chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: went to get a Fluzone Quadrivalent prefilled syringe (no preservative) vaccine, however the HCP accidentally gave the Fluzone Quadrivalent MDV instead with no reported adverse event; Patient is in her third trimester of pregnancy; HCP accidentally gave the Fluzone Quadrivalent MDV with no reported adverse event; Initial information was received on 17-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional under Global Medical Information (GMI) Inquiry Number: 00862192  This case involves a 38 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in context of went to get a fluzone quadrivalent prefilled syringe (no preservative) vaccine, however the health care professional accidentally gave the fluzone quadrivalent multi dose vial (mdv) instead with no reported adverse event (wrong product administered) and patient was in her third trimester of pregnancy (exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e,  before pregnancy outcome was known.  Unknown gestation period, the gestation period at onset and gestation period at exposure data needs to be populated, if available.  The date of last menstrual period was not reported.  The estimated due date was 08-Jan-2022.  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.  The patient's previous pregnancy/ies were unknown.   On 10-Nov-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: U7729AC and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "The caller stated that she wants to enroll in the pregnancy registry for Fluzone. The patient then called her (obstetrician-gynaecologist) OB/GYN who said that it should be fine, however encouraged her to get on the pregnancy registry."  It was a case of actual medication error due to wrong vaccine administered and vaccine exposure during pregnancy (latency: same day).  Relevant prenatal testing after exposure were not known.   Additionally, at time of reporting, the pregnancy was still ongoing.  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 by the regulatory authority. 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: 66.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine exposed to 31 degrees Fahrenheit for a couple of days with no A/E; Initial information was received on 18-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist via a consumer via physician via phone call (under Medical Information Inquiry Number: 00864185).  This case is linked to cases 2021SA392836, 2021SA392839 and 2021SA392842(CLUSTER).  This case involves a 66 years old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] that was exposed to 31 degrees Fahrenheit for a couple of days with no adverse event (product storage error).  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On 13-Nov-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ764AC and expiry date: 30-Jun-2022) via intramuscular route in the left arm for prophylactic vaccination.  It was reported "Caller stated that co-worker called in to report the excursion on Monday. Caller wanted to know what would happen if patient took product after being exposed to temperatures 31Fahrenheit degrees. What to the product when exposed to low temperatures?"  It was case of an actual medication error due to product storage error temperature too low (latency was on same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 2.0
Sex: M
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: supposed to administer Pentacel- gave the DTAP and IPV but didn't reconstitute with the HIB powder/ was given only the diluent portion of the Pentacel vaccine with no reported adverse event; Initial information was received on 18-Nov-2021 regarding an unsolicited valid non-serious case from an other health professional via a consumer via phone call (under Medical Information (MI) Inquiry Number: 00864370).  This case involves a 2 years old male patient who was supposed to administer DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] he was given the dtap and ipv but didn't reconstitute it with the hib powder and was given only the diluent portion of the pentacel vaccine with no reported adverse event (product preparation issue).  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On 02-Nov-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: UJ474888 and expiry date: 18-Jul-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "What are the next steps for handling?"  It was case of an actual medication error due to inappropriate reconstitution technique (latency was on same day).   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 66.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received an expire vaccine of  ACTHIB, with no reported adverse event; Initial information received on 18-Nov-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00864547).  This case involves a 66 year old male patient who was vaccinated with the expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient past medical history included Stem cell transplant.  The patient past medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP HEPB) for Prophylactic vaccination.  On 18-Nov-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ4D4AA and expiry date: 04-Oct-2021) (Frequency once) via intramuscular route in the arm not otherwise specified (nos) for prophylactic vaccination.  It was an actual medication error case due to expired product administered (latency on same day).  It was reported "Caller states that a patient in her office received an ACTHIB vaccine that expired on 04OCT2021. asked how to proceed and asked for information on expired product to be emailed to her. Caller states that the patient received ACTHIB because he is a stem cell transplant recipient".  At time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 74-year-old patient received two doses of FLUZONE HIGH-DOSE QUADRIVALENT, one was on 9/13/2021 and 2 month apart second on 11/18/2021 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a Physician via the Regulatory Authority (Reference number- 00864734) and transmitted to Sanofi on 18-Nov-2021.  This case involves a 74-year-old female patient who vaccinated with a 0.7 mL (once) dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiry date not reported) via intramuscular route in the left deltoid on 13-Sep-2021 and 2 months apart received another 0.7 mL (once) dose of the same vaccine (lot UJ774AA, expiry date 30-Jun-2022) via intramuscular route in the left deltoid on 18-Nov-2021 for prophylactic vaccination (extra dose administered).  Medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medication reported no other vaccines at the time of vaccination.  It was a case of actual medication error due to extra dose administered (latency was on same day as per second dose).  It was reported "The caller wanted to know if there is any concern if a patient was administer 2 doses of Fluzone High dose, 2 month apart. The patient received two dose of Fluzone HD Quad. One was on 9/13/2021, the second was 11/18/2021."  At the time of report, 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: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Hypotension, Nausea, Tachycardia, Tremor
Clinical narrative: body shakes; nausea; tachycardia; had a headache  10/10; vomiting; hypotension; Initial information received on 19-Nov-2021 regarding an unsolicited valid serious case from an other health professional via Global Media Information (under the reference 00865883).  This case is linked to case 2021SA393667 (same reporter).  This case involves a 16 years old female patient who had body shakes (tremor), nausea, tachycardia, had a headache 10/10 (headache), vomiting and hypotension after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) and INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) (Lot number and expiration date not provided for both) via unknown route in an unknown administration site for prophylactic vaccination.  On 17-Nov-2021, the patient received a dose of suspect MENACTRA (0.5 ml, total, once, lot U7207AB and expiration date: 08-FEB-2023) via intramuscular route in the left deltoid for prophylactic vaccination.   On 17-Nov-2021, the patient developed a serious body shakes (tremor), nausea, tachycardia, had a headache 10/10 (headache), vomiting and hypotension, one day following the administration of vaccine.   This events were assessed as medically significant.  No laboratory data reported.  It was reported that adverse reactions with two patients after they received the MENACTRA vaccine. Caller was wanting to know if the vaccine is safe to continue to use. Both patients were seen in the emergency room. The status of the first patient had only been reported so far from the emergency room and released.  The patient was treated with IBUPROFEN (second dose, Intravenous fluids) at home.  The patient recovered from the all reported events on an unknown date.; Sender's Comments: This case concerns a 16-year-old female patient who had tremor, nausea, tachycardia, headache, vomiting and hypotension after vaccination with MENACTRA. Concomitant medications included TRUMENBA and FLUZONE [INFLUENZA VACCINE]. The time to onset is compatible. However, patient's medical condition at the time of vaccination and other relevant laboratory data were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: body shakes; nausea; tachycardia; had a headache  10/10; vomiting; hypotension; Initial information received on 19-Nov-2021 regarding an unsolicited valid serious case from an other health professional via Global Media Information (under the reference 00865883).  This case is linked to case 2021SA393667 (same reporter).  This case involves a 16 years old female patient who had body shakes (tremor), nausea, tachycardia, had a headache 10/10 (headache), vomiting and hypotension after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) and INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) (Lot number and expiration date not provided for both) via unknown route in an unknown administration site for prophylactic vaccination.  On 17-Nov-2021, the patient received a dose of suspect MENACTRA (0.5 ml, total, once, lot U7207AB and expiration date: 08-FEB-2023) via intramuscular route in the left deltoid for prophylactic vaccination.   On 17-Nov-2021, the patient developed a serious body shakes (tremor), nausea, tachycardia, had a headache 10/10 (headache), vomiting and hypotension, one day following the administration of vaccine.   This events were assessed as medically significant.  No laboratory data reported.  It was reported that adverse reactions with two patients after they received the MENACTRA vaccine. Caller was wanting to know if the vaccine is safe to continue to use. Both patients were seen in the emergency room. The status of the first patient had only been reported so far from the emergency room and released.  The patient was treated with IBUPROFEN (second dose, Intravenous fluids) at home.  The patient recovered from the all reported events on an unknown date.; Sender's Comments: This case concerns a 16-year-old female patient who had tremor, nausea, tachycardia, headache, vomiting and hypotension after vaccination with MENACTRA. Concomitant medications included TRUMENBA and FLUZONE [INFLUENZA VACCINE]. The time to onset is compatible. However, patient's medical condition at the time of vaccination and other relevant laboratory data were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Heart rate increased, Pharyngeal swelling
Clinical narrative: anaphylaxis (hives, shortness of breath, face nose and throat swelling, difficulty swallowing, rapid heart rate. ER visit: diphenhydramine, solu-medrol, famotidine, epinephrine, oxygen, IV fluids.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: anaphylaxis (hives, shortness of breath, face nose and throat swelling, difficulty swallowing, rapid heart rate. ER visit: diphenhydramine, solu-medrol, famotidine, epinephrine, oxygen, IV fluids.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Apathy, Blood test, Breast mass, Breast pain
Clinical narrative: Arm soreness, left body swelling (leg, arm, back/shoulder, neck), chest pain, shortness of breath, inability to make it through a workout like before the vaccine, inability to exercise arm without pain, headaches, dizziness, hair loss, fat loss around injection site, arm deformity,  fatigue, mood changes, bowel issues, no desire to do anything/no motivation/depression, constant soreness/pain in arm around injection site, frequent infections, breast lumps/pain
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Cardiac stress test, Chest pain, Depression, Dizziness
Clinical narrative: Arm soreness, left body swelling (leg, arm, back/shoulder, neck), chest pain, shortness of breath, inability to make it through a workout like before the vaccine, inability to exercise arm without pain, headaches, dizziness, hair loss, fat loss around injection site, arm deformity,  fatigue, mood changes, bowel issues, no desire to do anything/no motivation/depression, constant soreness/pain in arm around injection site, frequent infections, breast lumps/pain
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Exercise tolerance decreased, Fat tissue decreased
Clinical narrative: Arm soreness, left body swelling (leg, arm, back/shoulder, neck), chest pain, shortness of breath, inability to make it through a workout like before the vaccine, inability to exercise arm without pain, headaches, dizziness, hair loss, fat loss around injection site, arm deformity,  fatigue, mood changes, bowel issues, no desire to do anything/no motivation/depression, constant soreness/pain in arm around injection site, frequent infections, breast lumps/pain
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Gastrointestinal disorder, Headache, Infection
Clinical narrative: Arm soreness, left body swelling (leg, arm, back/shoulder, neck), chest pain, shortness of breath, inability to make it through a workout like before the vaccine, inability to exercise arm without pain, headaches, dizziness, hair loss, fat loss around injection site, arm deformity,  fatigue, mood changes, bowel issues, no desire to do anything/no motivation/depression, constant soreness/pain in arm around injection site, frequent infections, breast lumps/pain
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction, Limb deformity, Mammogram, Mood altered
Clinical narrative: Arm soreness, left body swelling (leg, arm, back/shoulder, neck), chest pain, shortness of breath, inability to make it through a workout like before the vaccine, inability to exercise arm without pain, headaches, dizziness, hair loss, fat loss around injection site, arm deformity,  fatigue, mood changes, bowel issues, no desire to do anything/no motivation/depression, constant soreness/pain in arm around injection site, frequent infections, breast lumps/pain
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Swelling, Thyroid function test, Ultrasound scan
Clinical narrative: Arm soreness, left body swelling (leg, arm, back/shoulder, neck), chest pain, shortness of breath, inability to make it through a workout like before the vaccine, inability to exercise arm without pain, headaches, dizziness, hair loss, fat loss around injection site, arm deformity,  fatigue, mood changes, bowel issues, no desire to do anything/no motivation/depression, constant soreness/pain in arm around injection site, frequent infections, breast lumps/pain
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: NEW ONSET OF SEIZURES 07/19/2021
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ecchymosis, Haemoglobin decreased, Immune thrombocytopenia, Petechiae, Platelet count decreased
Clinical narrative: Immune thrombocytopenic purpura: Patient developed petechiae and ecchymoses on the day after vaccination (11/24), and she was found to have a platelet count of 8 on 11/26. She will be hospitalized for close monitoring of her platelet levels and treated with IV steroids.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count normal
Clinical narrative: Immune thrombocytopenic purpura: Patient developed petechiae and ecchymoses on the day after vaccination (11/24), and she was found to have a platelet count of 8 on 11/26. She will be hospitalized for close monitoring of her platelet levels and treated with IV steroids.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Contusion, Full blood count abnormal, Immune thrombocytopenia, Platelet count decreased
Clinical narrative: Immune thrombocytopenic purpura: Patient developed petechiae and ecchymoses on the day after vaccination (11/24), and she was found to have a platelet count of 8 on 11/26. She will be hospitalized for close monitoring of her platelet levels and treated with IV steroids.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash macular, Vaccination complication
Clinical narrative: Immune thrombocytopenic purpura: Patient developed petechiae and ecchymoses on the day after vaccination (11/24), and she was found to have a platelet count of 8 on 11/26. She will be hospitalized for close monitoring of her platelet levels and treated with IV steroids.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Palpitations
Clinical narrative: Heart arrhythmia with 3-5 palpitations per minute. Condition lessened each day and appears to be completely gone after 10 days.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting and responsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: received shot stable sat in waiting seats, father yelled name, came out of room father holding pt, laid pt on floor responsive, A&OX3, BP 110-90 x3, pupils reactive, red bruise overr left eye, no blood or swelling, pt expressed nausea, called EMS, per EMS vitals stable got to ER parents declined transport and drove pt, escorted pt and family to car, cold compress applied to bruise.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting and responsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: received shot stable sat in waiting seats, father yelled name, came out of room father holding pt, laid pt on floor responsive, A&OX3, BP 110-90 x3, pupils reactive, red bruise overr left eye, no blood or swelling, pt expressed nausea, called EMS, per EMS vitals stable got to ER parents declined transport and drove pt, escorted pt and family to car, cold compress applied to bruise.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature decreased, Chills, Fatigue, Flushing, Hyperhidrosis
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: low temp 92.0-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Lethargy, Tremor
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: low temp 92.0-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Systemic: Premature Ventricular Contractions-Medium
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Systemic: Pain in both forearms and wrists and limited wrists mobility-Medium
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Crying, Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Mild, Additional Details: Patient reported a sharp pain and burning sensation strong enough for her to cry out when administered the shot, and the patient reported a radiating pain in the arm/shoulder after administration.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Mild, Additional Details: Patient reported a sharp pain and burning sensation strong enough for her to cry out when administered the shot, and the patient reported a radiating pain in the arm/shoulder after administration.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Night sweats, Pain, Pyrexia
Clinical narrative: I had fever, body aches, Chills and night sweats. The fever lasted longer than the original series. I had a fever for 2 days. The body aches in my lower back were concerning. I?ve had night sweats for now 3 nights.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Ear discomfort, Tinnitus
Clinical narrative: Mild confusion short episode followed by clogged ears and loud ringing in both ears for about an hour before sleep. I took ibuprofen. Ringing is better this  morning but still noticeable.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Injury associated with device, Needle issue
Clinical narrative: Systemic: pt moved while trying to admin vaccine and got scratched by needle-Mild, Additional Details: pt moved while getting shot and got scratched by needle. the site bled and vaccine was wasted on her skin.  rph had to re-admin a new shot to different site. pt ok.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Mild, Additional Details: 10 minutes after vaccination, patient began to sweat then passed out and unresponsive for about 30 seconds or so (shook a few times) & then came to with continued sweating.  EMS was called who checked him out but he did refuse transport and left later on his own after about 45 to 60 minutes .
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: ems came, evaluated pt. pt refused ambulance and signed a waiver. walked out with his mother on his own accord
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: ems came, evaluated pt. pt refused ambulance and signed a waiver. walked out with his mother on his own accord
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Tinnitus
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tinnitus-Mild, Additional Details: Pt reported that she had not eaten before getting vaccination. Pt stated she felt lightheaded/dizzy right after vaccination adminstration. Pt stated she had ringing in her ears and then fainted while seated. Pt regained consciousness and became sweaty. Pt drank water and ate a bar with nuts.  After sitting a few minutes she said the ringing in her ears had stopped and she felt better.  She was able to stand and walk to another chair.  After drinking additional water, she left store with parent.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tinnitus-Mild, Additional Details: Pt reported that she had not eaten before getting vaccination. Pt stated she felt lightheaded/dizzy right after vaccination adminstration. Pt stated she had ringing in her ears and then fainted while seated. Pt regained consciousness and became sweaty. Pt drank water and ate a bar with nuts.  After sitting a few minutes she said the ringing in her ears had stopped and she felt better.  She was able to stand and walk to another chair.  After drinking additional water, she left store with parent.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Laboratory test abnormal, Myelitis transverse, Neuromyelitis optica spectrum disorder, Paralysis
Clinical narrative: Transverse myelitis  numbness in lower extremities  paralysis in lower body from hips to feet from  July to present
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Headache, Influenza like illness, Nasopharyngitis, Pain
Clinical narrative: He started with mild cold like symptoms but then it progressed to severe flu like symptoms.  Headaches,  sinus issues,  body hurting everywhere. Swollen face,  burning face
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinus disorder, Swelling face
Clinical narrative: He started with mild cold like symptoms but then it progressed to severe flu like symptoms.  Headaches,  sinus issues,  body hurting everywhere. Swollen face,  burning face
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Seizure
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Seizure-Medium
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Site: Redness at Injection Site-Mild, Additional Details: rash at injection site
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Acoustic stimulation tests abnormal, Hypoacusis, Tinnitus
Clinical narrative: I have had constant ringing in my left ear since the shots.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Numbness in left arm from elbow down x 14 days. Denies any other side effects such as pain, redness, swelling, warmth. Pt says he is also unable to fully extend the arm.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Amylase increased, Blood test, Lipase increased, Pancreatitis
Clinical narrative: I started experiencing upper abdominal pain on my left side Monday,  November 22, 2021, three days after my booster (3rd) Pfizer vaccine.  On Thursday, November 25, 2021, I went to the Emergency Room at the Hospital on Thursday, November 25, 2021, where I was diagnosed with Pancreatitis.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Chest pain, Computerised tomogram thorax abnormal, Deep vein thrombosis, Nodule
Clinical narrative: Approx 7-8 days following his second vaccination via Pfizer he began having symptoms of a knot in his Left leg that then began to painfully spread down the leg. He presented to ED on 26NOV and was found to have "extensive left lower extremity deep venous thrombosis from the level of the proximal superficial femoral vein into the calf".  He then was started on apixaban and the following morning was awaken from sleep 2 hours sooner than expected by 2-4/10 pleuritic chest pain; he then represented to the ED on 27NOV and was found to have 7-10/10 pain in the left lower leg requiring opiate pain management and CT Angiogram Chest PE Protocol showed "bilatera pulmonary emboli".
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pleuritic pain, Pulmonary embolism, Sleep disorder, Ultrasound Doppler abnormal
Clinical narrative: Approx 7-8 days following his second vaccination via Pfizer he began having symptoms of a knot in his Left leg that then began to painfully spread down the leg. He presented to ED on 26NOV and was found to have "extensive left lower extremity deep venous thrombosis from the level of the proximal superficial femoral vein into the calf".  He then was started on apixaban and the following morning was awaken from sleep 2 hours sooner than expected by 2-4/10 pleuritic chest pain; he then represented to the ED on 27NOV and was found to have 7-10/10 pain in the left lower leg requiring opiate pain management and CT Angiogram Chest PE Protocol showed "bilatera pulmonary emboli".
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: My armpit got swollen after the vaccine in the same arm and is still really sore and swollen.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Gastrointestinal pain, Nausea
Clinical narrative: GI distress: severe diarrhea, severe bowel cramping, short term nausea and vomiting, chills, fever.  So far the symptoms have lasted for an entire week.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: GI distress: severe diarrhea, severe bowel cramping, short term nausea and vomiting, chills, fever.  So far the symptoms have lasted for an entire week.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acupuncture, Cardiac stress test, Chest X-ray, Chest pain, Computerised tomogram head
Clinical narrative: Nerve pain in both arms starting in right arm but moving to left,  radiating from neck to fingers, acupuncture moved it to just tingling and numbness.  Similar but less intense tingling and numbness in legs.  Possibly unrelated (yet to be determined) sudden incident of hypertensive crisis on 11/7/2021 with chest pain.  Resolved 11/8/21 but no definitive diagnosis.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electromyogram, Hypertensive crisis, Hypoaesthesia, Neck pain
Clinical narrative: Nerve pain in both arms starting in right arm but moving to left,  radiating from neck to fingers, acupuncture moved it to just tingling and numbness.  Similar but less intense tingling and numbness in legs.  Possibly unrelated (yet to be determined) sudden incident of hypertensive crisis on 11/7/2021 with chest pain.  Resolved 11/8/21 but no definitive diagnosis.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve conduction studies, Neuralgia, Pain in extremity, Paraesthesia
Clinical narrative: Nerve pain in both arms starting in right arm but moving to left,  radiating from neck to fingers, acupuncture moved it to just tingling and numbness.  Similar but less intense tingling and numbness in legs.  Possibly unrelated (yet to be determined) sudden incident of hypertensive crisis on 11/7/2021 with chest pain.  Resolved 11/8/21 but no definitive diagnosis.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: On 10/30/2021 around 10:30 Am, I mistakenly allowed a 16 year old to be given the 1st dose of Moderna, covid 19 vaccine, due to not appropriately going through the five rights paramedics and other health care personnel  are trained to go through before administering a drug or vaccine. I entered the residence that the minor was living in, went through my questionnaire with the minors mother, and obtained consent after I advised the mother that I was there to administer the 1st dose of the moderna vaccine to the 16 year old child. The mother understood some of the risk that could have come along with the vaccine administration and still proceeded to give me consent to allow the vaccine to be administered. After the vaccine was administered, we observed the 16 year old for 15 minutes since the 16 year old did not have a prior history of severe allergic reactions . We observed to ensure that the 16 year old did not have an allergic reaction after administration. After the observation period was complete, my partner and I proceeded on with our day to our other appointments. There was no treatment given to the child since there was no adverse reaction that occurred. Almost a month later when the minor was due for the second dose, scheduling from the company I work for saw that the minor was given the moderna vaccine when he wasn?t supposed to. I was notified of this error on 11/25/2021 sometime in the early evening. I then proceeded to remove myself from work and ultimately placed myself on suspension so that I could review protocols and await the result of my error.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Moderna was given to 16 y/o pt due to scheduling, mapping, STL, and crew discrepancy  No symptoms or adverse reactions
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Rash papular, Skin swelling
Clinical narrative: On day 8 after receiving the vaccine, a red swollen spot appeared, similar to how a mosquito bite looks, but there were two close together, about the size of a quarter. A few hours later, another appeared farther up my arm. These spread to the point of connecting and a third spot appeared, farther up my arm. These spread together, too. It has continued to grow, up my arm/shoulder. The edges are red and swollen like a ridge. It?s now (5 days of spreading) an oval shape measuring 3.5 inches by 2.5 inches. Ice on it made the puffiness subside for a few hours, but didn?t stop the spread. Tea tree essential oil (for hives) did nothing. Benedryl before bed didn?t do anything by morning either.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Injected limb mobility decreased, Irritability, Limb discomfort, Pain in extremity
Clinical narrative: Since this vaccine has been given in my left arm in March, I have had pain and discomfort.  To start I was unable to lift the left arm completely over my head with out pain.  I went to urgent care and an ultrasound was given to see if there was fluid build up and none was found, the doctor then sent me to occupational  therapy for stretching.  I have been doing the stretching and it has assisted me with lifting my arm above my head, however I am still having a lot of pain and discomfort of this arm.  The area affected is also swollen and now it is waking me during the night.  I have recently gone back to urgent care to have this reexamined in hopes that the doctor would obtain some imaging to see what is happening.  Nothing was done except muscle relaxer and lidocaine patches.  I tried that and the medicines side affects were bothering me to a point that I was very irritable to my friends and family, short temper and so on.  I emailed my primary care doctor  and she scheduled my left arm for an MRI.  I explained that this is really bothersome and I am not wanting to be in pain any longer.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Sleep disorder, Ultrasound scan normal
Clinical narrative: Since this vaccine has been given in my left arm in March, I have had pain and discomfort.  To start I was unable to lift the left arm completely over my head with out pain.  I went to urgent care and an ultrasound was given to see if there was fluid build up and none was found, the doctor then sent me to occupational  therapy for stretching.  I have been doing the stretching and it has assisted me with lifting my arm above my head, however I am still having a lot of pain and discomfort of this arm.  The area affected is also swollen and now it is waking me during the night.  I have recently gone back to urgent care to have this reexamined in hopes that the doctor would obtain some imaging to see what is happening.  Nothing was done except muscle relaxer and lidocaine patches.  I tried that and the medicines side affects were bothering me to a point that I was very irritable to my friends and family, short temper and so on.  I emailed my primary care doctor  and she scheduled my left arm for an MRI.  I explained that this is really bothersome and I am not wanting to be in pain any longer.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Neuritis, Rash, Vision blurred, Visual field tests
Clinical narrative: immediately i got a rash on my neck they gave me benadryl.  a few days later my vision became slightly blurry and progressively got worse.  I was afraid it was optic neuritis again or i needed new glasses so i saw dr.  He said my optic nerve was inflamed most likely from the vaccine as I hadn't had anything new since.  Luckily it wasn't permanent this time.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site joint movement impairment, Injection site pain, Pain, Product administered at inappropriate site, Sleep disorder
Clinical narrative: Injection given too high in arm resulting in pain, soreness & loss of range of motion in the shoulder. For example, unable to lift arm higher than shoulder level because of extreme pain. Unable to sleep on left side. These symptoms still persist as of this submission.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Back pain, COVID-19, Chills, Cough
Clinical narrative: 11/18 covid shot 11/22 - severe headache & vomiting at school 11/23 - covid Test NEGATIVE & mild headache  11/24 - Sore throat, sore back, cough 11/25 - Headache, severe sore throat with swollen tonsils, congestion, partial loss of voice, cough that hurts, headache 11/26 - severe headache, fatigue, lethargic, fever 100.3, chills, partial loss of voice, swollen neck glands, extreme fatigue, cough, severe conjestion. At home covid test positive 3:30pm. Sleep 5-7pm, 7:30-10:30pm, 11pm-5:30am, 6am-10am
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Lethargy, Lymphadenopathy
Clinical narrative: 11/18 covid shot 11/22 - severe headache & vomiting at school 11/23 - covid Test NEGATIVE & mild headache  11/24 - Sore throat, sore back, cough 11/25 - Headache, severe sore throat with swollen tonsils, congestion, partial loss of voice, cough that hurts, headache 11/26 - severe headache, fatigue, lethargic, fever 100.3, chills, partial loss of voice, swollen neck glands, extreme fatigue, cough, severe conjestion. At home covid test positive 3:30pm. Sleep 5-7pm, 7:30-10:30pm, 11pm-5:30am, 6am-10am
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive, Tonsillar hypertrophy
Clinical narrative: 11/18 covid shot 11/22 - severe headache & vomiting at school 11/23 - covid Test NEGATIVE & mild headache  11/24 - Sore throat, sore back, cough 11/25 - Headache, severe sore throat with swollen tonsils, congestion, partial loss of voice, cough that hurts, headache 11/26 - severe headache, fatigue, lethargic, fever 100.3, chills, partial loss of voice, swollen neck glands, extreme fatigue, cough, severe conjestion. At home covid test positive 3:30pm. Sleep 5-7pm, 7:30-10:30pm, 11pm-5:30am, 6am-10am
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 11/18 covid shot 11/22 - severe headache & vomiting at school 11/23 - covid Test NEGATIVE & mild headache  11/24 - Sore throat, sore back, cough 11/25 - Headache, severe sore throat with swollen tonsils, congestion, partial loss of voice, cough that hurts, headache 11/26 - severe headache, fatigue, lethargic, fever 100.3, chills, partial loss of voice, swollen neck glands, extreme fatigue, cough, severe conjestion. At home covid test positive 3:30pm. Sleep 5-7pm, 7:30-10:30pm, 11pm-5:30am, 6am-10am
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site induration, Injection site nodule
Clinical narrative: Note: I did not react to the first 2 doses of Moderna (2/2/21 and 3/4/21) SWELLING: Within 24 hours, 2 (two) knots (firm swellings) a bit larger than a quarter arose on the arm at the injection site. The 2 firm knots barely touched at 1 point. Having 2 (two) knots was very odd! Within 48-hours, swelling continued (looked like the typical covid arm) and the two knots were parts of a larger swelling that measured just over 8 cm X 7 cm.  Additional symptoms included: joint pain (particularly of the left shoulder, elbow, neck), soreness in the left armpit but swollen lymph nodes, intense headache for approximately 4 hours, intermittent tingling in the wrist (I have never felt this before), and fatigue that lasted for over 48 hours.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymph node pain, Lymphadenopathy, Paraesthesia
Clinical narrative: Note: I did not react to the first 2 doses of Moderna (2/2/21 and 3/4/21) SWELLING: Within 24 hours, 2 (two) knots (firm swellings) a bit larger than a quarter arose on the arm at the injection site. The 2 firm knots barely touched at 1 point. Having 2 (two) knots was very odd! Within 48-hours, swelling continued (looked like the typical covid arm) and the two knots were parts of a larger swelling that measured just over 8 cm X 7 cm.  Additional symptoms included: joint pain (particularly of the left shoulder, elbow, neck), soreness in the left armpit but swollen lymph nodes, intense headache for approximately 4 hours, intermittent tingling in the wrist (I have never felt this before), and fatigue that lasted for over 48 hours.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Injected limb mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: Shoulder pain with movement and limited range of motion started at approximately 5 pm in the evening on the same day the vaccine was given (11/11/21).  I looked at vaccine site and could see that the site was too high, just under the acromion.  I went to urgent care at 7;30 pm that evening and was prescribed Prednisone 60 mg daily for 5 days.  I took this with some improvement in pain and range of motion. However, upon stopping steroids after 5 days,  the pain and limited range of motion returned. I  have been taking ibuprofen since and went to PT but the symptoms are worsening.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Lip blister
Clinical narrative: shingles herpes like lip blister - left side of face
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Severe left shoulder/arm pain, long-lasting. Severe pain happened a few days after initial shot. Severe pain to the point where I cannot lift my left shoulder or use my left arm to reach for anything or carry anything with any weight. I cannot lay on my left side either.