chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Electromyogram
Clinical narrative: had diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart disorder" (unspecified if ongoing); "Blood pressure abnormal" (unspecified if ongoing); "Blood cholesterol abnormal" (unspecified if ongoing); "swelling on my leg" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for peripheral swelling; ESPERAL taken for peripheral swelling; CALCIUM and other routine medicine for blood pressure and cholesterol. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "I had in the first two shots and I had no problem but ever since I had the shot the very right next day I have had diarrhea". The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "had diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea  Additional information: Patient was treated with Alka Seltzer, Tums and Imodium.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Electromyogram
Clinical narrative: had diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "swelling on my leg" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN (E.C.) taken for peripheral swelling; ESPERAL taken for peripheral swelling; CALCIUM; and other routine medicine for blood pressure and cholesterol. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "had diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea with Alka Seltzer, Tums and Imodium.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300222264 same patient/suspect product; different dose and events;US-PFIZER INC-202300222255 same patient/suspect product; different dose and events;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "BP/Blood pressure abnormal" (unspecified if ongoing); "cholesterol/cholesterol abnormal" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "pelvic floor tightness" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known Allergies: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 07Jun2023 to 12Jun2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300222293 Same patient, different drug, different event;
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation
Clinical narrative: Disorientation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jun2023 at 10:00 as dose 1, single (Lot number: Glo446) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hip replacement" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies : tree nuts" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Tetanus, for Immunization, reaction(s): "Known allergies: Tetanus". The following information was reported: DISORIENTATION (non-serious) with onset 13Jun2023 at 08:00, outcome "recovering". Therapeutic measures were not taken as a result of disorientation.  Additional information: no other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: my health is not that good; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "my health is not that good". Additional information: Patient thought he/she was getting a boost, but instead it looks like they used an experimental drug, which his/her health was not that good and he/she need them to tell him/her when they are going to do it. Patient told not to give him/her the information after they give him/her the shot. He/she wish he/she would have known it was a trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she got COVID; she got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose number unknown (booster), single (Lot number: GJ2524) at the age of 81 years intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "have blood pressure medications" (unspecified if ongoing), notes: have blood pressure medications. The patient took concomitant medications. Vaccination history included: Covid. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Dec2022, outcome "unknown" and all described as "she got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Dec2022) Positive.  Clinical course details: Patient was not hospitalized with Covid, through home testing she determined there was Covid. She was very sick but was not hospitalized.
Sex: M
Vaccine: COVID19
Symptoms: Carditis
Clinical narrative: develop inflammation around his heart; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "congestive heart failure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CARDITIS (death), outcome "fatal", described as "develop inflammation around his heart". The patient date of death was unknown. Reported cause of death: "develop inflammation around his heart". It was not reported if an autopsy was performed. Clinical course: Reporter's brother died from this vaccine and she was trying to understand why. Reporter wanted to know that even if someone had an underlying condition, what made him develop inflammation around his heart. Are they even notifying people with heart conditions to not get this vaccine. Because it's making the underlying condition worse. Reporter's brother died from this vaccine, he had congestive heart failure. They were telling people with heart disease to get this vaccine, and they should never had been vaccinated. Caller stated that she wanted to know what does Biontech mean. Called about the Pfizer vaccine. Wanted to speak with someone. Her brother died from this. Wanted to speak with a lawyer about this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: develop inflammation around his heart
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 17:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lichen plano pilarus" (unspecified if ongoing). Concomitant medication(s) included: PIOGLITAZONE, start date: 01Jan2015. Past drug history included: Amoxycillin, reaction(s): "known allergies: Amoxycillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 01Jun2023 to 06Jun2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300222720 same reporter/patient, different drug/event;
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Batch/Lot number: unknown), on 18Apr2021 as dose 2, single (Batch/Lot number: unknown), on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 22May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "generalized depression and anxiety" (unspecified if ongoing); "generalized depression and anxiety" (unspecified if ongoing). There were no concomitant medications. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID-19 Treatment with Paxlovid from 05Jun2023 to 09Jun2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300222670 same patient, different drugs and events;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I was diagnosed with COVID; I was diagnosed with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I was diagnosed with COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Paxlovid for 5 days. Consumer stated he/she have had 5 Pfizer shots for COVID. Consumer added that he/she just came back into the country, a week ago and was diagnosed with COVID for which he/she got medication from local pharmacy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300222823 same patient, different drug/event;
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diverticulitis" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: 100.6, notes: patient had 100.6 temperatures; SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: For three plus days with positive test for Covid 19 via home tests; Positive, notes: For three plus days with positive test for Covid 19 via home tests; Positive, notes: For three plus days with positive test for Covid 19 via home tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 02Jun2023 to 07Jun2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300223658 same patient, different drug, different events;
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Pericarditis
Clinical narrative: recently diagnosed with pericarditis/ thickening of the heart muscle/ tachycardia/ chest pain on the left side where heart it/ shortness of breath; cholesterol doubled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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: Bnt162b2 (DOSE 1, SINGLE, Batch/ Lot number not reported), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Batch/ Lot number not reported), for COVID-19 immunization. The following information was reported: PERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "recently diagnosed with pericarditis/ thickening of the heart muscle/ tachycardia/ chest pain on the left side where heart it/ shortness of breath"; BLOOD CHOLESTEROL INCREASED (hospitalization), outcome "unknown", described as "cholesterol doubled". The patient underwent the following laboratory tests and procedures: Blood cholesterol: doubled.  Clinical Course: The patient reported that she was having heart issues after getting the Pfizer COVID-19 vaccine and had no heart issues prior to that. She got two doses and then a booster. Patient was recently diagnosed with Pericarditis, also found with thickening of the heart muscle, tachycardia, cholesterol doubled and experienced chest pain on the left side where the heart is. Patient wanted to know if there have been previous reports of these symptoms. The patient further asked what was Pfizer doing about that and asked if they were going to pay the hospital bills. Also liked to know if Pfizer had information regarding the health status of those patients who developed pericarditis after they got the COVID-19 vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300224481 same patient, different doses and events;
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: patient experienced severe leg cramps at night in both legs (calf area); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 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 (Dose:1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose:2, Unknown manufacturer), for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "patient experienced severe leg cramps at night in both legs (calf area)".  Additional information: After receiving his booster COVID vaccine, patient experienced severe leg cramps at night in both legs (calf area). Cramps have gotten less severe but still has them occasionally. Patient's booster was in Dec2022. Patient did not have this issue with the first 2 shots. He is concerned about getting additional boosters. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymphadenopathy; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lupus" (ongoing), notes: has a history of lupus. The patient's 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke". Clinical Course: patient got the vaccine, Name of Product: Pfizer bivalent vaccine and had a stroke 2.5 weeks later. Event took place after use of product. Patient also had a history of lupus.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 1.42
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: early dose administered of FLUZONE QIV NP to a pediatric patient/ medical assistants inadvertently missed the dosing interval time was earlier than recommended,with no reported adverse event; Initial information received on 13-Jun-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 17 months old female patient who had early dose administered of fluzone qiv np to a pediatric patient/ medical assistants inadvertently missed the dosing interval time was earlier than recommended,with no reported adverse event after receiving vaccine influenza quadrival a-b vaccine [fluzone qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Jun-2023, the patient received a dose 3 0.5 ml of suspect influenza quadrival a-b vaccine Suspension for injection lot UT7731JA, 30-JUN-2023 via intramuscular route in the left thigh for immunisation.  On 13-Jun-2023 the patient developed a non-serious early dose administered of fluzone qiv np to a pediatric patient/ medical assistants inadvertently missed the dosing interval time was earlier than recommended,with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  Action taken was not applicable.  Outcome: Unknown for the event early dose administered of fluzone qiv np to a pediatric patient/ medical assistants inadvertently missed the dosing interval time was earlier than recommended,with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 51.0
Sex: F
Vaccine: YF, YF
Symptoms: Fatigue, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: the area is a little itchy; injection site reaction; swollen area that continues to get bigger and currently measuring 3-inches by 2-inches to the back of the left arm.; feeling fatigued; Initial information was received on 14-Jun-2023 regarding an unsolicited valid non-serious case received from an other health professional (Nurse).  This case involves a 51 years old female patient who experienced the area is a little itchy, injection site reaction, swollen area that continues to get bigger and currently measuring 3-inches by 2-inches to the back of the left arm and feeling fatigued after being vaccinated with yellow fever vaccine [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included typhoid vaccine live oral (typhoid vaccine live oral) for Prophylactic vaccination (Immunisation).  On 08-Jun-2023, the patient received suspect yellow fever vaccine (strength: standard) at dose of 0.50 ml once (lot: UJ819AA, expiration date: 18-Apr-2023) via subcutaneous route in the left arm for immunization (immunisation).  On 11-Jun-2023 the patient developed a non-serious events of the "area is a little itchy" (vaccination site pruritus), "injection site reaction" (vaccination site reaction), "swollen area that continues to get bigger and currently measuring 3-inches by 2-inches to the back of the left arm" (vaccination site swelling) and "feeling fatigued" (fatigue) 3 days following the administration of yellow fever vaccine.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all the events (feeling fatigued, injection site reaction, the area is a little itchy, swollen area that continues to get bigger and currently measuring 3-inches by 2-inches to the back of the left arm.).  Outcome was Not Recovered for all the events.
Age: 51.0
Sex: F
Vaccine: YF, YF
Symptoms: Fatigue, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: the area is a little itchy; injection site reaction; swollen area that continues to get bigger and currently measuring 3-inches by 2-inches to the back of the left arm.; feeling fatigued; Initial information was received on 14-Jun-2023 regarding an unsolicited valid non-serious case received from an other health professional (Nurse).  This case involves a 51 years old female patient who experienced the area is a little itchy, injection site reaction, swollen area that continues to get bigger and currently measuring 3-inches by 2-inches to the back of the left arm and feeling fatigued after being vaccinated with yellow fever vaccine [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included typhoid vaccine live oral (typhoid vaccine live oral) for Prophylactic vaccination (Immunisation).  On 08-Jun-2023, the patient received suspect yellow fever vaccine (strength: standard) at dose of 0.50 ml once (lot: UJ819AA, expiration date: 18-Apr-2023) via subcutaneous route in the left arm for immunization (immunisation).  On 11-Jun-2023 the patient developed a non-serious events of the "area is a little itchy" (vaccination site pruritus), "injection site reaction" (vaccination site reaction), "swollen area that continues to get bigger and currently measuring 3-inches by 2-inches to the back of the left arm" (vaccination site swelling) and "feeling fatigued" (fatigue) 3 days following the administration of yellow fever vaccine.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all the events (feeling fatigued, injection site reaction, the area is a little itchy, swollen area that continues to get bigger and currently measuring 3-inches by 2-inches to the back of the left arm.).  Outcome was Not Recovered for all the events.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac assistance device user, Cardiomegaly, Catheterisation cardiac normal, Dyspnoea
Clinical narrative: Soreness, feverish,  weaknesses,  hard to breathe
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Implantable defibrillator insertion, Loss of personal independence in daily activities, Muscle spasms, Oesophageal dilatation
Clinical narrative: Soreness, feverish,  weaknesses,  hard to breathe
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Soreness, feverish,  weaknesses,  hard to breathe
Age: 53.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Peripheral swelling, Rash
Clinical narrative: Patient complained from a swollen arm, rash, and she had to see her doctor who prescribed her prednisone according to her.
Age: 53.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient complained from a swollen arm, rash, and she had to see her doctor who prescribed her prednisone according to her.
Age: 53.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Pain in extremity, Peripheral swelling, X-ray
Clinical narrative: Patient complained from a swollen arm, rash, and she had to see her doctor who prescribed her prednisone according to her.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site rash, Peripheral swelling
Clinical narrative: PATIENT RECEIVED 2 VACCINES ON 06/04/2023 ( ADACEL ON THE RIGHT ARM) AND ( SHINGRIX ON THE LEFT ARM). SHE COMPLAINED FROM SWOLLEN ARM AND RASH IN HER ( RIGHT ARM ONLY) WHERE ADACEL WAS INJECTED , AND HER LEFT ARM WAS OKAY, SHE CONTACTED HER HEALTH CAREPROVIDER WHO ASKED HER TO CONTACT THE PHARMACY AND REPORT THIS REACTION
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Gave the Moderna Bivalent vaccine after 2 months from the last Moderna Bivalent vaccine. No adverse effects reported from patient.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Brain natriuretic peptide abnormal, Chest X-ray normal, Chest pain
Clinical narrative: I developed chest pain and shortness of breath which started 3 hours after getting the vaccine.  I almost passed out walking back to my car. The symptoms persisted, so I went to urgent care 24 hours later and was diagnosed with bilateral pulmonary embolism.  I received oxygen via nasal cannula, oral aspirin, and am now on Lovenox.  I will be transitioned to oral medication (Pradaxa) in 5 days.  I was discharged from an overnight stay after less than 24 hours.  My chest pain and shortness of breath are slowly improving.  I have a follow up appointment next week.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram abnormal, Fibrin D dimer increased, Laboratory test normal
Clinical narrative: I developed chest pain and shortness of breath which started 3 hours after getting the vaccine.  I almost passed out walking back to my car. The symptoms persisted, so I went to urgent care 24 hours later and was diagnosed with bilateral pulmonary embolism.  I received oxygen via nasal cannula, oral aspirin, and am now on Lovenox.  I will be transitioned to oral medication (Pradaxa) in 5 days.  I was discharged from an overnight stay after less than 24 hours.  My chest pain and shortness of breath are slowly improving.  I have a follow up appointment next week.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Troponin I abnormal
Clinical narrative: I developed chest pain and shortness of breath which started 3 hours after getting the vaccine.  I almost passed out walking back to my car. The symptoms persisted, so I went to urgent care 24 hours later and was diagnosed with bilateral pulmonary embolism.  I received oxygen via nasal cannula, oral aspirin, and am now on Lovenox.  I will be transitioned to oral medication (Pradaxa) in 5 days.  I was discharged from an overnight stay after less than 24 hours.  My chest pain and shortness of breath are slowly improving.  I have a follow up appointment next week.
Age: 86.0
Sex: M
Vaccine: PNC20
Symptoms: Urticaria
Clinical narrative: Patient called this morning (6/17/23) and stated he thought he was reacting to the vaccine given on 5/30/23. He states that roughly 1-2 days ago he noticed he has hives from his waist down to his feet on both legs. I suggested that since it is Saturday morning he should start taking benadryl, and call his doctor first thing Monday morning if not better, or go to an ER if it persists or is severe enough that it can't wait until Monday to see a doctor.  He said he has not reached out to a doctor at this time.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Disorientation, Fall, Head injury, Loss of consciousness, Presyncope
Clinical narrative: Patient had a vasovagal reaction. Upon passing out he hit the front on his head, just above his right eyebrow on the counter top then fell backwards and hit the back of his head on the ground. He was disoriented for 1-2 minutes before answering questions. Patient continued to report vision changes and experienced multiple episodes of vomiting when EMS was called and patient was transported to the ER for concerns about the head injury.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Visual impairment, Vomiting
Clinical narrative: Patient had a vasovagal reaction. Upon passing out he hit the front on his head, just above his right eyebrow on the counter top then fell backwards and hit the back of his head on the ground. He was disoriented for 1-2 minutes before answering questions. Patient continued to report vision changes and experienced multiple episodes of vomiting when EMS was called and patient was transported to the ER for concerns about the head injury.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Formication, Injection site pain, Nausea
Clinical narrative: Severe stabbing pains and aches throughout body, nausea, extreme fatigue, sensation of skin crawling, pain at injection site, redness 2 days after, now (after 3 days) redness almost all gone and rest of symptoms gone except skin crawling sensation (mild)
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Severe stabbing pains and aches throughout body, nausea, extreme fatigue, sensation of skin crawling, pain at injection site, redness 2 days after, now (after 3 days) redness almost all gone and rest of symptoms gone except skin crawling sensation (mild)
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Syncope
Clinical narrative: After receiving Second injection Patient experienced syncope/lightheadedness. Patient stated he hadn't eaten that morning. Patient also stated he Worked out the previous night and had not had much water. Patient given water and crackers and felt better after 30 min of observation.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: pt developed swelling and itching of his right forearm, hand, and fingers that started on wednesday 6/14/23
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 5.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Wrong vaccine was given, patient wanted to get M-M-R, no adverse event reported within 24 hours.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the PRIVACY recommends being revaccinated at their earliest convenience.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoaesthesia
Clinical narrative: A few hours after vaccination patient reported feeling numbness in his arm and hand. He says this feeling improved the next day without treatment but has worsened again and not improved since.  He has not sought any treatment or used any medication at this time but still has a numb feeling in the arm and hand.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the PRIVACY recommends being revaccinated at their earliest convenience.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the PRIVACY recommends being revaccinated at their earliest convenience.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the PRIVACY recommends being revaccinated at their earliest convenience.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the PRIVACY recommends being revaccinated at their earliest convenience.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: Administration Error - bivalent booster administered less than 2 months after last monovalent dose
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: Administration error - bivalent booster dose administered 1 month after previous bivalent booster dose
Age: 91.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: Administration Error - bivalent booster dose administered 1 month after receiving bivalent booster
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the State Department of Health recommends being revaccinated at their earliest convenience.
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the State Department of Health recommends being revaccinated at their earliest convenience.
Age: 21.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the PRIVACY recommends being revaccinated at their earliest convenience.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the PRIVACY recommends being revaccinated at their earliest convenience.