chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLUA4
Symptoms: Blister, Product administered to patient of inappropriate age, Rash
Clinical narrative: Patient under 65 received Fluad QIV; Rash of both arms and hands with blisters on L hand side (injected arm); Rash of both arms and hands with blisters on L hand side (injected arm); This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04837) and concerned a 51-year-old, female patient.   The patient's medical history included psoriasis. The patient's concomitant medications were not reported.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for an influenza prophylaxis. The batch number reported was 286592.   On an unspecified date in 2020, an unknown time after receiving Fluad Quadrivalent, the patient experienced rash of both arms and hands with blisters on left (L) hand side of injected arm. The patient visited dermatologist, who stated it could have been from the flu shot. The patient did not receive any corrective treatment.  The outcome of the events was not reported.  The reporter assessed all events as related to Fluad Quadrivalent.   The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter).  Company comment: A 51-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed rash and blister. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Reporter's Comments: The reporter stated that the events could have been from the flu shot.; Sender's Comments: A 51-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed rash and blister. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
Age: 28.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Injection site pain, Oropharyngeal pain, Product administered to patient of inappropriate age
Clinical narrative: Patient under 65 received Fluad QIV; Sore throat; Injection site pain; Headache; This spontaneous case was received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04820) and concerned a 28-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reported.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unknown date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced injection site pain, headache and sore throat. The patient started treatment with Tylenol (paracetamol).   The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097, 202006098 (the same reporter).  Company comment: A 28-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed oropharyngeal pain, headache and vaccination site pain. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 28-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed oropharyngeal pain, headache and vaccination site pain. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
Age: 28.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: Patient under 65 received Fluad QIV; Injection site was very sore; Headache; This spontaneous case was received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04838) and concerned a 28-year-old, female patient.   The patient's concurrent conditions included carcinoma (reported as 'CA') and asthma. The patient's concomitant medications were not reported.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unknown date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient's injection site was very sore, and she had a headache. The patient started treatment with Tylenol (paracetamol).  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006090, 202006091, 202006092, 202006095, 202006097, 202006098 (the same reporter).  Company comment: The events of headache and 'vaccination site pain' are assessed as related to Fluad Quadrivalent, while the event of 'Inappropriate age at vaccine administration' is assessed as not related.; Sender's Comments: The events of headache and 'vaccination site pain' are assessed as related to Fluad Quadrivalent, while the event of 'Inappropriate age at vaccine administration' is assessed as not related.
Age: 58.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Nodule, Peripheral swelling, Product administered to patient of inappropriate age, Skin warm
Clinical narrative: Patient under 65 received Fluad QIV; Hot and red knot; Hot and red knot; Swollen arm; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04816) and concerned a 58-year-old, female patient.   The patient's medical history included hypothyroidism. The patient's concomitant medications were not reprorted.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influneza prophylaxis. The batch number reported was 286592.  On an unspecified date in 2020, unknown time after receiving Fluad Quadrivalent, the patient developed hot and red knot, swollen arm. The patient was treated with Tylenol (paracetamol).  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter).  Company comment: A 58-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed peripheral swelling, nodule and feeling hot (hot and red knot). With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 58-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed peripheral swelling, nodule and feeling hot (hot and red knot). With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
Age: 38.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Feeling cold, Malaise, Myalgia, Product administered to patient of inappropriate age
Clinical narrative: Patient under 65 received Fluad QIV; Feeling cold; Generalized malaise; Joint pain; Muscle ache; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04825) and concerned a 38-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reported.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.  On an unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced generalized malaise, joint pain, muscle aches, and was feeling cold. The patient started treatment with Tylenol (paracetamol).  The outcome of the events was not reported.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.   This case is linked with the cases 202004845, 202006067, 202006068, 202006069, 202006072, 202006074, 202006077, 202006078, 202006079, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006088, 202006089, 202006090, 202006092, 202006093, 202006095, 202006096, 202006097, 202006099 (the same reporter).  Company comment: A 38-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced malaise, arthralgia, myalgia and was feeling cold. With information available, causal role of the suspect vaccine is assessed as possibly. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 38-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced malaise, arthralgia, myalgia and was feeling cold. With information available, causal role of the suspect vaccine is assessed as possibly. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
Age: 52.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Hypoaesthesia, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Patient under 65 received Fluad QIV; Soreness; Left arm with numb fingers; Headache; This spontaneous case was received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04803) and concerned a 52-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reprorted.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced severe soreness, left arm with number fingers and headache. The patient was treated with Tylenol (paracetamol) and Aleve (naproxen).   The outcome of events was not reported.   The reporter did not provide causality assessment.   The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006095, 202006097 and 202006098 (the same reporter).  Company comment: A 52-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain, headache and hypoaesthesia. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 52-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain, headache and hypoaesthesia. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
Age: 57.0
Sex: M
Vaccine: FLUA4
Symptoms: Fatigue, Headache, Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: Patient under 65 received Fluad QIV; Site pain for 3 days; Headache; Fatigue for 48h; This spontaneous case was received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04836) and concerned a 57-year-old, male patient.   The patient's concurrent conditions included hypertension (HTN). The patient's concomitant medications were not reported.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced site pain for three days, headache and fatigue for 48h. The patient was treated with Tylenol (paracetamol).   On an unknown date in 2020, the patient recovered from the events of 'vaccination site pain' and fatigue.  The outcome of the event of headache was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006097, 202006098 (the same reporter).  Company comment: The events of headache, 'vaccination site pain' and fatigue are considered as related to Fluad Quadrivalent, while the event of 'Inappropriate age at vaccine administration' is considered as not related to Fluad Quadrivalent.; Sender's Comments: The events of headache, 'vaccination site pain' and fatigue are considered as related to Fluad Quadrivalent, while the event of 'Inappropriate age at vaccine administration' is considered as not related to Fluad Quadrivalent.
Age: 53.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Patient under 65 received Fluad QIV; Arm pain; Injection site redness; This spontaneous case was received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04834) and concerned a 53-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reported.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient developed injection site redness and arm pain. No corrective treatment was given for the events.   The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095 and 202006098 (the same reporter).  Company comment: A 53-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain in extremity and vaccination site erythema. With information available, causal role of the suspect vaccine is assessed as possibly. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 53-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain in extremity and vaccination site erythema. With information available, causal role of the suspect vaccine is assessed as possibly. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
Age: 50.0
Sex: F
Vaccine: FLUA4
Symptoms: Cardiac disorder, Injection site pain, Pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Patient under 65 received Fluad QIV; Body aches; Fever; Injection site soreness; This spontaneous case from the  was received on 05-Nov-2020 from other health professional (nurse) via The Agency (reference number: SEQW20-04824) and concerned a 50-year-old, female patient.   The patient's relevant medical history included heart disease and hypertension (HTN). The patient's concomitant medications were not reported.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced fever, body aches and injection site soreness. The patient was treated with ibuprofen.    The outcome of the events was not reported.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095 and 202006097 (the same reporter).  Company comment: The patient experienced pain (reported as 'body ache'), pyrexia and vaccination site pain on an unspecified date after administration of Fluad Quadrivalent. Causality is assessed as possibly related for vaccination site pain (due to anatomical plausibility) and unassessable for pyrexia and pain (temporal association is unclarified, and the patient also suffers from unspecified heart disease). Patient under 65 received Fluad QIV- product administration error is assessed as unrelated per company conventions.; Sender's Comments: Company comment: The patient experienced pain (reported as 'body ache'), pyrexia and vaccination site pain on an unspecified date after administration of Fluad Quadrivalent. Causality is assessed as possibly related for vaccination site pain (due to anatomical plausibility) and unassessable for pyrexia and pain (temporal association is unclarified, and the patient also suffers from unspecified heart disease). Patient under 65 received Fluad QIV- product administration error is assessed as unrelated per company conventions.
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Emotional distress, Wrong product administered
Clinical narrative: The patient requested the high dose vaccine several times and FLD QUAD was administered; Very upset; This spontaneous case from was received on 10-Nov-2020 from other non-health professional (consumer) via The Agency (reference number: SEQW20-04960) and concerned a 72-year-old, male patient.   The patient's medical history and concomitant medications were not reported.  On 26-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid) for flu prophylaxis. The batch number was not reported. The patient requested the high dose vaccine, and in the pharmacy, they confirmed that Fluad Quadrivalent was a high dose vaccine. Later the patient was advised that Fluad Quadrivalent was a standard dose vaccine (explicitly coded as 'Wrong vaccine administered').  On an unspecified date in 2020, after receiving Fluad Quadrivalent, the patient was very upset that Fluad Quadrivalent was being marketed by the pharmacy as a high dose vaccine.  The outcome of the event was not reported.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: The patient experienced emotional distress on an unspecified date after administration of Fluad Quadrivalent. Reportedly, the patient requested the high dose vaccine several times and FLD QUAD. Wrong product administered is assessed as unrelated per company conventions and emotional distress is also assessed as unrelated. There is no suggestion that the product produced this event. Temporal association is unclarified and there is no biological background for this association.; Sender's Comments: The patient experienced emotional distress on an unspecified date after administration of Fluad Quadrivalent. Reportedly, the patient requested the high dose vaccine several times and FLD QUAD. Wrong product administered is assessed as unrelated per company conventions and emotional distress is also assessed as unrelated. There is no suggestion that the product produced this event. Temporal association is unclarified and there is no biological background for this association.
Age: 65.0
Sex: M
Vaccine: FLUA4
Symptoms: Cough, Dizziness, Hyperhidrosis
Clinical narrative: Cough; On and off dizziness; Heavy sweating; This spontaneous case from the was received on 23-Nov-2020 from other health professional via The Agency (reference number: SEQW20-05390) and concerned a 65-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 20-Nov-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: left arm) for influenza prophylaxis. The batch number reported was 279812 and expiry date was 30-Jun-2021.  On the same day, 30 minutes after receiving Fluad Quadrivalent, the patient developed heavy sweating. The patient also had on and off dizziness.  On 23-Nov-2020, sweating returned as well as a cough.  At the time of initial reporting on 23-Nov-2020, the patient had not recovered from the events, reported as not improved.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  Company comment: A 65-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, 30 minutes after receiving Fluad Quadrivalent, the patient developed hyperhidrosis and dizziness. Three days later the patient also experienced cough. Causality is assessed as possibly related for all events. Causal role of the suspect vaccine is assessed as possibly related for all events.; Sender's Comments: A 65-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, 30 minutes after receiving Fluad Quadrivalent, the patient developed hyperhidrosis and dizziness. Three days later the patient also experienced cough. Causality is assessed as possibly related for all events. Causal role of the suspect vaccine is assessed as possibly related for all events.
Age: 83.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site pain
Clinical narrative: Pain at injection site; This spontaneous case was received on 27-Nov-2020 from other non-health professional (consumer) via Agency (reference number: SEQW20-05445) and concerned a 83-year-old, male patient.  The patient's medical history and concomitant medications were not reported. The patient stated he was very healthy.  On an unspecified date in Nov-2020, reported as a week ago, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date in Nov-2020, unknown amount of time after receiving Fluad Quadrivalent, the patient has not had any response only developed mild pain at the injection site.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  This case is linked to 202007428 due to same patient and reporter.  Company comment: The event of 'vaccination site pain' is considered as related to Fluad Quadrivalent.; Sender's Comments: The event of 'vaccination site pain' is considered as related to Fluad Quadrivalent.
Age: 84.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Pain in extremity, Tenderness
Clinical narrative: Pain in her upper arm/shoulder/ pain in her left arm/tender and hurts at night; Pain in her upper arm/shoulder/ pain in her left arm/ tender and hurts at night; Pain in her upper arm/shoulder/ pain in her left arm/ tender and hurts at night; This spontaneous case from the  was received on 07-Dec-2020 from other non-health professional (consumer) via The agency (reference number: SEQW20-05636) and concerned an 84-year-old female patient.  The patient's medical history included blood pressure abnormal, blood cholesterol abnormal and fibroid. The patient's concomitant medications included blood pressure, cholesterol medications and fibroid pill. The patient's historical vaccine included influenza vaccines, after which her arm was sore and painful, but not for long period of time as in this report.   On 08-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml; anatomical location: left arm; route of administration: not reported) for prevention of seasonal influenza. The batch number was not reported.   On 10-Sep-2020, two days after receiving Fluad Quadrivalent, the patient experienced pain in her upper arm and shoulder, it was tender and hurt at night. The patient also had difficulty dressing.     On an unknown date in 2020, the patient went to doctor, and was provided a prescription for meloxicam, but she was still experiencing pain and soreness in her arm.  At the time of initial reporting on 07-Dec-2020, the patient had not recovered from the events, as she was still experiencing pain in her left arm three months after the injection.  The reporter did not provide a causality assessment.  This case is linked with case 202007548 (the same patient and reporter).  Company comment: A 84-year-old patient was vaccinated with Fluad Quadrivalent. Two days after receiving Fluad Quadrivalent, the patient experienced pain in extremity, arthralgia and tenderness. Causality is assessed as possibly related for all events.; Sender's Comments: A 84-year-old patient was vaccinated with Fluad Quadrivalent. Two days after receiving Fluad Quadrivalent, the patient experienced pain in extremity, arthralgia and tenderness. Causality is assessed as possibly related for all events.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Abdominal discomfort, Asthenia, Bedridden, Decreased appetite, Injection site pain
Clinical narrative: Pain and heat at injection site; Sick to her stomach; Feeling weak; Had to stay in bed; Arm was swollen; Couldn't eat anything; Nauseous; Fever; Pain and heat at injection site; This spontaneous case from the  was received on 11-Dec-2020 from other non-health professional via The agency (reference number: SEQW20-05716) and concerned a 70-year-old female patient.  The patient's medical history and concomitant medications were not reported.  On 16-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain and heat at injection site for several days, fever for three to four days, was sick to her stomach and could not eat anything. She was also nauseous, felt weak, her arm was swollen and she had to stay in bed.  On an unspecified date in 2020, the patient recovered from events of 'vaccination site warmth', fever and 'vaccination site pain'.   At the time of initial reporting on 11-Dec-2020, the patient was recovering from events 'stomach discomfort', 'weakness', 'bedridden', 'appetite lost', 'swollen arm' and nauseous, as she had improved.   The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  Company comment: A 70-year-old patient was administered Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain and heat at injection site for several days, fever for three to four days, was sick to her stomach and could not eat anything. She was also nauseous, felt weak, her arm was swollen and she had to stay in bed. No alternative aetiology was provided. Causality is assessed as possibly related for vaccination site pain, vaccination site warmth, nausea, pyrexia, abdominal discomfort, decreased appetite, asthenia, bedridden and peripheral swelling.; Sender's Comments: A 70-year-old patient was administered Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain and heat at injection site for several days, fever for three to four days, was sick to her stomach and could not eat anything. She was also nauseous, felt weak, her arm was swollen and she had to stay in bed. No alternative aetiology was provided. Causality is assessed as possibly related for vaccination site pain, vaccination site warmth, nausea, pyrexia, abdominal discomfort, decreased appetite, asthenia, bedridden and peripheral swelling.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site warmth, Nausea, Peripheral swelling
Clinical narrative: Pain and heat at injection site; Sick to her stomach; Feeling weak; Had to stay in bed; Arm was swollen; Couldn't eat anything; Nauseous; Fever; Pain and heat at injection site; This spontaneous case from the  was received on 11-Dec-2020 from other non-health professional via The agency (reference number: SEQW20-05716) and concerned a 70-year-old female patient.  The patient's medical history and concomitant medications were not reported.  On 16-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain and heat at injection site for several days, fever for three to four days, was sick to her stomach and could not eat anything. She was also nauseous, felt weak, her arm was swollen and she had to stay in bed.  On an unspecified date in 2020, the patient recovered from events of 'vaccination site warmth', fever and 'vaccination site pain'.   At the time of initial reporting on 11-Dec-2020, the patient was recovering from events 'stomach discomfort', 'weakness', 'bedridden', 'appetite lost', 'swollen arm' and nauseous, as she had improved.   The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  Company comment: A 70-year-old patient was administered Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain and heat at injection site for several days, fever for three to four days, was sick to her stomach and could not eat anything. She was also nauseous, felt weak, her arm was swollen and she had to stay in bed. No alternative aetiology was provided. Causality is assessed as possibly related for vaccination site pain, vaccination site warmth, nausea, pyrexia, abdominal discomfort, decreased appetite, asthenia, bedridden and peripheral swelling.; Sender's Comments: A 70-year-old patient was administered Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain and heat at injection site for several days, fever for three to four days, was sick to her stomach and could not eat anything. She was also nauseous, felt weak, her arm was swollen and she had to stay in bed. No alternative aetiology was provided. Causality is assessed as possibly related for vaccination site pain, vaccination site warmth, nausea, pyrexia, abdominal discomfort, decreased appetite, asthenia, bedridden and peripheral swelling.
Sex: U
Vaccine: FLUA4
Symptoms: Anxiety
Clinical narrative: Worried; This spontaneous case from the  was received on 14-Dec-2020 from other non-health professional (consumer) via the agency (reference number: SEQW20-05741) on 14-Dec-2020, and concerned an elderly, female patient.  The patient's medical history and concomitant medications were not reported. It was reported that the patient typically got vaccinated in late September and early October.  On 19-Aug-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; anatomical location, dose, indication, route of administration: not reported). The batch number was not reported.  On an unspecified date in 2020, unknown amount of time after receiving Fluad Quadrivalent, the patient became worried that she would not have effective coverage through to April.  At the time of initial reporting on 14-Dec-2020, the patient had not recovered from the event.  The reporter did not provide causality assessment to Fluad (TIV).  Company comment:The patient developed anxiety unknown amount of time after receiving the suspect product, Fluad Quadrivalent. Reportedly, the patient was worried that she would not have effective coverage through to April. The patient's medical history and concomitant medications were not reported. Causality is assessed as not related due to biological implausibility.; Sender's Comments: The patient developed anxiety unknown amount of time after receiving the suspect product, Fluad Quadrivalent. Reportedly, the patient was worried that she would not have effective coverage through to April. The patient's medical history and concomitant medications were not reported. Causality is assessed as not related due to biological implausibility.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Palpitations
Clinical narrative: heart racing above 100 for over 10 minutes when inactive. coughing.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Pyrexia
Clinical narrative: Insomnia, joint aches, low-grade fever
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT RECIEVED A 3RD DOSE
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Feeling hot, Headache, Syncope, Tremor
Clinical narrative: Patient received second covid shot from technician certified to vaccinate. Tech knocked on door, because when patient went to stand she felt like putting her head between her legs and fainting. I went in there and it looked like previous episodes of fainting I have seen so I tried to calm her and have her breath while patient was getting the blood pressure machine. Patient then fainted again a little more intensely, but still not alarming me that much. She came to and again I was talking with her to try to keep her alert. I asked her how she was feeling. She said she was extremely hot (she kept repeating this), that she had a headache, and asked for water. I told her we couldn't give her food or water until she felt better. We now had blood pressure monitor on her and it wouldn't read her pressure or pulse it kept saying error. I just used it on another patient with high blood pressure and it had been functional. I had been manually holding her pulse and it was strong and normal. Then she fainted again and started shaking. the shaking quickly stopped. She woke up and said that she couldn't see.  I asked tech to call 911, while I stayed with her and kept assessing her. Tech got the headset got 911 on the phone and turned the phone over to me. I asked her to grab another blood pressure monitor. We tried again and at 3:55pm it was 88/50 and pulse of 66. I was talking 911 and responding to all questions over the phone. I had to ask the patient for the responses (many COVID related questions). I told the lady her blood pressure and the lady said I don't need to know any of that. She wanted me to keep asking the patient questions. The blood pressure was 87/49 and pulse of 65 at 3:58. Now the EMT had arrived and assessed her. They said she fainted and she said she did not want to go with them. So they left. The patient remained at pharmacy for 45 to 90 min more until she was sure she felt okay enough to catch an uber home. I called her at 8:43pm and she said she feels much better, has eaten, and is with her boyfriend in case she experiences anymore ADRS. Upon asking who her primary physician is she said she last saw a doctor in another country.  She said her md only speaks another language. I asked her to call her MD and report to her in a different language what happened since I am unable to speak with her.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT UNDERAGE
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin swelling, Urticaria
Clinical narrative: Both of my legs  developed an itchy red rash approx 60 hours after the vaccine.  Hives/bumps and  patchy redness  on both  both calves and thighs.  My neck also feels itchy but not severe and no hives or red itchy rash.  I took two benedryl and used an OTC anti-itch cream  tonight and will see my doctor it it persists.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count decreased, Purpura
Clinical narrative: ITP with wet purpura and platelet count <10. No ICH at the time of admission.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Fatigue, Headache, Pain
Clinical narrative: Sore arm, dizzy, feeling tired, muscle aches, shaking, takes a lot of effort to stand, slight headache
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: Sore arm, dizzy, feeling tired, muscle aches, shaking, takes a lot of effort to stand, slight headache
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Confusional state, Fatigue, Headache
Clinical narrative: Fever of 102.3, severe body and muscle aches aches, throat pain, chills, confusion, headache, fatigue
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever of 102.3, severe body and muscle aches aches, throat pain, chills, confusion, headache, fatigue
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Throat tightness
Clinical narrative: Throat tightening, hoarseness starting 12 hours after and progressing.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Palpitations
Clinical narrative: After four days with no noticeable side effects or problems, I laid down for the night & noticed that my heart seemed to be struggling a great deal as in it seemed to be pounding hard, racing, & along with arrhythmia.  This continued with a severe & continuous struggle around the clock, but more extreme throughout the night.  I at first thought maybe I had some dehydration, but this did not seem to be the case.  I was diagnosed with light Tachycardia in 1987, but have never experienced anything like what has happened since the COVID-19 vaccine.  I searched the internet & noticed there are reports of other people suffering with the same issue & that a country has opened an investigation related to these heart struggles resulting in Myocarditis following the vaccine.  I am under the care of a cardio Dr. in a city who prescribed Metoprolol ER Succinate 50 mg  1 x daily, ordered a 30 day event monitor which just arrived in the mail, & has ordered an MRI, along with some lab work.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Rash, Rash macular, Rash pruritic
Clinical narrative: On monday morning may 10, we went to emergency at 1am in the morning.  My wife started to get red spots on her front chest, lower abdomen, and back on may 8.  Over a couple days it got more red and more dots.  The morning of may 10 it got ichy so she couldn't sleep and found there were more red dots so we went to emergency.  Doctor checked on it and said her experience is it will go away after a week.  It has been a few days and there are less dots and they are slightly less red.  Hopefully it will completely go away.  At the hospital she was given one pill of benadryl and a liquid steroid.  she was prescribed benadryl but she didn't want to take it.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Oral herpes, Tenderness, Tongue discomfort
Clinical narrative: I developed a herpes sore on my top lip 2 weeks post injection for both doses. Treated topically at home with OTC Abreva cream, resolved about 1 week later.  I also experienced oral discomfort on my hard palate and tongue about 24-48 following both injections. It was similar to a chemo side effect but not as severe, tenderness, kind of raw/burning sensation. Resolved on its own after several days
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Severe  unrelenting muscle cramps in right thigh
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Arthralgia, Chills, Eye swelling, Headache
Clinical narrative: About 6-7 hours after receiving the vaccine, I started to develop hives around my body, including on feet, stomach, ears, face, back, and legs. I had fever and chills, muscle aches, joint pain,  headaches,  and nausea later that night as well. The next morning, my left eye was swollen, left side of tongue completely swollen, lips swollen, and left side of throat closed (anaphylaxis). I took prednisone, Benadryl, and Tylenol to relieve the symptoms, and the swelling around my left eye, tongue, throat, and lips went away. Throughout the day, more hives have developed around my body and face, including my right eye.  I am continuing to take Benadryl and Tylenol and finish doses of prednisone. The fever and chills, muscles aches, joint pains, hives, headache, and nausea are still present.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Myalgia, Nausea, Pyrexia, Swollen tongue
Clinical narrative: About 6-7 hours after receiving the vaccine, I started to develop hives around my body, including on feet, stomach, ears, face, back, and legs. I had fever and chills, muscle aches, joint pain,  headaches,  and nausea later that night as well. The next morning, my left eye was swollen, left side of tongue completely swollen, lips swollen, and left side of throat closed (anaphylaxis). I took prednisone, Benadryl, and Tylenol to relieve the symptoms, and the swelling around my left eye, tongue, throat, and lips went away. Throughout the day, more hives have developed around my body and face, including my right eye.  I am continuing to take Benadryl and Tylenol and finish doses of prednisone. The fever and chills, muscles aches, joint pains, hives, headache, and nausea are still present.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: About 6-7 hours after receiving the vaccine, I started to develop hives around my body, including on feet, stomach, ears, face, back, and legs. I had fever and chills, muscle aches, joint pain,  headaches,  and nausea later that night as well. The next morning, my left eye was swollen, left side of tongue completely swollen, lips swollen, and left side of throat closed (anaphylaxis). I took prednisone, Benadryl, and Tylenol to relieve the symptoms, and the swelling around my left eye, tongue, throat, and lips went away. Throughout the day, more hives have developed around my body and face, including my right eye.  I am continuing to take Benadryl and Tylenol and finish doses of prednisone. The fever and chills, muscles aches, joint pains, hives, headache, and nausea are still present.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Lymphadenopathy
Clinical narrative: Injection site muscle tenderness/soreness shortly after injection. Swollen lymph node on the same side as injection 3-4 days after vaccine. Redness at injection site that appeared 7 days after vaccine and lasted for about a day; visited the doctor regarding the lymph node and redness since it was a delayed symptom.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood magnesium normal, Blood phosphorus normal, Blood thyroid stimulating hormone normal, Computerised tomogram thorax normal
Clinical narrative: Patient reported  symptomatic heart palpitations after receiving the 2nd dose of the Pfizer SARS-CoV2 mRNA vaccine on 5/11/2021 at 1pm which lasted a few hours. She then presented to her urgent care clinic around 3pm and was transferred to the Hospital ED. She was found to be in sinus tachycardia to HR 140s-150s. Work-up as described below was largely unrevealing. Plan for TTE on this hospital admission. Overall believe that severe anxiety is a the driving factor behind her sinus tachycardia, and that the SARS-CoV2 vaccination was just coincidental in time course.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Electrocardiogram abnormal, Fibrin D dimer increased, Full blood count normal, Metabolic function test normal
Clinical narrative: Patient reported  symptomatic heart palpitations after receiving the 2nd dose of the Pfizer SARS-CoV2 mRNA vaccine on 5/11/2021 at 1pm which lasted a few hours. She then presented to her urgent care clinic around 3pm and was transferred to the Hospital ED. She was found to be in sinus tachycardia to HR 140s-150s. Work-up as described below was largely unrevealing. Plan for TTE on this hospital admission. Overall believe that severe anxiety is a the driving factor behind her sinus tachycardia, and that the SARS-CoV2 vaccination was just coincidental in time course.