chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an ACT-HIB vaccine that expired 28-Feb-2025 with no reported adverse event; Initial information received on 04-Mar-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who received HIB (PRP/T) vaccine [ACT-HIB] that expired 28-Feb-2025 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Mar-2025, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (expiry date 28-Feb-2025) (lot number and strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization) with no reported adverse event (expired product administered) (Latency: same day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.67
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of FLUBLOK to a 7 month old patient (with no reported adverse event); Initial information received on 04-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 8-month-old female patient who received Influenza trivalent recombinant vaccine [Flublok TIV] (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Mar-2025, the patient received 0.5ml dose of suspect Influenza trivalent recombinant vaccine Solution for injection , once (strength-standard) (lot TFAA2429) (expiry date-30-Jun-2025) via intramuscular route in left leg for Immunization (with no reported adverse event) (product administered to patient of inappropriate age) (latency-same day).  Action taken with was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received another set of 6 month vaccines with no reported adverse event; Initial information received on 05-Mar-2025 regarding an unsolicited valid  non-serious case received from Other Health Care Professional.  This case involves 5 months old male patient who received another set of 6 month HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Pediarix), pneumococcal vaccine conj 7v (CRM197) (Prevnar) and rotavirus vaccine live reassort oral 5 V (Rotateq) for prophylactic vaccintion (Immunisation)   On 25-Feb-2025, the patient received a dose of 0.5 ml (dose 4) of suspect HIB (PRP/T) vaccine [ACT-HIB], Powder and solvent for solution for injection (lot number UK113AB and expiry date 30-Sep-2025) (Frequency: Possibly 4 times and strength: standard) via intramuscular route in the left thigh for Immunisation with no reported adverse event (extra dose administered) (Latency: same day).  Reportedly, Caller is calling because they have a 6 month old male patient and the patient first received the vaccines and then traveled for two months and got vaccines while traveling. When the patient came back for his six-month appointment, his shot record was not clear. He received another set of 6 month vaccines. The patient's dad wants the HCP to call and see if there is any information about adverse reactions to a child being essentially double vaccinated. They are requesting if there's anything that could happen beside redness, swelling of the injection site, fussiness, decreased appetite, fever, and all that stuff.  Action taken was not applicable.   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: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of an expired product (with no reported adverse event); Initial information received on 05-Mar-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 2 years old male patient who was administrated with expired product HIB (PRP/T) Vaccine [ACT-HIB] (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 04-Mar-2025, the patient received 0.5mL (dose 4) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK010AA, expiry date 28-Feb-2025) via intramuscular route in the left thigh for immunisation and administration of an expired product (with no reported adverse event) (expired product administered) (latency same day)  Action taken was not applicable.  Reportedly, Nurse Manager called asking if the given dose for patient was valid or if another dose must be given after realizing that the vaccine has expired last 28-Feb-2025.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of expired pentacel with no reported adverse event; Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old male patient who was administered with expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine conj 13v (CRM197) (Prevnar 13) for Immunisation.  On 27-Jan-2025, the patient received an expired 0.5ml (once) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(Vero)/HIB(PRP/T) Vaccine, Powder and suspension for suspension for injection, Unknown Strength, Expiry date 19-Mar-2024 and lot UJ876AA via intramuscular route in unknown administration site for Immunization with no reported adverse event (Expired vaccine used) (Latency same day).  Reportedly, A nurse called to inform that a patient had been given expired Pentacel. She wanted to get a recommendation of what to do next after this event. Nurse is unsure of the treatment that was provided. They said that patient was fine.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 15 months old patient was given expired Act HIB with no reported adverse event; Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case received from a Other Health Care Professional.  This case involves 15 months old male patient who received HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine conj 7v (CRM197) (Prevnar) and diphtheria vaccine toxoid, Pertussis vaccine acellular 5-component, Tetanus vaccine toxoid (Adacel) for prophylactic vaccination (Immunisation).  On 04-Mar-2025, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot number UK009AB and expiry date 28-Feb-2025) (frequency: once, strength: standard) via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (Latency: same day).  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient took expired acthib with no reported adverse event; Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves 12 months and 18 days old female patient who received expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 20V (CRM197) (prevnar 20), measles vaccine, mumps vaccine, rubella vaccine (MMR); aesculus hippocastanum [varivax] and hepatitis A vaccine (hepatitis A vaccine), all for Immunisation.  On 03-Mar-2025, the patient received standard dose of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection once with lot UJ992AA and expiry date 28-Feb-2025 via intramuscular route in unknown administration site for immunization (expired product administered) (Latency same day)  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Cheilitis, Dark circles under eyes, Ear swelling, Miliaria, Mouth swelling
Clinical narrative: Saturday March 1st began itching head, face, neck chest and eyes puffy , Sunday March 2nd mouth, face, ear swelling, heat looking rash to face neck chest and upper back rash on neck raised taken to ER given high dose oral steroids and Benadryl with no improvement. Rash spread from head to toe over next day dark circles brown around eyes, white sores to inner lower lip, everywhere rash was peeled
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Periorbital swelling, Pruritus, Rash, Rash papular, Skin exfoliation
Clinical narrative: Saturday March 1st began itching head, face, neck chest and eyes puffy , Sunday March 2nd mouth, face, ear swelling, heat looking rash to face neck chest and upper back rash on neck raised taken to ER given high dose oral steroids and Benadryl with no improvement. Rash spread from head to toe over next day dark circles brown around eyes, white sores to inner lower lip, everywhere rash was peeled
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Swelling face
Clinical narrative: Saturday March 1st began itching head, face, neck chest and eyes puffy , Sunday March 2nd mouth, face, ear swelling, heat looking rash to face neck chest and upper back rash on neck raised taken to ER given high dose oral steroids and Benadryl with no improvement. Rash spread from head to toe over next day dark circles brown around eyes, white sores to inner lower lip, everywhere rash was peeled
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Erythema, Fatigue, Laboratory test
Clinical narrative: Loss of test, tired, egg shape lump and red arm, neck pain, after about a week trouble breathing, chest pain coughing up brown phlegm, heart racing, aching, neck pain, itching in right arm, swollen glands in neck, and right arm out, severe itching right breast.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck mass, Neck pain, Pain, Palpitations
Clinical narrative: Loss of test, tired, egg shape lump and red arm, neck pain, after about a week trouble breathing, chest pain coughing up brown phlegm, heart racing, aching, neck pain, itching in right arm, swollen glands in neck, and right arm out, severe itching right breast.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Pruritus, Sputum discoloured
Clinical narrative: Loss of test, tired, egg shape lump and red arm, neck pain, after about a week trouble breathing, chest pain coughing up brown phlegm, heart racing, aching, neck pain, itching in right arm, swollen glands in neck, and right arm out, severe itching right breast.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Ophthalmic herpes zoster, Vaccination failure, Visual impairment
Clinical narrative: Suspected Vaccination failure; little sight in my right eye/shingles from below my right eye; got shingles on right side of my face through hair and down neck all on the right side of my head; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 77-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: little sight in my right eye/shingles from below my right eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: got shingles on right side of my face through hair and down neck all on the right side of my head). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and facial herpes zoster were resolved.   The reporter considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster to be related to Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. The company considered the facial herpes zoster to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2025 This case was reported by a patient via interactive digital media. The patient had the shingles vaccine but at 77 he got shingles from below his right eye over the right side of his face,through his hair and down neck all on the right side of his head.  The doctor at emergency room said it would have been much worse if patient had not had the shot.  It was bad for 5 or 6 weeks and had very little sight in his right eye and numbness over the right side of his head.  The patient stated get the shot it did helped. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; light case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: light case of shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 02-MAR-2025 This case was reported by a patient via (Facebook) interactive digital media. Patient reported that if he/she had received the Shingrix vaccination, but had a light case of shingles after the vaccination. Patient asked if he/she repeat the vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: painful rash developing on the arm two weeks after administration of Shingrix first dose.; painful rash developing on the arm two weeks after administration of Shingrix first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number X5T42, expiry date 30-JAN-2027) for prophylaxis.   On 14-FEB-2025, the patient received the 1st dose of Shingrix. In FEB-2025, 2 weeks after receiving Shingrix, the patient experienced rash (Verbatim: painful rash developing on the arm two weeks after administration of Shingrix first dose.) and pain (Verbatim: painful rash developing on the arm two weeks after administration of Shingrix first dose). The outcome of the rash and pain were unknown.   It was unknown if the reporter considered the rash and pain to be related to Shingrix.     It was unknown if the company considered the rash and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-FEB-2025 Pharmacist reported that a patient had a painful rash developing on the arm two weeks after administration of Shingrix.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Reported Symptms: 10013963:DYSPNEA; 10033556:PALPITATION; Narrative: A 53yo female patient with PMH of HTN, Asthma, Constipation and GERD, presented to the facility to establish care. On October 28, 2024, the staff RN reported the patient had a historical ADR of influenza vaccine induced Palpitations and Dyspnea. No other detailed information regarding the reaction date or treatment and the vaccine, was provided. i.e. ( when, where and by who the vaccine was administered, Mfg, lot#, Exp. date, etc) Last facility influenza immunization record for the patient - Feb. 22, 2019 (Influenza split virus, quadrivalent, PF. ) Other Relevant HX: Other: PALPITATIONS; DYSPNEA
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Narrative: A 25 yo female with PMH of GERD, Pain bilateral knee region and Chronic PTSD. On October 25, 2024, the patient presented to PCC to establish care. The clinic's RN reported the patient had a historical ADR of Pfizer Covid-19 vaccine induced rash with the first vaccine and no problem with the subsequent vaccines. No other detailed information was provided regarding treatment or the vaccine, i.e. (where and by who it was administered, the Lot #. Expiration date etc.)  The patient has no clinic immunization record.  Other Relevant HX: Other: RASH
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Reported Symptoms: 10046735:URTICARIA; Narrative: A 94yo male with PMH of Subarachnoid Hemorrhage, OA, Dilation of Aorta, GERD, Chronic Rhinitis, Cerebral Infraction, HTN, A-Fib, Aortic Regurgitation and Pulmonary HTN. On October 7, 2024, attending Physician reported the patient had a historical ADR of Influenza vaccine induced Urticaria. The patient presented to the facility to establish care No other detailed information provided regarding the treatment for the ADR or the vaccine (i.e. when, where and who administered the vaccine, Mfg, Lot#, Exp. date. No immunization record on influenza vaccine. Other Relevant HX: Other: URTICARIA
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling, Urticaria
Clinical narrative: Reported Symptoms: 10042674:SWELLING; 10046735:URTICARIA; Narrative: Other Relevant HX: Other: URTICARIA; Swelling
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Reported Symptoms: 10008531:CHILLS; Narrative: Other Relevant HX: Other: CHILLS
Age: 92.0
Sex: M
Vaccine: RSV
Symptoms: Hemiparesis
Clinical narrative: Report systems: 10065780:MUSCLE WEAKNESS LEFT-SIDED; Narrative: Patient seen via home-based primary care and received COVID-19 and RSV vaccines. Patients wide contacted provider three days later stating that after the vaccines the patient experienced left-sided weakness (overall weakness on the left side of the body). Wife followed up the next day to report that patient is getting stronger with overall improvements. Other Relevant HX: Other: Left-sided weakness
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Crepitations, Death, Dyspnoea, Guillain-Barre syndrome
Clinical narrative: Reported Symptoms: 10038687:RESPIRATORY DISTRESS: Narrative:  This was a hospice patient that had a history of Guillain Barre to other vaccinations, CHF , permanent AF, CKD stage 3, colon cancer s/p colostomy. Healthcare surraogate agreed for the patient to receive the COVID-19 booster "In an attempt to minimize or prevent the risks of getting covid-19, and its potential complications. Patient presented with dyspnea and low oxygen saturations the following day. Patient had wheezes and crackles but was in minimal distress. Patient was admitted for further follow-up and due to poor prognosis found during adult was transferred to hospice where patient experienced worsening Guillain Barre deemed to be due to COVID vaccine. Patient passed away 12 days after receiving vaccine. Other Relevant HX: Other: Respiratory distress - History of Guillain Barre
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Respiratory distress, Wheezing
Clinical narrative: Reported Symptoms: 10038687:RESPIRATORY DISTRESS: Narrative:  This was a hospice patient that had a history of Guillain Barre to other vaccinations, CHF , permanent AF, CKD stage 3, colon cancer s/p colostomy. Healthcare surraogate agreed for the patient to receive the COVID-19 booster "In an attempt to minimize or prevent the risks of getting covid-19, and its potential complications. Patient presented with dyspnea and low oxygen saturations the following day. Patient had wheezes and crackles but was in minimal distress. Patient was admitted for further follow-up and due to poor prognosis found during adult was transferred to hospice where patient experienced worsening Guillain Barre deemed to be due to COVID vaccine. Patient passed away 12 days after receiving vaccine. Other Relevant HX: Other: Respiratory distress - History of Guillain Barre
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Reported Symptoms: 10037087:PRURITUS; 10046735:URTICARIA; Narrative: Other Relevant HX: Other: URTICARIA; PRURITUS
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Reported Symptoms: 10013963:DYSPNEA; Narrative: A 49 yo male with PM.H of GERD, Carcinoma of Thyroid (status post thyroidectomy), Lumbar  Radiculopathy, Hypothyroidism, Barrett's  Esophagus and Exposure to potentially hazardous substance. On October 02, 2024, PCC RN reported the patient had a historical ADR of Covid-1, 9 vaccine induced Dyspnea. No other information was provided regarding treatment or the vaccine i.e. vaccine Mfg., lot #, Expiration date, where and who administered the vaccine, what time and when it occurred etc.) However the Med. Center indicated the patient received Pfizer Covid-19 Vaccine, Mrna, LPN-S, Pf, 30mcg/0.3ml on April 1 2021@9:00 and April 22, 2021@9:00AM. Both vaccines administered IM to R. deltoid and without complication. Administered by RN on the one in April 1, 2021 and by RN on the one on April 22, 2021. Other Relevant HX: Other DYSPNEA
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Reported symptoms: 10022086:INJECTION SITE PAIN; Narrative: Went to ED for injection site pain 12 hours after COVID-19 vaccine administration. Given dexamethasone IM and diphenhydramine in ED. Discharged with prednisone. Other Relevant HX: Patient received the Moderna COVID-19 vaccine 5 times since 2021. Other: Injection site pain
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, C-reactive protein increased, Cardiomegaly, Chest X-ray abnormal, Computerised tomogram abdomen abnormal
Clinical narrative: Reported Symptoms: 10013966:DYSPNEA EXERTIONAL; 10016256:FATIGUE; 10034484:PERICARDITIS; 10047862:WEAKNESS; Narrative: 84M w/ PMH of CAD s/p multiple PCIs (last 2019), HTN, HLD, thoracoabdominal aortic aneurysm, and COPD presenting to the ED 11/5/24 d/t pericarditis, generalized weakness/fatigue, and DOE post flu vaccine (10/15/24). CT A/P showed moderate pericardial effusion. Was admitted for further management, where pt had pericardiocentesis procedure 11/6/24. Was started on colchicine and aspirin at discharge 11/9/24. Other Relevant HX: Other: pericarditis, weakness, fatigue, dyspnea on exertion
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea exertional, Echocardiogram, Echocardiogram normal, Fatigue, Pericardial drainage
Clinical narrative: Reported Symptoms: 10013966:DYSPNEA EXERTIONAL; 10016256:FATIGUE; 10034484:PERICARDITIS; 10047862:WEAKNESS; Narrative: 84M w/ PMH of CAD s/p multiple PCIs (last 2019), HTN, HLD, thoracoabdominal aortic aneurysm, and COPD presenting to the ED 11/5/24 d/t pericarditis, generalized weakness/fatigue, and DOE post flu vaccine (10/15/24). CT A/P showed moderate pericardial effusion. Was admitted for further management, where pt had pericardiocentesis procedure 11/6/24. Was started on colchicine and aspirin at discharge 11/9/24. Other Relevant HX: Other: pericarditis, weakness, fatigue, dyspnea on exertion
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Pericardial effusion, Pericarditis, Red blood cell sedimentation rate increased, Troponin I increased
Clinical narrative: Reported Symptoms: 10013966:DYSPNEA EXERTIONAL; 10016256:FATIGUE; 10034484:PERICARDITIS; 10047862:WEAKNESS; Narrative: 84M w/ PMH of CAD s/p multiple PCIs (last 2019), HTN, HLD, thoracoabdominal aortic aneurysm, and COPD presenting to the ED 11/5/24 d/t pericarditis, generalized weakness/fatigue, and DOE post flu vaccine (10/15/24). CT A/P showed moderate pericardial effusion. Was admitted for further management, where pt had pericardiocentesis procedure 11/6/24. Was started on colchicine and aspirin at discharge 11/9/24. Other Relevant HX: Other: pericarditis, weakness, fatigue, dyspnea on exertion
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: A 78yo male with PMH of PTSD who presented for initial Psychiatric visit by phone on Nov. 26, 2024, was reported with a historical ADR of influenza vaccine induced rash by the clinic physician. The MD's report included a note " remote history via application". No other detailed information regarding the vaccine, severity, including where and by who it was administered, was provided. Other Relevant HX: Other: RASH
Age: 86.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Diarrhoea, Pain, Tremor, Vomiting
Clinical narrative: Reported Symptoms: 10000424:ACHE; 10012727:DIARRHEA; 10040527:SHAKINESS; 10047700;VOMITING; Narrative: Pt reported vomiting, body aches, shaking, and diarrhea post vaccine administration of influenza and  RSV vaccines. Other Relevant HX: DN, HTN, insomnia, Parkinson's Disease, CKD, hearing loss, exposure to hazardous chemical, tinnitus, vitamin d deficiency, hyperlipidemia, GERD, lower back pain, Hx of coronary artery bypass grafting, Hx of squamous cell carcinoma of skin Other: shaking; body aches
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis
Clinical narrative: Reported Systems: 10012431:DERMATITIS; 10037844:RASH;  Narrative: Other Relevant HX: Covid-19 booster vaccine; no previous reactions reported Other: DERMATITIS
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Reporter Symptoms: 10046735: URTICARIA; Narrative: A 58 yo male with PMH of HTN, OA, HLD, Asthma, Rhinitis, GERD, Dry Eyes, OSA and Sarcoidosis, who on Nov 8, 2024, presented as a new patient via Tele Health. The PCC physician reported the patient had a historical ADR of influenza vaccine induced urticaria classified as moderate. No other detailed information regarding the vaccine, (i.e. Mfr., Exp. date, lot#, reaction treatment, where and by who it was administered) was provided. Other Relevant HX: Other: URTICARIA
Age: 52.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Myalgia
Clinical narrative: Reported Symptoms: 10003239:ARTHRALGIA; 10028322:MUSCLE PAIN; Narrative: Other relevant HX: Other MUSCLE PAIN
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Reporter Symptoms: 100292328:NEUROPATHY; Narrative: Other Relevant HX:  Other: Neuropathy
Sex: M
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Reported Symptoms: 10037087:PRURITIS; Narrative: Other Relevant HX: PRURITIS
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Drug hypersensitivity, Headache, Impaired work ability, Injection site warmth
Clinical narrative: Very tired, low grade fever of 99.9 F, body aches, slight headache, slightly upset stomach. To bed at 12:40pm. Slept off and on all afternoon/evening. Two Aleve at midnight for body aches and headache. Slept off and on till 11am next day. Aleve again at 8am. Advil the remainder of day and next day. Body aches still on Monday. Stayed home from work and in bed all day. Feeling better. Used heating pad for achy hips on Monday. Slept well on Monday evening. Noticed red arm about the size of a fist in the shot area. Tender area to sleep on, but not too uncomfortable. Went to work on Tuesday but left after an hour and a half. Shared my story with co-worker and touched arm. Warm to the touch and had not noticed before. Resting on Tuesday and napped for a short time.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tenderness
Clinical narrative: Very tired, low grade fever of 99.9 F, body aches, slight headache, slightly upset stomach. To bed at 12:40pm. Slept off and on all afternoon/evening. Two Aleve at midnight for body aches and headache. Slept off and on till 11am next day. Aleve again at 8am. Advil the remainder of day and next day. Body aches still on Monday. Stayed home from work and in bed all day. Feeling better. Used heating pad for achy hips on Monday. Slept well on Monday evening. Noticed red arm about the size of a fist in the shot area. Tender area to sleep on, but not too uncomfortable. Went to work on Tuesday but left after an hour and a half. Shared my story with co-worker and touched arm. Warm to the touch and had not noticed before. Resting on Tuesday and napped for a short time.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: Developed pityriasis rosea rash on trunk within 48 hours of vaccination. Herald patch erupted first then spread over trunk over the first 2-3 days.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Headache, Night blindness
Clinical narrative: Occular headaches, severe double vision in right eye, severe impaired vision at night
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Discomfort, Tenderness
Clinical narrative: Massive lump with fluid inside. Pain and uncomfortable at touch
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: warm ,red and swelling, itching, around injection site, extending about 3-4 inches. patient reported to pharmacy on 1 week later and at that time it was getting better.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Pain, Skin lesion
Clinical narrative: Patient got vaccines on 3/4/25 and they called our office on 3/6/25 to report it. After observation, the patient was given Cephalexin 250 mg/5mL to treat for cellulitis due to concern on examination and pression of lesion with pain. Patient was advised to go to ER or return to clinic with anything worsens.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Additional doses give no adverse reaction
Age: 70.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: pt reports that starting 03/5 or 03/06, he started having swelling, redness and itching on the arm that he received the vaccine in. He started to apply Benadryl gel to the area, and it helped with the itching, but it continued to spread and swell. Pt presented to the pharmacy 03/09 with redness and swelling from the bicep area to below the elbow on the left arm.  Recommend pt see a doctor to rule out cellulitis
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Injection site pain, Pain in extremity, Pruritus
Clinical narrative: At 5:00 am 3/5/25, patient told mom he felt bad with headache, mild aching in legs, and itching on his arms and shoulders. Left arm was sore at injection site. Mom noticed a rash said he had a fever and brought him into the clinic.  Provider saw patient and determined adverse reaction to Moderna Covid vaccine administered 3/4/25: pityriasis rosea- like rash to arms, upper torso, and face: Dose Benadryl 12.5mg/5mL 5mL po given at 9:20 am in the office.  10:07 am patient reported itching had improved. Mom was instructed to continue benedryl for rash/itching and tylenol for fever/aches. In addition,  prescription given for Loratadine 10 mg once daily for at 2 weeks. and TCA 0.1% cream twice daily to localized itchy spots only.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: At 5:00 am 3/5/25, patient told mom he felt bad with headache, mild aching in legs, and itching on his arms and shoulders. Left arm was sore at injection site. Mom noticed a rash said he had a fever and brought him into the clinic.  Provider saw patient and determined adverse reaction to Moderna Covid vaccine administered 3/4/25: pityriasis rosea- like rash to arms, upper torso, and face: Dose Benadryl 12.5mg/5mL 5mL po given at 9:20 am in the office.  10:07 am patient reported itching had improved. Mom was instructed to continue benedryl for rash/itching and tylenol for fever/aches. In addition,  prescription given for Loratadine 10 mg once daily for at 2 weeks. and TCA 0.1% cream twice daily to localized itchy spots only.
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Unevaluable event
Clinical narrative: patient requested after asking if she had vaccine for above
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Impetigo, Injection site infection, Injection site pruritus, Injection site swelling, Product administered at inappropriate site
Clinical narrative: patient noticed itching/swelling at site went to urgent care and was given keflex for skin infection due to shot. physician at time of visit said shot was given way too low.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Inadvertently administered only the liquid conjugate component without the reconstituted powder
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest discomfort, Dyspnoea, Hyperhidrosis, Lip swelling, Nausea
Clinical narrative: 1206 pt received Varicella virus vaccine into left upper back arm at 1230 pm pt demonstrated an allergic reaction to the vaccine, c/o nausea, sob and chest discomfort, lips swollen and eye lids swollen, pt noted to be diaphoretic  pt alert and oriented  x 3 during event episode,  provider  at bedside IV access placed  pt received Benadryl 25 mg IV x 2 , and a bolus of L/R 500 cc than L/R at 125 cc/hr to a total volume of 900cc LR, v/s/s, O2 Sat 97-100 % on RA ,, EKG done Sinus Tachycardia, at 1400 pt states she is feeling much better and feels her symptoms are resolving and slept to 1545, sinus tach resolved , heart rate 70, pt denies sob, chest discomfort  and nausea, pt discharged to home by provider
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling of eyelid
Clinical narrative: 1206 pt received Varicella virus vaccine into left upper back arm at 1230 pm pt demonstrated an allergic reaction to the vaccine, c/o nausea, sob and chest discomfort, lips swollen and eye lids swollen, pt noted to be diaphoretic  pt alert and oriented  x 3 during event episode,  provider  at bedside IV access placed  pt received Benadryl 25 mg IV x 2 , and a bolus of L/R 500 cc than L/R at 125 cc/hr to a total volume of 900cc LR, v/s/s, O2 Sat 97-100 % on RA ,, EKG done Sinus Tachycardia, at 1400 pt states she is feeling much better and feels her symptoms are resolving and slept to 1545, sinus tach resolved , heart rate 70, pt denies sob, chest discomfort  and nausea, pt discharged to home by provider
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood test, Computerised tomogram head, Computerised tomogram thorax, Diplopia
Clinical narrative: Myasthenia Gravis....Diplopia, muscle weakness  Symptoms started December 2024.  Diagnosis March 6 2025 by Neurologist Dr  Started pyRIDostigmine 60mg for weakness and double vision and infusion will be started once approved by insurance
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Muscular weakness, Myasthenia gravis
Clinical narrative: Myasthenia Gravis....Diplopia, muscle weakness  Symptoms started December 2024.  Diagnosis March 6 2025 by Neurologist Dr  Started pyRIDostigmine 60mg for weakness and double vision and infusion will be started once approved by insurance
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Cardiac arrest, Death
Clinical narrative: Patient had a fatal cardiac arrest on February 14, 2024
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypotension, Syncope
Clinical narrative: PATIENT WAS GIVEN VACCINE AT 9:30 AM AND THEN AT AROUND 7 PM FAINTED AT HOME.  HE THEN FAINTED THE NEXT MORNING.  HE SAID THIS WAS UNUSUAL BUT HE CALLED HIS DOCTOR AND THEY TOLD HIM TO HYDRATE BECAUSE HIS BLOOD PRESSURE WAS LOW
Age: 73.0
Sex: F
Vaccine: PNC21, TDAP, VARZOS
Symptoms: Unevaluable event
Clinical narrative: State Board of Pharmacy Inspector reported to Market Director that it was reported to them that the patient visited an emergency department on the evening of the day the vaccines were administered. This is all the information that was given so far.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Laboratory test, Ultrasound Doppler abnormal
Clinical narrative: Acute deep vein thrombosis (DVT) of axillary vein of left upper extremity
Age: 88.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given a DTAP injection instead of a TDAP. patient came in for a wound on finger and needed a booster per doctor's request. After speaking the Sanofi and confirming there is no harm to an 88-yr old getting a pediatric dose of DTAP. Patient has not had any complaints or side effects of the vaccine. patient was notified by provider. No further actions are needed in regard to the patient.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Calcium ionised, Chronic obstructive pulmonary disease, Computerised tomogram thorax abnormal
Clinical narrative: Discharge Summary MD (Physician) ? General Medicine BRIEF OVERVIEW: Admission Date: 2/21/2025 Discharge Date: 2/27/2025 Discharge Disposition:  Home without services  Active Issues Requiring Follow-up: COPD DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Mixed metabolic and respiratory acidosis of newborn [P84] Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung [J18.9] Acute on chronic hypoxic respiratory failure [J96.21] Acute on chronic respiratory failure [J96.20]  HOSPITAL COURSE: 64 y.o. female with a history of  COPD on 1.5-2 L nasal cannula at baseline, OSA, morbid obesity, and Crohn's disease who presented for increased shortness of breath and dyspnea.    Acute on chronic hypoxic respiratory failure - resolved COPD Exacerbation  - improving Leukocytosis  Recent COVID-19 infection - On Chronic 1.5-2L of O2 at home but now requiring HFNC.  O2 supplementation PRN w/ goal O2 saturation 88-92% - CT chest notable for extensive multifocal airspace disease - Remdesivir  - Levaquin, metronidazole, vancomycin - Oral dexamethasone - Symbicort - Continued home montelukast  - Albuterol PRN  - Supportive care  Hypertension  - Continue home amlodipine - Home losartan increased from 25 to 50 mg; continue  Hyperglycemia in the setting of steroid use Type II Diabetes, not on long term insulin  - HbA1c 7.2 - Held home oral diabetic medications - Lantus 34U - Basal bolus insulin - Carb Control Diet  History of CVA - Continued ASA, statin   GAD - Continued BuSpar  - Held trazodone - PRN Atarax  Chronic low back pain  Glaucoma - Continued eye drops  Hyponatremia, mild - stable   Hypocalcemia - resolved - Checked ionized calcium  - Checked vitamin D  History of Crohns  Does not appear to be on immunomodulating therapy - Continued Bentyl   Vertigo - PRN meclizine   Microcytic anemia   Morbid obesity   CONSULTS / RECOMMENDATION:  IP CONSULT TO NUTRITION Discharged to Home.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Glycosylated haemoglobin increased, Leukocytosis, Lung opacity
Clinical narrative: Discharge Summary MD (Physician) ? General Medicine BRIEF OVERVIEW: Admission Date: 2/21/2025 Discharge Date: 2/27/2025 Discharge Disposition:  Home without services  Active Issues Requiring Follow-up: COPD DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Mixed metabolic and respiratory acidosis of newborn [P84] Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung [J18.9] Acute on chronic hypoxic respiratory failure [J96.21] Acute on chronic respiratory failure [J96.20]  HOSPITAL COURSE: 64 y.o. female with a history of  COPD on 1.5-2 L nasal cannula at baseline, OSA, morbid obesity, and Crohn's disease who presented for increased shortness of breath and dyspnea.    Acute on chronic hypoxic respiratory failure - resolved COPD Exacerbation  - improving Leukocytosis  Recent COVID-19 infection - On Chronic 1.5-2L of O2 at home but now requiring HFNC.  O2 supplementation PRN w/ goal O2 saturation 88-92% - CT chest notable for extensive multifocal airspace disease - Remdesivir  - Levaquin, metronidazole, vancomycin - Oral dexamethasone - Symbicort - Continued home montelukast  - Albuterol PRN  - Supportive care  Hypertension  - Continue home amlodipine - Home losartan increased from 25 to 50 mg; continue  Hyperglycemia in the setting of steroid use Type II Diabetes, not on long term insulin  - HbA1c 7.2 - Held home oral diabetic medications - Lantus 34U - Basal bolus insulin - Carb Control Diet  History of CVA - Continued ASA, statin   GAD - Continued BuSpar  - Held trazodone - PRN Atarax  Chronic low back pain  Glaucoma - Continued eye drops  Hyponatremia, mild - stable   Hypocalcemia - resolved - Checked ionized calcium  - Checked vitamin D  History of Crohns  Does not appear to be on immunomodulating therapy - Continued Bentyl   Vertigo - PRN meclizine   Microcytic anemia   Morbid obesity   CONSULTS / RECOMMENDATION:  IP CONSULT TO NUTRITION Discharged to Home.