chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo vaccine, and employee use sterile diluent instead of using the liquid component of the Menveo,; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA98XA, expiry date 30-SEP-2025) for prophylaxis.   On an unknown date, the patient did not receive Menveo. On 22-JUL-2024, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo vaccine, and employee use sterile diluent instead of using the liquid component of the Menveo,). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 05-AUG-2024 A reporter reported that he/she just had a question about the Menveo vaccine, and employee use sterile diluent instead of using the liquid component of the Menveo which led to wrong solution used for drug reconstitution. The reporter wanted to know how we proceed with that. The vaccine administration facility was the same as primary reporter. The reporter did not have the specific date, they only said that it was 2 weeks ago, he/she set 22 July 2024 due to the system do not allow to left this space in blank. Also they confirmed that they did administer this vaccine to the patient.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Insomnia, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Vomiting, Low grade fever, excessively snotty nose, inability to sleep.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong technique in device usage process, Wrong technique in product usage process
Clinical narrative: she administered Havrix to a 12 month old male using a 5/8 inch needle instead of 1 inch needle; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong technique in device usage process in a 12-month-old male patient who received HAV (Havrix) for prophylaxis.   On 31-JUL-2024, the patient received Havrix. On 31-JUL-2024, an unknown time after receiving Havrix, the patient experienced wrong technique in device usage process (Verbatim: she administered Havrix to a 12 month old male using a 5/8 inch needle instead of 1 inch needle). The outcome of the wrong technique in device usage process was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-AUG-2024 The reporter reported the patient administered Havrix to the patient using a 5 by 8 inch needle instead of 1 inch needle (1 inch needle recommended by (centers for disease control)CDC), which led wrong technique in device usage process. The reporter consented to follow up.
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Temperature went down to minus 2.9 degree C, and then 8 hours later the vaccine was given to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 10-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number Z7L7H, expiry date 09-AUG-2026) for prophylaxis.   On 05-AUG-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Temperature went down to minus 2.9 degree C, and then 8 hours later the vaccine was given to a patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-AUG-2024 A nurse reported that a problem with the refrigerator, temperature went down to minus 2.9 degree Celsius, and then 8 hours later the vaccine was given to a patient which led to incorrect storage of drug. The reporter wanted to know do we have to revaccinate him. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024097592:Same reporter/Different patient US-GSK-US2024097595:Same reporter/Different patient
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-AUG-2024, the patient received the 2nd dose of Shingrix. In AUG-2024, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: headache). The outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.     It was unknown if the company considered the headache to be related to Shingrix.   Additional Information: GSK receipt date: 06-AUG-2024 The customer reported developing a headache after receiving his second shingrix dose one day ago. Did not consent to follow-up.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expire dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received MMR (Priorix) (batch number L322P, expiry date 01-AUG-2024) for prophylaxis.   On 05-AUG-2024, the patient received the 1st dose of Priorix. On 05-AUG-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Expire dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-AUG-2024 The reporter reported that the patient had an expired Priorix vaccine that was given, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: headache that is like a migraine; This non-serious case was reported by a consumer via call center representative and described the occurrence of migraine type headaches in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-AUG-2024, the patient received the 2nd dose of Shingrix. On 05-AUG-2024, less than a day after receiving Shingrix, the patient experienced migraine type headaches (Verbatim: headache that is like a migraine). The outcome of the migraine type headaches was unknown.   It was unknown if the reporter considered the migraine type headaches to be related to Shingrix.     It was unknown if the company considered the migraine type headaches to be related to Shingrix.   Additional Information: GSK receipt date: 06-AUG-2024 The reporter was a friend calling on behalf of a female patient that received the second dose of the Shingrix vaccine yesterday (day before reporting) and reported having a headache that is like a migraine, that started yesterday.  The reporter had no information about the Shingrix vaccine.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received MMR (Priorix) (batch number L322P, expiry date 01-AUG-2024) for prophylaxis.   On 06-AUG-2024, the patient received Priorix. On 06-AUG-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-AUG-2024 The registered nurse reported that the patient received an expired dose of Priorix vaccine, giving limited data on patient, vaccine and event,which led to expired vaccine used. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: MENB, MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inappropriate age; inappropriate age; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 82-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included aortic surgery and splenectomy.   On 16-NOV-2023, the patient received the 2nd dose of Bexsero. On 23-AUG-2021, the patient received the 1st dose of Bexsero. On 23-AUG-2021, not applicable after receiving Bexsero and an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: inappropriate age). On 16-NOV-2023, the patient experienced inappropriate age at vaccine administration (Verbatim: inappropriate age). The outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-AUG-2024 The patient self-reported this case for herself. The patient was 82 years old at the time of reporting and the approval age for Bexsero was 10 to 25 years old. The patient received 2 doses of Bexsero at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: RSV, RSV
Symptoms: Atrial fibrillation, Heart rate increased
Clinical narrative: atrial fibrillation; elevated heart rate; This serious case was reported by a pharmacist via call center representative and described the occurrence of atrial fibrillation in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: atrial fibrillation) (serious criteria GSK medically significant) and heart rate increased (Verbatim: elevated heart rate). The outcome of the atrial fibrillation and heart rate increased were unknown.   It was unknown if the reporter considered the atrial fibrillation and heart rate increased to be related to Arexvy.     The company considered the atrial fibrillation to be unrelated to Arexvy. It was unknown if the company considered the heart rate increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-AUG-2024 The pharmacist reported that, the patient developed an elevated heart rate and atrial fibrillation the day after receiving the Arexvy vaccine.; Sender's Comments: Atrial fibrillation is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Influenza like illness, Meningism, Mobility decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: feels like meningitis; neck is so stiff/ can't move it left or right, if bends forward it is bad; neck hurts so bad; This is a spontaneous report received from a Nurse.  A 54-year-old female patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 06Aug2024 at 09:00 as dose 1, 0.5 ml single (Batch/Lot number: unknown) at the age of 54 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID oral taken for hyperthyroidism (ongoing); LISINOPRIL oral taken for hypertension, start date: 20 years ago (ongoing); PRILOSEC [OMEPRAZOLE] oral taken for gastrooesophageal reflux disease, start date: 30 years ago (ongoing); CRESTOR oral taken for hyperlipidaemia, start date: about 2 months ago (ongoing). The patient did not receive any prior vaccinations within 4 weeks. The following information was reported: MENINGISM (medically significant) with onset 06Aug2024, outcome "not recovered", described as "feels like meningitis"; NECK PAIN (medically significant) with onset 06Aug2024, outcome "not recovered", described as "neck hurts so bad"; MUSCULOSKELETAL STIFFNESS (medically significant) with onset 06Aug2024, outcome "not recovered", described as "neck is so stiff/ can't move it left or right, if bends forward it is bad". The clinical course was reported as follows: The patient expected achiness and mild flu like symptoms, but stated this was horrible, felt like had meningitis, neck was so stiff, hurt so bad, couldn't move it left or right, if bent forward it was bad. The events started within 12 hours of getting the vaccine, reported only on the left side, which is the side that the patient received the vaccine.  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: A possibly contributory role of PREVNAR 20 in triggering the onset of all reported events cannot be fully excluded, considering the temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Pain
Clinical narrative: feels like meningitis; neck is so stiff/ can't move it left or right, if bends forward it is bad; neck hurts so bad; This is a spontaneous report received from a Nurse.  A 54-year-old female patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 06Aug2024 at 09:00 as dose 1, 0.5 ml single (Batch/Lot number: unknown) at the age of 54 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID oral taken for hyperthyroidism (ongoing); LISINOPRIL oral taken for hypertension, start date: 20 years ago (ongoing); PRILOSEC [OMEPRAZOLE] oral taken for gastrooesophageal reflux disease, start date: 30 years ago (ongoing); CRESTOR oral taken for hyperlipidaemia, start date: about 2 months ago (ongoing). The patient did not receive any prior vaccinations within 4 weeks. The following information was reported: MENINGISM (medically significant) with onset 06Aug2024, outcome "not recovered", described as "feels like meningitis"; NECK PAIN (medically significant) with onset 06Aug2024, outcome "not recovered", described as "neck hurts so bad"; MUSCULOSKELETAL STIFFNESS (medically significant) with onset 06Aug2024, outcome "not recovered", described as "neck is so stiff/ can't move it left or right, if bends forward it is bad". The clinical course was reported as follows: The patient expected achiness and mild flu like symptoms, but stated this was horrible, felt like had meningitis, neck was so stiff, hurt so bad, couldn't move it left or right, if bent forward it was bad. The events started within 12 hours of getting the vaccine, reported only on the left side, which is the side that the patient received the vaccine.  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: A possibly contributory role of PREVNAR 20 in triggering the onset of all reported events cannot be fully excluded, considering the temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeding disorder, Tongue coated
Clinical narrative: She got a metal taste in her mouth; She can't even eat properly; Her tongue turned white and cannot get rid of; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "She got a metal taste in her mouth"; FEEDING DISORDER (non-serious), outcome "unknown", described as "She can't even eat properly"; TONGUE COATED (non-serious), outcome "unknown", described as "Her tongue turned white and cannot get rid of". Additional information: it was reported that the patient got Pfizer COVID vaccine and after 3 weeks she got a metal taste in her mouth, stated she can't even eat properly, and her tongue turned white and cannot get rid of. She was asking what she can do to get rid of that.  Batch/lot number is not provided, and it cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Nurse.  A 72-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Jun2024 as dose 1, single (Lot number: LE1811) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "HX of NHL in remission" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; GABAPENTIN. Past drug history included: Compazine, reaction(s): "Allergy: Compazine"; Phenergan, reaction(s): "Allergy: Phenergan". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE), for COVID-19 immunization.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient had no other vaccine in four weeks. The patient had other medications in two weeks.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: a serious case of hives/very bad hives; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. No other vaccine administered on the same date. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (medically significant), outcome "recovered", described as "a serious case of hives/very bad hives". The event "a serious case of hives/very bad hives" required physician office visit. Therapeutic measures were taken as a result of urticaria. The patient sought expert care from a dermatologist that prescribed a steroid treatment that eliminated her hives symptoms. She had no known allergies but her doctors and herself were confident the vaccine gave her very bad hives.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test negative, Malaise
Clinical narrative: gets sick often; This is a spontaneous report received from a Physician. Other Case identifier(s): 02647237.  A child patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "gets sick often". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that the child patient received an entire "primary series" with Prevnar 13, but now has "limited titers". The HCP also reported the patient "gets sick often".   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered outside the timeframe recommended by the manufacturer.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Fall, Paraesthesia, Syncope
Clinical narrative: About 15 to 20 minutes after receiving vaccination patient was found lying on the ground. She was awake when I got to her. She said she felt tingling and weak and that she had fainted.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered outside the timeframe recommended by the manufacturer.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Loss of consciousness
Clinical narrative: MOTHER REPORTED THAT PATIENT PASSED OUT FEW MINUTES AFTER THEY LEFT THE IMMINIZATION ROOM AFTER RECIEVING THE VACCINCE. 911 CALL WAS MADE IMMIDIATELY . UPPON ARRIVAL OF THE PARAMEDICS, THE PATIENT WAS ABLE TO TALK TO THEM . THE PARAMEDICS CHECKED HIS BLOOD PRESURE AND HEART RATE WHICH WAS IN THE NORMAL RANGE. THE PARAMEDICS RECOMENDED TO TAKE THE PATIENT TO THE HOSPITAL WHICH WAS REFUSED BY THE MOTHER CLAIMIMG SHE WILL TAKE HIM TO THE HOSPITAL HERSELF. THE NEXT DAY A CALL WAS MADE TO CHECK ON HIM AND THE MOTHER STATED HE IS DOING WELL.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered outside the timeframe recommended by the manufacturer.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered outside the timeframe recommended by the manufacturer.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: 6 Yrs 5 Mo Male presented to clinic and rapid response was called at 12:38PM. The nursing team and Dr. arrived immediately.  Mother was present and provided the full history.  The patient received varicella vaccination on 08/12 and reports left arm swelling with bumps forming.  Reports history of similar reaction after prior administration but had multiple vaccinations at the same time. Denies difficulty breathing, nausea, vomiting. as given Tylenol yesterday due to fever 101 but has not required any other Tylenol.? Diphenhydramine 25mg IM was ordered  by the provider and administered by MA in clinic. The patient was not in respiratory distress. The mother was made aware about ED precautions by the provider.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered outside the timeframe recommended by the manufacturer.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Palpitations, Pyrexia
Clinical narrative: Patient stated they received two vaccines on Saturday and on Sunday experienced fever, rash, palpitations, and dizziness. They noticed that the rash occurred on their face, neck, and arm and appears to be spreading on the arm with shoulder pain. They also reported having stomach pains. Patient said they have not ever experienced an adverse reaction to any other vaccine.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Patient stated they received two vaccines on Saturday and on Sunday experienced fever, rash, palpitations, and dizziness. They noticed that the rash occurred on their face, neck, and arm and appears to be spreading on the arm with shoulder pain. They also reported having stomach pains. Patient said they have not ever experienced an adverse reaction to any other vaccine.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered outside the timeframe recommended by the manufacturer.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered outside the timeframe recommended by the manufacturer.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient had body wide itching, hives across torso and both arms and down to hand/neck that lasted two weeks, and
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Impaired work ability, Influenza virus test negative, Nausea, Pain, Pyrexia
Clinical narrative: Fever, nausea, achy body for more than 5 days(unable to go to work)
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Fever, nausea, achy body for more than 5 days(unable to go to work)
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered outside the timeframe recommended by the manufacturer.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered outside the timeframe recommended by the manufacturer.
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: The patient received 2 doses of this vaccine.  One on 8/1/24 and the second on 8/13/24.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Headache, Myalgia, Sleep disorder
Clinical narrative: Starting five days after vaccine began to have severe headache, muscle aches and joint pain. No fever. Now on the fifth day of severe muscle and joint pain.  No more headache. The pain is so bad ar times I can?t sleep. Been taking ibuprofen and Tylenol now for five days.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Blood pressure abnormal, Dizziness, Dyspnoea, Lethargy, Pallor
Clinical narrative: Became dizzy, pale & Lethargic. B/P 60/40. Breathing became Labored. O2 @ 2Lpm placed on patient. Elevated feet/legs. EMS called. While waiting on EMS B/P began to return to normal, color returned to face & lips. et breathing became regular and non-labored. EMS refused upon arrival. Patient sat with O2 x 15 min & vitals returned to baseline. Patient alert/oriented. Advised not to drive today. Mother to monitor @ home & if any dizziness or SOA she will take to ER.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Allodynia, Biopsy lung abnormal, Biopsy skin abnormal, Burning sensation, Chest pain
Clinical narrative: J&J Vaccine 9-24-21@ Public Health Department (HD) Lot # 212A21A  See continuation page for further details: Reactions starting on day 4 after vaccine shot and listed in sequence has it occurred:  *****9-28-21 Allodynia in legs on day 4 after vaccine. DIAGNOSED BY NEURO SURGEON  2-14-22. Currently to be permanent damage.  *****10-1-21 Pins & needles, burning, and numbness on day 7 after Vaccine.  *****2-21-22 DIAGNOSED WTH SMALL FIBER Neuropathy BY SKIN BIOPSY FROM NEUROLOGIST OFFICE AND THRU LABS - pathology I refused proposed depression medication to control nerve pain/sfn. Sought holistic relief from nerve pain and staying off my feet for 4 months+ = chair bound.  As weeks/months progressed, so did reactions over a long period of time: On/off general feeling of malaise and fatigue - Continues on/off. Adrenal dumps/sleep distrubance -  first 3 weeks after vaccine constantly in a high state of  alertness. Could not sleep due to shocks/body zaps/adrenal dump episodes when trying to lay down for night. Continues on/off at lesser degree. Tremors throughout body and limbs - Continues on/off -especially when trying to go to sleep. Circadian rhythm off? Severe inflammation & pain right side of neck / lower neck into top of shoulder blade. Resolved. Extreme tight muscles shoulder / upper back area and throughout body - Continues on/off. Vision disturbances & diagnosed PVD - 5 weeks after vaccine. White flashes and floaters Continue! Skin rash on face - been treated 2x by Dermatologist - keeps coming back. Not fungus or bacterial based. Continues on/off. Sporadic blurry vision - no known cause - seen 3 different eye/retina specialists. Resolved. Tinnitus - in both ears - Continues. Random visceral pains throughout chest/ torso. Continues On/off.  *****July 2022 discovered a lung nodule via chest ct scan; rechecked in October 2022; Determined lung nodule increased in size and Mediastinal lymph nodes swollen. PetScan was ordered with unfavorable results; Lung Biopsy was ordered by Pulmonogist Lung Specialist.   ******DIAGNOSED 11-22-22 WITH SARCOIDOSIS THROUGH LUNG BIOPSY AT HOSPITAL. Was put on Prednisone for 2 months to control inflammation in lungs and mediastinal lymph nodes.  ******June 2024 - Rheumatologist diagnosed with Fibromyalgia.  As of August 2024; not in complete remission and struggling with most of the above symptoms on/off.  The worst symptoms for me to deal with is the neuropathy in legs/feet, vision disturbances and the body tremors.  VAERS NOTE:  Neurologist with Medical Group originally submitted a VAERS report August 2022 with a file # of E875238; however VAERS was never able to send me my final official report as I requested back in 2023.  I requested several times to include the paperwork with my notarized signature. VAERS suggested I re-submit a VAERS report to include all the updated diagnosis.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Circadian rhythm sleep disorder, Computerised tomogram thorax abnormal, Electric shock sensation, Epinephrine increased, Fatigue
Clinical narrative: J&J Vaccine 9-24-21@ Public Health Department (HD) Lot # 212A21A  See continuation page for further details: Reactions starting on day 4 after vaccine shot and listed in sequence has it occurred:  *****9-28-21 Allodynia in legs on day 4 after vaccine. DIAGNOSED BY NEURO SURGEON  2-14-22. Currently to be permanent damage.  *****10-1-21 Pins & needles, burning, and numbness on day 7 after Vaccine.  *****2-21-22 DIAGNOSED WTH SMALL FIBER Neuropathy BY SKIN BIOPSY FROM NEUROLOGIST OFFICE AND THRU LABS - pathology I refused proposed depression medication to control nerve pain/sfn. Sought holistic relief from nerve pain and staying off my feet for 4 months+ = chair bound.  As weeks/months progressed, so did reactions over a long period of time: On/off general feeling of malaise and fatigue - Continues on/off. Adrenal dumps/sleep distrubance -  first 3 weeks after vaccine constantly in a high state of  alertness. Could not sleep due to shocks/body zaps/adrenal dump episodes when trying to lay down for night. Continues on/off at lesser degree. Tremors throughout body and limbs - Continues on/off -especially when trying to go to sleep. Circadian rhythm off? Severe inflammation & pain right side of neck / lower neck into top of shoulder blade. Resolved. Extreme tight muscles shoulder / upper back area and throughout body - Continues on/off. Vision disturbances & diagnosed PVD - 5 weeks after vaccine. White flashes and floaters Continue! Skin rash on face - been treated 2x by Dermatologist - keeps coming back. Not fungus or bacterial based. Continues on/off. Sporadic blurry vision - no known cause - seen 3 different eye/retina specialists. Resolved. Tinnitus - in both ears - Continues. Random visceral pains throughout chest/ torso. Continues On/off.  *****July 2022 discovered a lung nodule via chest ct scan; rechecked in October 2022; Determined lung nodule increased in size and Mediastinal lymph nodes swollen. PetScan was ordered with unfavorable results; Lung Biopsy was ordered by Pulmonogist Lung Specialist.   ******DIAGNOSED 11-22-22 WITH SARCOIDOSIS THROUGH LUNG BIOPSY AT HOSPITAL. Was put on Prednisone for 2 months to control inflammation in lungs and mediastinal lymph nodes.  ******June 2024 - Rheumatologist diagnosed with Fibromyalgia.  As of August 2024; not in complete remission and struggling with most of the above symptoms on/off.  The worst symptoms for me to deal with is the neuropathy in legs/feet, vision disturbances and the body tremors.  VAERS NOTE:  Neurologist with Medical Group originally submitted a VAERS report August 2022 with a file # of E875238; however VAERS was never able to send me my final official report as I requested back in 2023.  I requested several times to include the paperwork with my notarized signature. VAERS suggested I re-submit a VAERS report to include all the updated diagnosis.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Gait disturbance, Hypervigilance, Hypoaesthesia, Inflammation
Clinical narrative: J&J Vaccine 9-24-21@ Public Health Department (HD) Lot # 212A21A  See continuation page for further details: Reactions starting on day 4 after vaccine shot and listed in sequence has it occurred:  *****9-28-21 Allodynia in legs on day 4 after vaccine. DIAGNOSED BY NEURO SURGEON  2-14-22. Currently to be permanent damage.  *****10-1-21 Pins & needles, burning, and numbness on day 7 after Vaccine.  *****2-21-22 DIAGNOSED WTH SMALL FIBER Neuropathy BY SKIN BIOPSY FROM NEUROLOGIST OFFICE AND THRU LABS - pathology I refused proposed depression medication to control nerve pain/sfn. Sought holistic relief from nerve pain and staying off my feet for 4 months+ = chair bound.  As weeks/months progressed, so did reactions over a long period of time: On/off general feeling of malaise and fatigue - Continues on/off. Adrenal dumps/sleep distrubance -  first 3 weeks after vaccine constantly in a high state of  alertness. Could not sleep due to shocks/body zaps/adrenal dump episodes when trying to lay down for night. Continues on/off at lesser degree. Tremors throughout body and limbs - Continues on/off -especially when trying to go to sleep. Circadian rhythm off? Severe inflammation & pain right side of neck / lower neck into top of shoulder blade. Resolved. Extreme tight muscles shoulder / upper back area and throughout body - Continues on/off. Vision disturbances & diagnosed PVD - 5 weeks after vaccine. White flashes and floaters Continue! Skin rash on face - been treated 2x by Dermatologist - keeps coming back. Not fungus or bacterial based. Continues on/off. Sporadic blurry vision - no known cause - seen 3 different eye/retina specialists. Resolved. Tinnitus - in both ears - Continues. Random visceral pains throughout chest/ torso. Continues On/off.  *****July 2022 discovered a lung nodule via chest ct scan; rechecked in October 2022; Determined lung nodule increased in size and Mediastinal lymph nodes swollen. PetScan was ordered with unfavorable results; Lung Biopsy was ordered by Pulmonogist Lung Specialist.   ******DIAGNOSED 11-22-22 WITH SARCOIDOSIS THROUGH LUNG BIOPSY AT HOSPITAL. Was put on Prednisone for 2 months to control inflammation in lungs and mediastinal lymph nodes.  ******June 2024 - Rheumatologist diagnosed with Fibromyalgia.  As of August 2024; not in complete remission and struggling with most of the above symptoms on/off.  The worst symptoms for me to deal with is the neuropathy in legs/feet, vision disturbances and the body tremors.  VAERS NOTE:  Neurologist with Medical Group originally submitted a VAERS report August 2022 with a file # of E875238; however VAERS was never able to send me my final official report as I requested back in 2023.  I requested several times to include the paperwork with my notarized signature. VAERS suggested I re-submit a VAERS report to include all the updated diagnosis.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lymphadenitis, Lymphadenopathy mediastinal, Malaise, Mobility decreased
Clinical narrative: J&J Vaccine 9-24-21@ Public Health Department (HD) Lot # 212A21A  See continuation page for further details: Reactions starting on day 4 after vaccine shot and listed in sequence has it occurred:  *****9-28-21 Allodynia in legs on day 4 after vaccine. DIAGNOSED BY NEURO SURGEON  2-14-22. Currently to be permanent damage.  *****10-1-21 Pins & needles, burning, and numbness on day 7 after Vaccine.  *****2-21-22 DIAGNOSED WTH SMALL FIBER Neuropathy BY SKIN BIOPSY FROM NEUROLOGIST OFFICE AND THRU LABS - pathology I refused proposed depression medication to control nerve pain/sfn. Sought holistic relief from nerve pain and staying off my feet for 4 months+ = chair bound.  As weeks/months progressed, so did reactions over a long period of time: On/off general feeling of malaise and fatigue - Continues on/off. Adrenal dumps/sleep distrubance -  first 3 weeks after vaccine constantly in a high state of  alertness. Could not sleep due to shocks/body zaps/adrenal dump episodes when trying to lay down for night. Continues on/off at lesser degree. Tremors throughout body and limbs - Continues on/off -especially when trying to go to sleep. Circadian rhythm off? Severe inflammation & pain right side of neck / lower neck into top of shoulder blade. Resolved. Extreme tight muscles shoulder / upper back area and throughout body - Continues on/off. Vision disturbances & diagnosed PVD - 5 weeks after vaccine. White flashes and floaters Continue! Skin rash on face - been treated 2x by Dermatologist - keeps coming back. Not fungus or bacterial based. Continues on/off. Sporadic blurry vision - no known cause - seen 3 different eye/retina specialists. Resolved. Tinnitus - in both ears - Continues. Random visceral pains throughout chest/ torso. Continues On/off.  *****July 2022 discovered a lung nodule via chest ct scan; rechecked in October 2022; Determined lung nodule increased in size and Mediastinal lymph nodes swollen. PetScan was ordered with unfavorable results; Lung Biopsy was ordered by Pulmonogist Lung Specialist.   ******DIAGNOSED 11-22-22 WITH SARCOIDOSIS THROUGH LUNG BIOPSY AT HOSPITAL. Was put on Prednisone for 2 months to control inflammation in lungs and mediastinal lymph nodes.  ******June 2024 - Rheumatologist diagnosed with Fibromyalgia.  As of August 2024; not in complete remission and struggling with most of the above symptoms on/off.  The worst symptoms for me to deal with is the neuropathy in legs/feet, vision disturbances and the body tremors.  VAERS NOTE:  Neurologist with Medical Group originally submitted a VAERS report August 2022 with a file # of E875238; however VAERS was never able to send me my final official report as I requested back in 2023.  I requested several times to include the paperwork with my notarized signature. VAERS suggested I re-submit a VAERS report to include all the updated diagnosis.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Neuralgia
Clinical narrative: J&J Vaccine 9-24-21@ Public Health Department (HD) Lot # 212A21A  See continuation page for further details: Reactions starting on day 4 after vaccine shot and listed in sequence has it occurred:  *****9-28-21 Allodynia in legs on day 4 after vaccine. DIAGNOSED BY NEURO SURGEON  2-14-22. Currently to be permanent damage.  *****10-1-21 Pins & needles, burning, and numbness on day 7 after Vaccine.  *****2-21-22 DIAGNOSED WTH SMALL FIBER Neuropathy BY SKIN BIOPSY FROM NEUROLOGIST OFFICE AND THRU LABS - pathology I refused proposed depression medication to control nerve pain/sfn. Sought holistic relief from nerve pain and staying off my feet for 4 months+ = chair bound.  As weeks/months progressed, so did reactions over a long period of time: On/off general feeling of malaise and fatigue - Continues on/off. Adrenal dumps/sleep distrubance -  first 3 weeks after vaccine constantly in a high state of  alertness. Could not sleep due to shocks/body zaps/adrenal dump episodes when trying to lay down for night. Continues on/off at lesser degree. Tremors throughout body and limbs - Continues on/off -especially when trying to go to sleep. Circadian rhythm off? Severe inflammation & pain right side of neck / lower neck into top of shoulder blade. Resolved. Extreme tight muscles shoulder / upper back area and throughout body - Continues on/off. Vision disturbances & diagnosed PVD - 5 weeks after vaccine. White flashes and floaters Continue! Skin rash on face - been treated 2x by Dermatologist - keeps coming back. Not fungus or bacterial based. Continues on/off. Sporadic blurry vision - no known cause - seen 3 different eye/retina specialists. Resolved. Tinnitus - in both ears - Continues. Random visceral pains throughout chest/ torso. Continues On/off.  *****July 2022 discovered a lung nodule via chest ct scan; rechecked in October 2022; Determined lung nodule increased in size and Mediastinal lymph nodes swollen. PetScan was ordered with unfavorable results; Lung Biopsy was ordered by Pulmonogist Lung Specialist.   ******DIAGNOSED 11-22-22 WITH SARCOIDOSIS THROUGH LUNG BIOPSY AT HOSPITAL. Was put on Prednisone for 2 months to control inflammation in lungs and mediastinal lymph nodes.  ******June 2024 - Rheumatologist diagnosed with Fibromyalgia.  As of August 2024; not in complete remission and struggling with most of the above symptoms on/off.  The worst symptoms for me to deal with is the neuropathy in legs/feet, vision disturbances and the body tremors.  VAERS NOTE:  Neurologist with Medical Group originally submitted a VAERS report August 2022 with a file # of E875238; however VAERS was never able to send me my final official report as I requested back in 2023.  I requested several times to include the paperwork with my notarized signature. VAERS suggested I re-submit a VAERS report to include all the updated diagnosis.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Paraesthesia, Pathology test, Photopsia, Pneumonitis
Clinical narrative: J&J Vaccine 9-24-21@ Public Health Department (HD) Lot # 212A21A  See continuation page for further details: Reactions starting on day 4 after vaccine shot and listed in sequence has it occurred:  *****9-28-21 Allodynia in legs on day 4 after vaccine. DIAGNOSED BY NEURO SURGEON  2-14-22. Currently to be permanent damage.  *****10-1-21 Pins & needles, burning, and numbness on day 7 after Vaccine.  *****2-21-22 DIAGNOSED WTH SMALL FIBER Neuropathy BY SKIN BIOPSY FROM NEUROLOGIST OFFICE AND THRU LABS - pathology I refused proposed depression medication to control nerve pain/sfn. Sought holistic relief from nerve pain and staying off my feet for 4 months+ = chair bound.  As weeks/months progressed, so did reactions over a long period of time: On/off general feeling of malaise and fatigue - Continues on/off. Adrenal dumps/sleep distrubance -  first 3 weeks after vaccine constantly in a high state of  alertness. Could not sleep due to shocks/body zaps/adrenal dump episodes when trying to lay down for night. Continues on/off at lesser degree. Tremors throughout body and limbs - Continues on/off -especially when trying to go to sleep. Circadian rhythm off? Severe inflammation & pain right side of neck / lower neck into top of shoulder blade. Resolved. Extreme tight muscles shoulder / upper back area and throughout body - Continues on/off. Vision disturbances & diagnosed PVD - 5 weeks after vaccine. White flashes and floaters Continue! Skin rash on face - been treated 2x by Dermatologist - keeps coming back. Not fungus or bacterial based. Continues on/off. Sporadic blurry vision - no known cause - seen 3 different eye/retina specialists. Resolved. Tinnitus - in both ears - Continues. Random visceral pains throughout chest/ torso. Continues On/off.  *****July 2022 discovered a lung nodule via chest ct scan; rechecked in October 2022; Determined lung nodule increased in size and Mediastinal lymph nodes swollen. PetScan was ordered with unfavorable results; Lung Biopsy was ordered by Pulmonogist Lung Specialist.   ******DIAGNOSED 11-22-22 WITH SARCOIDOSIS THROUGH LUNG BIOPSY AT HOSPITAL. Was put on Prednisone for 2 months to control inflammation in lungs and mediastinal lymph nodes.  ******June 2024 - Rheumatologist diagnosed with Fibromyalgia.  As of August 2024; not in complete remission and struggling with most of the above symptoms on/off.  The worst symptoms for me to deal with is the neuropathy in legs/feet, vision disturbances and the body tremors.  VAERS NOTE:  Neurologist with Medical Group originally submitted a VAERS report August 2022 with a file # of E875238; however VAERS was never able to send me my final official report as I requested back in 2023.  I requested several times to include the paperwork with my notarized signature. VAERS suggested I re-submit a VAERS report to include all the updated diagnosis.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Positron emission tomogram abnormal, Pulmonary mass, Rash, Refusal of treatment by patient, Sarcoidosis
Clinical narrative: J&J Vaccine 9-24-21@ Public Health Department (HD) Lot # 212A21A  See continuation page for further details: Reactions starting on day 4 after vaccine shot and listed in sequence has it occurred:  *****9-28-21 Allodynia in legs on day 4 after vaccine. DIAGNOSED BY NEURO SURGEON  2-14-22. Currently to be permanent damage.  *****10-1-21 Pins & needles, burning, and numbness on day 7 after Vaccine.  *****2-21-22 DIAGNOSED WTH SMALL FIBER Neuropathy BY SKIN BIOPSY FROM NEUROLOGIST OFFICE AND THRU LABS - pathology I refused proposed depression medication to control nerve pain/sfn. Sought holistic relief from nerve pain and staying off my feet for 4 months+ = chair bound.  As weeks/months progressed, so did reactions over a long period of time: On/off general feeling of malaise and fatigue - Continues on/off. Adrenal dumps/sleep distrubance -  first 3 weeks after vaccine constantly in a high state of  alertness. Could not sleep due to shocks/body zaps/adrenal dump episodes when trying to lay down for night. Continues on/off at lesser degree. Tremors throughout body and limbs - Continues on/off -especially when trying to go to sleep. Circadian rhythm off? Severe inflammation & pain right side of neck / lower neck into top of shoulder blade. Resolved. Extreme tight muscles shoulder / upper back area and throughout body - Continues on/off. Vision disturbances & diagnosed PVD - 5 weeks after vaccine. White flashes and floaters Continue! Skin rash on face - been treated 2x by Dermatologist - keeps coming back. Not fungus or bacterial based. Continues on/off. Sporadic blurry vision - no known cause - seen 3 different eye/retina specialists. Resolved. Tinnitus - in both ears - Continues. Random visceral pains throughout chest/ torso. Continues On/off.  *****July 2022 discovered a lung nodule via chest ct scan; rechecked in October 2022; Determined lung nodule increased in size and Mediastinal lymph nodes swollen. PetScan was ordered with unfavorable results; Lung Biopsy was ordered by Pulmonogist Lung Specialist.   ******DIAGNOSED 11-22-22 WITH SARCOIDOSIS THROUGH LUNG BIOPSY AT HOSPITAL. Was put on Prednisone for 2 months to control inflammation in lungs and mediastinal lymph nodes.  ******June 2024 - Rheumatologist diagnosed with Fibromyalgia.  As of August 2024; not in complete remission and struggling with most of the above symptoms on/off.  The worst symptoms for me to deal with is the neuropathy in legs/feet, vision disturbances and the body tremors.  VAERS NOTE:  Neurologist with Medical Group originally submitted a VAERS report August 2022 with a file # of E875238; however VAERS was never able to send me my final official report as I requested back in 2023.  I requested several times to include the paperwork with my notarized signature. VAERS suggested I re-submit a VAERS report to include all the updated diagnosis.