chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Diabetic nephropathy, Respiratory failure
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 6/1/2021 DM 2 W RENAL MANIFESTATION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/2/2021 DM 2 W RENAL MANIFESTATION J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/30/2021 DM 2 W RENAL MANIFESTATION
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus, Insulin therapy, Shock hypoglycaemic
Clinical narrative: In August I was hospitalized for diabetes. I was going into diabetic shock. I began taking insulin shots daily.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Anaemia of chronic disease, Atrial fibrillation, Cataract diabetic, Chronic kidney disease
Clinical narrative: I95.9 HYPOTENSION 1/18/2022 ANEMIA I95.9 HYPOTENSION 1/18/2022 NEUTROPENIC FEVER, UNSPECIFIED I95.9 HYPOTENSION 1/18/2022 ANEMIA I95.9 HYPOTENSION 1/18/2022 ATRIAL FIBRILLATION, PAROXYSMAL I95.9 HYPOTENSION 1/18/2022 DM 2 W CATARACT I95.9 HYPOTENSION 1/18/2022 PANCYTOPENIA I95.9 HYPOTENSION 1/18/2022 NEUTROPENIC FEVER, UNSPECIFIED I95.9 HYPOTENSION 1/18/2022 ANEMIA OF CHRONIC DISEASE I95.9 HYPOTENSION 1/18/2022 CKD STAGE 2 (GFR 60-89 W OTHER KIDNEY DAMAGE MARKER) I95.9 HYPOTENSION 1/18/2022 PALLIATIVE CARE
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Febrile neutropenia, Glomerular filtration rate, Hypotension, Pancytopenia, Type 2 diabetes mellitus
Clinical narrative: I95.9 HYPOTENSION 1/18/2022 ANEMIA I95.9 HYPOTENSION 1/18/2022 NEUTROPENIC FEVER, UNSPECIFIED I95.9 HYPOTENSION 1/18/2022 ANEMIA I95.9 HYPOTENSION 1/18/2022 ATRIAL FIBRILLATION, PAROXYSMAL I95.9 HYPOTENSION 1/18/2022 DM 2 W CATARACT I95.9 HYPOTENSION 1/18/2022 PANCYTOPENIA I95.9 HYPOTENSION 1/18/2022 NEUTROPENIC FEVER, UNSPECIFIED I95.9 HYPOTENSION 1/18/2022 ANEMIA OF CHRONIC DISEASE I95.9 HYPOTENSION 1/18/2022 CKD STAGE 2 (GFR 60-89 W OTHER KIDNEY DAMAGE MARKER) I95.9 HYPOTENSION 1/18/2022 PALLIATIVE CARE
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient received a lower than age appropriate dose, receiving the 10mcg dose instead of 20mcg dose of Engerix-B. Patient is aware of incorrect dose, and will return to the pharmacy for an adult dose in the coming days as recommended by the clinical team contacted for GlaxoSmithKline
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Pain, Retching
Clinical narrative: Mild headache that night so took Tylenol 650mg, slept ok. Got up 5/5 thinking everything was OK, started to do things but very tired. Around 9AM dry heaves and exhaustion, dizziness, extreme weakness, mild headache and whole body aches. Could hardly get out of bed to the bathroom for dry heaves. Unable to keep sips of water down. This lasted until about 9:15 PM when water stayed down. 9:30 I ate a light meal then slept all night. Tired and slightly achy 5/6, rested all day. Better 5/7, and almost back to normal 5/8. Seem to be fine 5/10..
Age: 59.0
Sex: F
Vaccine: COVID19-2, HEPAB, TDAP
Symptoms: Balance disorder, Dizziness, Malaise
Clinical narrative: The patient received 3 vaccinations in the following order.  Covid19 in the right arm, then Tdap in the left arm, then Twinrix in the left arm.  Shortly after the Twinrix, the pt stated that she didn't feel well.  Pt stated that she felt faint and wobbly.   Pt was provided a cold compress to place on the back of her neck.  A short period of time later, she felt better and left after making an appointment for her 2nd dose of Twinrix.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Influenza virus test negative, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: In late April 2023 I had a very sore throat, and it lasted several days.  I had a telehealth visit.  I began taking amoxicillin.  I had another visit with an in-person doctor.  I tested negative for COVID-19 and the flu.  After another 5 days I began to feel better but fatigued and a bit congested.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood cholesterol normal, Cardiac disorder, Coronary arterial stent insertion, Laboratory test, Overweight
Clinical narrative: 10 days after my booster I ended up in the hospital for five days with an previously unknown heart condition requiring two stents.   My cholesterol levels were all in the green and other than being overweight had no red flags for the condition.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Shingles-like rash on left side of torso. Itchy and painful. Taking ibuprofen
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, No adverse event, Product quality issue
Clinical narrative: No additional AE reported; Patient got additional dose (4th dose) of GARDASIL 9; This spontaneous report was received from a pharmacist referring to a 25 years old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided.  From 2009 to 2010, the patient completed the 3-dose series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported). On 14-APR-2023, the patient was vaccinated with additional dose (the 4th dose) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # W011264, expiration date: 05-SEP-2024) 0.5 ml for prophylaxis (strength and route of administration were not reported) (extra dose administered). No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Temperature excursion; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient. The patient's pertinent medical history was not reported. The patient's concurrent conditions, drug reactions and allergies were not reported. Concomitant therapies were not reported.  On 09-FEB-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W019627, expiration date: 19-DEC-2023, administered intramuscularly in right thigh for prophylaxis. On 20-JAN-2023, the vaccine underwent a temperature excursion in the range 6 Fahrenheit degrees to 14 Fahrenheit degrees  (-14 Celsius degrees to -10° Celsius degrees) for 1 hour. Digital data logger was involved (Product storage error). No additional adverse events (AE) reported (No adverse event).  This is one of several reports from the same reporter.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: did not receive the 3rd dose/missed the 32 week cut off for the 3rd dose; No additional information or AE's reported.; This spontaneous report was received from a pharmacist who refers to her son, currently 8-month-old male patient. His medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in November 2022, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml by mouth, administered orally for prophylaxis (strength, lot #, and expiry date were not provided). On an unknown date in January 2023, the patient received the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml by mouth, administered orally for prophylaxis (strength, lot #, and expiry date were not provided). The reporter stated that her son's physician refused to give rotavirus vaccine, live, oral, pentavalent (ROTATEQ) so she had to get it at another physician's office but realized she missed the 32 week cut off for the third dose. She stated the patient is about 2 days past 8 months (32 weeks, 2 days). At the time of reporting, the patient did not receive the third dose (incomplete course of vaccination). She confirmed the patient had no side effects or adverse reactions (no adverse event).
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist reported that a 21 years old patient received first and only dose of GARDASIL 9 when she was 14 years old; No additional adverse events were reported; This spontaneous report was received from a registered pharmacist and refers to a 21-year-old female patient. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.     On unknown date in 2016 when the patient was 14-years-old, the patient received first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  for prophylaxis (quantity dose, lot #, expiration date and route were not reported) (inappropriate schedule of product administration). No additional adverse events and nor product quality complain were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperature excursion; This spontaneous report was received from an HBP with responsibility for vaccine storage referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 21-APR-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (1x dose, lot#: W025273, expiration date: 10-AUG-2024; strength, dose, route of administration, and anatomical location were not reported) for prophylaxis. The vaccine administered experienced temperature excursion at -10 C for 59 minutes on an unknown date (product storage error). No additional adverse events (no adverse event).
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Post herpetic neuralgia, Visual impairment
Clinical narrative: post herpetic neuralgia; vision problems; balance issues; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender, who was approximately 66 years old at the time of reporting. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or about 16-NOV-2016, the patient was administered zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for the long-term prevention of shingles and zoster-related conditions.  Subsequently, on an unknown date, the patient was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: multiple outbreaks of herpes zoster, post herpetic neuralgia, vision problems and balance issues.  The outcome of the events was unknown. All events were considered to be related to zoster vaccine live (ZOSTAVAX) by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: other zoster-related conditions; shingles; Information has been received regarding a case in litigation from a lawyer and referred to a patient (pt) of unknown age and gender. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. On or about 29-JAN-2008, the pt was administered the zoster vaccine live (ZOSTAVAX) (dose, strength, route, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions by a physician. On an unknown date (reported as subsequently), the pt was treated by physicians, for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related conditions (Ill-defined disorder). The outcome of the events was not provided. The reporter considered the events was related to the suspect vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VARIVAX was administered to a patient after a temperature excursion; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-APR-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, once, lot #W022293, expiration date: 13-JUL-2024, administered for prophylaxis (dose, strength, and route of administration were not provided). It was reported that the vaccine underwent temperature excursion prior to administration (product storage error). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: no symptomatic side effects were reported; administration of expired RECOMBIVAXHB to a pediatric patient; This spontaneous report was received from a medical assistant and refers to a pediatric patient of an unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 08-MAY-2023, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) thimerosal free (RECOMBIVAX HB) pre-filled syringe, intramuscular injection, 5/0.5 mcrg/ml, 0.5 milliliter, once, lot #U032668, expiration date: 24-APR-2023 (administration site, and route of administration were not provided) administered for prophylaxis (expired product administered). The administered vaccine did not have any temperature excursions. No symptomatic side effects were reported (no adverse event).
Age: 32.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event, Off label use
Clinical narrative: No Additional AE; 1st dose of MMR II ON 3/30/2023, and then 9 days later on April 8, 2023 was given VARIVAX; The pharmacist stated he knew that live vaccines should be given 28 days apart; This spontaneous report was received from a pharmacist and referred to a 32-year-old male patient. The patient's concurrent condition, concomitant therapy and medical history were not reported. The drug reactions/allergies were unknown.  On 30-MAR-2023, the patient was administered with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, lot #, expiration date, route and anatomical location were not provided) for prophylaxis. On 08-APR-2023 (reported as 9 days later), the patient was administered with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, lot #, expiration date, route and anatomical location were not provided) for prophylaxis. The pharmacist stated he knew that live vaccines should be given 28 days apart, and patient received the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) now only 9 days apart from the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (inappropriate schedule of product administration and off label use). On 01-MAY-2023, patient received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, lot #, expiration date, route and anatomical location were not provided) for prophylaxis. On 08-MAY-2023 (reported as today), the patient received the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, lot #, expiration date, route and anatomical location were not provided) for prophylaxis. It was unknown if the patient sought medical attention and gave treatment for event. No additional adverse event (AE) (no adverse event).
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Possible expired Engerix administered; Possible 4th Hep B dose given; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 10-year-old female patient who received HBV (Engerix B) (batch number K329E, expiry date 24-APR-2023) for prophylaxis.   On 27-APR-2023, the patient received the 4th dose of Engerix B. On 27-APR-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Possible expired Engerix administered) and extra dose administered (Verbatim: Possible 4th Hep B dose given). The outcome of the expired vaccine used and extra dose administered were unknown.   Additional Information: GSK receipt date: 02-May-2023 The nurse reported that the patient received a dose of Engerix-B. Upon reviewing the electronic medical record, nurse discovered that this dose would have been the patient's fourth hepatitis B dose.  The nurse was questioning if the dose was actually given or if it was charted in error since she was unable to find documentation of why a fourth dose would have been administered.  The nurse planned further research for this situation.  The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. The patient received expired 4th dose of Engerix B, which led to expired vaccine used and extra dose administered.
Age: 82.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Incomplete course of vaccination, Pruritus
Clinical narrative: Itchy spots chest and back, like mosquito bite; Slight blister; 1st dose 8 months ago, 2nd not yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In SEP-2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pruritus (Verbatim: Itchy spots chest and back, like mosquito bite), blister (Verbatim: Slight blister) and incomplete course of vaccination (Verbatim: 1st dose 8 months ago, 2nd not yet). The outcome of the pruritus and blister were not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pruritus and blister to be related to Shingrix.     It was unknown if the company considered the pruritus and blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAY-2023 The reporter was the patient. The patient received his first dose of Shingrix about 8 months ago and had not yet received the second dose (AE-Inappropriate schedule of vaccine). For the last 2-3 months, the patient had been experiencing itchy spots on his chest and back which were reminiscent of a past outbreak of shingles.  The patient described the itchy spots as mosquito bite like with a slight blister. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test negative, Serology test, Therapy non-responder
Clinical narrative: Did not develop antibodies after 2 doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.  Concurrent medical conditions included immunocompromised.  On 06-FEB-2020, the patient received the 2nd dose of Shingrix. On 18-NOV-2019, the patient received the 1st dose of Shingrix. On 01-MAY-2023, 1180 days after receiving Shingrix and 1260 days after receiving Shingrix, the patient experienced therapy non-responder (Verbatim: Did not develop antibodies after 2 doses). The outcome of the therapy non-responder was unknown.   Additional Information: GSK Receipt Date: 04-MAY-2023 Pharmacist reported a potential revaccination with Shingrix in an immunocompromised patient who does not developed serum antibodies after the 2 dose series. The serological testing completed on 1 May 2023. Patient was about to start medication that had a high risk of varicella re-activation, so antibody testing was recommended prior to starting therapy. Unable to provide any patient demographics due to hospital policy. The reporter had consented to follow up. The patient received the complete schedule of Shingrix vaccine and does not developed serum antibodies, which had led to therapy non-responder.
Sex: U
Vaccine: DTAP, HEPA, MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Vx administered after inappropriate storage; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Bexsero, Boostrix, Infanrix, Menveo and Havrix. On an unknown date, an unknown time after receiving Bexsero, Boostrix, Infanrix, Menveo and Havrix, the patient experienced incorrect storage of drug (Verbatim: Vx administered after inappropriate storage). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-MAY-2023 The nurse called to report, had a fridge that stores Bexsero, Boostrix, Infanrix, Menveo, Havrix that had a temperature excursion of minus 4 degree Celsius and some vaccines might had been administered, which led to incorrect storage of drug. The reporter did not know which vaccine, lot number or patients it could had been administered. The reporter did not consent to follow-up.
Sex: U
Vaccine: RV1
Symptoms: Accidental underdose, Regurgitation
Clinical narrative: Spitting the dose out, regurgitation; Spitting the dose out, regurgitation; This non-serious case was reported by a other health professional via call center representative and described the occurrence of regurgitation of medication in an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patients received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patients experienced regurgitation of medication (Verbatim: Spitting the dose out, regurgitation) and accidental underdose (Verbatim: Spitting the dose out, regurgitation). The outcome of the regurgitation of medication and accidental underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 05-MAY-2023 Health care professional reported, it was noticing that a large portion of patients were spitting the dose out compared with the old formulation, which led to regurgitation of medication and accidental underdose. The reporter wondered if other institutions had the same issues or if this had been reported in the clinical studies.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Hypoaesthesia oral, Lip swelling, Muscle disorder, Throat irritation
Clinical narrative: MUSCLE PROBLEMS IN HER ARMS AND LEGS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; TONGUE NUMB; THROAT NOT RIGHT, IT FELT SCRATCHY AND STILL GRAVELLY; LIPS SWOLLEN; This spontaneous report received from a patient via other company (Pfizer Inc) concerned a 65 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic to carvone which was in essential oils, and allergy to mint. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had developed muscle problems in her arms and legs after the vaccine (Dose number in series 1). The patient received non-company suspect Moderna covid-19 vaccine, (elasomeran), (Dose number in series 2), (form of admin, route of admin, batch number and expiry date were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient also received non-company suspect Moderna covid-19 vaccine, (elasomeran), (Dose number in series 3), (form of admin, route of admin, batch number and expiry date were not reported), dose, start therapy date were not reported for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 3). The patient also received non-company suspect drugs Nurtec ODT, (rimegepant sulfate), (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported from 30-APR-2023 for an unspecified indication.  On 30-APR-2023 at night, after the drug Nurtec patient experienced throat was not right, it felt scratchy and was still gravelly, lips was swollen, and tongue was numb (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (dose 2), and elasomeran (dose 3) was not applicable; and action taken with rimegepant sulfate was not reported. The patient had not recovered from throat not right, it felt scratchy and still gravelly, lips swollen, and tongue numb, and the outcome of muscle problems in her arms and legs and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Caller who was administered 1st GARDASIL 9 Dose on 12/28/2022 was administered 2nd GARDASIL 9 Dose on 03/23/2023; No additional AE reported; This spontaneous report has been received from the patient referring to themself as a patient of unknown age and gender.  The patient's medical history, past drug reactions or allergies, concurrent conditions, and concomitant medications were not reported.  On 28-DEC-2022, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection and the second dose was administered on 23-MAR-2023 (strength, doses, route of administration, anatomical location, lot numbers, and expiry dates were not provided) administered as prophylaxis (Inappropriate schedule of product administration).The reporter requested HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) prescribing information specific to alternative schedule.  No further information provided. No additional adverse event was reported. In addition, the patient did not wish for physician to be contacted in future.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body tinea, Pruritus, Rash, Rash erythematous
Clinical narrative: I noticed the symptoms in March of 2022. They appeared as red circular patches on my leg. Some became itchy. After a few months, I decided it was ringworm. I started over the counter medication. After being unsuccessful in treating it, I went to the doctor March of 2023. He prescribed terbinafine 250mg 1x day. I've been taking that for six weeks with a one-week break. It's gotten worse. I have an appointment with a Dermatologist on Monday.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Cardiac ablation, Chest X-ray abnormal, Dyspnoea
Clinical narrative: In May 2022, My Fitbit alarmed that my heartbeat was beating fast, and I was in A-fib. I was experiencing shortness of breath, rapid heartbeat. I was hospitalized in May 2022 for Atrial Fibrillation. I was also diagnosed with Sleep Apnea. I was given medication for my A-Fib, and they have taken me off for now because my heart was beating too slow. I had an electrical Ablation twice. The last one was in February 2023, and I am scheduled for surgery on 06/06/2023.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Heart rate decreased, Heart rate increased, Sleep apnoea syndrome
Clinical narrative: In May 2022, My Fitbit alarmed that my heartbeat was beating fast, and I was in A-fib. I was experiencing shortness of breath, rapid heartbeat. I was hospitalized in May 2022 for Atrial Fibrillation. I was also diagnosed with Sleep Apnea. I was given medication for my A-Fib, and they have taken me off for now because my heart was beating too slow. I had an electrical Ablation twice. The last one was in February 2023, and I am scheduled for surgery on 06/06/2023.
Age: 66.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Asthenia, Malaise, Pyrexia
Clinical narrative: Fever of 101.1 F.  Generally just feeling crummy and weak.
Age: 1.5
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: No adverse events observed. Completing VAERS to document and incorrect dose administered. Child was administered 0.2 mL of undiluted COVID19 vaccine.
Age: 37.0
Sex: M
Vaccine: TD
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Patient called via telephone stating he has pain at the injection site and tingling sensation to his fingertips.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Dyspnoea, Eye movement disorder, Posture abnormal, Sneezing
Clinical narrative: Almost immediately, she felt light headed and put her head between her legs.  She then leaned back and her eyes rolled back in her head and she slumped over to the right.  She was unresponsive and began wheezing/gasping for air, along with a few sneezes.  Someone called EMS and I gave her an Epipen in her right leg.  Within a few seconds, she became responsive and was dizzy and shaking.  The EMT arrived and checked her over.  She was able to stand and opted to go home, instead of the hospital.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Tremor, Unresponsive to stimuli, Wheezing
Clinical narrative: Almost immediately, she felt light headed and put her head between her legs.  She then leaned back and her eyes rolled back in her head and she slumped over to the right.  She was unresponsive and began wheezing/gasping for air, along with a few sneezes.  Someone called EMS and I gave her an Epipen in her right leg.  Within a few seconds, she became responsive and was dizzy and shaking.  The EMT arrived and checked her over.  She was able to stand and opted to go home, instead of the hospital.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, FLU4, HEPA
Symptoms: Anxiety, Fear of injection, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Client fainted immediately post vaccination; offered juice and took a few sips, immediately vomited X1 Client was increasingly anxious upon receiving vaccinations and when seeing syringe/needle--encouraged to look other way but still was tense and held breath upon vacination(s) No injury to client as brother was nearby to "catch" client; mother and nurse able to calm client and offer comfort measures such a a cool cloth and resting with family members within reach Client rested quietly sitting in chair for about 10 minutes until color returned to face (pale upon fainting and vomting episode) and able to stand and walk to car with nurse and family members in attendance without further incidence occurring
Age: 6.0
Sex: F
Vaccine: DTAPIPV, FLU4, HEPA
Symptoms: Tension, Vomiting
Clinical narrative: Client fainted immediately post vaccination; offered juice and took a few sips, immediately vomited X1 Client was increasingly anxious upon receiving vaccinations and when seeing syringe/needle--encouraged to look other way but still was tense and held breath upon vacination(s) No injury to client as brother was nearby to "catch" client; mother and nurse able to calm client and offer comfort measures such a a cool cloth and resting with family members within reach Client rested quietly sitting in chair for about 10 minutes until color returned to face (pale upon fainting and vomting episode) and able to stand and walk to car with nurse and family members in attendance without further incidence occurring
Age: 11.0
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No averse signs at this time. Not treatment needed.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast discomfort, Breast disorder female, Breast pain, Computerised tomogram abdomen, Mammogram normal
Clinical narrative: 1. New onset change of body odor - strong onion-like more pronounced under left axilla as compared to right axilla - no treatment outcome remains unchanged 2. Pain discomfort to left breast with palpable changes matrix of breast tissue and discomfort pain voiced upon examination of left breast as compared to right breast. Treatment monitor for three months with Mammogram and ultrasound. Outcome pain and discomfort resolved on its own after three months with findings of normal diagnostic imaging. 3. New onset of Endometrial polyp with abnormal pathology upon polypectomy pre cancerous proliferation recommended laparoscopic partial hysterectomy - awaiting outcome.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pathology test, Precancerous cells present, Procedure aborted, Skin odour abnormal, Ultrasound breast normal
Clinical narrative: 1. New onset change of body odor - strong onion-like more pronounced under left axilla as compared to right axilla - no treatment outcome remains unchanged 2. Pain discomfort to left breast with palpable changes matrix of breast tissue and discomfort pain voiced upon examination of left breast as compared to right breast. Treatment monitor for three months with Mammogram and ultrasound. Outcome pain and discomfort resolved on its own after three months with findings of normal diagnostic imaging. 3. New onset of Endometrial polyp with abnormal pathology upon polypectomy pre cancerous proliferation recommended laparoscopic partial hysterectomy - awaiting outcome.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan vagina, Uterine polyp, Uterine polypectomy
Clinical narrative: 1. New onset change of body odor - strong onion-like more pronounced under left axilla as compared to right axilla - no treatment outcome remains unchanged 2. Pain discomfort to left breast with palpable changes matrix of breast tissue and discomfort pain voiced upon examination of left breast as compared to right breast. Treatment monitor for three months with Mammogram and ultrasound. Outcome pain and discomfort resolved on its own after three months with findings of normal diagnostic imaging. 3. New onset of Endometrial polyp with abnormal pathology upon polypectomy pre cancerous proliferation recommended laparoscopic partial hysterectomy - awaiting outcome.
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: pt here to received Dose 2 of Moderna covid vaccine. pt is 2 years old. Vax received at Facility (vax clinic held by Covid Mobile Team) Instead of receiving 0.25 ml of Bivalent (6 months+) (Dark Blue Cap / Gray Border), pt received 0.2 ml of Bivalent (6 months - 5 years) (Dark Pink Cap). pt stayed in observation for 15 minutes. per mom, pt was feeling fine.
Age: 1.92
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: pt here to received first dose of covid vaccine. pt is 23 months old. Instead of receiving 0.25 ml of Bivalent (6 months+) (Dark Blue Cap / Gray Border), pt received 0.2 ml of Bivalent (6 months - 5 years) (Dark Pink Cap). pt stayed in observation for 15 minutes. per mom, pt was feeling fine.
Age: 1.92
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: pt here to received first dose of covid vaccine. pt is 23 months old. Vax received at a Covid Mobile Team Pop-up vax event  Instead of receiving 0.25 ml of Bivalent (6 months+) (Dark Blue Cap / Gray Border), pt received 0.2 ml of Bivalent (6 months - 5 years) (Dark Pink Cap). pt stayed in observation for 15 minutes. per mom, pt was feeling fine.
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose, Wrong product administered
Clinical narrative: pt here to received dose 2 of Moderna of covid vaccine. pt is 2 years old. Instead of receiving 0.25 ml of Bivalent (6 months+) (Dark Blue Cap / Gray Border), pt received 0.2 ml of Bivalent (6 months - 5 years) (Dark Pink Cap). pt stayed in observation for 15 minutes. per mom, pt was feeling fine.
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose, Wrong product administered
Clinical narrative: pt here to received first dose of covid vaccine. pt is 6 months old. Instead of receiving 0.25 ml of Bivalent (6 months+) (Dark Blue Cap / Gray Border), pt received 0.2 ml of Bivalent (6 months - 5 years) (Dark Pink Cap). pt stayed in observation for 15 minutes. per mom, pt was feeling fine.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Pyrexia
Clinical narrative: Fever and achey
Age: 1.0
Sex: M
Vaccine: COVID19, DTAPHEPBIP
Symptoms: Adverse drug reaction, Diabetic ketoacidosis, General physical health deterioration, Influenza virus test negative, Irritability
Clinical narrative: Patient had typical side effects for 1-2 days after the vaccine and then recovered. Then a week or two later was exhibiting increased thirst (nursing much more frequently than usual) and fussiness. This was not recognized at early signs of diabetes yet. He developed a fever in late 11/2022. The fever resolved but he remained lethargic. Flu, covid, and rsv were ruled out on 11/30/22. He deteriorated further and then developed DKA and was admitted and diagnosed with Type 1 diabetes on 12/7/22.
Age: 1.0
Sex: M
Vaccine: COVID19, DTAPHEPBIP
Symptoms: Lethargy, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Thirst
Clinical narrative: Patient had typical side effects for 1-2 days after the vaccine and then recovered. Then a week or two later was exhibiting increased thirst (nursing much more frequently than usual) and fussiness. This was not recognized at early signs of diabetes yet. He developed a fever in late 11/2022. The fever resolved but he remained lethargic. Flu, covid, and rsv were ruled out on 11/30/22. He deteriorated further and then developed DKA and was admitted and diagnosed with Type 1 diabetes on 12/7/22.
Age: 1.0
Sex: M
Vaccine: COVID19, DTAPHEPBIP
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Patient had typical side effects for 1-2 days after the vaccine and then recovered. Then a week or two later was exhibiting increased thirst (nursing much more frequently than usual) and fussiness. This was not recognized at early signs of diabetes yet. He developed a fever in late 11/2022. The fever resolved but he remained lethargic. Flu, covid, and rsv were ruled out on 11/30/22. He deteriorated further and then developed DKA and was admitted and diagnosed with Type 1 diabetes on 12/7/22.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin abnormal, Eczema, Extravasation blood, Hyperkeratosis lenticularis perstans, Impaired quality of life
Clinical narrative: By about end of August/early September, I started to notice the skin on the front of my calves getting oddly bumpy. The bumps traveled up my legs to my buttocks. I then started to notice bumps on my arms. I called a dermatologist for an appt. By the time I could see the Dr(took about 2 weeks), the bumps had multiplied and enlarged. The Dr looked at me and wanted to put me into the hospital. Instead, he decided to put me onto prednisonewhich I was on for a month. It made a little difference. I've seen about 7 dermatologists and 2 allergists and no one can really figure out what is wrong with me. I've had 3 biopsies with 3 different diagnosis. Nothing had really helped. I'm now receiving ozone therapy and IV chelation
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lichenoid keratosis, Parakeratosis, Rash, Rhinorrhoea, Throat clearing
Clinical narrative: By about end of August/early September, I started to notice the skin on the front of my calves getting oddly bumpy. The bumps traveled up my legs to my buttocks. I then started to notice bumps on my arms. I called a dermatologist for an appt. By the time I could see the Dr(took about 2 weeks), the bumps had multiplied and enlarged. The Dr looked at me and wanted to put me into the hospital. Instead, he decided to put me onto prednisonewhich I was on for a month. It made a little difference. I've seen about 7 dermatologists and 2 allergists and no one can really figure out what is wrong with me. I've had 3 biopsies with 3 different diagnosis. Nothing had really helped. I'm now receiving ozone therapy and IV chelation
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Grip strength decreased, Injection site pain, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Patient reports losing control of fingers/hands momentarily/temporarily.  There is also a surge of pain down his right should to his hand.  His example is when he was drinking a cup of coffee, his hand temporarily lost control of the cup and the coffee spilled all over him.
Age: 0.75
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Incorrect Moderna given for primary series
Age: 0.58
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Underdose
Clinical narrative: given wrong dose of Moderna for primary series
Age: 0.58
Sex: F
Vaccine: COVID19-2, DTAP, FLU4
Symptoms: Underdose
Clinical narrative: Given wrong dose of Moderna Bivalent covid vaccine for primary series.
Age: 1.0
Sex: M
Vaccine: COVID19-2, HEPA, MMR, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Gave wrong Moderna Bivalent 6mon-5yr for primary series
Age: 0.58
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Gave wrong Moderna Bivalent dose for Primary series
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Brain fog, Depression, Fall, Fatigue
Clinical narrative: Brain Itch Brain Fog Exhaustion Anxiety Depression Pain Extreme Pain Walking Issues Falling Leg moving to left when going straight
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Magnetic resonance imaging, Musculoskeletal disorder, Pain, Pruritus
Clinical narrative: Brain Itch Brain Fog Exhaustion Anxiety Depression Pain Extreme Pain Walking Issues Falling Leg moving to left when going straight
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Brain Itch Brain Fog Exhaustion Anxiety Depression Pain Extreme Pain Walking Issues Falling Leg moving to left when going straight
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Dyspnoea, Factor V Leiden mutation, Pulmonary embolism
Clinical narrative: Shortness of breath. Deep vein thrombosis. Pulmonary Embolism. Discovered Factor V Leiden mutation
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Myocarditis, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI MYOCARDITIS 10/18/2021 -- RECURRENCE OF SAME SYMPTOMS
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Administration site pain, Feeling hot
Clinical narrative: Patient report feeling "hot" in the evening, mother took temperature reported no fever. Next day patient report a severe pain in area of administration.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Injection site reaction, Peripheral swelling, Tenderness
Clinical narrative: 2 days after administration had local pain, malaise, 3 days after injection fevers, local swelling down to elbow and redness with induration. 7 days after administration mother noticed a large knot, redness, swelling and very painful. ER visit, treated with clindamycin tabs, not tolerated, used after that Keflex. 3rd visit to ER and others to urgent care, an ultrasound is performed, pocket of 2.4 ml with fluid noticed. Draine, obtained about 12-14 ml of purulent discharge. Culture negative. Treated with IV Ancef, then completed orally Keflex. 10 days. Assessed again 5.10.24 still 5 cm induration, redness, tender and still serosanguineous discharge. Started Clindamycin. Pain control.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Aspiration bone marrow normal, Basophil percentage, Blood culture negative, Culture negative, Discharge
Clinical narrative: 2 days after administration had local pain, malaise, 3 days after injection fevers, local swelling down to elbow and redness with induration. 7 days after administration mother noticed a large knot, redness, swelling and very painful. ER visit, treated with clindamycin tabs, not tolerated, used after that Keflex. 3rd visit to ER and others to urgent care, an ultrasound is performed, pocket of 2.4 ml with fluid noticed. Draine, obtained about 12-14 ml of purulent discharge. Culture negative. Treated with IV Ancef, then completed orally Keflex. 10 days. Assessed again 5.10.24 still 5 cm induration, redness, tender and still serosanguineous discharge. Started Clindamycin. Pain control.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Drainage, Eosinophil count normal, Eosinophil percentage decreased, Erythema, Fluid retention
Clinical narrative: 2 days after administration had local pain, malaise, 3 days after injection fevers, local swelling down to elbow and redness with induration. 7 days after administration mother noticed a large knot, redness, swelling and very painful. ER visit, treated with clindamycin tabs, not tolerated, used after that Keflex. 3rd visit to ER and others to urgent care, an ultrasound is performed, pocket of 2.4 ml with fluid noticed. Draine, obtained about 12-14 ml of purulent discharge. Culture negative. Treated with IV Ancef, then completed orally Keflex. 10 days. Assessed again 5.10.24 still 5 cm induration, redness, tender and still serosanguineous discharge. Started Clindamycin. Pain control.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Gram stain positive, Granulocyte percentage, Haematocrit normal, Haemoglobin normal, Hyperaemia
Clinical narrative: 2 days after administration had local pain, malaise, 3 days after injection fevers, local swelling down to elbow and redness with induration. 7 days after administration mother noticed a large knot, redness, swelling and very painful. ER visit, treated with clindamycin tabs, not tolerated, used after that Keflex. 3rd visit to ER and others to urgent care, an ultrasound is performed, pocket of 2.4 ml with fluid noticed. Draine, obtained about 12-14 ml of purulent discharge. Culture negative. Treated with IV Ancef, then completed orally Keflex. 10 days. Assessed again 5.10.24 still 5 cm induration, redness, tender and still serosanguineous discharge. Started Clindamycin. Pain control.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Immature granulocyte count, Induration, Joint swelling, Lymphocyte count, Lymphocyte percentage increased
Clinical narrative: 2 days after administration had local pain, malaise, 3 days after injection fevers, local swelling down to elbow and redness with induration. 7 days after administration mother noticed a large knot, redness, swelling and very painful. ER visit, treated with clindamycin tabs, not tolerated, used after that Keflex. 3rd visit to ER and others to urgent care, an ultrasound is performed, pocket of 2.4 ml with fluid noticed. Draine, obtained about 12-14 ml of purulent discharge. Culture negative. Treated with IV Ancef, then completed orally Keflex. 10 days. Assessed again 5.10.24 still 5 cm induration, redness, tender and still serosanguineous discharge. Started Clindamycin. Pain control.