chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE; inadvertent administration of a GARDASIL 9 Vaccine to a 4 month old patient; This spontaneous report has been received from a registered nurse, referring to a 4-month-old patient of unknown gender. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 06-NOV-2024, the patient was inadvertently vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), lot# X025115, expiry date 19-MAY-2026, for prophylaxis (dose, route of administration and anatomical location were not provided) (Product administered to patient of inappropriate age). No symptoms reported (No adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: she "got her GARDASIL 9 injection 2 months ago and it was painful.; she had a bruise; This spontaneous report has been received from other health care professional, referring a  female patient of unknown age. The patient's medical history, drug reactions or allergies, concurrent conditions, and concomitant medications were not provided.   On unspecified date in September 2024 reported as 2 months ago, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, frequency, route of administration, site of administration, vaccination scheme, lot #, and expiration date were not provided) as a prophylaxis. It was painful (pain) and worse than getting a tattoo. On unspecified date in 2024, she had a bruise (contusion). The health care professional pointed to upper right deltoid area. At the reporting time, the outcome of the events was not provided.       The causal relationship between suspect vaccine with the events was not provided.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: New allergy to pneumovax; This spontaneous report was received from and adult female patient reporting on herself via other company.  The patient's medical history was not reported. The patient's concurrent conditions included idiopathic urticaria for which she received dupilumab (DUPIXENT) (on January 2022). Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient developed a new allergy to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (allergy to vaccine), it was not reported if the patient received a corrective treatment for the event. At the time of reporting, the outcome of this event was not known.   The reporter did not provide a causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) but it was internally assessed as related.  Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Hypogammaglobulinaemia, Immune thrombocytopenia, Immunodeficiency common variable
Clinical narrative: poor responsiveness to pneumococcal polysaccharide vaccines; Literature Report.  The patient's medical history was not reported, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient started was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (manufacturer unknown) (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced poor responsiveness to pneumococcal polysaccharide vaccines (immunology showed hypogammaglobulinemia (IgG, IgM)).  The reporter considered poor responsiveness to pneumococcal polysaccharide vaccines to be related to pneumococcal 23v polysaccharide vaccine (manufacturer unknown).  This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a 9-year-old male patient.
Sex: F
Vaccine: HEP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; HCP reported a patient received a fourth dose of RECOMBIVAX HB after completing a 3-dose series adolescent RECOMBIVAX HB multiple years ago (exact date unknown); This spontaneous report was received from a medical assistant and refers to a 24-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (reported as when the patient was adolescent), the patient was vaccinated with three doses of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On 06-NOV-2024, the patient was vaccinated with the fourth dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 milliliter, lot #Y009436, expiration date: 12-FEB-2027, administered for prophylaxis (strength, and route of administration were not provided) (Extra dose administered). No side effects or symptoms reported.  No Additional information reported.
Age: 0.83
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE; HCP called regarding MMR II. MMR II was administered to a 10 month old patient "two months ago." No reported signs/symptoms of adverse effects. Caller wanted to know it it was a 'valid dose' or if they should revaccinate. Permission to contact HCP; This spontaneous report was received from a medical assistant and refers to a 10-month-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant therapies were not reported.  On an unknown date in September 2024 (reported as two months ago), the patient was vaccinated with 1st dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No reported signs/symptoms of adverse effects. The reporter wanted to know it was a 'valid dose' or if the patient should be revaccinated. No additional adverse event (no adverse event).
Sex: F
Vaccine: COVID19, HPV9
Symptoms: Rash
Clinical narrative: Patient that experienced a rash after the first dose; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On the same day, she was vaccinated with a dose of covid-19 vaccine (strength, formulation, dose, lot #, expiry date, route of administration, and indication were not provided) in different sites (details not provided).   On an unknown date, the patient experienced a rash after the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). It was mentioned that the additional covid-19 vaccine was administered without reaction (details not provided). At the time of reporting, the outcome of the event of rash was not known.  The reporter requested information on whether should proceed with giving second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The causal relationship between the event of rash and the suspect vaccines was not provided.   Additional information is not expected.
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation
Clinical narrative: AFib/Atrial fibrillation; This serious case was reported by a nurse via sales rep and described the occurrence of atrial fibrillation in a 85-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy (unknown deltoid). On an unknown date, an unknown time after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: AFib/Atrial fibrillation) (serious criteria GSK medically significant and other: serious as per reporter). The outcome of the atrial fibrillation was resolving.   It was unknown if the reporter considered the atrial fibrillation to be related to Arexvy.     The company considered the atrial fibrillation to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 20-NOV-2024 The nurse practitioner reported that the patient received Arexvy had an atrial fibrillation which was an cardiovascular disease.; Sender's Comments: Atrial fibrillation is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 76-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 05-NOV-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with aciclovir (Acyclovir) and gabapentin. The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-NOV-2024 Reporter stated that patient had the shingles vaccine many years ago and she was diagnosed with shingles. Also wanted to know if the booster shot was required as patient was 76 years old. Patient were given Gabapentine / Acyclovair on 5 Nov 2024. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: receive the hepatitis A vaccine and realize it was 3 days expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis.   On 05-NOV-2024, the patient received the 2nd dose of Havrix. On 05-NOV-2024, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: receive the hepatitis A vaccine and realize it was 3 days expired). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-NOV-2024 The healthcare professional reported that they had a patient that came in to receive the 2nd of dose of hepatitis A vaccine and they did not realized it was 3 days expired, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient can get the second dose of Shingrix if the first dose was 2 and a half years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose two and a half years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient can get the second dose of Shingrix if the first dose was 2 and a half years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-NOV-2024 The pharmacist called and asked if a patient could get the second dose of Shingrix if the first dose was given two and a half years ago. The reporter asked can she get the second dose or did she needed to start over the series. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; developed Shingles 1 year after vaccination; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed Shingles 1 year after vaccination). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 21-NOV-2024 Health care professional wanted to know if her patient who had been fully vaccinated with 2 doses completed for Shingrix, developed Shingles 1 year after vaccination, should be re-vaccinated with Shingrix again. This case was considered as suspected vaccination failure as details of laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus
Clinical narrative: It itches and wakes; bumps on the arm, at the injection site.; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PRURITUS (It itches and wakes) and VACCINATION SITE MASS (bumps on the arm, at the injection site.) in a 71-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Arrhythmia and Knee replacement. Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine (Has received all Moderna Covid vaccines once a year since the Covid shot came out.). Past adverse reactions to the above products included No adverse effect with Moderna Covid-19 vaccine. Concurrent medical conditions included Multiple allergies and AFib.    On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (It itches and wakes) and VACCINATION SITE MASS (bumps on the arm, at the injection site.). The patient was treated with Hydrocortisone valerate (Cortisone) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (It itches and wakes) and VACCINATION SITE MASS (bumps on the arm, at the injection site.) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient received a dose of Spikevax "About 2 months ago" at the time of reporting. Patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine and she has never had a reaction to Moderna before. Symptoms started about 2-4 weeks ago and are ongoing, severity has stayed about the same. Patient had visited HCP and no diagnosis made, no test results available. She started cortisone cream but, symptoms have not gone away nor improved. Patient had taken Flu "a few weeks prior".   Most recent FOLLOW-UP information incorporated above includes: On 27-Nov-2024: Live follow-up received contains non-significant information. Added reference numbers.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dermal filler reaction, Periorbital swelling, Tenderness
Clinical narrative: PATIENT REPORTS AN ADVERSE REACTION (SWELLING AND TENDERNESS  UNDER HER EYES) BEGINNING ONE DAY AFTER SPIKEVAX IMMUNIZATION. SHE REPORTS THAT SHE WORK FOR A PLASTIC SURGEON AND SHE RECEIVES VOLUMA (FACIAL FILLER) FROM HER EMPLOYER THE PLASTIC SURGEON. SHE CALLED PHARMACY  MONDAY DECEMBER 2, 2024 TO REPORT. SHE WAS ASSURED BY HER EMPLOYER THAT IT WOUL CLEAR UP OVER TIME. HER CONSENT FORM DOES NOT INDICATE THAT SHE HAD RECEIVED DERMAL FILLER (BLOCK NOT CHECKED). SHE REPORTS SHE LAST RECEIVED VOLUMA IN OCTOBER BUT WAS UNSURE OF EXACT DATE.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was given IPV vaccine at appointment. Unknown to the nurse who gave the vaccine, the vaccine was not viable due to a temperature excursion (too cold). Education nurse called family afterwards and notified PCP. Pt did not report symptoms.
Age: 77.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Dry skin, Pruritus
Clinical narrative: Beginning 2-3 days post immunization, pt reports that her skin became extremely dry and is itchy. Recommended cetirizine, hydrocortisone and eucerin intensive repair to pt.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Throat irritation
Clinical narrative: the following monday night itchy throat and ears; no redness.  Cleared up 1 week later.  Benadryl helped with symptoms. Pt states felt similiar to an allergic reaction she had previously to a different medication, but without hives.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Tenderness, Urticaria
Clinical narrative: patient reported hives and tenderness. area is hard to touch. no fever at this time. on saturday pt stated hives are gone . on Monday still warm to touch but hives are gone
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: About 4.5 hours after getting the vaccine (11/27/24), he developed a raised, hard, painful lump on the thigh that was about 3x3 inches. This lasted about 24-30 hours then he said it was no longer painful. Friday 11/29/24 morning he was nauseated and lethargic and vomited then was back to normal by midday Friday. The lump started to flatten on Friday and became a little larger and was less bright red. Today, 12/2/24 (Monday), I notified the pediatrician office in the morning and the area has faded but is still slightly red.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Lethargy, Nausea, Type III immune complex mediated reaction, Vomiting
Clinical narrative: About 4.5 hours after getting the vaccine (11/27/24), he developed a raised, hard, painful lump on the thigh that was about 3x3 inches. This lasted about 24-30 hours then he said it was no longer painful. Friday 11/29/24 morning he was nauseated and lethargic and vomited then was back to normal by midday Friday. The lump started to flatten on Friday and became a little larger and was less bright red. Today, 12/2/24 (Monday), I notified the pediatrician office in the morning and the area has faded but is still slightly red.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Heart rate, Heart rate increased
Clinical narrative: feeling very week; light-headed; shaking; chills; heart-rate was very elevated; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Nov2024 at 17:30 as dose 1, single (Lot number: LP-1780) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Have some issues with Neck/Spine" (unspecified if ongoing); "Have some issues with Neck/Spine" (unspecified if ongoing); "immunization" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: ROSUVASTATIN, start date: 01Dec2023; GABAPENTIN, start date: 18Nov2024; FLUZONE [INFLUENZA VACCINE] taken for immunisation, on 22Nov2024 as dose 1, single. The following information was reported: CHILLS (hospitalization) with onset 26Nov2024 at 09:00, outcome "recovering"; ASTHENIA (hospitalization) with onset 26Nov2024 at 09:00, outcome "recovering", described as "feeling very week"; HEART RATE INCREASED (hospitalization) with onset 26Nov2024 at 09:00, outcome "recovering", described as "heart-rate was very elevated"; DIZZINESS (hospitalization) with onset 26Nov2024 at 09:00, outcome "recovering", described as "light-headed"; TREMOR (hospitalization) with onset 26Nov2024 at 09:00, outcome "recovering", described as "shaking". The patient was hospitalized for asthenia, dizziness, tremor, chills, heart rate increased (hospitalization duration: 1 day). The patient underwent the following laboratory tests and procedures: Heart rate: very elevated, notes: also my heart-rate was very elevated. Therapeutic measures were taken as a result of asthenia, dizziness, tremor, chills, heart rate increased. Clinical course: The patient was walking around a grocery store and started feeling very week, light-headed and started shaking/experienced chills, also my heart-rate was very elevated.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: feeling very week; light-headed; shaking; chills; heart-rate was very elevated; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Nov2024 at 17:30 as dose 1, single (Lot number: LP-1780) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Have some issues with Neck/Spine" (unspecified if ongoing); "Have some issues with Neck/Spine" (unspecified if ongoing); "immunization" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: ROSUVASTATIN, start date: 01Dec2023; GABAPENTIN, start date: 18Nov2024; FLUZONE [INFLUENZA VACCINE] taken for immunisation, on 22Nov2024 as dose 1, single. The following information was reported: CHILLS (hospitalization) with onset 26Nov2024 at 09:00, outcome "recovering"; ASTHENIA (hospitalization) with onset 26Nov2024 at 09:00, outcome "recovering", described as "feeling very week"; HEART RATE INCREASED (hospitalization) with onset 26Nov2024 at 09:00, outcome "recovering", described as "heart-rate was very elevated"; DIZZINESS (hospitalization) with onset 26Nov2024 at 09:00, outcome "recovering", described as "light-headed"; TREMOR (hospitalization) with onset 26Nov2024 at 09:00, outcome "recovering", described as "shaking". The patient was hospitalized for asthenia, dizziness, tremor, chills, heart rate increased (hospitalization duration: 1 day). The patient underwent the following laboratory tests and procedures: Heart rate: very elevated, notes: also my heart-rate was very elevated. Therapeutic measures were taken as a result of asthenia, dizziness, tremor, chills, heart rate increased. Clinical course: The patient was walking around a grocery store and started feeling very week, light-headed and started shaking/experienced chills, also my heart-rate was very elevated.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Post-acute COVID-19 syndrome; Post-acute COVID-19 syndrome; This is a spontaneous report received from a Physician and an Other HCP.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 28Apr2021 as dose 1, single (Batch/Lot number: unknown), on 19May2021 as dose 2, single (Batch/Lot number: unknown) and on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Post-acute COVID-19 syndrome". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received first oral dose of Paxlovid/placebo on 24May2024 at 12:15 and completed dosing on 18Jun2024 at 07:30.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure and COVID-19 cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Acute coronary syndrome, Acute myocardial infarction
Clinical narrative: Acute Coronary Syndrome; STEMI following MRNA COVID-19 vaccination; This is a literature report for the following literature source(s).  A patient (age and gender not 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 and concomitant medications were not reported. The following information was reported: ACUTE CORONARY SYNDROME (medically significant), outcome "unknown"; ACUTE MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "STEMI following MRNA COVID-19 vaccination".; Sender's Comments: Limited information precludes a comprehensive causality assessment, however based on the implied temporal association, the contributory role of suspect drug BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown) cannot be excluded for the reported events. Information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. Case will be reassessed should additional information becomes available.  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.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had a Prevnar 20 given on 11/20/2024 at Pharmacy.  The person who administered the vaccine went too low in her left arm and she had immediate severe shooting nerve pain radiating from the site.   They did not have her slip her arm out of her shirt (sleeve was tight).  the vaccine was not administered in her deltoid muscle.   In addition 48 hours later, Patient developed redness and swelling in the mid upper arm at the site of injection.  it has been itchy since then.  She continues to have nerve tingling in the left arm down to her hand.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Neuralgia, Pain, Paraesthesia, Product administered at inappropriate site
Clinical narrative: Patient had a Prevnar 20 given on 11/20/2024 at Pharmacy.  The person who administered the vaccine went too low in her left arm and she had immediate severe shooting nerve pain radiating from the site.   They did not have her slip her arm out of her shirt (sleeve was tight).  the vaccine was not administered in her deltoid muscle.   In addition 48 hours later, Patient developed redness and swelling in the mid upper arm at the site of injection.  it has been itchy since then.  She continues to have nerve tingling in the left arm down to her hand.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 flu vaccines. No adverse reactions.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lip swelling, Myalgia, Peripheral swelling, Pruritus
Clinical narrative: On Monday, 11/25,  about 4 hours after the vaccination, started getting itching on arms, but not on vaccination site. Primarily in elbow area. Took benedryl to go to sleep that evening. The next day (Tuesday) in the afternoon the itching and hives across my body came, and got progressively worse throughout the afternoon into the evening. Itching, hives, and minor swelling has visible on my stomach, back, thighs, arms, and neck. Took benedryl again. In the morning (Wednesday) I woke up and the hives and itching had spread to my hands and feet on the palms as well. Fingers, lips, and eyelids were swollen. Went to hospital and was prescribed Zicam. Hives, itcihng, and swelling continued until Friday of that week. Now (1 week after vaccination) the hives and swelling have subsided, and I only have minor itching across my body. I also had intense joint pain and muscle soreness until Saturday. Still have minor join pain 1 week after vaccination. Never had trouble breathing or feeling my airways closing.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling of eyelid, Urticaria
Clinical narrative: On Monday, 11/25,  about 4 hours after the vaccination, started getting itching on arms, but not on vaccination site. Primarily in elbow area. Took benedryl to go to sleep that evening. The next day (Tuesday) in the afternoon the itching and hives across my body came, and got progressively worse throughout the afternoon into the evening. Itching, hives, and minor swelling has visible on my stomach, back, thighs, arms, and neck. Took benedryl again. In the morning (Wednesday) I woke up and the hives and itching had spread to my hands and feet on the palms as well. Fingers, lips, and eyelids were swollen. Went to hospital and was prescribed Zicam. Hives, itcihng, and swelling continued until Friday of that week. Now (1 week after vaccination) the hives and swelling have subsided, and I only have minor itching across my body. I also had intense joint pain and muscle soreness until Saturday. Still have minor join pain 1 week after vaccination. Never had trouble breathing or feeling my airways closing.
Age: 73.0
Sex: M
Vaccine: PNC21
Symptoms: Rash
Clinical narrative: Rash on both arms and legs
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: A few hours after patient received the vaccine he experience loss of mobility of the arm. This continued for approximately three days. Ibuprofen relieved symptoms and was used for about two days. Pt states as of 12/2 he feels the arm is better.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Hot flush, Nausea
Clinical narrative: HOT FLASHES , NAUSEA, HEADACHE
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Head injury, Syncope
Clinical narrative: Patient fainted after vaccination and hit her head, which bled. 911 was called and paramedics came to take her to the hospital for treatment. Patient was conscious the whole time.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient was accidentally given an additional RSV vaccination today. Pt is 63 years old and has diabetes. She received a RSV vaccination last year 10/27/2023 here at our facility.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Patient given the wrong vaccine (Kinrix) that is only indicated for patients 4 years and older.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Cold sweat, Contusion, Fatigue, Heart rate increased
Clinical narrative: High heart rate, high blood pressure, fatigue, clamminess, sore arm, chills, feverish, bruising. Did not take any OTC medications, did not go to doctor's office/urgent care.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Hypertension, Pain in extremity, Pyrexia
Clinical narrative: High heart rate, high blood pressure, fatigue, clamminess, sore arm, chills, feverish, bruising. Did not take any OTC medications, did not go to doctor's office/urgent care.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Cold sweat, Disorientation, Dizziness, Erythema, Injection site haemorrhage
Clinical narrative: 17 year old patient, presented with Mother, to receive HPV and Flu Vaccine. Went over with patient about the bandaid how all the bleeding will stay in the middle hole. Patient was very anxious about get a shot. Patient asked if I would count to 3 before I give the shot and her cough during the vaccine because she read it helps with the pain. Gave the 2 vaccines. The patient did bleed put stayed inside the barrier bandaid, but I could tell when she saw the blood inside the barrier bandage she didn't like that so I covered the barrier bandaid with a skin tone adhesive bandaid to cover the blood. Patient stayed sitted in the booth and her mother went in the booth and I told them to call me if they needed me. I was doing a medication counsel, and I heard the mother say, "she is passing out." I went back to the booth to see the patient slid down in her chair and mother was over her and said "redacted" and patient came too, but was disoriented for a few seconds of where she was. Patient then was able to sit back up in her chair but was pale, clammy to the touch, dizzy, and had a straight red mark on her forehead where she slid towards the IMZ table edge when she fainted. With the help of technician, a cold ice pack was placed onto the patient's neck and we propped her feet up in a chair. We continued to monitor her for 15 more minutes. Patient informed me during this time that she has fainted at the doctor's office, when they draw blood. We got another cold ice pack and put it on her wrist and when she was able to stand on her own and felt better her mother took her home. I called to check in on the patient and her mother said she got the patienet a burger and a shake from a drive-in and when they got home she went to bed. I told the mother to call me if needed.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Loss of consciousness, Pallor, Syncope
Clinical narrative: 17 year old patient, presented with Mother, to receive HPV and Flu Vaccine. Went over with patient about the bandaid how all the bleeding will stay in the middle hole. Patient was very anxious about get a shot. Patient asked if I would count to 3 before I give the shot and her cough during the vaccine because she read it helps with the pain. Gave the 2 vaccines. The patient did bleed put stayed inside the barrier bandaid, but I could tell when she saw the blood inside the barrier bandage she didn't like that so I covered the barrier bandaid with a skin tone adhesive bandaid to cover the blood. Patient stayed sitted in the booth and her mother went in the booth and I told them to call me if they needed me. I was doing a medication counsel, and I heard the mother say, "she is passing out." I went back to the booth to see the patient slid down in her chair and mother was over her and said "redacted" and patient came too, but was disoriented for a few seconds of where she was. Patient then was able to sit back up in her chair but was pale, clammy to the touch, dizzy, and had a straight red mark on her forehead where she slid towards the IMZ table edge when she fainted. With the help of technician, a cold ice pack was placed onto the patient's neck and we propped her feet up in a chair. We continued to monitor her for 15 more minutes. Patient informed me during this time that she has fainted at the doctor's office, when they draw blood. We got another cold ice pack and put it on her wrist and when she was able to stand on her own and felt better her mother took her home. I called to check in on the patient and her mother said she got the patienet a burger and a shake from a drive-in and when they got home she went to bed. I told the mother to call me if needed.
Age: 58.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injection site bruising, Mobility decreased
Clinical narrative: Vaccines caused bruises on both shoulders and patient was unable to turn his neck all the way to the side.
Age: 7.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Contusion, Urticaria
Clinical narrative: Hives covering the upper arm in the general area the vaccine was administered. Small bruise but not hive directly at the injection sites. No fever or other symptoms outside of hives and itching. Hives appeared over 24 hours after vaccines. Administered Benadryl per doctor?s instructions. It took 4 days for hives to fully disappear.
Age: 31.0
Sex: U
Vaccine: RSV
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Patient was given a second dose of RSV vaccine during a subsequent pregnancy. First given during previous pregnancy in 2023.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Dizziness, Pyrexia, Vomiting
Clinical narrative: feeling ill; fever; chills; vomiting; terrible  dizziness; Initial information received on 26-Nov-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 75 years old female patient who had feeling ill, fever, chills, vomiting and terrible dizziness after receiving influenza USP trival A-B high dose subvirion vaccine [fluzone HD].  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On 19-Nov-2024, the patient received 0.5 ml of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe of standard strength once with lot UT8463DA and expiry date 30J-Jun-2025 via intramuscular route in the left deltoid for Immunization.  On 19-Nov-2024 the patient developed feeling ill (illness), fever (pyrexia), chills, vomiting and terrible dizziness (dizziness) following the administration of influenza USP trival A-B high dose subvirion vaccine.  Reportedly, Nurse calling as she has a patient with her who received the FLUZONE HD on 19Nov2024. Patient woke up around 2:00 AM that same day, feeling ill, fever, chills, vomiting, and terrible dizziness. Patient stated she as the vaccine in the past, and never had a reaction to it. She is still has dizziness. Her HCP is out of town now. She wants to know the ingredients as she things she may have been allergic to something in the vaccines. Nurse clarified that it's this year's version for fluzone HD. The patient doesn't have any more symptoms aside from she is still feeling dizzy until during the call. Patient is allergic to poison ivy, so she'd like to check for the product composition of the product. Call was on loudspeaker and the patient is with the nurse on the other line. They asked what the difference between the Fluzone High-Dose Qiv is and fluzone HD for this year. She reiterated that the patient didn't have any reaction to last year's version.  Action taken was not applicable.  The patient was treated with oxymetazoline hydrochloride (coricidin).  At time of reporting, the outcome was Unknown for the event feeling ill,vomiting, chills and fever and was Not Recovered / Not Resolved for the event terrible dizziness, .
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Dizziness, Malaise, Pyrexia, Vomiting
Clinical narrative: feeling ill; fever; chills; vomiting; terrible  dizziness; Initial information received on 26-Nov-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 75 years old female patient who had feeling ill, fever, chills, vomiting and terrible dizziness after receiving influenza USP trival A-B high dose subvirion vaccine [fluzone HD].  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On 19-Nov-2024, the patient received 0.5 ml of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe of standard strength once with lot UT8463DA and expiry date 30J-Jun-2025 via intramuscular route in the left deltoid for Immunization.  On 19-Nov-2024 the patient developed feeling ill (illness), fever (pyrexia), chills, vomiting and terrible dizziness (dizziness) following the administration of influenza USP trival A-B high dose subvirion vaccine.  Reportedly, Nurse calling as she has a patient with her who received the FLUZONE HD on 19Nov2024. Patient woke up around 2:00 AM that same day, feeling ill, fever, chills, vomiting, and terrible dizziness. Patient stated she as the vaccine in the past, and never had a reaction to it. She is still has dizziness. Her HCP is out of town now. She wants to know the ingredients as she things she may have been allergic to something in the vaccines. Nurse clarified that it's this year's version for fluzone HD. The patient doesn't have any more symptoms aside from she is still feeling dizzy until during the call. Patient is allergic to poison ivy, so she'd like to check for the product composition of the product. Call was on loudspeaker and the patient is with the nurse on the other line. They asked what the difference between the Fluzone High-Dose Qiv is and fluzone HD for this year. She reiterated that the patient didn't have any reaction to last year's version.  Action taken was not applicable.  The patient was treated with oxymetazoline hydrochloride (coricidin).  At time of reporting, the outcome was Unknown for the event feeling ill,vomiting, chills and fever and was Not Recovered / Not Resolved for the event terrible dizziness, .
Sex: M
Vaccine: PNC, PPV
Symptoms: Pneumococcal infection
Clinical narrative: pneumococcal infection; This spontaneous report has been downloaded from Regulatory Authority referred to a male patient between 15-years-old and 19-years-old. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2023, the patient started therapy with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, dose number 1, administered for prophylaxis (strength, dose, frequency, scheme, lot #, expiry date, route of administration, and anatomical location were not provided); and on an unknown dates in 2023, the patient was vaccinated with 3 doses of pneumococcal vaccine conj 7v (crm197) (PREVENAR), administered for prophylaxis (strength, dose, frequency, scheme, formulation, lot #, expiry date, route of administration and anatomical location were not provided).  On an unknown date in 2023, the patient experienced Invasive Pneumococcal Disease, Streptococcus Pneumoniae (pneumococcal infection). On an unknown date in 2023, Streptococcus pneumoniae serotyping was reported as not available.   At the time of reporting, the outcome of the event pneumococcal infection was not known.   The reporter did not assess the causal relationship between pneumococcal infection and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) and pneumococcal vaccine conj 7v (crm197) (PREVENAR).   Upon internal review, the event pneumococcal infection was determined to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; exposed to temperature excursions beginning in May 2024; This spontaneous report was received from medical Assistant and referred to a patient of unknown gender and age. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.   Medical Assistant stated that the supply of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (0.5 ml, lot #Y007585, expiration date: 31-OCT-2025) at their facility was exposed to temperature excursions beginning in May 2024. On 05-SEP-2024, the patient was vaccinated with improper storage hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 ml / two dose series, lot #Y007585, expiration date: 31-OCT-2025, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided) (product storage error). Medical Assistant confirmed the patient involved had not reported any medical concerns or symptoms after being administered the improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (no adverse event). No additional information provided.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Labelled drug-drug interaction issue
Clinical narrative: Received MMR vaccine while treated with dupilumab (DUPIXENT)/She received the MMR vaccine on 05-OCT-2024 and she wanted to know what will could happen since it is a live vaccine; This spontaneous report was received from a 38-year-old female patient reporting on herself via other company.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient started therapy with dupilumab (DUPIXENT), 200 milliliter solution for injection, (dose description, lot #, expiry date, route of administration, and indication were not provided), afterwards, on 05-OCT-2024, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), therefore, she wanted to know what could happen since it was a live vaccine (Labelled drug-drug interaction issue). The action taken with dupilumab (DUPIXENT) was reported as not applicable.