chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Candida infection
Clinical narrative: thrush; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An elderly male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: diagnosed 5 years before this report when he was 65. It will be six years he was diagnosed in July; "COPD" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation; ATENOLOL taken for heart rate; LOSARTAN HCTZ; MONTELUKAST. The following information was reported: CANDIDA INFECTION (non-serious), outcome "unknown", described as "thrush". Therapeutic measures were taken as a result of candida infection.  Additional information: This patient is reporting about Pfizer Covid vaccine, has had all the doses. Every 3 months after getting the vaccines he has thrush. He has had thrush 8 times now. The doctor has given him some medicine.  Caller states he has one vocal cord and that is why he sounds funny. Caller clarified that he had one vocal cord prior to getting Pfizer Covid vaccines. All his Covid vaccines were manufactured by Pfizer. He hasn't missed a shot. He has got them from the beginning and the last one he got was in Sep2023. The thrush didn't start until after getting the Covid vaccines. Caller clarified any of the times he gets Covid shot within 6 months he has had thrush twice, every time.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400061744 same patient/drug, different dose/AE;US-PFIZER INC-202400061506 same patient/drug, different dose/AE;
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 2, single (Lot number: EW0153) at the age of 55 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "Elevated a1c" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Acetaminophen, reaction(s): "Drug Allergy"; Meloxicam, reaction(s): "Drug Allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (2024) and all described as "COVID-19". The patient received COVID-19 treatment with nirmatrelvir, ritonavir (PAXLOVID) from 27Feb2024 to 03Mar2024.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Headache, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Dose 01, 02, 03, 04, 06= Moderna; Dose 05= Pfizer; minor headache; In 2023, SARS-CoV-2 test: Positive; In 2023, SARS-CoV-2 test: Positive; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-756646 (Moderna).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Glucose tolerance impaired", start date: 1994 (ongoing), notes: Pre-diabetic (gestational); "Lyme disease", start date: Jul2011 (unspecified if ongoing), notes: having a long history of having Lyme disease; "Fungal infection", start date: Jan2022, stop date: 01Oct2022, notes: It got worse in November 2023 after having improved; "Allergy Contrast media allergy" (ongoing), notes: Contrast dye; "Diabetes Mellitus" (ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; NYSTATIN taken for fungal infection; KETOCONAZOLE taken for fungal infection; PSEUDOWINTERA COLORATA taken for fungal infection. Past drug history included: Reglan, reaction(s): "dystonic reaction", notes: Ongoing; Reglan, reaction(s): "Allergy Drug hypersentivity", notes: Ongoing. Vaccination history included: Influenza vaccine, administration date: 2005, for Immunization, reaction(s): "Ototoxicity"; Influenza vaccine, administration date: 2006, for Immunization, reaction(s): "Deafness unilateral"; Flu vaccine (Ongoing), for Immunization, reaction(s): "Allergy to Vaccine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "In 2023, SARS-CoV-2 test: Positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 01, 02, 03, 04, 06= Moderna; Dose 05= Pfizer"; HEADACHE (non-serious), outcome "unknown", described as "minor headache". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 11.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Refrigerator door was left open. Max/low temperature reached: 34.5F to 47.1F Duration out of labelled range: Total of 1 Hour and 30 Minutes with no reported adverse event; Opened IPOL was given to patient post excursion with no reported adverse event; Initial information was received on 29-Feb-2024 regarding an unsolicited valid  non-serious case received from health care professional.  This case is linked to case 2024SA071298.  This case involves a 11 years old female patient who experienced opened  IPV (VERO) [IMOVAX POLIO] was given to patient post excursion (with no reported adverse event) and Refrigerator door was left open. Max/low temperature reached: 34.5F to 47.1F Duration out of labelled range: Total of 1 Hour and 30 Minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), Concomitant medications and family history were not provided.   On 23-Feb-2024, the patient received a unknown dose of suspect IPV (VERO) (Suspension for injection) (lot W1A191M,Expiry date: 16-Feb-2025,strength was unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and opened ipol was given to patient post excursion (with no reported adverse event) (poor quality product administered) (latency : same day) and Refrigerator door was left open. Max/low temperature reached: 34.5F to 47.1F Duration out of labelled range: Total of 1 Hour and 30 Minutes with no reported adverse event (product storage error).  Reportedly "Human error: Yes Does extended stability data cover the excursion: Yes - opened IPOL is not covered by the extended stability data. If negative advice, was the product administered to a patient: Opened IPOL was given to 2 patients.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: nurse called stating that they have given a dose of tenivac to a patient past the expiration date with no reported adverse event; Initial information received on 06-Mar-2024 regarding an unsolicited valid non-serious case received from a nurse via call center.  This case involves an unknown age and unknown gender patient who was given a dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] past the expiration date 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 had received (dose and units unknown) suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids (Suspension for injection) (lot U7183AA; expiry date: 24-Sep-2023; strength not reported) via unknown route in unknown administration site for immunization (expired product administered) (Latency: same day).  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: 11.0
Sex: M
Vaccine: MEN
Symptoms: Circumstance or information capable of leading to medication error, Exposure via skin contact, Scratch, Underdose
Clinical narrative: the needle came out leave a scratch on the patient`s arm; menquadfi was given first in the left arm, but the patient moved, and the needle came out leave a scratch on the patient`s arm, the medication leaking down from the arm with; menquadfi was given first in the left arm, but the patient moved, and the needle came out leave a scratch on the patient`s arm, the medication leaking down from the arm with; Initial information received on 06-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who was given first in the left arm, but the patient moved, and the needle came out leave a scratch on the patient`s arm, the medication leaking down from the arm after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Prophylactic vaccination; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination; and HPV VACCINE (HPV VACCINE) for Prophylactic vaccination.  On 19-Feb-2024, the patient received a dose less that 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (lot U7986AA, Expiry: mar-2026 with unknown strength) via intramuscular route in the left deltoid as prophylactic vaccination but the patient moved, and the needle came out leave a scratch on the patient`s arm, the medication leaking down from the arm (scratch) (incorrect dose administered) and (accidental exposure to product) (latency: same day).  It was reported "the medication leaking down from the arm and a minimal amount was left in the syringe as well. The Medical assistant giving the vaccine did not draw another MENQUADFI vaccine"  Action taken: not applicable.  The medical assistant cleaned the scratch and put a band-aid on it.  At time of reporting, the outcome was Unknown for the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was given the liquid vaccine component (dtap-ipv component) only and not the lyophilized vaccine component (acthib vaccine) with no reported adverse event; Initial information received on 06-Mar-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 months old patient of an unknown gender who was given the liquid vaccine component (DTAP-IPV component) only and not the lyophilized vaccine component (ACTHIB vaccine) of pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine and pneumococcal vaccine CONJ (Pneumococcal Conjugate Vaccine) for Prophylactic vaccination.  On 28-Feb-2024, the patient received a dose of 0.5 ml (dose 1) once of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (strength: standard; lot: UJ848AA; expiry dare: 16-Apr-2024) via intramuscular route in the left thigh for Immunization.  On 28-Feb-2024 the patient was given the liquid vaccine component (DTAP-IPV component) only and not the lyophilized vaccine component (ACTHIB vaccine) with no reported adverse event (product preparation error) (latency: same day).  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: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient was given an insufficient amount of  COVID vaccine. Patient was given the 0.25ml dosage for children under 12 years of age. Patient was 13 years of age at the time. This was only time patient has ever been to this clinic and attempts have been made to call patient parent in order to notify but parent has not responded to voicemails as of this date.
Age: 52.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Patient called about 50 -55 minutes after being vaccinated with localized swelling in the left arm.  She said it was significantly swollen but not itchy or painful.  I advised taking benadryl and applying a cool rag.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Dr. ordered Covid Vaccine for pt; I thought pt was 12 years and found he is 11 years ; Gave the Comirnaty 2023-2024 vaccine instead of the Pfizer BioNTech 2023-2024 vaccine
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Between evening of 3/8/24 to morning of 3/9/24, pt started to experience injection site pain and swelling. Symptoms progressed with slight fever and headache. On 3/10/24, patient's symptoms worsened with severe arm pain, arm was swelling at injection site and was red and hot. Patient went to the emergency room. At the ER, her throat swelled up, blood pressure dropped to 75/50, and patient was treated with EpiPen. She was then discharged and was given a prescription for acyclovir and EpiPen. Patient is now okay and was instructed to use the acyclovir just in case if there were any flare ups.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity, Pharyngeal swelling, Pyrexia
Clinical narrative: Between evening of 3/8/24 to morning of 3/9/24, pt started to experience injection site pain and swelling. Symptoms progressed with slight fever and headache. On 3/10/24, patient's symptoms worsened with severe arm pain, arm was swelling at injection site and was red and hot. Patient went to the emergency room. At the ER, her throat swelled up, blood pressure dropped to 75/50, and patient was treated with EpiPen. She was then discharged and was given a prescription for acyclovir and EpiPen. Patient is now okay and was instructed to use the acyclovir just in case if there were any flare ups.
Age: 31.0
Sex: M
Vaccine: COVID19, FLU4, HEP, MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: COVID-19 vaccine administered subcutaneous instead of intramuscular. No symptoms or signs at time of vaccination. Interim clinical considerations consulted. Pt advised of administration error, that dose does not need to be repeated, repeated education on local and systemic side effects.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 62.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: On 3/11/24 patient got 2 vaccines (Arexvy in right arm, Shingrix in left arm). Patient called today stating he has a headache, feels achy all over and both of his arms are sore. I explained to him that these are normal and expected side effects of vaccines. I recommended OTC treatments to him and to rest. He was satisfied with this response.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Pt was injected with just the diluent lot number B9J49
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: patient had a loss of consciousness after injection
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Axillary pain, Back pain, Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient had extreme pain at injection site and axillary region immediately following vaccination. Approximately 5 minutes later, she experience extreme lower back pain which radiated to abdominal region.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient had extreme pain at injection site and axillary region immediately following vaccination. Approximately 5 minutes later, she experience extreme lower back pain which radiated to abdominal region.
Age: 71.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: a pediatric dose was administered to an adult
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site discolouration, Injection site erythema, Injection site infection, Injection site nodule, Injection site warmth
Clinical narrative: The injection site is red, warm and has a know. There are white spots in the red patch. Per patient, doctor said that it was an infection and that it was "really bad" and that if it got any worse after starting Keflex 750mg  TID X 10 days to get to the ER for a stronger antibiotic.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Depressed level of consciousness, Floppy infant, Hypotonic-hyporesponsive episode, Pallor
Clinical narrative: Baby was given vaccines in the afternoon.  By late evening parents reported symptoms that are consistent with a hypotonic hyporesponsive episode including pallor, decreased level of alertness and floppiness.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pallor, Rash, Rash macular
Clinical narrative: chest, upper abdomen, upper back macular, erythematous, blanching rash began approx 26 hours after the injection. the rash started to fade 40 hours after it started but is not yet fully resolved
Age: 73.0
Sex: U
Vaccine: COVID19-2
Symptoms: Tremor
Clinical narrative: SHAKINESS AFTER VACCINE
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with covid; fully vaccinated with 1 booster
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 1 booster
Sex: F
Vaccine: RSV, RSV
Symptoms: Computerised tomogram, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Very painful; Drug use for unapproved indication; This non-serious case was reported by a consumer and described the occurrence of pain in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 31-JAN-2024, the patient received Arexvy. On 31-JAN-2024, an unknown time after receiving Arexvy, the patient experienced drug use for unapproved indication (Verbatim: Drug use for unapproved indication). On an unknown date, the patient experienced pain (Verbatim: Very painful). The outcome of the pain was not resolved and the outcome of the drug use for unapproved indication was unknown.   It was unknown if the reporter considered the pain to be related to Arexvy.     It was unknown if the company considered the pain to be related to Arexvy.   Additional Information: GSK receipt date: 05-MAR-2024 The reporter reported seriousness for very painful was Intervention required. The reporter was requested for follow up.
Sex: F
Vaccine: RSV, RSV
Symptoms: Pain, Product use in unapproved indication
Clinical narrative: Very painful; Drug use for unapproved indication; This non-serious case was reported by a consumer and described the occurrence of pain in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 31-JAN-2024, the patient received Arexvy. On 31-JAN-2024, an unknown time after receiving Arexvy, the patient experienced drug use for unapproved indication (Verbatim: Drug use for unapproved indication). On an unknown date, the patient experienced pain (Verbatim: Very painful). The outcome of the pain was not resolved and the outcome of the drug use for unapproved indication was unknown.   It was unknown if the reporter considered the pain to be related to Arexvy.     It was unknown if the company considered the pain to be related to Arexvy.   Additional Information: GSK receipt date: 05-MAR-2024 The reporter reported seriousness for very painful was Intervention required. The reporter was requested for follow up.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: date of vaccination: annually; adverse reaction or side effects experienced (if any): none; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for Zoster Vaccine Live (ZOSTAVAX) (2104USA001190), concerning a female patient, who was approximately71-year old at the time of the report but whose age at the time of event could not be established. The patient never smoked or used tobacco products. Her medical history and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (manufacturer unknown) (reported as an unspecified pneumonia vaccine) formulation has been defaulted to injection (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis at a pharmacy. It was reported that the patient was vaccinated annually (inappropriate schedule of vaccine administered); it was not provided how many doses of pneumococcal 23v polysaccharide vaccine (manufacturer unknown) were administered. She experienced none adverse reaction or side effects.   This is one of two reports created for the same patient (cross-referenced with report 2104USA001190).; Sender's Comments:  US-009507513-2104USA001190:
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Under 18 years old, and Received Heplisav-B; Initial report received on 22-Jan-2024.  A pharmacist reported that a 17-year-old male patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.  On 18-Jan-2024, the 17-year-old patient received a dose of HEPLISAV-B (Lot number 944609, expiration date 29 Jan 2026, and NDC number 43528-0003-05) intramuscularly in the left deltoid. The patient was under 18-years-old. No adverse effects were reported by the patient.  No further information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient in his 70's received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (ongoing), notes: Eczema right wrist., Occasional Not Often; "Legs knees hurts", start date: 27Jan2021 (unspecified if ongoing); "Shoulder Hurt", start date: 28Jan2021 (unspecified if ongoing); "hard to sit or stand" (unspecified if ongoing); "Allergy relief-Sinus" (ongoing); "Low VIt d Levels" (ongoing); "High Blood Pressure" (ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, in 2023 as dose number unknown, single; RSV VACCINE taken for immunisation, in 2023 as dose number unknown, single; PNEUMOCOCCAL VACCINE taken for immunisation, in 2023 as dose number unknown, single; TETANUS VACCINE taken for immunisation, in 2023 as dose number unknown, single. Past drug history included: Triamcinolone acetonide for Eczema, notes: Previously used triamcinolone acetonide cream 0.1 % at 4:20 pm right wrist. Vaccination history included: BNT162b2 (Dose 1, Single (at 11:40), Lot number: EL9264, location: right arm, intramuscular), administration date: 09Feb2021, for COVID-19 Immunization; BNT162b2 (Dose 2, Single (at 11:45), Lot number: EL9262, location: right deltoid, intramuscular), administration date: 02Mar2021, for COVID-19 Immunization; BNT162b2 (Dose 3 (Booster), Single (at 10:45), Lot number: 30131BA, location: left deltoid, intramuscular), administration date: 27Sep2021, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Mar2024, outcome "recovering" and all described as "got COVID". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient got COVID Sars on 04Mar2024 and was on the Paxlovid. The symptoms centered around the throat, hacky dry cough burned throat every time the patient coughed, chills body aches. By Thursday (07Mar2024), the patient was free of the hacky hurtful cough. The patient still coughs but it was not as dry. The breathing was different, slower. Luckily, the patient had the flu shot, RSV, pneumonia vaccine, tetanus vaccine each two weeks apart since the COVID booster vaccine on 17Oct2023. This COVID SARs hurt.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: FLUX, PNC20
Symptoms: COVID-19, Influenza, SARS-CoV-2 test positive
Clinical narrative: influenza; tested positive for Covid-19; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2023-736300 (Moderna).  A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 07Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE), on 07Oct2022 as dose number unknown, single) for immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 23Sep2022 as dose 5 (booster), single (Lot number: AS71418) for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer", start date: 2013 (unspecified if ongoing); "Hernia repair", start date: 09Sep2022 (unspecified if ongoing). Concomitant medication(s) included: ELIGARD taken for neoplasm malignant (ongoing). Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COVID-19 (non-serious) with onset 07May2023, outcome "recovered", described as "tested positive for Covid-19"; INFLUENZA (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 1.67
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: 1 patient was adminitered with fluzone quadrivalent temperature excursion with no reported adverse event; Initial information received on 07-Mar-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 1-year-old male patient was adminitered with fluzone quadrivalent temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (DIP TOX) (Menactra) for Prophylactic vaccination.  On 04-Jan-2024, the patient received an unknown dose of suspect influenza quadrival A-B vaccine, Suspension for injection (strength: unknown) (lot: U8230CA, expiry date: 30-Jun-2024) via unknown route in unknown administration site for prophylactic vaccination (immunization) and patient was adminitered with fluzone quadrivalent temperature excursion (poor quality product administered) (latency: same day).  Reportedly, Reason: POWER OUTAGE DUE TO THE STORM Max/low Temperature: -0.8 C Time of excursion: 77 HOURS AND 54 MINUTES   human error: no   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: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Lethargy, Pain
Clinical narrative: Swelling pain at injection site x 4 days.   Lethargy and aches that started 12 hours after injection and last 36 hrs.  Chills and fever that started  114 hours after injection
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Swelling pain at injection site x 4 days.   Lethargy and aches that started 12 hours after injection and last 36 hrs.  Chills and fever that started  114 hours after injection
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Noninfective sialoadenitis, Otitis externa, Pain in jaw
Clinical narrative: Inflammation of right salivary (parotid) glands 2 days after Covid vaccine; visible swollen for a week.  Fever of 101.8 for 36 hrs s, from 12 hrs after admin.  Still sore two months after (relapse?) esp when eating, talking.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Parotid gland enlargement, Pyrexia, Salivary gland pain
Clinical narrative: Inflammation of right salivary (parotid) glands 2 days after Covid vaccine; visible swollen for a week.  Fever of 101.8 for 36 hrs s, from 12 hrs after admin.  Still sore two months after (relapse?) esp when eating, talking.
Sex: U
Vaccine: RSV
Symptoms: Dyspnoea, Productive cough
Clinical narrative: Patient experienced cough after receiving Arexvy; Wet cough; dyspnea; This non-serious case was reported by a consumer via call center representative and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included smoker (patient was a smoker for 30 years, from 1975 to 2005).   On 30-NOV-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cough (Verbatim: Patient experienced cough after receiving Arexvy), productive cough (Verbatim: Wet cough) and dyspnea (Verbatim: dyspnea). The outcome of the cough, productive cough and dyspnea were not reported.   It was unknown if the reporter considered the cough, productive cough and dyspnea to be related to Arexvy.     It was unknown if the company considered the cough, productive cough and dyspnea to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024 The patient experienced cough after receiving Arexvy. Wet cough with dyspnea.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Muscle disorder, Muscular weakness
Clinical narrative: The majority of my muscles were affected with ABRYSVO vial with diluent plus a headache. I do not have COVID. I got the RSV vaccine to hopefully keep me protected during my April open heart surgery. My doctor prescribed muscles relaxers and Advil plus heat. I still have muscle weakness. This side effect was noted in the information. I was aware it could happen. I have RA and I thought the vaccine may not work as well because of my immunity issues, but I did not think I would be the one to get muscle pain. just extreme muscle weakness for several weeks
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: My 17 year old son went in to clinic to receive a required vaccine for public school but was administered a different one. Here is the note/email from the staff... ear Mr. & Mrs., Yesterday, patient came into out immunization clinic to receive a meningitis vaccination. My receptionist indicated she spoke with parent over the phone and received a verbal consent to provide the vaccine for patient. At that time parent indicated she wanted him to only have the meningitis vaccine that was required by state law. Our immunization nurse inadvertently administered the serogroup B meningococcal vaccine (BEXSERO lot# X4BK3), instead of the meningococcal conjugate vaccine (MenQuadfi) which is the vaccine that is required by state law. I'm the supervisor for this division and will be working with my staff to determine how this incident occurred and determine if we need to make any internal process changes to ensure this doesn't happen again. I would also like to provide you with links to information for each of the vaccines. Please feel free to give me a call if you have any questions as you are reading through the information.
Age: 39.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine is supposed to be administered intradermal or sub cutaneous. Vaccine was administered IM instead by error. Pt did not report any adverse side effects during or since administration that have been reported.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Pain, Pain in extremity, X-ray limb
Clinical narrative: Patient reports pain and numbness in left arm since Tdap injection. Patient reports pain during injection on 3/7/24 at clinic when getting vaccinated for a PRN job. Saw PCP on 3/11/24. PCP noted severe pain with sleeping and pain with range of motion in the arm. Needing to support arm and wearing sling.
Age: 16.0
Sex: F
Vaccine: HIBV, HIBV, MEN
Symptoms: Wrong product administered
Clinical narrative: Patient had order to receive Meningococcal  Vaccine, HIB  was drawn up by MA 1 & then administered by MA 2, Pt received wrong Vaccine, Provider and MA Supervisor made aware of Incident immediately, will notify patient after speaking to Manufacturer.
Age: 16.0
Sex: F
Vaccine: HIBV, HIBV, MEN
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient had order to receive Meningococcal  Vaccine, HIB  was drawn up by MA 1 & then administered by MA 2, Pt received wrong Vaccine, Provider and MA Supervisor made aware of Incident immediately, will notify patient after speaking to Manufacturer.
Age: 66.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was given Energix-B peds instead of Energix-B adult.
Age: 52.0
Sex: F
Vaccine: YF
Symptoms: Dyspnoea, Pruritus
Clinical narrative: Triage note: "Pt presents to the ER from UC for further evaluation of allergic reaction. Pt received the yellow fever vaccine at another facility, drove herself to UC d/t feeling like she was having a reaction with itching. Began have trouble breathing at UC. Received IM epi twice at UC, 125 mg solumerol, 700ml NS and pt took benadryl prior to going to UC. Pt well appearing upon initial assessment upon arrival to ER."  1705 Patient states that her symptoms have resolved.  She does have a EpiPen at home.  Will have her follow-up with PCP
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, COVID-19, Computerised tomogram abnormal, Cough, Echocardiogram normal
Clinical narrative: Admit date: 3/5/2024  Discharge date: 3/7/2024  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician: No primary care provider on file., None  Reason for Admission:  Subarachnoid hemorrhage GLF Orthostatic hypotension secondary to dual COVID/flu infections  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  From H&P 67 YOfemale with no known PMHx who presented to the hospital last evening after a GLF at home. She speaks Hindi and all information was obtained via chart review, discussion with CCU team, and translation by her son-in-law. Patients family was at home with her last evening and heard a sound from the bathroom. They went to open the door and she was on the ground behind the door. She hit her head on the left side and has a large hematoma and small laceration in the left periorbital region and eyebrow. She does not remember the events of the fall or if she had any presyncopal symptoms prior to her fall. She notes an intermittent mild headache on the right that will come and go with any coughing.   Hospital Course: Patient monitored in the CCU evaluated by neurosurgery. Repeat CT scan showed stable hemorrhage, and patient was cleared for general floors on 3/6. Today her labs are unremarkable, she is feeling better, and is deemed clinically stable for discharge.  Patient noted to have orthostatic hypotension, likely related to COVID and flu infections. Outpatient rx sent for Tamiflu and Paxlovid given severity of symptoms. Hypotension induced syncope presumed cause of her fall. Patient has no recollection of events and was sluggish following return of consciousness. Echo done, systolic function normal. Could consider Zio patch if this recurs however with proven orthostatic hypotension will hold off on this at the moment. No sign of arrhythmia on telemetry. Zofran sent for nausea.  Patient does have some headaches that persist, especially wth coughing. Discussed acetaminophen for pain relief, no NSAIDs until follow up with neurosurgery. Family agreed. She is to have a repeat CT in two weeks and will follow with them.   For her eye laceration, with possible foreign body, I have sent a referral to ophtho and ENT to determine if she needs follow up for this. Potentially a ceramic piece of her bangle which broke during the fall. CT head will also reimage this, planned for two weeks out. Family can remove any pieces they see as her swelling improves  Issues Requiring Follow Up: (Who, what, when, and how communicated?)  Repeat CT in two weeks ENT/ophtho follow up for L eye laceration Discharged to Home Health Care.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Head injury, Headache, Influenza, Laboratory test normal
Clinical narrative: Admit date: 3/5/2024  Discharge date: 3/7/2024  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician: No primary care provider on file., None  Reason for Admission:  Subarachnoid hemorrhage GLF Orthostatic hypotension secondary to dual COVID/flu infections  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  From H&P 67 YOfemale with no known PMHx who presented to the hospital last evening after a GLF at home. She speaks Hindi and all information was obtained via chart review, discussion with CCU team, and translation by her son-in-law. Patients family was at home with her last evening and heard a sound from the bathroom. They went to open the door and she was on the ground behind the door. She hit her head on the left side and has a large hematoma and small laceration in the left periorbital region and eyebrow. She does not remember the events of the fall or if she had any presyncopal symptoms prior to her fall. She notes an intermittent mild headache on the right that will come and go with any coughing.   Hospital Course: Patient monitored in the CCU evaluated by neurosurgery. Repeat CT scan showed stable hemorrhage, and patient was cleared for general floors on 3/6. Today her labs are unremarkable, she is feeling better, and is deemed clinically stable for discharge.  Patient noted to have orthostatic hypotension, likely related to COVID and flu infections. Outpatient rx sent for Tamiflu and Paxlovid given severity of symptoms. Hypotension induced syncope presumed cause of her fall. Patient has no recollection of events and was sluggish following return of consciousness. Echo done, systolic function normal. Could consider Zio patch if this recurs however with proven orthostatic hypotension will hold off on this at the moment. No sign of arrhythmia on telemetry. Zofran sent for nausea.  Patient does have some headaches that persist, especially wth coughing. Discussed acetaminophen for pain relief, no NSAIDs until follow up with neurosurgery. Family agreed. She is to have a repeat CT in two weeks and will follow with them.   For her eye laceration, with possible foreign body, I have sent a referral to ophtho and ENT to determine if she needs follow up for this. Potentially a ceramic piece of her bangle which broke during the fall. CT head will also reimage this, planned for two weeks out. Family can remove any pieces they see as her swelling improves  Issues Requiring Follow Up: (Who, what, when, and how communicated?)  Repeat CT in two weeks ENT/ophtho follow up for L eye laceration Discharged to Home Health Care.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Orthostatic hypotension, Periorbital haematoma, Periorbital injury, Sluggishness
Clinical narrative: Admit date: 3/5/2024  Discharge date: 3/7/2024  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician: No primary care provider on file., None  Reason for Admission:  Subarachnoid hemorrhage GLF Orthostatic hypotension secondary to dual COVID/flu infections  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  From H&P 67 YOfemale with no known PMHx who presented to the hospital last evening after a GLF at home. She speaks Hindi and all information was obtained via chart review, discussion with CCU team, and translation by her son-in-law. Patients family was at home with her last evening and heard a sound from the bathroom. They went to open the door and she was on the ground behind the door. She hit her head on the left side and has a large hematoma and small laceration in the left periorbital region and eyebrow. She does not remember the events of the fall or if she had any presyncopal symptoms prior to her fall. She notes an intermittent mild headache on the right that will come and go with any coughing.   Hospital Course: Patient monitored in the CCU evaluated by neurosurgery. Repeat CT scan showed stable hemorrhage, and patient was cleared for general floors on 3/6. Today her labs are unremarkable, she is feeling better, and is deemed clinically stable for discharge.  Patient noted to have orthostatic hypotension, likely related to COVID and flu infections. Outpatient rx sent for Tamiflu and Paxlovid given severity of symptoms. Hypotension induced syncope presumed cause of her fall. Patient has no recollection of events and was sluggish following return of consciousness. Echo done, systolic function normal. Could consider Zio patch if this recurs however with proven orthostatic hypotension will hold off on this at the moment. No sign of arrhythmia on telemetry. Zofran sent for nausea.  Patient does have some headaches that persist, especially wth coughing. Discussed acetaminophen for pain relief, no NSAIDs until follow up with neurosurgery. Family agreed. She is to have a repeat CT in two weeks and will follow with them.   For her eye laceration, with possible foreign body, I have sent a referral to ophtho and ENT to determine if she needs follow up for this. Potentially a ceramic piece of her bangle which broke during the fall. CT head will also reimage this, planned for two weeks out. Family can remove any pieces they see as her swelling improves  Issues Requiring Follow Up: (Who, what, when, and how communicated?)  Repeat CT in two weeks ENT/ophtho follow up for L eye laceration Discharged to Home Health Care.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Admit date: 3/5/2024  Discharge date: 3/7/2024  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician: No primary care provider on file., None  Reason for Admission:  Subarachnoid hemorrhage GLF Orthostatic hypotension secondary to dual COVID/flu infections  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  From H&P 67 YOfemale with no known PMHx who presented to the hospital last evening after a GLF at home. She speaks Hindi and all information was obtained via chart review, discussion with CCU team, and translation by her son-in-law. Patients family was at home with her last evening and heard a sound from the bathroom. They went to open the door and she was on the ground behind the door. She hit her head on the left side and has a large hematoma and small laceration in the left periorbital region and eyebrow. She does not remember the events of the fall or if she had any presyncopal symptoms prior to her fall. She notes an intermittent mild headache on the right that will come and go with any coughing.   Hospital Course: Patient monitored in the CCU evaluated by neurosurgery. Repeat CT scan showed stable hemorrhage, and patient was cleared for general floors on 3/6. Today her labs are unremarkable, she is feeling better, and is deemed clinically stable for discharge.  Patient noted to have orthostatic hypotension, likely related to COVID and flu infections. Outpatient rx sent for Tamiflu and Paxlovid given severity of symptoms. Hypotension induced syncope presumed cause of her fall. Patient has no recollection of events and was sluggish following return of consciousness. Echo done, systolic function normal. Could consider Zio patch if this recurs however with proven orthostatic hypotension will hold off on this at the moment. No sign of arrhythmia on telemetry. Zofran sent for nausea.  Patient does have some headaches that persist, especially wth coughing. Discussed acetaminophen for pain relief, no NSAIDs until follow up with neurosurgery. Family agreed. She is to have a repeat CT in two weeks and will follow with them.   For her eye laceration, with possible foreign body, I have sent a referral to ophtho and ENT to determine if she needs follow up for this. Potentially a ceramic piece of her bangle which broke during the fall. CT head will also reimage this, planned for two weeks out. Family can remove any pieces they see as her swelling improves  Issues Requiring Follow Up: (Who, what, when, and how communicated?)  Repeat CT in two weeks ENT/ophtho follow up for L eye laceration Discharged to Home Health Care.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Impaired driving ability, Pyrexia
Clinical narrative: Felt like I had been run over by a Mack truck. Unable to drive. Extreme fatigue, fever and chills.