physician because she thought it could be a sinus infection. The doctor told her she had no sinus infection, cold and stated it would be due to adverse reaction from the flu vaccine.  The outcome of the events (sneezing, runny nose, pain in arm and headache) was resolved on an unspecified date in 2018 and the outcome of the event (tingling) was recovering.  The reporter assessed this case as non-serious.  Non-significant follow-up received on 18-Jan-2019: The patient refused to provide additional information. Added med info number (SEQ19-00382) in the additional information tab. No changes were made in the narrative.; Reporter's Comments: A 75-year-old female patient developed sneezing, runny nose, pain in arm, tingling and headache, 1 day after administration of Fluad (TIV) vaccine. The company assessed the causality of the events as related to the suspect vaccine, due to plausible temporal relationship between the events and suspect vaccine.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Sneezing, Vaccination complication
Clinical narrative: Sudden sneezing; Runny nose; Soreness in arm; Headache; Tingling in sinuses; This is a spontaneous case, initially received from other non-health professional (consumer) on 18-Dec-2018, concerning a 75-year-old, elderly, female patient.  The patient's historical conditions included emphysema and arthritis (on an unspecified date). The current conditions included diabetes type 2, high blood pressure, high cholesterol and glaucoma (since an unspecified date). The patient's concomitant medications included Humalog, Enalapril, Lovastatin, Glipizide, Alphagan p (brimonidine tartrate), Travatan, Advair (fluticasone propionate, salmeterol xinafoate) for Victoza (liraglutide) for unknown indications.  On 10-Dec-2018, 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: deltoid, batch number: 250800 and expiry date: 31-May-2019] for influenza prophylaxis.  On 11-Dec-2018, the patient experienced tingling in her sinuses, runny nose and headache. The patient had sudden sneezing about 20 times in 2 hours. The patient also experienced little soreness in her arm. The patient went to primary care physician because she thought it could be a sinus infection. The doctor told her she had no sinus infection, cold and stated it would be due to adverse reaction from the flu vaccine.  The outcome of the events (sneezing, runny nose, pain in arm and headache) was resolved on an unspecified date in 2018 and the outcome of the event (tingling) was recovering.  The reporter assessed this case as non-serious.  Non-significant follow-up received on 18-Jan-2019: The patient refused to provide additional information. Added med info number (SEQ19-00382) in the additional information tab. No changes were made in the narrative.; Reporter's Comments: A 75-year-old female patient developed sneezing, runny nose, pain in arm, tingling and headache, 1 day after administration of Fluad (TIV) vaccine. The company assessed the causality of the events as related to the suspect vaccine, due to plausible temporal relationship between the events and suspect vaccine.
Sex: F
Vaccine: FLUA3
Symptoms: Headache, Pain in extremity, Paraesthesia, Rhinorrhoea, Sneezing
Clinical narrative: Sneezing; Runny nose; Soreness in arm; Headache; Tingling in sinuses; This is a spontaneous case reported by other non-health professional on 18-Dec-2018, concerning a female patient of an unspecified age.  On 10-Dec-2018, 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: deltoid, batch number: 250800 and expiry date: 31-May-2019) for influenza prophylaxis.  On an unspecified date after vaccination, the patient experienced tingling in her sinuses and sudden sneezing, runny nose and headache. The patient also experienced a little soreness in her arm.  The outcome of the events was not reported.  The reporter assessed the case as non-serious.  This case was linked to case: 201806213 due to same reporter.; Reporter's Comments: A female patient of an unspecified age experienced tingling in sinuses, sneezing, headache, runny nose and pain in arm, on an unspecified date after the administration of Fluad (TIV). The causality of the events was unassessable due to lack of information regarding onset latency. The case will be further assessed upon receipt of follow up information.