chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Joint range of motion decreased, Pain, X-ray limb
Clinical narrative: On Friday, Dec. 29, 2023, I received the Prevnar 20 (PF) vaccine at my PCP's office after a routine follow-up appointment with her. The vaccine administrator walked into the room and injected my upper left arm, approximately 1 finger-width below the acromion (needle size unknown but, for reference I am 5'9" and weigh 138 lbs, normal BMI), while she was standing and I was seated. Within 2-3 hours of receiving the shot, I started experiencing extreme pain and a limited range of motion in my left shoulder, which steadily worsened over the course of the evening. Throughout the weekend, I took 400mg ibuprofen 1-2 times/day and alternately applied ice and a red/near-infrared light device to my shoulder but felt little relief. I notified my PCP on Monday, Jan. 3, 2024, and a nurse instructed me to take 600mg-800mg ibuprofen 3 times/day and continue icing twice/day for another 5-7 days, which I did. Two weeks post-vaccine, I still experienced severe pain with certain movements of my left shoulder. I notified my PCP and explained that this was a textbook case of SIRVA. She was not familiar with SIRVA but referred me to an orthopedist. On Feb. 21, 2024, I saw a CNP in a specialty clinic. As expected, X-ray revealed no break or dislocation; the CNP suspected tendinitis and gave me instructions for physical therapy I could do at home. I declined an MRI due to the high cost I would have to pay out of pocket per my insurance policy. I continue to apply my red/near-infrared light device to my left shoulder for 40 minutes, several nights per week as that seems to help the most. As of this writing (March 11, 2024), full range of motion has been restored but, I still experience some pain in my shoulder--particularly when lifting my arm when it is across my body or behind me--that seems to lessen on some days and worsen on others.
Age: 44.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no symptoms noted, no treatment needed
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Having a fever for 3 days from 3/9 to 3/11 (today), with body temperature ranging from 37.5 to 39.3 degree Celsius. Took Tylenol 2-3 times a day.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: Very large, hard ridge (bigger / wider than a regular lump) under the skin at the injection site, is not going away, redness, itchiness at the injection site .
Age: 42.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Burning sensation, Chills, Fatigue, Lethargy
Clinical narrative: Fatigue, chills, tingling/prickly skin, lethargic, burning sensation, muscle/joint pain, over sensitivity of pins and needles. Physical symptoms of pain started to appear the next morning (March 2 at around 9-11AM, with fever like symptoms beginning with pain on the right foot and climbing its way up. Lesions on right foot appeared with lesions and bite-like marks appearing throughout my entire body, climbing up to my face.  The nurse who administered the vaccine drew one separate needle (Needle #1)  from one vile. Needle #1 was capped off and left on the counter, not given to me. A separate needle (Needle #2) was drawn from a separate vile, and this was the medication administered into my right arm. Needle #1 was never given to me, but this situation was suspicious to me.
Age: 42.0
Sex: M
Vaccine: MMR
Symptoms: Myalgia, Pain, Pain in extremity, Paraesthesia, Skin lesion
Clinical narrative: Fatigue, chills, tingling/prickly skin, lethargic, burning sensation, muscle/joint pain, over sensitivity of pins and needles. Physical symptoms of pain started to appear the next morning (March 2 at around 9-11AM, with fever like symptoms beginning with pain on the right foot and climbing its way up. Lesions on right foot appeared with lesions and bite-like marks appearing throughout my entire body, climbing up to my face.  The nurse who administered the vaccine drew one separate needle (Needle #1)  from one vile. Needle #1 was capped off and left on the counter, not given to me. A separate needle (Needle #2) was drawn from a separate vile, and this was the medication administered into my right arm. Needle #1 was never given to me, but this situation was suspicious to me.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Biopsy lung, Biopsy lymph gland abnormal, Cerebrovascular accident, Chest X-ray abnormal
Clinical narrative: Condition started with a persistent cough in summer of 2023.  Chest xray in fall of 2023 revealed Right upper lobe mass and left lower lobe lung masses.  Subsequent MRI of chest suspicious for cancer.  Transbroncial biopsy 12/28/23 on pathology revealed Adenocarcinoma of pulmonary origin in right upper lobe and left lower lobe.  Mediastinal node biopsy also positive for cancer.  So this is a stage 4 NSCLC lung cancer.  Patient is a former smoker but quite smoking 50 years ago and lives with her son who is not a smoker. MRI brain 1/9/2024 reveal a recent stroke.  Patient started on Tagrisso 80mg and had to drop to 40mg daily due to adverse reactions.  Hospitalized due to confusion, weakness, and probable adverse reaction to Tagrisso on 3/8/24 onward.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Cough, Lung adenocarcinoma, Magnetic resonance imaging head abnormal, Magnetic resonance imaging thoracic abnormal
Clinical narrative: Condition started with a persistent cough in summer of 2023.  Chest xray in fall of 2023 revealed Right upper lobe mass and left lower lobe lung masses.  Subsequent MRI of chest suspicious for cancer.  Transbroncial biopsy 12/28/23 on pathology revealed Adenocarcinoma of pulmonary origin in right upper lobe and left lower lobe.  Mediastinal node biopsy also positive for cancer.  So this is a stage 4 NSCLC lung cancer.  Patient is a former smoker but quite smoking 50 years ago and lives with her son who is not a smoker. MRI brain 1/9/2024 reveal a recent stroke.  Patient started on Tagrisso 80mg and had to drop to 40mg daily due to adverse reactions.  Hospitalized due to confusion, weakness, and probable adverse reaction to Tagrisso on 3/8/24 onward.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant, Non-small cell lung cancer stage IV, Pathology test, Pulmonary mass
Clinical narrative: Condition started with a persistent cough in summer of 2023.  Chest xray in fall of 2023 revealed Right upper lobe mass and left lower lobe lung masses.  Subsequent MRI of chest suspicious for cancer.  Transbroncial biopsy 12/28/23 on pathology revealed Adenocarcinoma of pulmonary origin in right upper lobe and left lower lobe.  Mediastinal node biopsy also positive for cancer.  So this is a stage 4 NSCLC lung cancer.  Patient is a former smoker but quite smoking 50 years ago and lives with her son who is not a smoker. MRI brain 1/9/2024 reveal a recent stroke.  Patient started on Tagrisso 80mg and had to drop to 40mg daily due to adverse reactions.  Hospitalized due to confusion, weakness, and probable adverse reaction to Tagrisso on 3/8/24 onward.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Death
Clinical narrative: Online report of death in victim. 6 months and 15 days after his inoculation with J&J he was diagnosed with ALS. After a two-year plus battle with he passed away on 01/28/2024. Information found in online obituary. DOSE1 Date 04/05/21. Poor image quality on lot# appears to end in 879
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Injection site reaction, Urticaria
Clinical narrative: Pt developed "welts" around (L) thigh injection site 3/7/24 during the night. 3/8/24 welts have spread and are now connected Some of the area is white & red. Pt was treated with Benadryl and cool pack to area. Area less itchy. To continue Benadryl & cool pack q 6 hours x 2
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Electrocardiogram normal, Fatigue, Immediate post-injection reaction, Pain in extremity
Clinical narrative: Felt weak and fatigue immediately after vaccine. Woke up from sleep same night with palpitations and weakness. Near syncope walking from car to ER, very sore arm.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Palpitations, Presyncope, Sleep disorder
Clinical narrative: Felt weak and fatigue immediately after vaccine. Woke up from sleep same night with palpitations and weakness. Near syncope walking from car to ER, very sore arm.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Endotracheal intubation, Hepatic failure
Clinical narrative: Online report of liver failure and death in 37-year old male. Online sorces state DOB. Victim appears to have abused alcohol. Online source indicates victim's symptoms onset around 11/08/20223 as victim stated he was entubated for four days on 11/15/2023. DOD 01/09/2024 DOSE1 date 04/16/21 LOT# 017B21A
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Report of sudden death from website partial photo of vax card, digits ending in "8737" visible on photo, good faith estimate lot# is Pfizer ER8737. DOSE1 date 03/30/21. Victim covered manufacturer and some of lot# with thumb. Online report victim died on 01/02/24. Hanwriting is sloppy for location of injection.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death in working age female victim. Copy of vax card after DOSE1 obtained. DOSE1 01/22/2021 LOT#EL3248. DOD reported as 04/23/22. Unaware of subsequent doses
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online Report of sudden death. Victim died suddenly on 12/01/2023. Copy of vax card on website DOSE1 DATE 03/31/21 LOT#026B21A DOSE2 DATE 04/28/2021 LOT#021C21A. Same facility listed as injection site both times.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Online report of death in recipient of two doses of COVID-19 vaccine, manufacturer UNK, DOSE1 date 04/27/21 DOSE2 date 06/01/2021. Online obituary states "passed away on Thursday, January 18, 2024, surrounded by loved ones" It implies a hospitalization. DOD 01/18/24
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Food poisoning, Sudden death, Vomiting
Clinical narrative: Online report of sudden death in 33-year-old EUA medical countermeasure recipient. Online obituary states date of death as 02/19/2024. City-county of residence unknown. Obituary indicates victim was an employee of government. Unable to ascertain any data on subsequent doses. DOSE1 DATE 08/27/2021 LOT#088D21A. Online source has a social media post from 02/15/2024 where victim states he vomited three times and suspected it was food poisoning. Onset Date 02/15/2024
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Laboratory test abnormal, Lung neoplasm malignant, Neoplasm
Clinical narrative: Online report of turbo lung cancer in recipient of Moderna. DOSE1 DATE 05/11/2021 LOT# UNK. DOD of 11/21/2023. Victim died at hospital. Online report says tumor the size of beefsteak tomato. Fluid around tumor tested positive for cancer. Report found on website.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death In working age male. DOD 12/13/21 DOSE1 date 04/01/21 LOT#ER8733 DOSE2 date 04/22/21 LOT#ER8731, image quality slightly blurred for DOSE2 LOT#.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death in young working male with copy of vax card. DOSE1 date 04/01/21 LOT#ER8737 DOSE2 date 04/22/2021 LOT#EW0171
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lung neoplasm malignant, Sudden death
Clinical narrative: Received reports from co-workers about the sudden death of a recently retired shipping company manager. The victim died of a turbo lung cancer two months from diagnosis. Sources state he was very pro-mask wearing and met the criteria of "fully vaccinated". Sources say victim was injected with Pfizer at least twice. Unaware of where victim received medical treatment of DOB. Victim was approximately 49 years old at time of injections.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Report of death at home for 77-year-old male. His obituary indicates he was from the Southern part of the state so it makes sense where he was inoculated although he died in the Northern part of the state. Copy of vax card online. DOSE1 date 02/12/21 LOT#EN6201 DOSE2 date 03/05/2021 LOT#EN6206. DOD 11/16/23
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: coughing; Itchiness in throat; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0150) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing); "sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COUGH (medically significant), outcome "unknown", described as "coughing"; THROAT IRRITATION (medically significant), outcome "unknown", described as "Itchiness in throat". The events "coughing" and "itchiness in throat" required physician office visit. Therapeutic measures were taken as a result of cough, throat irritation. Clinical course: It was reported that the patient had only one dose of the COVID-19 vaccine. Pfizer EW0150 on 07Apr2021. The patient had an adverse reaction (coughing, itchiness in throat) and was given 50 mg Benadryl IM. The patient's doctor recommended and receive no further COVID vaccine; in accordance with CDC recommendations.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400022159 Same patient/product, different dose/events;
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Throat irritation
Clinical narrative: coughing; Itchiness in throat; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0150) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing); "sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COUGH (medically significant), outcome "unknown", described as "coughing"; THROAT IRRITATION (medically significant), outcome "unknown", described as "Itchiness in throat". The events "coughing" and "itchiness in throat" required physician office visit. Therapeutic measures were taken as a result of cough, throat irritation. Clinical course: It was reported that the patient had only one dose of the COVID-19 vaccine. Pfizer EW0150 on 07Apr2021. The patient had an adverse reaction (coughing, itchiness in throat) and was given 50 mg Benadryl IM. The patient's doctor recommended and receive no further COVID vaccine; in accordance with CDC recommendations.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400022159 Same patient/product, different dose/events;
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, Foreign travel, Life support, Malaise
Clinical narrative: Patient started to feel sick July 18th 2022, No FEVER, No COUGH, tested positive for covid at 11pm on July 18 2022, went to the er July 20th because she started to feel really light headed, she sat in the er waiting room for 4 hours before collapsing and going in to cardiac arrest, worked on for a hour, Air flown to to the hospital, after having 2 more cardiac arrests, Placed on ECMO and during her 17 days in at he hospital she passed away her limb turned black from the first day, her organs shut down,. she was treated with remdesivir.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient started to feel sick July 18th 2022, No FEVER, No COUGH, tested positive for covid at 11pm on July 18 2022, went to the er July 20th because she started to feel really light headed, she sat in the er waiting room for 4 hours before collapsing and going in to cardiac arrest, worked on for a hour, Air flown to to the hospital, after having 2 more cardiac arrests, Placed on ECMO and during her 17 days in at he hospital she passed away her limb turned black from the first day, her organs shut down,. she was treated with remdesivir.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death, Lung assist device therapy
Clinical narrative: Patient started to feel sick July 18th 2022, No FEVER, No COUGH, tested positive for covid at 11pm on July 18 2022, went to the er July 20th because she started to feel really light headed, she sat in the er waiting room for 4 hours before collapsing and going in to cardiac arrest, worked on for a hour, Air flown to to the hospital, after having 2 more cardiac arrests, Placed on ECMO and during her 17 days in at he hospital she passed away her limb turned black from the first day, her organs shut down,. she was treated with remdesivir.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death, Dizziness, Lung assist device therapy, Malaise
Clinical narrative: Patient started to feel sick July 18th 2022, No FEVER, No COUGH, tested positive for covid at 11pm on July 18 2022, went to the er July 20th because she started to feel really light headed, she sat in the er waiting room for 4 hours before collapsing and going in to cardiac arrest, worked on for a hour, Air flown to to the hospital, after having 2 more cardiac arrests, Placed on ECMO and during her 17 days in at he hospital she passed away her limb turned black from the first day, her organs shut down,. she was treated with remdesivir.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Multiple organ dysfunction syndrome, SARS-CoV-2 test positive, Skin discolouration, Syncope
Clinical narrative: Patient started to feel sick July 18th 2022, No FEVER, No COUGH, tested positive for covid at 11pm on July 18 2022, went to the er July 20th because she started to feel really light headed, she sat in the er waiting room for 4 hours before collapsing and going in to cardiac arrest, worked on for a hour, Air flown to to the hospital, after having 2 more cardiac arrests, Placed on ECMO and during her 17 days in at he hospital she passed away her limb turned black from the first day, her organs shut down,. she was treated with remdesivir.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; an expired dose of MMR II was administered; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, and concomitant therapies were not reported.  On 18-FEB-2024, the patient was vaccinated with one expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, lot #W019428, expiration date not reported, but upon internal validation established as 07-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). The vaccine was not involved in any temperature excursions. No patient symptoms had been reported. No additional information was provided. No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; Caller reported expired dose of MMR II was administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  01-MAR-2024, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliters, lot #W007041, expiration date: 29-FEB-2024, administered intramuscularly for prophylaxis (strength was not provided) that was expired.  No additional adverse events were provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report inadvertent administration of expired MMR-II to a patient. Product expired on 01MAR2024 and was administered to a patient on 04MAR2024. Limited patient demographics provided. No additional AE/PQC.; 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, historical drugs, and concomitant therapies were not reported.  On 04-MAR-2024, the patient was inadvertently vaccinated with an expired dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II) injection (lot number W007180 was verified to be valid, expiration date reported and confirmed as 01-MAR-2024) (Expired product administered), administered as prophylaxis by a Healthcare Professional (exact dose, route of administration, and anatomical location were not provided).  No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: PNC15
Symptoms: Pain
Clinical narrative: the reporter communicated that several patients experienced painful symptoms following the administration with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE); This spontaneous report was received from a physician via a field business employee (FBE) and refers to an unknown number of patients of unspecified ages and genders.  The patients' medical histories, concurrent conditions and concomitant therapies were not reported.  On an unknown dates, the patient received pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered for prophylaxis (strengths, dose descriptions, lot #s, expiration dates, and routes of administration were not provided).  On an unknown date, the reporter communicated that the patients experienced painful symptoms following the administration of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE). It was unknown by the reporter if the patients received any treatment for the event or if any lab diagnostics and studies were performed. No additional details were provided. It was confirmed that there were no product quality issues to report and no other adverse events.  The causal relationship between the event and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was not provided.  This case was considered non-valid due to the unknown number of patients and the lack of their identifiers.
Sex: U
Vaccine: HIBV, UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: delayed dose of PEDVAX HIB; No additional AE/PQC; This spontaneous report was received from a nurse and refers to an 18-month-old patient of unknown gender.   The patient's medical history, concurrent conditions, previous drug reacions and oncomitant therapies were not reported.  On an unknown date, the patient was vaccinated diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).   On an unknown date, the patient's fourth dose (that should have been administered between 12-15 months) of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was delayed (inappropriate schedule of vaccine administered, conflicting information as information is not clear regarding to what vaccine was delayed).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Laboratory test
Clinical narrative: Stemi
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Cold sweat, Dysphonia, Feeling abnormal, Mydriasis, Pallor
Clinical narrative: Pt. Received Anthrax and Typhoid today on 12MAR2024.  13:37 Check-in the time. Pt. announced he had seizure last time when he received Anthrax and JEV. Pt. announced that it was totally fine (no reactions) when he received an influenza vaccine on 08NOV2023. 13:41 Today when pt. received the vaccine: Anthrax and Typhoid. 1st. Pt received Typhoid. Pt. was fine. 2nd. Pt. received Anthrax and then 10 second after pt. announced "doesn't feel good."  13:42 Pt. had pale skin, eyes dilated, cold sweat, and tunnel vision. Pt. was able to answer a few questions during he had vasovagal reactions; however, his voice was weak.  13:44 Took vital: BP 90/68, Plus 48, Oxy 99%. Took him to ACA room by a wheelchair and follow-up.  Pt. was able to lay down on the bed from the wheelchair by himself at ACA room.  Called the ACA provider to see the patient. Pt. still had pale skin and cold sweat. Pt was. able to speak and answer questions.  13:49 Pt. was able to sit and talk on the bed. Looks much better and no pale skin and no cold sweat. Staff had been taking care of the patient during he was at the ACA.  14:09 Pt. was discharged from ACA.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Presyncope, Tunnel vision
Clinical narrative: Pt. Received Anthrax and Typhoid today on 12MAR2024.  13:37 Check-in the time. Pt. announced he had seizure last time when he received Anthrax and JEV. Pt. announced that it was totally fine (no reactions) when he received an influenza vaccine on 08NOV2023. 13:41 Today when pt. received the vaccine: Anthrax and Typhoid. 1st. Pt received Typhoid. Pt. was fine. 2nd. Pt. received Anthrax and then 10 second after pt. announced "doesn't feel good."  13:42 Pt. had pale skin, eyes dilated, cold sweat, and tunnel vision. Pt. was able to answer a few questions during he had vasovagal reactions; however, his voice was weak.  13:44 Took vital: BP 90/68, Plus 48, Oxy 99%. Took him to ACA room by a wheelchair and follow-up.  Pt. was able to lay down on the bed from the wheelchair by himself at ACA room.  Called the ACA provider to see the patient. Pt. still had pale skin and cold sweat. Pt was. able to speak and answer questions.  13:49 Pt. was able to sit and talk on the bed. Looks much better and no pale skin and no cold sweat. Staff had been taking care of the patient during he was at the ACA.  14:09 Pt. was discharged from ACA.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Systemic lupus erythematosus
Clinical narrative: Developed lupus
Sex: U
Vaccine: VARZOS
Symptoms: Deafness unilateral
Clinical narrative: lost the hearing in right ear; This serious case was reported by a consumer via interactive digital media and described the occurrence of hearing loss 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 hearing loss (Verbatim: lost the hearing in right ear) (serious criteria GSK medically significant). The outcome of the hearing loss was not reported.   It was unknown if the reporter considered the hearing loss to be related to Shingles vaccine.     It was unknown if the company considered the hearing loss to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAR-2024 This case was reported by a patient via interactive digital media. The patient had the shot and lost hearing in right ear.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: My cousin got the vaccine and got shingles shortly after; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: My cousin got the vaccine and got shingles shortly after). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2024 This case was reported by a consumer via (social media) interactive digital media. The reporter reported the shingles vaccine could give you shingles. The reporters cousin got the vaccine and got shingles shortly after. Every single person the reporter know who got the covid vaccine wound up getting covid.
Sex: F
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Expired product administered, Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: 11 year-old patient is repeating the entire Engerix-B series because after a test no immune response was observed; Engerix-B - Administration of expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 11-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) (batch number FB9RH, expiry date 21-JAN-2024) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b) and Hepatitis b vaccine rHBsAg (yeast) (Engerix b).   On an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On 29-FEB-2024, the patient received the 6th dose of Engerix B. On 29-FEB-2024, not applicable after receiving Engerix B, Engerix B and Engerix B and an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B - Administration of expired dose). On an unknown date, the patient experienced therapy non-responder (Verbatim: 11 year-old patient is repeating the entire Engerix-B series because after a test no immune response was observed). The outcome of the therapy non-responder and expired vaccine used were unknown.   Additional Information: RA Receipt Date: 01-Mar-2024 The reporter reported that the patient was repeating the entire Engerix-B series because after a test no immune response was observed, which led to therapy non-responder. The reporter stated that yesterday the patient received the sixth dose, so the third dose to complete the repeated series, and this dose was expired, which led to expired vaccine used. The reporter wanted to know if the last dose should be repeated. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Tenderness at the injection site; Terrible headache; muscle achiness; tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site tenderness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site tenderness (Verbatim: Tenderness at the injection site), headache (Verbatim: Terrible headache), muscle pain (Verbatim: muscle achiness) and tiredness (Verbatim: tiredness). The outcome of the injection site tenderness, headache, muscle pain and tiredness were not reported.   It was unknown if the reporter considered the injection site tenderness, headache, muscle pain and tiredness to be related to Arexvy.     It was unknown if the company considered the injection site tenderness, headache, muscle pain and tiredness to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024 This case was reported via (Open field AE monitoring) interactive digital media. The patient had terrible headache the day after, tenderness at the injection site, muscle achiness and tiredness.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: An expired vaccine (Exp. 1/18/2024) was administered with no adverse signs or symptoms to report.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Lung neoplasm malignant
Clinical narrative: Online report of death in 63-year-old female on December 16, 2023 after a 2.5 year battle with lung cancer. Copy of vax card online. DOSE1 date 03/09/21 LOT#EN6199 DOSE2 date 03/30/21 LOT#ER8733
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure acute, Cardiomegaly, Sudden cardiac death
Clinical narrative: Report of sudden cardiac death in 38-year-old former professional athlete. Although the dead countermeasure recipient lived in one location he died in another location. The Coroner claims that he died of an "enlarged heart with acute heart failure". Victim was extremely active on social media and posted a copy of his vax card online after DOSE1 07/17/21. Based on his statements about non-recipients it's likely he was at minimum a DOSE2 receipient. Victim messaged multiple times a day. Online researcher obtained a copy of message with vax card after DOSE1
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death in working 48-year-old male. Based off info in obituary it's likely he lived in specific county not other county. DOSE1 Date 04/02/21 LOT# ER8729. Unknown if recipient received additional doses since he was in a non-medical white collar profession.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death from website, copy of vax card online. Recipient passsed away on November 13, 2023. Victim lived to to be 55.5 years old at the time of death. DOSE1 DATE 04/10/21 LOT#1808980. Online photos of the victim indicate high BMI and Obesity as underlying condition
Sex: F
Vaccine: DTAPIPV
Symptoms: Aphasia, Memory impairment
Clinical narrative: Received Quadracel 2/27/24 and on 3/1/24 mom states she "couldn't get her words out" and forgot her dance routine at dance class.  Never was unresponsive, no LOC No seizure activity No loss of coordination
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Inflammation, Myalgia
Clinical narrative: Muscle pain and area around joints, shoulder, knees and hips. Progressively worse with pain and discomfort at its highest 12/2023. Subsequently pain and inflammation decreasing  as time progressed towards 3/11//2023.
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Per Triage Call by RN: Call back to pt-states that she got a vaccine in her L upper arm the afternoon of 3/5/24 at her PCP's office. Reports that her L upper arm was sore that night, sl reddened. The next morning, she developed a low grade fever and chills-felt really "lousy". L arm cont to be sore, hurts to use L arm, L upper arm is swollen, reddened area is spreading and is now the size of her hand. Very warm to the touch.  Denies: red streaks, L arm weakness.   Pt has been using Advil for discomfort and applying a cold pack with little relief.   Dx Cellulitis Rx ABX
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site warmth, Malaise, Pain, Pyrexia
Clinical narrative: Per Triage Call by RN: Call back to pt-states that she got a vaccine in her L upper arm the afternoon of 3/5/24 at her PCP's office. Reports that her L upper arm was sore that night, sl reddened. The next morning, she developed a low grade fever and chills-felt really "lousy". L arm cont to be sore, hurts to use L arm, L upper arm is swollen, reddened area is spreading and is now the size of her hand. Very warm to the touch.  Denies: red streaks, L arm weakness.   Pt has been using Advil for discomfort and applying a cold pack with little relief.   Dx Cellulitis Rx ABX
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Feeling hot, Oropharyngeal pain, Pain in extremity, Panic attack
Clinical narrative: heat and swelling in left arm, very sore arm, diarreah, a painful burning starting in back of throat, travelled down to near clavicle and up to right ear. very painful and scary. i then experienced a severe panic attack, had to call neighbor to come stay with me until symptoms subsided, which was most of the day.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Throat irritation
Clinical narrative: heat and swelling in left arm, very sore arm, diarreah, a painful burning starting in back of throat, travelled down to near clavicle and up to right ear. very painful and scary. i then experienced a severe panic attack, had to call neighbor to come stay with me until symptoms subsided, which was most of the day.
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt received a PVV 20 to her right arm on 2/29 and reports in the beginning was sore for a few day but then developed redness that is spreading, warm to touch and very itchy  Appt booked for eval today   Dx Cellulitis RX ABX
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Injection site reaction
Clinical narrative: After taken 4 COVID-19 Moderna injections, he reports still has a residual "deep bone ache" on his arms where the vaccine was administration that will occasionally hurt - still reporting as of 2024
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscle injury
Clinical narrative: Vaccine was given in the right muscle of the arm, pt stated that it hurt when administered and "a few hours later, the pain suddenly got much, much worse." Patient went to primary care office on 11/02/23 with difficulty in range of movement and "muscle injury." Per Dr.'s office, there were "no significant findings." Patient went back on 01/27/24 with complaints of shoulder still hurting.  On 03/11/24 a letter was received from the patient stating the issues being reported in this form.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: She receibed  PCV 20 at the office on 3/5 in left arm. That same night, had body aches, took 2 Tylenol. Next day, had worseniung body aches and fever. Took Tylenol alt with Advik RTC. Today area when she received is swollen, warm to touch, and has a burning pain. Continues with the Tylenol alt with Advil  RTC so no fever but little relif of pain/swelling.relief. Tried icing with no effect. Requesting eval in office  Dx Cellulitis RX ABX
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia
Clinical narrative: She receibed  PCV 20 at the office on 3/5 in left arm. That same night, had body aches, took 2 Tylenol. Next day, had worseniung body aches and fever. Took Tylenol alt with Advik RTC. Today area when she received is swollen, warm to touch, and has a burning pain. Continues with the Tylenol alt with Advil  RTC so no fever but little relif of pain/swelling.relief. Tried icing with no effect. Requesting eval in office  Dx Cellulitis RX ABX
Age: 45.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site hypersensitivity, Injection site reaction, Injection site urticaria, Skin exfoliation
Clinical narrative: On 03/12/2024 Pt reported to clinic with a photo of an allergic rxn - a quarter-sized wheal of flaking skin.  Pt reports the area was discovered more than 72 hours after vaccine administration on 02/08/2024.  Pt was unclear as to the timeline, as her significant other noticed the wheal. Pt reports there was no itching, redness, swelling  or discomfort from that site.  Wheal was located RUDA where the TWINRIX vaccine had been administered previously. No treatment required, resolved on its own. Assessment today 03/12/2024 is unremarkable.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Pruritus, Rash, Swelling
Clinical narrative: Patient reports Anaphylaxis, Hives, Itching, Rash, Shortness of Breath, and swelling following vaccination. Further details are unavailable.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient reports Anaphylaxis, Hives, Itching, Rash, Shortness of Breath, and swelling following vaccination. Further details are unavailable.
Age: 1.08
Sex: F
Vaccine: DTAPIPV, IPV
Symptoms: Wrong product administered
Clinical narrative: Quadracel was given accidently instead of DTAP.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough infection.
Age: 0.33
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: Patient is high risk and was recommended by hematology to receive Meningitis vaccine. Patient was given MenQuadFi and it is off label for under 2 years of age. No reaction from patient. Patient doing well. Will work with local Health Dept to order Menveo for next doses.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, Pain
Clinical narrative: PATIENT ASKED FOR AREXVY VACCINE AND RECEIVED IT ON 3/11/2023.  HOWEVER I LATER DISCOVERED SHE ALREADY RECEIVED A DOSE ON 12/31/2023.  I GAVE PATIENT A CALL MORNING OF 03/12/24 TO ASK HOW SHE'S DOING. SHE SAID SHE A LITTLE ACHY BUT OTHERWISE FINE.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute psychosis, Chest pain, Echocardiogram normal, Electrocardiogram, Hypertension
Clinical narrative: JANSSEN #1 5/21/2021 JANSSEN #2 3/9/2022 SEVERAL MONTHS LATER DEVELOPS SEVERE HTN REQUIRES MEDICATION.  PALPITATIONS CHEST PAIN TREATED WITH HYPERBARIC OXYGEN THERAPY WITH RESOLUTION.  MARCH 2023 HAS ACUTE PSYCHOTIC BREAK AND FOUND RUNNING NAKED IN (Privacy), JAILED, PER HIS REPORT NO DRUGS OR ALCOHOL INVOLVED, WAS RETRIEVED BY FATHER AFTER ONE DAY IN JAIL.  WORKS AS A DEEP SEA OFF SHORE DIVER AND HELIOBOX WORKER ON OCEAN FLOOR.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Palpitations
Clinical narrative: JANSSEN #1 5/21/2021 JANSSEN #2 3/9/2022 SEVERAL MONTHS LATER DEVELOPS SEVERE HTN REQUIRES MEDICATION.  PALPITATIONS CHEST PAIN TREATED WITH HYPERBARIC OXYGEN THERAPY WITH RESOLUTION.  MARCH 2023 HAS ACUTE PSYCHOTIC BREAK AND FOUND RUNNING NAKED IN (Privacy), JAILED, PER HIS REPORT NO DRUGS OR ALCOHOL INVOLVED, WAS RETRIEVED BY FATHER AFTER ONE DAY IN JAIL.  WORKS AS A DEEP SEA OFF SHORE DIVER AND HELIOBOX WORKER ON OCEAN FLOOR.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm, Swelling
Clinical narrative: She got her vaccine, had soreness in her arm.  Then she got a red welt, raised and it felt warm to touch.  She did not treat it with anything.    The welt was there for 4-5 days, and it gradually went away.  It did itch but that went away as well.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Urticaria
Clinical narrative: She got her vaccine, had soreness in her arm.  Then she got a red welt, raised and it felt warm to touch.  She did not treat it with anything.    The welt was there for 4-5 days, and it gradually went away.  It did itch but that went away as well.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pt received pfizer vaccine for pediatric (5-11 years) pts instead of 12+. P
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient was given ActHib vaccine but vaccine was reconstituted with Sterile Diluent rather than the designated 0.4% sodium chloride diluent. No adverse effect happened but patient will have to return to be re-vaccinated as this dose was invalid/ineffective per manufacturer
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain in extremity, Sensory disturbance, Sleep disorder
Clinical narrative: When I got the shot, it felt different. Like the needle didn't go into my muscle as deeply as other shots and I mentioned it at the time. I had arm pain a day after, but it never went away. I have PMR, so I thought is was related. But, PMR is bilateral and I was in remission from the rest of the usual PMR pain. On Feb. 7, 2024, I finally visited my Dr. and he told me to up the prednisone to 3 mg and apply diclofenac sodium topical gel 1% 3X day. That did nothing for the pain. I am back at 2mg of prednisone to avoid other side effects it gives me.(stomach issues, acne, weight gain etc.) The pain has worsened and effects my sleep, hobbies and housekeeeping. I have another appointment to see my Dr. on March 14 (video call).
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given formula dose for 12 years of age and older.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Injection site erythema, Listless
Clinical narrative: She got her vaccine, later that day she had a minor reaction with a sore arm.  Then the next day in the morning she felt weak, not too bad.  She took her usual walk, started having chills and fever.  She was tired, listless, weak.  She took her temperature she had a 100.4 temp.  She took a Tylenol as it reduces fever and after about 3 hours it went away, but still felt weak and tired.  On day #3 she felt much better, which was just yesterday, but she started to get an itchy arm, was still a tiny bit sore, but really itchy.  She had not looked at it and it's red around the injection site of that arm and that continues today.  She hopes that it will go away, and it says that the reaction would start within 1-3 days, and then the symptoms would go away within 3 days.  She did not know if it would go away completely on it's own and she called her doctor to see if he has anything she can take, and is waiting for that phone call.  She has had 6 previous vaccines, and has never had a reaction from any of those vaccines.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Pyrexia
Clinical narrative: She got her vaccine, later that day she had a minor reaction with a sore arm.  Then the next day in the morning she felt weak, not too bad.  She took her usual walk, started having chills and fever.  She was tired, listless, weak.  She took her temperature she had a 100.4 temp.  She took a Tylenol as it reduces fever and after about 3 hours it went away, but still felt weak and tired.  On day #3 she felt much better, which was just yesterday, but she started to get an itchy arm, was still a tiny bit sore, but really itchy.  She had not looked at it and it's red around the injection site of that arm and that continues today.  She hopes that it will go away, and it says that the reaction would start within 1-3 days, and then the symptoms would go away within 3 days.  She did not know if it would go away completely on it's own and she called her doctor to see if he has anything she can take, and is waiting for that phone call.  She has had 6 previous vaccines, and has never had a reaction from any of those vaccines.