chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity
Clinical narrative: Dull ache when she is at rest and a shooting pain when she moves her left arm; Dull ache when she is at rest and a shooting pain when she moves her left arm; This spontaneous case was received on 29-Oct-2020 from other non-health professional via Med Communications (reference number: SEQW20-04480) and concerned a 42-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 08-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: intramuscular; anatomical location: left arm; dose and indication: not reported). The batch number reported was 276567 and expiry date was 30-Jun-2021.  On an unknown date in Oct-2020, within two days after receiving Flucelvax QIV, the patient experienced dull ache when she was at rest and shooting pain when she moved her left arm.   At the time of initial reporting on 29-Oct-2020, the patient had not recovered from events. As reported, the symptoms were still present.   The reporter did not provide a causality assessment.  Company comment: The patient experienced pain and pain in extremity (both reported as 'dull ache when she is at rest and a shooting pain when she moves her left arm') 2 days after administration of Flucelvax QIV. Causality is assessed as possibly related for both events due to lack of another confounder and based on temporal and anatomical plausibility.; Sender's Comments: The patient experienced pain and pain in extremity (both reported as 'dull ache when she is at rest and a shooting pain when she moves her left arm') 2 days after administration of Flucelvax QIV. Causality is assessed as possibly related for both events due to lack of another confounder and based on temporal and anatomical plausibility.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Hypoaesthesia, Injection site pain, Myalgia
Clinical narrative: Pain in the muscle and injection/muscle ache; Headache; Pain in the muscle and injection/muscle ache; Numbness; This spontaneous case was received on 30-Oct-2020 from pharmacist via Med Communications (reference number: SEQW20-04558) and concerned a 48-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 08-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: arm and route of administration: intramuscular) for influenza prophylaxis. The batch number reported was 276564. Expiry date reported was 30-JUN-2021. This was the first time the patient had ever received the vaccine.  On 09-Oct-2020, one day after vaccination, the patient felt pain in the muscle and injection site. The patient also had other typical side effects such as muscle ache and headache.  On an unspecified date in Oct-2020, reported as around that time, the numbness started, but the patient still felt numbness especially in the morning.  On an unspecified date in Oct-2020, the patient recovered from the event 'muscle ache', 'vaccination site pain' and headache. The reporter stated all these symptoms have gone away. Patient has no pain anymore.  At the time of initial reporting on 30-Oct-20220, the patient had not recovered from the event 'numbness'. The reporter stated, the numbness is not improving.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the events as non-serious.  Company comment:The patient developed hypoaesthesia, myalgia, headache and vaccination site pain after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. The patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed hypoaesthesia, myalgia, headache and vaccination site pain after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. The patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Age: 84.0
Sex: M
Vaccine: FLUA3
Symptoms: Asthenia, Extra dose administered, Nausea
Clinical narrative: Weakness; Nausea; Patient received 2 doses of Fluad TIV in the same season; This spontaneous case was received on 30-Oct-2020 from a physician via Med Communications (reference number: SEQW20-04549) and concerned a 84-year-old, male patient.  The patient's concurrent conditions included severe systolic and diastolic heart failure, kidney disease, hyperlipidemia and glaucoma. The patient's concomitant medications included Baby Aspirin (acetylsalicylic acid), atorvastatin, furosemide, hydralazine (reported as hydro lysine), adjuvanted inhaler Advair diskus (fluticasone propionate, salmeterol xinafoate), albuterol (salbutamol), all for unreported indications.  On an unspecified date in Oct-2020 (reported as 06-Oct-2020 and 23-Oct-2020), the patient was vaccinated with Fluad (TIV) (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 reported was 279736 and expiry date was 04-May-2021.  On 29-Oct-2020, the patient was vaccinated with the second dose of Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) (explicitly coded as 'Extra dose administered') for influenza prophylaxis. The batch number reported was 279736 and expiry date was 04-May-2021.  On the same day, 20 minutes after receiving the second dose of Fluad (TIV), the patient experienced nausea and weakness.  On an unspecified date in Oct-2020, the patient recovered from the event of nausea.  At the time of initial reporting on 30-Oct-2020, the patient was recovering form the event of weakness.  The reporter did not provide a causality assessment.  The reporter assessed events of weakness and nausea as non-serious.  Company comment: On an unspecified date in Oct-2020, the patient was vaccinated with Fluad (TIV). On 29-Oct-2020, the patient was vaccinated with the second dose of Fluad (TIV). On the same day, 20 minutes after receiving the second dose of vaccine, the patient experienced nausea and asthenia. Chronology is plausible. Based on provided information, causality is assessed as possibly related for both events. Extra dose administered is assessed as not related per company's conventions.; Sender's Comments: On an unspecified date in Oct-2020, the patient was vaccinated with Fluad (TIV). On 29-Oct-2020, the patient was vaccinated with the second dose of Fluad (TIV). On the same day, 20 minutes after receiving the second dose of vaccine, the patient experienced nausea and asthenia. Chronology is plausible. Based on provided information, causality is assessed as possibly related for both events. Extra dose administered is assessed as not related per company's conventions.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Petechiae, Pruritus, Rash papular
Clinical narrative: Itchy legs; Whole body was covered in rash/The rash appeared it started spreading to other parts of his body/Rash as red dots which were bumpy, raised, very itchy and some had popped; Whole body was covered in rash/The rash appeared it started spreading to other parts of his body/Rash as red dots which were bumpy, raised, very itchy and some had popped; Whole body was covered in rash/The rash appeared it started spreading to other parts of his body/Rash as red dots which were bumpy, raised, very itchy and some had popped; This spontaneous case was received on 09-Nov-2020 from other non-health professional via Med Communications (reference number: SEQW20-04943) and concerned a 42-year-old male patient.  The patient's medical history was not reported. The patient's concomitant medications included Zyrtec (cetirizine hydrochloride) for unreported indication.  On 04-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration and anatomical location: not reported) for prevention of seasonal influenza. The batch number was not reported.  On an unspecified date in Oct-2020, within a week after receiving Afluria Quadrivalent, the patient started to get itchy legs, just above his knees.  On an unspecified date in Oct-2020, two days after the itch, the rash appeared it started spreading to other parts of his body. The patient described the rash as red dots which were bumpy, raised, very itchy and some had popped.  On an unspecified date in Oct-2020, the patient had seen his physician which provided him with antibiotics, doxycycline and steroid topical cream which did not work for him. The patient also had taken six Benadryl (diphenhydramine hydrochloride) tablets a day which did not do anything. Additionally, ice packs help. Furthermore, the patient had seen a dermatologist and was given a steroid injection. Lastly, the patient's physician has advised him to take an allergy test.  The outcome of the evet was not reported.  The reporter did not provide a causality assessment.  Company comment: The events of 'erythematous rash', 'raised rash', 'itchy rash' and 'pruritus' are considered as related to Afluria Quadrivalent vaccine.; Sender's Comments: The events of 'erythematous rash', 'raised rash', 'itchy rash' and 'pruritus' are considered as related to Afluria Quadrivalent vaccine.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Swelling; Burning at the injection site; Hives; This spontaneous case was received on 12-Nov-2020 from a nurse via Med Communications (reference number: SEQW20-05059) and concerned a 31-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 16-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose; 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prevention. The batch number reported was 276539, and expiration date was reported as 14-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient experienced burning at the injection site, swelling and hives. The patient went to urgent care where she was told to take ice and Benadryl (diphenhydramine hydrochloride).  At the time of initial report on 12-Nov-2020, the patient was recovering from the events, and she was feeling better.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  This case is linked to a case 2020006297 (the same reporter).  Company comment: A 31-year-old, female patient was administered Flucelvax QIV. On the same day, soon after receiving vaccine, the patient experienced burning at the injection site, swelling and hives. The patient had no relevant medical history and was not taking any concomitant medications. Causal role of the suspect vaccine is assessed as possibly related for vaccination site pain, urticaria and swelling.; Sender's Comments: A 31-year-old, female patient was administered Flucelvax QIV. On the same day, soon after receiving vaccine, the patient experienced burning at the injection site, swelling and hives. The patient had no relevant medical history and was not taking any concomitant medications. Causal role of the suspect vaccine is assessed as possibly related for vaccination site pain, urticaria and swelling.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Blister, Nodule, Swelling, Urticaria
Clinical narrative: Swelling; Knot; Blistering welts; Hives; This spontaneous case was received on 12-Nov-2020 from other health professional (nurse) via agency (reference number: SEQW20-05062) and concerned a 32-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications. The patient's historical vaccine included Flucevax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent), without adverse reactions.   On 02-Nov-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prevention. The batch number reported was 276539 and expiry date was 14-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient experienced swelling, knot, hives and blistering welts. The patient was advised to apply ice.   At the time of initial reporting on 12-Nov-2020, the patient was recovering from the events, and she was feeling better.   The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to cases 202006294 (the same reporter).  Company comment: A 32-year-old, female patient was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient experienced swelling, mass (knot), urticaria and blister. With information available, causal role of suspect vaccine is assessed as possibly related.; Sender's Comments: A 32-year-old, female patient was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient experienced swelling, mass (knot), urticaria and blister. With information available, causal role of suspect vaccine is assessed as possibly related.
Sex: F
Vaccine: FLUC4
Symptoms: Local reaction
Clinical narrative: A large local reaction to Flucelvax; This spontaneous case was received on 12-Nov-2020 from physician via Med Communications (reference number: SEQW20-05057) and concerned an adult, female patient. The patient's age at the time of reporting was 24 years.   The patient's medical history and concomitant medications were not reported.  On unspecified date in 2019, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, indication, dose, anatomical location and route of administration: not reported). The batch number was not reported.  On unspecified date in 2019, an unknown amount of time after receiving Flucelvax QIV, the patient was having a large local reaction to Flucelvax.  The outcome of the event was not reported.  The reporter assessed the event to be related to Flucelvax QIV.  This case is linked to 202006474 (the same patient).  Company comment: The patient developed local reaction an unknown amount of time after receiving Flucelvax QIV. Although onset date for the event was not provided, narrative suggested plausible temporal relationship. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed local reaction an unknown amount of time after receiving Flucelvax QIV. Although onset date for the event was not provided, narrative suggested plausible temporal relationship. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Pain every time he rised the arm; Arm hurting; Pain at injection site; This spontaneous case was received on 13-Nov-2020 from pharmacist via Med Communications (reference number: SEQW20-05095) and concerned a 44-year-old male patient.  The patient's concurrent conditions included allergy to sulfites. The patient's concomitant medications were not reported.  On 13-Oct-2020, the patient was vaccinated with Flucelvax QIV vaccine (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: arm and indication: not reported). The batch number reported was 276543, expiration date: 19-Jun-2021.  On an unknown date, unknown amount of time after receiving Flucelvax QIV, the patient felt pain at injection site. As reported, the patient felt the arm hurting since he received the vaccine and had pain every time he raised the arm. No treatment measures were taken.  At the time of initial reporting on 13-Nov-2020, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 44-year-old male patient was vaccinated with Flucelvax QIV. An unknown amount of time after receiving Flucelvax QIV, the patient developed vaccination site pain, pain in extremity and pain upon movement. With information available, causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: A 44-year-old male patient was vaccinated with Flucelvax QIV. An unknown amount of time after receiving Flucelvax QIV, the patient developed vaccination site pain, pain in extremity and pain upon movement. With information available, causal role of the suspect vaccine is assessed as possibly related.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm was in sighificant pain; Most sore when I lift it up or am changing shirts; This spontaneous case was received on 16-Nov-2020 via Med Communications (reference number: SEQW20-05139) from pharmacist with an additional document received on the same day from the same reporter (being processed together) and concerned a 30-year-old, female patient.  The patient's relevant medical history was not reported. The patient's concomitant medication was Kariva (desogestrel, ethinylestradiol), used for birth control. The patient's vaccination history included annual flu shot for many years.  On 02-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; anatomical location: upper left arm, route of administration: intramuscular, dose: not reported) for flu prophylaxis for the first time. The batch number reported was 276580 and expiry date was 30-Jun-2021.  On the same day, by evening, after receiving Flucelvax QIV, the patient's arm was in significant pain where she could not use it.   On 03-Oct-2020, reported as next morning, most of the pain had resolved, but it was still sore.  At the time of initial reporting on 16-Nov-2020, the patient had not recover from the events, as she reported her arm had been sore every day since vaccination, and it was still sore, now. It was the most sore when the patient lifted it up or she was changing shirts.  The reporter assessed the events to related to Flucelvax QIV. The reporter stated, would like to report an adverse event with Flucelvax.  The reporter assessed the events as non-serious.  Company comment: A 30-year-old, female patient was administered Flucelvax QIV. On the same day, after receiving Flucelvax QIV, the patient experienced pain in extremity. Reportedly, it was the most sore when the patient lifted it up or she was changing shirts. Causality is assessed as possibly related for pain in extremity and pain upon movement, due to plausible temporal relationship and no alternative aetiology provided.; Reporter's Comments: The reporter stated, would like to report an adverse event with Flucelvax.; Sender's Comments: A 30-year-old, female patient was administered Flucelvax QIV. On the same day, after receiving Flucelvax QIV, the patient experienced pain in extremity. Reportedly, it was the most sore when the patient lifted it up or she was changing shirts. Causality is assessed as possibly related for pain in extremity and pain upon movement, due to plausible temporal relationship and no alternative aetiology provided.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Nausea, Peripheral swelling
Clinical narrative: Limb swelling; Chilling and nausea; Chilling and nausea; This spontaneous case was received on 16-Nov-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-05148) and concerned a 44-year-old, female patient.  The patient's concurrent condition included blood clots. The patient's concomitant medications included Aspirin (acetylsalicylic acid) for unreported indication.  On 13-Nov-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 mL, route of administration: intramuscular and anatomical location: deltoid) as flu prophylaxis. The batch number reported was 279841 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient experienced chilling and nausea.  On 15-Nov-2020, three days after receiving Flucelvax QIV, the patient developed swelling in her limb.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  This case is linked to case 202006418 (the same reporter).  Company comment: A 44-year-old, female patient was vaccinated with Flucelvax QIV. On the same day, after receiving Flucelvax QIV, the patient experienced chilling and nausea. Three days after receiving Flucelvax QIV, the patient developed swelling in her limb. Causality is assessed as possibly related for peripheral swelling, chills and nausea, due to plausible chronology.; Sender's Comments: A 44-year-old, female patient was vaccinated with Flucelvax QIV. On the same day, after receiving Flucelvax QIV, the patient experienced chilling and nausea. Three days after receiving Flucelvax QIV, the patient developed swelling in her limb. Causality is assessed as possibly related for peripheral swelling, chills and nausea, due to plausible chronology.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Nausea
Clinical narrative: Chilling and nausea; Chilling and nausea; This spontaneous case was received on 16-Nov-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-05148) and concerned a 28-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 13-Nov-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 mL, route of administration: intramuscular and anatomical location: deltoid) as flu prophylaxis. The batch number reported was 279841 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient experienced chilling and nausea.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  This case is linked to case 202006417 (the same reporter).  Company comment: The events of nausea and chills are considered as related to Flucelvax QIV.; Sender's Comments: The events of nausea and chills are considered as related to Flucelvax QIV.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site scab
Clinical narrative: Mark near injection site, looks like a scab; This spontaneous case was received on 20-Nov-2020 from pharmacist via Med Communications (reference number: SEQW20-05342) and concerned a 59-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications. As reported, this was the patient's first flu shot.  On 15-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, anatomical location: right arm, indication and route of administration: not reported). The batch number reported was P100240196, expiry date: 19-May-2021.   On the same day, after receiving Afluria Quadrivalent, the patient developed mark near injection site that looked like a scab. No corrective treatment was given for the event.  At the time of initial reporting on 20-Nov-2020, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: The patient developed scab on the same day after receiving Afluria Quadrivalent. Since several days are needed for scab to form, chronology is implausible. The patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship is assessed as not related due to temporal implausibility.; Sender's Comments: The patient developed scab on the same day after receiving Afluria Quadrivalent. Since several days are needed for scab to form, chronology is implausible. The patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship is assessed as not related due to temporal implausibility.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Lymphadenopathy, Night sweats
Clinical narrative: Lymph node swellings under her arm pit; Night sweats; This spontaneous case was received on 25-Nov-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-05432) and concerned a 61-year-old female patient.  The patient's medical history and concomitant medications were not reported.   On 06-Nov-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: intramuscular, indication, dose, anatomical location: not reported). The batch number was not reported.  On 07-Nov-2020, one day after receiving Flucelvax QIV, the patient experienced night sweats and lymph node swellings under her arm pit.  At the time of initial reporting, the patient had not recovered from the events and was monitoring the events.  The reporter did not provide a causality assessment.  Company comment: A 61-year-old female patient developed lymphadenopathy and night sweats one day after vaccination with the suspect product, Flucelvax QIV. Information regarding the patients underlying medical history and concomitant medications have not been provided. More information regarding the anatomical location of the vaccination as well as the location of lymphadenopathy is needed. With information presented, causality cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes).; Sender's Comments: A 61-year-old female patient developed lymphadenopathy and night sweats one day after vaccination with the suspect product, Flucelvax QIV. Information regarding the patients underlying medical history and concomitant medications have not been provided. More information regarding the anatomical location of the vaccination as well as the location of lymphadenopathy is needed. With information presented, causality cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes).
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Pain, Pyrexia, Skin disorder, Urticaria
Clinical narrative: Hives all over her torso, calves, armpits, and the back of her hands; Two red dots appear on the skin around her ribcage; Chills; Fever; Body aches; This spontaneous case  was received on 30-Nov-2020 via Med Communications (reference number: SEQW20-05480), received by other non-health professional (consumer) and concerned a 58-year-old, female patient.  The patient's historical vaccine included vaccination with Fluvirin on 6-Oct-2015 and 27-Nov-2016 and Afluria QIV on 25-Nov-2019 and the patient experienced no issues after receiving those vaccines. The patient's relevant medical history and concomitant medications were not reported.  On 25-Nov-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: left deltoid, and route of administration: not reported) for protection against seasonal influenza. The batch number was not reported.  On the same day, shortly after receiving Flucelvax QIV, the patient saw two red dots appear on the skin around her ribcage.  On an unspecified day in Nov-2020, reported as overnight after receiving Flucelvax QIV, the patient developed body aches, chills, and fever. These issues worsened through the night and by the time the patient woke up for breakfast the next day, these issues still persisted.  On 28-Nov-2020, three days after receiving Flucelvax QIV, the patient developed hives all over her torso, calves, armpits, and the back of her hands.   On 29-Nov-2020, the patient went to an urgent care center and received a steroid shot, but it did not seem to work. The patient subsequently received a dexamethasone shot and it seems to have worked a little, but the symptoms were coming back.  At the time of initial reporting on 30-Nov-2020, the patient had not recovered from the events.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reported assessed the events as non-serious.  Company comment: A 58-year-old, female patient developed general body pain, skin disorder (reported as two red dots appear on the skin around her ribcage), chills, pyrexia and urticaria after vaccination with the suspect product, Flucelvax QIV. Information regarding the underlying medical history and concomitant drugs have not been provided. With information presented, causality cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes).; Sender's Comments: A 58-year-old, female patient developed general body pain, skin disorder (reported as two red dots appear on the skin around her ribcage), chills, pyrexia and urticaria after vaccination with the suspect product, Flucelvax QIV. Information regarding the underlying medical history and concomitant drugs have not been provided. With information presented, causality cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes).
Sex: U
Vaccine: FLUC4
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This spontaneous case was received on 02-Dec-2020 from physician via Med Communications (reference number: SEQW20-05537) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza vaccine, that the reporter believed was Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose, route of administration and anatomical location: not reported) as protection against seasonal influenza, but was not completely sure. The batch number was not reported.   On an unknown date, an unknown amount of time after receiving Flucelvax QIV, the patient developed reaction to vaccine, which was assumed to be an allergic reaction. The reporter did not know any additional information.   The outcome of the event was not reported.   The reporter assessed the event as related to Flucelvax QIV.  The reporter assessed the event as non-serious.  Case updated on 10-Feb-2021: Correction made to information received on 02-Dec-2020: Company causality changed from related to unassessable for the event of 'allergic reaction'. No changes were made in narrative. Company comment updated accordingly.   Company comment: The event of 'allergic reaction' is considered as unassesseable to Flucelvax QIV.; Reporter's Comments: Patient received an influenza vaccine and developed a reaction to it.; Sender's Comments: The event of 'allergic reaction' is considered as unassesseable to Flucelvax QIV.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Pruritic urticarial rash; Pruritic urticarial rash; This spontaneous case was received on 07-Dec-2020 from a physician via Med Communications (reference number: SEQW20-05632) and concerned a 57-year-old female patient.   The patient's concurrent condition included high cholesterol and palpitations. The patient's concomitant medications included Crestor (rosuvastatin calcium), levothyroxine, metoprolol and trazodone, all used for an unreported indication.  On 04-Dec-2020, the patient was vaccinated with Flucelvax QIV vaccine (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: arm) for influenza prophylaxis. The batch number reported was 279841 and expiration date: 20-Jun-2021.    On 05-Dec-2020, one day after receiving Flucelvax QIV, the patient developed pruritic urticarial rash.   On an unspecified date in Dec-2020, the patient was treated with Benadryl (diphenhydramine hydrochloride) and prednisone for the events.  At the time of initial reporting on 07-Dec-2020, the patient was recovering from the event, as it was reported that the patient was feeling better.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The both events are assessed as related to Flucelvax QIV vaccine.; Sender's Comments: The both events are assessed as related to Flucelvax QIV vaccine.
Age: 39.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Local reaction, Tenderness
Clinical narrative: A localized reaction with erythema and tenderness in the arm; A localized reaction with erythema and tenderness in the arm; This spontaneous case was received on 11-Dec-2020 via agency (reference number: SEQW20-05717), reported by a physician and concerned a 39-year-old, female patient.  The patient's relevant medical history and concomitant medications were not reported.  On 08-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279847 and expiry date was 30-Jun-2021.  On an unreported date in 2020, after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. The patient did not receive any treatment.  On an unreported date in 2020, within 48h to 72h, the patient recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to cases 202007626, 202007628 and 202007631 due to the same reporter.  Company comment: A 39-year-old patient was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. Causality is assessed as possibly related for both events.; Sender's Comments: A 39-year-old patient was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. Causality is assessed as possibly related for both events.
Age: 20.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Local reaction, Tenderness
Clinical narrative: A localized reaction with erythema and tenderness in the arm; A localized reaction with erythema and tenderness in the arm; This spontaneous case was received on 11-Dec-2020 via agency (reference number: SEQW20-05718), reported by a physician and concerned a 20-year-old, female patient.  The patient's relevant medical history and concomitant medications were not reported.  On 04-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279847 and expiry date was 30-Jun-2021.  On an unreported date in 2020, after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. The patient did not receive any treatment.  On an unreported date in 2020, within 48h to 72h, the patient recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to cases 202007626, 202007627 and 202007628 due to the same reporter.  Company comment: A 20-year-old patient was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. Causality is assessed as possibly related for both events.; Sender's Comments: A 20-year-old patient was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. Causality is assessed as possibly related for both events.
Sex: M
Vaccine: FLUC3
Symptoms: SARS-CoV-2 test negative, Thyroiditis
Clinical narrative: Thyroiditis was diagnosed; This spontaneous case was received on 14-Dec-2020  from a physician via agency (reference number: SEQW20-05764) with an additional document received on the same day from a physician via agency (reference number: SEQW20-05762) (being processed together) and concerned a male patient of unknown age.  The patient had no relevant medical history. The patient's concomitant medications included unspecified vitamin D for an unreported indication.  On 06-Nov-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration and anatomical location: not reported) for flu prevention. The batch number was not reported and expiry date was 30-Jun-2021.   On 11-Nov-2020, five days after receiving Flucelvax Quadrivalent, the patient started feeling palpitation, severe muscle pain and severe headache.   On 21-Nov-2020, the patient was tested for COVID and was negative.  On 23-Nov-2020, the patient was diagnosed with thyroiditis. No other infections or signs were reported.   On an unspecifed date in 2020, the patient started treatment with Inderal (propranolol hydrochloride) at a dose of 40 mg, three times a day, for thyroiditis.   The outcome of the event thyroiditis was not reported.  The reporter reporter assessed the event as related to Flucelvax Quadrivalent. The reporter considered the event was a vaccine side effect.   The reporter assessed the event of thyroiditis as non-serious.  Company comment: A male patient experienced sympthoms of thyroiditis 5 days after administration of Flucelvax Quadrivalent. Thyroiditis was diagnosed 17 days post vaccination. The patient had no relevant medical history, while concomitant medications included unspecified vitamin D for an unreported indication. The patient was tested for COVID and was negative. Causality is assessed as possibly related due to lack of other confounding factors.; Reporter's Comments: The reporter considered the event was a vaccine side effect.; Sender's Comments: A male patient experienced sympthoms of thyroiditis 5 days after administration of Flucelvax Quadrivalent. Thyroiditis was diagnosed 17 days post vaccination. The patient had no relevant medical history, while concomitant medications included unspecified vitamin D for an unreported indication. The patient was tested for COVID and was negative. Causality is assessed as possibly related due to lack of other confounding factors.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Temporary but loud tinnitus and hearing loss. Comes and goes every few days
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: Heavier menstruation and heavier cramping, cycle is also 3 weeks early
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: 8 days after shot, dime sized bruising appeared at injection site,  along with a red circle about two inches in diameter. Was not raised, painful, or sensitive. Went away with no treatment after about 2 days.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Oligomenorrhoea
Clinical narrative: Abnormal menstruation following vax. Longer & heavier menstrual bleeding. Periods usually ~7 days light to moderate. After vaccines, period was 12 days and heavier than usual 1-28-21 to 2-8-21. Next period was 20 days of extremely heavy bleeding (most I've ever had) 3-5-21 to 3-24-21. And now it has been 6.5 weeks since that period with no spotting or period.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Diverticulitis, Hot flush
Clinical narrative: Diverticulitis starting 2/14/21 (this condition had never been diagnosed previously). After second vaccine on 3/2/21 began experiencing hot flashes.  Have not experienced them for many years as I am post menopausal.  As time has passed I seem to be experiencing even more hot flashes.  As of today, I am still experiencing hot flashes.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nosebleeds for 3 days after getting the vaccine. One bleed per day
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Audiogram abnormal, Deafness unilateral, Dysphagia, Headache, Myringotomy
Clinical narrative: Patient started to notice Rt sided hearing loss  4hrs 15mins post COVID-19 Moderna 2nd dose. Conducted Audiology hearing test 3 weeks post second shot secondary to on-going and pronounced hearing loss within right ear.  Patient referred to ENT. ENT provider prescribed oral steroids for one week.  Hearing loss persisted with worsening of symptoms throughout treatment with steroids and at 1-wk post conclusion of steroid treatment. ENT performed a myringotomy of the right ear on 04 MAY 21, with no improvement of hearing post-procedure. Meanwhile additional symptoms have presented with difficulty swallowing water and oral secretions on right sided, with pinpointed right-sided headaches starting on 08 MAY 21.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Salivary hypersecretion, Tympanometry
Clinical narrative: Patient started to notice Rt sided hearing loss  4hrs 15mins post COVID-19 Moderna 2nd dose. Conducted Audiology hearing test 3 weeks post second shot secondary to on-going and pronounced hearing loss within right ear.  Patient referred to ENT. ENT provider prescribed oral steroids for one week.  Hearing loss persisted with worsening of symptoms throughout treatment with steroids and at 1-wk post conclusion of steroid treatment. ENT performed a myringotomy of the right ear on 04 MAY 21, with no improvement of hearing post-procedure. Meanwhile additional symptoms have presented with difficulty swallowing water and oral secretions on right sided, with pinpointed right-sided headaches starting on 08 MAY 21.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Audiogram, Cough, Deafness unilateral, Dizziness
Clinical narrative: Patient started to notice Rt sided hearing loss  4hrs 15mins post COVID-19 Moderna 2nd dose. Conducted Audiology hearing test 3 weeks post second shot secondary to on-going and pronounced hearing loss within right ear.  Patient referred to ENT. ENT provider prescribed oral steroids for one week.  Hearing loss persisted with worsening of symptoms throughout treatment with steroids and at 1-wk post conclusion of steroid treatment. ENT performed a myringotomy of the right ear on 04 MAY 21, with no improvement of hearing post-procedure. Meanwhile additional symptoms have presented with difficulty swallowing water and oral secretions on right sided, with pinpointed right-sided headaches starting on 08 MAY 21.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Ear discomfort, Ear pruritus, Mixed deafness, Myringotomy
Clinical narrative: Patient started to notice Rt sided hearing loss  4hrs 15mins post COVID-19 Moderna 2nd dose. Conducted Audiology hearing test 3 weeks post second shot secondary to on-going and pronounced hearing loss within right ear.  Patient referred to ENT. ENT provider prescribed oral steroids for one week.  Hearing loss persisted with worsening of symptoms throughout treatment with steroids and at 1-wk post conclusion of steroid treatment. ENT performed a myringotomy of the right ear on 04 MAY 21, with no improvement of hearing post-procedure. Meanwhile additional symptoms have presented with difficulty swallowing water and oral secretions on right sided, with pinpointed right-sided headaches starting on 08 MAY 21.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Phonophobia, Saliva altered, Vertigo
Clinical narrative: Patient started to notice Rt sided hearing loss  4hrs 15mins post COVID-19 Moderna 2nd dose. Conducted Audiology hearing test 3 weeks post second shot secondary to on-going and pronounced hearing loss within right ear.  Patient referred to ENT. ENT provider prescribed oral steroids for one week.  Hearing loss persisted with worsening of symptoms throughout treatment with steroids and at 1-wk post conclusion of steroid treatment. ENT performed a myringotomy of the right ear on 04 MAY 21, with no improvement of hearing post-procedure. Meanwhile additional symptoms have presented with difficulty swallowing water and oral secretions on right sided, with pinpointed right-sided headaches starting on 08 MAY 21.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Migraine
Clinical narrative: Two days after the first dose of the Pfizer vaccine I had a migraine, and I took Tylenol. The next day I had another bad migraine. I have not had a migraine in a while and now it?s leading me to believe that these two migraines were caused by the vaccine.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Sudden crash/exhaustion (within an hour), full body soreness(several hours later), further symptoms pending(if any)
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Subcutaneous haematoma
Clinical narrative: I developed subcutaneous hematomas/large circular bruising on both of the tops of my thighs about 5 days after the 1st vaccine. Has this ever been reported by anyone? Bruises went away in about 3 days.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Burns second degree, Erythema, Pain, Pruritus
Clinical narrative: Large, red blotches and blisters consistent with second degree burns on both hands. Severe pain and itching going into 3rd week.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Large, red blotches and blisters consistent with second degree burns on both hands. Severe pain and itching going into 3rd week.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Discomfort
Clinical narrative: No issues other than a slightly sore arm at the injection sight until about 12 hours after the shot: -Fever (101.5° at highest temp taken) for about 15 hours -Body aches (Joints hurt, skin hurt to touch, muscle aches) for 36 hours -Chills and difficulty getting warm for 1 to 2 hours then switching to hot flashes/sweating and difficulty cooling off (back and forth for about 24 hours) -Difficulty sleeping due to discomfort and fever for 24 hours -Heavy fatigue and difficulty moving and walking due to lack of energy for improving over 72 hours -No appetite for 24 hours
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Hot flush, Hyperhidrosis, Injection site pain
Clinical narrative: No issues other than a slightly sore arm at the injection sight until about 12 hours after the shot: -Fever (101.5° at highest temp taken) for about 15 hours -Body aches (Joints hurt, skin hurt to touch, muscle aches) for 36 hours -Chills and difficulty getting warm for 1 to 2 hours then switching to hot flashes/sweating and difficulty cooling off (back and forth for about 24 hours) -Difficulty sleeping due to discomfort and fever for 24 hours -Heavy fatigue and difficulty moving and walking due to lack of energy for improving over 72 hours -No appetite for 24 hours