chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PNC13
Symptoms: Ultrasound scan abnormal
Clinical narrative: I have severe pain in my arm and my neck broke out, loosed out; I have severe pain in my arm and my neck broke out, loosed out; I have no or any movement in my arm; I have limited mobility in my arm; They found a fluid sac where the injection was put in that; I have a fluid around where the injection was in my arm; This is a spontaneous report from a contactable consumer reported a 66-year-old male received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on Sep2020 either 17 or 24th at a single dose on his arm for immunization. The patient's medical history was not reported. The patient took 'Fragmin' and he was not sure what he took his wife does all that for him. The reporter stated that he had the shot a month ago and ever since then for the first two weeks, he had severe pain in his arm and his neck broke out, loosed out, now that healed up, his doctor put him on couple of medications (Unspecified Medication) but now he had no or any movement in his arm and now the doctor was going to send him to an orthopedic. He had an ultrasound of the arm and shoulder done and they found a fluid sac where the injection was put in that, now do ever hear anything like that. The patient did not know if they had any solutions to how he can solve this because his doctor put him on antibiotics (unspecified medication) but that did not work. The sac (Intent: fluid sac) on the injection was immobilizing the patient. The patient added he can move his neck and limited mobility in his arm. The consumer stated that he had been taking Gabapentin 300 mg capsules and just started Amoxicillin-Clav 125 mg and the doctor had him on some pain pills but he didn't really take pain pills (Unspecified Medications). The outcome of the events severe pain in his arm and his neck broke out, loosed out was recovered and the outcome of the other events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: U
Vaccine: UNK
Symptoms: Inflammation, Injection site erythema, Pain in extremity
Clinical narrative: My arm became so painful; I see that it has some kind of inflammation in front of it; inflammation in front of it and where the shot was inserted on the muscles; Where the shot was inserted on my muscles and the skin has turned red; This is a spontaneous report from a contactable consumer (patient).  This patient of unspecified age and gender received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) via an unspecified route of administration on 19Oct2020 at single dose for immunisation. Relevant medical history and concomitant medications were not reported. In Oct2020, the patient stated that his/her arm became so painful; he/she saw that it had some kind of inflammation in front of it and where the shot was inserted on the muscles and the skin had turned red. The patient specified that he/she got a pneumonia shot and his/her arm became so painful and he/she noticed that it had some kind of inflammation in front of it. Where the shot was inserted on his/her muscles and the skin had turned red. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conjugate vaccine (dipht crm197 protein) in the country of incidence. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conjugate vaccine (dipht crm197 protein) has submitted the same report to the regulatory authorities.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injected limb mobility decreased, Injection site pain, Pain, Peripheral swelling
Clinical narrative: She could not lay on the arm (upper arm like below the shoulder), she could not put a pillow up on it; When she wanted to lift it, she could only lift it from my sides to 45 degrees; It was getting swell; she was tired so she took a nap; She didn't feel anything except that little sting that she said that would have; This is a spontaneous report from a contactable consumer (patient).   A 55-year-old female patient (height: 175 cm) received the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose, on an unspecified date, at about 10:15 this morning, for immunization. Relevant medical history was none. Concomitant medications included flu shot (unspecified medication). Patient specified that she got a flu shot (Unspecified medication) in her right arm and pneumococcal 13-val conj vac (dipht crm197 protein) in her left. The patient stated that, on an unspecified date, she could not lay on the arm (upper arm like below the shoulder), she could not put a pillow up on it. When she wanted to lift it, she could only lift it from my sides to 45 degrees. It was getting swell and she was tired so she took a nap. She didn't feel anything except that little sting that she said that would have. Clinical outcome of the adverse events was unknown at time of this report.   No follow up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: FLUA4
Symptoms: Dysphagia, Lymph node pain, Lymphadenopathy
Clinical narrative: Difficulty swallowing; Tender and swollen lymph nodes; Tender and swollen lymph nodes; This is a spontaneous case, initially received from a pharmacist via Agency (reference number: SEQW20-01032) on 29-Aug-2020, concerning a 74-year-old, female patient.  The patient had no relevant medical history.  The patient's concomitant medications included ibuprofen and clindamycin, both used for unreported indications.  On 28-Aug-2020, the patient was administered 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, batch number: 279784 and expiration date: 13-May-2021] for an influenza prophylaxis.  On 29-Aug-2020, one day after vaccination, the patient experienced tender and swollen lymph nodes, and difficulty swallowing. No corrective treatment was applied for the events.  At the time of this report, the patient did not recover from the events.  The reporter assessed the case as non-serious.  The reporter did not provide causality assessment.  Company comment: The patient developed dysphagia, lymph node pain and lymphadenopathy one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. No information about medical history was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed dysphagia, lymph node pain and lymphadenopathy one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. No information about medical history was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Myalgia, Pain, Pain in extremity
Clinical narrative: Pain in left arm; Generalized pain that she experienced most when lifting her arm; Feels like muscle pain; This spontaneous case was received on 31-Aug-2020 from Agency (reference number: SEQW20-01066), reported by pharmacist and concerned a 72-year-old, female patient.  The patient's concurrent condition included hypertension.  The patient's concomitant medications were not reported.  On 21-Aug-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 deltoid, route of administration and indication: not reported].   The batch number reported was 279791, expiration date reported was 28-May-2021.  On 22-Aug-2020, one day after receiving Fluad Quadrivalent, the patient experienced pain in left arm. The patient stated that the pain was not just limited at the injection site, but generalised pain most experienced when lifting her arm, and that felt like a muscle pain. The patient was advised to visit doctor.   At the time of initial reporting on 31-Aug-2020, the patient had not recovered from the events.  The reporter assessed the case as non-serious.  The reporter did not provide a causality assessment.  Company comment: A 72-year-old, female patient was administered Fluad Quadrivalent vaccine. On 22-Aug-2020, one day after receiving Fluad Quadrivalent, the patient reported pain in extremity, pain upon movement and myalgia. Causality is assessed as possibly related for all events, due to plausible chronology.; Sender's Comments: A 72-year-old, female patient was administered Fluad Quadrivalent vaccine. On 22-Aug-2020, one day after receiving Fluad Quadrivalent, the patient reported pain in extremity, pain upon movement and myalgia. Causality is assessed as possibly related for all events, due to plausible chronology.
Sex: F
Vaccine: FLUX
Symptoms: Pain, Swelling
Clinical narrative: Pain; Swelling; This spontaneous case was received on 31-Aug-2020 from other non-health professional via agency (reference number: SEQW20-01068) and concerned a female patient of unknown age.  The patient's medical history and concomitant medications were not reported.   The patient's past vaccines included unspecified flu vaccines after which the patient experienced pain and swelling (see case 202004353).   On an unspecified date, the patient was vaccinated with INN Seasonal flu vaccine [influenza virus vaccine polyvalent; dose, route of administration, anatomical location: not reported] for flu prevention.   The batch number was not reported.  On an unspecified date in 2019, an unknown amount of time after receiving INN Seasonal flu vaccine, the patient experienced pain and swelling.   The outcome of events was not reported.  The reporter did not provide causality assessment.  This case is linked to case 202004353 (the same patient).  Company comment: The patient developed pain and swelling on an unknown date and unknown amount of time after vaccination with the suspect product, INN Flu Vaccine Seasonal. Chronology is unclear. No information regarding concomitant medication and medical history was provided. Based on this information, causal relationship for both events is assessed as unassessable.; Sender's Comments: The patient developed pain and swelling on an unknown date and unknown amount of time after vaccination with the suspect product, INN Flu Vaccine Seasonal. Chronology is unclear. No information regarding concomitant medication and medical history was provided. Based on this information, causal relationship for both events is assessed as unassessable.
Age: 70.0
Sex: M
Vaccine: FLUA4
Symptoms: Body temperature increased, Headache, Mobility decreased, Myalgia, Pain
Clinical narrative: Burning pain in his arm and all over his body; Could not move to reach the phone; Headache; Myalgia; Temperature of 99.9 F; This spontaneous case was received on 01-Sep-2020 from a physician via Med Communications (reference number SEQW20-01130) and concerned a 70-year-old, male patient.  The patient's concurrent conditions included atrial fibrillation, atherosclerosis, dyslipidemia, benign prostatic hypertrophy, insulin resistance, gastroesophageal reflux disease (GERD) and gout.  The patient's concomitant medications included Indocin (indometacin), Aspirin (acetylsalicylic acid), chloroquine, magnesium, Crestor (rosuvastatin), Prevacid (lansoprazole), fish oil, carvedilol, irbesartan, chromium picolinate, tadalafil, Nature's Bounty probiotic, Vit D3 (colecalciferol), Mulivitamin unspecified, all used for unreported indications.   On 31-Aug-2020 at about 3:30 pm, the patient was vaccinated with Fluad Quad (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, dose: 0.5 ml, indication: influenza prophylaxis, route of administration: intramuscular, anatomical location: deltoid). The batch number was 279798, expiry date: 15-Jun-2021.   On 01-Sep-2020, at around 2 am, about ten and a half hours after receiving Fluad Quad, the patient woke up with burning pain in his arm and all over his body and headache. The patient reported it was hurting so much he could not move to reach his phone. In the morning, when the patient woke up the burning pains and headache were gone, the injection site was not tender nor red. The patient felt only mild myalgia that was getting better by the hour. The patient also had a temperature of 99.9 F but he did not retake his temperature.   At the time of initial reporting on 01-Sep-2020, the patient recovered from the events pain burning', movement disorder' and headache' and was recovering from the event myalgia'.  The outcome of the event fever' was not reported.  The reporter did not provide a causality assessment.  Company comment:The patient developed pain, movement disorder, headache, myalgia and pyrexia one day after vaccination with the suspect product, Fluad Quad. Chronology is plausible. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed pain, movement disorder, headache, myalgia and pyrexia one day after vaccination with the suspect product, Fluad Quad. Chronology is plausible. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Sex: M
Vaccine: FLUX
Symptoms: Discomfort, Peripheral swelling
Clinical narrative: Discomfort; Leg swells twice the size; This spontaneous case was received on 02-Sep-2020, from other health professional via agency (reference number: SEQW20-01197) and concerned a male patient of unspecified age. At the time of this report the patient was a 3-year-old.   The patient's concurrent condition included anaphylaxis to eggs. The patient's concomitant medications were not reported.   On an unknown date, the patient was vaccinated with INN Seasonal flu vaccine (influenza virus vaccine polyvalent, dose, route of administration and anatomical location: not reported) for influenza prophylaxis.   The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving INN Seasonal flu vaccine, the patient's leg swelled twice the size and the patient experienced discomfort.   On an unspecified date, reported as one to two weeks after the onset, the patient recovered from the events.  The reporter assessed the events of 'unilateral leg swelling' and discomfort to be related to INN Seasonal flu vaccine.  The reporter assessed the events as non-serious.  Company comment:The patient developed discomfort and peripheral swelling on an unknown date and unknown amount of time after vaccination with the suspect product, INN Flu Vaccine Seasonal. Chronology is unclear. No information regarding concomitant medication was provided. Based on this information, causal relationship for both events is assessed as unassessable.; Sender's Comments: The patient developed discomfort and peripheral swelling on an unknown date and unknown amount of time after vaccination with the suspect product, INN Flu Vaccine Seasonal. Chronology is unclear. No information regarding concomitant medication was provided. Based on this information, causal relationship for both events is assessed as unassessable.
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Fatigue, Feeling hot, Hyperhidrosis, Pyrexia
Clinical narrative: Did not have any energy/Low energy; Felt hot; Sweaty; Fatigue; Felt feverish; This spontaneous case was received on 03-Sep-2020 from other non-health professional via agency (reference number: SEQW20-01208) with an additional document received on 08-Sep-2020 (being processed together) and concerned a 73-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 25-Aug-2020, patient was vaccinated with Fluad Quad (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 mg (as reported), anatomical location: reported as left, route od administration: not reported) for an influenza prophylaxis.   The batch number was not reported.  On 26-Aug-2020, one day after receiving Fluad Quad, the patient experienced fatigue, she had no energy, felt hot and sweaty. She checked her temperature and did not have a temperature but felt feverish. The patient called her health care professional (HCP) and the pharmacy and took acetaminophen.   At the time of initial reporting on 03-Sep-2020, the patient was recovering from the events. She was some better, but not completely.   The reporter did not provide a causality assessment.  Company comment: Asthenia, feeling hot, hyperhidrosis, fatigue and pyrexia were associated with the use of the suspect product Fluad Quad. The events occurred one day after receiving the product. Chronology seems plausible. The patient started recovering from the events with corrective treatment. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as possibly related for all events (except for fatigue for which causality was assessed as unlikely due to reported asthenia/ low energy) considering temporal association and lack of confounders. (''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: Asthenia, feeling hot, hyperhidrosis, fatigue and pyrexia were associated with the use of the suspect product Fluad Quad. The events occurred one day after receiving the product. Chronology seems plausible. The patient started recovering from the events with corrective treatment. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as possibly related for all events (except for fatigue for which causality was assessed as unlikely due to reported asthenia/ low energy) considering temporal association and lack of confounders. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Injection site was red, hard and hot, looked aggravated; Injection site was red, hard and hot, looked aggravated; She started to ache a little at the injection site; Injection site was red, hard and hot, looked aggravated; This spontaneous case was received on 04-Sep-2020, from pharmacist (reference number: SEQW20-01270) and concerned a 72-year-old, female patient.  The patient's past medical history included hospitalisation in 1970s once due to a flu vaccine. The patient's concomitant medications were not reported.   On 31-Aug-2020, patient was vaccinated with unspecified Fluad Quadrivalent [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration, anatomical location: not reported] for influenza prophylaxis. The batch number reported was 279787, expiry date: 18-May-2021.  On 01-Sep-2020, on Tuesday, the patient started to ache a little at the injection site and then at night the injection site was red, hard and hot, looked aggravated.   On 03-Sep-2020, the patient called health care professional (HCP) and was advised to place warm packs on the site and if not better schedule an appointment to see the HCP.  At the time of initial reporting on 04-Sep-2020, the patient was recovering from the events. The patient stated it has started to go away now, but still pink with a hard spot where injection was administered.  The reporter did not provide a causality assessment.   This case is linked to case number 202004317 (the same reporter).  Company comment: The patient developed all events one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed all events one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Her arm is sore and unable to move it very well; Her arm is sore and unable to move it very well; This spontaneous case was received on 08-Sep-2020 from a physician via Agency (reference number SEQW20-01365) and concerned a 77-year-old, female patient.  The patient's concurrent conditions included diabetic, high cholesterol and heart disease. The patient's concomitant medications were not reported.  On 08-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, dose: 0.5 ml, indication: influenza prophylaxis, route of administration: intramuscular, anatomical location: right deltoid). The batch number reported was 279794, expiry date: 29-May-2021.   On the same day, the patient's arm was sore and she could hardly move it. The patient was placing ice and did not take any over the counter medications.  At the time of initial reporting on 08-Sep-2020, the patient did not recover from the events.   The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  Company comment: The patient developed movement disorder and pain in extremity on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and both events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed movement disorder and pain in extremity on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and both events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Age: 74.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Limb mass, Rash
Clinical narrative: Red arm after receiving the vaccine; Some kind of a hard mass underneath; Rash moved down and now it is on her breast, not painful or itchy; This spontaneous case from was received on 08-Sep-2020 from a pharmacist via Agency (reference number: SEQW20-01321) and concerned a 74-year-old female patient.   The patient's medical history was not reported. The patient's concomitant medications included atorvastatin and levothyroxine, both for unreported indication.   On 01-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 and anatomical location: not reported) for an influenza prophylaxis. The batch number was not reported, and expiry date was 12-May-2021.   On the same day, after receiving Fluad Quadrivalent, the patient had a red arm and some kind of mass underneath.   On an unspecified date in Sep-2020, after that (as reported), pharmacist called to check on the patient and she said that her arm was no longer red, but the rash moved down and was on her breast. It was not painful or itchy.  At the time of initial reporting on 08-Sep-2020, the patient had not recovered from 'rash'.    The outcome of upper extremity mass' was not reported.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  Company comment: The patient developed erythema and limb mass on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. The event of rash occurred on an unspecified date, making temporal relationship unclear. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and the event of rash is assessed as unassessable, while for other two events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed erythema and limb mass on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. The event of rash occurred on an unspecified date, making temporal relationship unclear. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and the event of rash is assessed as unassessable, while for other two events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Sex: F
Vaccine: FLUX
Symptoms: Pain, Swelling
Clinical narrative: Pain; Swelling; This spontaneous case was received on 31-Aug-2020 from other non-health professional via agency (reference number: SEQW20-01068) and concerned a female patient of unknown age.  The patient's medical history and concomitant medications were not reported.   On an unspecified dates, reported as in the previous years, the patient was vaccinated with INN Seasonal flu vaccines [influenza virus vaccine polyvalent; dose, route of administration, anatomical location: not reported] for flu prevention.   The batch number was not reported.  On an unspecified dates, an unknown amount of time after receiving INN Seasonal flu vaccine, the patient experienced pain and swelling.   The outcome of events was not reported.  The reporter did not provide causality assessment.  This case is linked to case 202004282 (the same patient).  Company comment:The patient developed pain and swelling on an unknown date and unknown amount of time after vaccination with the suspect product, INN Flu Vaccine Seasonal. Chronology is unclear. No information regarding concomitant medication and medical history was provided. Based on this information, causal relationship for both events is assessed as unassessable.; Sender's Comments: The patient developed pain and swelling on an unknown date and unknown amount of time after vaccination with the suspect product, INN Flu Vaccine Seasonal. Chronology is unclear. No information regarding concomitant medication and medical history was provided. Based on this information, causal relationship for both events is assessed as unassessable.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Back pain, Bursitis, Chest pain
Clinical narrative: Left shoulder blade bursa inflammation; This spontaneous case was received on 11-Sep-2020 from pharmacist via Agency (reference number: SEQW20-01552) and concerned a 71-year-old, female patient.  The patient's medical history and concomitant medications were not reported.   On 07-Sep-2020, the patient was vaccinated wit 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 279784 and expiry date was 12-May-2021.   On 08-Sep-2020, one day after administration of Fluad Quadrivalent, the patient experienced back pain, shoulder pain and chest pain radiating to her back. She was seen by her medical doctor (MD) and was diagnosed with left shoulder blade bursa inflammation. There was no reaction reported to injection site. The patient was given naproxen at an unknown dose for an unknown amount of time and it was helping with the pain.   On 10-Sep-2020, the patient called to report adverse reaction to the vaccine.   At the time of initial reporting on 11-Sep-2020, the patient had not recovered from the event.   The reporter assessed the event as related to Fluad Quadrivalent.   The reporter assessed the event as non-serious.  Company comment: The patient developed bursitis one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and the event is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed bursitis one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and the event is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Pruritus, Rash, Rash erythematous, Skin warm
Clinical narrative: Arm was warm to the touch; Arm was red; Red rash on thigh/red rash on neck; It was itching; This spontaneous case was received on 11-Sep-2020, from other non-health professional (consumer) to agency (reference number: SEQW20-01540) and concerned a 67-year-old, female patient.  The patient's medical history was not reported. The patient was healthy. The patient did not have high blood pressure and did not take any medications for cholesterol. The patient's concomitant medications included Premarin (estrogens conjugated) and unspecified vitamins, both used for unreported indications.  On 08-Sep-2020, 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 arm] for influenza prophylaxis. The batch number was 279787 and expiry date: 18-May-2021.  On 09-Sep-2020, one day after receiving Fluad Quadrivalent, the patient noticed that her arm was red, and when the patient felt it, it was also warm. At the evening, the patient noticed that there was red rash on her thigh. Firstly, the patient thought that it was a mosquito bite, but the patient was wearing long pants and was not sure.   On 11-Sep-2020, the rash got larger and was itching and the patient noticed red rash on her neck when was putting her beauty cream. No corrective treatment was applied for the events.  At the time of initial reporting on 11-Sep-2020, the patient's arm was less red and less warm to the touch, and outcome of these events was considered as resolving, while the outcome for the events of red rash' and itching' was not reported.  The reporter did not provide a causality assessment.   This case was assessed as non-serious.  Company comment: The patient developed all events one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. No information about medical history was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed all events one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. No information about medical history was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Contusion, Pain, Pain in extremity
Clinical narrative: Some pain; Her arm was sore; Bruising/black and blue from the shoulder to the elbow; This spontaneous case was received on 14-Sep-2020 from a pharmacist via Agency (reference number SEQW-01637) and concerned a 78-year-old, female patient.  The patient's medical history and concomitant medication details were not reported.  On 10-Sep-2020, the patient was vaccinated with Fluad Quad (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number was reported as 279784, expiration date: 13-May-2021.   On the same day, the patient noticed some pain and her arm was sore. The patient was treated with Advil (ibuprofen).  On an unspecified date in Sep-2020, the patient noticed the bruising. The pharmacist said that it was black and blue from the shoulder to the elbow and that it looked severe.  At the time of initial reporting on 14-Sep-2020, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  Company comment: The patient developed all events after vaccination with the suspect product, Fluad Quad. Chronology is plausible. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed all events after vaccination with the suspect product, Fluad Quad. Chronology is plausible. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Chills; Started feeling tired, aches and pains; Started feeling tired, aches and pains; This spontaneous case was received on 15-Sep-2020 from a other non health professional (consumer) via agency (reference number SEQW-01682) and concerned a 77-year-old, female patient.  The patient's medical history included high blood pressure and rheumatoid arthritis. The patient's concomitant medication included prednisone, Plaquinol (hydroxychloroquine sulfate), Cozaar (losartan potassium), Norvasc (amlodipine besilate) used for unreported indication.  On 04-Sep-2020, in the morning, the patient was vaccinated with Fluad Quad (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 mL, route of administration: intramuscular, anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.   On the same day, later in the evening, around 10:30 pm, the patient started feeling tired, aches and pains, and got chills afterwards.  On 05-Sep-2020, the patient was 100.1 °F on fever (usually her body temperature was 97.3 °F). After taking two extra strength Tylenol (paracetamol), the patient felt more comfortable. The patient also, drank a lot of water.  On 06-Sep-2020, reported as on Sunday, the temperature started to come down.  On 08-Sep-2020, the patient recovered from the events.  The reporter assessed the event to be related to Fluad Quad. This was the first-time patient had a side effect from a flu shot.  The reporter assessed the case as non-serious.  Company comment: The patient developed all events within one day after vaccination with the suspect product, Fluad Quad. Chronology is suggestive. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Reporter's Comments: This was the first-time patient had a side effect from a flu shot.; Sender's Comments: The patient developed all events within one day after vaccination with the suspect product, Fluad Quad. Chronology is suggestive. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Diarrhoea, Flatulence, Influenza like illness
Clinical narrative: Lot of gas; Flu-like symptoms; Diarrhea; This spontaneous case was received on 15-Sep-2020 from a other non-helath professional (consumer) via Med Communications (reference number SEQW-01738) and concerned a 71-year-old, male patient.  The patient's medical history and concomitant medication were not reported.  On 27-Aug-2020, the patient was vaccinated with Fluad Quad (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, anatomical location: left deltoid, dose, route of administration: not reported) for protection against seasonal influenza. The batch number was not reported.  On an unspecified date in Sep-2020, reported as about 10 days after vaccination with Fluad Quad, the patient started to experience flu-like symptoms.  On an unspecified date in Sep-2020, reported as two days later, the patient started to experience diarrhoea and had a lot of gas.  On an unspecified date in Sep-2020, the patient started treatment with over-the-counter antidiarrhoeal for the diarrhoea.  At the time of initial reporting on 15-Sep-2020, the patient had not recovered from the event.  The reporter assessed the case as non-serious and did not provide causality assessment.  Company comment: Flatulence, influenza-like illness (reported as 'Flu-like symptoms') and diarrhoea were associated with the use of the suspect product Fluad Quad. The events occurred approx. 10-12 days after vaccination making chronology unsuggestive for flatulence and diarrhoea and compatible for influenza-like illness. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as unrelated for flatulence and diarrhoea and unlikely related for influenza-like illness. (''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: Flatulence, influenza-like illness (reported as 'Flu-like symptoms') and diarrhoea were associated with the use of the suspect product Fluad Quad. The events occurred approx. 10-12 days after vaccination making chronology unsuggestive for flatulence and diarrhoea and compatible for influenza-like illness. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as unrelated for flatulence and diarrhoea and unlikely related for influenza-like illness. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Depressed level of consciousness, Hypotension, Immediate post-injection reaction, Syncope, Visual impairment
Clinical narrative: patient was "seeing stars" immediately after injection (told mom, not immunizer)--mom had her remain seated for ~5 min, then when she was feeling better she attempted to walk away and made it about 20 yards when she had episode of syncope. following fainting episode she came to be alert again in under a min; she heard pharmacist on duty direct technician to call 911. following episode, she remained seated at pharmacy for ~30 min, her blood pressure was low, and she was given water while seated. she had just eaten lunch prior to immunization, so unlikely due to low blood sugar.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: pain in arm for over a week
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flucelvax is only approved for use in patients age 4 and up. This patient was only 3 years 6 months at the time the vaccination was given. We have contacted the manufacturer and are awaiting information on their clinical trials regarding patients under age 4. Patient's parent states no adverse reaction to the vaccine given on 10/23 nor the 70 hours since the vaccine was administered
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Unevaluable event
Clinical narrative: Pt reports shoulder since vaccination, but that it has gradually gotten better.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Dyspnoea, Injection site erythema, Injection site irritation
Clinical narrative: Patient states she became short of breath and wheezy within a half hour of having the injection on Friday. She became weak and had to have assistance getting into the house. She sat to rest briefly, then got up to go to the bathroom and noticed her legs, feet, and hands had swollen, felt as though something was squeezing/pinching her wrists. She also had redness, swelling, and irritation at the injection site. Over the weekend, her daughter encouraged her to seek medical attention, so patient called a provider office. She declined further evaluation and states her symptoms are improving, and she feels much better today.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Peripheral swelling, Wheezing
Clinical narrative: Patient states she became short of breath and wheezy within a half hour of having the injection on Friday. She became weak and had to have assistance getting into the house. She sat to rest briefly, then got up to go to the bathroom and noticed her legs, feet, and hands had swollen, felt as though something was squeezing/pinching her wrists. She also had redness, swelling, and irritation at the injection site. Over the weekend, her daughter encouraged her to seek medical attention, so patient called a provider office. She declined further evaluation and states her symptoms are improving, and she feels much better today.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Patient reports having arm pain/soreness when reaching up or putting her coat on, or when laying on that arm in bed.  She states that is started within a few days to within a week of receiving the immunization. She has been taking Extra Strength Tylenol to help with the pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Body aches, Chills, Headache, Pain and swelling at injection site, Lethargy, Fatigue, Possible fever on 10/24,
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pain
Clinical narrative: Body aches, Chills, Headache, Pain and swelling at injection site, Lethargy, Fatigue, Possible fever on 10/24,
Age: 17.0
Sex: U
Vaccine: FLU4
Symptoms: Confusional state, Dizziness, Electrocardiogram normal, Eye movement disorder, Hyperhidrosis
Clinical narrative: 17 Y male came for flu vaccination received flu vaccine on his left deltoid. 5 minutes later, patient complained of dizziness to mother and started passing out. Assisted patient to the ground by mother and nurse. Observed patient with eyes rolled to the back and with confusion. Patient recovered in 45 sec. Patient assisted to chair. Patient given juice and came around. 10 minutes later patient had complaints of dizziness and blurry vision. Pale in appearance. Called ambulance and patient transferred to hospital. Per ED Notes Precipitating or alleviating factors: had some vagal sx before(Last year when he had rhinosinusitis),  , Associated signs and symptoms: vagal sx. Symptoms were positive for diaphoresis, syncope
Age: 17.0
Sex: U
Vaccine: FLU4
Symptoms: Loss of consciousness, Pallor, Vision blurred
Clinical narrative: 17 Y male came for flu vaccination received flu vaccine on his left deltoid. 5 minutes later, patient complained of dizziness to mother and started passing out. Assisted patient to the ground by mother and nurse. Observed patient with eyes rolled to the back and with confusion. Patient recovered in 45 sec. Patient assisted to chair. Patient given juice and came around. 10 minutes later patient had complaints of dizziness and blurry vision. Pale in appearance. Called ambulance and patient transferred to hospital. Per ED Notes Precipitating or alleviating factors: had some vagal sx before(Last year when he had rhinosinusitis),  , Associated signs and symptoms: vagal sx. Symptoms were positive for diaphoresis, syncope
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Hallucination, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced redness/swelling/tendernous at the site of injection. She had flu like symptoms with a fever of 100.8, along with hallucinations that her skin was popping out of her arms on the injected site
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient experienced redness/swelling/tendernous at the site of injection. She had flu like symptoms with a fever of 100.8, along with hallucinations that her skin was popping out of her arms on the injected site
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia, Rash
Clinical narrative: Aches, headache, shivers, fever, rash and hives
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Aches, headache, shivers, fever, rash and hives
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Decreased appetite, Tachycardia
Clinical narrative: Patient states she started to experience  severe anxiety that lasted for days after the vaccination. She also states that she has been experiencing tachycardia and a loss of appetite. Patient states that all these symptoms started about a week after the shot and is still having these symptoms persist. The patient is currently being accessed by her physician.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling face, Urticaria
Clinical narrative: Face completely swelled( eyes almost shut) and red. Hives and redness on body worse on thigh, neck and face
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: I took 2 Aleve's for injection redness & red discomfort - left arm. Redness went away after 5 - 6 days. I had big red blotch at site of injection. It was still red on my whole left arm for 5 or more days. It was tender. It bothered me. I took 2 Aleves. I was told to inquire if I should take a second shot 2-6 months later. My mother had a severe reaction to the Shingles shot, that I remember. She had to lie down. I was not dizzy, but I did have pain at the site - about 8 on a scale of 1 to 10. 5/29/2020 Pharmacy advised to take 2nd injection I had the second Shingrix (Shingles injection at. Pharmacy again on Oct 23, 2020. The site felt hot - but no other reaction.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Tenderness
Clinical narrative: I took 2 Aleve's for injection redness & red discomfort - left arm. Redness went away after 5 - 6 days. I had big red blotch at site of injection. It was still red on my whole left arm for 5 or more days. It was tender. It bothered me. I took 2 Aleves. I was told to inquire if I should take a second shot 2-6 months later. My mother had a severe reaction to the Shingles shot, that I remember. She had to lie down. I was not dizzy, but I did have pain at the site - about 8 on a scale of 1 to 10. 5/29/2020 Pharmacy advised to take 2nd injection I had the second Shingrix (Shingles injection at. Pharmacy again on Oct 23, 2020. The site felt hot - but no other reaction.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Nausea generalized aching lasting 1 day
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Lip exfoliation, Paraesthesia, Pruritus
Clinical narrative: Rash Hives - itching  peeling skin First place-between breast Did not go away - redness (rash) Prickling skin
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Rash Hives - itching  peeling skin First place-between breast Did not go away - redness (rash) Prickling skin