chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: VOMITING; CHILLS; FEVER; HEADACHE; NAUSEATED; TIREDNESS; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: no alcohol use, and non smoker, and other pre-existing medical conditions included: Patient had no medical conditions and no chronic medications. Patient had no known allergies. No drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022) dose was not reported, administered on 26-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-NOV-2021, the patient experienced tiredness. On 27-NOV-2021, the patient experienced nauseated. On 28-NOV-2021, the patient experienced headache. On 29-NOV-2021, the patient experienced chills. On 29-NOV-2021, the patient experienced fever. On 30-NOV-2021, the patient experienced vomiting. Treatment medications (dates unspecified) included: ibuprofen.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient recovered from tiredness, and headache on 28-NOV-2021, and had not recovered from chills, fever, nauseated, and vomiting. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; CHILLS; FEVER; HEADACHE; NAUSEATED; TIREDNESS; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: no alcohol use, and non smoker, and other pre-existing medical conditions included: Patient had no medical conditions and no chronic medications. Patient had no known allergies. No drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022) dose was not reported, administered on 26-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-NOV-2021, the patient experienced tiredness. On 27-NOV-2021, the patient experienced nauseated. On 28-NOV-2021, the patient experienced headache. On 29-NOV-2021, the patient experienced chills. On 29-NOV-2021, the patient experienced fever. On 30-NOV-2021, the patient experienced vomiting. Treatment medications (dates unspecified) included: ibuprofen.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient recovered from tiredness, and headache on 28-NOV-2021, and had not recovered from chills, fever, nauseated, and vomiting. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event, Product storage error
Clinical narrative: product was exposed at 19 degree Celsius for 2 days/no AE; Extra dose administered; Initial information received on 17-Nov-2021 regarding an unsolicited valid non-serious case received from pharmacist and consumer/non-healthcare professional via call center via the Agency (Reference number- 00862480).  This case involves a 61-year-old female patient who was administered extra dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] as she was given vaccine exposed to temperature at 19 degree Celsius for 2 days (product storage error and extra dose administered).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On 08-Nov-2021, the patient received a 0.5 mL  dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number: VT7316LA and expiry date: 30-Jun-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to product storage error and extra dose administered (latency: same day).  It was reported "A patient received a dose of the Fluzone that was from this reported excursion: and immediately after was given a second injection of the Fluzone. Was the dose appropriate to give? Was it correct to re-dose Fluzone QIV if a product was not suitable for use due to a temperature excursion?"  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: F
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, Medication error
Clinical narrative: 13 year old whom has not had all of their IPOL shots is able to get it patient is behind schedule and only received one dose with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (MI) (Reference number- 00864486) and transmitted to Sanofi on 18-Nov-2021.  This case involves a 13-year-old female patient who did not have all their IPV (VERO) [IPOL] (lot number, expiry date not reported) shots was able to get it, was behind schedule and only received one dose via unknown route at an unknown administration site on an unknown date for prophylactic vaccination (inappropriate schedule of product administration).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to inappropriate schedule of vaccine administered (latency was on same day).  At the time of report, no adverse event reported.  It was reported "Medical Assistant calling to find out if a 13-year-old whom has not had all of their IPOL shots is able to get it. Caller stated patient is behind schedule and only received one dose. Caller stated patient only had one injection of IPOL initially."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Product preparation issue
Clinical narrative: nurse administered PENTACEL to a patient without mixing the powder form (HIB) with no adverse event; Initial information received on 22-Nov-2021 regarding an unsolicited valid non-serious case from nurse and physician via The Regulatory Authority (under reference 00867952).  This case is linked to case 2021SA393946 (Cluster).  This case involves a 2 months old female patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without mixing the powder form (hib) [product preparation issue].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX), HEPATITIS B VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) [lot number and expiration date were not reported] via unknown route in an unknown administration site for Prophylactic vaccination.  On 19-Nov-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (TOTAL, lot UJ504AAA and expiration date: 29-May-2022) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate reconstitution technique (same day latency).  It was reported "The caller stated that a nurse administered PENTACEL to a patient without mixing the powder form (HIB). The caller would like to know how to care for the patient. The caller stated that she was reading online that Sanofi will send them a diluent to mix with the other portion to administer to the patient."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain
Clinical narrative: Pain in the armpit; This spontaneous case was received on 22-Oct-2021 from other healthcare professional (nurse) via the Regulatory Authority (reference number: SEQW21-04427) and concerned a 29-year-old, female patient.  The patient's medical history was not reported, and she had no allergies. The patient was not taking any concomitant medications.  On 20-Oct-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was P100354286 and expiry date was 15-Jun-2022.  On the same day, after receiving Afluria Quadrivalent, the patient experienced pain in the armpit. The corrective treatment included ibuprofen.  At the time of initial reporting on 22-Oct-2021, the patient had not recovered from the event as armpit continued to become sorer.  The reporter did not provide a causality assessment.  The reporter assessed the event as non-serious.  Company comment: A 29-year-old patient was vaccinated with Afluria Quadrivalent. On the same day, after receiving Afluria Quadrivalent, the patient experienced pain in the armpit. Causal role of the suspect vaccine is assessed as possibly related, considering plausible time relationship.; Sender's Comments: A 29-year-old patient was vaccinated with Afluria Quadrivalent. On the same day, after receiving Afluria Quadrivalent, the patient experienced pain in the armpit. Causal role of the suspect vaccine is assessed as possibly related, considering plausible time relationship.
Age: 74.0
Sex: F
Vaccine: FLUC3
Symptoms: Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Sore, swollen arm; Sore, swollen arm; Tired; This spontaneous case was received on 23-Oct-2021 from other non-health care professional (consumer) via the Regulatory Authority  (reference number: SEQW21-04460) and concerned a 74-year-old, female patient.  The patient's concurrent conditions included Grave's disease, hypertension, arthritis,  leaky valve and the patient was allergic to formaldehyde. The patient's concomitant medications were unknown.  On an unspecified day in 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: deltoid) for influenza prophylaxis. The batch number was not reported.   On an unspecified day in Sep-2020, after receiving Flucelvax Quadrivalent, the patient became tired and her arm was sore and swollen for eight days. The patient did not receive any corrective treatment.  On an unspecified day in 2020, the patient recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  Company comment: A 74-year-old female patient experienced arm pain and swelling along with fatigue after vaccination with Flucelvax Quadrivalent. Due to the lack of information regarding chronology, causality for the reported events is unassessable.; Sender's Comments: A 74-year-old female patient experienced arm pain and swelling along with fatigue after vaccination with Flucelvax Quadrivalent. Due to the lack of information regarding chronology, causality for the reported events is unassessable.
Age: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Induration, Product administered at inappropriate site
Clinical narrative: This spontaneous case was retrieved on 25-Oct-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1771491-1), reported by other healthcare professional and concerned a 13-year-old, female patient. The patient's concurrent condition included anxiety. The patient was not taking any concomitant medications. The patient had no known allergies. On 05-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: intramuscular (IM), anatomical location: right arm (RA) below the deltoid, between the bicep and triceps muscle, dose: 'one' as reported and indication: not reported) (explicitly coded as  'Vaccine administered at inappropriate site'). The batch number reported was 308541 (reported batch number was identified as potential 308451 by Seqirus to be linked to new suspect product Flucelvax Quadrivalent). On 08-Oct-2021, three days after receiving Flucelvax Quadrivalent, the patient experienced ten cm by eight cm patch of erythema and induration just distal to the injection site on the right arm. The patient visited physician's office. The outcome of the events was unknown. The reporter did not provide a causality assessment. The case was assessed as non-serious. Company Comment: A 13-year-old, female patient, was vaccinated with Flucelvax Quadrivalent below the deltoid, between the bicep and triceps muscle (explicitly coded as 'Vaccine administered at inappropriate site'). Three days after vaccination, the patient experienced erythema and induration. Information regarding diagnostic findings was not provided. Vaccine administered at inappropriate site is assessed as not related per company's conventions. Causal role of the suspect vaccine is assessed as possibly related for other events, due to biological and chronological plausibility.; Sender's Comments: A 13-year-old, female patient, was vaccinated with Flucelvax Quadrivalent below the deltoid, between the bicep and triceps muscle (explicitly coded as 'Vaccine administered at inappropriate site'). Three days after vaccination, the patient experienced erythema and induration. Information regarding diagnostic findings was not provided. Vaccine administered at inappropriate site is assessed as not related per company's conventions. Causal role of the suspect vaccine is assessed as possibly related for other events, due to biological and chronological plausibility.
Age: 39.0
Sex: F
Vaccine: FLUC3
Symptoms: Throat irritation, Wheezing
Clinical narrative: Scratchy throat; Wheezing; This spontaneous case was received on 21-Nov-2021 from other non-healthcare professional (consumer) via Med Communications (reference number: SEQW21-05559) and concerned a 39-year-old, female patient.  The patient's concurrent conditions included depression, Hashimoto's, PCOS (polycystic ovary syndrome) and ADHD (attention-deficit/hyperactivity disorder). The patient's historical vaccine included influenza vaccine in past with no reaction. The patient's concomitant medications included Wellbutrin XR (bupropion hydrochloride), Lexapro (escitalopram oxalate), levothyroxine, Zyrtec (cetirizine hydrochloride), hydroxyzine, multivitamin, Focalin XR (dexmethylphenidate hydrochloride), Metformin (metformin hydrochloride) and spironolactone, all used for an unreported indication.  On 22-Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 308466.  On the same day, after receiving Flucelvax Quadrivalent, the patient experienced scratchy throat and wheezing.  On the same day, the patient went to Urgent Care and received albuterol, epinephrine and cortisol shot. Then, she was sent to ER (emergency room) where received additional albuterol treatment for wheezing. It was resolved within seven hours. The patient was sent home with prednisone taper.  On 22-Sep-2021, the patient recovered from the events.   The reporter assessed the event as of scratchy throat as related to Flucelvax Quadrivalent and did not provide assessment for the event of wheezing. The patient stated she had a throat reaction after receiving Flucelvax Quadrivalent.   The events of scratchy throat and wheezing were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 39-year-old, female patient, experienced scratchy throat and wheezing, on the same day after vaccination with the suspect product Flucelvax Quadrivalent. The patient was treated with albuterol, epinephrine and cortisol shot. Based on suggestive time relationship, causality is assessed as possibly related. Brighton Collaboration criteria for anaphylaxis could not be assessed due to insufficient information.; Reporter's Comments: The patient stated she had a throat reaction after receiving Flucelvax Quadrivalent.; Sender's Comments: A 39-year-old, female patient, experienced scratchy throat and wheezing, on the same day after vaccination with the suspect product Flucelvax Quadrivalent. The patient was treated with albuterol, epinephrine and cortisol shot. Based on suggestive time relationship, causality is assessed as possibly related. Brighton Collaboration criteria for anaphylaxis could not be assessed due to insufficient information.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dark circles under eyes, Dizziness, Feeding disorder, Gait inability, Pain
Clinical narrative: DRIZZY, UNABLE TO WALK, UNABLE TO EAT, DARK CIRCLES UNDER EYES, PAIN THROUGH OUT BODY.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eyelid pain, Fatigue, Injection site pain, Injection site rash
Clinical narrative: Hot, red, raised rash at injection site. Body aches all over. Every joint and muscle aches. Even my eyelids hurt. Had a fever of 100.4 earlier (day after 2nd shot) and now at 99.5. Very painful arm at injection site. Extremely tired.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Myalgia, Pain, Pyrexia, Rash erythematous
Clinical narrative: Hot, red, raised rash at injection site. Body aches all over. Every joint and muscle aches. Even my eyelids hurt. Had a fever of 100.4 earlier (day after 2nd shot) and now at 99.5. Very painful arm at injection site. Extremely tired.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Skin warm
Clinical narrative: Hot, red, raised rash at injection site. Body aches all over. Every joint and muscle aches. Even my eyelids hurt. Had a fever of 100.4 earlier (day after 2nd shot) and now at 99.5. Very painful arm at injection site. Extremely tired.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: pruritic rash to neck/chest/back that started one day afterwards
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Hallucination, visual
Clinical narrative: Severely cold, chills, visual hallucinations
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Nausea
Clinical narrative: Body aches, chills, headache, dizziness, weakness, nausea
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Body aches, chills, headache, dizziness, weakness, nausea
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Pain, Pain in extremity
Clinical narrative: just getting over them/ I got them; pain; pain in my leg; pain in lower back; pain in knee; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles, pain, leg pain, low back pain and knee pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain, leg pain, low back pain and knee pain were recovered/resolved.   It was unknown if the reporter considered the shingles, pain, leg pain, low back pain and knee pain to be related to Shingles vaccine.  Additional details were provided as follows: This patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced shingles and worst pain of his/her life for 14 days. The patient's doctor said its a virus that enters and lands on a nerve, so he/she had so much pain in his/her leg ,lower back and knee. The patient stated that he/she never want this agian and he/she could get it agian he/she was told so please get your shingles vaccine. The patient was waiting for his/her next dose. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a other health professional via (Shingrix GSK) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 14th Months ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked did need to resatart series.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Interchange of vaccine products
Clinical narrative: This case was reported by a consumer via (Shingrix GSK) interactive digital media and described the occurrence of interchange of vaccine products in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (ZOSTAVAX) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of ZOSTAVAX. On an unknown date, unknown after receiving Shingrix, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received first dose of Shingrix vaccine and the second dosed Zostavax vaccine, which led to interchange of vaccine products.
Sex: F
Vaccine: MENB
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: Bexsero / administered before the results of the urine HCG test / positive / pregnancy; This prospective pregnancy case was reported by a other health professional and described the occurrence of vaccine exposure during pregnancy in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB06DA, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th January 2021, the patient received Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Bexsero at an unknown time during the pregnancy. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported to primary health physician office to receive the Bexsero vaccine.  The Bexsero was inadvertently administered before the results of the urine HCG test were reviewed.  The urine HCG test was positive, gestation and due date of the pregnancy was unknown at the time of call. The reporter consented to follow up.   Follow-up information received on 26th November 2021: After completion of all the follow up attempts, the pregnancy case was considered as lost to follow up.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram, Myocardial infarction, Palpitations
Clinical narrative: Heart palpitations began roughly 24-48hrs after first vaccine. They were mild and unconcerning, but kind of annoying. Could feel heart racing, and could even feel onset of when heart was about to begin racing.  Symptoms worsened after second shot. Became more frequent and intense. On 4/27/21- that morning around 9am, symptoms began being very concerning. Heart was racing and really heavy beating. Became lightheaded at work, and finally sought medical attention. Resting walk heart rate at urgent care was 104+, and EKG was abnormal. Was sent to ER for further testing. Everything ?serious? (blood clot, etc) ruled out.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: COVID Arm:  Red patch around injection site.  Hot to the touch.  Tight and sore. Symptoms continue as of day 5 after vaccine administered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Oedema peripheral
Clinical narrative: Vaccine site reaction redness at the site tenderness. Swelling of the left armpit tenderness
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctivitis, Ear pain, Influenza like illness, Nasal congestion, Neck pain
Clinical narrative: Mild Flu like symptoms, chest congestion, pink eye like symptoms,  runny/congestion of the nose, sore/scratchy throat starting approximately 24-36 hours after running for 7days. Now neck pains then right ear ache/tinnitus
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea, Throat irritation, Tinnitus
Clinical narrative: Mild Flu like symptoms, chest congestion, pink eye like symptoms,  runny/congestion of the nose, sore/scratchy throat starting approximately 24-36 hours after running for 7days. Now neck pains then right ear ache/tinnitus
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: After a month of receiving the shot I have been having issues with my arm my muscle in my shoulder have been sore the pain shoots down my whole arm when I first got the pain I had to take pain killers from my mother just to be able to sleep and of of today I am still taking over the counter pain killers and still have pain I can't use my arm for long periods of time and still have moments of weakness i the arm that I got the shot.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Aphasia, Back pain, Cardiac monitoring, Colonoscopy
Clinical narrative: left arm/hand went numb, wrist pain, injection spot was hard, insomnia with fast heart rate, wakening with jolts from my heart and blood pressure spikes. Second Moderna vaccine given 5/12/21 039B21A.  on 5/22 vision changes, vertigo, headaches, loss of bladder control, could not have bowel movements, internal tremors, pelvic pain, memory loss, word loss, speech problems, sever fatigue, leg and arm weakness, adrenalin rushes and extreme sensations of "over sensitivity through out entire body. 2 days of not being able to swallow solid food. Lost 14 lbs in 3 weeks. The feeling the my body was being attacked from within. Clenching feeling from back of head down my neck to my chest. flushing and sweating. lower back pain.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Constipation, Dysphagia, Electric shock sensation, Electrocardiogram
Clinical narrative: left arm/hand went numb, wrist pain, injection spot was hard, insomnia with fast heart rate, wakening with jolts from my heart and blood pressure spikes. Second Moderna vaccine given 5/12/21 039B21A.  on 5/22 vision changes, vertigo, headaches, loss of bladder control, could not have bowel movements, internal tremors, pelvic pain, memory loss, word loss, speech problems, sever fatigue, leg and arm weakness, adrenalin rushes and extreme sensations of "over sensitivity through out entire body. 2 days of not being able to swallow solid food. Lost 14 lbs in 3 weeks. The feeling the my body was being attacked from within. Clenching feeling from back of head down my neck to my chest. flushing and sweating. lower back pain.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Fatigue, Flushing, Headache, Heart rate increased
Clinical narrative: left arm/hand went numb, wrist pain, injection spot was hard, insomnia with fast heart rate, wakening with jolts from my heart and blood pressure spikes. Second Moderna vaccine given 5/12/21 039B21A.  on 5/22 vision changes, vertigo, headaches, loss of bladder control, could not have bowel movements, internal tremors, pelvic pain, memory loss, word loss, speech problems, sever fatigue, leg and arm weakness, adrenalin rushes and extreme sensations of "over sensitivity through out entire body. 2 days of not being able to swallow solid food. Lost 14 lbs in 3 weeks. The feeling the my body was being attacked from within. Clenching feeling from back of head down my neck to my chest. flushing and sweating. lower back pain.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypertension, Hypoaesthesia, Injection site induration, Insomnia
Clinical narrative: left arm/hand went numb, wrist pain, injection spot was hard, insomnia with fast heart rate, wakening with jolts from my heart and blood pressure spikes. Second Moderna vaccine given 5/12/21 039B21A.  on 5/22 vision changes, vertigo, headaches, loss of bladder control, could not have bowel movements, internal tremors, pelvic pain, memory loss, word loss, speech problems, sever fatigue, leg and arm weakness, adrenalin rushes and extreme sensations of "over sensitivity through out entire body. 2 days of not being able to swallow solid food. Lost 14 lbs in 3 weeks. The feeling the my body was being attacked from within. Clenching feeling from back of head down my neck to my chest. flushing and sweating. lower back pain.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of bladder sensation, Magnetic resonance imaging, Muscular weakness, Nerve conduction studies, Pelvic pain
Clinical narrative: left arm/hand went numb, wrist pain, injection spot was hard, insomnia with fast heart rate, wakening with jolts from my heart and blood pressure spikes. Second Moderna vaccine given 5/12/21 039B21A.  on 5/22 vision changes, vertigo, headaches, loss of bladder control, could not have bowel movements, internal tremors, pelvic pain, memory loss, word loss, speech problems, sever fatigue, leg and arm weakness, adrenalin rushes and extreme sensations of "over sensitivity through out entire body. 2 days of not being able to swallow solid food. Lost 14 lbs in 3 weeks. The feeling the my body was being attacked from within. Clenching feeling from back of head down my neck to my chest. flushing and sweating. lower back pain.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal examination, Speech disorder, Tremor, Vertigo, Visual impairment
Clinical narrative: left arm/hand went numb, wrist pain, injection spot was hard, insomnia with fast heart rate, wakening with jolts from my heart and blood pressure spikes. Second Moderna vaccine given 5/12/21 039B21A.  on 5/22 vision changes, vertigo, headaches, loss of bladder control, could not have bowel movements, internal tremors, pelvic pain, memory loss, word loss, speech problems, sever fatigue, leg and arm weakness, adrenalin rushes and extreme sensations of "over sensitivity through out entire body. 2 days of not being able to swallow solid food. Lost 14 lbs in 3 weeks. The feeling the my body was being attacked from within. Clenching feeling from back of head down my neck to my chest. flushing and sweating. lower back pain.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: left arm/hand went numb, wrist pain, injection spot was hard, insomnia with fast heart rate, wakening with jolts from my heart and blood pressure spikes. Second Moderna vaccine given 5/12/21 039B21A.  on 5/22 vision changes, vertigo, headaches, loss of bladder control, could not have bowel movements, internal tremors, pelvic pain, memory loss, word loss, speech problems, sever fatigue, leg and arm weakness, adrenalin rushes and extreme sensations of "over sensitivity through out entire body. 2 days of not being able to swallow solid food. Lost 14 lbs in 3 weeks. The feeling the my body was being attacked from within. Clenching feeling from back of head down my neck to my chest. flushing and sweating. lower back pain.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION (RUNNING NOSE, CONGESTION, SORE THROAT, SINUS PRESSURE, AND MILD BODY ACHES); This spontaneous report received from a consumer concerned a 34 year old male. The patient's height, and weight were not reported.  The patient's past medical history included: stomach ulcers, and concurrent conditions included: ulcerative colitis. The patient was previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, 1 in total, administered on 30-APR-2021 for prophylactic vaccination (Dose number series 1). On 12-NOV-2021, the patient received additional covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, 1 in total, for prophylactic vaccination (Booster dose, dose number series 2). Concomitant medications included omeprazole DR (delayed release) (20 mg, capsule) for prevention of stomach ulcers, mesalazine DR (1.2 g, Tablet) for ulcerative colitis, and prednisone (10 mg, tablet) for ulcerative colitis flare. On 20-NOV-2021, the patient tested positive for COVID-19 infection (BinaxNOW) (suspected covid-19 infection and suspected clinical vaccination failure) with symptoms - running nose, congestion, sore throat, sinus pressure, and mild body aches. (Dose number series 2). Laboratory data included: COVID-19 antigen test (NR: not provided) which came positive on 20-NOV-2021 via home antigen testing kit. (Dose number series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211149678-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Diarrhoea, Feeling abnormal, Headache, Malaise
Clinical narrative: This spontaneous report received from a patient via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced almost near to death, bed ridden, so sick for more than 15 days, headache, muscle ache, throw up, and diarrhea.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The outcome of the so sick for more than 15 days, headache, muscle ache, bed ridden, throw up, diarrhea and almost near to death was not reported.This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vomiting
Clinical narrative: This spontaneous report received from a patient via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced almost near to death, bed ridden, so sick for more than 15 days, headache, muscle ache, throw up, and diarrhea.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The outcome of the so sick for more than 15 days, headache, muscle ache, bed ridden, throw up, diarrhea and almost near to death was not reported.This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious. This case, involving the same patient is linked to 20211100495.
Age: 92.0
Sex: M
Vaccine: FLUA4
Symptoms: Haemorrhage, Injection site mass
Clinical narrative: This spontaneous case was retrieved on 11-Oct-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1701102-1), reported by other healthcare professional and concerned a 92-year-old, male patient. The patient's medical history and concomitant medications were not reported. On 15-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: reported as one, route of administration: intramuscular and anatomical location: right arm) for unknown indication. The batch number reported was 312828. On the same day, after receiving Fluad Quadrivalent, the patient developed a lump at the injection site and was bleeding profusely. After a few minutes of applied pressure, the patient stopped bleeding. The lump was still present when the patient left facility. On the same date, the patient recovered from the event of 'vaccination site haemorrhage'. At the time of initial reporting, the outcome of the event of 'vaccination site lump' was unknown. The reporter did not provide a causality assessment. This case was assessed as non-serious. Company comment: A 92-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient developed a lump at the injection site and was bleeding profusely. Information regarding the underlying medical history and concomitant medications has not been provided. Causality is assessed as possibly related based on plausible time relationship.; Sender's Comments: A 92-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient developed a lump at the injection site and was bleeding profusely. Information regarding the underlying medical history and concomitant medications has not been provided. Causality is assessed as possibly related based on plausible time relationship.
Age: 0.83
Sex: M
Vaccine: FLUC3
Symptoms: Hypersomnia, Somnolence
Clinical narrative: Groggy; Slept a lot; This spontaneous case from was received on 11-Oct-2021 from other non-health professional (consumer's grandfather) via Communications (reference number: SEQW21-03627) and concerned a 10-month-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 07-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route od administration and anatomical location: not reported) as a prevention of seasonal influenza. The batch number was not reported.  On an unspecified date in Oct-2021, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient was groggy and slept a lot, otherwise seemed fine with no rash.   The outcome of the events was not reported.  The reporter did not provide a causality assessment.  Company comment: A 10-month-old, male patient was vaccinated with the suspect product Flucelvax Quadrivalent. An unknown amount of time after vaccination the patient was groggy and slept a lot. Information regarding the underlying medical history and concomitant medications has not been provided. Due to unclear chronology, causality is unassessable.; Sender's Comments: A 10-month-old, male patient was vaccinated with the suspect product Flucelvax Quadrivalent. An unknown amount of time after vaccination the patient was groggy and slept a lot. Information regarding the underlying medical history and concomitant medications has not been provided. Due to unclear chronology, causality is unassessable.
Age: 82.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Feeling abnormal, Skin abrasion
Clinical narrative: Very large warm and red area in the arm; Very large warm and red area in the arm; Felt very bad; This spontaneous case from was received on 11-Oct-2021 from registered other health professional via the Regulatory Authority (reference number: SEQW21-03662) and concerned an 82-year-old female patient.   The patient's medical history and concomitant medications were not reported.   On an unspecified date in 2019, 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: deltoid) for influenza prophylaxis. The batch number was 261200 and expiration date was 21-Jun-2020.  On an unspecified date in 2019, an unspecified amount of time after receiving Flucelvax Quadrivalent, the patient felt very bad. She experienced very large warm and red area in the arm.  At the time of this initially reporting, the outcome of the events 'felt very bad' and 'very large warm and red area in the arm' (redness and skin warm) was not reported.  This case was assessed as non-serious.  Case updated on 26-Nov-2021: Correction made to information received on 11-Oct-2021: Company causality assessment was amended from 'related' to 'unassessable'. No changes made in narrative.  Company comment: An 82-year-old female patient was vaccinated with the suspect product Flucelvax Quadrivalent. An unknown amount of time after vaccination the patient was feeling abnormal and experienced warm skin and erythema of arm. Due to limited information provided, causality is unassessable.; Sender's Comments: An 82-year-old female patient was vaccinated with the suspect product Flucelvax Quadrivalent. An unknown amount of time after vaccination the patient was feeling abnormal and experienced warm skin and erythema of arm. Due to limited information provided, causality is unassessable.
Age: 59.0
Sex: M
Vaccine: FLUC3
Symptoms: Paraesthesia, Rhinalgia, Swelling, Tenderness
Clinical narrative: Felt tinging in my nose; Nose starting swelling and was tender and painful; Nose starting swelling and was tender and painful; Nose starting swelling and was tender and painful; This spontaneous case was received on 13-Oct-2021 from other non-health professional (consumer) via The Regulatory Authority (reference number: SEQW21-03865) and concerned a 59-year-old male patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 06-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (Influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical: deltoid left arm) for influenza prophylaxis. The batch number reported was 309613, expiration date: 25-Jun-2022.  On 07-Oct-2021, one day after vaccination with Flucelvax Quad, the patient felt tinging in his nose   On an unspecified date in Oct-2021, by Friday as reported, the patient's nose starting swelling and was tender and painful. He went to his doctor and he did not see anything but stated that this may be a reaction from flu vaccine. The patient was prescribed prednisone and pharmacist gave him Benadryl (diphenhydramine hydrochloride).  The outcome of the events 'nasal pain', 'tenderness' and 'localised tingling' was not reported.  At the time of this report on 13-Oct-2021, swelling was going down, the patient was recovering from te event 'nasal mucosal swelling'.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 59-year-old patient developed nasal congestion, rhinalgia, nose tenderness, and paraesthesia (reported as tinging in nose) within seven days after receiving the suspect product Flucelvax Quadrivalent. Due to plausible chronology, causality is assessed as possibly related.; Sender's Comments: A 59-year-old patient developed nasal congestion, rhinalgia, nose tenderness, and paraesthesia (reported as tinging in nose) within seven days after receiving the suspect product Flucelvax Quadrivalent. Due to plausible chronology, causality is assessed as possibly related.