chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dizziness, Dry mouth, Dry throat
Clinical narrative: On 04/03/2022, I developed a mild headache, itchy eyes and feeling down in the mouth (dryish). That night, I woke up several times feeling off and having mild nausea. On 04/04/2022 I had a mild temperature going up to 99.4 and mild dizziness and nausea which I treated with acetaminophen. I had a scratchy throat that I treated with Vicks Vaporub. On 04/05/2022, I developed a mild productive cough, slight sore throat with mild pain and dryness. I treated with Zicam Tablets and Vicks Vaporub. On 04/06/2022, I had a continuing productive cough and dry throat. Mild runny/stuffy nose and eye pressure in both eyes. I treated the symptoms with Vicks Vaporub and Zicam Tablets. I tested positive on 04/06/2022 at the Clinic and she gave me Benzonate, Flonase, Guaifenesin and I used Saline Nasal Mist. She also told me to keep my electrolytes up to stay hydrated. I took the medicine as prescribed. I had a mild cough that lasted until about 04/20/2022. I was feeling fine during the day most of the episode. I felt completely fine by about a month afterwards.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Feeling abnormal, Headache, Nasal congestion, Nausea
Clinical narrative: On 04/03/2022, I developed a mild headache, itchy eyes and feeling down in the mouth (dryish). That night, I woke up several times feeling off and having mild nausea. On 04/04/2022 I had a mild temperature going up to 99.4 and mild dizziness and nausea which I treated with acetaminophen. I had a scratchy throat that I treated with Vicks Vaporub. On 04/05/2022, I developed a mild productive cough, slight sore throat with mild pain and dryness. I treated with Zicam Tablets and Vicks Vaporub. On 04/06/2022, I had a continuing productive cough and dry throat. Mild runny/stuffy nose and eye pressure in both eyes. I treated the symptoms with Vicks Vaporub and Zicam Tablets. I tested positive on 04/06/2022 at the Clinic and she gave me Benzonate, Flonase, Guaifenesin and I used Saline Nasal Mist. She also told me to keep my electrolytes up to stay hydrated. I took the medicine as prescribed. I had a mild cough that lasted until about 04/20/2022. I was feeling fine during the day most of the episode. I felt completely fine by about a month afterwards.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Oropharyngeal pain, Productive cough, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: On 04/03/2022, I developed a mild headache, itchy eyes and feeling down in the mouth (dryish). That night, I woke up several times feeling off and having mild nausea. On 04/04/2022 I had a mild temperature going up to 99.4 and mild dizziness and nausea which I treated with acetaminophen. I had a scratchy throat that I treated with Vicks Vaporub. On 04/05/2022, I developed a mild productive cough, slight sore throat with mild pain and dryness. I treated with Zicam Tablets and Vicks Vaporub. On 04/06/2022, I had a continuing productive cough and dry throat. Mild runny/stuffy nose and eye pressure in both eyes. I treated the symptoms with Vicks Vaporub and Zicam Tablets. I tested positive on 04/06/2022 at the Clinic and she gave me Benzonate, Flonase, Guaifenesin and I used Saline Nasal Mist. She also told me to keep my electrolytes up to stay hydrated. I took the medicine as prescribed. I had a mild cough that lasted until about 04/20/2022. I was feeling fine during the day most of the episode. I felt completely fine by about a month afterwards.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Throat irritation
Clinical narrative: On 04/03/2022, I developed a mild headache, itchy eyes and feeling down in the mouth (dryish). That night, I woke up several times feeling off and having mild nausea. On 04/04/2022 I had a mild temperature going up to 99.4 and mild dizziness and nausea which I treated with acetaminophen. I had a scratchy throat that I treated with Vicks Vaporub. On 04/05/2022, I developed a mild productive cough, slight sore throat with mild pain and dryness. I treated with Zicam Tablets and Vicks Vaporub. On 04/06/2022, I had a continuing productive cough and dry throat. Mild runny/stuffy nose and eye pressure in both eyes. I treated the symptoms with Vicks Vaporub and Zicam Tablets. I tested positive on 04/06/2022 at the Clinic and she gave me Benzonate, Flonase, Guaifenesin and I used Saline Nasal Mist. She also told me to keep my electrolytes up to stay hydrated. I took the medicine as prescribed. I had a mild cough that lasted until about 04/20/2022. I was feeling fine during the day most of the episode. I felt completely fine by about a month afterwards.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Ear pain, Eyelid pain, Injection site pain, Pain in extremity
Clinical narrative: Patient said after the vaccine he started to feel achy in his legs and knees.  He also felt like the top of his ears and eye lids were hurting and tingly.  He did also mention that he had a sore arm at the injection site.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Patient said after the vaccine he started to feel achy in his legs and knees.  He also felt like the top of his ears and eye lids were hurting and tingly.  He did also mention that he had a sore arm at the injection site.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Patient received Pfizer COVID vaccine on 3/30/21 and 4/20/21. On 6/4/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure, COVID-19 pneumonia, and acute on chronic COPD exacerbation.  Patient was discharged home earlier today (6/8/22).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient received Pfizer COVID vaccine on 3/30/21 and 4/20/21. On 6/4/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure, COVID-19 pneumonia, and acute on chronic COPD exacerbation.  Patient was discharged home earlier today (6/8/22).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Menstruation irregular, Nasal congestion
Clinical narrative: On 5-8-2022, I started having a cough, stuffy/runny nose and fatigue. On 5-10, I took a home Covid test and it was positive. I went and got a rapid test/PCR Covid test at local Covid testing Center in my neighborhood. The rapid antigen was positive. My PCR was negative but I still quarantined. On 5-11, I had a telehealth visit with my PCP and they performed another Covid test on me in their parking lot that day with positive results. They prescribed a cough suppressant, Vit D, Vit C and Zinc. I am feeling better but still have a lingering cough. I am also having irregular menses cycles.  I am reporting my breakthru case of Covid.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: On 5-8-2022, I started having a cough, stuffy/runny nose and fatigue. On 5-10, I took a home Covid test and it was positive. I went and got a rapid test/PCR Covid test at local Covid testing Center in my neighborhood. The rapid antigen was positive. My PCR was negative but I still quarantined. On 5-11, I had a telehealth visit with my PCP and they performed another Covid test on me in their parking lot that day with positive results. They prescribed a cough suppressant, Vit D, Vit C and Zinc. I am feeling better but still have a lingering cough. I am also having irregular menses cycles.  I am reporting my breakthru case of Covid.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Client came to vaccination table today requesting COVID card to be updated. Per records, client was vaccinated by team public health nurse (PHN), on 5.25.2022 with 2nd dose of COVID Moderna, 0.5 ml Lot # 054A22A at 9:11 am in the left arm. Client's record indicated that he received 3 total doses of COVID Moderna vaccine (02/05/2021, 03/05/2021, and 01/26/2022.) The PHN looked up client in records, which forecasted only the doses given on 1.26.2022 and 5.25.2022. The PHN, discussed the other doses with client, whom stated "he doesn't remember mentioning them" when he came for his vaccination on 5.25.2022, and documentation was not provided. The PHN texted the doctor at 10:01 the situation, requesting to condense COVID vaccine cards and add 0.5 ml dose on booster line of COVID vaccine card and to complete a report. Doctor agreed. The PHN added dose given on 5.25.2022 to COVID vaccine record client provided today.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Lymph node pain, Lymphadenopathy
Clinical narrative: Painful swollen lymph glad I under right arm. Lasted that evening very uncomfortable then not as bad the next day?by third day only hurt if pushed on.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune hepatitis, Biopsy liver abnormal, Blood test normal
Clinical narrative: Auto Immune Hepatitis  I suspect Covid vaccine to be the cause. Not all care providers are in agreement and none are on the record.  My biopsy references the condition as chronic but blood work pre Vaccine was normal.    Any suspected cases are reported.   My diagnosis did not come until April  of 2022 but I ignored minor symptoms for about a year.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram thorax abnormal, Death, Endarterectomy, Interstitial lung disease
Clinical narrative: Patient had recent endarterectomy presented to ED with c/o of stating her oxygen has been dropping.  Patient has mild pain on left side,  in ED CT showed severe bilateral multifocal mixed interstitial alvelolar PNA.  Patient was placed on NC oxygen.  Patient was admitted to hospital services.  On 12/28/2021, rapid response called, family requested hospice services.  Covid-19 PCR came back positive on 12/29/2021.  Patient expired on 12/30/2021.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pain, SARS-CoV-2 test positive
Clinical narrative: Patient had recent endarterectomy presented to ED with c/o of stating her oxygen has been dropping.  Patient has mild pain on left side,  in ED CT showed severe bilateral multifocal mixed interstitial alvelolar PNA.  Patient was placed on NC oxygen.  Patient was admitted to hospital services.  On 12/28/2021, rapid response called, family requested hospice services.  Covid-19 PCR came back positive on 12/29/2021.  Patient expired on 12/30/2021.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Adverse event did not occur. We are reporting a vaccine administration error for a wrong dose given. The 12yr old patient was inadvertently given the Pfizer 5-11yr dose for his booster on 06/04/2022 at the vaccination clinic.  The patient previously received the Pfizer 5-11yr dose for his 1st and 2nd dose. He turned from 11 to 12yrs of age one month before his booster appointment.  We contacted the vaccine manufacturer (Pfizer) and CDC for guidance. We also spoke with patient's mother on 06/07/2022 and was informed that patient is doing  ok with no adverse events. Informed patient's mother of the advice from the CDC provider that her child does not need to not repeat the booster dose, and that there's no safety concerns other than the typical side effects expected after COVID-19 vaccinations. Patient's mother expressed understanding and had no further questions.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Lethargy, Oropharyngeal pain
Clinical narrative: No adverse effects from vaccine; contracted COVID in mid-January 2022, it lasted about a week and a half. I was lethargic, had a sore and swollen throat, body aches, a fever, a cough, congestion, and shortness of breath.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pharyngeal swelling, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: No adverse effects from vaccine; contracted COVID in mid-January 2022, it lasted about a week and a half. I was lethargic, had a sore and swollen throat, body aches, a fever, a cough, congestion, and shortness of breath.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: No adverse effects from vaccine; contracted COVID in mid-January 2022, it lasted about a week and a half. I was lethargic, had a sore and swollen throat, body aches, a fever, a cough, congestion, and shortness of breath.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for Covid-19 on 01/19/2022 at PCP office.  Patient expired on 01/30/2022.  Patients PCP office located.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Cardio-respiratory arrest, Death, Unresponsive to stimuli
Clinical narrative: Patient arrived to ER via EMS d/t being found unresponsive.  Patient admitted to hospital for comfort measures.  Diagnosed with cardiopulmonary arrest, Covid-19 PNA, acute hypoxic respiratory failure.  Patient expired on 01/13/2022.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Fatigue, Feeling cold, Oropharyngeal pain, Pain
Clinical narrative: Sinus pressure. Congestion. Runny nose. Body aches. Fatigue. Fever like chills. Sore throat
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paranasal sinus discomfort, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Sinus pressure. Congestion. Runny nose. Body aches. Fatigue. Fever like chills. Sore throat
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever, chills, headache, achy joints, fatigue lasting several days
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pt was given undiluted vaccine, did not report any AEs at time of injection or 2 hours later
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival bleeding, Heavy menstrual bleeding
Clinical narrative: bleeding gingiva prolonged menses (2 weeks)
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given Prevnar-20 IMZ on 6/5/22. It was later discovered that she had previously received Prevnar-20 on 4/28/22. Only 1 dose of Prevnar-20 is recommended. Patient has had no adverse reaction and is feeling fine.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Malaise, Speech disorder
Clinical narrative: Patient did not feel well after receiving vaccine. She was seated. She was alert but said she did not feel like she could talk. She was able to respond to commands. 911 was called immediately as a precautions and paramedics arrived after about 7 minutes.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was given a dose 24 hours  and 20 mins post punctured
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood test, Chest X-ray, Chest pain
Clinical narrative: Started with chest pain, palpitations, difficulty breathing, sweating, dizziness, and headaches. But sweating went away overtime.  Now I am experiencing joints pain, dyspnea with minimal exertion, persistent chest pain and overwhelming headaches. Also tingling on the medial side of both hands, back pain, and generalized fatigue. I used to be a very healthy person, but right now I am suspended from driving as result of having multiple episodes of syncope that I have never had before. I cannot concentrate on anything; I will never be able to play tennis anymore. I am just desperate for my health and I am convinced that my life will never be the same. I am just praying God to keep me alive!
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Disturbance in attention, Dizziness, Dyspnoea, Dyspnoea exertional
Clinical narrative: Started with chest pain, palpitations, difficulty breathing, sweating, dizziness, and headaches. But sweating went away overtime.  Now I am experiencing joints pain, dyspnea with minimal exertion, persistent chest pain and overwhelming headaches. Also tingling on the medial side of both hands, back pain, and generalized fatigue. I used to be a very healthy person, but right now I am suspended from driving as result of having multiple episodes of syncope that I have never had before. I cannot concentrate on anything; I will never be able to play tennis anymore. I am just desperate for my health and I am convinced that my life will never be the same. I am just praying God to keep me alive!
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Electroencephalogram, Exercise tolerance decreased, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Started with chest pain, palpitations, difficulty breathing, sweating, dizziness, and headaches. But sweating went away overtime.  Now I am experiencing joints pain, dyspnea with minimal exertion, persistent chest pain and overwhelming headaches. Also tingling on the medial side of both hands, back pain, and generalized fatigue. I used to be a very healthy person, but right now I am suspended from driving as result of having multiple episodes of syncope that I have never had before. I cannot concentrate on anything; I will never be able to play tennis anymore. I am just desperate for my health and I am convinced that my life will never be the same. I am just praying God to keep me alive!
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired driving ability, Influenza A virus test negative, Influenza B virus test, Lymphocyte percentage decreased, Lymphocyte percentage increased
Clinical narrative: Started with chest pain, palpitations, difficulty breathing, sweating, dizziness, and headaches. But sweating went away overtime.  Now I am experiencing joints pain, dyspnea with minimal exertion, persistent chest pain and overwhelming headaches. Also tingling on the medial side of both hands, back pain, and generalized fatigue. I used to be a very healthy person, but right now I am suspended from driving as result of having multiple episodes of syncope that I have never had before. I cannot concentrate on anything; I will never be able to play tennis anymore. I am just desperate for my health and I am convinced that my life will never be the same. I am just praying God to keep me alive!
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Mean cell volume normal, Mean platelet volume normal, Neutrophil percentage decreased, Neutrophil percentage increased
Clinical narrative: Started with chest pain, palpitations, difficulty breathing, sweating, dizziness, and headaches. But sweating went away overtime.  Now I am experiencing joints pain, dyspnea with minimal exertion, persistent chest pain and overwhelming headaches. Also tingling on the medial side of both hands, back pain, and generalized fatigue. I used to be a very healthy person, but right now I am suspended from driving as result of having multiple episodes of syncope that I have never had before. I cannot concentrate on anything; I will never be able to play tennis anymore. I am just desperate for my health and I am convinced that my life will never be the same. I am just praying God to keep me alive!
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Platelet count decreased, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Started with chest pain, palpitations, difficulty breathing, sweating, dizziness, and headaches. But sweating went away overtime.  Now I am experiencing joints pain, dyspnea with minimal exertion, persistent chest pain and overwhelming headaches. Also tingling on the medial side of both hands, back pain, and generalized fatigue. I used to be a very healthy person, but right now I am suspended from driving as result of having multiple episodes of syncope that I have never had before. I cannot concentrate on anything; I will never be able to play tennis anymore. I am just desperate for my health and I am convinced that my life will never be the same. I am just praying God to keep me alive!
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, White blood cell count decreased
Clinical narrative: Started with chest pain, palpitations, difficulty breathing, sweating, dizziness, and headaches. But sweating went away overtime.  Now I am experiencing joints pain, dyspnea with minimal exertion, persistent chest pain and overwhelming headaches. Also tingling on the medial side of both hands, back pain, and generalized fatigue. I used to be a very healthy person, but right now I am suspended from driving as result of having multiple episodes of syncope that I have never had before. I cannot concentrate on anything; I will never be able to play tennis anymore. I am just desperate for my health and I am convinced that my life will never be the same. I am just praying God to keep me alive!
Age: 22.0
Sex: M
Vaccine: HEPAB
Symptoms: Cold sweat, Feeling hot, Nausea
Clinical narrative: DONOR BECAME HOT, CLAMMY AND NAUSEATED ABOUT 5 MINS AFTER VACCINATION. DONOR WAS GIVEN COLD PACKS AND EMESIS BAG. GIVEN GATORADE AFTER NAUSEA SUBSIDED.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Asthenia, Bone pain, Headache, Impaired work ability
Clinical narrative: Stabbing pain all over my body, weakness, headache, aching in my bones, feeling feverish, forehead broke out into little painful pimples, missed 3 days of work!
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Stabbing pain all over my body, weakness, headache, aching in my bones, feeling feverish, forehead broke out into little painful pimples, missed 3 days of work!
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth for 2 hours after vaccine
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Chest discomfort
Clinical narrative: Pressure in chest, never experienced before or since, exactly in the area of the heart, that increased with physical activity (walking), and lasted 3 weeks, even after treatment with colchicine.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral lichen planus, Oral soft tissue biopsy
Clinical narrative: developed oral lichen planus
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache
Clinical narrative: I had my shot at 11 AM on the morning of April 4th and had a mild headache.  That is the only reaction I had had with the other 3 shots previously.  At night I applied Voltaren cream to my inner thighs.  In the morning when I had bruising on both inner thighs where I had applied the Voltaren.  You could see the stealing where my fingers had minimized the amount of Voltaren.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Fatigue, Pain
Clinical narrative: Body aches, fatigue, temperature up to 100.2 degrees F
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: Woke up on 7 June with a head cold like symptoms.  Took home COVID test which showed positive.  By the time filling out this form, 8 June (9:30 PM) feeling normal.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Product preparation issue
Clinical narrative: Pt received undiluted PEDS dose of .3 mL instead of Pfizer 12 + vaccine pt reports slight headache only
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Product preparation issue
Clinical narrative: pt recieved undiluted pediatric dose 0.3 ML of vaccine-instead of pfizer 12 + dose. pt reports soreness to arm where injection was given
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Moderna vaccine on 5/5/2022 on this date she was only 15 years 7 months old and  Moderna is not FDA approved for children under the age of 18. No harm noted to patient.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: facial numbness and tingling
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fear, Injection site erythema, Injection site swelling, Intervertebral disc degeneration
Clinical narrative: Chills will start on RIGHT and LEFT side near hip, like a current, moves to back, up and down, Like a popsicle Had COVID-19 vaccine on 4/12/21 Injection(s) site redness, swelling, RESOLVED. Had a chest rash but now gone. Intermittent Chills like a current running in my body:  Chills will start on RIGHT and LEFT side near hip, like a current, moves to back, up and down, Like a popsicle Had low grade fever, resolved She states the chills feeling is Very irritating and she is  Very scared. also, started to have nightmare, with kicking.  diagnosed with parasomnia, seen by sleep specialist. chills is now the only persistent symptom over 1 yr after her moderna vaccine
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Meningioma, Nightmare
Clinical narrative: Chills will start on RIGHT and LEFT side near hip, like a current, moves to back, up and down, Like a popsicle Had COVID-19 vaccine on 4/12/21 Injection(s) site redness, swelling, RESOLVED. Had a chest rash but now gone. Intermittent Chills like a current running in my body:  Chills will start on RIGHT and LEFT side near hip, like a current, moves to back, up and down, Like a popsicle Had low grade fever, resolved She states the chills feeling is Very irritating and she is  Very scared. also, started to have nightmare, with kicking.  diagnosed with parasomnia, seen by sleep specialist. chills is now the only persistent symptom over 1 yr after her moderna vaccine
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Parasomnia, Pyrexia, Rash, Vertebral foraminal stenosis
Clinical narrative: Chills will start on RIGHT and LEFT side near hip, like a current, moves to back, up and down, Like a popsicle Had COVID-19 vaccine on 4/12/21 Injection(s) site redness, swelling, RESOLVED. Had a chest rash but now gone. Intermittent Chills like a current running in my body:  Chills will start on RIGHT and LEFT side near hip, like a current, moves to back, up and down, Like a popsicle Had low grade fever, resolved She states the chills feeling is Very irritating and she is  Very scared. also, started to have nightmare, with kicking.  diagnosed with parasomnia, seen by sleep specialist. chills is now the only persistent symptom over 1 yr after her moderna vaccine
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID today; Tested positive for COVID today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EJ1685), in left arm, on 25Mar2021 as dose 2, single (Lot number: EK5730), in left arm and on 09Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cephalosporins, reaction(s): "known allergies: Cephalosporins"; Mastisol, reaction(s): "known allergies: Mastisol". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jun2022 at 07:30, outcome "not recovered" and all described as "Tested positive for COVID today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Facility type vaccine was Pharmacy or Drug Store.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Back pain, Body temperature, Burning sensation, Contusion, Dysphonia
Clinical narrative: then got covid Mar2022; then got covid Mar2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 20Jun2021 at 15:30 as dose 1, single (Lot number: EW0172), in right arm and on 19Jul2021 at 15:30 as dose 2, single (Lot number: EW0164), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "then got covid Mar2022".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Pyrexia, SARS-CoV-2 test
Clinical narrative: then got covid Mar2022; then got covid Mar2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 20Jun2021 at 15:30 as dose 1, single (Lot number: EW0172), in right arm and on 19Jul2021 at 15:30 as dose 2, single (Lot number: EW0164), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "then got covid Mar2022".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: then got covid Mar2022; then got covid Mar2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 20Jun2021 at 15:30 as dose 1, single (Lot number: EW0172), in right arm and on 19Jul2021 at 15:30 as dose 2, single (Lot number: EW0164), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "then got covid Mar2022".  No follow-up attempts are possible. No further information is expected.
Age: 1.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Syringe issue, Underdose
Clinical narrative: No additional AE details.; Nurse calling states she went to administer VAQTA into the thigh of a 12-month old patient and the vaccine squirted out onto his leg instead of going into his muscle. Nurse would like to know if she needs to re-vaccinate this patient. Nurse states sh; Nurse calling states she went to administer VAQTA into the thigh of a 12-month old patient and the vaccine squirted out onto his leg instead of going into his muscle. Nurse would like to know if she needs to re-vaccinate this patient. Nurse states sh; This spontaneous report has been received from a nurse, concerning to 12-months-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On an unknown date of 2022, the patient was administered vaccine hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliters (ml) administered intramuscularly (valid lot number U026792 [expiration date 28-OCT-2022]) (vaccination scheme, and frequency were not provided) for prophylaxis, and the vaccine squirted out onto the patient's leg instead of going into his muscle (accidental underdose, accidental exposure to product), the reporter stated that she inspected the syringe after that happened and she did not see any cracks in the syringe and the needle was on tight.  No additional adverse events (AE) details were reported.
Age: 1.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Exposure via skin contact, No adverse event, Underdose
Clinical narrative: No additional AE details.; Nurse calling states she went to administer VAQTA into the thigh of a 12-month old patient and the vaccine squirted out onto his leg instead of going into his muscle. Nurse would like to know if she needs to re-vaccinate this patient. Nurse states sh; Nurse calling states she went to administer VAQTA into the thigh of a 12-month old patient and the vaccine squirted out onto his leg instead of going into his muscle. Nurse would like to know if she needs to re-vaccinate this patient. Nurse states sh; This spontaneous report has been received from a nurse, concerning to 12-months-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On an unknown date of 2022, the patient was administered vaccine hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliters (ml) administered intramuscularly (valid lot number U026792 [expiration date 28-OCT-2022]) (vaccination scheme, and frequency were not provided) for prophylaxis, and the vaccine squirted out onto the patient's leg instead of going into his muscle (accidental underdose, accidental exposure to product), the reporter stated that she inspected the syringe after that happened and she did not see any cracks in the syringe and the needle was on tight.  No additional adverse events (AE) details were reported.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary mass, Lymphadenopathy
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Relapsing remitting multiple sclerosis" (unspecified if ongoing), notes: Relapsing remitting multiple sclerosis; "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Fatigue" (unspecified if ongoing); "Complex PTSD" (unspecified if ongoing), notes: Complex PTSD; "Lactose intolerant" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing); "Disk bulging" (unspecified if ongoing), notes: Disk bulging; "Disk degeneration" (unspecified if ongoing), notes: Disk degeneration; "Dysphagia" (unspecified if ongoing); "Flare up" (unspecified if ongoing), notes: flare up; "Swollen lymph node" (unspecified if ongoing), notes: swollen lymph node; "Marijuana usage" (unspecified if ongoing), notes: Marijuana usage; "Multiple sclerosis" (ongoing). Concomitant medication(s) included: WELLBUTRIN XL; PAXLOVID; VITAMIN B COMPLEX; VITAMIN D3; CALCIUM MAGNESIUM WITH VITAMIN D3; TYLENOL; IBUPROFEN; CBD OIL. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 12May2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 12May2022, outcome "recovering" and all described as "COVID". Clinical course: On 23Apr2021, it was reported that patient experienced: Recurring swollen lymph node, recurring flare up started Dec2021 and COVID started 12May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Relapsing remitting multiple sclerosis" (unspecified if ongoing), notes: Relapsing remitting multiple sclerosis; "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Fatigue" (unspecified if ongoing); "Complex PTSD" (unspecified if ongoing), notes: Complex PTSD; "Lactose intolerant" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing); "Disk bulging" (unspecified if ongoing), notes: Disk bulging; "Disk degeneration" (unspecified if ongoing), notes: Disk degeneration; "Dysphagia" (unspecified if ongoing); "Flare up" (unspecified if ongoing), notes: flare up; "Swollen lymph node" (unspecified if ongoing), notes: swollen lymph node; "Marijuana usage" (unspecified if ongoing), notes: Marijuana usage; "Multiple sclerosis" (ongoing). Concomitant medication(s) included: WELLBUTRIN XL; PAXLOVID; VITAMIN B COMPLEX; VITAMIN D3; CALCIUM MAGNESIUM WITH VITAMIN D3; TYLENOL; IBUPROFEN; CBD OIL. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 12May2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 12May2022, outcome "recovering" and all described as "COVID". Clinical course: On 23Apr2021, it was reported that patient experienced: Recurring swollen lymph node, recurring flare up started Dec2021 and COVID started 12May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Contusion, Convalescent, Diplopia, Fall
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: patient said the adverse effects were the following: Severe headaches, nausea/vomiting, dry heaving-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Head injury, Headache, Hypertension, Laboratory test
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: patient said the adverse effects were the following: Severe headaches, nausea/vomiting, dry heaving-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Nausea, Vision blurred
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: patient said the adverse effects were the following: Severe headaches, nausea/vomiting, dry heaving-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain, Nausea, Retching, Vomiting
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: patient said the adverse effects were the following: Severe headaches, nausea/vomiting, dry heaving-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Mar2021 at 12:00 as dose 2, single (Lot number: EN6198), in left arm and on 29Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 301358) at the age of 66 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 03Mar2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Information from Product Complaint Team, provided from division Regulatory Authority includes conclusion of Investigation for lot# EN6198: As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS # and/or #. Refer to the below table for details: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6198 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6198, fill lot EN5330, and the formulated drug product lot EN5319. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The information on the batch/lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Mar2021 at 12:00 as dose 2, single (Lot number: EN6198), in left arm and on 29Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 301358) at the age of 66 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 03Mar2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Information from Product Complaint Team, provided from division Regulatory Authority includes conclusion of Investigation for lot# EN6198: As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS # and/or #. Refer to the below table for details: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6198 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6198, fill lot EN5330, and the formulated drug product lot EN5319. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The information on the batch/lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID Infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID Infection) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 09-May-2022, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID Infection). In May 2022, COVID-19 (COVID Infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: positive positive (Nasal swab).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment drug was reported. Company comment-This spontaneous case concerns an elderly male patient with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving the 1st dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient has received second and 3rd dose of co suspect TOZINAMERAN (interchange of vaccine products).The event occurred 7 days after the 3rd dose of co suspect TOZINAMERAN in covid 19 vaccination series.  Home rapid test was positive as on 16th May2022. No further details on clinical course, lab test results and treatment received were reported. Outcome of the event was resolved at the time of report. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case concerns an elderly male patient with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving the 1st dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient has received second and 3rd dose of co suspect TOZINAMERAN (interchange of vaccine products).The event occurred 7 days after the 3rd dose of co suspect TOZINAMERAN in covid 19 vaccination series.  Home rapid test was positive as on 16th May2022. No further details on clinical course, lab test results and treatment received were reported. Outcome of the event was resolved at the time of report. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.