chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: had a little pain on the arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had a little pain on the arm injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: J&J COVID-19 vaccine (received one J&J COVID-19 vaccine ). Past adverse reactions to the above products included No adverse event with J&J COVID-19 vaccine.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (had a little pain on the arm injection site). At the time of the report, VACCINATION SITE PAIN (had a little pain on the arm injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704245, US-MODERNATX, INC.-MOD-2023-704428 (Linked Report). This case was linked to MOD-2023-704428 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704245:Child case US-MODERNATX, INC.-MOD-2023-704428:Wife case
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Tremor
Clinical narrative: she's shaking, her hands are shaking; she's having a hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (she's shaking, her hands are shaking) and DYSPNOEA (she's having a hard time breathing) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (she's shaking, her hands are shaking) and DYSPNOEA (she's having a hard time breathing). At the time of the report, TREMOR (she's shaking, her hands are shaking) and DYSPNOEA (she's having a hard time breathing) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: 11 adult patients received the expired Bivalent booster beyond 30 days; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days) outcome was unknown and NO ADVERSE EVENT (no adverse event) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days).    No concomitant and treatment medications were provided.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: a patient received PENTACEL plus an additional dose of DTAP and HIB with no reported adverse event; Initial information received on 24-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who received diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)]   plus an additional dose of dtap and 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 diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (INFANRIX) and hib vaccine conj (TET TOX) (ACTHIB) for Prophylactic vaccination.  On 23-Sep-2022, the patient received a (dose 4) 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine suspension for injection (lot UJ640AAA, expiry date: 28-Jan-2023, strength not reported) via intramuscular route in the left thigh as immunization.  On 23-SEP-2022, a patient received pentacel plus an additional dose of dtap and hib with no reported adverse event (extra dose administered) on same day  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event    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: 65.0
Sex: F
Vaccine: UNK
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Tinnitis worsened.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Injection site erythema, Nasopharyngitis, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever, sore arm , red ness at injection site, cough, cold symptoms
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Narrative: An error occurred while administering the Modern Bivalent booster on 10/05/2022/. Patient was given .25mL instead of the full dose of 0.5mL vaccine. Patient was return to clinic for an addition.25mL dose on 10/06/2022
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Endometrial ablation, Postmenopausal haemorrhage
Clinical narrative: post menopausal bleeding Narrative: uterine ablation performed 12/2021 due several months of post menopause bleeding.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Skin lesion, Urticaria
Clinical narrative: UrticariaPruritus tiny sore Narrative: urticaria and tiny sore that isn't healing
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Compression garment application, Dysphagia, Myalgia, Pain in extremity
Clinical narrative: Myalgia, Arthralgia, Severe arm pain right arm, swelling to right hand for a few weeks, difficulty swallowing saliva/food/liquids. Since November 2022 left foot pain.  Narrative: Employee did see a podiatrist for evaluation of foot pain, treatment included compression stocking, inserts, and recommended to file adverse vaccine event.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: Myalgia, Arthralgia, Severe arm pain right arm, swelling to right hand for a few weeks, difficulty swallowing saliva/food/liquids. Since November 2022 left foot pain.  Narrative: Employee did see a podiatrist for evaluation of foot pain, treatment included compression stocking, inserts, and recommended to file adverse vaccine event.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administration error, Underdose
Clinical narrative: Narrative: An error occurred while administering the Moderna Bivalent booster on 10/05/2022. Patient was given .25mL instead of the full dose of 0.5mL vaccine. Patient was return to campus for an addition.25mL dose on 10/06/2022.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Narrative: Moderna bivalent booster 10/5/22 at the clinic, he was given half a dose of the vaccine which is 0.25 ml instead of 0.5 ml.
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Narrative: Moderna bivalent booster 10/5/2022 at the clinic, patient was given half a dose of the vaccine which is 0.25 ml instead of 0.5 ml.
Age: 95.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Narrative: patient were given half a dose of the vaccine which is 0.25ml instead of 0.5 ml.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administration error, Underdose
Clinical narrative: Narrative: an error occurred while dispensing the Moderna bivalent booster 10/5/22 at the vaccine clinic, he was given half a dose of the vaccine which is 0.25 ml instead of 0.5 ml.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Narrative: while administering the Moderna bivalent booster 10/5/22 at the clinic, he was given half a dose of the vaccine which is 0.25 ml instead of 0.5 ml.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Brachial plexopathy, Electromyogram abnormal, Neuralgic amyotrophy
Clinical narrative: Narrative:  Per Neurology Progress note on 11/3/22, "clinical history, neurologic exam and EMG do support a diagnosis of brachial plexitis/Parsonage-Turner syndrome on the left, abnormalities on EMG are supportive of either a left upper trunk brachial plexopathy or C5/C6 radiculopathy. Imaging not strongly suggestive of cervical radiculopathy. It is probably not a coincidence that patient received Moderna COVID-19 booster in left deltoid on 02/18/2022 and then developed clinical symptoms of left brachial plexitis in 04/2022. Advised caution with any future COVID 19 boosters"
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Gastrointestinal disorder, Laboratory test, Respiratory disorder
Clinical narrative: Been to ED over 10 times.  Breathing problems  Gastrointestinal  problems Heart  problems
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: blisters-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Weakness-Medium, Additional Details: blisters appeared around the injection site. pt left it alone and the blisters popped and dried up. pt reported the adr 20 days after the injection. pt still has some blisters
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 34.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Botulinum toxin injection, Headache, Migraine
Clinical narrative: Systemic: Headache-Severe, Additional Details: patient said day after receiving vaccine she has migraine attacks. she has been on botox and migraine medication. she wants distric leader to follow up for the next step.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case. Moderna 2/5/21 010M20A, 3/4/21 010M20A, and boosted 1/12/22 028K21A
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anticoagulant therapy, Asthenia, Blood test, Cerebrovascular accident, Computerised tomogram
Clinical narrative: TIA stroke requiring hospitalization overnight. Symptoms were vertigo like, left sided weakness. Treatment included statin, plavix, aspirin. Not sure its related to covid vaccine but wanted it reported just in case
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hemiparesis, Magnetic resonance imaging, Neurological symptom, Transient ischaemic attack
Clinical narrative: TIA stroke requiring hospitalization overnight. Symptoms were vertigo like, left sided weakness. Treatment included statin, plavix, aspirin. Not sure its related to covid vaccine but wanted it reported just in case
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Heart rate increased, Hypotension, Malaise
Clinical narrative: I felt a little sick the day after receiving the vaccine. On 11/17/2022 I was at physical therapy, and they said my blood pressure was low and they recommended that I keep an eye on it. I went to see my endocrinologist and had blood work and my cholesterol was higher than normal. My fitness watch indicated my resting heart rate was elevated. At this time, I am watching what I eat.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Loss of personal independence in daily activities, Nasopharyngitis, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: 12/11/2022 began having mild cold symptoms with congestion. Symptoms continued to worsen tested negative 12/12. Tested positive for COVID-19 on at home COVID-19 test on 12/13. Called PCP and was instructed to give her advair. Was instructed to monitor her symptoms and push fluids. Symptoms persisted for about 5 days and she returned to school on the following Monday. Tested negative on at home prior to returning to school.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction/ Dose given after best used date.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction/ Dose given after best used date.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Localized reaction at injection site.  Arm swelled, red, hardened, warm to touch.  patient given OTC antihistamine
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction/ Dose given after best used date
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received the 2nd dose of the Pfizer Covid-19 vaccine after BUD-expiration date. as per Dr. he recommends patient to repeat the dose. Patient's parents were contacted to informed of the Adverse event and to inform that the vaccine is recommended to be repeated. Patient's parents reported no symptoms or signs related to the vaccines received.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction/ Dose given after best used date
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction/ Dose given after best used date
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction/ Dose given after best used date
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction/ Dose given after best used date
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Angiogram cerebral, Computerised tomogram, Diplopia, Headache
Clinical narrative: july 28 developed severe headache and visual disturbances- blurry double vision
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Vision blurred, Visual impairment
Clinical narrative: july 28 developed severe headache and visual disturbances- blurry double vision
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer Covid-19 vaccine dose # 2 after BUD-expiration date.  Doctor recommended for dose to be repeated. patient's parents were informed of the adverse event, they reported no symptoms or signs related to this adverse event. patients was offered to be revaccinated.
Age: 67.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Aphasia, Blood test, Cerebrovascular accident, Computerised tomogram, Hemiplegia
Clinical narrative: At 5am on the morning of 10/30, three days after receiving both vaccines, he suffered a severe stroke in his sleep.  The stroke was an occipital frontal lobe, resulting in paralyzation on his right side and global aphasia, and a 55% reduction in his mental capacity.   He was hospitalized and in rehab for approximately six months.  He now requires full-time care in home with no change in his condition since the stroke.
Age: 67.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging, Mental disorder
Clinical narrative: At 5am on the morning of 10/30, three days after receiving both vaccines, he suffered a severe stroke in his sleep.  The stroke was an occipital frontal lobe, resulting in paralyzation on his right side and global aphasia, and a 55% reduction in his mental capacity.   He was hospitalized and in rehab for approximately six months.  He now requires full-time care in home with no change in his condition since the stroke.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: For the first round of this vaccine my arm swelled, and I had pain radiating up to my head.  This dose I had injection site swelling and my arm has large red lines circling it.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer Covid-19 vaccine dose # 2 after BUD-expiration date.  Doctor recommended for dose to be repeated. patient's parents were informed of the adverse event, they reported no symptoms or signs related to this adverse event. Patient was offered to be revaccinated.
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pruritus, Rash
Clinical narrative: Rash, similar to poison ivy/sumac, but without the oozing or pussing. Itching over a very large portion of my body including but not limited to biceps, thighs, under arms, hips.  Treated with calamine to soothe the itch (because I thought it was poison ivy/sumac)  After ~48-72 hours I woke up and the rash was completely gone with no symptoms
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Seizure
Clinical narrative: I had a seizure and continue to have them now. No history of seizures prior to vaccine. Cause hasn?t been established to date. The vaccine is the only thing I can contribute it to. I had covid in Jan 2022, after the vaccine and after the seizures had started.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Dyspnoea, Feeling abnormal, Fibromyalgia
Clinical narrative: I was sick for about two weeks after receiving the vaccine. I had bad headaches, hot flashes and just felt bad. I tested positive for COVID-19 on 11/3/2022. I contacted my doctor, and I was given a prescription for prednisone because I had a terrible time breathing. I recently saw my doctor because my fibromyalgia is worse after the last vaccine. I was taken CYMBALTA and my doctor increased the doses and prednisone.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Malaise, SARS-CoV-2 test positive
Clinical narrative: I was sick for about two weeks after receiving the vaccine. I had bad headaches, hot flashes and just felt bad. I tested positive for COVID-19 on 11/3/2022. I contacted my doctor, and I was given a prescription for prednisone because I had a terrible time breathing. I recently saw my doctor because my fibromyalgia is worse after the last vaccine. I was taken CYMBALTA and my doctor increased the doses and prednisone.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chest discomfort, Hyperhidrosis, Nodule, Pain
Clinical narrative: 6x3 inch knot on arm, joints and upper body hurt all weekend fever Saturday night, sweating more than usual, and chest tightness since Friday night..
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: 6x3 inch knot on arm, joints and upper body hurt all weekend fever Saturday night, sweating more than usual, and chest tightness since Friday night..
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Pallor, Respiratory arrest, Seizure like phenomena, Syncope
Clinical narrative: Child was given TDAP, Hep A in Left Deltoid, then given Flu in Right Deltoid.  While administering the additional vaccine (Menveo) in rt deltoid, the child had syncope.  He turned pale and was not breathing.  He was lowered to the floor; his feet were elevated.  Sternal rub started, he began to have seizure like activity and he took a breath.  Episode lasted approximately 20 seconds.  Ambulance was called for the child. No further treatment occurred.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Asthenia, Condition aggravated, Headache, Incorrect product formulation administered
Clinical narrative: Hi,   My I am the mother of a patient and here I would like to report an incident that happened on 12/30/2022. I schedule for Covid Vaccination for My Son  at a local clinic:    Clinic started the Covid vaccination 1st shot and after that my son was sick for 4-5 days with high  fever, headache, stomach upset, weakness etc. On 12/30/23 nurse didn't tell us that she has given him incorrect sort of Covid Vaccination.   After 21 days, on 01/20/2023 when we went for his 2nd shot of Covid vaccination, nurse/clinic supervisor says, they don't have second shot of Covid vaccination and I should go to a local pharmacy and get second shot, I said okay, please give me a Covid vaccination card and I can go and get the second shot. At that time first they give me a yellow stick note specifying name, dob, and saying he got first shot of covid vaccination. I got surprise by that as no office does such things for patient records, I told them and requested them to provide me the valid copy otherwise no other pharmacy will accept that and after wait of a hours they gave me a copy of the document which says patient got "COV-2 - Bivalent Booster" and when I saw that I enquiry for it and Clinic Supervisor says these days Covid 1st sort and booster are giving together and that why it's written this way.   As they don't have the Covid vaccine available they auto schedule for second shot to different clinic office location:   on 1/27/2023.   When I went their on 01/27/2023, nurse checked the document and says this is wrong, boy shoudn't get the booster sort first, I said as per the Previous office clinic supervisor these days 1st sort and booster you guys giving together, she says nope that is never a case, she went and checked the lot of medicine 2 times as well as checked with her clinic supervisor/manager and they confirmed that this lot is booster shot not Covid 1st shot and then we come to know that my son got booster sort first instead of regular Covid vaccination shots on 01/27/2023 and nurse says they cannot start the vaccination now.  After this, I went to the vaccinators doctors office and told them what I come to know and then they said, the other clinic is saying incorrectly but kind of accepted that it's booster and it was a mistake. So by reading all this now you can see, the doctors office administrator is misguided, pass incorrect information, not taking patient parent/guardians concern before giving the shot to minor and not transparent with patient on the mistakes they did.   As my son keep complaining about headache after every 3/4 since 12/30/2022, so now knowing all this, I've scheduled a visit to review/discuss this case and see what all impact my son can face and how it will impact his overall health because of negligence incidents. I tried to reach out to Manager/upper staff of that facility with no luck and they didn't response.  Please let me know if you have any further question. I can be reach at my email address
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Malaise, Pyrexia
Clinical narrative: Hi,   My I am the mother of a patient and here I would like to report an incident that happened on 12/30/2022. I schedule for Covid Vaccination for My Son  at a local clinic:    Clinic started the Covid vaccination 1st shot and after that my son was sick for 4-5 days with high  fever, headache, stomach upset, weakness etc. On 12/30/23 nurse didn't tell us that she has given him incorrect sort of Covid Vaccination.   After 21 days, on 01/20/2023 when we went for his 2nd shot of Covid vaccination, nurse/clinic supervisor says, they don't have second shot of Covid vaccination and I should go to a local pharmacy and get second shot, I said okay, please give me a Covid vaccination card and I can go and get the second shot. At that time first they give me a yellow stick note specifying name, dob, and saying he got first shot of covid vaccination. I got surprise by that as no office does such things for patient records, I told them and requested them to provide me the valid copy otherwise no other pharmacy will accept that and after wait of a hours they gave me a copy of the document which says patient got "COV-2 - Bivalent Booster" and when I saw that I enquiry for it and Clinic Supervisor says these days Covid 1st sort and booster are giving together and that why it's written this way.   As they don't have the Covid vaccine available they auto schedule for second shot to different clinic office location:   on 1/27/2023.   When I went their on 01/27/2023, nurse checked the document and says this is wrong, boy shoudn't get the booster sort first, I said as per the Previous office clinic supervisor these days 1st sort and booster you guys giving together, she says nope that is never a case, she went and checked the lot of medicine 2 times as well as checked with her clinic supervisor/manager and they confirmed that this lot is booster shot not Covid 1st shot and then we come to know that my son got booster sort first instead of regular Covid vaccination shots on 01/27/2023 and nurse says they cannot start the vaccination now.  After this, I went to the vaccinators doctors office and told them what I come to know and then they said, the other clinic is saying incorrectly but kind of accepted that it's booster and it was a mistake. So by reading all this now you can see, the doctors office administrator is misguided, pass incorrect information, not taking patient parent/guardians concern before giving the shot to minor and not transparent with patient on the mistakes they did.   As my son keep complaining about headache after every 3/4 since 12/30/2022, so now knowing all this, I've scheduled a visit to review/discuss this case and see what all impact my son can face and how it will impact his overall health because of negligence incidents. I tried to reach out to Manager/upper staff of that facility with no luck and they didn't response.  Please let me know if you have any further question. I can be reach at my email address
Age: 55.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Arthralgia, COVID-19, Cough, Fatigue, Headache
Clinical narrative: I contracted COVID. The symptoms started with exhaustion, runny nose, a headache, and very quickly progressed to becoming a mild fever of 100. I took the afternoon off work, gave myself a COVID, and a positive result came out within a minute. Did a really strict quarantine and stayed in my room for 5 days. The fever started going down within 3 days. I been having joint ache, fatigue, and coughing. I called my doctor office and was given PAXLOVID. I took it for the 5 day course and the symptoms eased off a lot. I still have exhaustion the joint ache and the coughing though.
Age: 55.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Impaired work ability, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I contracted COVID. The symptoms started with exhaustion, runny nose, a headache, and very quickly progressed to becoming a mild fever of 100. I took the afternoon off work, gave myself a COVID, and a positive result came out within a minute. Did a really strict quarantine and stayed in my room for 5 days. The fever started going down within 3 days. I been having joint ache, fatigue, and coughing. I called my doctor office and was given PAXLOVID. I took it for the 5 day course and the symptoms eased off a lot. I still have exhaustion the joint ache and the coughing though.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 Moderna 4/13/21  025B21A dose 2 Moderna  5/10/21 048B21A
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received Pfizer Covid-19 vaccine dose # 2 after BUD-expiration date.  Doctor recommended for dose to be repeated. patient's parents were informed of the adverse event, they reported no symptoms or signs related to this adverse event. Patient was offered to be revaccinated.
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Vaccination error
Clinical narrative: Vaccine error.  We had an RN administer the Moderna Covid-19 Vaccine Bivalent Booster to a 17 year old female patient on 1/27/23 and the patient did not receive any primary doses prior to being given the bivalent booster dose.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: 12/29/22 presents to ED for "shortness of breath". PMHx of "hypertension, CAD, CHF, A. fib on Eliquis, and emphysema"
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Dizziness, Hyperhidrosis, Loss of personal independence in daily activities
Clinical narrative: Within 5 minutes of the injection, I was weak and lightheaded, my BP dropped to around60/40, began sweating profusely, wasn't able to function.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Testicular pain, Ultrasound scan abnormal, Varicocele
Clinical narrative: Whole body ache. I had severe testicular pain and after several days the whole body ache goes away but the testicular pain doesn't go away and persist till today.
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Exposure to SARS-CoV-2, Headache, Pain, Pyrexia
Clinical narrative: About two months after receiving the Moderna Bivalent Booster, I tested positive for COVID. I started experiencing symptoms while in Germany before I headed home. I was on a trip with my spouse and 4 of our friends. Five out of Six of us tested positive for Covid-19. My symptoms included sneezing, body aches, fever, headache and a runny nose. After experiencing these symptoms, I woke up the next morning with just sneezing and a runny nose. I performed two home tests once I got home and they were both positive. I contacted my PCP and he prescribed Paxlovid for me. I took Paxlovid and I feel like it definitely helped me.
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: About two months after receiving the Moderna Bivalent Booster, I tested positive for COVID. I started experiencing symptoms while in Germany before I headed home. I was on a trip with my spouse and 4 of our friends. Five out of Six of us tested positive for Covid-19. My symptoms included sneezing, body aches, fever, headache and a runny nose. After experiencing these symptoms, I woke up the next morning with just sneezing and a runny nose. I performed two home tests once I got home and they were both positive. I contacted my PCP and he prescribed Paxlovid for me. I took Paxlovid and I feel like it definitely helped me.
Age: 42.0
Sex: M
Vaccine: IPV
Symptoms: Injection site bruising, Injection site erythema, Injection site rash, Wrong product administered
Clinical narrative: Client had IPV administered instead of PPD for the TB skin test on 1/27/23. Client reported having a little rash and red ring around the site, as well as bruising. No other adverse reaction reported. No treatment needed.
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: Redness, swelling, itching around injection site - Raised red patch size, hot to the touch compared to surrounding skin, increased from 2 in diameter on 26-Jan to 6 in diameter over 4 days.  Bruising at extreme edges of red patch (approx 4 in from injection site).  Hard painful lump at injection site approx 1 in by 0.5 in.  30-Jan redness has started to fade, size of erythema no longer increasing in area.  Itching present but subsiding.
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, itching around injection site - Raised red patch size, hot to the touch compared to surrounding skin, increased from 2 in diameter on 26-Jan to 6 in diameter over 4 days.  Bruising at extreme edges of red patch (approx 4 in from injection site).  Hard painful lump at injection site approx 1 in by 0.5 in.  30-Jan redness has started to fade, size of erythema no longer increasing in area.  Itching present but subsiding.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 12/29/22 presents to ED for "fever" "corona virus concern". PMHx of "multiple myeloma on chemo  and PE on anticoagulation"
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient reports waking up at 8AM with red, swollen arm hot to touch and painful lasting three days. Patient took Benadryl and acetaminophen and hot/cold compress
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Body temperature increased, Disorganised speech, Feeling abnormal, Headache, Hypersomnia
Clinical narrative: He seemed fine as soon as he get out, he mentioned the site was painful. 30 mins later, he started having a severe headache. As soon as he said that, his body started trembling, from foot all the way up. We were heading to town, so I started driving straight to the hospital there. His body went limp as he was trembling. Trembling was nonstop, he said his body was in full pain. He was saying stuff that didn't make sense. His sentences did not make any sense. That lasted a whole 30-45 mins. As soon as I got there, his trembling body stopped. I asked him if he still have a headache, he said his head felt better, so we just waited in the parking lot of the hospital. Within an hour the trembles and headache was gone, but he just didn't feel good. When we came back home, he wanted to lay down. I took his temp, cause he was hot, and his temp was at 104. So I stripped him down. The high temp lasted more that about 10 mins, then it dropped back down to 103 and then it begin to normalize. He then slept  like all day. When he woke up, he had an appetite, he was acting normal.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Hypotonia, Injection site pain, Pain, Tremor
Clinical narrative: He seemed fine as soon as he get out, he mentioned the site was painful. 30 mins later, he started having a severe headache. As soon as he said that, his body started trembling, from foot all the way up. We were heading to town, so I started driving straight to the hospital there. His body went limp as he was trembling. Trembling was nonstop, he said his body was in full pain. He was saying stuff that didn't make sense. His sentences did not make any sense. That lasted a whole 30-45 mins. As soon as I got there, his trembling body stopped. I asked him if he still have a headache, he said his head felt better, so we just waited in the parking lot of the hospital. Within an hour the trembles and headache was gone, but he just didn't feel good. When we came back home, he wanted to lay down. I took his temp, cause he was hot, and his temp was at 104. So I stripped him down. The high temp lasted more that about 10 mins, then it dropped back down to 103 and then it begin to normalize. He then slept  like all day. When he woke up, he had an appetite, he was acting normal.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Erythema, Musculoskeletal stiffness, Pain, Pruritus
Clinical narrative: Associate experienced sharp pain, redness, swelling, itching,  burning, stiff neck. 1/27 and 1/28 she took Benedryl and Motrin over the counter for her symptoms. Presented to associate health 1/30/2023 and was sent to Solutions for assessment by a provider.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Swelling
Clinical narrative: Associate experienced sharp pain, redness, swelling, itching,  burning, stiff neck. 1/27 and 1/28 she took Benedryl and Motrin over the counter for her symptoms. Presented to associate health 1/30/2023 and was sent to Solutions for assessment by a provider.
Age: 92.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: Hospitilization
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: 18JAN2023 I woke up and felt something was wrong not normal I had a lot of congestion in my nose and throat over the next several days it got worse I was able to cough up a lot of mucous out of my throat it was clear as was the mucous in my nose I had no fever but I was very tired an weak and did not have a normal appetite but made my self eat. These symptoms continued then today 30JAN2023 I tested negative for the first time. I am still bringing up mucous from my throat and nasal passages and still feel tired.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nasal congestion, Productive cough, Respiratory tract congestion, SARS-CoV-2 test positive, Secretion discharge
Clinical narrative: 18JAN2023 I woke up and felt something was wrong not normal I had a lot of congestion in my nose and throat over the next several days it got worse I was able to cough up a lot of mucous out of my throat it was clear as was the mucous in my nose I had no fever but I was very tired an weak and did not have a normal appetite but made my self eat. These symptoms continued then today 30JAN2023 I tested negative for the first time. I am still bringing up mucous from my throat and nasal passages and still feel tired.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer Covid-19 vaccine dose # 1 after BUD-expiration date.  Doctor recommended for dose to be repeated. patient's parents were informed of the adverse event, they reported no symptoms or signs related to this adverse event. Patient was offered to be revaccinated.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Acupuncture, Audiogram, Deafness unilateral, Dizziness
Clinical narrative: Sudden onset hearing loss in left ear with dizziness and tinnitus on 2-26-21.  Woke up with tinnitus, as day progressed I got dizziness, by late afternoon was deaf in left ear. Went to Urgent Care/ER that night where ENT was consulted.  Was put on 60 mg prednisone daily for 1 week, taking first dose in the ER. The next morning I had regained a little hearing and was no longer completely deaf in that ear.  Dizziness was severe for several days, continued for 2-3 weeks. I  followed up in clinic with ENT MD 4 days after onset of symptoms. Hearing test showed severe hearing loss in left ear.  MRI ordered and completed which showed left ear signal alteration with possible labrynthitis. My next clinic appointment with Dr. was 1 week after the first appointment, with hearing test showing no improvement in hearing.  I then started a series of 3 steroid injections in my left ear.  The injections were one week apart.  Very little to no improvement was achieved with the injections.  I then started hyperbaric oxygen therapy which has helped some patients in the past but is not consisitently effective with all who try it.  I did 22 sessions of hyperbaric oxygen therapy with no real improvement. Dr. approximated I have 80% hearing loss in my left ear.  I have not noticed any improvement in my hearing since completion of treatments.  Tinnitus is still constant in that ear.  I have nerve damage also so any hearing I do have in my left ear is distorted, like a broken speaker.  I use a Private system hearing aids to aid in my hearing.  I have also tried accupuncture with no improvement.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperbaric oxygen therapy, Magnetic resonance imaging head abnormal, Nerve injury, Tinnitus
Clinical narrative: Sudden onset hearing loss in left ear with dizziness and tinnitus on 2-26-21.  Woke up with tinnitus, as day progressed I got dizziness, by late afternoon was deaf in left ear. Went to Urgent Care/ER that night where ENT was consulted.  Was put on 60 mg prednisone daily for 1 week, taking first dose in the ER. The next morning I had regained a little hearing and was no longer completely deaf in that ear.  Dizziness was severe for several days, continued for 2-3 weeks. I  followed up in clinic with ENT MD 4 days after onset of symptoms. Hearing test showed severe hearing loss in left ear.  MRI ordered and completed which showed left ear signal alteration with possible labrynthitis. My next clinic appointment with Dr. was 1 week after the first appointment, with hearing test showing no improvement in hearing.  I then started a series of 3 steroid injections in my left ear.  The injections were one week apart.  Very little to no improvement was achieved with the injections.  I then started hyperbaric oxygen therapy which has helped some patients in the past but is not consisitently effective with all who try it.  I did 22 sessions of hyperbaric oxygen therapy with no real improvement. Dr. approximated I have 80% hearing loss in my left ear.  I have not noticed any improvement in my hearing since completion of treatments.  Tinnitus is still constant in that ear.  I have nerve damage also so any hearing I do have in my left ear is distorted, like a broken speaker.  I use a Private system hearing aids to aid in my hearing.  I have also tried accupuncture with no improvement.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Peripheral swelling, Rash
Clinical narrative: Severely swollen arm. Very large rash.  Extreme tiredness. Temperature of 100
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction/ used after the best used date
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Blood test, Cardiac stress test, Dizziness, Magnetic resonance imaging heart
Clinical narrative: Weakness, dizziness, heart racing
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Palpitations
Clinical narrative: Weakness, dizziness, heart racing
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction/ used after the best used date
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer Covid-19 vaccine dose # 1 after BUD-expiration date.  Doctor recommended for dose to be repeated. patient's parents were informed of the adverse event, they reported no symptoms or signs related to this adverse event. Patient was offered to be revaccinated.