Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia, Respiration abnormal, Swelling face
Clinical narrative: Chest feels strange; Shortness of breath; Affected breathing; Immune system doesn't work well; Bedridden due to the pain; Very low energy; Lump nodules were swollen under chin and underarms; Trouble moving around doing normal tasks; Tingling in face, hands, and feet; Tired quickly; Feel full; Underarm lymph nodes and chin lymph nodes were hurting; Bedridden due to the pain; Face swollen; Body temperature 102 and 104; Joints still hurt greatly/sore joints/joints hurting; This is a spontaneous case, initially received from other non-health professional via agency (reference number: SEQ20-00719) on 24-Feb-2020 with an additional document received on the same day (being processed together), concerning a 64-year-old, female patient.  The patient's relevant medical history included increased body mass index (BMI), cigarette smoker, allergy to ciprofloxacin, sulfadiazine and dexlansoprazole, vitamin B12 deficiency disease, bladder muscle dysfunction - overactive, diverticular disease of colon, obstructive sleep apnea syndrome, mixed hyperlipidemia, mild intermittent asthma, spinal stenosis of lumbar region, nicotine dependence, panacinar emphysema and tobacco dependence in remission. The patient had two surgical procedures bilateral oophorectomy and hysterectomy.  The patient's past medications included unspecified flu shot, Zoster vaccine live (varicella zoster vaccine live), Pneumococcal 13 valent vaccine (pneumococcal vaccine 13v), Pneumococcal 23-polyvalent vaccin (pneumococcal vaccine polysacch 23v) and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid).  The patient's concomitant medications included ranitidine, oxybutynin, Symbicort (budesonide, formoterol fumarate), budesonide;formoterol, amlodipine and Albuterol (salbutamol) all for unknown indication.  On 04-Oct-2019, the patient was administered with Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261222, dose, route of administration, anatomical location and expiration date: not reported] for unknown indication. It was reported that no other medication was given at the time of shot.  On the same day, ever since (as reported) after vaccination, the patient's chest felt strange.  On 05-Oct-2019, one day after vaccination, the patient's face became swollen just a little, but she went to a play. By the end of night after vaccination, the patient developed sore joint and had temperature of 102. The patient took Aspirin (acetylsalicylic acid).  On 06-Oct-2019, reported as Sunday, two days after vaccination, the patient was bedridden.  On 07-Oct-2019, reported as Monday, three days after vaccination, the patient's temperature was 104 while joints, underarms lymph nodes and chin lymph nodes were hurting. The patient went to emergency room (ER) and was given unspecified intravenous (IV) steroid therapy and to her physician who discharged her the same day with diagnosis of adverse reaction to influenza vaccine. The vital signs showed blood pressure 122/89 mmHG. No laboratory tests for vaccine were performed. Assessment and Plan included scheduled tests on radiology: Bone density (BD), hip and bone spine (BS) on 06-Jan-2020, X ray chest 2 views post anterior (PA) and lateral (LAT) standard protocol on 09-Dec-2019, magnetic resonance imaging (MRI) of brain with contrast completed on 13-Dec-2019 and mammogram (MG) screen bilateral with tomosynthesis (Tomo) and coronary artery disease (CAD) standard protocol on 06-Jan-2020.  On an unspecified date, after vaccination, the patient's lump nodules under her chin and underarms were swollen. Most days, the patient had trouble moving around and doing normal tasks. Some days, the patient was bedridden due to the pain. It has affected patient's breathing, tingling in face, hands, feet. Also, the patient's joints still hurt greatly and shortness of breath was still an issues. The patient had very low energy, felt full, got tired quickly and her immune system didn't work well anymore. The patient stated that other physicians didn't known how to treat an adverse effect of a vaccine, so she was going to the medical facility, but Covid-19 came out. The patient was taking unspecified probiotics NOS, lots of vitamin C (ascorbic acid) and Elderberry (sambucus nigra) for what she believed that kept her going.  At the time of this report, the patient had not recovered from the events of 'mobility decreased', 'bedridden', 'pain', 'chest discomfort', 'tiredness', 'shortness of breath', 'immune system disorder (NOS)', 'energy decreased', 'arthralgia' and 'feeling abnormal'. The outcome of the events 'swelling face', 'swollen lymph nodes',  'lymph node pain', 'body temperature increased', 'tingling', and 'abnormal breathing' was not reported.  The reporter assessed the events as related to Flucelvax Quadrivalent, according to physician's diagnosis.  Follow up information received from other health professional on 05-Jun-2020: New reporter added and race updated. Batch number was confirmed while expiration date was confirmed as unknown. Start date for the events of 'swelling face', 'bedridden' and 'painful joints' was updated. New events of 'lymph node pain', 'body temperature increased', 'chest discomfort', 'tiredness', 'shortness of breath', 'immune system disorder (NOS)', 'energy decreased' and 'feeling abnormal' added. Treatment measures with Aspirin (acetylsalicylic acid), unspecified probiotics NOS, vitamin C (ascorbic acid) and Elderberry (sambucus nigra) added. Ranitidine, oxybutynin, Symbicort (budesonide, formoterol fumarate), budesonide;formoterol, amlodipine and Albuterol (salbutamol) added as concomitant medication. Vaccine facility information updated while blood pressure measurement and body temperature added as laboratory tests. Medical history updated for increased (BMI), cigarette smoker, allergy to ciprofloxacin, sulfadiazine and dexlansoprazole, vitamin B12 deficiency disease, overactive bladder, diverticular disease of colon, obstructive sleep apnea syndrome, mixed hyperlipidemia, mild intermittent asthma, spinal stenosis of lumbar region, nicotine dependence, unspecified colon disease, panacinar emphysema, tobacco dependence in remission and two surgical procedures bilateral oophorectomy and hysterectomy. The case and all events changed from medically confirmed as 'NO' to 'YES'. Event Trouble moving around doing normal tasks recoded to 'movement disorder' and therefore case downgraded. Narrative amended accordingly.  Significant case correction performed on 14-Jul-2020: The event of Trouble moving around doing normal tasks was recoded from LLT: Movement disorder to LLT: Mobility decreased. The narrative was amended accordingly.  Company comment: The patient experienced swelling face, chest discomfort, respiration abnormal, lymph node pain, body temperature increased and arthralgia after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. On an unspecified date, after vaccination the patient also developed lymphadenopathy, mobility decreased, pain, bedridden, paraesthesia, dyspnoea, asthenia, feeling abnormal, immune system disorder and fatigue. The patient's relevant medical history included increased body mass index (BMI), cigarette smoker, diverticular disease of colon, obstructive sleep apnea syndrome, mixed hyperlipidemia, mild intermittent asthma, spinal stenosis of lumbar region, panacinar emphysema and tobacco dependence in remission. Considering all the above mentioned, causality between suspect product and the events cannot be excluded and is assessed as possibly related except for lymphadenopathy, mobility decreased, pain, bedridden, paraesthesia, dyspnoea, asthenia, feeling abnormal, immune system disorder and fatigue, which is unassessable.; Reporter's Comments: The events are assessed as 'adverse reaction to influenza vaccine'; Sender's Comments: The patient experienced swelling face, chest discomfort, respiration abnormal, lymph node pain, body temperature increased and arthralgia after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. On an unspecified date, after vaccination the patient also developed lymphadenopathy, mobility decreased, pain, bedridden, paraesthesia, dyspnoea, asthenia, feeling abnormal, immune system disorder and fatigue. The patient's relevant medical history included increased body mass index (BMI), cigarette smoker, diverticular disease of colon, obstructive sleep apnea syndrome, mixed hyperlipidemia, mild intermittent asthma, spinal stenosis of lumbar region, panacinar emphysema and tobacco dependence in remission. Considering all the above mentioned, causality between suspect product and the events cannot be excluded and is assessed as possibly related except for lymphadenopathy, mobility decreased, pain, bedridden, paraesthesia, dyspnoea, asthenia, feeling abnormal, immune system disorder and fatigue, which is unassessable.