chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram, Pain, Pain in extremity, Peripheral venous disease
Clinical narrative: Blood pooling into the elbow; Right upper extemity pain radiating into his right hand; Right upper extemity pain radiating into his right hand; This is a spontaneous case] and initially received on 26-Nov-2019, concerning a 51-year-old, male patient.  The patient's medical history included heart stent, hypertension, coronary arteriosclerosis, depression, headaches, high cholesterol and sleep apnea. The patient's concomitant medications included atorvastatin, citalopram, clopidogrel, lisinopril with hydrochlorthiazide, metformin, metoprolol tartrate, Nitroglicerin (glyceryl trinitrate) and Topamax (topiramate).  On 11-Nov-2019, the patient was administered Afluria Quadrivalent [Influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: P100123051, expiration date: 30-Jun-2020] for influenza prophylaxis.  On 15-Nov-2019, four days after vaccination, the patient experienced blood pooling into the elbow and right upper extremity pain radiating into his right hand. The patient was seen in the Emergency Room (ER) and had computerised tomography (CT) scans, however, the results were not provided. The patient was given pain medication as a corrective treatment. The patient was also advised to continue wearing the fling and to follow-up with orthopaedic doctors for further therapy details.  On 18-Nov-2019, the patient was still experiencing some pain.  At the time of initial reporting, the patient was recovering from the events of radiating pain and pan in upper extremities, while the outcome for the event venous stasis was not reported.  The reporter assessed the case as non-serious.  The reporter did not provide causality assessment.  Company Comment: The patient experienced peripheral venous disease, pain and pain in extremity 4 days after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Medical history of hypertension, high cholesterol and depression may have contributed to development of the events. 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 possibly related.; Sender's Comments: The patient experienced peripheral venous disease, pain and pain in extremity 4 days after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Medical history of hypertension, high cholesterol and depression may have contributed to development of the events. 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 possibly related.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Neck pain, Pain
Clinical narrative: Pain at injection site radiating to neck; Pain at injection site radiating to neck; This is a spontaneous case, reported by a pharmacist to Company (reference number: SEQ19-03673) on 01-Oct-2019, concerning a 41-year-old, female patient.  The patient's medical history and concomitant medications were not provided.  On 19-Sep-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular (IM), anatomical location: deltoid, batch number: P100100576 and expiration date:31-May-2020] for influenza prophylaxis.  On an unknown date in Sep-2019, after vaccination, the patient experienced pain at injection site radiating to neck. Two weeks after vaccine administration, the patient complained of shoulder pain that started one week prior vaccination. The corrective treatment for the events was not provided.  At the time of this report, the outcome of the events was not resolved.  The reporter assessed this case as non-serious and did not provide causality assessment to Afluria Quadrivalent .  Company comment: The patient developed vaccination site pain and pain (reported as radiating to neck) associated with the suspect product, Afluria Quadrivalent. 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 vaccination site pain and pain (reported as radiating to neck) associated with the suspect product, Afluria Quadrivalent. 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: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A patient experienced a red ring around the injection site, a little swelling and it is warm to touch for 24 hours; A patient experienced a red ring around the injection site, a little swelling and it is warm to touch for 24 hours; A 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, initially received from other health professional (paramedic) via Company (reference number: SEQ19-06586) on 13-Nov-2019, concerning a 41-year-old, female patient.  The patient's medical history was not provided. The patient's concomitant medications were not provided.  On an unspecified date in 2018, 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: 261983, expiration date: not reported] for influenza prophylaxis.  On an unspecified date in 2018, unknown amount of time after vaccination, the patient developed a red ring around the injection site, a little swelling and the site was warm to touch for 24 hours.   The outcome of all events was resolved.  This case is linked to cases 201905853 and 201905854 (the same reporter).  Follow up received from other health professional via Company (reference number: SEQ19-06882) on 21-Nov-2019: It was confirmed that the patient received vaccine in 2018/2019 season. Date of vaccination updated and expiration date of Flucelvax QIV removed. Start and stop dates for the events updated.The narrative was amended accordingly.  Company Comment: The patient experienced vaccination site warmth, vaccination site erythema and vaccination site swelling after vaccination with the suspect product Flucelcax 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 warmth, vaccination site erythema and vaccination site swelling after vaccination with the suspect product Flucelcax 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.
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: A lot of pain in her entire left arm and neck on her left side; A lot of pain in her entire left arm and neck on her left side; Patient reports that she cannot raise her left arm all the way up, and when she does raise it, she experiences a throbbing pain; Patient reports that she cannot raise her left arm all the way up, and when she does raise it, she experiences a throbbing pain; This is a spontaneous case, initially received from other non-health professional (consumer) via Agency (reference number: SEQ19-07184) on 02-Dec-2019, concerning a female patient of unknown age.   The patient's relevant medical history was not reported.  The patient's concomitant medications were not reported.  On 11-Nov-2019, the patient was administered with Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: intramuscular, anatomical location: left arm, dose, batch number and expiration date: not reported] as protection against seasonal influenza.  On the same day, one hour after receiving the vaccine, the patient experienced a lot of pain in her entire left arm and left side of the neck.  On an unspecified date in Nov-2019, the patient experienced trouble moving her left arm. The patient could not raise her left arm all the way up, and when she did raise it, she experienced a throbbing pain.  On an unspecified date in Nov-2019, reported as a week after receiving the vaccine, the patient was recovering from the events of pain in left arm and neck pain.   At the time of this report, the patient did not recover from the events of mobility decreased and throbbing pain.  The case was assessed as non-serious.  Causality assessment to Flucelvax Quadrivalent was not reported.  The patient did not provide consent to be contacted for further follow up.  Company Comment: The patient experienced pain in extremity, neck pain, mobility decreased and pain 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 pain in extremity, neck pain, mobility decreased and pain 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: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: Small rash; This is a spontaneous case, reported by other non-health professional to agency (reference number: SEQ19-07176) and initially received on 02-Dec-2019, concerning an 8-year-old, female patient.  The patient had no medical history. The patient did not take any concomitant medications.  On 23-Nov-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiration date: not reported] for influenza prophylaxis.  On 24-Nov-2019, one day after vaccination, the patient experienced a small rash. The patient did not receive any corrective treatment for the event.  On 25-Nov-2019, two days after vaccination, the patient recovered from the small rash.  The reporter assessed the event as non-serious and did not provide causality assessment to Flucelvax QIV.  This case is linked to the case 201907058 due to the same reporter.  Company Comment: The event is considered as related to Flucelvax QIV.; Sender's Comments: The event is considered as related to Flucelvax QIV.
Sex: F
Vaccine: FLUX
Symptoms: Injection site nodule, Pain in extremity
Clinical narrative: Knot at injection site; Arm became very sore; This is a spontaneous case, reported by other non-health professional (consumer) to Company [reference number: SEQ19-07192] and initially received on 03-Dec-2019, concerning a female patient of unspecified age. At the time of this report the patient was 77-year-old.   The patient's relevant medical history was not reported. The patient's concomitant medications were not reported.  On an unspecified date, the patient was administered with unspecified Flu Vaccine [Influenza virus vaccine; dose, anatomical location, route of administration, batch number and expiration date: not reported] for an unknown indication.  On an unspecified date, an unknown amount of time after vaccination, the patient's arm became very sore and she developed a knot at the injection site.  On an unspecified date, the patient recovered from the event of vaccination site lump.  At the time of this report, the outcome for the event of pain in arm was not reported.  The case was assessed as non-serious.  The reporter assessed the events to be related to Flu vaccine.   The patient did not provide consent to be contacted for further follow up.  Company comment: Patient developed adverse events after vaccination, however latency interval is unknown. As no alternative aetiology was reported, both events are assessed as related to an unspecified Flu vaccine.; Sender's Comments: Patient developed adverse events after vaccination, however latency interval is unknown. As no alternative aetiology was reported, both events are assessed as related to an unspecified Flu vaccine.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus
Clinical narrative: Itching behind her ears, head, shoulders, neck, both sides of ribs and top of foot; This is a spontaneous case, initially received from other non-health professional via agency [reference number: SEQ19-07212] on 03-Dec-2019, concerning a 63-year-old, female patient.   The patient's medical history included heart attack. The patient's concomitant medications included Norvasc (amlodipine besilate), Aspirin (acetylsalicylic acid) and Plavix (clopidogrel bisulfate) for heart attack, Crestor (rosuvastatin calcium), Celexa (citalopram hydrobromide) and Nexium (esomeprazole sodium) for unknown indication.   On 25-Nov-2019, the patient was administered Fluclevax (QIV) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: right arm, batch number: 262565, expiration date: 30-Jun-2020, route of administration: intramuscular (IM)] for influenza prophylaxis.  On 28-Nov-2019, three days after vaccination, the patient experienced itching behind her ears, on her head, shoulders, neck, both sides of ribs and top of foot. The most intense was around the ears, neck and upper chest area. The patient went to urgent care and they ruled out scabies.   On 01-Dec-2019, the patient received Benadryl (diphenhydramine hydrochloride) and prednisolone as a corrective treatment. Also, it was reported that the patient stooped treatment with Plavix.  At the time of this report, the patient had not recovered from the event.   The reporter assessed the event as non-serious.   The reporter did not provide causality assessment to Flucelvax (QIV).  Company comment: The event of itching is assessed as related to Flucelvax (QIV).; Sender's Comments: The event of itching is assessed as related to Flucelvax (QIV).
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Musculoskeletal pain, Myalgia, Pain, Pruritus
Clinical narrative: Shoulder soreness; Body aches; Fatigue; Muscle aches; Itching; This is a spontaneous case initially received from other non-health professional via Company on 05-Dec-2019 with additional document received on the same day (being process together), concerning a 65-year-old female patient.   The patient's historical vaccine included Flucelvax (QIV) which she was administered last year. It was reported that the patient had no side effects at all. The patient's concomitant medications were not provided.   On 02-Dec-2019, the patient was administered Flucelvax (QIV) [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: right deltoid, route of administration: intramuscular (IM), batch number and expiration date: not reported] for influenza prophylaxis.   On the same day, one hour after vaccination, the patient experienced shoulder soreness, mild itching, fatigue and muscle aches. The patient also experienced body aches. The patient did not receive any treatment.  On 04-Dec-2019, the outcome of the events shoulder soreness, mild itching, fatigue, body and muscle aches was resolved.   The case was assessed as non-serious per patient. The reporter did not provide causality assessment to Fluclevax (QIV).  Company Comment: The patient experienced musculoskeletal pain, pain, fatigue, myalgia and pruritus after vaccination with the suspect product, Flucelvax (QIV). Chronology is plausible. No diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as related.; Sender's Comments: The patient experienced musculoskeletal pain, pain, fatigue, myalgia and pruritus after vaccination with the suspect product, Flucelvax (QIV). Chronology is plausible. No diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as related.
Sex: M
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Itching all over his body; This is a spontaneous case, reported by other health professional (medical assistant - MA) to agency (reference numbers: SEQ19-07308) on 09-Dec-2019, concerning a male patient of unknown age.  The patient's medical history and concomitant medications were not provided.  On an unspecified date in November 2019, the patient was administered Afluria Quadrivalent [Influenza Vaccine, bath number reported as 4F42909 (Seqirus batch umber: YF42909), dose, route of administration, anatomical location and expiry date: not reported] for prevention of seasonal influenza in the hospital .  On the same day, after receiving the vaccine, the patient developed severe itching all over his body. The corrective treatment for itching was not provided.  At the time of this report, the outcome of the event was not reported.  The reporter did not provide the causality assessment to Afluria Quadrivalent.  The reporter did not give permission to be contacted for follow up.  Company comment: The event of itching all over was assesses as related to Afluria Quadrivalent.; Sender's Comments: The event of itching all over was assesses as related to Afluria Quadrivalent.
Age: 69.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Bad reaction around the injection area/itching, redness, hot, and it's swollen, it also started to spread at the injection site; Bad reaction around the injection area/itching, redness, hot, and it's swollen, it also started to spread at the injection site; Bad reaction around the injection area/itching, redness, hot, and it's swollen, it also started to spread at the injection site; Bad reaction around the injection area/itching, redness, hot, and it's swollen, it also started to spread at the injection site; This is a spontaneous case initially received from other non-health professional via agency (reference number: SEQ19-07417) on 12-Dec-2019 concerning a 69-year-old, male patient.   The patient's medical history included diabetes, heart disease, high cholesterol, high blood pressure, sleep apnea, the patient had a history of a heart attack and a stroke.  The patient's past medications included flu vaccine every year without any adverse events. The patient's concomitant medications included pasmetformin, Plavix (clopidogrel bisulfate), Aspirin (acetylsalicylic acid), Coreg (carvedilol), digoxin, simvastatin, Multivitamin (vitamins nos), Humalog (insulin lispro), Lantus (insulin glargine) and Jardiance (empagliflozin), all used for unknown indications.  On 10-Dec-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 261233, expiry date: 30-Jun-2020] for influenza prophylaxis.   On the same day, an unknown amount of time after vaccination, the patient experienced bad reaction around the injection area. He experienced itching, redness, hot, and it was swollen. It had also started to spread at the injection site.   On an unspecified date in Dec-2019, the patient started treatment with Benadryl (diphenhydramine hydrochloride) and put some Cortisol (hydrocortisone) cream at the site and ice pack on it.   At the time of initial report, the patient did not recover from the events.   The reporter assessed this case as non-serious.  The reported did not provided causality to Flucelvax QIV.  Company comment: Temporal relationship is suggestive for the causal role of Flucelvax. Causality assessment is confounded by use of concomitant drugs. Based on the available information, all events are assessed as related to Flucelvax.; Sender's Comments: Temporal relationship is suggestive for the causal role of Flucelvax. Causality assessment is confounded by use of concomitant drugs. Based on the available information, all events are assessed as related to Flucelvax.
Age: 78.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Left arm swelled up at site and was painful; Left arm swelled up at site and was painful; This is a spontaneous case, initially received from other non-health professional via Company (reference number: SEQ19-07425) on 13-Dec-2019, concerning a 78-year-old female patient.   The patient's historical condition included gall bladder removal and lyme disease. The patient's current condition included alpha gall allergy, possible heart murmur and hypothyroidism.   The patient's concomitant medications included Synthroid (levothyroxine sodium), unspecified vitamins and alprazolam, all for an unknown indication.   On 10-Dec-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, batch number: 261983, expiration date: 30-Jun-2020, route of administration: intramuscular and anatomical location: left deltoid] for and influenza prophylaxis.  On the same day, three hours after vaccination, the patient's left arm swelled up at the site and was painful.   On 11-Dec-2019, the patient went to urgent care and received steroid shot. On the same day, the patient recovered.   The case was assessed as non-serious.  The reporter did not provide causality assessment.  Company comment: The patient developed pain in extremity and vaccination site swelling, three hours after Flucelvax Quadrivalent was administered. Chronology is plausible. Based on provided information, causal role of the suspect product is assessed as probably related.; Sender's Comments: The patient developed pain in extremity and vaccination site swelling, three hours after Flucelvax Quadrivalent was administered. Chronology is plausible. Based on provided information, causal role of the suspect product is assessed as probably related.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Influenza B virus test positive
Clinical narrative: Patient developed the flu after receiving the vaccine; This is a spontaneous case, initially received from other health professional via Agency (reference number: SEQ19-07478) on 16-Dec-2019, concerning a 7-year-old, female patient.   The patient had no relevant medical history.   The patient did not use any concomitant medications.  On 28-Nov-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 261204 and expiration date: 26-Feb-2020] for influenza prophylaxis.  On the same day, after vaccination, the patient developed flu.  On an unspecified date in 2019, the patient was seen by her paediatrician and was positive for strain B. Treatment medication Tamiflu (oseltamivir phosphate) was given for flu.   On an unspecified date, the patient recovered from the event of flu.  The event of flu was considered as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Follow up was received by other health professional on 18-Feb-2020: It was reported that the patient had no medical history and took no other medications. The outcome for the event of flu' was amended from not recovered' to recovered'. Narrative was amended accordingly.  Company comment: The patient developed influenza, on the same day after Flucelvax Quadrivalent was administered. Chronology is plausible. Based on provided information, causal role of the suspect product is assessed as related.; Sender's Comments: The patient developed influenza, on the same day after Flucelvax Quadrivalent was administered. Chronology is plausible. Based on provided information, causal role of the suspect product is assessed as related.
Sex: U
Vaccine: FLUC4
Symptoms: Asthenia, Feeling cold, Influenza, Malaise, Oropharyngeal pain
Clinical narrative: Flu symptoms; Suddenly started cold; Weakness in body; Sore throat; I take flu shot and that make me sick; Fever (on and off); This is a spontaneous case from initially received from other non-health professional(consumer) via agency (reference number: SEQ19-07489) on 16-Dec-2019, concerning a patient of unspecified age and gender.   The patient's medical history and concomitant medications were not reported.   On 13-Dec-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication.    On 14-Dec-2019, one day after vaccination, the patient experienced flu symptoms, suddenly started cold, fever (on and off), weakness in body and sore throat.   The patient stated that after taking a flu shot, that made her/him sick.   The event of flu symptoms' was assessed as serious due to the criterion of medical significance, per company.   The reporter considered the events as related to Flucelvax Quadrivalent.  Company comment: The patient developed influenza, feeling cold, asthenia, oropharyngeal pain, malaise and pyrexia one day after Flucelvax Quadrivalent was administered. Chronology is plausible. More information regarding medical history and concomitant medications is needed. Based on provided information, causal role of the suspect product is assessed as related.; Sender's Comments: The patient developed influenza, feeling cold, asthenia, oropharyngeal pain, malaise and pyrexia one day after Flucelvax Quadrivalent was administered. Chronology is plausible. More information regarding medical history and concomitant medications is needed. Based on provided information, causal role of the suspect product is assessed as related.
Sex: U
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: Flu symptoms; Suddenly started cold; Weakness in body; Sore throat; I take flu shot and that make me sick; Fever (on and off); This is a spontaneous case from initially received from other non-health professional(consumer) via agency (reference number: SEQ19-07489) on 16-Dec-2019, concerning a patient of unspecified age and gender.   The patient's medical history and concomitant medications were not reported.   On 13-Dec-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication.    On 14-Dec-2019, one day after vaccination, the patient experienced flu symptoms, suddenly started cold, fever (on and off), weakness in body and sore throat.   The patient stated that after taking a flu shot, that made her/him sick.   The event of flu symptoms' was assessed as serious due to the criterion of medical significance, per company.   The reporter considered the events as related to Flucelvax Quadrivalent.  Company comment: The patient developed influenza, feeling cold, asthenia, oropharyngeal pain, malaise and pyrexia one day after Flucelvax Quadrivalent was administered. Chronology is plausible. More information regarding medical history and concomitant medications is needed. Based on provided information, causal role of the suspect product is assessed as related.; Sender's Comments: The patient developed influenza, feeling cold, asthenia, oropharyngeal pain, malaise and pyrexia one day after Flucelvax Quadrivalent was administered. Chronology is plausible. More information regarding medical history and concomitant medications is needed. Based on provided information, causal role of the suspect product is assessed as related.
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Emotional distress, Immediate post-injection reaction, Injection site erythema, Injection site induration
Clinical narrative: Pain at the injection site; Swelling, hardness, redness and heat at the injection site; Immediately felt itching at the injection site; Swelling, hardness, redness and heat at the injection site; Swelling, hardness, redness and heat at the injection site; Swelling, hardness, redness and heat at the injection site; She was very upset; This is a spontaneous case initially received from other non-health professional (consumer) via agency (reference number: SEQ19-07498) on 17-Dec-2019, concerning an over 65-year-old female patient.   The patient's medical history was not provided. The patient's historical vaccine included Flucelvax (QIV) last year and the year before without any adverse reaction. The patient's concomitant medications were not provided.   On 22-Oct-2019, 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 influenza prophylaxis.  On the same day, after vaccination, the patient immediately felt itching at the injection site. About an hour after the vaccination, the patient developed swelling, hardness, redness and heat at the injection site.   On the same day, the outcome of the event vaccination site itching was resolved.  On 23-Oct-2019, one day after vaccination, the patient developed pain at the injection site. The patient was very upset.   On 24-Oct-2019, the outcome of all events which occurred at the injection site was resolved. However, it was not reported whether the patient still was upset. It was unknown whether the patient received any corrective treatment for the events.  The reporter assessed all the events as non-serious and did not provide causality assessment to Flucelvax (QIV).  Company comment: The patient developed vaccination site warmth, anxiety, vaccination site pruritus, vaccination site swelling, vaccination site induration, vaccination site erythema, vaccination site pain on the same day after Flucelvax (QIV) was administered. Chronology is plausible. More information regarding medical history and concomitant medications is needed. Based on provided information, causal role of the suspect product is assessed as related for all events.; Sender's Comments: The patient developed vaccination site warmth, anxiety, vaccination site pruritus, vaccination site swelling, vaccination site induration, vaccination site erythema, vaccination site pain on the same day after Flucelvax (QIV) was administered. Chronology is plausible. More information regarding medical history and concomitant medications is needed. Based on provided information, causal role of the suspect product is assessed as related for all events.
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pain at the injection site; Swelling, hardness, redness and heat at the injection site; Immediately felt itching at the injection site; Swelling, hardness, redness and heat at the injection site; Swelling, hardness, redness and heat at the injection site; Swelling, hardness, redness and heat at the injection site; She was very upset; This is a spontaneous case initially received from other non-health professional (consumer) via agency (reference number: SEQ19-07498) on 17-Dec-2019, concerning an over 65-year-old female patient.   The patient's medical history was not provided. The patient's historical vaccine included Flucelvax (QIV) last year and the year before without any adverse reaction. The patient's concomitant medications were not provided.   On 22-Oct-2019, 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 influenza prophylaxis.  On the same day, after vaccination, the patient immediately felt itching at the injection site. About an hour after the vaccination, the patient developed swelling, hardness, redness and heat at the injection site.   On the same day, the outcome of the event vaccination site itching was resolved.  On 23-Oct-2019, one day after vaccination, the patient developed pain at the injection site. The patient was very upset.   On 24-Oct-2019, the outcome of all events which occurred at the injection site was resolved. However, it was not reported whether the patient still was upset. It was unknown whether the patient received any corrective treatment for the events.  The reporter assessed all the events as non-serious and did not provide causality assessment to Flucelvax (QIV).  Company comment: The patient developed vaccination site warmth, anxiety, vaccination site pruritus, vaccination site swelling, vaccination site induration, vaccination site erythema, vaccination site pain on the same day after Flucelvax (QIV) was administered. Chronology is plausible. More information regarding medical history and concomitant medications is needed. Based on provided information, causal role of the suspect product is assessed as related for all events.; Sender's Comments: The patient developed vaccination site warmth, anxiety, vaccination site pruritus, vaccination site swelling, vaccination site induration, vaccination site erythema, vaccination site pain on the same day after Flucelvax (QIV) was administered. Chronology is plausible. More information regarding medical history and concomitant medications is needed. Based on provided information, causal role of the suspect product is assessed as related for all events.
Sex: U
Vaccine: FLUC4
Symptoms: Vaccination site pain
Clinical narrative: After vaccine administration patient has pain at injection site; This is a spontaneous case, initially received from nurse via agency (reference number: SEQ19-07511) on 18-Dec-2019, concerning an adult patient of an unknown gender. The patient was between 40 and 60 years old.  The patient's medical history was not provided.   The patient's concomitant medications were not provided.  On 17-Oct-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) for influenza prophylaxis.  On the same day, after vaccination, the patient experienced pain at vaccination site. It was reported that the patient was referred to health care professional, but further details were not provided. The patient did not experience any other adverse reaction.  At the time of initial reporting, the event of vaccination site pain was not resolved.  The case was assessed as non-serious.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  This case is linked to cases 201907371 and 201907372 (due to the same reporter).  Company comment: The event of vaccination site pain is assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The event of vaccination site pain is assessed as related to Flucelvax Quadrivalent.
Sex: U
Vaccine: FLUC4
Symptoms: Vaccination site pain
Clinical narrative: After vaccine administration patient has pain at injection site; This is a spontaneous case, initially received from nurse via Company (reference number: SEQ19-07511) on 18-Dec-2019, concerning an adult patient of an unknown gender. The patient was between 40 and 60 years old.  The patient's medical history was not provided.   The patient's concomitant medications were not provided.  On 17-Oct-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) for influenza prophylaxis.  On the same day, after vaccination, the patient experienced pain at vaccination site. It was reported that the patient was referred to health care professional, but further details were not provided. The patient did not experience any other adverse reaction.  At the time of initial reporting, the event of vaccination site pain was not resolved.  The case was assessed as non-serious.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  This case is linked to cases 201907370 and 201907372 (due to the same reporter).  Company comment: The event of vaccination site pain is assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The event of vaccination site pain was assessed as related to Flucelvax Quadrivalent.
Sex: U
Vaccine: FLUC4
Symptoms: Vaccination site pain
Clinical narrative: After vaccine administration patient has pain at injection site; This is a spontaneous case, initially received from nurse via Company (reference number: SEQ19-07511) on 18-Dec-2019, concerning an adult patient of an unknown gender. The patient was between 40 and 60 years old.  The patient's medical history was not provided.   The patient's concomitant medications were not provided.  On 17-Oct-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) for influenza prophylaxis.  On the same day, after vaccination, the patient experienced pain at vaccination site. It was reported that the patient was referred to health care professional, but further details were not provided. The patient did not experience any other adverse reaction.  At the time of initial reporting, the event of vaccination site pain was not resolved.  The case was assessed as non-serious.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  This case is linked to cases 201907370 and 201907371 (due to the same reporter).  Company comment: The event of vaccination site pain is assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The event of vaccination site pain was assessed as related to Flucelvax Quadrivalent.
Age: 21.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza
Clinical narrative: Received Flucelvax Quadrivalent and has now developed Flu; This is spontaneous case initially reported by other health professional to agency (reference number: SEQ19-07513) on 18-Dec-2019, concerning 21-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On 26-Sep-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261204; expiry date: 26-Jun-2020; route of administration: intramuscular; anatomical location: left deltoid] for influenza prophylaxis.   On 17-Dec-2019, 81 days after vaccine administration, the patient was diagnosed with flu at Urgent Care and was treated with Tamiflu (oseltamivir phosphate).   At the time of initial reporting, the outcome of event was ongoing.  The event of flu was considered serious due to the criterion of medical significance per company.   The reporter did not provide causality assessment.  Company comment: The patient experienced influenza (reported as flu) associated with Flucelvax QIV. Reportedly, 81 days after vaccine administration, the patient was diagnosed with flu at Urgent Care and was treated with Tamiflu (oseltamivir phosphate). Chronology seems plausible. The patient's medical history and concomitant medications were not provided. With information provided, causality is assessed as possibly related.; Sender's Comments: The patient experienced influenza (reported as flu) associated with Flucelvax QIV. Reportedly, 81 days after vaccine administration, the patient was diagnosed with flu at Urgent Care and was treated with Tamiflu (oseltamivir phosphate). Chronology seems plausible. The patient's medical history and concomitant medications were not provided. With information provided, causality is assessed as possibly related.
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness, Skin mass, Skin warm
Clinical narrative: The reaction was a knot under the skin that was hot to the touch.; The reaction was a knot under the skin that was hot to the touch.; Flu-like symptoms; This is a spontaneous case, initially received from other non health professional via Merck & Co., Inc., via Company (reference number: SEQ19-07522) on 18-Dec-2019, concerning an approximately 18-year-old, male patient.   The patient's medical history was not reported.   The concomitant medications of patient were not reported.   On an unknown date in 2019, the patient was administered INN seasonal flu vaccine [influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number and expiration date: not reported] for an unknown indication.   On an unknown date in 2019, unknown after vaccination,the patient had a severe reaction to an unknown flu vaccine that was a knot' under the skin that was hot to the touch. There were also flu-like symptoms that were subsequently treated.  On an unknown date in 2019, the patient went back to the health care professional (HCP) who administered the shot. The HCP stated that reactions were unrelated to INN seasonal flu vaccine.  At the time of initial reporting, the outcome of all the events was not reported.  The reporter assessed all the events as related to INN seasonal flu vaccine.  Any follow up information received by Merck & Co., Inc. regarding this case would be forwarded upon receipt.  Company comment: The patient experienced skin mass, skin warm and influenza like illness associated with INN Flu Vaccine Seasonal. Chronology needs more clarification. The patient's medical history and concomitant medications were not provided. Reportedly, the HCP stated that reactions were unrelated to INN seasonal flu vaccine. With information provided, causality is assessed as unlikely related for all events.; Reporter's Comments: The patient had a severe reaction to an unknown flu vaccine. The HCP stated that reactions were unrelated to INN seasonal flu vaccine.; Sender's Comments: The patient experienced skin mass, skin warm and influenza like illness associated with INN Flu Vaccine Seasonal. Chronology needs more clarification. The patient's medical history and concomitant medications were not provided. Reportedly, the HCP stated that reactions were unrelated to INN seasonal flu vaccine. With information provided, causality is assessed as unlikely related for all events.
Age: 94.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Back pain, Presyncope
Clinical narrative: Started having back pain; Weakness; Nearly collapsed after receiving the vaccine; This is spontaneous case initially reported by other health professional to Company (reference number: SEQ19-07591) on 23-Dec-2019, concerning a 94-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 13-Dec-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml; route of administration: intramuscular; anatomical location, batch number and expiration date: not reported] for prevention of seasonal influenza.   On the same day, after vaccination, the patient developed back pain, weakness and was nearly collapsed. The patient visited her physician due to adverse events which she experienced.    At the time of this report, the outcome of all events was not reported.   The reporter did not provide causality assessment to Fluad (TIV).  Company comment: The patient experienced back pain, asthenia and presyncope, on the same day after administration of Fluad (TIV). Advanced age (94) may have contributed to the events. More information regarding medical history and concomitant medications is needed. Considering the plausible temporal relationship between vaccination and reported events, causality is assessed as related.; Sender's Comments: The patient experienced back pain, asthenia and presyncope, on the same day after administration of Fluad (TIV). Advanced age (94) may have contributed to the events. More information regarding medical history and concomitant medications is needed. Considering the plausible temporal relationship between vaccination and reported events, causality is assessed as related.
Sex: F
Vaccine: FLUC4
Symptoms: Hypersensitivity
Clinical narrative: Fairly significant allergic reaction after the shot; This is a spontaneous case, reported by other non-health professional (consumer) to Company (reference number: SEQ20-00011) on 02-Jan-2020, concerning a female patient of unknown age.   The patient's medical history was not provided. The patient had never had allergic reaction to flu vaccine in the past. Last year the patient was administered vaccine with batch number 02944621A and no adverse reactions were reported. 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, batch number: 259814, dose, route of administration, anatomical location and expiry date: not reported] for prevention of seasonal influenza.  On an unspecified date, after the flu shot, the patient developed fairly significant allergic reaction. It was unknown whether the patient applied any corrective treatment for the event.  At the time of this report, the outcome of the event was unknown.  The reporter did not provide event seriousness. The reporter assessed the event of fairly significant allergy reaction as related to Flucelvax QIV.  Company comment: The event of fairly significant to vaccine is assessed as related to Flucelvax QIV.; Sender's Comments: The event of fairly significant to vaccine is assessed as related to Flucelvax QIV.
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Nausea
Clinical narrative: Feeling nauseous; Pain at the injection site after receiving vaccine; This is a spontaneous case reported by other non-health professional (consumer) to Company (reference number: SEQ20-00068) and initially received on 06-Jan-2020, concerning a male patient of an unspecified age.  The patient's medical history and concomitant medications were not provided.  On 04-Jan-2020, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiration date: not reported] as influenza prophylaxis.  On 04-Jan-2020, after unknown amount of time after receiving vaccine, the patient experienced pain at the injection site.  On 06-Jan-2020, two days after vaccination, the patient started feeling nauseous after eating pizza. The patient did not receive any corrective treatment for the events.  On an unspecified date in Jan-2020, the outcome of the event of vaccination site pain was resolved.  At the time of this report, the outcome of the event of nausea was not resolved.  The reporter assessed the case as non-serious and did not provide causality assessment to Flucelvax Quadrivalent.  Company Comment: All events were considered as related to Flucelvax Quadrivalent.; Sender's Comments: All events were considered as related to Flucelvax Quadrivalent.