chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Attention deficit hyperactivity disorder, Autism spectrum disorder, Foetal exposure during pregnancy
Clinical narrative: AUTISM; ADHD; DRUG EXPOSURE IN UTERO; This spontaneous pregnancy report received from a patient concerned a male child of unspecified age. The patient's weight, height, and medical history were not reported. The patient's mother concurrent conditions included: allergic to pickles, and allergic to salami. The patient's mother received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration not reported) 800 mg, administered in 21-SEP-2020(also reported as 18-SEP-2021) for covid-19 prophylaxis. The baby was exposed to covid-19 vaccine ad26.cov2.s via transplacental route (drug exposure in utero). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced autism, adhd, and drug exposure in utero (Dose number in series 1). Patient mother had a complicated pregnancy and was in a lot of pain, stomach, vagina, a lot of headaches constantly ongoing, diarrhea for weeks at a time. A lot of complications with delivery with child heavy bleeding nonstop for about 25 to 30 minutes painful going on constantly and patient mother told the doctor and nurse more than 10 times and they did not believe me when patient mother told them so patient came out and slipped out of the doctor and nurse hand, they grabbed head, neck legs, back, stomach very hard almost dropping him on the floor squeezing out they hands, strongly think that they damage patient because now patient had serious behavior problems, autism, ADHD (Attention-deficit/hyperactivity disorder), constantly fighting with sister and other family members and friends on three different medications to calm down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drug exposure in utero, and the outcome of autism and adhd was not reported. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20231231754.; Sender's Comments: V0: Attention deficit hyperactivity disorder, Autism spectrum disorder. . The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: NATURE OF EVENT(Elderly pregnancy in mother, complications during pregnancy). Therefore, this event is considered inconsistent with vaccine administration.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE; Nurse called to report temperature excursion for the following vaccines:  VAQTA, PEDVAXHIB, ROTATEQ, and GARDASIL 9.  Upon reviewing excursion questions, Nurse stated unsure if vaccines had been administered as the vaccines had several prior excursio; This spontaneous report was received from a nurse refers to a 2-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 29-DEC-2023, the patient was vaccinated with an improperly stored second dose of hepatitis a vaccine, inactivated (VAQTA), formulation: intramuscular injection, lot # X010373, expiration date: 13-NOV-2024, intramuscular in the left thigh (exact dose was not provided) for prophylaxis.  It was reported that the vaccines storage unit temperature excursion was identified after vaccines administered on 29-DEC-2023. Administered doses of vaccines were exposed to the temperature excursion on 20-DEC-2023 of 1.6 (units not provided); on 21-DEC-2023 of 1.1 C for 3 hours and 41 minutes; on 22-DEC-2023 of 1.0 (units not provided) for 5 hours and 24 minutes; on 23-DEC-2023 of 1.4 (units not provided) for 4 hours and 25 minutes; on 24-DEC-2023 of 1.4 C for 4 hours and 47 minutes; on 25-DEC-2023 of 1.0 (units not provided) for 5 hours and 36 minutes; on 27-DEC-2023 of 0.3 (units not provided) for 4 hours and 37 minutes; on 28-DEC-2023 of 2.4 (units not provided) for 4 hours and 8 minutes; and on 29-DEC-2023 of 1.7 (units not provided) for 1 hour and 44 minutes (product storage error). No additional adverse event reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic adverse events reported. No additional AE/PQC.; the patient may have received a dose of VARIVAX that suffered a Temperature Excursion; This spontaneous report has been received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was not provided.  On 26-DEC-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection 0.5 milliliter as prophylaxis (lot number W025274 has been verified to be valid, expiration date 10-AUG-2024; route of administration and anatomical location of vaccination were not provided), which suffered temperature excursions of -13 degrees Celsius (C) during 1 hour and 30 minutes and -4C during 1 hour (product storage error). There were no symptomatic adverse events reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; an expired dose of MMR II was inadvertently administered to a patient; This spontaneous report has been received from a pharmacist and refers to a 12-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies were not provided. Concomitant medications included sterile diluent.  On 21-DEC-2023, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) injection as prophylaxis (lot number U039907 has been verified to be valid, expiration date 16-DEC-2023; dose, route of administration and anatomical location of vaccination were not provided) (expired product administered). There were no additional adverse events.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received the first dose at about 2 months, the second dose at about 4 months, and the booster dose about 6 months; Patient did not experienced any side effects; This spontaneous report was received from a patient's family member and refers to an infant patient of unknown age and gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.  On an unknown date, the patient received the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) at about 2 months of age, the second dose at about 4 months of age, and the booster dose at about 6 months of age, for prophylaxis (quantity dose, lot #, expiration date and route were not reported). The product insert recommended that the booster dose be administered at age 12-15 months (product administered to patient of inappropriate age ). The patient did not experience any side effects that the reporter aware of.
Sex: F
Vaccine: HEPAB
Symptoms: Arthralgia, Limb discomfort, Myalgia
Clinical narrative: Elbow pain; Muscle pain; Discomfort when squeezing a tube of something, such as toothpaste.; This non-serious case was reported by a consumer via patient support programs and described the occurrence of pain in elbow in a 75-year-old female patient who received HAB (Twinrix) (batch number 2PG39, expiry date 19-SEP-2026) for prophylaxis.   Concurrent medical conditions included urinary tract disorder, herpes virus infection, osteopenia, vaginal prolapse and rosacea. Additional patient notes included The patient had no previous problems of this type with any vaccine. . Concomitant products included methenamine hippurate, valaciclovir (Valacyclovir), risedronate sodium (Risendron), estrogens conjugated (Premarin) and metronidazole (Metrogel).   On 01-DEC-2023, the patient received the 1st dose of Twinrix. On 03-DEC-2023, 2 days after receiving Twinrix, the patient experienced pain in elbow (Verbatim: Elbow pain), muscle pain (Verbatim: Muscle pain) and discomfort (Verbatim: Discomfort when squeezing a tube of something, such as toothpaste.). The outcome of the pain in elbow, muscle pain and discomfort were not resolved.   It was unknown if the reporter considered the pain in elbow, muscle pain and discomfort to be related to Twinrix and Twinrix Pre-Filled Syringe Device.  It was unknown if the company considered the pain in elbow, muscle pain and discomfort to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   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: 18-JAN-2024 The patient had elbow pain, muscle aches and discomfort when arm was by her side or carrying objects, discomfort when squeezing a tube of something, such as toothpaste.  Pain and discomfort varied from day to day. The patient received it strictly as a preventive. She had reported these side effects to her primary care doctor, and to the pharmacists where she received the vaccine.  The pharmacy had reported that to VAERS, the Vaccine Adverse Event Reporting System. The reporter consented to follow up.
Sex: U
Vaccine: DTAP, DTAPIPV, HPVX, MNQ
Symptoms: Product storage error
Clinical narrative: Product storage error; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in an unspecified number of patient's who received Men ACWY-CRM NVS (Menveo) (batch number 3553D), (batch number AMVA985A) and (batch number AMVA986A) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) (batch number 34M4F9) for prophylaxis, HPV 16-18 (HPV vaccine) (batch number X005579) for prophylaxis and DTPa (DTaP vaccine) (batch number 58773) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, the patient received Kinrix, HPV vaccine and DTaP vaccine. On 10-NOV-2023, an unknown time after receiving Menveo, Kinrix, HPV vaccine and DTaP vaccine, the patient experienced incorrect storage of drug (Verbatim: Product storage error). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 18-Jan-2024 The reporter reported that the vaccines which are Menveo, Kinrix, HPV and DTAP kept at temperatures that are out of specification for product storage and even though those conditions of storage were not kept in line with described storage conditions the vaccines had been provided to patients. The reporter gave just the general information, no information on patients neither effects were provided.  The reporter wanted to know what shall be done. The storage temperatures should be kept between 36 to 46 F and the temperatures noted during audit of temperatures conditions were as during 10th, 11th, 12th, 13th November 2023 the recorded temperatures were 47,7F; 47,3F; 47,5F; 47,7 F, where F stands for Fahrenheit temperature, which led to incorrect storage of drug. The reporter did not provided further details had been given neither on patients nor any effects observed.  The reporter advised that no vaccines, products shall be provided to any patient if vaccines/product had been stored in conditions that were out of specification for storage.  The reporter was informed that in case of any effects observed the patients shall refer to their physicians and all the respective reports of conditions observed shall be reported using regular local rules for such the events being either adverse reactions or quality complaints. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient with 2 plus years since first dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date, received first dose 2 plus years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient with 2 plus years since first dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-JAN-2024 The reporter asked about the efficacy of shingles vaccination when second dose would be given beyond 6 months from first dose.  Patient was 2 plus years since first dose of Shingrix, which led to incomplete course of vaccination. No further details were provided on form.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late for 2nd dose/not receive 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose few years back). Additional patient notes included Not immunocompromised.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: late for 2nd dose/not receive 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-JAN-2024 A pharmacist reported that a patient received first dose of Shingrix few years back (no date available) and did not get the 2nd dose.  The reporter wanted to know repeat the series. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 1.42
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: ADACEL vaccine was accidentally administered to a17-month-old instead of flu vaccine with no reported adverse event; ADACEL vaccine was accidentally administered to a 17-month-old instead of flu vaccine with no reported adverse event; Initial information received on 19-Jan-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2024SA025939(CLUSTER).  This case involves 17 months old and unknown gender patient who was accidentally administered Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] instead of Influenza Vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or no other vaccines: NO   On 19-Jan-2024, the patient was accidentally administered a standard dose of 0.5 ml of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (with an unknown expiry date, lot number) (Frequency: Once) via intramuscular route in the left deltoid for immunization instead of influenza vaccine produced by unknown manufacturer with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency- same day). Information on the batch number was requested  Caller stated that the vaccine was accidentally administered to a 2 year and 17-month-old instead of flu vaccine. Caller would like to know the potential adverse effects and what to monitor in the children.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Depression, Dizziness, Epstein-Barr virus infection
Clinical narrative: EBV, Mono 2 weeks after injection. Very sick, slept over 15 hours a day for 3-4 months, could not walk far, and had to take the elevator at school. Chronic fatigue, muscle/joint pain, dizziness. Still experiencing chronic pain, muscle/joint pain, depression, and anxiety over a chronic illness, now approaching three years.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Heart rate increased, Hepatic enzyme increased, Hypersomnia
Clinical narrative: EBV, Mono 2 weeks after injection. Very sick, slept over 15 hours a day for 3-4 months, could not walk far, and had to take the elevator at school. Chronic fatigue, muscle/joint pain, dizziness. Still experiencing chronic pain, muscle/joint pain, depression, and anxiety over a chronic illness, now approaching three years.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Infectious mononucleosis, Malaise, Myalgia, Non-alcoholic fatty liver, Pain
Clinical narrative: EBV, Mono 2 weeks after injection. Very sick, slept over 15 hours a day for 3-4 months, could not walk far, and had to take the elevator at school. Chronic fatigue, muscle/joint pain, dizziness. Still experiencing chronic pain, muscle/joint pain, depression, and anxiety over a chronic illness, now approaching three years.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Polycystic ovarian syndrome, Pruritus, Skin disorder
Clinical narrative: EBV, Mono 2 weeks after injection. Very sick, slept over 15 hours a day for 3-4 months, could not walk far, and had to take the elevator at school. Chronic fatigue, muscle/joint pain, dizziness. Still experiencing chronic pain, muscle/joint pain, depression, and anxiety over a chronic illness, now approaching three years.
Age: 41.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Skin hyperpigmentation, Skin lesion, Vaccination failure
Clinical narrative: she has hyperpigmentation where the shingles rash/lesions were on located on her skin; Suspected vaccination failure; she was diagnosed with shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 42-year-old female patient who received Herpes zoster (Shingrix) (batch number BX7yf, expiry date 10-MAY-2025) and (batch number 9372K, expiry date 05-AUG-2024) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunosuppression.   On 20-JUN-2023, the patient received the 2nd dose of Shingrix (left deltoid). On 21-APR-2023, the patient received the 1st dose of Shingrix. On 22-DEC-2023, 185 days after receiving Shingrix and 245 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: she was diagnosed with shingles). On an unknown date, the patient experienced skin hyperpigmentation (Verbatim: she has hyperpigmentation where the shingles rash/lesions were on located on her skin). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved and the outcome of the skin hyperpigmentation was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and skin hyperpigmentation to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and skin hyperpigmentation to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 22-JAN-2024 The patient self reported tis case for herself. The patient had her 1st dose of shingrix administered on 21st April 2023 and the 2nd dose was administered on 20th June 2023. The patient stated, she was diagnosed with Shingles on 22nd December 2023. The patient reported she had hyperpigmentation where the shingles rash/lesions were on located on her skin. No further information is known. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Vision blurred
Clinical narrative: vaccine affected the right eye; her eyes are blurred; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (vaccine affected the right eye) and VISION BLURRED (her eyes are blurred) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE DISORDER (vaccine affected the right eye) and VISION BLURRED (her eyes are blurred). At the time of the report, EYE DISORDER (vaccine affected the right eye) and VISION BLURRED (her eyes are blurred) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-758286 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2024: Follow-up received: Reference id added; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-758286:Same Reporter Different Patient
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 7.0
Sex: M
Vaccine: TD
Symptoms: Rash, Scratch, Wound
Clinical narrative: Bumps all over his body that he scratches until they?re open wounds.  It?s been a full month nothing is helping it go away. I have tried over the counter Cortizone and  oat  baths.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time normal, Anticoagulation drug level therapeutic, Atrial fibrillation, Blood creatinine normal, Condition aggravated
Clinical narrative: Patient presented with left leg pain and swelling on apixaban 5mg po bid for 19 days prior, diagnosed with an acute extensive left leg DVT. reported recent use of COVID boosted on 11/4/23 (6th in series, with prior vaccines on 1/29/21, 2/19/21, 10/7/21, 5/6/22, 12/25/22, all Pfizer COVID vaccine). Concerned about breakthrough thrombotic case while on apixaban for a cardiac indication in the setting of recent COVID booster vaccination,
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, International normalised ratio increased, Liver function test normal, Metabolic function test normal, Pain in extremity
Clinical narrative: Patient presented with left leg pain and swelling on apixaban 5mg po bid for 19 days prior, diagnosed with an acute extensive left leg DVT. reported recent use of COVID boosted on 11/4/23 (6th in series, with prior vaccines on 1/29/21, 2/19/21, 10/7/21, 5/6/22, 12/25/22, all Pfizer COVID vaccine). Concerned about breakthrough thrombotic case while on apixaban for a cardiac indication in the setting of recent COVID booster vaccination,
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Prothrombin time prolonged, Prothrombin time shortened, Troponin normal, Ultrasound Doppler abnormal
Clinical narrative: Patient presented with left leg pain and swelling on apixaban 5mg po bid for 19 days prior, diagnosed with an acute extensive left leg DVT. reported recent use of COVID boosted on 11/4/23 (6th in series, with prior vaccines on 1/29/21, 2/19/21, 10/7/21, 5/6/22, 12/25/22, all Pfizer COVID vaccine). Concerned about breakthrough thrombotic case while on apixaban for a cardiac indication in the setting of recent COVID booster vaccination,
Age: 67.0
Sex: U
Vaccine: RSV
Symptoms: Arthropathy, Condition aggravated, Injected limb mobility decreased, Injection site pain, Magnetic resonance imaging abnormal
Clinical narrative: went to the Pharmacy at approximately 11:30 am non 9/6/2023 where I received an RSV vaccination. Approximately two hours after the shot my On September 6, 2023 at approximately 11:30 am my husband and I went to our local Pharmacy for RSV vaccinations. Approximately two hours later my right shoulder became incredibly painful and I could barely move it. My husband called local EMTs and they recommended I go to the emergency room. Within four hours my right arm was frozen and the pain was excruciating. I was immediately admitted to Hospital. The initial concern was a stroke and two days were spent in hospital ruling that out while I was administered morphine and later oxycodone to control the pain. When I finally saw an orthopedic surgeon, he was initially flummoxed, but after an internet search discovered my symptoms aligned with something called SIRVA, a condition resulting from improper vaccine administration. The doctor recommended suggested I follow up with my rheumatologist (I've had rheumatoid arthritis for 45 years), and with my orthopedic surgeon at Clinic. On October 12 I learned that my MRI at Clinic showed massive shoulder arthropathy. Dr. recommended a shoulder replacement. It was explained to me by his PA that the existing degenerative condition of my right shoulder, which had been completely asymptomatic until this ordeal, was exacerbated by damage done to the deltoid muscle (I may have the anatomy wrong here) by the RSV shot. Until I decide when such a major surgery can happen, I've been getting cortisone injections to control the pain.
Age: 67.0
Sex: U
Vaccine: RSV
Symptoms: Magnetic resonance imaging joint, Muscle injury, Musculoskeletal disorder, Periarthritis, Tendon disorder
Clinical narrative: went to the Pharmacy at approximately 11:30 am non 9/6/2023 where I received an RSV vaccination. Approximately two hours after the shot my On September 6, 2023 at approximately 11:30 am my husband and I went to our local Pharmacy for RSV vaccinations. Approximately two hours later my right shoulder became incredibly painful and I could barely move it. My husband called local EMTs and they recommended I go to the emergency room. Within four hours my right arm was frozen and the pain was excruciating. I was immediately admitted to Hospital. The initial concern was a stroke and two days were spent in hospital ruling that out while I was administered morphine and later oxycodone to control the pain. When I finally saw an orthopedic surgeon, he was initially flummoxed, but after an internet search discovered my symptoms aligned with something called SIRVA, a condition resulting from improper vaccine administration. The doctor recommended suggested I follow up with my rheumatologist (I've had rheumatoid arthritis for 45 years), and with my orthopedic surgeon at Clinic. On October 12 I learned that my MRI at Clinic showed massive shoulder arthropathy. Dr. recommended a shoulder replacement. It was explained to me by his PA that the existing degenerative condition of my right shoulder, which had been completely asymptomatic until this ordeal, was exacerbated by damage done to the deltoid muscle (I may have the anatomy wrong here) by the RSV shot. Until I decide when such a major surgery can happen, I've been getting cortisone injections to control the pain.
Age: 67.0
Sex: U
Vaccine: RSV
Symptoms: Tendon rupture
Clinical narrative: went to the Pharmacy at approximately 11:30 am non 9/6/2023 where I received an RSV vaccination. Approximately two hours after the shot my On September 6, 2023 at approximately 11:30 am my husband and I went to our local Pharmacy for RSV vaccinations. Approximately two hours later my right shoulder became incredibly painful and I could barely move it. My husband called local EMTs and they recommended I go to the emergency room. Within four hours my right arm was frozen and the pain was excruciating. I was immediately admitted to Hospital. The initial concern was a stroke and two days were spent in hospital ruling that out while I was administered morphine and later oxycodone to control the pain. When I finally saw an orthopedic surgeon, he was initially flummoxed, but after an internet search discovered my symptoms aligned with something called SIRVA, a condition resulting from improper vaccine administration. The doctor recommended suggested I follow up with my rheumatologist (I've had rheumatoid arthritis for 45 years), and with my orthopedic surgeon at Clinic. On October 12 I learned that my MRI at Clinic showed massive shoulder arthropathy. Dr. recommended a shoulder replacement. It was explained to me by his PA that the existing degenerative condition of my right shoulder, which had been completely asymptomatic until this ordeal, was exacerbated by damage done to the deltoid muscle (I may have the anatomy wrong here) by the RSV shot. Until I decide when such a major surgery can happen, I've been getting cortisone injections to control the pain.
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Balance disorder, Dizziness, Loss of consciousness
Clinical narrative: Donor was immunized following her plasmapheresis donation in her left arm with her 3rd dose of 0.5 ml of td Tenivac tetanus vaccine. Immunization was performed with no complications and donor stated she felt fine. Donor was seated for 13 minutes into her 15-minute observatory period when she began to feel lightheaded and stood up to ask for assistance from staff. Upon approaching the front desk/reception, donor felt weak and dizzy and began to lose stability. Donor caught herself by holding onto the desk and then eased herself down onto the ground in a supine position and then lost consciousness for less than 10 seconds, gaining consciousness shortly after around approximately 10:51. Donor was provided comfort care, the donors' legs were elevated, ice packs applied, and vitals where taken (85/58 HR 58 @10:53). Donor had facial pallor and was noted to be sweating. Donor expressed she felt slight dizziness and lightheaded seconds prior to loss of consciousness. Donor disclosed she had 2 eggs at 7 am and approximately a gallon of water prior to donating. Donor denied taking any medication at this time. Donor's immunization site was normal in appearance, with no signs of local reaction. Donor was transported to exam room via wheelchair and was monitored and provided snacks and electrolyte beverage to consume to manage symptoms. Donor stated symptoms ceased/resolved approximately around 11:05am. Donor had remaining 2 sets of vitals taken whilst in exam room: 2nd set: 94/68 HR: 83@11:00 3RD set: 107/70 HR 88 @11:10. Donor left center unaccompanied at 11:30am approximately with a stable; vital signs, gait, and appearance.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Paranasal sinus hypersecretion, Productive cough, Rash
Clinical narrative: Patient receives soreness from initial shot, later to encounter redness, swollen, "rash" on left arm. Following  two days,  patient has chills, tiredness, and unable to lay on shoulder.  Patient covered in blankets, rested, and drink plenty of fluids.  During this time, sinus nasal drainage, sneezing, and release minor phlegm.   I did receive any treatment from urgent care.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous, Rash papular, Sneezing
Clinical narrative: Patient receives soreness from initial shot, later to encounter redness, swollen, "rash" on left arm. Following  two days,  patient has chills, tiredness, and unable to lay on shoulder.  Patient covered in blankets, rested, and drink plenty of fluids.  During this time, sinus nasal drainage, sneezing, and release minor phlegm.   I did receive any treatment from urgent care.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 71.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Arthralgia, Basophil count, C-reactive protein
Clinical narrative: Started aching in shoulder and hip joints by nighttime.  St first hips were worse, then somewhat subsided.  Arms and shoulders progressively got worse.  It is affecting most daily activities.  Have been taking ibuprophen.  Starting a trilal of prednisone.
Age: 71.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Eosinophil count, Loss of personal independence in daily activities, Lymphocyte count, Mean cell volume, Monocyte count
Clinical narrative: Started aching in shoulder and hip joints by nighttime.  St first hips were worse, then somewhat subsided.  Arms and shoulders progressively got worse.  It is affecting most daily activities.  Have been taking ibuprophen.  Starting a trilal of prednisone.
Age: 71.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Neutrophil count, Pain in extremity, Platelet count, Red blood cell count, Red cell distribution width
Clinical narrative: Started aching in shoulder and hip joints by nighttime.  St first hips were worse, then somewhat subsided.  Arms and shoulders progressively got worse.  It is affecting most daily activities.  Have been taking ibuprophen.  Starting a trilal of prednisone.
Age: 71.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Rheumatoid factor, White blood cell count
Clinical narrative: Started aching in shoulder and hip joints by nighttime.  St first hips were worse, then somewhat subsided.  Arms and shoulders progressively got worse.  It is affecting most daily activities.  Have been taking ibuprophen.  Starting a trilal of prednisone.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Persistent left shoulder pain and stiffness after one week of vaccine injection , not improving with symptomatic measures including ice compression and ibuprofen
Age: 70.0
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Ended up giving wrong vaccine no adverse event has occurred.
Age: 13.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediarix given outside of age recommended.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Delivery, Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: Patient was scheduled to receive a TDAP, a flu vaccine was given, no adverse reaction. Patient was 34 weeks pregnant at the time of vaccine. G2, P2 baby weight at delivery 7lbs.14oz
Age: 0.5
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient was to receive Pediarix vaccine however, the clinical staff administered Tdap (Boostrix) instead.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administerred Pfizer COVID-19 23-24 in error. Last Day of Use was 01/22/2024. Parent notified.
Age: 14.0
Sex: M
Vaccine: MMR
Symptoms: Hypotonia, Tremor
Clinical narrative: Pt. received MMR vaccine and started to close his eyes and get limp. I held him and his mother came over and he started to shake for a few seconds and then stop. He opened his eyes and we started to check his blood pressure at 10:07 am 102/52 Pulse 82. The patient had not eaten anything so we asked for a family member to get some food and drink for him.  Checked his blood pressure at 10:15 119/74 Pulse 69. He ate a breakfast taco and drank some juice.  Pt. stated he was feeling good to finish vaccinating him so I did. Checked his blood pressure at 10:38 115/74 Pulse 75 and patient was released to leave at 10:50am.
Age: 54.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Blister, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Pateint reported that approximated 3 hours after receiving the vaccine, he developed self reported fever, sweating, aching in joints and all over body aches and little, puple colored blisters on his hands.  He states these symptoms lasted for a few days.  He reports that after 3-4 days he felt better and the only symptom he still has is the rash on his hands.
Age: 54.0
Sex: M
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: Pateint reported that approximated 3 hours after receiving the vaccine, he developed self reported fever, sweating, aching in joints and all over body aches and little, puple colored blisters on his hands.  He states these symptoms lasted for a few days.  He reports that after 3-4 days he felt better and the only symptom he still has is the rash on his hands.
Age: 66.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak  in usual location  of shingles outbreaks for 15 years, on left hip.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Differential white blood cell count, Dyspnoea, Full blood count, Heart rate increased, Human chorionic gonadotropin
Clinical narrative: I took the vaccine at 12:45 pm. Around 6 pm, I started having trouble breathing and had a rapid heart rate.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Thyroxine free, Troponin T
Clinical narrative: I took the vaccine at 12:45 pm. Around 6 pm, I started having trouble breathing and had a rapid heart rate.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: gave expired vaccine
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: gave expired vaccine. expired 01/02/2024 and child received in 01/29/2024
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Vaccine given 6 days after expiration date.  Patient did not have an adverse reaction.
Age: 62.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Unevaluable event
Clinical narrative: PT STATED HE WAS HERE FOR 2ND MONKEYPOX, NO SCREEN OR RECORDS GIVEN AT TIME OF REGISTRATION. WENT BASED OFF PT REPORTING THAT HE WAS HERE FOR SECOND DOSE.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: his arm swelled up from shoulder joint to elbow joint, was rock hard, red, patchy and very hot to touch the next morning after the flu vaccine. He also ran a fever.  We could see his arm continuing to swell and get harder in the afternoon so we took him to urgent care. He was diagnosed with bacterial cellulitis from the flu shot. We were told this happens from unsanitary techniques or a bad lot. We were advised by doctor to call health department Monday morning. Health department has us filling out this form and contacting pharmacy where vaccine was given. Our son is starting to improving from the antibiotics and steroids the doctor prescribed for the bacterial cellulitis.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: his arm swelled up from shoulder joint to elbow joint, was rock hard, red, patchy and very hot to touch the next morning after the flu vaccine. He also ran a fever.  We could see his arm continuing to swell and get harder in the afternoon so we took him to urgent care. He was diagnosed with bacterial cellulitis from the flu shot. We were told this happens from unsanitary techniques or a bad lot. We were advised by doctor to call health department Monday morning. Health department has us filling out this form and contacting pharmacy where vaccine was given. Our son is starting to improving from the antibiotics and steroids the doctor prescribed for the bacterial cellulitis.
Age: 71.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse effects just wrong vaccine given
Age: 99.0
Sex: F
Vaccine: RSV
Symptoms: Gait disturbance, Injection site erythema, Injection site mass, Injection site pain, Injection site paraesthesia
Clinical narrative: She got her vaccine in the upper right buttock, she had a sensitivity where the shot was, red and a lump, but nothing terrible.  Then the lump was still there for a while, but then the redness went down and the tingling went down.  Then after about 5 days the thigh started being sensitive, weak and painful and travels down the right side to the knee.  She is taking Tylenol to help her for the pain and a heating pad.  She did contact her doctor and he told her not to take the new COVID vaccine yet, and they have asked around and they have had reactions from the vaccine as well.   The leg continues to feel weak and has difficulty walking.  From the moment she wakes up she feels the pain and the heating pad which does help but once the Tylenol wears off she has to take more.  When she lies down flat she is OK, but when she is up and above she feels the pain.  She is a very active person and since the vaccine she has been limiting by her activities due to the pain.    With her CLL you seem to have swollen lymph nodes, which hers are swollen around her arm pits and her neck.   She  has gotten all of her other vaccines in her arm, but she had swollen lymph nodes the last time not knowing if it was from the CLL or vaccine, so they decided not to proceed with future vaccines in her arm.
Age: 99.0
Sex: F
Vaccine: RSV
Symptoms: Loss of personal independence in daily activities, Lymphadenopathy, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: She got her vaccine in the upper right buttock, she had a sensitivity where the shot was, red and a lump, but nothing terrible.  Then the lump was still there for a while, but then the redness went down and the tingling went down.  Then after about 5 days the thigh started being sensitive, weak and painful and travels down the right side to the knee.  She is taking Tylenol to help her for the pain and a heating pad.  She did contact her doctor and he told her not to take the new COVID vaccine yet, and they have asked around and they have had reactions from the vaccine as well.   The leg continues to feel weak and has difficulty walking.  From the moment she wakes up she feels the pain and the heating pad which does help but once the Tylenol wears off she has to take more.  When she lies down flat she is OK, but when she is up and above she feels the pain.  She is a very active person and since the vaccine she has been limiting by her activities due to the pain.    With her CLL you seem to have swollen lymph nodes, which hers are swollen around her arm pits and her neck.   She  has gotten all of her other vaccines in her arm, but she had swollen lymph nodes the last time not knowing if it was from the CLL or vaccine, so they decided not to proceed with future vaccines in her arm.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Erythema, Injection site erythema, Pruritus
Clinical narrative: Vaccination done on 1/18/24.  The following day noticed redness around injection site, dark redness across upper torso all around to back.  Burning sensation and itchy.  No blistering, welts or seepage.  Took over the counter Benadryl to help with itch.  Not sure what reaction was from as I never had a reaction from any vaccination and went through process of elimination of what I may have ingested, touched etc.  Redness, burning and itch still present 6 days later.  Saw my physician 1/25/24 who documented it was an adverse reaction to the AREXVY vaccination and prescribed MethylPHEDNISolone to be taken for 6 days.  She advised to return if symptoms do not clear up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Psoriasis, Psoriatic arthropathy
Clinical narrative: Psoriasis flare and Severe Psoriatic Arthritis diagnosis
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site bruising, Injection site nodule, Injection site pain
Clinical narrative: Soreness at injection site, headache, fatigue;  headache and fatigue continued for 10 days and some lingers at a lower level;  soreness at injection site has not gone away - there remains a bruised at painful knot at the area some 3 weeks after the shot
Age: 37.0
Sex: M
Vaccine: FLUR4, HPV9, VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is not eligible for Shingrix vaccine at current age.  Was administered in the right arm and patient reported no side effects.  Patient will get this vaccine when they are at the appropriate age of 50 unless recommendations change.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Blood glucose normal, Dizziness, Loss of consciousness, Slow response to stimuli, Tonic clonic movements
Clinical narrative: After the patient received her 2nd dose of Gardasil she went down to lab for routine tests.  After getting her blood drawn, the patient lost consciousness and had some mild tonic/clonic activity Patient lost control of her bladder during the event.  The event lasted  approximately 1 minute and patient was slow to become responsive afterwards taking approximately 30-45 seconds to become fully responsive.  Patient reported being dizzy but no other complaints.  She had a poptart for breakfast and this happened at about 11am.  Her blood sugar was 91 with a normal blood pressure.  she had done OK with her first dose of Gardasil except for some dizziness but no syncope.  There is a family  history of seizures but the patient has never had a seizure before.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Urinary incontinence
Clinical narrative: After the patient received her 2nd dose of Gardasil she went down to lab for routine tests.  After getting her blood drawn, the patient lost consciousness and had some mild tonic/clonic activity Patient lost control of her bladder during the event.  The event lasted  approximately 1 minute and patient was slow to become responsive afterwards taking approximately 30-45 seconds to become fully responsive.  Patient reported being dizzy but no other complaints.  She had a poptart for breakfast and this happened at about 11am.  Her blood sugar was 91 with a normal blood pressure.  she had done OK with her first dose of Gardasil except for some dizziness but no syncope.  There is a family  history of seizures but the patient has never had a seizure before.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Angiogram pulmonary abnormal, Pulmonary embolism, Troponin
Clinical narrative: Hospitilizaiton for NSTEMI and pulmonary embolus
Age: 59.0
Sex: M
Vaccine: COVID19-2, FLUC4, HEP, MMR, TDAP
Symptoms: Dizziness, Eye pruritus, Visual impairment
Clinical narrative: Lightheadedness 2 days after(did not occur again). Progressively worsening far-sightedness. Eye itching