chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Pain in extremity, Product administration error
Clinical narrative: Shoulder pain; Extreme pain in arm; During administration the needle did not go in perpendicularly; This is a spontaneous case, initially received from other health professional via Med Communication (reference number: SEQ19-04449) on 11-Oct-2019, concerning a 27-year-old, male patient.   The patient's relevant medical history and concomitant medications were not reported.  On 26-Sep-2019, the patient was administered with Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 261204 and expiration date: 26-Jun-2020] for influenza prophylaxis. It was reported that during administration, the needle did not go perpendicularly into arm (explicitly coded as Product administration error').  On 01-Oct-2019, the patient experienced extreme pain in the arm and shoulder pain.  On 09-Oct-2019, the patient visited his physician, and was advised to visit orthopaedist, and to rest from heavy activity and lifting. The patient used Tylenol (paracetamol), administered via oral route and Voltaren (diclofenac), administered topically, as a corrective treatment for shoulder pain, and was also advised to use ice.  On an unknown date in Oct-2019, within two weeks from vaccination, the events of pain in arm and shoulder pain were resolved.  The case was assessed as non-serious.  The reporter did not provide a causality assessment.  Follow up received from other health professional via Med Communication (reference number: SEQ19-05528) on 24-Oct-2019: Stop date for the events pain in arm and shoulder pain was provided and the outcome was changed from not resolved to resolved. The narrative was amended accordingly.  Company comment: The patient experienced musculoskeletal pain and pain in extremity after product administration error with the suspect drug Flucelvax Quadrivalent. No medical history, diagnostic findings or concomitant medications were reported. Reported events were likely result of administration error, and as such are considered unlikely related to the vaccine as a suspect product (defaulted to Related causality in the safety database). Product administration error is assessed as not related per company conventions.; Sender's Comments: The patient experienced musculoskeletal pain and pain in extremity after product administration error with the suspect drug Flucelvax Quadrivalent. No medical history, diagnostic findings or concomitant medications were reported. Reported events were likely result of administration error, and as such are considered unlikely related to the vaccine as a suspect product (defaulted to Related causality in the safety database). Product administration error is assessed as not related per company conventions.
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: The patient had hives on her torso; This is a spontaneous case, reported by other health professional (nurse) to Agency (case ID: SEQ19-04530) and initially received on 11-Oct-2019, concernig a 69-years-old female patient.  The patient had no relevant medical history and concomitant medications were not provided.  On 08-Oct-2019, the patient was administered Afluria Quadrivalent [Influenza vaccine, dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: P100123035 expiration date: 30-Jun-2020] for influenza prophylaxis.   On 09-Oct-2019, one day after vaccination, the patient developed hives on her torso. It went away during the night and reappeared the following day. The patient was treated with Benadryl (diphenhydramine hydrochloride).  On 11-Oct-2019, the event of hives was resolved.  The reporter assessed the case as non-serious and did not provide causality criteria.  Non-significant follow-up reported by Agency [reference number: SEQ19-05425] on 23-Oct-2019: Additional Agency reference number added. No changes in narrative.  Follow up received from nurse via Agency (reference number: SEQ19-05425) on 14-Nov-2019: Stop date for the event of hives was updated. The narrative was amended accordingly.  Company comment: Event was assessed as related to Afluria Quadrivalent.; Sender's Comments: Event was assessed as related to Afluria Quadrivalent.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Rash
Clinical narrative: Small rash and redness; Small rash and redness; This is a spontaneous case initially received from pharmacist via Med Communication (case ID: SEQ19-04542) on 11-Oct-2019, concerning a 59-year-old, female patient.   The patient's medical history and concomitant medications were not reported.   On 10-Oct-2019, the patient was administered Flucelavax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid left arm, batch number: 261210 and expiration date: 30-Jun-2020] for influenza prophylaxis.   On 11-Oct-2019, the patient experienced small rash and redness. Pharmacist advised to place ice on the area.   On an unspecified date in 2019, the events were resolved.  The reporter assessed the case as non-serious, but did not provide causality assessment.  Follow up information received from pharmacist via Med Communications (reference number: SEQ19-06239) on 22-Nov-2019) included: The outcome of the events was provided and changed from not resolved to resolved. Additional number was added. The narrative was amended accordingly.  Company comment: Events were assessed as related to Flucelvax Quadrivalent.; Reporter's Comments: The reporter assessed the case as non-serious.; Sender's Comments: Events were assessed as related to Flucelvax Quadrivalent.
Sex: F
Vaccine: FLUC4
Symptoms: Administration site bruise, Administration site swelling
Clinical narrative: Bump at site of administration; Bruising at site of administration; Swelling at site or administration; Vaccine may have been administered subcutaneously; This is a spontaneous case, reported by pharmacist to Agency (case ID: SEQ19-04551) and initially received on 12-Oct-2019, concernig a 47-year-old female patient.  The patients relevant medical history and concomitant medications were not provided.  On 12-Oct-2019, the patient was administered Flucelvax (QIV) [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml batch number: 261208, expiration date: 30-Jun-2020, anatomical location and route of administration: not reported] (explicitly coded as Inappropriate route of vaccination') for influenza prophylaxis.  On the same day, after vaccination, the patient experienced a bump, bruising and swelling at site of administration. The reporter believed the needle may not have reached the muscle and may have been administered subcutaneously.  The outcome of the event was reported as unknown.  The reporter assessed the case as non-serious and did not provide causality assessment.  Company comment: A 47-years-old, female patient has experienced vaccination site mass, vaccination site bruising, vaccination site swelling and incorrect route of product administration associated with Flucelvax QIV. Chronology seems plausible. The patient's relevant medical history and concomitant medications were not provided. Reportedly, the reporter believed the needle may not have reached the muscle and may have been administered subcutaneously. This situation could explain all reported adverse reactions. Causality assessment was not provided by the reporter. With information gathered, causality is assessed as unlikely related for vaccination site mass, vaccination site bruising and vaccination site swelling and not related to incorrect route of product administration.; Reporter's Comments: The reporter assessed the case as non-serious.; Sender's Comments: A 47-years-old, female patient has experienced vaccination site mass, vaccination site bruising, vaccination site swelling and incorrect route of product administration associated with Flucelvax QIV. Chronology seems plausible. The patient's relevant medical history and concomitant medications were not provided. Reportedly, the reporter believed the needle may not have reached the muscle and may have been administered subcutaneously. This situation could explain all reported adverse reactions. Causality assessment was not provided by the reporter. With information gathered, causality is assessed as unlikely related for vaccination site mass, vaccination site bruising and vaccination site swelling and not related to incorrect route of product administration.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Rotator cuff syndrome
Clinical narrative: Tendinitis [and bursitis] on her left shoulder; [Tendinitis and] bursitis on her left shoulder; This is a spontaneous case from, reported by physician to agency [reference number: SEQ19-04570] and initially received on 14-Oct-2019, concerning a 57-year-old, female patient.  The patient's medical history was not reported. The patient was taking concomitant medications, however, the reporter did not have a list of them.  On 08-Oct-2019, the patient was administered Flucelvax (QIV) [Influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid (left shoulder), route of administration: intramuscular, batch number: 259807 expiration date: 31-May-2020] for influenza prophylaxis.  On the same day, after vaccination, the patient developed tendinitis and bursitis on her left shoulder where the vaccine was administered. The patient was treated with unspecified anti-inflammatory and steroid medications.  At the time of initial reporting, the patient had not recovered from the events.   The case was assessed as non-serious.  The reporter did not provide a causality assessment.  Non-significant follow up received from a physician on 25-Oct-2019: Reference number (SEQ19-05493) added. No changes were made to the narrative.  Company comment: The patient developed rotator cuff syndrome and bursitis on the same day when Flucelvax QIV was administered. Chronology is plausible. More information regarding the patient's medical history and concomitant medication is needed. With information currently available, causal role of the suspect product is assessed as possibly related.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Anxiety, Rash papular, Rash pruritic
Clinical narrative: Healing rash under the armpit area/rash was an 8th of an inch raised and itched a lot; This is a spontaneous case, reported by pharmacist to Agency (Case: SEQ19-04608) and initially retrieved on 14-Oct-2019, concerning a 72-year-old, female patient.  Patients medical history included anxiety and concomitant medications included Lorazepam for unknown indication.  On 27-Sep-2019, the patient was administered Fluad [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF 59, dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 262000 and expiration date: 31-May-2020] for influenza prophylaxis.   On unspecified date, several days after vaccination, the patient reported a healing rash under the armpit area. The rash was an 8th of an inch raised and itched a lot. Pharmacist states it seemed more like where the band aid was removed, not where she got the injection, but the patient was insisting that it was in reference to the shot.  On unspecified date, the patient was seen at an Urgent Care and given an unknown prescription for the rash. The patient had cancelled an appointment with her doctor that was scheduled for 15-Oct-19 as she was feeling better.  On 14-Oct-2019, the patient came in today regarding rash and states it was causing her anxiety.  At the time of follow-up reporting, the patient was recovering from the event. It was reported that the pharmacist did not have further information regarding the event.  The reporter assessed the case as non-serious.  Event's causality was assessed as related to the suspect product per company.  Follow-up reported by pharmacist to Agency [reference number: SEQ19-05431] on 23-Oct-2019: The outcome of the event was still recovering, as the pharmacist did not have further information. Additional Agency reference number added. Narrative amended accordingly.; Sender's Comments: Event's causality was assessed as related to the suspect product per company.
Sex: M
Vaccine: FLUA3
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: (Pain and) swelling with a knot where the clavicle meets the shoulder; The vaccine seems to have been injected subcutaneously; Raised, painful red area at the injection site; Raised, (painful) red area at the injection site; This is a spontaneous case, reported by pharmacist to Agency (case ID: SEQ19-04690) and initially received on 15-Oct-2019 with aditional document (case ID: SEQ19-04688, beeing processed together),  concernig a 72-year-old male patient.  The patients relevant medical history and concomitant medications were not provided.  On 13-Oct-2019, the patient was administered Fluad (TIV) [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59 dose: 0.5 ml, anatomical location: deltoid, route of administration: subcutaneous, batch number: 261277, expiration date: 31-May-2020] for influenza prophylaxis.  On the same day, after vaccine administration, the patient developed a pawn on his arm which was a raised, painful red area at the injection site. The reporter mentioned the patient received the injection quite high up in the arm (closer to shoulder) and not sure if it was injected in the muscle. The patient explained the dose seemed to have been injected subcutaneously and experienced pain and swelling with a knot where the clavicle meets the shoulder.  The outcome of the events were not reported.  The reporter assessed the case as non-serious and did not provide causality criteria.  This case is linked with companion case 201905269 due to the same reporter.  Non-significant follow-up reporter by other non health professional from Agency [reference number: SEQ19-05571] on 13-Nov-2019: Additional Agency reference number added. No changes in narrative.  Non-significant follow-up reporter by other non health professional from Agency [reference number: SEQ19-05590] on 13-Nov-2019: Additional Agency reference number added. No changes in narrative.  Company Comment: The patient experienced vaccination site pain, injection site erythema, and vaccination site swelling after incorrect route of product administration with the suspect product Fluad (TIV). Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Incorrect route of product administration is assessed as not related per company conventions. Considering all the above mentioned, causal relationship between the suspect product and all other events is assessed as related.; Reporter's Comments: The reporter assessed the case as non-serious.
Sex: M
Vaccine: FLUA3
Symptoms: Product administered at inappropriate site
Clinical narrative: (Pain and) swelling with a knot where the clavicle meets the shoulder; The vaccine seems to have been injected subcutaneously; Raised, painful red area at the injection site; Raised, (painful) red area at the injection site; This is a spontaneous case, reported by pharmacist to Agency (case ID: SEQ19-04690) and initially received on 15-Oct-2019 with aditional document (case ID: SEQ19-04688, beeing processed together),  concernig a 72-year-old male patient.  The patients relevant medical history and concomitant medications were not provided.  On 13-Oct-2019, the patient was administered Fluad (TIV) [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59 dose: 0.5 ml, anatomical location: deltoid, route of administration: subcutaneous, batch number: 261277, expiration date: 31-May-2020] for influenza prophylaxis.  On the same day, after vaccine administration, the patient developed a pawn on his arm which was a raised, painful red area at the injection site. The reporter mentioned the patient received the injection quite high up in the arm (closer to shoulder) and not sure if it was injected in the muscle. The patient explained the dose seemed to have been injected subcutaneously and experienced pain and swelling with a knot where the clavicle meets the shoulder.  The outcome of the events were not reported.  The reporter assessed the case as non-serious and did not provide causality criteria.  This case is linked with companion case 201905269 due to the same reporter.  Non-significant follow-up reporter by other non health professional from Agency [reference number: SEQ19-05571] on 13-Nov-2019: Additional Agency reference number added. No changes in narrative.  Non-significant follow-up reporter by other non health professional from Agency [reference number: SEQ19-05590] on 13-Nov-2019: Additional Agency reference number added. No changes in narrative.  Company Comment: The patient experienced vaccination site pain, injection site erythema, and vaccination site swelling after incorrect route of product administration with the suspect product Fluad (TIV). Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Incorrect route of product administration is assessed as not related per company conventions. Considering all the above mentioned, causal relationship between the suspect product and all other events is assessed as related.; Reporter's Comments: The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUA3
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: (Pain and) swelling with a knot where the clavicle meets the shoulder; The vaccine seems to have been injected subcutaneously; Raised, painful red area at the injection site; Raised, (painful) red area at the injection site; This is a spontaneous case, reported by pharmacist to Agency  (case ID: SEQ19-04690) and initially received on 15-Oct-2019 with aditional document (case ID: SEQ19-04688, beeing processed together), concernig a 70-year-old female patient.  The patients relevant medical history and concomitant medications were not provided.  On 13-Oct-2019, the patient was administered Fluad (TIV) [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59 dose: 0.5 ml, anatomical location: deltoid, route of administration: subcutaneous, batch number: 261277, expiration date: 31-May-2020] explicitly coded as Inappropriate route of vaccination') for influenza prophylaxis.  On the same day, after vaccine administration, the patient developed a pawn on his arm which is a raised, painful red area at the injection site. The reporter mentioned the patient received the injection quite high up in the arm (closer to shoulder) and not sure if it was injected in the muscle. The patient explained the dose seems to have been injected subcutaneously and experienced pain and swelling with a knot where the clavicle meets the shoulder.  The outcome of the events 'pain' and 'swelling' were not resolved and the outcome of the event 'red area at the injection site' was not reported.  The reporter assessed the case as non-serious and did not provide causality criteria.  This case is linked with companion case 201905268 due to the same reporter.  Non-significant follow-up reporter by other non health professional from Agency [reference number: SEQ19-05571] on 13-Nov-2019: Additional Agency reference number added. No changes in narrative.  Company Comment: The patient experienced vaccination site pain, injection site erythema, and vaccination site swelling after incorrect route of product administration with the suspect product Fluad (TIV). Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Incorrect route of product administration is assessed as not related per company conventions. Considering all the above mentioned, causal relationship between the suspect product and all other events is assessed as related.; Reporter's Comments: The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Pain in extremity
Clinical narrative: Inflammation in left arm post-vaccination; Pain in left arm post-vaccination; This is a spontaneous case from reported by other health professional to agency (Case: SEQ19-04738), and initially retrieved on 15-Oct-2019, concerning female patient of unknown age.  The patient's medical history and concomitant medications were not reported.  On unspecified date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose, batch number, expiration date, route of administration and anatomical location: not reported] for unknown indication.  On unspecified date, unknown time after vaccination, the patient experienced pain and inflammation in her left arm.  The outcome of the event pain and inflammation in her left arm was not reported.  Non-significant follow-up reported by other health professional to agency [reference number: SEQ19-05586]: Additional agency reference number added (SEQ19-05586). No changes in narrative.  Company Comment: The patient experienced vaccination site inflammation and vaccination site pain 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, causal role of the suspect product is assessed as related.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Night sweats, Throat irritation, Throat tightness, Tongue pruritus
Clinical narrative: Tightness in the chest; Throat itchiness; Tongue itchiness; Night flashes; This is a spontaneous case reported by other health professional to Med Communications (Case: SEQ19-04742) and initially retrieved on 15-Oct-2019, concerning a 63-year-old, female patient.  Patient's medical history included egg allergy and no concomitant medications were reported.  On 01-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: 259811 and expiration date: 30-May-2020] for prevention of influenza.   On 02-Oct-2019, the following day after vaccination, patient experienced the following symptoms: tightness in the chest, throat and tongue itchiness, and night flashes.  The outcome of the events was not reported, at the time of the initial reporting.  The reporter assessed the case as non-serious, but did not provide causality.  Non-significant follow-up reported by other non health professional from Med Communications [reference number: SEQ19-05587] on 14-Nov-2019: Additional Med Communications reference number added. No changes in narrative.  Company comment: The patient experienced chest discomfort, throat irritation, oral pruritus and night sweats after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. No diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Erythema, Hypoaesthesia, Immediate post-injection reaction, Peripheral swelling
Clinical narrative: Red [and swollen] arm; [Red and] swollen arm; Arm went numb not even 20 seconds after the shot; This is a spontaneous case, initially received from other non-health professional via Agency (reference number: SEQ19-04752) on 15-Oct-2019 concerning a 9-year-old female patient.  The patients medical history and concomitant medications were not provided.  On 14-Oct-2019, around 4:30 pm, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, route of administration: intramuscular, anatomical location: deltoid, dose, batch number and expiration date: not reported] for prevention of seasonal influenza. On the same day, not even 20 seconds after vaccination, the patients arm went numb. Around bedtime, at 9:00 pm, the patient's arm was red and swollen.   On 15-Oct-2019, one day after vaccination, at 6:30 am, it spread in a circle about two inches around and red also raised. Over the next few days it continued to spread wider and got darker in color.  On 19-Oct-2019, it was noted that the swelling had gone down and the redness had turned into what looked like a bruise.  On 25-Oct-2019, it could no longer be noticed.   The outcome for the event numbness in arm was unknown.  The case was assessed as non-serious and the reporter did not provide causality assessment.  Follow up received from other non-health professional on 13-Nov-2019: patient's initials, date of birth, age and the outcome of the events swollen arm and red arm were updated. The narrative was updated accordingly.  Company comment: The patient experienced hypoaesthesia, erythema and peripheral swelling after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced hypoaesthesia, erythema and peripheral swelling after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: at injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case, initially received from other health professional via Agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  This case is linked to cases 201905317, 201905318, 201905319, 201905320, 201905321, 201905322, 201905323, 201905324, 201905325 due to same reporter.  Follow up received from other health professional via Agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company Comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: At injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case from, initially received from other health professional via agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  The case is linked to 201905307, 201905318, 201905319, 201905320, 201950321, 201905322, 201905323, 201905324 and 201905325 due to same reporter.  Follow up received from other health professional via agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company Comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: At injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case, initially received from other health professional via Agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  The case is linked to 201905307, 201905317, 201905319, 201905320, 201950321, 201905322, 201905323, 201905324 and 201905325 due to same reporter.  Follow up received from other health professional via Agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company Comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: at injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case from, initially received from other health professional via agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  The case is linked to 201905307, 201905317, 201905318, 201905320, 201950321, 201905322, 201905323, 201905324 and 201905325 due to same reporter.  Follow up received from other health professional via agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: at injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case, initially received from other health professional via agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  The case is linked to 201905307, 201905317, 201905318, 201905319, 201950321, 201905322, 201905323, 201905324 and 201905325 due to same reporter.  Follow up received from other health professional via agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: At injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case, initially received from other health professional via agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  The case is linked to 201905307, 201905317, 201905318, 201905319, 201950320, 201905322, 201905323, 201905324 and 201905325 due to same reporter.  Follow up received from other health professional via agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: At injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case, initially received from other health professional via agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  The case is linked to 201905307, 201905317, 201905318, 201905319, 201950320, 201905321, 201905323, 201905324 and 201905325 due to same reporter.  Follow up received from other health professional via agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: At injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case from, initially received from other health professional via agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  The case is linked to 201905307, 201905317, 201905318, 201905319, 201950320, 201905321, 201905322, 201905324 and 201905325 due to same reporter.  Follow up received from other health professional via agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: At injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case, initially received from other health professional via agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  The case is linked to 201905307, 201905317, 201905318, 201905319, 201950320, 201905321, 201905322, 201905323 and 201905325 due to same reporter.  Follow up received from other health professional via agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.