chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Off label use, Product use issue, Triple positive breast cancer, Tumour marker test
Clinical narrative: breastfed my children; breastfed my children; developed triple positive invasive ductal carcinoma; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: (005570). The reporter is the patient.  A female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "breastfed" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TRIPLE POSITIVE BREAST CANCER (medically significant) with onset Jun2022, outcome "unknown", described as "developed triple positive invasive ductal carcinoma"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "breastfed my children". The patient underwent the following laboratory tests and procedures: Mammogram: (Dec2020) negative; Tumour marker test: (unspecified date) have no genetic markers for cancer. The clinical course was reported as follows: The patient reported that she had developed triple positive invasive ductal carcinoma that was diagnosed in Jun2022, had a negative mamogram Dec2020. She had not hit menopause she had never taken hormones and never been on birth control. She breastfed her children and had the genetics test done and have no genetic markers for cancer. She is traveling to (city and state withheld) for treatment. They have put all the pieces together and have come to the conclusion that the vaccine caused this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The company does not attribute the triple positive breast cancer to BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), considering the event being intercurrent disease.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201060872 same report/drug, mother/baby case;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. She was by no means overweight and her diet was primarily gluten free products and balanced diet with supplements.The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Contracted COVID". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4494422-00.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: 1162439), as dose 2, single (Lot number: 1162439) and as dose 3 (booster), single (Lot number: 1162439), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162439), subcutaneous for crohn's disease. 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 "recovering" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  Clinical course: The patient used Prescription drug from another patient. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Causality as per reporter (Drug/Vaccine) was not reported for HUMIRA for event COVID-19. Causality as per reporter (Drug/Vaccine) was reported as possible for Pfizer BioNTech Covid-19 Vaccine for event COVID-19.  The reporter considered "covid" related to BNT162b2.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the reported events: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be completely excluded.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Sinusitis, Uveitis
Clinical narrative: Triggered uveitis in eyes; Sinus infection; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4500071-00 Regulatory authority.  A 43-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160836) at unk, citrate free, subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UVEITIS (medically significant), outcome "unknown", described as "Triggered uveitis in eyes"; SINUSITIS (non-serious), outcome "not recovered", described as "Sinus infection". The action taken for adalimumab was unknown. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) triggered Uveitis in eyes and Sinus infection of was not provided. Causality as per reporter (Drug/Vaccine) : Not Reported. Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): The reporter's causality for the event(s) triggered Uveitis in eyes and Sinus infection of was possible. Concomitant drugs and dates of administration (Exclude those used to treat event). Concomitant drugs not reported.  The reporter considered "triggered uveitis in eyes" related to BNT162b2. The reporter's assessment of the causal relationship of "sinus infection" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events UVEITIS , SINUSITIS  cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002797.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PEG allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown". The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Hidradenitis, Pneumonia, Vaccine breakthrough infection
Clinical narrative: Pneumonia; Vaccine breakthrough infection; Hidradenitis suppurativa; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4503127-00.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1155991), subcutaneous for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HIDRADENITIS (non-serious) with onset May2022, outcome "unknown", described as "Hidradenitis suppurativa"; PNEUMONIA (medically significant), outcome "unknown"; VACCINE BREAKTHROUGH INFECTION (non-serious), outcome "unknown". The action taken for adalimumab was dosage permanently withdrawn.  Clinical information: Solicited report by a consumer (patient) with events of non-serious hidradenitis suppurativa flare up and reaction to first covid vaccine ended up getting pneumonia with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced reaction to first covid vaccine ended up getting pneumonia. In May2022, the patient experienced hidradenitis suppurativa flare up. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of hidradenitis suppurativa flare up, reaction to first covid vaccine ended up getting pneumonia unknown onset and reaction to first covid vaccine ended up getting pneumonia unknown onset was not provided.  Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the event(s) of hidradenitis suppurativa flare up was not provided, reaction to first covid vaccine ended up getting pneumonia unknown onset and reaction to first covid vaccine ended up getting pneumonia unknown onset was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Pneumonia, Hidradenitis and Vaccine breakthrough infection and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Oedema, Skin test
Clinical narrative: edema; redness to her midface; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): GL-081222-20072.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; hyaluronic acid (RESTYLANE), on 01Apr2022 as dose 1, single (Lot number: 19423, Expiration Date: 31Mar2024) and on 01Apr2022 as dose 2, single (Lot number: 19921, Expiration Date: 31Aug2024). The patient's relevant medical history included: "Last dental procedure 1.5 yrs ago" (unspecified if ongoing), notes: Last dental procedure 1.5 yrs ago; "Allergic to PCN" (unspecified if ongoing); "dental procedure" (unspecified if ongoing), notes: Last dental procedure 1.5 yrs ago. The patient's concomitant medications were not reported. Past drug history included: Simvastatin for increased cholesterol. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, She had Pfizer Covid-19 vaccines on: 08Mar2021), administration date: 08Mar2021, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, She had Pfizer Covid-19 vaccines on: 29Mar2021), administration date: 29Mar2021, for COVID-19 immunization.  The following information was reported: OEDEMA (non-serious) with onset 01Jul2022, outcome "unknown", described as "edema"; ERYTHEMA (non-serious) with onset 01Jul2022, outcome "unknown", described as "redness to her midface". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oedema, erythema.  Clinical course: On 01Apr2022, the consumer was injected with 2 vials of Restylane Lyft-1 vial on each side of the midface for midface volume loss. The lot number and expiration were Lot 19921, Exp 31Aug2024 given to the right side & Lot 19423 Exp 31Mar2024 given to the left side. The consumer experienced late onset edema and redness to her midface bilaterally and intermittently beginning on 01Jul2022. She was treated by HCP with Hylenex 300u to affected areas on 11Aug2022 as a filler reversal. Medical history includes Fitzpatrick 3, Healthy, Simvastatin for increased cholesterol. Allergic to PCN, Last dental procedure 1.5 yrs ago. She had Pfizer Covid-19 vaccines on:08Mar2021; 29Mar2021 and Pfizer booster on 08Oct2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Culture, Genital herpes, Genital rash
Clinical narrative: had genital herpetic reaction/ herpetic outbreak/rash; had genital herpetic reaction/ herpetic outbreak/rash; This is a spontaneous report received from contactable reporter(s) (Physician).  A 16-year-old female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: GENITAL HERPES (non-serious), GENITAL RASH (non-serious), outcome "recovered" and all described as "had genital herpetic reaction/ herpetic outbreak/rash". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of genital herpes, genital rash.   Additional information: 16 year-old female patient received Comirnaty vaccine initial dosage and had genital herpetic reaction that was not reported as culture verified. Dermatologist reported full recovery of patient with "standard treatment". During medical conference, speaker/dermatologist reported herpetic outbreak/rash in 16 yo female patient after receiving covid 19 vaccine-Comirnaty. She reported no associated health problems or medications taken by the patient.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: HIBV
Symptoms: Intercepted product prescribing error, Medication error, No adverse event
Clinical narrative: physician ordered the medication due to the 18 years old nonpregnant female having a low white blood cell count with no reported adverse event; Initial information received on 11-Aug-2022 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2022SA336909(CLUSTER).  This case involves 18 years old female patient for whom physician ordered the medication due to the 18 years old nonpregnant female having a low white blood cell count with no reported adverse event for vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date the physician ordered the medication due to the 18 years old nonpregnant female having a low white blood cell count with no reported adverse event (intercepted product prescribing error) (unknown latency) for HIB (PRP/T) VACCINE. Nurse wanted to know if it could be administered to someone who was 18 years of age as the package insert states 1-5 years of age and if there is a change in dosing for the older child.  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 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: 4.0
Sex: M
Vaccine: DTAP, MMR, TDAP, VARCEL
Symptoms: Incorrect dose administered, Medication error, No adverse event, Wrong product administered
Clinical narrative: patient was inadvertently administered an ADACEL vaccination 11AUG2022 instead of the intended 5th dose of DTaP with no reported adverse event; Initial information received on 11-Aug-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 years old male patient who was inadvertently administered an adacel vaccination 11aug2022 instead of the intended 5th dose of dtap with no reported adverse event while receiving vaccines DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On an unknown date, the patient received suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunisation. On 11-Aug-2022, the patient received suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at a suspect at a dose of 0.5 ml once (lot U6923AA, expiry date: 21-Jan-2023) via intramuscular route in the left thigh for immunisation.  On 11-Aug-2022 the patient was inadvertently administered an adacel vaccination instead of the intended 5th dose of dtap with no reported adverse event (wrong product administered) same day latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  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: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: administered menactra to a 12-year-old patient which is a dose too early with no reported adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient and it was reported that menactra (MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE) was administered to a 12-year-old patient which is a dose too early with no reported adverse event while receiving vaccine [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation; COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation; and TETANUS VACCINE (TETANUS VACCINE) for Immunisation.  On 05-Aug-2022, the patient received a  dose of 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (formulation, strength: unknown) lot U7483AA via intramuscular route in the right deltoid as immunization.  On 05-AUG-2022 the patient was administered menactra which is a dose too early with no reported adverse event (inappropriate schedule of product administration) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered menactra to a 12-year-old patient which is a dose too early with no reported adverse event).  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 1.08
Sex: M
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: Child had 3 HIB vaccines on a delayed schedule, the third injection being after 13 month with no reported adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid non-serious case received from a patient  mother. Gmi number: 01233057  This case involves a 13-month-old male patient who had 3 HIB (PRP/T) VACCINE [ACT-HIB] vaccines on a delayed schedule, the third injection being after 13 months with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received dose 1 and 2 of ACT-HIB vaccine at (unknown: formulation, strength, dose, route, administration site) for prophylactic vaccination.  On unknown date, the patient received 3rd dose of suspect ACT-HIB at (unknown: formulation, strength, dose, route, administration site) for prophylactic vaccination on a delayed schedule, the third injection being after 13 month with no reported adverse event (inappropriate schedule of product administration) at same day latency.  It was reported that "Patient mother reported her son was on a delayed schedule for Hib administration. She asks if ActHib is effective immunity when not on recommended schedule? She asks what is recommended, because agency says no additional dose after a year old but we recommendation a dose 15 - 18 months?"   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 8.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: vaccines that were exposed to highest temperature of 8.4 degrees C for 30 minutes with no reported adverse event; IPOL was used post excursion with no reported adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 years old male patient who was administered ipol post excursion with no reported adverse event and vaccines that were exposed to highest temperature of 8.4 degrees c for 30 minutes with no reported adverse event, after receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Aug-2022, the patient received a  dose of suspect IPV (VERO)( lot TIE872M and expiration: 10-Oct-2022) at a dose of 0.5ml once via intramuscular route in the right deltoid for immunization.  On an unknown date,  the reporter stated that the vaccines that were exposed to highest temperature of 8.4 degrees c for 30 minutes with no reported adverse event (product storage error) .  On 10-Aug-2022(latency: same day), the patient administered ipol post excursion with no reported adverse event (poor quality product administered) following the administration of IPV (VERO).  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 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.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Had a mildly sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient experienced mild sore arm. The patient said that there was not a big deal at all. Follow-up would not possible, as no contact details were available.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Injection site bruising, Lethargy, Lymphadenopathy
Clinical narrative: Site: Bruising at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: overall tiredness in body-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: Weakness-Mild, Additional Details: mild mucus production in the chest
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Secretion discharge
Clinical narrative: Site: Bruising at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: overall tiredness in body-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: Weakness-Mild, Additional Details: mild mucus production in the chest
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Rash
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Patient developed a red rash on her arm and it had some bruising as well she went to the doctor and he gave her cephalexin to take incase of skin infection
Age: 94.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site inflammation, Injection site pain, Injection site reaction, 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, Systemic: injection site reaction limited to left arm-Medium, Additional Details: Injection site had inflammation and formed crust. Appears potentially infected.
Age: 94.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab
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, Systemic: injection site reaction limited to left arm-Medium, Additional Details: Injection site had inflammation and formed crust. Appears potentially infected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Positive test for COVID on noted date.  Took Paxlovid.  Minor cough, runny nose.  Isolated from wife (she's negative).  Two tests since Paxlovid end have been negative - two days apart.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Poor quality sleep, Tinnitus
Clinical narrative: Approximately 3 days after having received Johnson and Johnson vaccine for first time on 8/4/2022, I started to have louder more consistent tinnitus in my ears louder than I ever have experienced before. I now am waking up with very loud ear ringing in middle of night and cannot sleep well. Tinnitus is still continuing to this day.
Age: 52.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Person  received Jynneos vaccine at the Health department due to work exposure to MPV.  On the day of the vaccine, the person reports (no medical attention sought) arm at the injection site became warm/hot with a 4 inch red welt and gulf ball sized lump. Patient also reports headache, dizziness, moderate pain in neck, arm and shoulder as well as weakness and fatigue. It took 4 days to begin resolving.
Age: 52.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site mass, Injection site urticaria, Injection site warmth, Neck pain
Clinical narrative: Person  received Jynneos vaccine at the Health department due to work exposure to MPV.  On the day of the vaccine, the person reports (no medical attention sought) arm at the injection site became warm/hot with a 4 inch red welt and gulf ball sized lump. Patient also reports headache, dizziness, moderate pain in neck, arm and shoulder as well as weakness and fatigue. It took 4 days to begin resolving.
Age: 52.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Person  received Jynneos vaccine at the Health department due to work exposure to MPV.  On the day of the vaccine, the person reports (no medical attention sought) arm at the injection site became warm/hot with a 4 inch red welt and gulf ball sized lump. Patient also reports headache, dizziness, moderate pain in neck, arm and shoulder as well as weakness and fatigue. It took 4 days to begin resolving.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: On  08/17/2022 patient's wife called to report patient had a "mini stroke and is currently hospitalized at local Hospital." Reports "waiting to be transferred to alternate facility for therapy."
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case dose 1 12/28/20 Pfizer EL0140 dose 2 1/19/21 Pfizer EL3248
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Flatulence, Headache, Neck pain, Pain
Clinical narrative: 8/12/22 PT RECEIVED 2ND MODERNA BOOSTER. PT STATED EVERYTHING WAS FINE ON THAT DAY. SHE WOKE UP SATURDAY  8/13/22 WITH HEADACH, NECK PAIN THAT RADIATED FROM LEFT TO RIGHT. IT HURT TO MOVE NECK IN ANY DIRECTION (UP, DOWN, SIDE) FELT LIKE THERE WAS SWELLING. IT HURT TO COUGH. TEMP OF 101.1(FEVER); AROUND 2-30-3 PM ON 8/13/22 BP 125/69 PULSE 86; RECHECKED AT 4 PM IT 173/91 PULSE 88.  STAYED IN BED ALL DAY, TOOK SHOWER, TOOK TYLENOL,DRANK WATER, ATE CHICKEN NOODLE SOUP ONLY; LATER SUNDAY 6-8 PM HEADACHE EASED UP. TOOK TYLENOL EVERY 6 HIURS AND SUNDAY NIGHT TEMP WAS 99.1. HEAD HURT MORE WHEN SNEEZED, PASSED GAS, AND TALKED.  MONDAY 8/14/22 AT 12 NOON, SEEMED ALL SYMPTOMS JUST WENT AWAY. TUESDAY NOT MUCH PAIN BUT TOOK TYLENOL TWICE DURING THE DAY. WEDNESDAY ALL PAIN AND FEVER GONE. ARM ITCHED AND PT RUBBED IT-IT WAS SMOOTH TO TOUCH. PT TOOK A SHOWER AND PUT COCOA BUTTER ON- WHILE PUTTING ON COCOA BUTTER, PT FELT LITTLE BUMPS ON ARM. SHE TOOK PICTURES AND CAME TO PHARMACY.  PT WAS INSTRUCTED TO  CONTINUE TO MONITOR SYMPTOMS AND TO FOLLOW UP WITH DERMATOLOGIST.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Sneezing, Swelling
Clinical narrative: 8/12/22 PT RECEIVED 2ND MODERNA BOOSTER. PT STATED EVERYTHING WAS FINE ON THAT DAY. SHE WOKE UP SATURDAY  8/13/22 WITH HEADACH, NECK PAIN THAT RADIATED FROM LEFT TO RIGHT. IT HURT TO MOVE NECK IN ANY DIRECTION (UP, DOWN, SIDE) FELT LIKE THERE WAS SWELLING. IT HURT TO COUGH. TEMP OF 101.1(FEVER); AROUND 2-30-3 PM ON 8/13/22 BP 125/69 PULSE 86; RECHECKED AT 4 PM IT 173/91 PULSE 88.  STAYED IN BED ALL DAY, TOOK SHOWER, TOOK TYLENOL,DRANK WATER, ATE CHICKEN NOODLE SOUP ONLY; LATER SUNDAY 6-8 PM HEADACHE EASED UP. TOOK TYLENOL EVERY 6 HIURS AND SUNDAY NIGHT TEMP WAS 99.1. HEAD HURT MORE WHEN SNEEZED, PASSED GAS, AND TALKED.  MONDAY 8/14/22 AT 12 NOON, SEEMED ALL SYMPTOMS JUST WENT AWAY. TUESDAY NOT MUCH PAIN BUT TOOK TYLENOL TWICE DURING THE DAY. WEDNESDAY ALL PAIN AND FEVER GONE. ARM ITCHED AND PT RUBBED IT-IT WAS SMOOTH TO TOUCH. PT TOOK A SHOWER AND PUT COCOA BUTTER ON- WHILE PUTTING ON COCOA BUTTER, PT FELT LITTLE BUMPS ON ARM. SHE TOOK PICTURES AND CAME TO PHARMACY.  PT WAS INSTRUCTED TO  CONTINUE TO MONITOR SYMPTOMS AND TO FOLLOW UP WITH DERMATOLOGIST.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough event. Pfizer 3/19/21 EN6200, 4/10/21 ER8733, and boosted 8/26/21 FC3182 and 4/8/22 FK9895.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 8/2/21, 8/23/21. Positive on 8/8/22
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient was suppose to get Meningococcal and received Meningococcal B in error. Vaccine was placed in with Meningococcal
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough event. Pfizer 2/1/21 EL9265, 2/26/21 EL9267, 11/24/21 FH8030.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/24/21, 3/25/21, 11/8/21. Positive on 8/16/22
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pt w/out s/s associated with Covid. Pt in hospital w/other concerns. Pt +Covid PCR while in hospital.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Moderna 4/18/21, 6/6/21, 12/11/21. Positive on 8/17/22
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/1/21, 3/1/21. Positive on 8/15/22
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Chills, Cough, Differential white blood cell count abnormal
Clinical narrative: Chills, aches, felt hot within 5 hours of Covid vaccine booster on 8/12/22.   No symptoms prior to vaccine and no ill contacts.  8/12 to 8/13: congestion and sore throat and face swollen.  8/14/22: cough.  Felt SOB with chest tightness 8/14/22.  Albuterol: 2x, not helping, last dose 3-4am.  Eyes red, not sleeping.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling hot, Full blood count abnormal, Influenza virus test negative, Insomnia
Clinical narrative: Chills, aches, felt hot within 5 hours of Covid vaccine booster on 8/12/22.   No symptoms prior to vaccine and no ill contacts.  8/12 to 8/13: congestion and sore throat and face swollen.  8/14/22: cough.  Felt SOB with chest tightness 8/14/22.  Albuterol: 2x, not helping, last dose 3-4am.  Eyes red, not sleeping.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Mean cell haemoglobin increased, Mean cell volume increased, Metabolic function test, Monocyte count increased, Neutrophil count increased
Clinical narrative: Chills, aches, felt hot within 5 hours of Covid vaccine booster on 8/12/22.   No symptoms prior to vaccine and no ill contacts.  8/12 to 8/13: congestion and sore throat and face swollen.  8/14/22: cough.  Felt SOB with chest tightness 8/14/22.  Albuterol: 2x, not helping, last dose 3-4am.  Eyes red, not sleeping.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Pain, Platelet morphology abnormal, Red blood cell count decreased
Clinical narrative: Chills, aches, felt hot within 5 hours of Covid vaccine booster on 8/12/22.   No symptoms prior to vaccine and no ill contacts.  8/12 to 8/13: congestion and sore throat and face swollen.  8/14/22: cough.  Felt SOB with chest tightness 8/14/22.  Albuterol: 2x, not helping, last dose 3-4am.  Eyes red, not sleeping.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory syncytial virus test negative, Respiratory tract congestion, SARS-CoV-2 test negative, Swelling face, White blood cell count increased
Clinical narrative: Chills, aches, felt hot within 5 hours of Covid vaccine booster on 8/12/22.   No symptoms prior to vaccine and no ill contacts.  8/12 to 8/13: congestion and sore throat and face swollen.  8/14/22: cough.  Felt SOB with chest tightness 8/14/22.  Albuterol: 2x, not helping, last dose 3-4am.  Eyes red, not sleeping.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Gallbladder disorder, Immediate post-injection reaction, Immune system disorder, Inflammation, Intensive care
Clinical narrative: Intense red rasied rash immediatley following both doses of Moderna. Second dose brought on 10 days of vomiting. Ended up in the ICU for a week with septic shock after immune system went haywire. Emergency stent placement. Mutli-organ involvement brought on by pyelonephritis.  Readmitted to hospital shortly after dischage for failing gallbladder and pancreas.  Culminated in diagnosis of Lupus in February of 2022. Have experienced two additional emergency room visits for inflammation.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Multi-organ disorder, Pancreatic failure, Pyelonephritis, Rash erythematous
Clinical narrative: Intense red rasied rash immediatley following both doses of Moderna. Second dose brought on 10 days of vomiting. Ended up in the ICU for a week with septic shock after immune system went haywire. Emergency stent placement. Mutli-organ involvement brought on by pyelonephritis.  Readmitted to hospital shortly after dischage for failing gallbladder and pancreas.  Culminated in diagnosis of Lupus in February of 2022. Have experienced two additional emergency room visits for inflammation.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Septic shock, Stent placement, Systemic lupus erythematosus, Vomiting
Clinical narrative: Intense red rasied rash immediatley following both doses of Moderna. Second dose brought on 10 days of vomiting. Ended up in the ICU for a week with septic shock after immune system went haywire. Emergency stent placement. Mutli-organ involvement brought on by pyelonephritis.  Readmitted to hospital shortly after dischage for failing gallbladder and pancreas.  Culminated in diagnosis of Lupus in February of 2022. Have experienced two additional emergency room visits for inflammation.
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Rash, Rash erythematous
Clinical narrative: Diffuse red rash that started on face and spread down body.  Also had several episodes of diarrhea.  Rash resolved within 8 days.  Diarrhea lasted 2 days.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Uvulitis
Clinical narrative: emergency room visit for uvulitis due to covid 19
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Sepsis
Clinical narrative: admission with acute respiratory failure and sepsis    covid 19
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: reports sx of sore throat and feeling "stuffy" , reports known exposure in community from positive boyfriend- tested positive for covid 8/18/22- has had 4 doses of covid vaccine- initial series Moderna plus 2 doses of pfizer
Age: 24.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: Patient was meant to receive varicella vaccine and received varicella zoster vaccine. Order was entered incorrectly by provider and administered as ordered in clinic. No harm came to patient.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Seizure
Clinical narrative: Patient reports going from 3 seizures a year to weekly seizures after her vaccine
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Loss of personal independence in daily activities, Mobility decreased, Oropharyngeal pain
Clinical narrative: Pt reports feeling like he had the flu for 8 months after receiving 2nd vaccine. He states he had extreme fatigue, sore throat, and weight gain of 30lbs. Unable to get up and complete his normal daily activities.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: Pt reports feeling like he had the flu for 8 months after receiving 2nd vaccine. He states he had extreme fatigue, sore throat, and weight gain of 30lbs. Unable to get up and complete his normal daily activities.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received Pediatric Pfizer vaccine initially, was given the Baby Formulation of Moderna for a 2nd vaccine.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Culture urine, Discomfort, Dyspnoea
Clinical narrative: Discharge Provider:  MD Primary Care Provider at Discharge: MD  Admission Date: 8/14/2022 Discharge Date: 08/17/2022  PRESENTING PROBLEM: Hypoxia [R09.02] End stage renal disease on dialysis [N18.6, Z99.2] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 50 y.o. female with past medical history significant for pulmonary hypertension, asthma, chronic hypoxemic respiratory failure oxygen dependent, ESRD on HD, morbid obesity, chronic diastolic heart failure, OSA on CPAP, hypothyroidism, mood disorder, hx DVT on warfarin, and non-insulin dependent DMT2 who presented to the emergency department with shortness of breath, headache, chills, nausea, sore throat, fatigue and productive cough.  She took a COVID test at home that resulted positive.  She has been fully COVID vaccinated with 1 booster. At baseline patient is on 2-3 L nasal cannula at rest and 5 L with any activity or while lying flat.  Patient reported that her home oxygen concentrator broke after falling a few days ago. Pulmonary rehab worked with supplier to replace however there is a supply shortage and will provide oxygen tanks until concentrator available. Patient is on hemodialysis for end-stage renal disease, her last dialysis session was 08/17/2022. She has new isolation chair arranged and Dr phoned dialysis orders there.      While hospitalized she also complained of bilateral flank pain. She has had intermittent flank pain previously and this was recently evaluated at Hospital. She was evaluated with urinalysis which was abnormal and urine cultures are pending at discharge. She did receive one dose of ceftriaxone in patient. Ultimately a CTABP was obtained to evaluate for hydronephrosis, renal calculus, or signs of pyelonephritis. This returned without any acute pathology and was reassuring. She did note not having a BM for several days and I suspect this is underlying cause of discomfort. She does have known gastroparesis, passing gas and follows with clinic for pacemaker. May be exacerbated by narcotic use.   Patient was initially treated with oral dexamethasone.  Patient was continued on supplemental oxygen at baseline. Therapy was consulted, who recommended home with assist.   Pulmonary Rehab was consulted for home oxygen.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: End stage renal disease, Fall, Fatigue, Flank pain, Haemodialysis
Clinical narrative: Discharge Provider:  MD Primary Care Provider at Discharge: MD  Admission Date: 8/14/2022 Discharge Date: 08/17/2022  PRESENTING PROBLEM: Hypoxia [R09.02] End stage renal disease on dialysis [N18.6, Z99.2] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 50 y.o. female with past medical history significant for pulmonary hypertension, asthma, chronic hypoxemic respiratory failure oxygen dependent, ESRD on HD, morbid obesity, chronic diastolic heart failure, OSA on CPAP, hypothyroidism, mood disorder, hx DVT on warfarin, and non-insulin dependent DMT2 who presented to the emergency department with shortness of breath, headache, chills, nausea, sore throat, fatigue and productive cough.  She took a COVID test at home that resulted positive.  She has been fully COVID vaccinated with 1 booster. At baseline patient is on 2-3 L nasal cannula at rest and 5 L with any activity or while lying flat.  Patient reported that her home oxygen concentrator broke after falling a few days ago. Pulmonary rehab worked with supplier to replace however there is a supply shortage and will provide oxygen tanks until concentrator available. Patient is on hemodialysis for end-stage renal disease, her last dialysis session was 08/17/2022. She has new isolation chair arranged and Dr phoned dialysis orders there.      While hospitalized she also complained of bilateral flank pain. She has had intermittent flank pain previously and this was recently evaluated at Hospital. She was evaluated with urinalysis which was abnormal and urine cultures are pending at discharge. She did receive one dose of ceftriaxone in patient. Ultimately a CTABP was obtained to evaluate for hydronephrosis, renal calculus, or signs of pyelonephritis. This returned without any acute pathology and was reassuring. She did note not having a BM for several days and I suspect this is underlying cause of discomfort. She does have known gastroparesis, passing gas and follows with clinic for pacemaker. May be exacerbated by narcotic use.   Patient was initially treated with oral dexamethasone.  Patient was continued on supplemental oxygen at baseline. Therapy was consulted, who recommended home with assist.   Pulmonary Rehab was consulted for home oxygen.