chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: leaking occurred between the needle and the cartridge when the plunger was depressed during administration with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from a pharmacist via Agency (Reference number- 00779083) and transmitted to Sanofi on 21-Sep-2021.  This case involves a 74-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was leaking occurred between the needle and the cartridge when the plunger was depressed during administration (needle issue).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 17-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ747AC, expiry date 30-Jun-2022) via intramuscular route in the deltoid NOS prophylactic vaccination.  It was an actual medication error due to needle issue (latency: same day).  It was reported when giving FLUZONE HIGH-DOSE QUADRIVALENT to a patient, the majority of the vaccine leaked out between the needle and the cartridge. The leaking occurred between the needle and the cartridge when the plunger was depressed during administration. The pharmacist asks if the vaccine was valid or if the patient should be revaccinated.  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: 4.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Ipol was administered to pediatric patient, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Global Medical Information (GMI) (Reference number- 00779244) and transmitted to Sanofi on 21-Sep-2021.  This case involves a four-year-old female patient to whom an expired IPV (VERO) [IPOL] was administered (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On 21-Sep-2021, the patient received a dose (0.5ml) of suspect IPV (VERO) (lot number: R1D972M; expiry date: 17-Jul-2021) via unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to expired vaccine used (latency: same day).  It was reported "IPOL was administered to a pediatric patient on 21SEP2021 (caller did not have demographics on patient) and the product expired on 17JUL2021"  The caller wanted to know the information on re-administration and possible adverse effects to look out for.  No adverse events were reported at the time of this report.  The outcome of the event was reported as unknown.  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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product preparation issue
Clinical narrative: patient was given the liquid portion (DTAP-IPV) but not the powder (ACTHIB) portion/no AE;Initial information was received on 21-Sep-2021 regarding an unsolicited valid non-serious case from other health professional and non-healthcare professional via call center via Medical Information (Reference number- 00779266).   This case involves a patient of (unknown demographics) who received the liquid (dtap-ipv) portion but not the powder (acthib) portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (on the same day).  It was reported "The doctors office contacted the pharmacy to obtain the correct diluent to reconstitute the ACTHIB with. The pharmacy technician would like to obtain the correct diluent from Sanofi."  At the time of report, the outcome was unknown for the event.  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 the batch number for this case.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A Child under the age of 4 who received Quadracel with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health-care professional via consumer/non-health care professional via Medical Information (Reference number- 00780546) and transmitted to Sanofi on 21-Sep-2021.   This case involves a patient (demographics unknown) who was under the age of 4 received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  It was reported "I need to find out if a child under the age of 4 who received Quadracel needs to be revaccinated due to Quadracel not being indicated under the age of 4."  No other 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 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 the batch number for this case.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: an expired FLUZONE QIV PFS administered to a pregnant patient, with no adverse event; an expired FLUZONE QIV PFS administered to a pregnant patient, with no adverse event; Initial information received on 22-Sep-2021 regarding an unsolicited valid non-serious case from nurse, consumer/non-healthcare professional and physician via Agency (under reference 00780606).  This case involves a 31 years old female pregnant (30 week) patient who received an expired dose of QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) [expired product administered and exposure during pregnancy].  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The reported event occurred during 30 weeks of gestation period.  The date of last menstrual period was not reported.  The estimated due date was 22-Nov-2021.  The information on patient's previous pregnancy/ies were not reported.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 15-Sep-2021, the patient received a 0.5mL dose of suspect FLUZONE QIV (Total, lot UT7002DA and expiration date: 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was also a case of vaccine exposure during pregnancy (same day latency).  It was reported "Would like to know if the dose is considered valid?"  At time of reporting, the outcome was unknown for the reported events.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  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: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 79 year old patient received Fluzone High Dose Quadrivalent on 03-Sep-2021 and again on 21-Sep-2021/no AE; Initial information was received on 22-Sep-2021 regarding an unsolicited valid  non-serious case received from a physician and health care professional via Agency - 00780734].  This case involves a 79 year-old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] on 03-Sep-2021 and again on 21-Sep-2021 (Extra dose administered).  The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Sep-2021 and on 21-Sep-2021, the patient received first and second dose 0.7 mL of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Strength: standard; lot UJ704AA and UJ741AB; expiry date 30-Jun-2022) via an unknown route at right and left deltoid respectively for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered (latency was on same day).   It was reported "Caller states that on 21-Sep-2021 a female patient age 79 received a dose of FLUZONE HIGH DOSE; after administration, staff realized patient had a dose of FLUZONE HIGH DOSE on 03-Sep-2021; caller would like to know of adverse effects to look out for. The caller states that this happened within the same practice but in two different locations".  At the time of report, no adverse event reported.   Outcome of event was unknown.   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.  Product used : Used  First time product used : No
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: ACT-HIB vaccine was given post expiration with no reported adverse event;Initial information received on 22-Sep-2021 regarding an unsolicited valid non-serious case received from another health care professional and consumer non health care professional via Medical Information number: 00780823.  This case involves a Four months old female patient who who was administered an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID VACCINE [DTAP] and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 30-Aug-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE batch number: UJ351AAB and expiry date: 09-AUG-2021 via intramuscular route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "that Medical assistant transferred. Obtained report details from medical assistant. Medical assistant asking if there are any studies regarding expired ACTHIB being administered. Medical assistant asking if the ACTHIB needs to be revaccinated. Medical assistant also asking why Merck would have different information for PedvaxHIB. Note: Contact Name and Contact Details obtained. Obtained and verified email address from medical assistant".  At time of reporting, the patient outcome was Unknown for the event.  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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Paraesthesia
Clinical narrative: Severe burning and pins and needles in feet evening of 9/28/21 starting at 5pm. Now morning of 9/29/21 at 7am has spread to calf muscles. Very painful.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migrain headache since received vaccine
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Headache, Myalgia
Clinical narrative: Total body myalgia, mild headache
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Armpit  swollen and tender on injection arm
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chest pain, Chills, Movement disorder, Muscle contractions involuntary
Clinical narrative: Extreme pain under arm, radiating to chest on left side. Unable to move , turn over. Extreme chills, vomiting. Bone pain throughout body, extreme. High fever 103. Seizure like experience, muscles contracted and chin felt stuck to my neck.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Seizure like phenomena, Vomiting
Clinical narrative: Extreme pain under arm, radiating to chest on left side. Unable to move , turn over. Extreme chills, vomiting. Bone pain throughout body, extreme. High fever 103. Seizure like experience, muscles contracted and chin felt stuck to my neck.
Age: 101.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, SARS-CoV-2 test, Urine analysis
Clinical narrative: Pt came to ER c/o flu like symptoms onset 4 days prior.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Neck pain, Pruritus, Vision blurred
Clinical narrative: Lower Back Pain; Blurry Vision; Sides of head temple  and neck  Pain; Itchy legs and arms; Throbbing's  behind ears
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Hyperhidrosis, Impaired work ability, Nausea
Clinical narrative: Woke up sweating, nauseous, alternating between hot and cold but always with sweat. Unable to work that night. Lasted about 20 hours
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain
Clinical narrative: Low-grade fever (99.2); mild body aches, dull headache, lethargy. Responds to Tylenol and rest. At ~19 hours post-onset, symptoms continue
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Fever and skilled lymph nodes
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Hyperhidrosis, Lymphadenopathy
Clinical narrative: 1) Very painful swelling in left armpit gland. Started on 9/27 and still have it as of 9/29. Has not went away yet. 2) Drenched in sweat on the evening of 9/27 but went away after about 2 hours.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: I had a fever, chills, headache, aches and fatigue. Pain at the injection site and the area was warm to the touch. This happened around 2:00 am post COVID-19 vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin warm
Clinical narrative: I had a fever, chills, headache, aches and fatigue. Pain at the injection site and the area was warm to the touch. This happened around 2:00 am post COVID-19 vaccination.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Pt came to ER c/o sore throat.  Onset 2 days prior.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: 6 hours following vaccine, noticed intense itching at vaccine site. 8 hours later whole body itching began, Site was firm, tender, and warm to the touch. Upon waking the next morning, a large welt appeared, approximately 2.5inches wide by 1.5 inches tall. Intense whole body itching continued but most prominent at vaccine site, and pain at ?welt? site began. Ibuprofen and Benadryl taken around the clock. Cortisone cream and Neosporin applied to injection site. To date, itching continues and growth of welt continues.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: 6 hours following vaccine, noticed intense itching at vaccine site. 8 hours later whole body itching began, Site was firm, tender, and warm to the touch. Upon waking the next morning, a large welt appeared, approximately 2.5inches wide by 1.5 inches tall. Intense whole body itching continued but most prominent at vaccine site, and pain at ?welt? site began. Ibuprofen and Benadryl taken around the clock. Cortisone cream and Neosporin applied to injection site. To date, itching continues and growth of welt continues.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Pain, Pain in extremity, Paraesthesia
Clinical narrative: STARTED EXPERIENCING NUMBNESS, TINGLING AND ACHINESS IN THE LEFT ARM THE DAY AFTER SHE RECEIVED THE INJECTION, DAY 2 STARTED WITH SWELLING AT NECK ABOVE CLAVICLE, CONTINUES WITH NUMBNESS, TINGLING, SHOOTING PAIN AND DECREASED FUNCTION IN LEFT ARM, SWELLING IN NECK PROGRESSIVELY WORSE
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: STARTED EXPERIENCING NUMBNESS, TINGLING AND ACHINESS IN THE LEFT ARM THE DAY AFTER SHE RECEIVED THE INJECTION, DAY 2 STARTED WITH SWELLING AT NECK ABOVE CLAVICLE, CONTINUES WITH NUMBNESS, TINGLING, SHOOTING PAIN AND DECREASED FUNCTION IN LEFT ARM, SWELLING IN NECK PROGRESSIVELY WORSE
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Dysgeusia, Feeling cold, Migraine
Clinical narrative: SEVERE reaction with 101 degree fever; chills; migraine-type headache; muscle weakness; dizziness; disorientation; strong metal taste in the mouth lasting in full intensity for 19 hours straight.  Subsided by 48 hours later.  Although patient experienced lesser reactive symptoms after first and second dose  with 8-10 hour duration, the third dose was, by far, more extreme!
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: SEVERE reaction with 101 degree fever; chills; migraine-type headache; muscle weakness; dizziness; disorientation; strong metal taste in the mouth lasting in full intensity for 19 hours straight.  Subsided by 48 hours later.  Although patient experienced lesser reactive symptoms after first and second dose  with 8-10 hour duration, the third dose was, by far, more extreme!
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram head, Laboratory test, Mental status changes, Pyrexia
Clinical narrative: Pt came to ER c/o worsening mental status for the past few days.  Febrile.  Family concerned pt has UTI.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Pt came to ER c/o worsening mental status for the past few days.  Febrile.  Family concerned pt has UTI.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Palpitations, Rash, Rash erythematous, Rash papular
Clinical narrative: Heart palpitations and rash 9 days after vaccination on the left arm at injection site. Rash was raised, red, itchy, and slight pain.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Heart palpitations and rash 9 days after vaccination on the left arm at injection site. Rash was raised, red, itchy, and slight pain.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Nausea, Pain in extremity, Swelling
Clinical narrative: Swelling , redness and pain in arm; Vertigo and nausea; Tiredness
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Swelling , redness and pain in arm; Vertigo and nausea; Tiredness
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: No treatment needed.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Induration, Skin discolouration, Skin lesion, Thrombotic thrombocytopenic purpura, Vaccination complication
Clinical narrative: Indurated firm purple lesion, TTP, likely arthus reaction.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pain
Clinical narrative: Sore body and shortness of breath
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Fatigue, Haemoptysis
Clinical narrative: onset 9/22/21 and on 9/29/21 came to ED with cough, shortness of breath, blood in sputum/phlegm, fatigue.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: onset 9/22/21 and on 9/29/21 came to ED with cough, shortness of breath, blood in sputum/phlegm, fatigue.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Disorientation, Heart rate increased, Oral pruritus, Pruritus
Clinical narrative: Disorientation/ confusion, day of vaccine, no treatment, went away after day 1; Day 3 after vaccine, itchiness on right side of body, neck, mouth, and throat/ throat started to close up/ rapid heart, Benadryl taken once, still itchy around outside of mouth
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Disorientation/ confusion, day of vaccine, no treatment, went away after day 1; Day 3 after vaccine, itchiness on right side of body, neck, mouth, and throat/ throat started to close up/ rapid heart, Benadryl taken once, still itchy around outside of mouth
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Decreased appetite, Dyspnoea, Headache, Injection site pain
Clinical narrative: Started having constant chest pain that felt like pressure and shortness of breath when I would breathe in. Started at 0545 the next day after I received my injection. I went to the Emergency Department and they gave me IV fluids with Toradol and also Valium to relax my muscles. I was given a prescription for Naproxen and Flexoril to take for the next 5 days. On the evening of September 28th around 6:00pm I noticed swollen lymph nodes in the right armpit area and upper right shoulder/collarbone area. Some other symptoms I have experienced starting at 12:30 am on September 28th were fever 100.3, headache, sore arm at the injection site, nausea, loss of appetite, and weakness in my legs. On September 29 at 7:30am I still have the swollen lymph nodes and my muscles are sore to the touch in the right armpit and collarbone area. Also my chest still hurts if I move or if I bend down.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscular weakness, Myalgia, Nausea, Pain
Clinical narrative: Started having constant chest pain that felt like pressure and shortness of breath when I would breathe in. Started at 0545 the next day after I received my injection. I went to the Emergency Department and they gave me IV fluids with Toradol and also Valium to relax my muscles. I was given a prescription for Naproxen and Flexoril to take for the next 5 days. On the evening of September 28th around 6:00pm I noticed swollen lymph nodes in the right armpit area and upper right shoulder/collarbone area. Some other symptoms I have experienced starting at 12:30 am on September 28th were fever 100.3, headache, sore arm at the injection site, nausea, loss of appetite, and weakness in my legs. On September 29 at 7:30am I still have the swollen lymph nodes and my muscles are sore to the touch in the right armpit and collarbone area. Also my chest still hurts if I move or if I bend down.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Started having constant chest pain that felt like pressure and shortness of breath when I would breathe in. Started at 0545 the next day after I received my injection. I went to the Emergency Department and they gave me IV fluids with Toradol and also Valium to relax my muscles. I was given a prescription for Naproxen and Flexoril to take for the next 5 days. On the evening of September 28th around 6:00pm I noticed swollen lymph nodes in the right armpit area and upper right shoulder/collarbone area. Some other symptoms I have experienced starting at 12:30 am on September 28th were fever 100.3, headache, sore arm at the injection site, nausea, loss of appetite, and weakness in my legs. On September 29 at 7:30am I still have the swollen lymph nodes and my muscles are sore to the touch in the right armpit and collarbone area. Also my chest still hurts if I move or if I bend down.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Heavy menstrual bleeding, Menstruation irregular, Muscle spasms
Clinical narrative: The day after the vax, I had fever, chills, and I started with debilitating headaches.  I have been taking my migraine prescription to no avail.  I also experienced nausea.  Two days after the vax I started my period (12 days early).  I had severe cramping, extremely heavy flow with clotting.  This went on for 3 days and just stopped.  I went from major clotting, cramping and bleeding to nothing at all.  No step down.  I am still experiencing nausea and horrible headaches.  It feels like my hormones have been disrupted.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pyrexia, Thrombosis
Clinical narrative: The day after the vax, I had fever, chills, and I started with debilitating headaches.  I have been taking my migraine prescription to no avail.  I also experienced nausea.  Two days after the vax I started my period (12 days early).  I had severe cramping, extremely heavy flow with clotting.  This went on for 3 days and just stopped.  I went from major clotting, cramping and bleeding to nothing at all.  No step down.  I am still experiencing nausea and horrible headaches.  It feels like my hormones have been disrupted.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Diarrhoea, Fatigue, Headache
Clinical narrative: Fatigue, headache, diarrhea, stuffy nose, loss of smell and taste, feeling a loss helplessness, can?t sleep, flu like symptoms.  This has been going on for five days.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Helplessness, Influenza like illness, Insomnia, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Fatigue, headache, diarrhea, stuffy nose, loss of smell and taste, feeling a loss helplessness, can?t sleep, flu like symptoms.  This has been going on for five days.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy, Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Painful cramping and very heavy flow period with clotting. All abnormal for me. This lasted 4-5 days.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient came in 15 days after receiving the first dose and was vaccinated before the normal 21 days.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Heart rate abnormal
Clinical narrative: Left sided chest pain/discomfort, on and off with heart rate fluctuations
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: After 2 weeks still have sore arm at injection site
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Two months ago I started having a rash on my leg and went to a Dermatologist and put on a varied things. He wasn't sure what it was. A couple of weeks ago I got another rash now on my back. Dr. said no clear diagnosis. Currently it's a annoying rash in a large area with no clear diagnosis.
Age: 68.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: Aches and malaise , very tired
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient reported she had never had a COVID19 vaccine. A search in system showed that the patient had had 2 doses of the Moderna vaccine.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Chest X-ray normal, Computerised tomogram head abnormal, Contusion
Clinical narrative: He noted that for days after receiving COVID 19 J&J vaccine, patient developed dizzy spells with nausea and decreased exercise tolerance.  On Sept 20th, he noted that the symptoms worsened and he developed a syncopal episode and hit his head.  He was seen in the Emergency Department.  He had head trauma which resulted in imaging (negative) but resulted in a head laceration requiring stitches.   He had cardiac enzymes screening accomplished which was negative.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Exercise tolerance decreased, Eye contusion, Full blood count, Head injury
Clinical narrative: He noted that for days after receiving COVID 19 J&J vaccine, patient developed dizzy spells with nausea and decreased exercise tolerance.  On Sept 20th, he noted that the symptoms worsened and he developed a syncopal episode and hit his head.  He was seen in the Emergency Department.  He had head trauma which resulted in imaging (negative) but resulted in a head laceration requiring stitches.   He had cardiac enzymes screening accomplished which was negative.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Leukocytosis, Metabolic function test, Myocardial necrosis marker normal, Nausea, Skin laceration
Clinical narrative: He noted that for days after receiving COVID 19 J&J vaccine, patient developed dizzy spells with nausea and decreased exercise tolerance.  On Sept 20th, he noted that the symptoms worsened and he developed a syncopal episode and hit his head.  He was seen in the Emergency Department.  He had head trauma which resulted in imaging (negative) but resulted in a head laceration requiring stitches.   He had cardiac enzymes screening accomplished which was negative.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Soft tissue swelling, Suture insertion, Syncope, Troponin normal, White blood cell count increased
Clinical narrative: He noted that for days after receiving COVID 19 J&J vaccine, patient developed dizzy spells with nausea and decreased exercise tolerance.  On Sept 20th, he noted that the symptoms worsened and he developed a syncopal episode and hit his head.  He was seen in the Emergency Department.  He had head trauma which resulted in imaging (negative) but resulted in a head laceration requiring stitches.   He had cardiac enzymes screening accomplished which was negative.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray limb normal
Clinical narrative: He noted that for days after receiving COVID 19 J&J vaccine, patient developed dizzy spells with nausea and decreased exercise tolerance.  On Sept 20th, he noted that the symptoms worsened and he developed a syncopal episode and hit his head.  He was seen in the Emergency Department.  He had head trauma which resulted in imaging (negative) but resulted in a head laceration requiring stitches.   He had cardiac enzymes screening accomplished which was negative.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN PER SLIP RECEIVED WITH VACCINE LOT 201A21A AND EXP 21SEP WHICH LED PHARMACIST TO BELIEVE EXPIRATION WAS 9/30/21 WHEN EXPIRED ON MFR WEBSITE WAS 9/21/21.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Eye infection
Clinical narrative: Ongoing diarrhea, stomach cramps, bloating. Symptoms continue for several weeks, never had it before for so long. Eye infection.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient received Pfizer vaccination on 1/15/2021 and 2/5/2021. Patient hospitalized for COVID-19 9/28/2021. Patient still currently hospitalized with breakthrough COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Blood test, Dermatitis, Lymphadenopathy
Clinical narrative: Development of chronic dermatitis affecting multiple body sites with associated lymphadenopathy, no associated fever.  She was treated with 2-3 months of oral prednisone and remains on long term therapy with topical steroids and may require a chronic systemic medication for dermatitis (Dupixent).  She does not have a prior history of dermatitis prior to vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Herpes zoster
Clinical narrative: Shortly after receiving the second dose of Moderna, I got shingles first (I have been vaccinated for Shingles) and now after that cleared, I was diagnosed with Bells Palsy in the ER.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Oxygen saturation decreased
Clinical narrative: MD H&P: Patient with recent exposure then diagnosis of Covid.  This started about 10 days ago.  Her O2 sats was checked by her daughter yesterday and was found to be under 90.  Because of that she was directed to emergency room.  She was admitted for further treatment.  Since admission patient been treated with Decadron oxygen supplementation and Has needed breathing treatments.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Extra dose administered, Nausea, Tremor, Vomiting
Clinical narrative: The patient stated that she felt "woozy", had shakes, and nausea/vomiting x1. The patient's vitals  167/108 L arm 92HR   at 0759 and 154/99 R arm 87HR at 0802. The patient was given 25mg of Diphenhydramine oral solution  at 0805. The patient was also reclined. The blood pressure was rechecked 188/116 L arm 88HR at 0833 and 172/92 R arm at 0835. The patient's supervisor was then notified to come. The patient gave permission for information to be shared with supervisor. The patient voiced understanding that she should go seek medical attention and treatment from hospital or her own personal doctor. The patient also voiced understanding that she cannot drive herself due to Diphenhydramine intake.  The patient's supervisor is witness to patient voicing understanding on both occasions.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Started period 2 days after shot and stayed on it until my following expected period, 3 weeks later.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Aphasia, Balance disorder, Biopsy brain, Blindness
Clinical narrative: I, recipient of shot, was in perfect health prior to shot on March 25, 2022. Eleven days later, on April 5, 2021, I started experiencing short 3-5 minute pockets of odd imbalance, confusion, delirium, no sense of gravity, loss of feeling in legs, and excessive high blood pressure spikes whenever I stood up. Health insurance with new kicked in late. I was finally able to go to my doctor after 90 days of experiencing adverse reactions.   Doctor ran many inconclusuve tests. On July 13, at about 11:00am I was proving child care to 4 children. I suddenly lost cognitive ability to read, to see, to understand,  and then loss consciousness.  I awoke while in ambulance transfer to hospital. I could not speak. I dud not know my name. I didn't know what year it was. After about 12 hours in ER, some speech & cognition came back.   Neurologist ran numerous tests. Some limited white matter and lesion evidence was seen. I set up follow up appointments and returned to work. I had another unexpected episode about a month later. Had been feeling fine but out of nowhere lost the ability to read, speak correctly, move correctly,  then lost the ability to know who I was and my brain underwent severe crippling pain. All symptoms subsided after about 12 hours.  Three other crippling,  terrifying, worsening episodes happened by mid September.  Multiple Neurologists have run many MRIs, and the spread of white matter and lesions gets rapidly worse.  I have lost more and more ability to focus and to hold memories.  I was given a brain biopsy on Sept 27, 2021 and am awaiting results. None of these cognitive symptoms existed before the civid shot.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cognitive disorder, Confusional state, Delirium, Disturbance in attention
Clinical narrative: I, recipient of shot, was in perfect health prior to shot on March 25, 2022. Eleven days later, on April 5, 2021, I started experiencing short 3-5 minute pockets of odd imbalance, confusion, delirium, no sense of gravity, loss of feeling in legs, and excessive high blood pressure spikes whenever I stood up. Health insurance with new kicked in late. I was finally able to go to my doctor after 90 days of experiencing adverse reactions.   Doctor ran many inconclusuve tests. On July 13, at about 11:00am I was proving child care to 4 children. I suddenly lost cognitive ability to read, to see, to understand,  and then loss consciousness.  I awoke while in ambulance transfer to hospital. I could not speak. I dud not know my name. I didn't know what year it was. After about 12 hours in ER, some speech & cognition came back.   Neurologist ran numerous tests. Some limited white matter and lesion evidence was seen. I set up follow up appointments and returned to work. I had another unexpected episode about a month later. Had been feeling fine but out of nowhere lost the ability to read, speak correctly, move correctly,  then lost the ability to know who I was and my brain underwent severe crippling pain. All symptoms subsided after about 12 hours.  Three other crippling,  terrifying, worsening episodes happened by mid September.  Multiple Neurologists have run many MRIs, and the spread of white matter and lesions gets rapidly worse.  I have lost more and more ability to focus and to hold memories.  I was given a brain biopsy on Sept 27, 2021 and am awaiting results. None of these cognitive symptoms existed before the civid shot.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypertension, Hypoaesthesia, Loss of consciousness
Clinical narrative: I, recipient of shot, was in perfect health prior to shot on March 25, 2022. Eleven days later, on April 5, 2021, I started experiencing short 3-5 minute pockets of odd imbalance, confusion, delirium, no sense of gravity, loss of feeling in legs, and excessive high blood pressure spikes whenever I stood up. Health insurance with new kicked in late. I was finally able to go to my doctor after 90 days of experiencing adverse reactions.   Doctor ran many inconclusuve tests. On July 13, at about 11:00am I was proving child care to 4 children. I suddenly lost cognitive ability to read, to see, to understand,  and then loss consciousness.  I awoke while in ambulance transfer to hospital. I could not speak. I dud not know my name. I didn't know what year it was. After about 12 hours in ER, some speech & cognition came back.   Neurologist ran numerous tests. Some limited white matter and lesion evidence was seen. I set up follow up appointments and returned to work. I had another unexpected episode about a month later. Had been feeling fine but out of nowhere lost the ability to read, speak correctly, move correctly,  then lost the ability to know who I was and my brain underwent severe crippling pain. All symptoms subsided after about 12 hours.  Three other crippling,  terrifying, worsening episodes happened by mid September.  Multiple Neurologists have run many MRIs, and the spread of white matter and lesions gets rapidly worse.  I have lost more and more ability to focus and to hold memories.  I was given a brain biopsy on Sept 27, 2021 and am awaiting results. None of these cognitive symptoms existed before the civid shot.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging head abnormal, White matter lesion
Clinical narrative: I, recipient of shot, was in perfect health prior to shot on March 25, 2022. Eleven days later, on April 5, 2021, I started experiencing short 3-5 minute pockets of odd imbalance, confusion, delirium, no sense of gravity, loss of feeling in legs, and excessive high blood pressure spikes whenever I stood up. Health insurance with new kicked in late. I was finally able to go to my doctor after 90 days of experiencing adverse reactions.   Doctor ran many inconclusuve tests. On July 13, at about 11:00am I was proving child care to 4 children. I suddenly lost cognitive ability to read, to see, to understand,  and then loss consciousness.  I awoke while in ambulance transfer to hospital. I could not speak. I dud not know my name. I didn't know what year it was. After about 12 hours in ER, some speech & cognition came back.   Neurologist ran numerous tests. Some limited white matter and lesion evidence was seen. I set up follow up appointments and returned to work. I had another unexpected episode about a month later. Had been feeling fine but out of nowhere lost the ability to read, speak correctly, move correctly,  then lost the ability to know who I was and my brain underwent severe crippling pain. All symptoms subsided after about 12 hours.  Three other crippling,  terrifying, worsening episodes happened by mid September.  Multiple Neurologists have run many MRIs, and the spread of white matter and lesions gets rapidly worse.  I have lost more and more ability to focus and to hold memories.  I was given a brain biopsy on Sept 27, 2021 and am awaiting results. None of these cognitive symptoms existed before the civid shot.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Hypoxia, SARS-CoV-2 test positive
Clinical narrative: Patient was fully vaccinated 3/10/21 and was admitted for COVID19 9/28/21. Patient remains admitted hypoxic, on oxygen
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient was fully vaccinated 3/10/21 and was admitted for COVID19 9/28/21. Patient remains admitted hypoxic, on oxygen
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chest pain, Chills, Cough
Clinical narrative: Fever, runny nose, sneezing, coughing, chest pain, chills, loss of smell and taste
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: Fever, runny nose, sneezing, coughing, chest pain, chills, loss of smell and taste
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head injury, Immunisation, Nausea, Pain
Clinical narrative: After 12 hours, high fever above 103, tremors After 24 hours, dizziness and nausea, body aches  After  48 hours, vertigo, fainted and hit head on the floor After I fainted I felt totally back to normal
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope, Tremor, Vertigo
Clinical narrative: After 12 hours, high fever above 103, tremors After 24 hours, dizziness and nausea, body aches  After  48 hours, vertigo, fainted and hit head on the floor After I fainted I felt totally back to normal
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Vaccine was reconstituted with sterile water instead of normal saline.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Fundus autofluorescence, Migraine, Optic disc hyperaemia, Photopsia
Clinical narrative: Pt experienced flashing lights in the right eye as well as a shadow in her vision in the right eye for 3 hours starting 5/10/21 am. In addition she had mild eye pain.   She was seen in the ER and dx with ocular migraine and told to f/u with our Ophthalmology practice.  We saw pt on 5/11/21 and vision was 20/20.  She was diagnosed with a mild Central retinal vein occlusion in the right eye. On exam pt had hyperemia of the right optic nerve and a few small intraretinal hemorrhages in the periphery.  She also had engorged and dilated retinal vessels.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Retinal haemorrhage, Retinal vascular disorder, Retinal vein occlusion, Ultrasound eye abnormal, Visual impairment
Clinical narrative: Pt experienced flashing lights in the right eye as well as a shadow in her vision in the right eye for 3 hours starting 5/10/21 am. In addition she had mild eye pain.   She was seen in the ER and dx with ocular migraine and told to f/u with our Ophthalmology practice.  We saw pt on 5/11/21 and vision was 20/20.  She was diagnosed with a mild Central retinal vein occlusion in the right eye. On exam pt had hyperemia of the right optic nerve and a few small intraretinal hemorrhages in the periphery.  She also had engorged and dilated retinal vessels.
Age: 63.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event, but patient was given high dose flu vaccine (fluad) and is only 63 years old.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Pain
Clinical narrative: About 10 days later I had severe joint pain to a point where it was incapacitating. I called my doctor who advised anti-inflammatory which we followed. For the first 2 weeks I could not walk, it was so painful. It improved after that but took 6 weeks to completely resolve. We took Tylenol to help.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Nausea, Vomiting
Clinical narrative: Nausea and vomiting immediately, then ceased overnight and resumed at 4am the next morning, ongoing every 30 minutes for hours
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Crying, Headache, Injection site erythema, Injection site indentation
Clinical narrative: From Pharmacy. Pfizer #1 on 09/24/21 @  3 pm. right arm.   Above the  injection site there is a round indented area on the skin., She said that she has never had headache in her life. She has had a headache since the vaccine. " In my frontal Lobe,  it is on & off. " She said that the first day she felt like there was an elephant sitting on her chest, & since then she has been feeling palpitations in her chest. Her  PCP is thru local HCF.  She denied fever or  99% HR 73. For the first 24 hours the site was tender and pink, swollen and it has all since resolved, exception of the  dimple. She said that about an hour after the vaccine she did the magnet to her arm and it was magnetized. She said that about 36 hours after the vaccine the magnet no longer stuck. I advised her to contact her PCP related to the palpitations she is intermittently experiencing. She cried heavily on the phone saying she got the vaccine or she would lose her job. A VAERS will need to be submitted..