chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Death, Hyperglycaemia, Resuscitation, Unresponsive to stimuli
Clinical narrative: Hyperglycemia/new onset; Death; Resuscitation; Unresponsive to stimuli; This is a spontaneous report received from Consumer or other non HCPs and a Physician from Regulatory Authority, Program ID. Regulatory number: 2504364 (FDA VAERS ID).  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 4 (booster), single (Lot number: GH9703) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "CHF" (unspecified if ongoing); "cardiac pacemaker" (unspecified if ongoing); "atherosclerotic heart disease" (unspecified if ongoing); "hx of VTE" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "MDD" (unspecified if ongoing); "Anxiety D/O" (unspecified if ongoing); "OAB" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "CKD" (unspecified if ongoing); "DMII" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Diverticulosis" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "adhesive" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; METOPROLOL; CITALOPRAM; ATORVASTATIN; GABAPENTIN; HYDRALAZINE; OMEPRAZOLE; POTASSIUM; METFORMIN. Past drug history included: Prednisone, reaction(s): "Allergies". Vaccination history included: Covid-19 vaccine (Dose 3), for Covid-19 Immunization; Covid-19 vaccine (Dose 2), for Covid-19 Immunization; Covid-19 vaccine (Dose 1), for Covid-19 Immunization. The following information was reported: UNRESPONSIVE TO STIMULI (death, medically significant) with onset 10Nov2022, outcome "fatal"; RESUSCITATION (death) with onset 10Nov2022 at 07:37, outcome "fatal"; DEATH (death, medically significant) with onset 10Nov2022 at 08:08, outcome "fatal"; HYPERGLYCAEMIA (non-serious), outcome "unknown", described as "Hyperglycemia/new onset". The patient date of death was 10Nov2022. Reported cause of death: "Death", "Unresponsive to stimuli", "Resuscitation". It was not reported if an autopsy was performed. Clinical course was reported as follows: patient found unresponsive lying in bed at 07:35. No VS present. Patient was last seen by nurse at 07:20, in bed, moving, nurse told res was time to get up for breakfast and left room. Staff returned to room at 07:35. 07:37 CPR (Cardiopulmonary resuscitation) initiated; 07:38 EMS (Emergency medical services) called; 07:41 EMS (Emergency medical services) took over CPR (Cardiopulmonary resuscitation), established IV, airway and suctioned; 07:50 Dr notified of situation; 08:08 EMS (Emergency medical services) pronounced patent death per Dr. No follow-up attempts are possible.  Follow-up (19Jun2024): This is a spontaneous follow-up report received from a physician.  Updated information: Patient's relevant medical history and lab data, concomitant drugs, treatment received for events and clinical course.  No follow-up attempts are possible.; Reported Cause(s) of Death: Death; Unresponsive to stimuli; Resuscitation
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported; the vaccine expired on 05/10/2024 and was administered to the patient on 06/13/2024; the MMR II had one prior T.E.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JUN-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, (recombinant Human albumin (rHA), lot number W035040, with expiration date: 10-MAY-2024, that has been verified to be valid, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). That was also reported that had a previous temperature excursion on an unknown date (product storage error). No adverse effects reported. No other information provided. No additional adverse event. No PQC.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received HEPLISAV-B 123 Days After First Dose; Received Series With Heplisav-B, and The Second Dose of Engerix-B, Engerix Was Given in Error; Initial report received on 29-Apr-2024.  A nurse reported that a 38-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received ENGERIX-B as the second dose for hepatitis B immunization.  Medical history and concomitant medications were not reported.  On 04-Dec-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, site and route not reported).     On 25-Jan-2024, 52 days after receiving the first dose of HEPLISAV-B, the patient received ENGERIX-B (Lot #, expiration date, NDC #, site and route not reported) as the second dose for hepatitis B immunization.  ENGERIX-B was given in error.    On 04-Apr-2024, 123 days after receiving the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot #, expiration date, NDC #, site and route not reported).  No adverse events were reported.  No additional information was reported.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: First Dose Received on 09/14/2023. Second Dose Has Not Been Given; Initial report received on 02-May-2024.  A consumer reported that he, a male (age, race, and ethnicity not provided), received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization eight months prior and has not received the second dose.  Medical history, allergies, and concomitant medications at the time of vaccination were not reported.   On 14-Sep-2023, the patient received the first dose of HEPLISAV-B (NDC number 43528-002-01, Lot number, expiration date, route of administration, and injection site not reported).   At the time of reporting on 02-May-2024, 232 days or approximately eight months after having been vaccinated with the first dose of HEPLISAV-B, the patient still has not received the second dose of HEPLISAV-B.   The reporter refused to provide any further information.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant and Received Heplisav-B; Initial report received on 20-May-2024.  This report was received from the pregnancy registry.  A pharmacist reported that a female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization when pregnant.  No relevant medical history or concomitant medications were reported.    On an unspecified date in Apr-2024, the patient received the first dose of HEPLISAV-B (Lot #443887, expiration date 01-May-2026 and NDC # 43528-002-01) intramuscularly (site not reported).  The patient was pregnant at the time.  No additional information was reported.   Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Extra dose administered, Off label use
Clinical narrative: Covid happened; Doctor informed them to restart the series; A third dose in April 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of covid-19 in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   In MAR-2019, the patient received the 1st dose of Shingrix. In APR-2024, the patient received the 3rd dose of Shingrix. In APR-2024, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced off label use (Verbatim: Doctor informed them to restart the series) and extra dose administered (Verbatim: A third dose in April 2024). On an unknown date, the patient experienced covid-19 (Verbatim: Covid happened). The outcome of the covid-19 was not reported and the outcome of the off label use and extra dose administered were unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     It was unknown if the company considered the covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-JUN-2024 The reporter had a question regarding the dosing of Shingrix. A patient took their first dose in March 2019, Covid happened and their doctor informed them to restart the series. So they got another dose in March 2023 and a third dose in April 2024, which led to off label use and extra dose administered.  The reporter enquired if they are complete with their series even though it is greater than 6 months apart. It appeared there may be more than one patient involved because the reporter then asked, so just to clarify should these patients get another dose.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: Td ordered and administered instead of Tdap
Age: 65.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: MenQuadfi vaccine was given SQ instead of IM. No ADE was reported at the time of injection or when the patient left the facility. Patient was informed of the mistake and possible ADE at the injection site. Patient walked out of pharmacy ok. Submitting the report in case patient reports ADE in the future.
Age: 0.92
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: an expired dose of Hiberix was accidentally given today, 17Jun2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received Hib (Hiberix) (batch number MP29Y, expiry date 13-JUN-2024) for prophylaxis.   On 17-JUN-2024, the patient received Hiberix. On 17-JUN-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: an expired dose of Hiberix was accidentally given today, 17Jun2024). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-JUN-2024 The nurse stated an expired dose of Hiberix vaccine was accidentally administered, which led to expired vaccine used.
Sex: U
Vaccine: COVID19-2, DTAPIPVHIB, PNC15, RV5
Symptoms: Expired product administered, Irritability
Clinical narrative: Vail was initially stored in refrigerator on 01-Jun-2023, first punctured on 08-Jun-2023 and was administered on 09-Jun-2023/Doses were given greater than 12 hours post puncture.; Fussy that night after vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vail was initially stored in refrigerator on 01-Jun-2023, first punctured on 08-Jun-2023 and was administered on 09-Jun-2023/Doses were given greater than 12 hours post puncture.) and IRRITABILITY (Fussy that night after vaccines) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for Prophylactic vaccination.    Co-suspect products included non-company products PENTACEL for Prophylactic vaccination, PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) for Prophylactic vaccination and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.    Concurrent medical conditions included Cough (ongoing at the time of event an prior to one month onwards) since 2023, Plagiocephaly (improving) since 12-Jan-2023 and Teething. Concomitant products included IBUPROFEN for Teething.   On 09-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient received third dose of PENTACEL (Intramuscular use) 1 dosage form, third dose of PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) (Intramuscular use) 1 dosage form and third dose of ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (unknown route) 1 dosage form. On 09-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vail was initially stored in refrigerator on 01-Jun-2023, first punctured on 08-Jun-2023 and was administered on 09-Jun-2023/Doses were given greater than 12 hours post puncture.) and IRRITABILITY (Fussy that night after vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vail was initially stored in refrigerator on 01-Jun-2023, first punctured on 08-Jun-2023 and was administered on 09-Jun-2023/Doses were given greater than 12 hours post puncture.) and IRRITABILITY (Fussy that night after vaccines) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included multivitamin (Vitamins NOS). No Treatment medications were reported.   Reporter did not allow further contact
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Hypersensitivity, Rash, Swelling, Swelling face
Clinical narrative: Allergic Reaction - Significant rash and swelling of the face and neck.   Treated w/prednisone, take 1 tablet (50mg) by mouth 1 time each day for 4 days.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Rash, Swelling, Swelling face
Clinical narrative: Allergic Reaction - Significant rash and swelling of the face and neck.   Treated w/prednisone, take 1 tablet (50mg) by mouth 1 time each day for 4 days.
Age: 32.0
Sex: F
Vaccine: MMRV
Symptoms: Hyperhidrosis, Injection site pain, Injection site vesicles
Clinical narrative: Local injection site reaction, blistering and pain. Patient immediately took shower, applied cold compress after shower, and took 600mg of over the counter Motrin. Swelling has lowered.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb mass, Nerve injury, Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated that she had been having a swollen and painful lump on her arm since the date of vaccination. She had been seen by multiple healthcare providers to assess this prior to going to the ER. She said per the ER doctor that this was because of nerve damage due to the injection.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dizziness, Erythema, Gaze palsy, Moaning
Clinical narrative: I am 70 years old. As a child in the, we were even vaccinated against the plague. I have NEVER had a reaction as terrifying and horrible as this one. It started the same night with nausea, several episodes of vomiting, fever, my face was red, my entire body was in pain, very bad pain in my stomach, headache, inability to even think about sitting up, I am a very healthy and robust person and I was just moaning with pain and felt that I had been poisoned. I had no reaction other than a sore arm to the first does. I believe that the second dose is an overdose only recommended so the pharma industry can sell more. I would request the FDA review that recommendation.  I didn't have the energy to go to an ER, the mere thought of trying to get upright was too much. Now, the pain in my inner organs remains and I am still dizzy.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: I am 70 years old. As a child in the, we were even vaccinated against the plague. I have NEVER had a reaction as terrifying and horrible as this one. It started the same night with nausea, several episodes of vomiting, fever, my face was red, my entire body was in pain, very bad pain in my stomach, headache, inability to even think about sitting up, I am a very healthy and robust person and I was just moaning with pain and felt that I had been poisoned. I had no reaction other than a sore arm to the first does. I believe that the second dose is an overdose only recommended so the pharma industry can sell more. I would request the FDA review that recommendation.  I didn't have the energy to go to an ER, the mere thought of trying to get upright was too much. Now, the pain in my inner organs remains and I am still dizzy.
Age: 64.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Urticaria
Clinical narrative: s/s: hives, dizziness.  pt took benadryl and that helped hives dissipate. dizziness also subsided.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I tested positive for Covid last night, 6/20/24. I had my last Pfizer vaccine on 03/02/24.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, ear ringing
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Injection site pain
Clinical narrative: On June 16, 2024, patient called the pharmacy and said he is experiencing  pain or numbness at injection site. He said he wasn't sure if it is pain or numbness. Pharmacy staff suggested if it is numbness, the patient should go to the emergency room. Patient said he wants to wait because he isn't sure and wants to follow up on this call later.  June 19, 2024, patient confirmed back to the pharmacy that it is numbness. Pharmacy staff asked the patient to go to the emergency room.
Age: 1.17
Sex: M
Vaccine: DTPPVHBHPB, MMR
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness/swelling in vaccination area
Age: 0.5
Sex: M
Vaccine: COVID19, DTAPHEPBIP, FLU4, PNC20
Symptoms: Expired product administered
Clinical narrative: Patient was administered vaccine on 6/20/24 which expired on 6/15/24. No adverse events reported as of the time of writing.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Anti-aquaporin-4 antibody negative, Anti-thyroid antibody, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Antiphospholipid antibodies negative
Clinical narrative: Pt woke with chest pains that radiated to his back at the level of T4 on the morning of 7/22 and was seen at Medical Center ED. Work up was negative and he was sent home. On 7/23 he started with weakness and numbness in both legs with abnormal gait which got progressively worse as the day progressed. He was seen again at Medical Center ED and admitted. He was found to have transverse mylelitis at T1-T2
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Back pain, Blood immunoglobulin G normal, Blood immunoglobulin M normal, CSF myelin basic protein normal, CSF oligoclonal band absent
Clinical narrative: Pt woke with chest pains that radiated to his back at the level of T4 on the morning of 7/22 and was seen at Medical Center ED. Work up was negative and he was sent home. On 7/23 he started with weakness and numbness in both legs with abnormal gait which got progressively worse as the day progressed. He was seen again at Medical Center ED and admitted. He was found to have transverse mylelitis at T1-T2
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: CSF test normal, Chest pain, Culture negative, Cytomegalovirus test, Cytomegalovirus test negative
Clinical narrative: Pt woke with chest pains that radiated to his back at the level of T4 on the morning of 7/22 and was seen at Medical Center ED. Work up was negative and he was sent home. On 7/23 he started with weakness and numbness in both legs with abnormal gait which got progressively worse as the day progressed. He was seen again at Medical Center ED and admitted. He was found to have transverse mylelitis at T1-T2
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Drug screen negative, Enterovirus test negative, Epstein-Barr virus test negative, Gait disturbance, Hypoaesthesia
Clinical narrative: Pt woke with chest pains that radiated to his back at the level of T4 on the morning of 7/22 and was seen at Medical Center ED. Work up was negative and he was sent home. On 7/23 he started with weakness and numbness in both legs with abnormal gait which got progressively worse as the day progressed. He was seen again at Medical Center ED and admitted. He was found to have transverse mylelitis at T1-T2
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Laboratory test normal, Muscular weakness, Myelitis transverse, Pain, Polymerase chain reaction negative
Clinical narrative: Pt woke with chest pains that radiated to his back at the level of T4 on the morning of 7/22 and was seen at Medical Center ED. Work up was negative and he was sent home. On 7/23 he started with weakness and numbness in both legs with abnormal gait which got progressively worse as the day progressed. He was seen again at Medical Center ED and admitted. He was found to have transverse mylelitis at T1-T2
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: West Nile virus test negative
Clinical narrative: Pt woke with chest pains that radiated to his back at the level of T4 on the morning of 7/22 and was seen at Medical Center ED. Work up was negative and he was sent home. On 7/23 he started with weakness and numbness in both legs with abnormal gait which got progressively worse as the day progressed. He was seen again at Medical Center ED and admitted. He was found to have transverse mylelitis at T1-T2
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: After patient left who administered the injection realized it was expired. Parent called by CMD and will reschedule for Covid vaccine. No reaction reported
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: After patient left who administered the injection realized it was expired. Parent called by CMD and will reschedule for Covid vaccine. No reaction reported.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: SPOKE TO DR AND MY NURSE MANAGER ABOUT THE SITUATION. ALSO CALLED MOTHER TO MAKE HER AWARE THAT I ACCIDENTALLY GAVE A 3RD DOSE OF HPV TO HER CHILD.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Muscle spasms, Muscle tightness, Seizure like phenomena
Clinical narrative: patient with immediate LOC, tightening of muscles with spasms. Provider concerned for seizure like event. Transported to ED. Event lasted 30 seconds.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given 2nd MCV too soon. Should not have received 2nd dose until age 16.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Mobility decreased, Muscular weakness
Clinical narrative: Began with severe inflammation, redness, and itchiness of the injection site the first day. The second day I started losing strength and mobility in my left hand and fingers. The sensation travelled from the pinky to the thumb over the course of a couple of days. Was not able to extend ring finger and pinky and needed both hand for simple tasks. Adverse effect lasted about 2 weeks with continuous weakness in the hand. No numbness, tingling, pain, or swelling in the hand.
Age: 77.0
Sex: M
Vaccine: PNC20, RSV, VARZOS
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Pt has a rash on neck, lower legs , stomach area going toward the back , and arms. Pt saw a Dr. who told him it could be shingles. Dr. may have told him to take diphenhydramine & maybe a topical. Pt didn't ask me to suggest any OTC products.  I called the patient back today 6/21/2024 who states that the rash is about the same and is itchy. No watery pustules, just a raised rash.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Headache, Pain, Pyrexia
Clinical narrative: Fever, Extreme Chills, Headache, Body aches from 10:30pm till morning.  Couldn't walk to the bathroom alone.  Took 2 ibuprofen during the night at about 02:30am.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient did not receive the hep B vaccine "birth dose" within 24 hours of birth. Potential language barrier issue so the parents initially refused the vaccine, however outpatient clinic was able to administer dose late 48 hours post birth.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: Started having Afib on DEC.  4 2023 continued having bouts with Afib until May 1st. for a total of 26 different occurrences over time.    Never had Afib before the RSV vaccine & no Afib since May 1st.  ( guess the RSV vaccine is getting out of my body ?
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Bladder catheterisation, Cystitis haemorrhagic, Dialysis, Endocarditis
Clinical narrative: He ended up with hemorrhic cystitis. He became septic due to a foley that had to be placed. He developed endocarditis needing 2 heart valves replaced. He developed AKI and needed dialysis for 3 months.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Heart valve replacement, Laboratory test, Sepsis, X-ray
Clinical narrative: He ended up with hemorrhic cystitis. He became septic due to a foley that had to be placed. He developed endocarditis needing 2 heart valves replaced. He developed AKI and needed dialysis for 3 months.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye irritation, Eye swelling, Lacrimation increased, Periorbital swelling
Clinical narrative: swollen watery eyes, irritated, puffy
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was inadvertently administered an expired vaccine. No adverse side effects noted. Patient to return on or after 30 days for re-administration.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Loss of consciousness, Posture abnormal, Syncope
Clinical narrative: Patient was given the typhoid IM vaccine in the left deltoid muscle.  Patient got up and moved to the other chair without any issues but all of a sudden had what appeared to be a syncopal episode.  He slouched down in the chair and appeared to lose consciousness.  His dad and I lowered the patient to the floor to lay him flat and he woke up immediately.  911 was immediately called.  I gave EMS a description of what was going on and an assessment of the patient.  The patient had no signs of an allergic reaction such as a rash, swelling of th lips, face, throat, eyes, no itching and no shortness of breath or trouble breathing.  EMS instructed me to hold off on giving the epinephrine  that I had already drawn up since the patient was awake and not showing signs of an allergic reaction.  I continuously talked to and assessed the patient until EMS arrived.  EMS had arrived quickly at 1139am.  When the paramedics arrived the patients blood pressure was 122/72, and his heart rate was 98 and oxygen sats were 100%.  His blood sugar was 98.  The paramedics had the patient stand up and instantly he started to have another syncopal episode.  His heart rate dropped to 32.  They lifted him up and placed him in the recliner and elevated his legs.  He came to once again.  They started an IV and gave IV fluids wide open.  They decided to take him to the hospital since this sycopal episode happedned a second time.  The dad accompanied the patient to the hospital.
Age: 35.0
Sex: F
Vaccine: PNC20
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received dose of Prevnar 20 instead of order vaccine, Gardasil.  No adverse side effects expected per PCP. Patient advised to return to clinic for Gardasil.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Immunisation reaction
Clinical narrative: MMR Vaccine reaction
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Immediate post-injection reaction, Lethargy, Swollen tongue
Clinical narrative: Parent brought these concerns up to provider 2 months after (was here for the 4m physical today). Was lethargic immediately after vaccines. A few hours later (while at home) patient had mild tongue swelling. Paramedics were called and informed parents that patient had no respiratory distress.  Symptoms lasted a few hours. Did not take infant to ED. Unsure concerns were due to vaccine reaction.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Immunisation reaction, Laboratory test, SARS-CoV-2 test
Clinical narrative: MMR vaccine Reaction
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension, Syncope
Clinical narrative: syncopal episode and hypotension the day following 2nd shingles shot. Reports similar symptoms after first during message but not as severe.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Immunisation reaction, Viral test
Clinical narrative: MMR Vaccine Reaction
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyond expiration date. borrowed vaccines from family medicine 6/20/24. Gave Varicella vaccine 6/21/24. Notified Supervisor as well as head RN's and pharmacist. Doctor Called pt to notify family as well.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Condition aggravated
Clinical narrative: Inflamed preexisting heart condition from 2019.
Age: 69.0
Sex: F
Vaccine: RV5
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: As I was depressing the plunger, medication leaked out the side of the connection port down her arm - the type of needle was a TKmd Safety needle 1.5 inch.  The patient was advised to repeat the dose since roughly 1/3 to 1/2 leaked down her arm.  I am ordering new needles of a different manufacturer prior to readministration.  She plans to return next week
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Blister, Burning sensation, Injection site discolouration, Injection site reaction, Pruritus
Clinical narrative: PATIENT CAME TO THE PHARMACY 12 DAYS AFTER ADMINISTERING VACCINE PREVNAR 20. 6/19/24  AND SHE SAID THE DAY OF ADMINISTRATION SHE FELT BURNING SENSATION FEW HOURS LATER.   THE DAY AFTER ITCHING. LATER A BLISTER. FEW DAYS LATER  THE SKIN STARTED PEELING OFF. SHE SHOWED ME THE SKING PEELING OFF AND A BIG BROWNS AREA AROUND THE VACCINATION SITE.  I TOLD HER TO CONTACT HER DOCTOR. TODAY I CALLED THE PATIENT AND THE DOCTOR GIVE APPOINTMENT FOR MONDAY JUNE 24 7:30AM. TODAY SHE SAID THE PEELING SECTION IS BIGGER.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Skin exfoliation
Clinical narrative: PATIENT CAME TO THE PHARMACY 12 DAYS AFTER ADMINISTERING VACCINE PREVNAR 20. 6/19/24  AND SHE SAID THE DAY OF ADMINISTRATION SHE FELT BURNING SENSATION FEW HOURS LATER.   THE DAY AFTER ITCHING. LATER A BLISTER. FEW DAYS LATER  THE SKIN STARTED PEELING OFF. SHE SHOWED ME THE SKING PEELING OFF AND A BIG BROWNS AREA AROUND THE VACCINATION SITE.  I TOLD HER TO CONTACT HER DOCTOR. TODAY I CALLED THE PATIENT AND THE DOCTOR GIVE APPOINTMENT FOR MONDAY JUNE 24 7:30AM. TODAY SHE SAID THE PEELING SECTION IS BIGGER.
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Patient had an allergic reaction to Proquad. Pt had slight swelling and redness on left thigh. Patient was given 2.5mL of 12.5mg/5mL of Benadryl P.O x1 in office.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Muscle contractions involuntary, Syncope
Clinical narrative: Patient fainted while on the elevator after shots were given. MCV, HPV and Tdap were given at the left arm per patient's preference and patient was observed at the clinic and left with no problems. Mom stated that patient has no breakfast and  arms and legs flexed and became stiff with LOC but improved after a code blue was called. Assistance was offered to go to the ED, patient and Mom refused.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: Tachycardia
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given past the BUD (beyond use date). BUD was 6/12/24 based on when it was removed from the freezer. Vaccine was administered 6/17/24.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered past the BUD (beyond use date) of 6/12/24. Vaccine administered 6/17/24.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Swelling, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: vaccine was given 6/7. The following days vaccine site remained red, hard, and hot to the touch. I developed a random bump following the vaccine on different areas of my body. they would appear and and some would be itchy and disappear after few hours. It would only be one bump but they look very similar to each other so I assume they are all triggered by the same thing. The weirdest location I had gotten a bump was above my eye on my eyelid. My last bump that appeared was yesterday 6/20/2024 at 10pm. When I woke up the bump was gone. As of today 6/21, vaccine site is still red and hard but bump is not as big.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Contraindication to vaccination, Exposure during pregnancy
Clinical narrative: Pt is 16w 4d pregnant, and received the live MMR vaccine subcutaneously today in clinic, which is contraindicated with pregnancy
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Flushing, Hyperhidrosis
Clinical narrative: Following receiving pneumovax 23 vaccination, patient started experciencing severe lower back pain, sweating, and flushing. Emergency services and management were notified. Her blood pressure was 200/85 and pulse was 76. Patient stated her blood pressure is always high. Emergency services arrived and took her blood pressure 160/86. Patient stated feeling better. She refused medical treatment and signed refusal form. She appeared less flushed.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Immunisation reaction
Clinical narrative: Moderna vax given 6/18/2024 on 6/20 patient noticed a erythrematous patch and went to urgent care.  Urgent care called it "covid arm"  and ruled out infection. When presenting to the pharmacy today (6/21) the patch reached from point of shoulder to about half way to elbow.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: The HCP stated the patient had not experienced any adverse issues or side effects from the expired dose; A HCP called to report that an expired dose of MMR II (Lot: W033285 Expiration: 05/03/2024) was inadvertently administered to a patient on 05/29/2024.; This spontaneous report has been received from a nurse, referring to a 12-month-old patient of unknown gender. The patient's concomitant therapies included sterile diluent (MERCK STERILE DILUENT). The information regarding the patient's concurrent conditions or medical history was not reported.  On 29-MAY-2024, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II), at a dose of 0.5 mL, administered once, lot# W033285, expiry date 03-MAY-2024 (route of administration and anatomical location were not reported), for prophylaxis (expired product administered). The patient had not experienced any adverse issues or side effects from the expired dose having been administered (no adverse event). The product had never undergone any temperature excursions.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired vaccine used; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-JUN-2024, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (0.5 milliliter, lot #X012185 was valid, expiration date: 03-JUN-2024, route of administration and anatomical location were not provided) for prophylaxis (Expired product administered). No symptoms reported. No additional adverse event (AE)/product quality complaint (PQC) (No adverse event).
Age: 9.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; first dose of GARDASIL 9 on 5/16/2024, and were inadvertently administered their second dose of GARDASIL 9 on 6/11/2024; This spontaneous report was received from  the medical assistant and refers to a 9-year-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-MAY-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, first dose (strength, dose description, lot #, expiration date, and route of administration were not provided), thereafter, on 11-JUN-2024, inadvertently,  it was administered a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter, lot #2014790, expiration date: 22-APR-2026, (strength, and route of administration were not provided), both doses administered for prophylaxis (Inappropriate schedule of vaccine administered). Medical Assistant confirmed the patient has not reported any medical concerns or symptoms.  Lot# is being requested and will be submitted if received.
Age: 1.75
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous report has been received from a lawyer, via an immunization record from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (MARRS #2405USA003892), concerning a 21-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-JUN-2005, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacture unknown) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). On 22-JUL-2008, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA)(M-M-R II) injection, 0.5 (unit not provided), administered for prophylaxis (lot # 0480X, expiry date was reported as 19-MAR-2010, strength and route of administration were not provided).  This is one of several reports for the same patient.; Sender's Comments:  US-009507513-2405USA003892: US-009507513-2406USA005492:
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Fatigue, Incorrect dose administered
Clinical narrative: a bit more tired than normal; After the visit, the doctors office made them aware that they had accidentally given their son an adult dose rather than a child's dose.; This spontaneous report was received from a consumer via company representative, referring to an about 13-year-old male patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  In Jun 2024 (reported as last week), the patient was accidentally vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (strength, lot #, expiry date, and route of administration were not provided) for prophylaxis ( Incorrect dose administered). After the visit the doctor's office made them aware that they had accidentally given the patient an adult dose rather than a child's dose.  On 15-JUN-2024, the patient seemed to be a bit more tired than normal (fatigue). The patient did not seem to have any adverse reaction other than the above fact. The outcome of the fatigue was unknown. There was no cancer. Conflicting information: therapy with suspect vaccine was reported as no discontinued. The causal relationship between fatigue and suspect vaccine was not reported.  Lot# is being requested and will be submitted if received.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: FBE reporting AE that was reported by unknown HCP.  HCP reported child received RECOMBIVAX at birth and again at 3 days old.  No other information provided.  No additional AEs or PQC reported.  FBE states he will try to contact HCP to obtain addition; No additional AEs or PQC reported; This spontaneous report was received from a consumer and refers to a 3-day-old patient of unknown gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On an unknown date (reported as "at birth") the patient was vaccinated with first dose hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On an unknown date (reported as "at 3 days old") the patient was vaccinated with second dose hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). It was reported child received hepatitis b vaccine (recombinant) (RECOMBIVAX HB) at birth and again at 3 days old. No additional adverse events (AEs) or product quality complaints (PQC) reported (inappropriate schedule of product administration and no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received their first dose on 11/07/2022 but never came back for the second and third doses; did not report any adverse issues or side effects; This spontaneous report was received from a pharmacist and refers to a currently 31 year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-NOV-2022, 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 (lot #1687293 has been verified to be a valid lot number, expiration date reported and upon internal validation established as 30-APR-2023) for prophylaxis (dose, strength, and route of administration were not provided). The patient never came back for the second and third doses (inappropriate schedule of product administration). The reporter inquired about the efficacy and immunogenicity of a single dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and whether she should start the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dosing series over, or continue the series. The patient did not report any adverse issues or side effects (no adverse event).  Additional information is not expected.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No symptomatic adverse events were reported; HCP called to report that a patient who is 28 weeks pregnant received GARDASIL 9. No symptomatic adverse events were reported. The HCP requested a copy of the Annual Pregnancy Report (Supplied in request case). No further information provide; This spontaneous prospective pregnancy report was received from a physician and refers to a female patient of unknown age. No information on patient's medical history, current conditions and concomitant medications was provided.  On 17-JUN-2024 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 2032274 and expiration date 19-JAN-2026, 0.5 milliliter (dose numer, route and site of administration were not provided). The patient who was 28 weeks pregnant received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No symptomatic adverse events were reported. The last menstrual period (LMP) and estimated due date (EDD) were not known (exposure during pregnancy and no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Had first dose, but has not had the second dose; Initial report received on 21-May-2024.  A pharmacist reported that a 79-year-old male (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but did not receive the second dose.  No relevant medical history or concomitant medications were reported.  On 08-May-2023, the patient received the first dose of HEPLISAV-B (Lot #941587, expiration date 31-Aug-2025, and NDC # 935280000305) intramuscularly (site not reported).    As of date of report, 21-May-2024, 379 days after the first dose of HEPLISAV-B, the patient had not received the second dose.  The reporter states that the patient reported no adverse effects related to this.   No further information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: RSV
Symptoms: Guillain-Barre syndrome, Immunisation reaction
Clinical narrative: patient was in hospital for Guillain Barre syndrome; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: patient was in hospital for Guillain Barre syndrome) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be related to Arexvy.     The company considered the guillain barre syndrome to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 17-JUN-2024 It was reported that patient was in hospital for Guillain Barre syndrome.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have had shingles twice since the vaccines; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have had shingles twice since the vaccines). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-JUN-2024 This case was reported by a patient via interactive digital media. The patient reported that the two part vaccines help but did not eliminate the risk. The patient had shingles twice since the vaccines, but no where near as painful. 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. Follow-up would not possible as no contact details were available.; 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 vaccine Shingles vaccine.