chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: a pregnant patient received the fluzone hd with no reported adverse event; Initial information received on 14-Nov-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age pregnant female patient who received influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The reported event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown number of previous pregnancy/ies.   On an unknown date, the pregnant patient received an unknown dose of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Immunization with no reported adverse event (exposure during pregnancy) (same day latency).  There was no information on relevant prenatal testing after exposure.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: Menquadfi was administered after post excursion with no reported adverse event; Menquadfi was exposed to temperature 41.85°F; low: negative 28.86°FDuration: 2 minutes with no reported adverse event; Initial information received on 14-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to US-SA-2024SA336648.  This case involves a 17 years old male patient to whom was administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] after post excursion (temperature 41.85°f; low: negative 28.86°fduration: 2 minutes) 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 B rfHbp/NadA/NHBA OMV (Bexsero) and Influenza vaccine inact split 3v (Trivalent influenza vaccine) for Immunisation.  On 13-Nov-2024, the patient received a 0.5 ml (Dose 2) dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (strength: standard, frequency: once, expiry date: and lot U8370AA) via intramuscular route in the left deltoid as Immunization (poor quality product administered) (latency: same day).  On an unknown date in 2024 the menquadfi was exposed to temperature 41.85°f; low: negative 28.86°fduration: 2 minutes with no reported adverse event (product storage error) (unknown latency).   Reportedly: "Excursion: None, Human error: Yes, Administered post-excursion: Yes, the extended stability data cover the excursion: 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.; Sender's Comments:  US-SA-2024SA336648:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Fatigue, Gastrointestinal disorder, Impaired work ability
Clinical narrative: Facial, throat, sinus swelling; tinnitus; sore throat; gastrointestinal issues; inflammation; PEM; ME/CFS . Still ongoing after three weeks. Not on the same prefer of magnitude as the mRNA vaccines. These are all exacerbations of long-term symptoms following my initial mRNA vaccine. I?m weary of dealing with vaccine injuries, worrying about getting COVID (which I have avoided so far), dealing with debilitating symptoms after each vaccine (my 10/23 Moderna left me in constant pain from extreme inflammation of all of my joints for 3 full months and lingered for six more). My allergist convinced me to try one more Covid shot, the Novovax he was unable to source last year. While it is not as bad, the fatigue from this one is a major impact on my life. If everyone who is able would get vaccinated and wear masks, I wouldn?t keep putting myself thru this misery. I doubt I?ll ever be able to work again.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Oropharyngeal pain, Pharyngeal swelling, SARS-CoV-2 antibody test, Sinus congestion
Clinical narrative: Facial, throat, sinus swelling; tinnitus; sore throat; gastrointestinal issues; inflammation; PEM; ME/CFS . Still ongoing after three weeks. Not on the same prefer of magnitude as the mRNA vaccines. These are all exacerbations of long-term symptoms following my initial mRNA vaccine. I?m weary of dealing with vaccine injuries, worrying about getting COVID (which I have avoided so far), dealing with debilitating symptoms after each vaccine (my 10/23 Moderna left me in constant pain from extreme inflammation of all of my joints for 3 full months and lingered for six more). My allergist convinced me to try one more Covid shot, the Novovax he was unable to source last year. While it is not as bad, the fatigue from this one is a major impact on my life. If everyone who is able would get vaccinated and wear masks, I wouldn?t keep putting myself thru this misery. I doubt I?ll ever be able to work again.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Tinnitus
Clinical narrative: Facial, throat, sinus swelling; tinnitus; sore throat; gastrointestinal issues; inflammation; PEM; ME/CFS . Still ongoing after three weeks. Not on the same prefer of magnitude as the mRNA vaccines. These are all exacerbations of long-term symptoms following my initial mRNA vaccine. I?m weary of dealing with vaccine injuries, worrying about getting COVID (which I have avoided so far), dealing with debilitating symptoms after each vaccine (my 10/23 Moderna left me in constant pain from extreme inflammation of all of my joints for 3 full months and lingered for six more). My allergist convinced me to try one more Covid shot, the Novovax he was unable to source last year. While it is not as bad, the fatigue from this one is a major impact on my life. If everyone who is able would get vaccinated and wear masks, I wouldn?t keep putting myself thru this misery. I doubt I?ll ever be able to work again.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Vomiting
Clinical narrative: Her cough has seemingly worsened since receiving the Flumist.  Now tonight, she woke up after being asleep for a couple hours and had vomited.  She vomited again about 30 minutes later.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Chest pain, Musculoskeletal chest pain, Swelling
Clinical narrative: Chest Pain,Shoulder pain,rib/trunk pain- swelling
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: Chest Pain,Shoulder pain,rib/trunk pain- swelling
Age: 16.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Abdominal pain, Chills, Dehydration, Fatigue, Headache
Clinical narrative: Felt well before vaccines and for 4-5 hrs after. Acute onset body aches, chills, fever, headache. Later deceloped nause and vomiting. Presented to school clinic 1 day later with tachycardia, fatigue abdominal pain. Dehydrated. Sent to ED.
Age: 16.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Nausea, Pain, Pyrexia, Tachycardia, Vomiting
Clinical narrative: Felt well before vaccines and for 4-5 hrs after. Acute onset body aches, chills, fever, headache. Later deceloped nause and vomiting. Presented to school clinic 1 day later with tachycardia, fatigue abdominal pain. Dehydrated. Sent to ED.
Age: 2.67
Sex: M
Vaccine: COVID19, HPV9
Symptoms: Wrong product administered
Clinical narrative: Patient inadvertently given HPV vaccine when FLU vaccine should have been given
Sex: F
Vaccine: FLU3
Symptoms: Haematoma, Pain in extremity
Clinical narrative: Pt presented to pharmacy 19 days post vaccine with upper arm pain and bruising. Pt said it had been happening since administration. Pharmacy recommended Dr visit diagnosed with hematoma by Dr will disapate in 3-4 more weeks.
Age: 16.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Felt well before vaccines & for 4-5 hours after. Acute onset body aches & chills. Both arms very sore, expecially (R) arm  - no redness or swelling at injection sites.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pruritus, Pyrexia, Throat irritation
Clinical narrative: Itchy throat, itchy ears, body aches, fever
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: severe upper arm pain, intermittent, over a few days, treated with pain killers (Acetaminophen 500 mg, Ibuprofen 200 mg, Bengay ointment, cold packs etc., (quantities and frequency as needed)
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: severe upper arm pain, intermittent, over a few days, treated with pain killers (Acetaminophen 500 mg, Ibuprofen 200 mg, Bengay ointment, cold packs etc., (quantities and frequency as needed)
Age: 0.67
Sex: U
Vaccine: DTPPVHBHPB, PNC20, RV5, RV5
Symptoms: Unevaluable event
Clinical narrative: No additional AE; 8 month old patient inadvertently received ROTATEQ during routine vaccination for PREVNAR 20 and VAXELIS; 8 month old patient inadvertently received ROTATEQ during routine vaccination for PREVNAR 20 and VAXELIS; This spontaneous report was received from medical assistant and refers to 8-month-old patient of unknown gender. The patient's concomitant vaccinations included pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (Vaxelis).  On 25-OCT-2024, the patient was inadvertently vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) single dose, administered orally (exact dose, lot # and expiration date were not reported) for prophylaxis (wrong product administered; product administered to patient of inappropriate age). No additional adverse event was reported.  Lot # is being requested and will be provided if available.
Age: 0.67
Sex: U
Vaccine: DTPPVHBHPB, PNC20, RV5, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE; 8 month old patient inadvertently received ROTATEQ during routine vaccination for PREVNAR 20 and VAXELIS; 8 month old patient inadvertently received ROTATEQ during routine vaccination for PREVNAR 20 and VAXELIS; This spontaneous report was received from medical assistant and refers to 8-month-old patient of unknown gender. The patient's concomitant vaccinations included pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (Vaxelis).  On 25-OCT-2024, the patient was inadvertently vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) single dose, administered orally (exact dose, lot # and expiration date were not reported) for prophylaxis (wrong product administered; product administered to patient of inappropriate age). No additional adverse event was reported.  Lot # is being requested and will be provided if available.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5, DTPPVHBHPB, PNC20, RV5
Symptoms: Biopsy lymph gland, Lymphadenitis, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: 11/04/2024 Infant was seen by PCP for Well child Visist and routine vaccines.  Patient reports that the evening of 11/04/2024 she noticed bilateral groin swelling; 11/11/2024 Infant was seen in Hospital ER for Inguinal Lymphadenopathy after Ultrasound confirmation; Instrutions were given to parent to follow up with PCP in the next day or 2 for repeat evaluation. 11/14/2024 Infant was seen by Peditrian at Hospital and repeat U/S imaging was consistent with Lymph Node abscess and infant was referred to ER. 11/14/2024 Infant was evaluated by Infection Disease MD, Pediatric Surgeon and started on the following IV antibiotics: Cefazolin, Ceftriaxone, Vancomycin; needle aspiration of inguinal abscess parent noted low grade fever since 11/4/2024 evening after vaccines administered; completed  Admitted to hospital for continuation of antibiotic and monitoring of Methicillian-sensitive Staphylococcus Aureus Bilateral Lymphadeitis; Per ID MD notes If had been vaccination contamination, would have expected infection at the site of the injection. Here, is as if bacteria arrived at lymph nodes, but could not be cleared Physcial assessment while in hosptial was noted for difficulty breast feeding, cough, creamy nasal secretions, Temp at Pedatric Office Visit 11/14/2024  99 F Rectal Temp 11/21/2024 Incision and Drainage performed on bilateral Groin Abscesses & Infant remains hospitalized
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5, DTPPVHBHPB, PNC20, RV5
Symptoms: Biopsy lymph gland, Blood culture, Chest X-ray, Cough, Full blood count
Clinical narrative: 11/04/2024 Infant was seen by PCP for Well child Visist and routine vaccines.  Patient reports that the evening of 11/04/2024 she noticed bilateral groin swelling; 11/11/2024 Infant was seen in Hospital ER for Inguinal Lymphadenopathy after Ultrasound confirmation; Instrutions were given to parent to follow up with PCP in the next day or 2 for repeat evaluation. 11/14/2024 Infant was seen by Peditrian at Hospital and repeat U/S imaging was consistent with Lymph Node abscess and infant was referred to ER. 11/14/2024 Infant was evaluated by Infection Disease MD, Pediatric Surgeon and started on the following IV antibiotics: Cefazolin, Ceftriaxone, Vancomycin; needle aspiration of inguinal abscess parent noted low grade fever since 11/4/2024 evening after vaccines administered; completed  Admitted to hospital for continuation of antibiotic and monitoring of Methicillian-sensitive Staphylococcus Aureus Bilateral Lymphadeitis; Per ID MD notes If had been vaccination contamination, would have expected infection at the site of the injection. Here, is as if bacteria arrived at lymph nodes, but could not be cleared Physcial assessment while in hosptial was noted for difficulty breast feeding, cough, creamy nasal secretions, Temp at Pedatric Office Visit 11/14/2024  99 F Rectal Temp 11/21/2024 Incision and Drainage performed on bilateral Groin Abscesses & Infant remains hospitalized
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5, DTPPVHBHPB, PNC20, RV5
Symptoms: Incisional drainage, Lymph node abscess, Lymphadenitis, Lymphadenopathy, Lymphocyte count
Clinical narrative: 11/04/2024 Infant was seen by PCP for Well child Visist and routine vaccines.  Patient reports that the evening of 11/04/2024 she noticed bilateral groin swelling; 11/11/2024 Infant was seen in Hospital ER for Inguinal Lymphadenopathy after Ultrasound confirmation; Instrutions were given to parent to follow up with PCP in the next day or 2 for repeat evaluation. 11/14/2024 Infant was seen by Peditrian at Hospital and repeat U/S imaging was consistent with Lymph Node abscess and infant was referred to ER. 11/14/2024 Infant was evaluated by Infection Disease MD, Pediatric Surgeon and started on the following IV antibiotics: Cefazolin, Ceftriaxone, Vancomycin; needle aspiration of inguinal abscess parent noted low grade fever since 11/4/2024 evening after vaccines administered; completed  Admitted to hospital for continuation of antibiotic and monitoring of Methicillian-sensitive Staphylococcus Aureus Bilateral Lymphadeitis; Per ID MD notes If had been vaccination contamination, would have expected infection at the site of the injection. Here, is as if bacteria arrived at lymph nodes, but could not be cleared Physcial assessment while in hosptial was noted for difficulty breast feeding, cough, creamy nasal secretions, Temp at Pedatric Office Visit 11/14/2024  99 F Rectal Temp 11/21/2024 Incision and Drainage performed on bilateral Groin Abscesses & Infant remains hospitalized
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5, DTPPVHBHPB, PNC20, RV5
Symptoms: Metabolic function test, Poor feeding infant, Pyrexia, Rhinorrhoea, Staphylococcal infection
Clinical narrative: 11/04/2024 Infant was seen by PCP for Well child Visist and routine vaccines.  Patient reports that the evening of 11/04/2024 she noticed bilateral groin swelling; 11/11/2024 Infant was seen in Hospital ER for Inguinal Lymphadenopathy after Ultrasound confirmation; Instrutions were given to parent to follow up with PCP in the next day or 2 for repeat evaluation. 11/14/2024 Infant was seen by Peditrian at Hospital and repeat U/S imaging was consistent with Lymph Node abscess and infant was referred to ER. 11/14/2024 Infant was evaluated by Infection Disease MD, Pediatric Surgeon and started on the following IV antibiotics: Cefazolin, Ceftriaxone, Vancomycin; needle aspiration of inguinal abscess parent noted low grade fever since 11/4/2024 evening after vaccines administered; completed  Admitted to hospital for continuation of antibiotic and monitoring of Methicillian-sensitive Staphylococcus Aureus Bilateral Lymphadeitis; Per ID MD notes If had been vaccination contamination, would have expected infection at the site of the injection. Here, is as if bacteria arrived at lymph nodes, but could not be cleared Physcial assessment while in hosptial was noted for difficulty breast feeding, cough, creamy nasal secretions, Temp at Pedatric Office Visit 11/14/2024  99 F Rectal Temp 11/21/2024 Incision and Drainage performed on bilateral Groin Abscesses & Infant remains hospitalized
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5, DTPPVHBHPB, PNC20, RV5
Symptoms: Staphylococcus test, Swelling, Ultrasound liver, Ultrasound scan abnormal
Clinical narrative: 11/04/2024 Infant was seen by PCP for Well child Visist and routine vaccines.  Patient reports that the evening of 11/04/2024 she noticed bilateral groin swelling; 11/11/2024 Infant was seen in Hospital ER for Inguinal Lymphadenopathy after Ultrasound confirmation; Instrutions were given to parent to follow up with PCP in the next day or 2 for repeat evaluation. 11/14/2024 Infant was seen by Peditrian at Hospital and repeat U/S imaging was consistent with Lymph Node abscess and infant was referred to ER. 11/14/2024 Infant was evaluated by Infection Disease MD, Pediatric Surgeon and started on the following IV antibiotics: Cefazolin, Ceftriaxone, Vancomycin; needle aspiration of inguinal abscess parent noted low grade fever since 11/4/2024 evening after vaccines administered; completed  Admitted to hospital for continuation of antibiotic and monitoring of Methicillian-sensitive Staphylococcus Aureus Bilateral Lymphadeitis; Per ID MD notes If had been vaccination contamination, would have expected infection at the site of the injection. Here, is as if bacteria arrived at lymph nodes, but could not be cleared Physcial assessment while in hosptial was noted for difficulty breast feeding, cough, creamy nasal secretions, Temp at Pedatric Office Visit 11/14/2024  99 F Rectal Temp 11/21/2024 Incision and Drainage performed on bilateral Groin Abscesses & Infant remains hospitalized
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no side effect; received MMR II twice; MMR II and VARIVAX was suppose to be adminstered; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 28-OCT-2024, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, administered for prophylaxis (lot #X028353, expiration date: 11-DEC-2025; strength, dose and route of administration were not provided). The patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) twice on the same day (Accidental overdose). Measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (strength, dose, route, lot# and expiration date were not reporte) were supposed to be administered to patient; instead, the patient inadvertently was administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on that day (Wrong product administered). It was the initial dose for the patient. No side effects had been reported.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 15 year old who was given a dose of PROQUAD; no additional AE; This spontaneous report was received from a medical assistant and refers to a 15-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date (reported as a few days ago), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, lot #, expiry date, dose, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse event (AE) was reported.  Lot# is being requested and will be submitted if received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Gastrointestinal disorder, Secretion discharge
Clinical narrative: he just got the COVID 8 days ago; difficult first 5 days after receiving the vaccine that had a lot of GI symptoms; profuse mucous; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (he just got the COVID 8 days ago), GASTROINTESTINAL DISORDER (difficult first 5 days after receiving the vaccine that had a lot of GI symptoms) and SECRETION DISCHARGE (profuse mucous) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 and Immunization (about 5 or 6 weeks prior probably in September 2024) in September 2024. Concurrent medical conditions included Chronic lymphocytic leukemia.    On 10-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In October 2024, the patient experienced GASTROINTESTINAL DISORDER (difficult first 5 days after receiving the vaccine that had a lot of GI symptoms) and SECRETION DISCHARGE (profuse mucous). In November 2024, the patient experienced COVID-19 (he just got the COVID 8 days ago). In October 2024, GASTROINTESTINAL DISORDER (difficult first 5 days after receiving the vaccine that had a lot of GI symptoms) and SECRETION DISCHARGE (profuse mucous) had resolved. At the time of the report, COVID-19 (he just got the COVID 8 days ago) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-777098 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-777098:same reporter (case for wife)
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Chest pain, Musculoskeletal chest pain, Swelling
Clinical narrative: red tender swollen and painful, ended up in ER
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: red tender swollen and painful, ended up in ER
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, heat, redness involving upper left arm (deltoid to mid point of the upper arm).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Extra dose administered
Clinical narrative: TECHNICIAN HAD TWO COVID VACCINES IN ONE TOTE AND ASSUMING PATIENT WAS GETTING COVID AND FLU. AFTER HE ADMINISTERED THE 2ND DOSE, PATIENT SAID SHE WAS ONLY HERE FOR COVID. THEN HE REALIZED THE 2ND COVID VACCINE WAS MEANT FOR PATIENT'S SPOUSE.  PATIENT WAS ANXIOUS AND PHARMACIST CHECKED HER BP 20 MINUTES AFTER, IT WAS HIGH 180/80, 5 MINUTES LATER CHECKED AGAIN AND IT WENT DOWN TO 159/84.  WE INFORMED HER PCP AND SPOKED WITH POISON CONTROL, NURSE FROM HER PCP WILL CHECK ON HER TONIGHT OR TOMORROW.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itchiness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pruritus (Verbatim: itchiness). The outcome of the pruritus was not reported.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     It was unknown if the company considered the pruritus to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-NOV-2024 This case was reported by a patient via interactive digital media. The patient was the reporter he/she reported that he/she had received Shingles vaccine and experienced more itchiness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the second dose is outside the 6 month window; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on 30th August 2023).   On 27-JUL-2024, the patient received the 2nd dose of Shingrix. On 27-JUL-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: the second dose is outside the 6 month window). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 23-OCT-2024  The patient self-reported this case for herself. The patient recently received a dose of Shingrix. When the patient received the dose this year, she was told by the pharmacy that she already received a first dose last year.  The patient does not think she got a Shingrix dose last year but the pharmacy records say that she did.  The reporter reported that if the records are correct, the second dose was outside the 6 month window. The patient received second dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule.
Age: 43.0
Sex: F
Vaccine: COVID19, HPV9
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain, redness, swelling at site.  Also having severe headache and body aches sever pain in extremities that began before the vaccines. I went to the dr there was nothing they could do. They think I might have fibromyalgia.
Age: 64.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Headache, Palpitations, Pyrexia, Vomiting
Clinical narrative: Fever Heart Palpitations Vomiting Red Face Base of the skull headache
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Borrelia test negative, Chest discomfort, Electrocardiogram, Eye swelling
Clinical narrative: pt says the next day she had hives on her torso that she applied cortisone cream. They went away and appreared in other areas. She had swollen eyes and hands. She went to her doctor and was prescribed steroids. They went away but she began having heaviness in her chest. She went back to the doctor. She had blood work and ekg. She was tested for lyme disease that was negative. Hormone level was high. She was referred to allergist, Dr. She was told to take Zyrtec every day. She was told to take prednisone as needed for swelling of the eyes. Both of these seem to help. She is to follow up with the allergist in two months.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Hormone level abnormal, Peripheral swelling, Urticaria
Clinical narrative: pt says the next day she had hives on her torso that she applied cortisone cream. They went away and appreared in other areas. She had swollen eyes and hands. She went to her doctor and was prescribed steroids. They went away but she began having heaviness in her chest. She went back to the doctor. She had blood work and ekg. She was tested for lyme disease that was negative. Hormone level was high. She was referred to allergist, Dr. She was told to take Zyrtec every day. She was told to take prednisone as needed for swelling of the eyes. Both of these seem to help. She is to follow up with the allergist in two months.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Hypoaesthesia, Rash
Clinical narrative: Numbness BLE and hands; chest tightness; face rash
Age: 0.5
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6month old male received x1 intramuscular dose of Abrysvo.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: ONGOING PAIN AT INJECTION SITE INCLUDING ENTIRE UPPER LEFT ARM STARTING AT TIME OF VACCINATION, PT CURRENTLY TAKING CELEBREX (HAD BEEN TAKING PRIOR TO EVENT) AND ICING AFFECTED AREA
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye infection, Eye inflammation, Eye swelling, Ocular hyperaemia
Clinical narrative: I received my annual flu vaccine on 10-17-2024 as required by my employer, Clinic.  On 10-19-2024 I woke up early in the morning with my right eye draining and inflamed along with severe symptoms of "pink eye". I managed the drainage, blurred vision throughout the day.  On Sunday, 10-20-2024 the symptoms were much worse, I now had a rash on the right side of my face and my left eye was not swollen, draining and red.  I was seen at the urgent care and given antibiotic eye drops in case I had an active infection.  The drops did nothing and the symptoms got worse and lasted 2 weeks.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Vision blurred
Clinical narrative: I received my annual flu vaccine on 10-17-2024 as required by my employer, Clinic.  On 10-19-2024 I woke up early in the morning with my right eye draining and inflamed along with severe symptoms of "pink eye". I managed the drainage, blurred vision throughout the day.  On Sunday, 10-20-2024 the symptoms were much worse, I now had a rash on the right side of my face and my left eye was not swollen, draining and red.  I was seen at the urgent care and given antibiotic eye drops in case I had an active infection.  The drops did nothing and the symptoms got worse and lasted 2 weeks.
Age: 66.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis on injection site
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Colitis ulcerative, Colonoscopy, Condition aggravated, Frequent bowel movements, Quality of life decreased
Clinical narrative: My Ulcerative colitis that was in remission for 20years became very active, resulting in 6 bowl movements a day and disrupting my life quality. Its now 3 years undergoing treatment to restore my life and bring the UC back in remission.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head normal, Confusional state, Depressed level of consciousness, Dizziness, Electrocardiogram normal
Clinical narrative: PARENTS REPORT: Went home yesterday after she got the Flu shot. Ate dinner. Lay down like she always does in the evening. Then mom heard a loud thump. Mom went to the room and she was on the floor. Head was on the dresser like she hit her head. She was awake but did not seem focused. Could barely walk, unable to get her leg up. Lay down. Talking but did not not make sense. Started saying "I can't see. I love you." She remained confused for about 3 hours.  Patient reports that she was lying down, sat up, felt dizzy like the room was spinning then passed out. She does not remember anything after that.  She was taken to ER and had CT scan of the head, labs, and EKG. Parents report all was normal. We have requested results.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Head injury, Incoherent, Laboratory test normal, Loss of consciousness
Clinical narrative: PARENTS REPORT: Went home yesterday after she got the Flu shot. Ate dinner. Lay down like she always does in the evening. Then mom heard a loud thump. Mom went to the room and she was on the floor. Head was on the dresser like she hit her head. She was awake but did not seem focused. Could barely walk, unable to get her leg up. Lay down. Talking but did not not make sense. Started saying "I can't see. I love you." She remained confused for about 3 hours.  Patient reports that she was lying down, sat up, felt dizzy like the room was spinning then passed out. She does not remember anything after that.  She was taken to ER and had CT scan of the head, labs, and EKG. Parents report all was normal. We have requested results.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Vertigo
Clinical narrative: PARENTS REPORT: Went home yesterday after she got the Flu shot. Ate dinner. Lay down like she always does in the evening. Then mom heard a loud thump. Mom went to the room and she was on the floor. Head was on the dresser like she hit her head. She was awake but did not seem focused. Could barely walk, unable to get her leg up. Lay down. Talking but did not not make sense. Started saying "I can't see. I love you." She remained confused for about 3 hours.  Patient reports that she was lying down, sat up, felt dizzy like the room was spinning then passed out. She does not remember anything after that.  She was taken to ER and had CT scan of the head, labs, and EKG. Parents report all was normal. We have requested results.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury, Product administered at inappropriate site
Clinical narrative: Patient came in on 11/17/24 for another vaccine and said she suffered nerve damage from the injection being too high. She said she had to see the doctor multiple times and be put on Gabapentin.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Rash, Rash erythematous
Clinical narrative: Injection site became red and swollen and spread to 3" diameter with streaks and red dots all around arm and red dot rash on chest and other arm on 11-21. By 11-22 7 AM rash had spread over entire body including face, back and legs.
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: None to my knowledge to the flu shot.  Just reaction to the Covid booster in right arm that is causing pain and hard to use that arm fully!  Sent message thru electronic records and was told to wait another week.  In the mean time to put ice or heat on it and take Tylenol.  Feels like the bicep is ripping at times, when moving it certain ways.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Generalised tonic-clonic seizure
Clinical narrative: TEMP TO 100.6 AND 3 GENERALIZED TONIC CLONIC SEZIURES LASTING < 1 MIN EACH.
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Rash, Skin discolouration, Urticaria
Clinical narrative: Purple/brown rash right arm and raised hives on right shoulder blade 2 days after vaccination
Age: 85.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Cough, Fatigue, Influenza, Limb discomfort, Oropharyngeal pain
Clinical narrative: pt says she started getting the flu symptoms including the coughing, aching all over, arms were heavy, sore raw throat, temperature, and fatigued. She has been alternating tylenol and aspirins for pain. These symptoms have lasted over a week so far. She still has a bad cough.
Age: 85.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Pain, Throat irritation
Clinical narrative: pt says she started getting the flu symptoms including the coughing, aching all over, arms were heavy, sore raw throat, temperature, and fatigued. She has been alternating tylenol and aspirins for pain. These symptoms have lasted over a week so far. She still has a bad cough.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Tremor
Clinical narrative: Patient reported getting vaccine in the morning and starting that evening she started shaking really bad and could not walk to her bedroom. Patient
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Contusion, Dizziness, Fall, Fatigue
Clinical narrative: I was so dizzy and nauseous during the night after receiving the Moderna COVID booster that I fell while trying to get to the bathroom and hit my head on the toilet bowl porcelain base!  As a result I had severe bruising on the entire left side of my face.  I am a physician but I did speak with my Primary Care Physician. I remained at rest in bed for 24 hours, but the nausea, dizziness, fatigue and 'brain fog' lasted for days afterwards, only resolving a whole week after the Moderna COVIC vaccine booster!
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Nausea
Clinical narrative: I was so dizzy and nauseous during the night after receiving the Moderna COVID booster that I fell while trying to get to the bathroom and hit my head on the toilet bowl porcelain base!  As a result I had severe bruising on the entire left side of my face.  I am a physician but I did speak with my Primary Care Physician. I remained at rest in bed for 24 hours, but the nausea, dizziness, fatigue and 'brain fog' lasted for days afterwards, only resolving a whole week after the Moderna COVIC vaccine booster!
Age: 21.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: Had a rash over chest and back that started two days after the vaccines was given. The night of the vaccines he had a fever and chills that was a normal response to vaccines given, the clt would say.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Headache, Herpes zoster, Malaise, Skin discharge
Clinical narrative: Employee received the influenza vaccination at 841 am. He Started not feeling well Friday evening. Overnight he developed areas to his head and down his V1 nerve route. He went to Urgent Care Sunday and was diagnosed with shingles. Was prescribed antivirals.  He started having pain into Monday and the patches moved down toward his right eye.  Right eye swollen at this time. He was seen by an ophthalmologist on Monday. Tuesday his eye was swollen shut, his head and eye areas were seeping and he had terrible pain..
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC20, RV5
Symptoms: Extra dose administered
Clinical narrative: Pediarix, Pedvax Hib, Prevnar 20, and Rotateq were ordered by the provider. The nurse gave Pentacel, Hib, Prevnar 20 and Rotateq.   The patient received two Hib vaccines on the same date, and did not receive a Hep B vaccine.
Age: 52.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site swelling
Clinical narrative: Patient received both vaccines in the left deltoid. As soon as 2nd vaccines was given, patient's arm started to swell at injection site. Patient was given diphenhydramine 25mg and water. Swelling started to decrease and patient was monitored for 15 minutes. Patient went home with no further complaints or reactions.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received Hep A too early. Minimum interval between dose 1 and dose 2 not met.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received Hep B and Dtap at incorrect interval.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Patient said the vaccine hurt and that it formed a small ball on her arm.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: She is very tired and has had a HA since the morning of 11/8, and states it hurts to turn her head in both directions. EE has not missed work because she doesn?t have any earned time. Employee feels able to work. Employee has tried Tylenol, motrin, alleve 3-4 times per day alternating between Tylenol 100 mg and motrin. Advised to take Tylenol 4 times daily (no other acetaminophen-containing products), alternating with ibuprofen with food.
Age: 79.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Full blood count, Metabolic function test, Muscular weakness, Pyrexia, Urine analysis
Clinical narrative: low grade temps TMAX 100.1, general lower extremity weakness.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: PATIENT HAD SORE ARM ALMOST IMMEDIATELY AFTER THAT   LASTED SEVERAL WEEKS; LIMITED RANGE OF MOTION AND DAILY ACTIVITIES; SOMEWHAT RELIEVED BY TYLENOL
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hot flush
Clinical narrative: Patient had shortness of breath and hot flashes after receiving the influenza vaccine
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, Pyrexia, Urinary tract infection
Clinical narrative: Upon reviewing immunizations for this patient, this nurse reviewed Immtrac2, and noticed that this patient received the flu vaccine on 11/05 in Health Dept. No AR noted at the time of vaccination, patient RP/Parent did not inform this staff here that the patient had already rec vaccines. This nurse spoke to RP, they stated the patient is fine at this time, they acknowledged pt rec 2 flu vaccines one week apart from each other, and the patient only had a fever and a UTI and they had taken the patient to a urgent care clinic for treatment with effective results.
Age: 20.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Vaccination failure
Clinical narrative: Pt came into clinic with report of serum immunity failure in hand/phone. Pt requested repeat for school entry. Pt was notified to present paperwork to admin staff to be scanned. Protocol changed that no repeat necessary.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Cardiac pacemaker insertion, Catheterisation cardiac abnormal, Coronary artery disease, Coronary artery occlusion
Clinical narrative: Patient collapsed while shoveling snow on 1/29/2023. He had received 3 COVID vaccines thus far (Moderna 3/2021 and 4/2021) with a booster (Janssen  12/2021).  No prior cardiac history.  Downtime was about 3-5 minutes. He received bystander CPR and woke up without need for a shock. He was admitted to Hospital. Echocardiogram showed a dilated cardiomyopathy with severe LV dysfunction (LVEF 20%). Cardiac catheterization showed single vessel CAD with a chronically occluded RCA. Cardiac MRI showed a transmural infarct of the inferior wall. We felt he had cardiac syncope/aborted cardiac arrest, likely due to ventricular tachycardia. He received a dual chamber ICD on 2/2/2023.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dilated cardiomyopathy, Echocardiogram abnormal, Left ventricular dysfunction, Loss of consciousness, Magnetic resonance imaging heart abnormal
Clinical narrative: Patient collapsed while shoveling snow on 1/29/2023. He had received 3 COVID vaccines thus far (Moderna 3/2021 and 4/2021) with a booster (Janssen  12/2021).  No prior cardiac history.  Downtime was about 3-5 minutes. He received bystander CPR and woke up without need for a shock. He was admitted to Hospital. Echocardiogram showed a dilated cardiomyopathy with severe LV dysfunction (LVEF 20%). Cardiac catheterization showed single vessel CAD with a chronically occluded RCA. Cardiac MRI showed a transmural infarct of the inferior wall. We felt he had cardiac syncope/aborted cardiac arrest, likely due to ventricular tachycardia. He received a dual chamber ICD on 2/2/2023.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocardial infarction, Resuscitation, Syncope, Ventricular tachycardia
Clinical narrative: Patient collapsed while shoveling snow on 1/29/2023. He had received 3 COVID vaccines thus far (Moderna 3/2021 and 4/2021) with a booster (Janssen  12/2021).  No prior cardiac history.  Downtime was about 3-5 minutes. He received bystander CPR and woke up without need for a shock. He was admitted to Hospital. Echocardiogram showed a dilated cardiomyopathy with severe LV dysfunction (LVEF 20%). Cardiac catheterization showed single vessel CAD with a chronically occluded RCA. Cardiac MRI showed a transmural infarct of the inferior wall. We felt he had cardiac syncope/aborted cardiac arrest, likely due to ventricular tachycardia. He received a dual chamber ICD on 2/2/2023.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Abnormal sensation in eye, Chills, Fatigue, Gait inability, Injection site induration
Clinical narrative: The patient states he experienced severe fatigue, he had chills, his eye were extremely hot, he had severe muscle aches to the point where he could not walk.  The site of injection was extremely sensitive and hard to the touch.  Both sides of his neck were painful as well.  The patient did not seek any treatment.  As of today he is still fatigued by is feeling much better.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Injection site pain, Myalgia, Neck pain
Clinical narrative: The patient states he experienced severe fatigue, he had chills, his eye were extremely hot, he had severe muscle aches to the point where he could not walk.  The site of injection was extremely sensitive and hard to the touch.  Both sides of his neck were painful as well.  The patient did not seek any treatment.  As of today he is still fatigued by is feeling much better.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Computerised tomogram, Genitourinary symptom, Hypoaesthesia, Infrequent bowel movements
Clinical narrative: pt says his left hand became numb two weeks after being vaccinated. He told his PA in Feb 2022 that his bowls were becoming more restricted and his urinating was becoming more refrequent. He has an extreme discomfort level of pain all of the time and his back has a pain that will come and go depending on the type of movement throughout his day. He went to the clinic for testing. He is being tested for Guillen Barre syndrome at this time and was given a bowel medicine to try. He has a CT coming up and more blood test. His left hand is still numb, he is still in contstant pain an  is still under continued care with his PA.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Magnetic resonance imaging, Pain, X-ray
Clinical narrative: pt says his left hand became numb two weeks after being vaccinated. He told his PA in Feb 2022 that his bowls were becoming more restricted and his urinating was becoming more refrequent. He has an extreme discomfort level of pain all of the time and his back has a pain that will come and go depending on the type of movement throughout his day. He went to the clinic for testing. He is being tested for Guillen Barre syndrome at this time and was given a bowel medicine to try. He has a CT coming up and more blood test. His left hand is still numb, he is still in contstant pain an  is still under continued care with his PA.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination failure
Clinical narrative: pt came into clinic with lack of immunity serum paperwork.pr desired imms to get into school program. pt given im but protocol had been updated.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: Re expression of AFib for two days.