chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Viral load
Clinical narrative: Pfizer vaccine bivalent didn't work/ has contracted Omicron subvariant BAA; Pfizer vaccine bivalent didn't work/ has contracted Omicron subvariant BAA; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-761315, MOD-2024-761316.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose 3 (booster), single) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Vitiligo" (ongoing), notes: He has an autoimmune disease vitiligo; "Does not smoke cigarettes, but used to over 2.5 years ago", stop date: 2021; "contracted Omicron in Dec2021", start date: Dec2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jan2024, outcome "unknown" and all described as "Pfizer vaccine bivalent didn't work/ has contracted Omicron subvariant BAA". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown results; SARS-CoV-2 test: (26Jan2024) positive; Viral load: (17Feb2024) high viral load, notes: and still detectable. Clinical course: The patient had extremely high viral load as of 17Feb2024, has contracted Omicron subvariant BAA on 25Jan2024 and tested positive on 26Jan2024. Patient stated he had 2 monovalent Moderna vaccines, and a Moderna bivalent booster vaccine. He did not currently know the dates he received them, but he started the process 3.5-4 years ago so his mRNA waned over time. He gave permission for them to contact (withheld) to verify exact dates. Had a Pfizer bivalent vaccine about 2 years ago at (Withheld) in (Withheld). Done many blood tests. Agent asked to clarify when he was diagnosed with COVID, he said 3 days ago, 17Feb2024. Patient was also dispensed Paxlovid through (withheld) in (withheld), per his request when he contracted Omicron in Dec2021. He was diagnosed around 01Dec. It was a 5 day packet. It worked, got rid of his migraine headaches and runny nose after 7 days. He had previously received the first 2 Moderna monovalent and then Moderna booster shot.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : 202400053641 same patient/product, different events;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she had a rebound case of Covid, already took paxlovid before; she had a rebound case of Covid, already took paxlovid before; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she had a rebound case of Covid, already took paxlovid before". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Pain
Clinical narrative: I feel so bad the next day; aches; chills; sweating; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 58-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), (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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I feel so bad the next day"; PAIN (non-serious), outcome "unknown", described as "aches"; CHILLS (non-serious), outcome "unknown"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating".  Additional information: The patient asked will the Covid vaccines be available in smaller doses because he feels so bad the next day. Patient got the Comirnaty vaccine and after this he was experiencing aches, chills and sweating, caller wanted to know if he can receive a lower dose or multiple small doses instead of just one.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: ADACEL administered to 5 years old child, with no reported adverse event; Initial information received on 29-Feb-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient who administered Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Varicella Zoster Vaccine (Varicella Vaccine) and Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR)for Prophylactic vaccination.  On 29-Feb-2024, the 5 years old patient received 0.5 ml (dose 5) of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (Suspension for injection)( lot U7948BA) (expiry date: 25-Nov-2029) (strength not reported) (product administered to patient of inappropriate age) (Latency: same day) via intramuscular route in the left thigh for Immunization.  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.
Sex: U
Vaccine: DTAP
Symptoms: Angioedema, Urticaria
Clinical narrative: angioedema; significant urticaria; Initial information received on 23-Feb-2024 regarding an unsolicited valid serious case received from a physician.  This case involves an unknown age and unknown gender patient who experienced angioedema and significant urticaria after receiving diphtheria-2/tetanus/5 AC pertussis vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Feb-2024, the patient received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot U7961AA, expiry date- 16-FEB-2025) (strength, unknown) via unknown route in unknown administration site for Immunization.  On 15-FEB-2024 the patient developed angioedema and significant urticaria (urticaria) 9 days following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.  Seriousness criteria: medically significant for the event angioedema.; Sender's Comments: Sanofi company comment dated 28-FEB-2024: This case an unknown age and unknown gender patient who experienced angioedema and significant urticaria after receiving diphtheria-2/tetanus/5 AC pertussis vaccine. Further information regarding medical history, concomitant medication, and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 0.5
Sex: U
Vaccine: HIBV, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: they have inadvertently administered a patient with pentacel instead of acthib with no reported adverse event.; Initial information received on 28-Feb-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old and unknown gender patient who was inadvertently administered a Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] instead of HIB (PRP/T) Vaccine [ACT-HIB]  with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Feb-2024, the patient was inadvertently administered 0.5 ml (Dose 2) of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection)  (lot UJ973AA) (expiry date: 19-Nov-2024) instead of HIB (PRP/T) with no reported adverse event (wrong product administered) (unknown latency) via intramuscular route for Immunization.  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: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: inappropriate use due to administration of expired Acthib with no reported adverse event; Initial information received on 28-Feb-2024 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 12 months old female patient who was inappropriately administered expired HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ 13V (CRM197) (Prevnar 13); Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar RA 27/3), Varicella Zoster Vaccine Live (OKA/MERCK) (Proquad); and Varicella Zoster Vaccine (Varicella Vaccine); all for Immunisation.  On 27-Feb-2024, the patient had inappropriately received 0.5ml (dose: 1) of expired suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot UJ839AA; Expiry date: 12-Feb-2024; strength not reported) via intramuscular route in the right thigh for Immunisation (expired product administered) (latency same day).   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: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: expired dose of ACTHIB was inadvertently administered with no reported adverse event; Initial information was received from Regulatory Authority on 28-Feb-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient to whom an expired dose of HIB (PRP/T) vaccine [ACT-HIB] was inadvertently administered, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Feb-2024, the patient received a 0.5 ml dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ834AA, expiry date:23-Feb-2024, strength: standard) via intramuscular route in the left thigh for Immunisation and expired dose of ACTHIB was inadvertently administered with no reported adverse event (expired product administered) (Latency: same day).  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: 4.0
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: patient received the IPV after the temperature excursion with no reported adverse event; Initial information was received on 29-Feb-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2024SA071065(CLUSTER), 2024SA071451(CLUSTER) and 2024SA071311(CLUSTER).  This case involves a 4 years old and unknown gender patient who received the IPV (VERO) [IPOL] after the temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Feb-2024, the patient received an unknown dose of suspect IPV (VERO) (Suspension for injection) (lot W1C831M, expiry date:21-Nov-2025, strength: unknown) via intramuscular route in right arm for prophylactic vaccination (Immunization) and received the ipv after the temperature excursion with no reported adverse event (poor quality product administered) (Latency: same day).  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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure / Shingles; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 year after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure / Shingles) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-Feb-2024 This case was reported by patient via interactive digital media. The patient stated that he/she received the vaccine as it was supposed to had but got a mild case of shingles a year later. The patient stated that probably the vaccine made the mild case of shingle. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Hypersensitivity
Clinical narrative: The caller reported has had 5 of the Covid vaccines, the Pfizer Covid vaccines and one Moderna and had the same reaction with both.; The caller had COVID-19; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (The caller reported has had 5 of the Covid vaccines, the Pfizer Covid vaccines and one Moderna and had the same reaction with both.) and COVID-19 (The caller had COVID-19) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy to grains (Rye allergy) and Asthma.    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 HYPERSENSITIVITY (The caller reported has had 5 of the Covid vaccines, the Pfizer Covid vaccines and one Moderna and had the same reaction with both.) and COVID-19 (The caller had COVID-19). At the time of the report, HYPERSENSITIVITY (The caller reported has had 5 of the Covid vaccines, the Pfizer Covid vaccines and one Moderna and had the same reaction with both.) and COVID-19 (The caller had COVID-19) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported. The patient had 5 of the Covid vaccines, the Pfizer Covid vaccines and one Moderna and had the same reaction with both. The patient was prescribed Paxlovid for COVID-19. No treatment medication was reported.
Age: 47.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: No symptoms reported; a pediatric dose was administered to a 47 year old male patient; a pediatric dose was administered to a 47 year old male patient; This spontaneous report has been received from a health business professional via a company representative, and referred to a 47-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 01-MAR-2024 the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) Intramuscular Injection (dose, route, strength, lot# and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age and incorrect dose administered). No symptoms were reported (no adverse event).  Lot# is being requested and will be submitted if received.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: Pregnant women were mistakenly given the alternative vaccine Arexvy; Pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Pregnant women were mistakenly given the alternative vaccine Arexvy) and wrong vaccine administered (Verbatim: Pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, both were administered to 128 pregnant women and 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 128 pregnant women and 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The pregnant patient received Arexvy vaccine instead of alternative Abrysvo vaccine, which led to vaccine exposure during pregnancy and to wrong vaccine administered. The follow up would not possible as no contact details were available. This case was 1 of 128 linked cases reported by the same reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog
Clinical narrative: I feel like I have had continuing brain fog that I did not experience with any of the other Moderna vaccines I had
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Cough, Decreased appetite, Influenza virus test negative, Irritability, Lethargy
Clinical narrative: 2/28 loss of appetite/ fussy. 3/1 cough and fever 100.3 lethargy. 3/2 cough with wheezing requiring duoneb tx. Temp 101.3. Development of whelp-like rash on cheeks and trunk. 3/3 continued lethargy, still no appetite, fussy, terrible cough, sneezing, snotty. Wheezing and duonebs not really working. 102 fever and woke up every 1 to 2 hours this night coughing and seeming in pain. Small whelp like rash on buttock at night time. 3/4 went to pediatrician temp 103 wheezing and still not eating. Negative for covid and flu. Ears look good. Tubed in place. No report of other kids at daycare with any illness. No siblings or family members with any viral infections either. Rash to arms and legs this night. 3/5 lethargic still no appetite wheezing and cough still present.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rhinorrhoea, SARS-CoV-2 test negative, Sneezing
Clinical narrative: 2/28 loss of appetite/ fussy. 3/1 cough and fever 100.3 lethargy. 3/2 cough with wheezing requiring duoneb tx. Temp 101.3. Development of whelp-like rash on cheeks and trunk. 3/3 continued lethargy, still no appetite, fussy, terrible cough, sneezing, snotty. Wheezing and duonebs not really working. 102 fever and woke up every 1 to 2 hours this night coughing and seeming in pain. Small whelp like rash on buttock at night time. 3/4 went to pediatrician temp 103 wheezing and still not eating. Negative for covid and flu. Ears look good. Tubed in place. No report of other kids at daycare with any illness. No siblings or family members with any viral infections either. Rash to arms and legs this night. 3/5 lethargic still no appetite wheezing and cough still present.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Wheezing
Clinical narrative: 2/28 loss of appetite/ fussy. 3/1 cough and fever 100.3 lethargy. 3/2 cough with wheezing requiring duoneb tx. Temp 101.3. Development of whelp-like rash on cheeks and trunk. 3/3 continued lethargy, still no appetite, fussy, terrible cough, sneezing, snotty. Wheezing and duonebs not really working. 102 fever and woke up every 1 to 2 hours this night coughing and seeming in pain. Small whelp like rash on buttock at night time. 3/4 went to pediatrician temp 103 wheezing and still not eating. Negative for covid and flu. Ears look good. Tubed in place. No report of other kids at daycare with any illness. No siblings or family members with any viral infections either. Rash to arms and legs this night. 3/5 lethargic still no appetite wheezing and cough still present.
Age: 6.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product administration error, Wrong product administered
Clinical narrative: Vaccine administration error.  Child was given Tdap vs Dtap per age appropriate guidelines on catch-up schedule.  No adverse reaction observed or reported.  Phone call to parent at time error was discovered.  Message left requested call back to discuss error and need for repeat vaccination with Dtap.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU4, TYP
Symptoms: Abdominal pain upper, Axillary pain, Injected limb mobility decreased, Injection site inflammation, Injection site pain
Clinical narrative: Patient describes that he is having trouble with mobility of left arm. There is some local inflammation (small) near injection site.  Member expresses soreness radiates from injection site to auxiliary to  Upper left quadrant.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU4, TYP
Symptoms: Pain
Clinical narrative: Patient describes that he is having trouble with mobility of left arm. There is some local inflammation (small) near injection site.  Member expresses soreness radiates from injection site to auxiliary to  Upper left quadrant.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Rash, Vomiting
Clinical narrative: vomiting, cough, rash
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Vaccine vial was mixed with the wrong diluent. Patient is to come back to clinic to receive vaccine again.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Blood test, Dry eye, Dry mouth, Ear dryness
Clinical narrative: mildly sore arm persisting even now, increasing dryness of the mouth becoming severe 1/27, dry eyes noticeable around 1/7, dry nose and ears noticed around 2/14
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Epstein-Barr virus antibody positive, Epstein-Barr virus infection, Nasal dryness, Pain in extremity
Clinical narrative: mildly sore arm persisting even now, increasing dryness of the mouth becoming severe 1/27, dry eyes noticeable around 1/7, dry nose and ears noticed around 2/14
Age: 80.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered Spikevax and Arexvy on 11/27/2023, but neither electronically uploaded into the vaccine record.  When she came back to the pharmacy the next month, there was no record on system of either vaccine, so she was administered another dose of each Spikevax and Arexvy on 12/14/2023.  Pharmacist noticed this on 3/5/2024 when neither of them were showing up still on the state registry, but was on the patient pharmacy profile.  Called the manufacturers to see if anything should be related to the patient, and then called patient.  She didn't even realize it and said she never experienced any adverse events or side effects either time.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: large red bump measuring approximately 5 inch x 3 inch , hot, really itchy
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Swelling
Clinical narrative: 4 years old male child went to ED with mother for evaluation of the left shoulder swelling after receiving immunization shots on 2/27/24 at doctor's office. Denied any fever. The patient had been acting normal and playful he's taking things by mouth. Mother concerned due to the large area of swelling.  The patient and patient's mother were instructed by ED Dr. to take Tylenol Advil for fever and pain, encourage fluids, and follow-up with primary care physician/referred pediatrician in a couple days or return or go to emergency room for any worsening of symptoms. ED doctor ordered ibuprofen (Motrin) that was given to patient in ER. The patient followed up on 3/4/24 with primary provider.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MNQ, PNC20, RV5
Symptoms: Underdose
Clinical narrative: Pt received 1 vial Menveo instead of 2 vial Menveo presentation.
Age: 68.0
Sex: F
Vaccine: COVID19-2, FLU4, RSV
Symptoms: Hemiplegia, Neurosurgery
Clinical narrative: Patient reported that half her body became paralyzed 26 days after vaccination.  Patient states this experience lead to a series of neurological procedures and admission into rehab facility. Patient claims her physician suggested that it could've possibly been post vaccination guillain barre syndrome.
Age: 0.83
Sex: F
Vaccine: MNQ
Symptoms: Blood culture, Haematocrit decreased, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Pt was administered 1 vial Menveo instead of 2 vial Menveo. Pt started with a fever on 3/4/2024 and was seen, labs and blood cultures drawn, respiratory swab obtained and antibiotics given.
Age: 0.83
Sex: F
Vaccine: MNQ
Symptoms: SARS-CoV-2 test negative, White blood cell count increased
Clinical narrative: Pt was administered 1 vial Menveo instead of 2 vial Menveo. Pt started with a fever on 3/4/2024 and was seen, labs and blood cultures drawn, respiratory swab obtained and antibiotics given.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: Patient developed a fever of 42 Celsius 2 days post vaccine. Had body aches. Missed school x2days. Tylenol was administered. Patient is better now. Family does not have questions at this time.
Age: 0.42
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FLVQ given at 5 months & 12 days old, before 6 month old requirement. Mother made aware that vaccine was too early and would be repeated at 6months old. Potential side effects reviewed with Mom, including local reaction, fever, fussiness. Recommendations given for management including cold compress, movement, fluids, and Tylenol if necessary.
Age: 70.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Arthralgia, Pain, X-ray limb
Clinical narrative: Acute pain in right shoulder that started a month ago after receiving vaccine.  Denies any injury or hx of pain to this shoulder. States prior to pain starting did get shot. Hurts when lying on R side at night or when lifting arm above her head. She has not been taking anything for pain. No numbness or tingling to R arm. No weakness.   Patient started seeing Occupational Therapy on 2/20/2024
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient reported significant arm pain that radiated down the arm. Denied cardiac history, symptoms, or concerns.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Patient received vaccine at 5pm on 3/4/24. On 3/5/24 early morning started having chills, nausea, and vomiting.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Wrong product administered
Clinical narrative: The order was for DTaP and Pediarix was given
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Blood test, Brain fog, Headache, Vertigo
Clinical narrative: A strange headache and a fog. And seems like a little vertigo type feeling     Tylenol helped for a little while. Just odd.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ascites, Cancer cells present, Carbohydrate antigen 125, Chemotherapy, Computerised tomogram abdomen abnormal
Clinical narrative: Diagnosed with stage 3c ovarian cancer 10/26/2023.  Began treatment with laparoscopic surgery to determine extent.  Started chemotherapy on 11/15/23.  After 3 infusions each 3 weeks apart had another surgery called cancer de-bulking with removal of the omentum and part of the peritoneum on 2/1/24.  Had 2 round of chemo to start on 2/14/24 and the 6th and final scheduled for 3/27/24.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cytoreductive surgery, Differential white blood cell count, Full blood count, Laboratory test, Laparoscopic surgery
Clinical narrative: Diagnosed with stage 3c ovarian cancer 10/26/2023.  Began treatment with laparoscopic surgery to determine extent.  Started chemotherapy on 11/15/23.  After 3 infusions each 3 weeks apart had another surgery called cancer de-bulking with removal of the omentum and part of the peritoneum on 2/1/24.  Had 2 round of chemo to start on 2/14/24 and the 6th and final scheduled for 3/27/24.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Omentectomy, Ovarian cancer stage III, Paracentesis, Peritoneal fluid analysis abnormal, Peritonectomy
Clinical narrative: Diagnosed with stage 3c ovarian cancer 10/26/2023.  Began treatment with laparoscopic surgery to determine extent.  Started chemotherapy on 11/15/23.  After 3 infusions each 3 weeks apart had another surgery called cancer de-bulking with removal of the omentum and part of the peritoneum on 2/1/24.  Had 2 round of chemo to start on 2/14/24 and the 6th and final scheduled for 3/27/24.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Scan with contrast abnormal, Ultrasound abdomen abnormal
Clinical narrative: Diagnosed with stage 3c ovarian cancer 10/26/2023.  Began treatment with laparoscopic surgery to determine extent.  Started chemotherapy on 11/15/23.  After 3 infusions each 3 weeks apart had another surgery called cancer de-bulking with removal of the omentum and part of the peritoneum on 2/1/24.  Had 2 round of chemo to start on 2/14/24 and the 6th and final scheduled for 3/27/24.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient came in the a few days after getting a flu shot and asked how long soreness in the arm would go away after a flu shot. discussed that it depends on  each individual. she said she experienced soreness after the flu shot.. she said she felt pain and has been unable to lift arm over her head. she had no swelling or bruises. she did share that this vaccine hurt more than other vaccines she received in the past. I suggested to the patient to make an appointment with her primary doctor.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: Patient describes alteration in her sense of smell - not taste - that started shortly after her COVID AND influenza vaccination, but she believes it's covid vaccine that did this, not flu as she has never had reaction to flu shots previously in all these years.   Smells like food is rancid or burned when it isn't.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: PATIENT WAS GIVEN SPIKEVAX AFTER THE BEST-USE-DATE OF 02/28/24. THE BOX HAD BEEN IN THE REFRIGERATOR FOR MORE THAN 30 DAYS.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccination for Dtap expired on 03/03/2024 and given to patient on 03/05/2024 at 11:10 AM. Patient monitored for adverse effect. No adverse effects noted. Patient feels well.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: Recieved Fluzone at same time. At approximately 24 hours post vaccine bright red urine noted which persisted for several hours gradually fading over the next twenty four hours to a normal yellow urine.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received two doses of Abrysvo on two separate days (9/05/23 and 11/17/23). Patient did not report any symptoms of muscle pain, fatigue, increased heart rate, or headaches.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Covid vaccine administered 2 days after BUD of 3-2-24.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Heplisav-B was given when the hepatitis 3 dose should have been given
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: EE stated she had a reaction; It was bumpy and inflamed, redness, swollen, itchy from the elbow to just below her shoulder. She stated she's been taking benadryl, applying cold compresses, and hydrocortisone cream. EE stated it began around nighttime on Thursday, and by Friday midday, it had began to irritate her and it was very swollen, warm, hard, and painful.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Skin irritation, Skin warm
Clinical narrative: EE stated she had a reaction; It was bumpy and inflamed, redness, swollen, itchy from the elbow to just below her shoulder. She stated she's been taking benadryl, applying cold compresses, and hydrocortisone cream. EE stated it began around nighttime on Thursday, and by Friday midday, it had began to irritate her and it was very swollen, warm, hard, and painful.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Vomiting
Clinical narrative: Severe achiness, fatigue, vomiting 3/4/23
Age: 8.0
Sex: M
Vaccine: FLU4, HEPA, IPV, MMRV
Symptoms: Joint swelling, Rash
Clinical narrative: 26 hours after vaccination, the sister comes to the front window saying he has had an allergic reaction possibly to the vaccines received the day prior.  He had a rash across his face, in both armpit areas, and in the groin area. Complained of a fever, but no documentation of a fever. Also states he had some swelling in his ankles and congestion, however child had congestion day of vaccination and it was not any worse than prior to vaccination. Consulted our standing orders and in house nurse practitioner: advice was given to the family to take oral OTC Benadryl 25-50mg every 4-6 hours, and use hydrocortisone on problem areas. Encouraged family to take him to the emergency dept if at any point he developed shortness of breath, difficulty breathing, itching/tingling in the mouth or throat. Attempted to call patient 3/5/24 to see how he was doing, but all phone numbers we have on file are invalid or we get a busy signal.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Contusion, Erythema, Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Severe bruising down the arm starting an inch from the injection site.  Mild swelling around the bicep.  Several deep red spots within the bruise and one appearing down in the forearm.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, COVID-19, Computerised tomogram head, Condition aggravated, Echocardiogram
Clinical narrative: MODERNA #1 3/19/21 MODERNA #2 4/16/2021 VACCINES FAILED TO PROTECT AGAINST SEVERE COVID, DEVELOPED ACUTE COVID IN JAN 2022 HOSPITALIZED, HYPOTENSION,  DEVELOPED POTS, LABILE BP, SYNCOPE, JUNE 2023 PAROXYSMAL AFIB SEVERE HTN HOSPITALIZED BY 245/145 MMHG ICU FOR FOUR DAYS BILATERAL RENAL ARTERY STENOSIS FOUND.  NEEDED 4-5 DRUGS FOR BP CONTROL WHICH FINALLY IMPROVED ON THREE MONTHS PLUSE OF  PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Hypertension, Hypotension, Intensive care, Labile blood pressure
Clinical narrative: MODERNA #1 3/19/21 MODERNA #2 4/16/2021 VACCINES FAILED TO PROTECT AGAINST SEVERE COVID, DEVELOPED ACUTE COVID IN JAN 2022 HOSPITALIZED, HYPOTENSION,  DEVELOPED POTS, LABILE BP, SYNCOPE, JUNE 2023 PAROXYSMAL AFIB SEVERE HTN HOSPITALIZED BY 245/145 MMHG ICU FOR FOUR DAYS BILATERAL RENAL ARTERY STENOSIS FOUND.  NEEDED 4-5 DRUGS FOR BP CONTROL WHICH FINALLY IMPROVED ON THREE MONTHS PLUSE OF  PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging head, Postural orthostatic tachycardia syndrome, Renal artery stenosis, Syncope
Clinical narrative: MODERNA #1 3/19/21 MODERNA #2 4/16/2021 VACCINES FAILED TO PROTECT AGAINST SEVERE COVID, DEVELOPED ACUTE COVID IN JAN 2022 HOSPITALIZED, HYPOTENSION,  DEVELOPED POTS, LABILE BP, SYNCOPE, JUNE 2023 PAROXYSMAL AFIB SEVERE HTN HOSPITALIZED BY 245/145 MMHG ICU FOR FOUR DAYS BILATERAL RENAL ARTERY STENOSIS FOUND.  NEEDED 4-5 DRUGS FOR BP CONTROL WHICH FINALLY IMPROVED ON THREE MONTHS PLUSE OF  PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: MODERNA #1 3/19/21 MODERNA #2 4/16/2021 VACCINES FAILED TO PROTECT AGAINST SEVERE COVID, DEVELOPED ACUTE COVID IN JAN 2022 HOSPITALIZED, HYPOTENSION,  DEVELOPED POTS, LABILE BP, SYNCOPE, JUNE 2023 PAROXYSMAL AFIB SEVERE HTN HOSPITALIZED BY 245/145 MMHG ICU FOR FOUR DAYS BILATERAL RENAL ARTERY STENOSIS FOUND.  NEEDED 4-5 DRUGS FOR BP CONTROL WHICH FINALLY IMPROVED ON THREE MONTHS PLUSE OF  PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient informed pharmacy he recieved the prev 23 but after looking into history pharmacy learned he recieved prevnar 20 one year ago
Age: 17.0
Sex: F
Vaccine: TDAP, TYP, YF
Symptoms: Fatigue, Headache, Influenza virus test negative, Mononucleosis heterophile test negative, Nausea
Clinical narrative: Pt received Vx the afternoon of February 29th, the following morning (March 1st) she was experiencing the following: sore throat, significant headache and body ache, and fatigue.  On March 2nd she additionally had a fever of 99.8 and nausea. On March 3rd she had the previous S/S still and vomiting. On March 4th she went to PCP for evaluation, at that time she was still experiencing all the previous S/S.
Age: 17.0
Sex: F
Vaccine: TDAP, TYP, YF
Symptoms: Oropharyngeal pain, Pain, SARS-CoV-2 test negative, Streptococcus test negative, Vomiting
Clinical narrative: Pt received Vx the afternoon of February 29th, the following morning (March 1st) she was experiencing the following: sore throat, significant headache and body ache, and fatigue.  On March 2nd she additionally had a fever of 99.8 and nausea. On March 3rd she had the previous S/S still and vomiting. On March 4th she went to PCP for evaluation, at that time she was still experiencing all the previous S/S.
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO SYMPTOMS
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bursitis, Chills, Confusional state, Echocardiogram
Clinical narrative: MODERNA #1 5/14/2021 DEVELOPED FEVER CHILLS, N V, WEAKNESS, UNABLE TO GO TO WORK, THEN PARESTHESIAS, LONGER TERM TO PRESENT HAS CONFUSION, SMALL FIBER NEUROPATHY, POST-EXERTIONAL MALAISE,  MYOPERICARDITIS, BURSITIS, POTS.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Impaired work ability, Laboratory test, Malaise, Myopericarditis
Clinical narrative: MODERNA #1 5/14/2021 DEVELOPED FEVER CHILLS, N V, WEAKNESS, UNABLE TO GO TO WORK, THEN PARESTHESIAS, LONGER TERM TO PRESENT HAS CONFUSION, SMALL FIBER NEUROPATHY, POST-EXERTIONAL MALAISE,  MYOPERICARDITIS, BURSITIS, POTS.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Postural orthostatic tachycardia syndrome, Pyrexia, Small fibre neuropathy
Clinical narrative: MODERNA #1 5/14/2021 DEVELOPED FEVER CHILLS, N V, WEAKNESS, UNABLE TO GO TO WORK, THEN PARESTHESIAS, LONGER TERM TO PRESENT HAS CONFUSION, SMALL FIBER NEUROPATHY, POST-EXERTIONAL MALAISE,  MYOPERICARDITIS, BURSITIS, POTS.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Treatment failure, Vomiting
Clinical narrative: MODERNA #1 5/14/2021 DEVELOPED FEVER CHILLS, N V, WEAKNESS, UNABLE TO GO TO WORK, THEN PARESTHESIAS, LONGER TERM TO PRESENT HAS CONFUSION, SMALL FIBER NEUROPATHY, POST-EXERTIONAL MALAISE,  MYOPERICARDITIS, BURSITIS, POTS.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Allergy test negative, Biopsy skin abnormal, Blood test, Dermatitis atopic, Dry skin
Clinical narrative: Incredibly dry skin patches developed starting May 2023.  Over the summer of 2023, these patches started creeping to the rest of my body causing paper thin, dry skin and itchiness.  By the fall of 2023 (October), it was diagnosed as full blown eczema and had invaded my scalp, eye lids and ear canals.  I have never had any skin issues nor has anyone in my family.  Various steroid creams and Prednisone were prescribed yet none gave any relief. Developed skin rash and raw patches. In December of 2023, blood tests were performed to identify any allergies (food or environmental). All came back normal but was getting worse (cont)... Biopsy was done on lower right leg and diagnosis was Atopic Dermatitis.  Prescribed additional steriodal creams and Dupixent. Nothing worked. Due to resistance of treatment, my dermatologist then changed diagnosis to Pityriasis rubra pilaris (PRP) in January.  I was then referred to specialist and saw a specialist in February, where additional blood tests and biopsies were performed. The tests did not show any additional presentations and diagnosis stands at PRP, an extremely rare skin disorder.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Eczema, Full blood count normal, Liver function test normal, Lymphadenopathy, Pityriasis rubra pilaris
Clinical narrative: Incredibly dry skin patches developed starting May 2023.  Over the summer of 2023, these patches started creeping to the rest of my body causing paper thin, dry skin and itchiness.  By the fall of 2023 (October), it was diagnosed as full blown eczema and had invaded my scalp, eye lids and ear canals.  I have never had any skin issues nor has anyone in my family.  Various steroid creams and Prednisone were prescribed yet none gave any relief. Developed skin rash and raw patches. In December of 2023, blood tests were performed to identify any allergies (food or environmental). All came back normal but was getting worse (cont)... Biopsy was done on lower right leg and diagnosis was Atopic Dermatitis.  Prescribed additional steriodal creams and Dupixent. Nothing worked. Due to resistance of treatment, my dermatologist then changed diagnosis to Pityriasis rubra pilaris (PRP) in January.  I was then referred to specialist and saw a specialist in February, where additional blood tests and biopsies were performed. The tests did not show any additional presentations and diagnosis stands at PRP, an extremely rare skin disorder.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pruritus, Rash, Skin atrophy, Skin erosion
Clinical narrative: Incredibly dry skin patches developed starting May 2023.  Over the summer of 2023, these patches started creeping to the rest of my body causing paper thin, dry skin and itchiness.  By the fall of 2023 (October), it was diagnosed as full blown eczema and had invaded my scalp, eye lids and ear canals.  I have never had any skin issues nor has anyone in my family.  Various steroid creams and Prednisone were prescribed yet none gave any relief. Developed skin rash and raw patches. In December of 2023, blood tests were performed to identify any allergies (food or environmental). All came back normal but was getting worse (cont)... Biopsy was done on lower right leg and diagnosis was Atopic Dermatitis.  Prescribed additional steriodal creams and Dupixent. Nothing worked. Due to resistance of treatment, my dermatologist then changed diagnosis to Pityriasis rubra pilaris (PRP) in January.  I was then referred to specialist and saw a specialist in February, where additional blood tests and biopsies were performed. The tests did not show any additional presentations and diagnosis stands at PRP, an extremely rare skin disorder.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: After looking in the Immunization Information System to access vaccine history for another vaccine, it was noted patient received a dose of Arexvy from a local pharmacy 8 days prior on 09/22/23. Pharmacy confirmed the vaccine was administered and the patient was informed of the error. He reported no adverse events from either dose of RSV vaccine.