chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: The patient described redness (three inches), swelling, white spot on arm where the injection was given; The patient described redness (three inches), swelling, white spot on arm where the injection was given; The patient described redness (three inches), swelling, white spot on arm where the injection was given; This is a spontaneous case from initially reported by nurse to agency (reference number: SEQ19-05986) on 31-Oct-2019, concerning a 70-year-old female patient.  The patient's medical history included chronic obstructive pulmonary disease, high blood pressure, high cholesterol and allergies to doxycycline, penicillin, Zithromax (azithromycin) and bee stings. The patient's concomitant medication included lisinopril, omeprazole, amlodipine, Aspirin (acetylsalicylic acid), calcium, loratadine and Albuterol (salbutamol), all used for unknown indications.  On 29-Oct-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm; batch number: P100110966; expiration date: 27-May-2020] for influenza prophylaxis.   On 30-Oct-2019, one day after vaccination, the patient developed redness (three inches), swelling, white spot on arm, where the injection was given.   On 31-Oct-2019, the patient was treated with Benadryl (diphenhydramine) once every day at bedtime and prednisone, twice a day, for three days.  At the time of initial reporting, the outcome of the events was not resolved.   The case was assessed as non-serious. The reporter did not provide causality assessment.  Follow-up received from nurse via agency (reference number: SEQ19-06740) on 18-Nov-2019: Start date for treatment medications was provided. The narrative was amendment accordingly.   Company comment:The patient developed vaccination site discolouration, vaccination site swelling and vaccination site erythema one day after Afluria Quadrivalent was administered. Chronology is plausible. Based on currently provided information, causality for all events is assessed as possibly related.; Sender's Comments: The patient developed vaccination site discolouration, vaccination site swelling and vaccination site erythema one day after Afluria Quadrivalent was administered. Chronology is plausible. Based on currently provided information, causality for all events is assessed as possibly related.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Glossodynia
Clinical narrative: Painful tongue issues; This is a spontaneous case, reported by other non-health professional (consumer) to Agency [reference number: SEQ19-06050] and initially received on 01-Nov-2019, concerning a 63-year-old, female patient.  The patient's relevant medical history included Crohn's disease, gluten intolerance, non-specific arthritis, sleep apnoea, acid reflux, breast cancer, diverticulosis, diverticulitis, polyps in colon (precancerous) and allergic rhinitis-seasonal. The patient's concomitant medications included Aprisi (as reported), Nexium (esomeprazole magnesium), duloxetine, vitamin D chewable, Vitamin B (vitamin B complex) liquid sublingual, Nasicortin nasal spray (dexamethasone tebutate, oxymetazoline hydrochloride), amitriptiline, Tylenol (paracetamol) and hydrocodone.  On 25-Oct-2019, the patient was administered Afluria Quadrivalent [Influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiration date: not reported] for influenza prophylaxis.  On 26-Oct-2019, one day after vaccination, the patient experienced painful tongue issues. The patient stated that the sore was kind a white and painful when she was eating, and it started to progress. The patient was treated with Tylenol (paracetamol) and Paradox mouthwash. The patient stopped using vitamin B complex and chewable vitamin D and brushed her tongue which seemed to help.  At the time of initial reporting, the patient had not recovered from the event.  The case was assessed as non-serious.  The reporter did not provide causality assessment.  Non-significant follow up received from Agency [reference number: SEQ19-06742] on 12-Dec-2019: Additional reference number added. No changes in narrative.  Company comment: The patient experienced glossodynia one day after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. Medical history of Crohn's disease, acid reflux and allergic rhinitis may provide more plausible alternative aetiology for the event. Causality was also confounded by therapy with multiple concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as unlikely related.; Sender's Comments: The patient experienced glossodynia one day after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. Medical history of Crohn's disease, acid reflux and allergic rhinitis may provide more plausible alternative aetiology for the event. Causality was also confounded by therapy with multiple concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as unlikely related.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced a red ring around the injection site, a little swelling, and it is warm to touch for 24 hours; Patient experienced a red ring around the injection site, a little swelling, and it is warm to touch for 24 hours; Patient experienced a red ring around the injection site, a little swelling, and it is warm to touch for 24 hours; This is a spontaneous case from, initially received from other health professional via agency (reference number: SEQ19-06030) on 01-Nov-2019, concerning a 55-year-old female patient.   The patient medical history was not reported. The patient concomitant medications were not provided.  On 30-Oct-2019, the patient was administered Flucelcax QIV [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid, batch number reported as 2461983 (Seqirus batch number 261983), expiration date: 30-Jun-2020] for influenza prophylaxis.  On 30-Oct-2019, the patient experienced a red ring around the injection site, a little swelling, and it is warm to touch for 24 hours.  Adverse events subsided after 24 hours.   The reporter assessed the case as non-serious but did not provide causality assessment.  This case is linked to case 201905854 and 201907038 (the same reporter).  Follow-up received from other health professional (reference number: SEQ19-06570) on 13-Nov-2019: Outcome of events vaccination site erythema and vaccination site swelling updated to recovered. Narrative updated accordingly.   Non-significant case correction was performed on 03-Dec-2019: Additional linked case and additional numbers added. Narrative was amended.  Company comment: The patient experienced vaccination site warmth, vaccination site erythema and vaccination site swelling after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site erythema and vaccination site swelling after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Headache, Oropharyngeal pain, Pain in jaw
Clinical narrative: Pain in chest, jaw, throat; Pain in chest, jaw, throat; Pain in chest, jaw, throat; Headache; This is a spontaneous case, reported by other non-healthcare professional to Company [reference number: SEQ19-06089] and initially received on 04-Nov-2019, concerning a 47-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications were not provided.  On 30-Sep-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, anatomical location: deltoid, route of administration, batch number and expiry date: not reported] for prevention of seasonal influenza.  On the same day, after vaccination, the patient experienced pain in the chest, jaw and throat, and developed headache. No corrective treatment was given for the events.  On 01-Oct-2019, the patient recovered from the events. It was reported that the events subsided after one day.  This case was assessed as non-serious.   The reporter did not provide the causality assessment.  This case is linked to cases: 201905875, 201905877 and 201905878 (same reporter).  Company comment: The patient developed chest pain, pain in jaw, oropharyngeal pain and headache associated with the suspect product, Afluria Quadrivalent. Reportedly, the patient developed mentioned events on the same day, after vaccination. Chronology is plausible. More information regarding medical history and concomitant drugs is needed. Causal role of the suspect vaccine is assessed as possibly related for all events.; Sender's Comments: The patient developed chest pain, pain in jaw, oropharyngeal pain and headache associated with the suspect product, Afluria Quadrivalent. Reportedly, the patient developed mentioned events on the same day, after vaccination. Chronology is plausible. More information regarding medical history and concomitant drugs is needed. Causal role of the suspect vaccine is assessed as possibly related for all events.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Delivery, Exposure during pregnancy, Pain in extremity
Clinical narrative: Flucelvax QIV administered to a pregnant patient; Sore arm; This is a spontaneous case, initially reported by other non-health professional to Agency (reference number: SEQ19-06140) on 04-Nov-2019 and additional information received on the same date (being processed together), concerning a 35-year-old, pregnant female patient.   The patient's medical history was not provided.   The patient's concomitant medications were not reported.   The patient's obstetrical history included two previous pregnancies. Also, the patient had no maternal or paternal history with major congenital malformations. The patient did not have a history of offspring with congenital malformation.   The patient's last menstrual period (LMP) date was 07-Apr-2019 and estimated delivery date (EDD) was reported as 12-Jan-2019.   On 28-Oct-2019, at gestational age of 29 weeks, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: upper right deltoid, batch number and expiry date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza prophylaxis.  On an unspecified date, an unknown amount of time after vaccination, the patient experienced sore arm.  On an unspecified date, three days after the onset, the patient recovered from sore arm.   At gestational age of approximately 39.6 weeks, the patient gave a live birth to a female neonate, delivered vaginally. It was reported that there were no problems with the delivery.  There were no problems since, and the baby was 'fat and healthy' as reported.   The reporter did not provide causality assessment to Flucelvax QIV.   Follow up information received from other non-health professional via Agency (reference number: SEQ19-06584) on 13-Feb-2020: Patient's date of birth amended. Pregnancy outcome received. Anatomical location for vaccination added. Sore arm added as new event. Hence, classification special case with no AE was removed. Stop date added and outcome changed from not reported to recovered for vaccine exposure during pregnancy. Narrative was amended accordingly.  Company comment: It is unknown when the patient developed sore arm, therefore the temporal and causal relationship between vaccination and this adverse event was considered unassessable. Vaccine exposure during pregnancy is unrelated to Flucelvax.; Sender's Comments: It is unknown when the patient developed sore arm, therefore the temporal and causal relationship between vaccination and this adverse event was considered unassessable. Vaccine exposure during pregnancy is unrelated to Flucelvax.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Rash, Urticaria
Clinical narrative: Patient broke out in hives, generalized rashes and sore throat; Patient broke out in hives, generalized rashes and sore throat; Patient broke out in hives, generalized rashes and sore throat; This is a spontaneous case, initially reported by pharmacist to Agency (reference number: SEQ19-05958) on 31-Oct-2019, concerning a 52-year-old, male patient.  The patient's medical history includes hypertension. The patient's concomitant medication included losartan, hydrochlorothiazide and vitamin D (vitamin D NOS), all used for unknown indications.  On 12-Sep-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported; batch number: P100100577; expiration date: Jun-2020] for influenza prophylaxis.   On 13-Sep-2019, one day after vaccination, the patient broke out in hives, generalized rashes and sore throat. Patient visited physician and was put on steroid dose.   It was also reported that the patient needed second dose of steroid to resolve generalized rashe which lasted for a month.   At the time of follow-up reporting, the patient was recovering from the events of hives and sore throat. The patient stated he was getting better now.  The reporter did not provide seriousness or causality assessment.  Follow-up received from a pharmacist via Agency [reference number: SEQ19-06734] on 18-Nov-2019: Additional reporter added. Start date of the events confirmed as 13-Sep-2019. Additional Agency reference number added. Narrative updated.  Non-significant follow up received from a pharmacist via Med Communications (reference number: SEQ19-07602) on 27-Dec-2019: Additional Med Communications reference number added. No changes in the narrative.  Company comment: Temporal relationship between introduction of Afluria and development of adverse events is plausible. The adverse events are suggestive of possible hypersensitivity reaction. Causality assessment is confounded by use of concomitant drugs. Nevertheless, all events are assessed as related to the suspect vaccine.; Sender's Comments: Temporal relationship between introduction of Afluria and development of adverse events is plausible. The adverse events are suggestive of possible hypersensitivity reaction. Causality assessment is confounded by use of concomitant drugs. Nevertheless, all events are assessed as related to the suspect vaccine.
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site induration, Injection site mass
Clinical narrative: She developed bruising and a hard lump at the injection site; She developed bruising and a hard lump at the injection site; This is a spontaneous case from initially reported by pharmacist to agency (reference number: SEQ19-06164) on 05-Nov-2019, concerning 42-year-old female patient.  The patient's medical history was not provided.  The patient's concomitant medications were not reported.    On 24-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular; anatomical location: right deltoid, batch number: 261727; expiration date: 30-Jun-2019] for influenza prophylaxis.   On an unknown date in 2019, after vaccination, the patient developed bruising and a hard lump at injection site. Pharmacist advised her to come in for him to see the site.   On an unknown date in 2019, the outcome of event was resolved on its own.   This case was assessed as non-serious and causality was not provided.  Follow up received from pharmacist on 17-Dec-2019: The outcome of events updated, stop dates added. Narrative amended accordingly.   Company comment: The patient experienced vaccination site mass and vaccination site bruising after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site mass and vaccination site bruising after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Disturbance in attention, Fatigue, Feeling abnormal, Hypoaesthesia
Clinical narrative: Pain in top of the hand; Patient has a numb feeling; Difficulty concentrating; Felt foggy; Patient has joint pain in her pinky, ring finger; Fatigue; This is a spontaneous case, initially received from other health professional via Agency (reference number: SEQ19-06370) on 07-Nov-2019, concerning a 38-year-old female patient.   The patient medical history include allergy to Percocet, codeine, aspirin in high dosage (gets hives and rash). The patient does not use any concomitant medications.  On 07-Nov-2019, at 11 AM, the patient was administered Flucelcax QIV [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid, batch number: 263334, expiration date: 30-Jun-2020] for influenza prophylaxis.  On the same day, after receiving the vaccine, the patient had joint pain in her pinky, ring finger and top of the hand, she has a numb feeling, she also felt foggy, fatigued, and had difficulty concentrating. The patient took a Tylenol (paracetamol) 5 minutes before speking to Seqirus.  On 10-Dec-2019, the reporter saw the patient's sister who stated that the patient was fine and had no adverse event.  On an unspecified date, the outcome of all the events was resolved.  The events were assessed as non-serious. The reporter did not provide causality assessment.  Significant follow-up received from other health professional (reference number: SEQ19-06774) on 10-Dec-2019: The outcome for all events was changed from not resolving to resolved. The narrative was amendment accordingly.   Company comment: The patient experienced pain in extremity, hypoaesthesia, disturbance in attention, feeling abnormal, arthralgia and fatigue on the same day, after vaccination with the suspect product Flucelcax QIV. Chronology is plausible. Reportedly, the patient did not use any concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced pain in extremity, hypoaesthesia, disturbance in attention, feeling abnormal, arthralgia and fatigue on the same day, after vaccination with the suspect product Flucelcax QIV. Chronology is plausible. Reportedly, the patient did not use any concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Pain in top of the hand; Patient has a numb feeling; Difficulty concentrating; Felt foggy; Patient has joint pain in her pinky, ring finger; Fatigue; This is a spontaneous case, initially received from other health professional via Agency (reference number: SEQ19-06370) on 07-Nov-2019, concerning a 38-year-old female patient.   The patient medical history include allergy to Percocet, codeine, aspirin in high dosage (gets hives and rash). The patient does not use any concomitant medications.  On 07-Nov-2019, at 11 AM, the patient was administered Flucelcax QIV [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid, batch number: 263334, expiration date: 30-Jun-2020] for influenza prophylaxis.  On the same day, after receiving the vaccine, the patient had joint pain in her pinky, ring finger and top of the hand, she has a numb feeling, she also felt foggy, fatigued, and had difficulty concentrating. The patient took a Tylenol (paracetamol) 5 minutes before speking to Seqirus.  On 10-Dec-2019, the reporter saw the patient's sister who stated that the patient was fine and had no adverse event.  On an unspecified date, the outcome of all the events was resolved.  The events were assessed as non-serious. The reporter did not provide causality assessment.  Significant follow-up received from other health professional (reference number: SEQ19-06774) on 10-Dec-2019: The outcome for all events was changed from not resolving to resolved. The narrative was amendment accordingly.   Company comment: The patient experienced pain in extremity, hypoaesthesia, disturbance in attention, feeling abnormal, arthralgia and fatigue on the same day, after vaccination with the suspect product Flucelcax QIV. Chronology is plausible. Reportedly, the patient did not use any concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced pain in extremity, hypoaesthesia, disturbance in attention, feeling abnormal, arthralgia and fatigue on the same day, after vaccination with the suspect product Flucelcax QIV. Chronology is plausible. Reportedly, the patient did not use any concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous case, initially received from non-health professional (consumer) via Agency (reference number: SEQ19-06509) on 11-Nov-2019, concerning a 72-year-old, female patient.   The patient's historical conditions included gallbladder operation, surgical operations for tonsil and removed part of the liver due to non-cancerous tumours.   The patient's current conditions included diverticulitis and colitis.  The patient's concomitant medications included Synthroid (levothyroxine) and methylamine, both for an unknown indication and occasionally medication for colitis.  The patient received Shingles shot (herpes zoster vaccine) reported as one month ago, for an unknown indication.  On 07-Nov-2019, the patient was administered with 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 expiration date: not reported] for influenza prophylaxis.   On 10-Nov-2019, the patient woke up with headache. It was reported the patient generally did not have headaches.  On an unspecified date in Nov-2019, reported as at noon, the patient received treatment medication Aspirin (acetylsalicylic acid), dose reported as 2, units were not specified.  On 11-Nov-2019, the outcome of headache was not resolved.  The reporter assessed the case as non-serious. The reporter did not provide causality assessment to Fluad (TIV).  Non-significant follow-up reported by other non-health professional from Agency [reference number: SEQ19-06817] on 12-Dec-2019: Additional reference number added. No changes in narrative.  Company comment: The event of headache was considered related to Fluad (TIV) .; Sender's Comments: Company comment: The event of headache was considered related to Fluad (TIV) .
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Tightening pain in right leg, then left leg, then moved to soles of feet, then hand; Itching, tightening, pain in extrenities; This is a spontaneous case initially received from a pharmacist via Agency (reference number: SEQ19-06540) on 12-Nov-2019, concerning a 77-year-old female patient.   The patient's medical history and concomitant medications were not reported.   On 11-Nov-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 262311 and expiration date: 30-Jun-2020] for influenza prophylaxis.  On the same day, after vaccination, the patient experienced tightening pain in right leg, then left leg, which moved to soles of feet and hand. The patient also had itching in extremities.  On an unknown date, the outcome of all events was resolved.  The reporter assessed the case as non-serious and did not provide causality assessment to Fluad (TIV).  Follow up received from pharmacist via Agency (reference number: SEQ19-06982) on 10-Dec-2019: Outcome of all events updated, additional reference number added. The narrative was amended accordingly.  Company comment: The patient developed pain in extremity and pruritus associated with the suspect product, Fluad (TIV). The patient developed mentioned events on the same day, after vaccination. Chronology is plausible. More information regarding medical history and concomitant drugs is needed. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: The patient developed pain in extremity and pruritus associated with the suspect product, Fluad (TIV). The patient developed mentioned events on the same day, after vaccination. Chronology is plausible. More information regarding medical history and concomitant drugs is needed. Causal role of the suspect vaccine is assessed as possibly related.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Influenza like illness, Limb discomfort, Pain, Pain in extremity
Clinical narrative: Patient's neck started to bother her; Patient experiencinced achiness; Patient's arms were aching and were bothering her for a couple of months; Flu-like symptoms; Pin prickly sensation in her spine; This is spontaneous case reported by consumer to Agency (reference number: SEQ19-06567) and initially received on 12-Nov-2019, concerning a 50-year-old female patient.  The patient's relevant medical history included previous stroke and mild cerebral palsy. The patient's concomitant medication was not provided.  On 17-Oct-2018, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, anatomical location: left deltoid, route of administration, expiry date and batch number: not reported] for prevention of seasonal influenza.  On the same day, the patient was administered unspecified pneumonia shot (anatomical location: left arm, brand name, dose, route of administration, batch number and expiry date: not reported) for an unknown indication.  On an unspecified date, shortly after vaccination with both vaccines, patient developed pin prickly sensation in her spine, her neck started to bother her, she experienced achiness and flu-like symptoms. Her arms were aching and were bother her for a couple of months after vaccination, but it eventually resolved.  At the time of initial report, the outcome of the event aching arms were recovered, while the outcome of all other events was not reported.  This case was assessed as non-serious.  The reporter did not provided causality assessment.  This case is linked to case 201906048 due to the same patient.  Company Comment: The patient experienced musculoskeletal discomfort, pain, pain in extremity, influenza like illness and paraesthesia erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is possible. Medical history of stroke and mild cerebral palsy may have contributed to development of the events.  No concomitant medications were provided. Considering all the above mentioned, causality between suspect products and the events is assessed as possibly related.; Sender's Comments: The patient experienced musculoskeletal discomfort, pain, pain in extremity, influenza like illness and paraesthesia erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is possible. Medical history of stroke and mild cerebral palsy may have contributed to development of the events.  No concomitant medications were provided. Considering all the above mentioned, causality between suspect products and the events is assessed as possibly related.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Patient's neck started to bother her; Patient experiencinced achiness; Patient's arms were aching and were bothering her for a couple of months; Flu-like symptoms; Pin prickly sensation in her spine; This is spontaneous case reported by consumer to Agency (reference number: SEQ19-06567) and initially received on 12-Nov-2019, concerning a 50-year-old female patient.  The patient's relevant medical history included previous stroke and mild cerebral palsy. The patient's concomitant medication was not provided.  On 17-Oct-2018, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, anatomical location: left deltoid, route of administration, expiry date and batch number: not reported] for prevention of seasonal influenza.  On the same day, the patient was administered unspecified pneumonia shot (anatomical location: left arm, brand name, dose, route of administration, batch number and expiry date: not reported) for an unknown indication.  On an unspecified date, shortly after vaccination with both vaccines, patient developed pin prickly sensation in her spine, her neck started to bother her, she experienced achiness and flu-like symptoms. Her arms were aching and were bother her for a couple of months after vaccination, but it eventually resolved.  At the time of initial report, the outcome of the event aching arms were recovered, while the outcome of all other events was not reported.  This case was assessed as non-serious.  The reporter did not provided causality assessment.  This case is linked to case 201906048 due to the same patient.  Company Comment: The patient experienced musculoskeletal discomfort, pain, pain in extremity, influenza like illness and paraesthesia erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is possible. Medical history of stroke and mild cerebral palsy may have contributed to development of the events.  No concomitant medications were provided. Considering all the above mentioned, causality between suspect products and the events is assessed as possibly related.; Sender's Comments: The patient experienced musculoskeletal discomfort, pain, pain in extremity, influenza like illness and paraesthesia erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is possible. Medical history of stroke and mild cerebral palsy may have contributed to development of the events.  No concomitant medications were provided. Considering all the above mentioned, causality between suspect products and the events is assessed as possibly related.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Left shoulder was swollen; Red and hot to the touch at the injection site; Arm is still swollen; Red and hot to the touch at the injection site; This is a spontaneous case, initially received from consumer via Company (reference number: SEQ19-06647) on 14-Nov-2019, concerning a 24-year-old, male patient.   The patient's relevant medical history was not reported.  The patient's concomitant medications were not provided.  On 12-Nov-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: P100110982 and expiration date: 03-Jun-2020] as prevention of seasonal influenza.   On the same day, after vaccination, the patient's left shoulder was swollen, red and hot to the touch at the injection site.   On an unspecified date in Nov-2019, the patient's arm was still swollen. It was reported that a 4 inch diameter was around injection site.  The patient did not recover from the events of swollen arm and swelling. The outcome for the events of vaccination site erythema and vaccination site warmth was not reported.  The case was assessed as non-serious. The reporter did not provide causality assessment to Afluria Quadrivalent.  Company Comment: The patient experienced swelling, vaccination site warmth, peripheral swelling and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is possible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: Company Comment: The patient experienced swelling, vaccination site warmth, peripheral swelling and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is possible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Injection site pain
Clinical narrative: A bruise covering most of her left arm; Pain at injection site; This is a spontaneous case, reported by pharmacist to Company (reference number: SEQ19-06756) and initially received on 18-Nov-2019, concerning an 80-year-old female patient.   The patient's relevant medical history was not reported.   The patient's concomitant medications were not reported.  On 15-Nov-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: P100107887 and expiration date: 20-Jun-2020] for influenza prophylaxis.  On an unspecified day in Nov-2019, the patient developed a bruise covering most of her left arm and pain at injection site.  Outcome for the events of vaccination site pain and bruising of arm was not reported.  The reporter did not provide causality or seriousness assessment.  Company Comment: The patient experienced contusion and vaccination site pain after vaccination with the suspect product Afluria Quadrivalent. Chronology is possible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced contusion and vaccination site pain after vaccination with the suspect product Afluria Quadrivalent. Chronology is possible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Age: 5.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Irritability, Pyrexia
Clinical narrative: Received a fever 103.5; Tired; This is a spontaneous case reported by other non-health care professional to agency (reference number: SEQ19-06766) and initially received on 18-Nov-2019, concerning a 5-year-old, female patient.  The patient had no medical history and did not take any concomitant medications.  On 16-Nov-2019, the patient was administered Flucelvax Tetra [Influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 263334, dose: 0.5 ml, route of administration: intramuscular, expiration date: 30-Jun-2020 and anatomical location: deltoid] for influenza prophylaxis.  On 17-Nov-2019, the patient was fussy and tired. The patient also developed a fever 103.5. The patient received treatment with Motrin (ibuprofen).  On 18-Nov-2019, fever was 99.7  At the time of initial reporting, the patient was recovering from the event of fever and outcome of the event fatigue was not recovered.  The reporter did not provide causality assessment.  Reporter assessed the events as non-serious.  Company comment: Events were assessed as related to Flucelvax Tetra.; Sender's Comments: Events were assessed as related to Flucelvax Tetra.
Age: 79.0
Sex: M
Vaccine: UNK
Symptoms: Bone pain, Gait disturbance, Myalgia
Clinical narrative: Difficulty walking; Severe muscle and bone aches all over his body; Severe muscle and bone aches all over his body; This is a spontaneous case, initially received from other non-health professional (consumer) via Company (reference number: SEQ19-06865) on 20-Nov-2019, concerning a 79-year-old, male patient.   The patient's relevant medical history included previous influenza vaccines without a reaction.  The patient's concomitant medications were not reported.  On 13-Oct-2019, the patient was administered unspecified INN Flu Vaccine [Influenza virus vaccine polyvalent, anatomical location: arm, dose, route of administration, batch number and expiration date: not reported] as protection against seasonal influenza.    On an unspecified date in Oct-2019, reported as 3 to 4 days after receiving the vaccine, the patient experienced severe muscle and bone aches all over his body.   On an unspecified date, the patient had difficulty walking, due to severe muscle and bone aches.  At the time of this report, the patient did not recover from the events of walking difficulty, muscle ache and bone pain.  The reporter assessed the case as non-serious and did not provide causality assessment to unspecified INN Flu Vaccine.  Company Comment: The patient experienced gait disturbance, bone pain and myalgia after vaccination with the suspect product, INN Flu Vaccine. Chronology is plausible. Advanced age (79) may have contributed to development of the events. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced gait disturbance, bone pain and myalgia after vaccination with the suspect product, INN Flu Vaccine. Chronology is plausible. Advanced age (79) may have contributed to development of the events. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous case, reported by pharmacist to Med Communications (case ID: SEQ19-06954) and initially received on 22-Nov-2019, concernig a female patient of unknown age.  The patients relevant medical history was not provided.  The patients concomitant medications were not provided.  On an unspecified date, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number and expiration date: not reported] for an unknown indication.  On an unspecified date, after vaccination the patient did have a rash. The patient wondered if it was because the vaccine might contain antibiotics.  The outcome of the event rash was not provided, at the time of this report.  The reporter did not provide causality and seriousness criteria.  Company Comment: Event's causality was assessed as related to the suspect product per company.; Sender's Comments: Event's causality was assessed as related to the suspect product per company.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injection site pain, Pain in extremity
Clinical narrative: Left arm has been hurting since vaccine was administered; This is a spontaneous case initially received from other health professional via agency (case ID: SEQ19-07051) on 26-Nov-2019, concerning a 48-year-old female patient.   The patient's current condition included hypertension. The patient's concomitant medication included amlodipine for unknown use.   On 25-Oct-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100118559, expiration date: 30-Jun-2020, anatomical location: left arm, route of administration: not reported] for influenza prophylaxis.  On the same day, after vaccination, the patient's arm had been hurting. As reported it had been hurting since the vaccine was administered.   On an unspecified date, about a month after vaccination, the patient's left arm where she received vaccine was still hurting. The patient had to change position to feel comfortable when lying down. It was reported that the patient iced it.  At the time of this report, the outcome of the event keft arm has been hurting since vaccine was administered' was not recovered.  The reporter did not provide causality criteria.  This case is linked with case 201906334 due to the same reporter.  Company Comment: Event's causality was assessed as related to the suspect product per company.; Sender's Comments: Event's causality was assessed as related to the suspect product per company.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Feeling abnormal, Injection site pain, Mobility decreased, Muscle spasms
Clinical narrative: Left arm and shoulder feels crampy; Stiffnes in arm; Soreness in arm / Left arm and shoulder where vaccine was administered hurts; Mobility is limited; Left arm and shoulder where vaccine was administered hurts; Expired vaccine used; This is a spontaneous case, reported by other health professional to Company (case ID: SEQ19-07051) and initially received on 26-Nov-2019, concernig a 44-year-old female patient.  The patient's medical history and concomitant medications were not provided.  On 25-Oct-2019, the patient was administered Afluria Quadrivalent [Influenza vaccine, dose: 0.5ml, anatomical location: left arm, batch number: P100118559, expiration date: 30-Jun-2019, route of administration: not reported] (explicitly coded as 'Expired vaccine used') for influenza prophylaxis.  On the same day, after vaccination the patient experienced stiffness and soreness in the arm. Left arm and shoulder where vaccine was administered started hurting, feeling crampy and the patient's mobility was limited.  On an unspecific date, the patient's shoulder was iced to relieve the pain.  On an unspecific date, one month later, left arm and shoulder where vaccine was administered still hurt, felt crampy and the patient's mobility was limited.  At the time of initial reporting the outcome of the events was not recovered.  The reporter did not provide causality and seriousness criteria.  This case is linked with companion case 201906333 due to the same reporter.  Company Comment: The patient experienced muscle spasms, musculoskeletal stiffness, pain in extremity, mobility decreased and musculoskeletal pain after administration of expired product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Expired product administered is assessed as not related per company's conventions.  Considering all the above mentioned, causality between suspect product and all other events is assessed as possibly related.; Sender's Comments: The patient experienced muscle spasms, musculoskeletal stiffness, pain in extremity, mobility decreased and musculoskeletal pain after administration of expired product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Expired product administered is assessed as not related per company's conventions.  Considering all the above mentioned, causality between suspect product and all other events is assessed as possibly related.
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Left arm and shoulder feels crampy; Stiffnes in arm; Soreness in arm / Left arm and shoulder where vaccine was administered hurts; Mobility is limited; Left arm and shoulder where vaccine was administered hurts; Expired vaccine used; This is a spontaneous case, reported by other health professional to Company (case ID: SEQ19-07051) and initially received on 26-Nov-2019, concernig a 44-year-old female patient.  The patient's medical history and concomitant medications were not provided.  On 25-Oct-2019, the patient was administered Afluria Quadrivalent [Influenza vaccine, dose: 0.5ml, anatomical location: left arm, batch number: P100118559, expiration date: 30-Jun-2019, route of administration: not reported] (explicitly coded as 'Expired vaccine used') for influenza prophylaxis.  On the same day, after vaccination the patient experienced stiffness and soreness in the arm. Left arm and shoulder where vaccine was administered started hurting, feeling crampy and the patient's mobility was limited.  On an unspecific date, the patient's shoulder was iced to relieve the pain.  On an unspecific date, one month later, left arm and shoulder where vaccine was administered still hurt, felt crampy and the patient's mobility was limited.  At the time of initial reporting the outcome of the events was not recovered.  The reporter did not provide causality and seriousness criteria.  This case is linked with companion case 201906333 due to the same reporter.  Company Comment: The patient experienced muscle spasms, musculoskeletal stiffness, pain in extremity, mobility decreased and musculoskeletal pain after administration of expired product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Expired product administered is assessed as not related per company's conventions.  Considering all the above mentioned, causality between suspect product and all other events is assessed as possibly related.; Sender's Comments: The patient experienced muscle spasms, musculoskeletal stiffness, pain in extremity, mobility decreased and musculoskeletal pain after administration of expired product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Expired product administered is assessed as not related per company's conventions.  Considering all the above mentioned, causality between suspect product and all other events is assessed as possibly related.