chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Incorrect route of product administration, Neurodermatitis
Clinical narrative: Probable hypersensitivity to Pfizer COVID-19 booster shots; Prurigo nodularis; rash all over her body with intense itching; BNT162b2 via subcutaneous route of administration; This is a spontaneous report received from a consumer, Program ID.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 10Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years subcutaneous for COVID-19 immunisation. The patient's relevant medical history included: "Depression", start date: 2016 (unspecified if ongoing), notes: After her son's death; "Son's death" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1; subcutaneous), administration date: 11Mar2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "Inappropriate route of vaccination"; Comirnaty (DOSE 2; subcutaneous), administration date: 01Apr2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "Inappropriate route of vaccination". The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 10Sep2021, outcome "unknown", described as "BNT162b2 via subcutaneous route of administration"; NEURODERMATITIS (medically significant) with onset 15Sep2021, outcome "recovering", described as "Prurigo nodularis; rash all over her body with intense itching"; ALLERGY TO VACCINE (medically significant), outcome "unknown", described as "Probable hypersensitivity to Pfizer COVID-19 booster shots". The event "probable hypersensitivity to pfizer covid-19 booster shots" required physician office visit. The event "prurigo nodularis; rash all over her body with intense itching" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of neurodermatitis. On 15Sep2021 (5 days after receiving her booster), the patient developed a rash all over her body (developed a rash over entire body within 5 days of booster). On 29Sep2021, the patient ended up visiting ED due to intense itching and was given intravenous prednisolone to alleviate the itch. The patient was then diagnosed by dermatologist with prurigo nodularis. The patient is currently on dupilumab (DUPIXENT). In diagnosis letter (22Aug2022), the dermatologist wrote probable hypersensitivity to Pfizer COVID-19 booster shots versus other dermatitis, now with prurigo nodularis. The patient was convinced that her prurigo nodularis was triggered as a direct result of the COVID-19 booster.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400259323 Same patient and product; different event and dose;US-PFIZER INC-202400259324 Same patient and product; different event and dose;
Age: 35.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Feeling hot, Peripheral swelling, Swelling face, Urticaria
Clinical narrative: I got the shot in the morning. By the afternoon I felt very flushed and starting having hot flashes. My face broke out in a rash. It was red and itchy and a little swollen. About 3 the rest of my body started itching.  I would got hot then cold and just felt off. The next morning I went back to the doctor to let them know what was going on. They asked me questions and took some documentation. I was still very itchy and my face was swollen. They gave me some allergy meds and told me to take Benadryl and monitor it. I could get a steroid shot if I wanted, but it would counteract the tdap shot. I declined. A week later I am still itchy and my face swells randomly.
Age: 35.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Erythema, Feeling abnormal, Feeling of body temperature change, Flushing, Hot flush
Clinical narrative: I got the shot in the morning. By the afternoon I felt very flushed and starting having hot flashes. My face broke out in a rash. It was red and itchy and a little swollen. About 3 the rest of my body started itching.  I would got hot then cold and just felt off. The next morning I went back to the doctor to let them know what was going on. They asked me questions and took some documentation. I was still very itchy and my face was swollen. They gave me some allergy meds and told me to take Benadryl and monitor it. I could get a steroid shot if I wanted, but it would counteract the tdap shot. I declined. A week later I am still itchy and my face swells randomly.
Age: 35.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Pruritus, Rash, Swelling face
Clinical narrative: I got the shot in the morning. By the afternoon I felt very flushed and starting having hot flashes. My face broke out in a rash. It was red and itchy and a little swollen. About 3 the rest of my body started itching.  I would got hot then cold and just felt off. The next morning I went back to the doctor to let them know what was going on. They asked me questions and took some documentation. I was still very itchy and my face was swollen. They gave me some allergy meds and told me to take Benadryl and monitor it. I could get a steroid shot if I wanted, but it would counteract the tdap shot. I declined. A week later I am still itchy and my face swells randomly.
Age: 1.92
Sex: F
Vaccine: COVID19-2, COVID19, FLUX
Symptoms: Abdominal discomfort, Diarrhoea, Diet refusal, Incorrect dose administered
Clinical narrative: was given the dosage for a 12yr old; was given the dosage for a 12yr old; upset stomach; pain at injection site; loose stool; This is a spontaneous report received from a Consumer or other non HCP.  A 23-month-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Sep2024 at 04:30 as dose 1, single (Batch/Lot number: unknown) at the age of 23 months, in thigh for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 09Sep2024 as unk, single), in right leg for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFANTILE DIARRHOEA (non-serious) with onset 09Sep2024, outcome "recovering", described as "loose stool"; VACCINATION SITE PAIN (non-serious) with onset 09Sep2024, outcome "recovering", described as "pain at injection site"; ABDOMINAL DISCOMFORT (non-serious) with onset 09Sep2024, outcome "recovering", described as "upset stomach"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 09Sep2024 at 04:30, outcome "recovering" and all described as "was given the dosage for a 12yr old". Therapeutic measures were not taken as a result of product administered to patient of inappropriate age, overdose, abdominal discomfort, vaccination site pain, infantile diarrhoea. Additional information: Patient received the covid 19 shot 2024-25 on 09Sep2024. Patient was notified the next day that she was given the dosage for a 12yr old. She has been experiencing symptoms like upset stomach, pain at injection site and loose stool. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 1.92
Sex: F
Vaccine: COVID19-2, COVID19, FLUX
Symptoms: Abdominal discomfort, Infantile diarrhoea, Overdose, Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: was given the dosage for a 12yr old; was given the dosage for a 12yr old; upset stomach; pain at injection site; loose stool; This is a spontaneous report received from a Consumer or other non HCP.  A 23-month-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Sep2024 at 04:30 as dose 1, single (Batch/Lot number: unknown) at the age of 23 months, in thigh for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 09Sep2024 as unk, single), in right leg for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFANTILE DIARRHOEA (non-serious) with onset 09Sep2024, outcome "recovering", described as "loose stool"; VACCINATION SITE PAIN (non-serious) with onset 09Sep2024, outcome "recovering", described as "pain at injection site"; ABDOMINAL DISCOMFORT (non-serious) with onset 09Sep2024, outcome "recovering", described as "upset stomach"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 09Sep2024 at 04:30, outcome "recovering" and all described as "was given the dosage for a 12yr old". Therapeutic measures were not taken as a result of product administered to patient of inappropriate age, overdose, abdominal discomfort, vaccination site pain, infantile diarrhoea. Additional information: Patient received the covid 19 shot 2024-25 on 09Sep2024. Patient was notified the next day that she was given the dosage for a 12yr old. She has been experiencing symptoms like upset stomach, pain at injection site and loose stool. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 1.25
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Nurse calling with a report on an adverse event regarding an expired administration of a dose of VAQTA.  Nurse reporting that the dose of VAQTA was administered on 7/14/2020 with an expiration date of 7/10/2020.  Nurse confirmed no reports of medical; Nurse calling with a report on an adverse event regarding an expired administration of a dose of VAQTA.  Nurse reporting that the dose of VAQTA was administered on 7/14/2020 with an expiration date of 7/10/2020.  Nurse confirmed no reports of medical; Information has been received from a nurse, referring to a 15-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 14-JUL-2020, the patient was vaccinated with an expire dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #S005723, expiration date: 10-JUL-2020, administered for prophylaxis (strength, and route of administration were not provided).  The reporting nurse stated that the dose of hepatitis a vaccine, inactivated (VAQTA) was administered on 14-JUL-2020 with an expiration date of 10-JUL-2020. The nurse confirmed no reports of medical concerns after the patient was administered the expired dose of hepatitis a vaccine, inactivated (VAQTA). Informed nurse on stability using the post expiry memo data per protocol. No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Caller reports administering an expired dose of PROQUAD.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from nurse, concerning a patient of unknown age and gender.   The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On 17-SEP-2024, the patient vaccinated with an expired vaccine of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, (lot #X007087, expiration date: 04-SEP-2024) (albumin status: recombinant human albumin (rHa)administered intramuscularly for prophylaxis (strength was not provided). No adverse events reported. No other information provided. The operator of device was healthcare professional.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Gardasil 1st dose on 05-MAY-2022 and 2nd dose on 03-AUG-2022 3rd dose delayed by two years; No adverse event; This spontaneous report was received from a nurse practitioner referring to a 36-year-old female.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 05-MAY-2022 and 03-AUG-2022, the patient was vaccinated with the first and second dose respectively of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry dates, and route of administration were not provided). It was noted that the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) third dose had been delayed by two years. The reporter stated that the patient inquired on 17-SEP-2024 if she could still receive the third dose due to an interrupted schedule.  At the time of the report, the patient had not received the third dose. No adverse event had been reported.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported.; Nurse reports GARDASIL 9 administration outside of recommended intervals/dose 2 7/15/2024 and dose 3 9/16/2024; This spontaneous report was received from a registered nurse (R. N.) concerning to a 44-year-old patient of unspecified gender.  The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On 16-MAY-2024, the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), on 15-JUL-2024 she received the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and on 16-SEP-2024, was vaccinated outside of recommended intervals with the 3rd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration) (exact doses, lot #s, expiry dates, anatomical locations and routes of administration were not provided). All doses were administered as prophylaxis.  No additional adverse events (AE) were reported (no adverse event.)  Lot #s are being requested and will be submitted if received.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 infection; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19 infection) in an 83-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Jun-2024, the patient experienced COVID-19 (COVID-19 infection). At the time of the report, COVID-19 (COVID-19 infection) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary oedema
Clinical narrative: Development of fluid in my lungs; This serious initial spontaneous safety report was received by Novavax on 13-Sep-2024 from a consumer via social media monitoring.  An individual of an unspecified age and gender was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula)(Intramuscular) (Lot number was not provided in the report) on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date after vaccination, the patient experienced Development of fluid in my lungs(Pulmonary oedema)(Serious: Other Medically Important Condition).  At the time of reporting, the event outcome of Pulmonary oedema was Not Recovered/Not Resolved/Ongoing.; Sender's Comments: This individual of an unspecified age and sex experienced Pulmonary oedema after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The event Pulmonary oedema was reported as serious.   Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Pulmonary oedema is considered possible.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Felt a little sick from them (Covid vaccine) like the flu; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Bradycardia" (unspecified if ongoing); "pacemaker" (unspecified if ongoing), notes: for 25 years; "Covid", start date: 2021 (unspecified if ongoing); "Giant cell arteritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 immunization, reaction(s): "Felt a little sick from them (Covid vaccine) like the flu"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "Felt a little sick from them (Covid vaccine) like the flu". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Felt a little sick from them (Covid vaccine) like the flu".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400256951 same patient and reporter, different dose and event;
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea
Clinical narrative: upset stomach; uncontrollable diarrhea for about 2 months.; stomach spasms; This non-serious case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included dupilumab (Dupixent) for product used for unknown indication.   Concurrent medical conditions included eczema.   On 28-JUN-2024, the patient received the 1st dose of Shingrix. In JUN-2024, the patient started Dupixent. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced upset stomach (Verbatim: upset stomach), diarrhea (Verbatim: uncontrollable diarrhea for about 2 months.) and gastric spasm (Verbatim: stomach spasms). The action taken with Dupixent was unknown. The outcome of the upset stomach, diarrhea and gastric spasm were resolved (duration 2 months).   It was unknown if the reporter considered the upset stomach, diarrhea and gastric spasm to be related to Shingrix.   It was unknown if the company considered the upset stomach, diarrhea and gastric spasm to be related to Shingrix.   Linked case(s) involving the same patient: US2024AMR113662   Additional Information: GSK Receipt Date: 10-SEP-2024 The reporter was the patient.  The patient received the first dose of Shingrix and Dupixent and experienced upset stomach, stomach spasms, and uncontrollable diarrhea for about 2 months. The patient received Dupixent 3 days prior to each dose of Shingrix. The patient receives Dupixent every other Tuesday. It was unknown if the reporter considered the upset stomach, diarrhea and gastric spasm to be related to Dupixent. For tolerance of 2nd dose refer case- US2024AMR113662.; Sender's Comments:  US-GSK-US2024AMR113662:same reporter, same patient, 2nd dose case
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphasia, Cerebrovascular accident, Encephalitis autoimmune, Encephalitis bacterial, Encephalitis viral
Clinical narrative: Encephalopathy; Headache; Information has been received from Regulatory agency (agency # AU-TGA-0000815884) on 16-SEP-2024, referring to an 80-year-old male patient.  The patient's concurrent conditions included hypertension, type 2 diabetes mellitus, and dyslipidemia. The patient's medical history and concomitant therapies were not reported.  On an unknown date in June 2024, the patient was vaccinated with zoster vaccine live (manufacturer unknown) subcutaneous injection (strength, dose, frequency, lot #, expiry date, route of administration, and indication were not provided).  On 09-JUL-2024, the patient experienced headache (also reported as headache for last few days since having shingles vaccine 2 weeks ago). On 11-JUL-2024, the patient experienced encephalopathy and was admitted to hospital. He woke at 2pm unable to speak and making sound only, followed by word finding difficulties. He was able to mobilize independently.  No recent illness, no coryzal symptoms, no pain. Differential diagnosis (DDx) included acute stroke, viral/bacterial encephalitis, post-vaccine encephalopathy, seizure with prolonged post-ictal period, autoimmune encephalitis. Aspirin loaded and high dose statin commenced in emergency department (ED), but ceases after stroke excluded. Commenced intravenous (IV) acyclovir on day 2 of admission (12-JUL-2024) for viral encephalitis. Lumbar puncture (LP) was performed on day 5 (15-JUL-2024) (delayed to wash-out aspirin dose given in ED) and no causative agents were identified. Discussed with "FSH" viral ID specialist to treat as potential post-vaccine encephalopathy (varicella zoster virus (VZV) vaccine = live attenuated) with 7 days IV acyclovir plus 14 days high-dose oral (PO) valaciclovir. On 17-JUL-2024, the patient was discharged (also reported as separated) from hospital. Symptoms improved by 80% at time of discharged according to wife. Length of stay (LOS) 7 days. Discharge summary stated principal diagnosis encephalopathy. Comorbidities included vitamin B12 deficiency and decreased vitamin D (not reported as adverse events). At the time of reporting, the patient was recovering from the event of encephalopathy, and the outcome of the event headache was not known.   The reporter considered both events to be related to zoster vaccine live (manufacturer unknown).   Upon internal review, the event encephalopathy was considered as medically significant.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Encephalopathy, Headache, Lumbar puncture normal, Seizure
Clinical narrative: Encephalopathy; Headache; Information has been received from Regulatory agency (agency # AU-TGA-0000815884) on 16-SEP-2024, referring to an 80-year-old male patient.  The patient's concurrent conditions included hypertension, type 2 diabetes mellitus, and dyslipidemia. The patient's medical history and concomitant therapies were not reported.  On an unknown date in June 2024, the patient was vaccinated with zoster vaccine live (manufacturer unknown) subcutaneous injection (strength, dose, frequency, lot #, expiry date, route of administration, and indication were not provided).  On 09-JUL-2024, the patient experienced headache (also reported as headache for last few days since having shingles vaccine 2 weeks ago). On 11-JUL-2024, the patient experienced encephalopathy and was admitted to hospital. He woke at 2pm unable to speak and making sound only, followed by word finding difficulties. He was able to mobilize independently.  No recent illness, no coryzal symptoms, no pain. Differential diagnosis (DDx) included acute stroke, viral/bacterial encephalitis, post-vaccine encephalopathy, seizure with prolonged post-ictal period, autoimmune encephalitis. Aspirin loaded and high dose statin commenced in emergency department (ED), but ceases after stroke excluded. Commenced intravenous (IV) acyclovir on day 2 of admission (12-JUL-2024) for viral encephalitis. Lumbar puncture (LP) was performed on day 5 (15-JUL-2024) (delayed to wash-out aspirin dose given in ED) and no causative agents were identified. Discussed with "FSH" viral ID specialist to treat as potential post-vaccine encephalopathy (varicella zoster virus (VZV) vaccine = live attenuated) with 7 days IV acyclovir plus 14 days high-dose oral (PO) valaciclovir. On 17-JUL-2024, the patient was discharged (also reported as separated) from hospital. Symptoms improved by 80% at time of discharged according to wife. Length of stay (LOS) 7 days. Discharge summary stated principal diagnosis encephalopathy. Comorbidities included vitamin B12 deficiency and decreased vitamin D (not reported as adverse events). At the time of reporting, the patient was recovering from the event of encephalopathy, and the outcome of the event headache was not known.   The reporter considered both events to be related to zoster vaccine live (manufacturer unknown).   Upon internal review, the event encephalopathy was considered as medically significant.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: hives
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism, Thrombectomy
Clinical narrative: Patient developed saddle pulmonary embolus and extensive Lt lower extremity DVT. Required Arterial thrombectomy
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Very sore arm.  Chills overnight followed by fever and headache.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a ProQuad (MMRV) with a Varivax (varicella) at the same office visit. As of 9/19/2024 patient is having no reaction, fever, or adverse reactions noted at this.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Insomnia, Night sweats, Pyrexia
Clinical narrative: chills, fever, night sweats, severe pain at injection site.  Unable to sleep. Lasted through much of the night.  Took combination of Advil and Tylenol around 4am, and did provided some relief.  As of 8am this morning; chills, fever, sweats are gone.  Injection site still very painful.   I have taken all prior  covid shots offered, and none with this reaction.
Age: 22.0
Sex: F
Vaccine: JEV1, TYP, YF
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Swelling, redness, tenderness at the site of the vaccines. Hives w/ itchiness all over R arm. Pt prescribed hydrocortisone and  diphenhydrAMINE for itchiness.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: Patient currently 36 weeks pregnant was given RSV vaccine that has not been approved to receive during pregnancy. The physician notified the patient. No adverse signs, symptoms at this time
Age: 78.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient unknowingly received FluAd on 8/8 at another store, and then requested another FluAd on 9/18 along with Comirnaty and Arexvy. Alerted patient about duplicate Fluad 9/20/24, patient has not experienced any adverse side effects from vaccines administered on 9/18/24.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin discolouration, Swelling
Clinical narrative: Red, swollen, raised, white dot in the middle, red dots around, itching
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: PATIENT GOT A SECOND RSV VACCINE. GOT ONE 1/4/24 AND 9/16/24
Age: 31.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: Patient currently 37 weeks pregnant was given RSV vaccine that has not been approved to receive during pregnancy. The physician notified the patient. No adverse signs, symptoms at this time
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at site of injection x 3 days
Age: 32.0
Sex: U
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: Patient currently 35weeks pregnant was given RSV vaccine that has not been approved to receive during pregnancy. The physician notified the patient. No adverse signs, symptoms at this time
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy, Fatigue, Immediate post-injection reaction, Injection site pain
Clinical narrative: Uncomplicated Pregnancy.  Very Healthy with No Risks. EDD - 3/20/2024. Baby Born Birth Weight - 8lbs 12 oz. Uncomplicated labor and delivery. Baby did well on monitors the whole time.   Shot received at 6 months  pregnant. I  experienced mild symptoms immediately after. Low grade fever, tired, soreness, swelling and heat at injection site.  Baby was then born with seizures and diagnosed with a perinatal ischemic stroke of the left MCA.  The cause of the stroke is from loss of oxygen to the brain.  It was likely due to a blood clot. No history of blood clots or clotting disorders in myself or family.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Neonatal disorder, Pyrexia
Clinical narrative: Uncomplicated Pregnancy.  Very Healthy with No Risks. EDD - 3/20/2024. Baby Born Birth Weight - 8lbs 12 oz. Uncomplicated labor and delivery. Baby did well on monitors the whole time.   Shot received at 6 months  pregnant. I  experienced mild symptoms immediately after. Low grade fever, tired, soreness, swelling and heat at injection site.  Baby was then born with seizures and diagnosed with a perinatal ischemic stroke of the left MCA.  The cause of the stroke is from loss of oxygen to the brain.  It was likely due to a blood clot. No history of blood clots or clotting disorders in myself or family.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given an MMR that was not due until 4 years of age. First dose of MMR was given on 3/11/2024
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: Patient currently 34weeks pregnant was given RSV vaccine that has not been approved to receive during pregnancy. The physician notified the patient. No adverse signs, symptoms at this time
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Patient received Arexvy vaccine on 9/13/24. She started having rash at the location of vaccination site on 9/17/2024, including pain. Rash was about 4 inches long, and swelling up. She tool benadryl tab and the rash went away next day, but the pain was still on. She reported to pharmacy team on 9/20/2024, and her left arm was clear but she still has pain at the injection site.
Age: 85.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Back pain, Decreased appetite, Myalgia, Pyrexia
Clinical narrative: Bad muscle ache in left arm and in lower mid back, feverish, no appetite
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: Patient currently 36 weeks pregnant was given RSV vaccine that has not been approved to receive during pregnancy. The physician notified the patient. No adverse signs, symptoms at this time
Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Crying, Emotional distress, Periorbital haemorrhage, Petechiae, Screaming
Clinical narrative: Patient developed periorbital and neck petechiae within 15 minutes after immunization. He was very upset during vaccination- screaming and crying. he then calmed down. He had NO wheezing, shortness of breath, LOC, other rashes, bleeding, neuro changes, swelling of lips/tongue, difficulty breathing, vomiting.
Age: 1.33
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient had received first dose of Hep A on 3/11/24 and would not have been due for their second dose until 6 months after. This Hep A was given approximately 2 months too soon.
Age: 1.33
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose of Varivax was given on 3/11/2024, second dose was due at 4 years but was given at 1 year 3 months.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Employee inadvertently administered expired MMR Priorix. Error was discovered on 9/18/24.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Employee inadvertently administered expired MMR Priorix. Error was discovered on 9/18/24
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Myalgia, Peripheral swelling
Clinical narrative: She got her vaccine, she felt fine, tired as usual and did not feel anything unusual until she woke up at 3:00 AM.  She first noticed that from her shoulder to her elbow was swollen, not a soft swelling, a hard swelling.  Every vaccine and booster that she has gotten has made her ill, but that did not deter her from getting them.  This time she was too ill to take care of herself.  Unfortunately there wasn't anyone to help her as they had traveled for the weekend.  She woke up with a temperature of 101, and it got up to 103.  Over the next few days it hasn't gotten quit that high again.  That lasted for about 24 hours, and since then she has been running a temperature of about 101 degrees steady.  The other reaction which she is not sure is vaccine related, it just could have been her bodies reaction to being so sick is hives which she normally has problems with it.  This is especially a severe case of hives, and the other vaccine had produced that result as well.  What is disturbing for her is that she has never been suicidal, and clinically speaking she is not depressed, but it really really alarmed her, she was really thinking about how to kill herself.  She has been ill for over 4 1/2 years now from the long-COVID illness and does understand why somebody would consider ending their life.  She was so out of it for over 24 hours that she forgot to feed her cat, which is not like her.  She tried to contact her doctor, and one of her friends that helps her was out of town.  She was able to contact her and she asked if she had called the doctor, and she told her that she did not call him as she knows what the answering service would have told her, which was to go to the ER.  In the community the ER is the last place you want to go, most especially if you are having a mental health crisis.  She took Tylenol for fever and she cannot take Advil or NSAIDS because she is a stroke risk, and the Tylenol did not have any effect on the fever, muscle aches, headache or any of her symptoms.  She has placed a phone call to her doctors office, but has not received any response from anybody.   This situation is enough for her to not get another COVID vaccination ever.  The sweling in her arm has not reduced at all, very red and hot to the touch, and itchy from her elbow to her shoulder on the front of her arm.   She is not angry and will continue to get her other vaccinations, but not a COVID.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Skin warm, Suicidal ideation, Urticaria
Clinical narrative: She got her vaccine, she felt fine, tired as usual and did not feel anything unusual until she woke up at 3:00 AM.  She first noticed that from her shoulder to her elbow was swollen, not a soft swelling, a hard swelling.  Every vaccine and booster that she has gotten has made her ill, but that did not deter her from getting them.  This time she was too ill to take care of herself.  Unfortunately there wasn't anyone to help her as they had traveled for the weekend.  She woke up with a temperature of 101, and it got up to 103.  Over the next few days it hasn't gotten quit that high again.  That lasted for about 24 hours, and since then she has been running a temperature of about 101 degrees steady.  The other reaction which she is not sure is vaccine related, it just could have been her bodies reaction to being so sick is hives which she normally has problems with it.  This is especially a severe case of hives, and the other vaccine had produced that result as well.  What is disturbing for her is that she has never been suicidal, and clinically speaking she is not depressed, but it really really alarmed her, she was really thinking about how to kill herself.  She has been ill for over 4 1/2 years now from the long-COVID illness and does understand why somebody would consider ending their life.  She was so out of it for over 24 hours that she forgot to feed her cat, which is not like her.  She tried to contact her doctor, and one of her friends that helps her was out of town.  She was able to contact her and she asked if she had called the doctor, and she told her that she did not call him as she knows what the answering service would have told her, which was to go to the ER.  In the community the ER is the last place you want to go, most especially if you are having a mental health crisis.  She took Tylenol for fever and she cannot take Advil or NSAIDS because she is a stroke risk, and the Tylenol did not have any effect on the fever, muscle aches, headache or any of her symptoms.  She has placed a phone call to her doctors office, but has not received any response from anybody.   This situation is enough for her to not get another COVID vaccination ever.  The sweling in her arm has not reduced at all, very red and hot to the touch, and itchy from her elbow to her shoulder on the front of her arm.   She is not angry and will continue to get her other vaccinations, but not a COVID.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Rash at injection site, itching, pain, firmness occurred 24 hours after vaccine and continued to worsen.
Age: 28.0
Sex: F
Vaccine: RSV, UNK
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pregnant. Estimated date of Delivery- October 30, 2024. Administered RSV vaccine to left arm on September 18, 2024 at OB office. Began developing pain, swelling, and redness at injection site approximately 36 hours later.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered on 7/15/20 to the patient, the vaccine administered had expired on 7/8/20.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV9, MNQ, TD, TDAP
Symptoms: Erythema
Clinical narrative: 60mm x 60mm  raised  warm erythematous area on left deltoid.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Employee inadvertently administered expired MMR Priorix. Error was discovered 9/18/24
Age: 8.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pre-filled syringe with the Moderna Covid 6m-11yr was defrosted from the freezer at Room temperature for 15-20 minutes. Manufacturer instructs state to defrost from the freezer at Room temperature for 45 minutes. Vaccine was not frozen when give. No patient reactions occured. Adverse event was the amount of time for defrosting at room temperature. Patient has no symptoms. Moderna company has been notified as well and has taken down information.
Age: 10.0
Sex: M
Vaccine: COVID19, FLU3, HPV9
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pre-filled syringe with the Moderna Covid 6m-11yr was defrosted from the freezer at Room temperature for 15-20 minutes. Manufacturer instructs state to defrost from the freezer at Room temperature for 45 minutes. Vaccine was not frozen when give. No patient reactions occured. Adverse event was the amount of time for defrosting at room temperature. Patient has no symptoms. Moderna company has been notified as well and has taken down information.
Age: 1.5
Sex: M
Vaccine: COVID19, FLU3, HEPA
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pre-filled syringe with the Moderna Covid 6m-11yr was defrosted from the freezer at Room temperature for 15-20 minutes. Manufacturer instructs state to defrost from the freezer at Room temperature for 45 minutes. Vaccine was not frozen when give. No patient reactions occured. Adverse event was the amount of time for defrosting at room temperature. Patient has no symptoms. Moderna company has been notified as well and has taken down information.
Age: 3.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pre-filled syringe with the Moderna Covid 6m-11yr was defrosted from the freezer at Room temperature for 15-20 minutes. Manufacturer instructs state to defrost from the freezer at Room temperature for 45 minutes. Vaccine was not frozen when give. No patient reactions occured. Adverse event was the amount of time for defrosting at room temperature. Patient has no symptoms. Moderna company has been notified as well and has taken down information.
Age: 11.0
Sex: F
Vaccine: COVID19, FLU3, MNQ, TDAP
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pre-filled syringe with the Moderna Covid 6m-11yr was defrosted from the freezer at Room temperature for 15-20 minutes. Manufacturer instructs state to defrost from the freezer at Room temperature for 45 minutes. Vaccine was not frozen when give. No patient reactions occured. Adverse event was the amount of time for defrosting at room temperature. Patient has no symptoms. Moderna company has been notified as well and has taken down information.
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient given pediatric Engerix-B intented for birth-19 years of age.  Patient received injection and tolerated well. Patient did not have any symptoms.
Age: 1.5
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pre-filled syringe with the Moderna Covid 6m-11yr was defrosted from the freezer at Room temperature for 15-20 minutes. Manufacturer instructs state to defrost from the freezer at Room temperature for 45 minutes. Vaccine was not frozen when give. No patient reactions occured. Adverse event was the amount of time for defrosting at room temperature. Patient has no symptoms. Moderna company has been notified as well and has taken down information.
Age: 17.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pre-filled syringe with the Moderna Covid Spikevax 12yr+  was defrosted from the freezer at Room temperature for 15-20 minutes. Manufacturer instructs state to defrost from the freezer at Room temperature for 45 minutes. Vaccine was not frozen when give. No patient reactions occured. Adverse event was the amount of time for defrosting at room temperature. Patient has no symptoms. Moderna company has been notified as well and has taken down information.
Age: 0.5
Sex: F
Vaccine: COVID19, DTPPVHBHPB, FLU3, PNC20
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pre-filled syringe with the Moderna Covid 6m-11yr was defrosted from the freezer at Room temperature for 15-20 minutes. Manufacturer instructs state to defrost from the freezer at Room temperature for 45 minutes. Vaccine was not frozen when give. No patient reactions occured. Adverse event was the amount of time for defrosting at room temperature. Patient has no symptoms. Moderna company has been notified as well and has taken down information.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Inflammation
Clinical narrative: Inflamed right ankle
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Flublox was ordered, given to patient.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient inadvertently received an additional dose of Dtap. No adverse side effects noted.
Age: 4.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered a Dose of MMRV and a Varicella at the same time as an error.  Clinical assistant did not realize the MMR was the Proquad with Varicella included.  Patients mom was contacted by provider to advise of any adverse effects such increased swelling, fatique and redness to the injection site.  Mom reports child was playing and feeling fine.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Flublox was ordered, given to patient.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy
Clinical narrative: swollen lymph node in armpit on injection side, sore shoulder at injection site.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Allergy test, Differential white blood cell count, Full blood count, Gait disturbance, Injection site pain
Clinical narrative: Patient experienced 2 episodes of non-bilious vomiting 6 hours after receiving vaccinations. Following vomiting, patient developed a petechial rash localized to only the face which worsened with minor swelling overnight. Patient is also limping and complaining of soreness at injection site,  starting the morning after receiving vaccines. There was no treatment given to the patient.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Petechiae, Rash, Swelling face, Vomiting
Clinical narrative: Patient experienced 2 episodes of non-bilious vomiting 6 hours after receiving vaccinations. Following vomiting, patient developed a petechial rash localized to only the face which worsened with minor swelling overnight. Patient is also limping and complaining of soreness at injection site,  starting the morning after receiving vaccines. There was no treatment given to the patient.
Age: 84.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Erythema, Hypersensitivity, Skin warm
Clinical narrative: Localized redness down left arm and warmth to touch. Pt recommended to take Benadryl every 8 hours as needed as well as Pepcid 20 mg daily for two weeks to help with allergic response.
Age: 31.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Aphasia, Blood potassium decreased, Computerised tomogram normal, Dysarthria, Eyelid function disorder
Clinical narrative: On Monday September 9th, I woke up and noticed that my left eye was tearing. It was watery/tearing all day and couldn?t fully close. Throughout the day, I noticed some trouble with speech while lecturing?difficulty finding my words and some slurring/stumbling of my speech.  In the evening, around 9pm, I noticed that my smile was uneven. The entire left side of my face was weak and droopy. I know about BE FAST and I didn?t think it was a stroke, but still went to the emergency department for evaluation.
Age: 31.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Facial nerve disorder, Facial paralysis, Facial paresis, Lacrimation increased, Magnetic resonance imaging head abnormal
Clinical narrative: On Monday September 9th, I woke up and noticed that my left eye was tearing. It was watery/tearing all day and couldn?t fully close. Throughout the day, I noticed some trouble with speech while lecturing?difficulty finding my words and some slurring/stumbling of my speech.  In the evening, around 9pm, I noticed that my smile was uneven. The entire left side of my face was weak and droopy. I know about BE FAST and I didn?t think it was a stroke, but still went to the emergency department for evaluation.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Impaired work ability, Urticaria
Clinical narrative: Patient described a burning sensation internally, and hives on both arms and the top of her head, this began the evening after her vaccine and she needed to call off work for the next day. Was able to continue work but has some mild hives still after 1 week. Patient took benadryl and some left over prednisone she had at her house.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Presyncope
Clinical narrative: 09:28- Patient was vasovagal. 09:29- RRT was called. 09:37- RRT team arrived.09:42- ER staff arrived.  09:47- Pt transferred to Emergency Room.
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: hep A vaccine was given 1 month early
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient didnt have any symptoms or reactions .  Private supply flu vaccine was given to a 6 month old baby .
Age: 72.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Hypertensive crisis
Clinical narrative: Blood pressures crisis level 189/100, 194/100,
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Nausea, Pain, Product administered to patient of inappropriate age
Clinical narrative: Patient inadvertently received high dose (65+) influenza vaccine. Manufacturer contacted and physician aware. Patient c/o headache, body aches, nausea, and diarrhea on 9/18/24.