chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Granuloma annulare
Clinical narrative: granuloma annular/on both arms, hands, neck and face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for Covid-19 immunization. The following information was reported: GRANULOMA ANNULARE (non-serious), outcome "not recovered", described as "granuloma annular/on both arms, hands, neck and face". Therapeutic measures were taken as a result of granuloma annulare.  Additional information: The patient has a generalized case of granuloma annular after receiving (Pfizer) COVID-19 booster shot. She has been receiving treatment (unspecified) for the past 10 months with only slight improvement. It was on both arms, hands, neck and face. Patient asked if she should be reporting this reaction in another way.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush, Malaise, Myalgia
Clinical narrative: Moderate chills; hot flashes at 10 hours after vaccination; headache; muscle soreness; malaise from 14 hours after vaccination for 5 hours.; Mild injection site pain yesterday; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 (BNT162B2, BNT162B2 ), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary Immunization completed, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Sep2022, outcome "unknown", described as "Mild injection site pain yesterday"; CHILLS (non-serious), 10 hrs after the suspect product administration, outcome "unknown", described as "Moderate chills"; HOT FLUSH (non-serious), 10 hrs after the suspect product administration, outcome "unknown", described as "hot flashes at 10 hours after vaccination"; HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "muscle soreness"; MALAISE (non-serious), 14 hrs after the suspect product administration, outcome "unknown", described as "malaise from 14 hours after vaccination for 5 hours.".  Additional information: Patient received the Pfizer BioNTech bivalent COVID booster. Patient experienced mild injection site pain yesterday (13Sep2022), moderate chills and hot flashes 10 hours after vaccination, headache, muscle soreness, and malaise 14 hours after vaccination for 5 hours.  The information on the batch/lot number for BNT162b2, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101760602 same patient/drug, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Moderate chills; hot flashes at 10 hours after vaccination; headache; muscle soreness; malaise from 14 hours after vaccination for 5 hours.; Mild injection site pain yesterday; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 (BNT162B2, BNT162B2 ), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary Immunization completed, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Sep2022, outcome "unknown", described as "Mild injection site pain yesterday"; CHILLS (non-serious), 10 hrs after the suspect product administration, outcome "unknown", described as "Moderate chills"; HOT FLUSH (non-serious), 10 hrs after the suspect product administration, outcome "unknown", described as "hot flashes at 10 hours after vaccination"; HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "muscle soreness"; MALAISE (non-serious), 14 hrs after the suspect product administration, outcome "unknown", described as "malaise from 14 hours after vaccination for 5 hours.".  Additional information: Patient received the Pfizer BioNTech bivalent COVID booster. Patient experienced mild injection site pain yesterday (13Sep2022), moderate chills and hot flashes 10 hours after vaccination, headache, muscle soreness, and malaise 14 hours after vaccination for 5 hours.  The information on the batch/lot number for BNT162b2, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101760602 same patient/drug, different dose/event;
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Patient administered vaccine post excursion with no reported advsere event; temperature excursion over the weekend, with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases 2022SA377654(CLUSTER) and 2022SA377972(CLUSTER).  This case involves an unknown age and  gender patient who  administered vaccine post excursion with no reported adverse event and temperature excursion over the weekend, with no reported adverse event ,after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7681KA and expiration date: 30-Jun-2023) at an unknown dose via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient administered vaccine post excursion with no reported adverse event (poor quality product administered) ( latency): same day) following the administration.   On 07-Sep-2022, the reporter stated temperature excursion over the weekend resulting from a refrigerator/temperature monitoring system malfunction. The refrigerator reached the lowest temperature of 31.3 degrees F for 1 and a half hours before returning to recommended storage conditions(product storage error).  Action taken:not applicable  It was not reported if the patient received a corrective treatment for the events.   Outcome: Unknown for both events   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: 1.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired Pentacel, with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 1 year old female patient who received an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 12-Sep-2022, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine injection at a dose of 0.5 ml total (lot UJ582AAA, expiry date: 10-Sep-2022) via unknown route in unknown administration site for immunisation.  On 12-Sep-2022 the patient received an expired pentacel, with no reported adverse event (expired product administered) (same day latency).  Action taken: Not applicable.  Outcome: 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: 4.0
Sex: U
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK by accident or the staff administered one to a 4 year old with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2022SA381569(CLUSTER).  This case involves a 4 years old and unknown gender patient to whom INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] dose was administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date flublok dose was administered to a4 years old with no adverse event (product administered to patient of inappropriate age) (same day latency). Physician said they received FLUBLOK by accident or they didn't order it but his staff is clearing that up. He wanted to know about safety issues and if it needs to be repeated.  Action taken: Not applicable.  Outcome: 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: F
Vaccine: FLUR3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: pregnant patient receives Flublok with no reported adverse event; Initial information received on 12-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who was exposed to vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] in context of pregnant patient receives flublok with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant patient receives Flublok with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation, strength: unknown) lot number not reported in unknown administration site as Immunization.  On an unknown date the pregnant patient receives flublok with no reported adverse event (exposure during pregnancy) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was asked If a pregnant patient receives Flublok, do they still need to call Sanofi to report the dose given.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (pregnant patient receives Flublok with no reported adverse event).  At time of reporting, the outcome was Unknown for the event pregnant patient receives flublok with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is unknown
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Blindness, Dizziness, Hyperventilation, Presyncope, Tinnitus
Clinical narrative: Extreme dizziness, ears ringing at first which then developed into static sound, wheezing, hyperventilating, loss of vision when attempted to walk, almost passed out.  Lasted about 15 minutes in total.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Extreme dizziness, ears ringing at first which then developed into static sound, wheezing, hyperventilating, loss of vision when attempted to walk, almost passed out.  Lasted about 15 minutes in total.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder irritation, Hypertonic bladder, Urine analysis normal
Clinical narrative: Ongoing bladder irritation/overactive bladder symptoms since 2nd dose in November 2021.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient came to the pharmacy with severe redness and pain in his left deltoid
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Dizziness, Fatigue, Lethargy, Pain
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site pain, Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient called pharmacy on 9-16-22 saying that she thought her flu shot was given too high in her arm yesterday 9-15-22. She is experiencing a lot of pain. Additionally, she is pregnant. She came in 9-16-22 for us to look at her arm. The injection site was too high and showed some redness. She demonstrated the mobility/pain she was experiencing at different spots when moving/rotating her arm. She stated that the immunizer was standing during the injection. Advised that she seek medical attention
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: Extreme Fatigue, Shivering, Headache, Muscle Ache, Injection Site - Swelling, Heat, Redness, Muscle Soreness, Brain Fog, Loss of  Appetite, Nausea Increased Arthritis Pain in Joints Duration - 8 days Slight Relief of Muscular Ache with Asprin
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Extreme Fatigue, Shivering, Headache, Muscle Ache, Injection Site - Swelling, Heat, Redness, Muscle Soreness, Brain Fog, Loss of  Appetite, Nausea Increased Arthritis Pain in Joints Duration - 8 days Slight Relief of Muscular Ache with Asprin
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: Extreme Fatigue, Shivering, Headache, Muscle Ache, Injection Site - Swelling, Heat, Redness, Muscle Soreness, Brain Fog, Loss of  Appetite, Nausea Increased Arthritis Pain in Joints Duration - 8 days Slight Relief of Muscular Ache with Asprin
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: PT GIVEN PRIVATE DOSE OF VACCINE THAT EXPIRED 6/2/2022 IN ERROR.  MULTIPLE PEOPLE INCLUDING NEW HIRE INVOLVED CAUSING CONFUSION IN GIVING VACCINE.  PT EXPERIENCED NO ADVERSE REACTIONS NOTED AS OF 9/20/2022.  PROVIDER CONTACTED PTS MOTHER/GUARDIAN REGARDING THIS.
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Dermatitis allergic, Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Additional Details: pt is at nursing facility and after the flu, overnight the pt developed rash on her limbs and the at the injection site it is red and hot to the touch. Pt is being seen at dermatologist office.
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Additional Details: pt is at nursing facility and after the flu, overnight the pt developed rash on her limbs and the at the injection site it is red and hot to the touch. Pt is being seen at dermatologist office.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: When screening patient, patient requested to receive Moderna (lot # 011B22A) as her 1st COVID vaccine dose , but received Pfizer (lot # FP7137) primary dose instead. I discussed the mistake with patient after dose given when it was recognized, in which patient reported that she was okay with receiving Pfizer instead, she just wanted to make sure that she was vaccinated.  I discussed differences in vaccines and timing differences for 2nd dose primary series.  The patient had no questions or concerns.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiopathy, Burning sensation, Dehydration, Dry mouth, Erythema
Clinical narrative: I became super dehydrated the night of my shot. My tongue and mouth were extremely dry and I kept drinking water but it didn?t really help. My whole right arm hurts, from shoulder to wrist, and I?m having vascular symptoms that I didn?t have with the other injections, such as red, burning hot hands, feet, and face, and I feel very hot but don?t have a fever. I?ve gotten symptoms like this before when extremely dehydrated so it could be from that, but there?s no reason for me to be this dried out?this is very unusual and the shot yesterday is the only new thing in my life. I really think it caused all this.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling hot, Pain in extremity, Tongue dry
Clinical narrative: I became super dehydrated the night of my shot. My tongue and mouth were extremely dry and I kept drinking water but it didn?t really help. My whole right arm hurts, from shoulder to wrist, and I?m having vascular symptoms that I didn?t have with the other injections, such as red, burning hot hands, feet, and face, and I feel very hot but don?t have a fever. I?ve gotten symptoms like this before when extremely dehydrated so it could be from that, but there?s no reason for me to be this dried out?this is very unusual and the shot yesterday is the only new thing in my life. I really think it caused all this.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anxiety, Asthenia, Chills, Hypotension, Syncope
Clinical narrative: Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Shakiness-Severe, Systemic: Weakness-Medium, Additional Details: PATIENT HAD ANXIETY BEFORE GETTING THE VACCINE.  AFTER RPH ADMINISTERED THE VACCINE, PATIENT SAT IN THE WAITING AREA AT WHICH POINT SHE FAINTED AND ENDED UP ON THE FLOOR, FACE DOWN SHAKING AND UNRESPONSIVE UNTIL SHE WAS TURNED TO HER SIDE AT WHICH POINT SHE BECAME RESPONSIVE.  SHE WAS PLACED ON HER BACK AND LEGS ELEVATED. HER BP DID COME BACK TO NORMAL AFTER ABOUT 1 HOUR AT WHICH POINT SHE LEFT.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Shakiness-Severe, Systemic: Weakness-Medium, Additional Details: PATIENT HAD ANXIETY BEFORE GETTING THE VACCINE.  AFTER RPH ADMINISTERED THE VACCINE, PATIENT SAT IN THE WAITING AREA AT WHICH POINT SHE FAINTED AND ENDED UP ON THE FLOOR, FACE DOWN SHAKING AND UNRESPONSIVE UNTIL SHE WAS TURNED TO HER SIDE AT WHICH POINT SHE BECAME RESPONSIVE.  SHE WAS PLACED ON HER BACK AND LEGS ELEVATED. HER BP DID COME BACK TO NORMAL AFTER ABOUT 1 HOUR AT WHICH POINT SHE LEFT.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 72.0
Sex: M
Vaccine: PNC20
Symptoms: Pain, Pyrexia, Tachycardia
Clinical narrative: Systemic: Body Aches Generalized-Mild, Systemic: Fever-Medium, Systemic: Tachycardia-Mild
Age: 53.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Urticaria
Clinical narrative: I started getting small hives on my legs, torso and face- consulted my doctor who I had seen earlier in the week for a poison ivy infection.  New hives looked very different from area affected by poison ivy. Dr. changed my morning antihistamine from Allegra to Levocetirizine to help as well as prescribing a steroid cream for the spots on my face. Steroid cream did help the spots on my face. However, I am now 8 days post injection and new small hives are still appearing all over my body.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Dyskinesia, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: After getting the flushot pt fainted and was unresponsive and had involuntary movements synoyms of a seizure! Per mom this has happened before with medical related procedures, covid vaccines and flushots in the past. He became responsive and normal within 3-5 movements! The immunizer tech and Rph on duty caught his body as he almost fell and laid him down on the bench he was actively having a seizure for about 1-2 mins. Per mom he has vagul disease they didnt want call medics!
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: HIVE LOOKING RED RAISED , HOT TO TOUCH WHERE INJECTION SITE IS ON RIGHT ARM. WENT TO EMPLOYEE HEALTH , THEY SUGGESTED TO REPORT IT.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Fatigue, Headache, Illness, Myalgia
Clinical narrative: Breakthrough case of COVID 19, started 8/10/22, tested positive on home test. Moderate case. Exhaustion, fever, headache, muscle ache. Sick for about a week, tested negative on the 13th day. Headache and fatigue continue to present day, seeing personal physician for Long Covid, no treatment except OTC pain relief acetaminophen/ibuprofen for head/muscle aches.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Post-acute COVID-19 syndrome, Pyrexia, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case of COVID 19, started 8/10/22, tested positive on home test. Moderate case. Exhaustion, fever, headache, muscle ache. Sick for about a week, tested negative on the 13th day. Headache and fatigue continue to present day, seeing personal physician for Long Covid, no treatment except OTC pain relief acetaminophen/ibuprofen for head/muscle aches.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fall, Injection site pain, Loss of consciousness, Nausea
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Additional Details: After administration, patient approached counter so I could print out a copy of her vaccination record. She said she felt nauseas, and started to feel dizzy. As I opened my mouth to tell her to maybe sit down for a little, she fell over and loss consciousness for about 15 seconds. After she came back, I gave her an ice pack as my technician called EMS. The paramedics came and spoke to her, but she refused transport and waited for her husband to pick her up.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Additional Details: After administration, patient approached counter so I could print out a copy of her vaccination record. She said she felt nauseas, and started to feel dizzy. As I opened my mouth to tell her to maybe sit down for a little, she fell over and loss consciousness for about 15 seconds. After she came back, I gave her an ice pack as my technician called EMS. The paramedics came and spoke to her, but she refused transport and waited for her husband to pick her up.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient developed a slight rash approximately 30- 40 minutes after vaccination.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cyanosis, Heart rate decreased, Hypertension, Hypoaesthesia, Peripheral coldness
Clinical narrative: Systemic: low pulse-Mild, Systemic: Hypertension-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Nurse practitioner from Clinic said it was Vasodilation from the vaccine. Symptoms of numbness/blue around lips, fingers cold, BP was 141-76 and pulse 64 resolve in 45 minutes. EMS was called and they did full check up and patient did not need to be transported to ER.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chest discomfort, Chest pain, Dizziness, Eye swelling
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Pt's chest pain resolved prior to transport to hospital
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Hyperhidrosis, Hypertension, Mouth swelling, Nausea
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Pt's chest pain resolved prior to transport to hospital
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face, Swollen tongue, Tremor
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Pt's chest pain resolved prior to transport to hospital
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction, but reporting the administrative error. The CDC recommends to receive bivalent vaccine at the time of vaccination, and error occurred by administering the monovalent vaccine instead.
Age: 41.0
Sex: M
Vaccine: UNK
Symptoms: Injection site cyst
Clinical narrative: I developed a series of cysts near the injection site 48 hours after the injection. They look like burns.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Patient is a 64 y.o. female patient of  CNP with history of pretension, chronic hypoxic respiratory failure secondary to COPD, obesity, GERD presented with shortness of breath.   Acute on Chronic hypoxic resp failure, 2L at home COVID pneumonia Covid-19 Virus Infection Date of onset of symptoms: 9/2/22 Symptoms present on admission: SOB and cough Date of covid positive test: 9/10/22 Vaccination status: vaccinated x 2 doses Imaging: CXR-bibasilar PNA Oxygen requirements on admission: 4L Current oxygen requirements: She was weaned off to 3 L which she does have home oxygen at the time of discharge Medical therapy: steroids Consultants following: none Anticipated special isolation end date: 9/21/22       Acute COPD exacerbation 2/2 above On 2-4L O2 at home Albuterol inhaler Incentive spirometer Added Symbicort Albuterol every 4 hours MDI Add IS. We will discharge the patient on 5 days of prednisone   OSA CPAP   Hypokalemia  Replaced.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Hypokalaemia, Obstructive sleep apnoea syndrome, Positive airway pressure therapy
Clinical narrative: Patient is a 64 y.o. female patient of  CNP with history of pretension, chronic hypoxic respiratory failure secondary to COPD, obesity, GERD presented with shortness of breath.   Acute on Chronic hypoxic resp failure, 2L at home COVID pneumonia Covid-19 Virus Infection Date of onset of symptoms: 9/2/22 Symptoms present on admission: SOB and cough Date of covid positive test: 9/10/22 Vaccination status: vaccinated x 2 doses Imaging: CXR-bibasilar PNA Oxygen requirements on admission: 4L Current oxygen requirements: She was weaned off to 3 L which she does have home oxygen at the time of discharge Medical therapy: steroids Consultants following: none Anticipated special isolation end date: 9/21/22       Acute COPD exacerbation 2/2 above On 2-4L O2 at home Albuterol inhaler Incentive spirometer Added Symbicort Albuterol every 4 hours MDI Add IS. We will discharge the patient on 5 days of prednisone   OSA CPAP   Hypokalemia  Replaced.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Patient is a 64 y.o. female patient of  CNP with history of pretension, chronic hypoxic respiratory failure secondary to COPD, obesity, GERD presented with shortness of breath.   Acute on Chronic hypoxic resp failure, 2L at home COVID pneumonia Covid-19 Virus Infection Date of onset of symptoms: 9/2/22 Symptoms present on admission: SOB and cough Date of covid positive test: 9/10/22 Vaccination status: vaccinated x 2 doses Imaging: CXR-bibasilar PNA Oxygen requirements on admission: 4L Current oxygen requirements: She was weaned off to 3 L which she does have home oxygen at the time of discharge Medical therapy: steroids Consultants following: none Anticipated special isolation end date: 9/21/22       Acute COPD exacerbation 2/2 above On 2-4L O2 at home Albuterol inhaler Incentive spirometer Added Symbicort Albuterol every 4 hours MDI Add IS. We will discharge the patient on 5 days of prednisone   OSA CPAP   Hypokalemia  Replaced.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: having full body tremors. treating with primidone and losartan. on going treatment and no better
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pulse abnormal, Somnolence, Unresponsive to stimuli
Clinical narrative: Unable to awaken, became unresponsive to verbal stimuli, pulse weak. Sent to ER, recovered completely, kept for observation over night.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anticoagulant therapy, Blood pressure increased, COVID-19, Cardiac disorder
Clinical narrative: Patient is a 84 y.o. male patient with PMHx of HTN, HLD, mild AR/AS, recently diagnosed covid-19 who presents to ED with increased shortness of breath who was found to be Covid-19 positive again with Acute pulmonary embolus with acute cor pulmonale and acute respiratory failure with hypoxia.   Acute provoked pulmonary embolus Acute respiratory failure with hypoxia Presented w SOB and and CP CT: moderate volume bilateral pulmonary emboli and suggestive of right heart strain Initially hypoxic requiring 2LNC- improved and was stable on RA  Started on iv heparin, Venous duplex: no DVT/SVT b/l 9/7 TTE shows LVEF 63%, no PHTN, cor pulmonale resolved Discussed with Interventional cardiology: no need for thrombectomy, due to hemodynamic stability Started eliquis 9/7, heparin gtt stopped Patient agreeable to $47 copay as outpatient Will need to be on Eliquis for 3months - RRT: pt did not qualify for home O2 - CM team: Home with HH    Covid-19 infection , lungs mostly CTAB ID following: was beyond timeframe for remdesivir, Dexamethasone until discharge - CM: pt agreeable to HHC  - PT: 2-3x/week, qualifying for HH - OT: no further therapy needed - Pt is requesting Hospital bed    Essential htn BP elevated 180's to 160's At home on metoprolol, hydrochlorothiazide and quinapril Metoprolol held prior to TTE, restarted Resumed home meds Feel elevated BPs is related to decadron - Hydralazine 10 mg IV PRN Q4 hrs for SBP>160.  Discussed close monitoring of vitals with nurse to ensure BP remains controlled - Amlodipine 5 mg will not be required at discharge - Better controlled BPs - Discharge with home meds  Aortic stenosis Aortic regurgitation 9/7 TTE - unchanged from prior TTE   Mixed hyperlipidemia Continue statin   Right lung nodule CT as above - f/u with PCP as outpatient for monitoring recommendations
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram thorax abnormal, Cor pulmonale acute, Dyspnoea, Echocardiogram
Clinical narrative: Patient is a 84 y.o. male patient with PMHx of HTN, HLD, mild AR/AS, recently diagnosed covid-19 who presents to ED with increased shortness of breath who was found to be Covid-19 positive again with Acute pulmonary embolus with acute cor pulmonale and acute respiratory failure with hypoxia.   Acute provoked pulmonary embolus Acute respiratory failure with hypoxia Presented w SOB and and CP CT: moderate volume bilateral pulmonary emboli and suggestive of right heart strain Initially hypoxic requiring 2LNC- improved and was stable on RA  Started on iv heparin, Venous duplex: no DVT/SVT b/l 9/7 TTE shows LVEF 63%, no PHTN, cor pulmonale resolved Discussed with Interventional cardiology: no need for thrombectomy, due to hemodynamic stability Started eliquis 9/7, heparin gtt stopped Patient agreeable to $47 copay as outpatient Will need to be on Eliquis for 3months - RRT: pt did not qualify for home O2 - CM team: Home with HH    Covid-19 infection , lungs mostly CTAB ID following: was beyond timeframe for remdesivir, Dexamethasone until discharge - CM: pt agreeable to HHC  - PT: 2-3x/week, qualifying for HH - OT: no further therapy needed - Pt is requesting Hospital bed    Essential htn BP elevated 180's to 160's At home on metoprolol, hydrochlorothiazide and quinapril Metoprolol held prior to TTE, restarted Resumed home meds Feel elevated BPs is related to decadron - Hydralazine 10 mg IV PRN Q4 hrs for SBP>160.  Discussed close monitoring of vitals with nurse to ensure BP remains controlled - Amlodipine 5 mg will not be required at discharge - Better controlled BPs - Discharge with home meds  Aortic stenosis Aortic regurgitation 9/7 TTE - unchanged from prior TTE   Mixed hyperlipidemia Continue statin   Right lung nodule CT as above - f/u with PCP as outpatient for monitoring recommendations
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, Pulmonary mass, SARS-CoV-2 test positive, Ultrasound Doppler normal
Clinical narrative: Patient is a 84 y.o. male patient with PMHx of HTN, HLD, mild AR/AS, recently diagnosed covid-19 who presents to ED with increased shortness of breath who was found to be Covid-19 positive again with Acute pulmonary embolus with acute cor pulmonale and acute respiratory failure with hypoxia.   Acute provoked pulmonary embolus Acute respiratory failure with hypoxia Presented w SOB and and CP CT: moderate volume bilateral pulmonary emboli and suggestive of right heart strain Initially hypoxic requiring 2LNC- improved and was stable on RA  Started on iv heparin, Venous duplex: no DVT/SVT b/l 9/7 TTE shows LVEF 63%, no PHTN, cor pulmonale resolved Discussed with Interventional cardiology: no need for thrombectomy, due to hemodynamic stability Started eliquis 9/7, heparin gtt stopped Patient agreeable to $47 copay as outpatient Will need to be on Eliquis for 3months - RRT: pt did not qualify for home O2 - CM team: Home with HH    Covid-19 infection , lungs mostly CTAB ID following: was beyond timeframe for remdesivir, Dexamethasone until discharge - CM: pt agreeable to HHC  - PT: 2-3x/week, qualifying for HH - OT: no further therapy needed - Pt is requesting Hospital bed    Essential htn BP elevated 180's to 160's At home on metoprolol, hydrochlorothiazide and quinapril Metoprolol held prior to TTE, restarted Resumed home meds Feel elevated BPs is related to decadron - Hydralazine 10 mg IV PRN Q4 hrs for SBP>160.  Discussed close monitoring of vitals with nurse to ensure BP remains controlled - Amlodipine 5 mg will not be required at discharge - Better controlled BPs - Discharge with home meds  Aortic stenosis Aortic regurgitation 9/7 TTE - unchanged from prior TTE   Mixed hyperlipidemia Continue statin   Right lung nodule CT as above - f/u with PCP as outpatient for monitoring recommendations
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Coordination abnormal, Electric shock sensation, Fatigue, Feeling hot
Clinical narrative: He got his vaccine, first off he got the shot very high and hit either a nerve or a bone as it was very painful.  She volunteered for the next hour, and after that he went home, started feelin fatigued, started feeling like he wanted to break out into a sweet.  His heart was racing, felt feverish as well but had no temp or heart racing.  Heart respirations and temp were all normal.  He then had tremors in his left arm, like somebody plunged him in ice cold water, electrical feeling.  It lasted about 90 minutes and was about to call emergency but it got better.  He has been having reoccurring symptoms in the left arm and hand of tremors and has felt fatigued and feels like it's now throughout his body.    He did got to his doctor after that, and he suggested that he does have the tremors and perhaps he needed to see a neurologist for that.  He does still have tremors and the fatigue, does not know what triggers them, but they continue.  He does have them every day that comes and goes throughout the day.  He feels all cramped out when he gets out of bed, achy in every joint, stretches and works it out, but feels like he has a hard time getting his coordination gone.  He is a painter and cannot do ladders and cannot ride his motorcycle anymore due to coordination issues.  He did get his subsequent vaccines after that on 4/7/21 (003F21A).  He did not have tremors/chills, electric shock or burn after that one, just felt fatigued and achy.   He got his booster and also did not have any symptoms other than a hard arm, soreness and fatigue for a day, which was a Pfizer vaccine on 11/24/21 (FH8027).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired driving ability, Impaired work ability, Injection site pain, Muscle spasms, Palpitations
Clinical narrative: He got his vaccine, first off he got the shot very high and hit either a nerve or a bone as it was very painful.  She volunteered for the next hour, and after that he went home, started feelin fatigued, started feeling like he wanted to break out into a sweet.  His heart was racing, felt feverish as well but had no temp or heart racing.  Heart respirations and temp were all normal.  He then had tremors in his left arm, like somebody plunged him in ice cold water, electrical feeling.  It lasted about 90 minutes and was about to call emergency but it got better.  He has been having reoccurring symptoms in the left arm and hand of tremors and has felt fatigued and feels like it's now throughout his body.    He did got to his doctor after that, and he suggested that he does have the tremors and perhaps he needed to see a neurologist for that.  He does still have tremors and the fatigue, does not know what triggers them, but they continue.  He does have them every day that comes and goes throughout the day.  He feels all cramped out when he gets out of bed, achy in every joint, stretches and works it out, but feels like he has a hard time getting his coordination gone.  He is a painter and cannot do ladders and cannot ride his motorcycle anymore due to coordination issues.  He did get his subsequent vaccines after that on 4/7/21 (003F21A).  He did not have tremors/chills, electric shock or burn after that one, just felt fatigued and achy.   He got his booster and also did not have any symptoms other than a hard arm, soreness and fatigue for a day, which was a Pfizer vaccine on 11/24/21 (FH8027).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Pyrexia, Sensory disturbance, Tremor
Clinical narrative: He got his vaccine, first off he got the shot very high and hit either a nerve or a bone as it was very painful.  She volunteered for the next hour, and after that he went home, started feelin fatigued, started feeling like he wanted to break out into a sweet.  His heart was racing, felt feverish as well but had no temp or heart racing.  Heart respirations and temp were all normal.  He then had tremors in his left arm, like somebody plunged him in ice cold water, electrical feeling.  It lasted about 90 minutes and was about to call emergency but it got better.  He has been having reoccurring symptoms in the left arm and hand of tremors and has felt fatigued and feels like it's now throughout his body.    He did got to his doctor after that, and he suggested that he does have the tremors and perhaps he needed to see a neurologist for that.  He does still have tremors and the fatigue, does not know what triggers them, but they continue.  He does have them every day that comes and goes throughout the day.  He feels all cramped out when he gets out of bed, achy in every joint, stretches and works it out, but feels like he has a hard time getting his coordination gone.  He is a painter and cannot do ladders and cannot ride his motorcycle anymore due to coordination issues.  He did get his subsequent vaccines after that on 4/7/21 (003F21A).  He did not have tremors/chills, electric shock or burn after that one, just felt fatigued and achy.   He got his booster and also did not have any symptoms other than a hard arm, soreness and fatigue for a day, which was a Pfizer vaccine on 11/24/21 (FH8027).
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: A day after I had the vaccination, I had weakness, mostly in my right leg, there are some in my left leg. When it first started, you would of thought I was out drinking, that's how bad the walking was. I can hold up my left leg, but when I try to hold up my right leg, at the same level, it starts to come down. From my waist down, I have no pain or nothing. This is so strange, I can hardly walk. When going up the stairs I have to walk: left, then bring up my right, left, then bring up my right.
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Full body itchiness 9/19/2022. Swollen hives from the neck down. Continued overnight, felt better the next day but still fairly swollen.  Self treated with Benadryl and cold shower
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Purpura senile, Skin fissures, Skin haemorrhage
Clinical narrative: Twenty minutes after vaccination, a senile purpura appeared on the top of my right wrist.  The top layers of skin in the purpura had split and were bleeding.  Within an hour of vaccination, another senile purpura opened on my right arm.  I was vaccinated on my right arm.  The second one, the top layers eventually peeled back and came off.  Senile purpura also appeared in the following days wherever adhesive bandages met the skin.  There were zero senile purpura on my left arm.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid positive pt, full vaccinated, hospitalized.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: I also had the flu vaccine, but I am not sure what type of vaccine, so I did not enter it above. On Sunday afternoon, I noticed hives all over my body and they have continued through today (9/20/22). I take one Allegra 24 hour and the hives subside but come back almost 24 hours on the dot. I have not, to my knowledge, been exposed to anything different in my environment - food, medicines, etc. When I received the prior covid-19 vaccines and booster (always Moderna), I would get a rash at the site of injection but it would disappear within a week of the injection.
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pfizer Bivalent booster given by mistake. Should have been given the Monovalent as this was the patients first Pfizer dose. Patient had no side effects.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt was supposed to get the last Rabies vaccine in her series (day 14) on 9/9/22 but got it on day 11 (9/5/22).
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient is 10 years old and received 20 mcg/0.2 mL of the adult formulation (12 + age range). Patient received double of the intended dose due to use of the incorrect product.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Feeling abnormal, Seizure
Clinical narrative: had a seizure 3 hours following administration of bivalent booster dose, unknown as to how long out, slow recovery reporting brain fog
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Hypoxia, SARS-CoV-2 test positive
Clinical narrative: SOB, HYPOXIA, COVID+ TWO WEEKS PRIOR TO  HOSPITALIZATION.