chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vital signs measurement
Clinical narrative: VS were normal, physical examination was remarkable for jaundice and mild RUQ tenderness; This is a literature report.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ulcerative colitis" (ongoing), notes: on home sulfasalazine. Concomitant medication(s) included: SULFASALAZINE taken for colitis ulcerative (ongoing). The following information was reported: AUTOIMMUNE HEPATITIS (hospitalization, medically significant), outcome "unknown", described as "VS were normal, physical examination was remarkable for jaundice and mild RUQ tenderness". The events "vs were normal, physical examination was remarkable for jaundice and mild ruq tenderness" required emergency room visit. The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 1476 IU/l; Aspartate aminotransferase: 1621 IU/l; Bilirubin conjugated: 4.5 mg/dl; Blood alkaline phosphatase: 167 IU/l; Blood bilirubin: 6.0 mg/dl; C-reactive protein: 3.40 mg/dl; Endoscopic ultrasound: diffuse abnormal echotexture, notes: in the visualized portion of the liver; Gamma-glutamyltransferase: 339; reactive oxygen species: Negative; Magnetic resonance imaging: unremarkable; Pathology test: No significant ductal pathology; physical examination: was remarkable for jaundice and mild RUQ tendernes; Red blood cell sedimentation rate: 99, notes: mm; Ultrasound abdomen: unremarkable; Vital signs measurement: Normal. Therapeutic measures were taken as a result of autoimmune hepatitis. Clinical course: The patient with ulcerative colitis on home sulfasalazine who presented to the emergency department (ED) with complaints of a vague, non-cramping, and dull RUQ abdominal pain for 3 weeks duration. The patient's social history is unremarkable. No recent travel, occupational exposures, herbal supplements use, or acetaminophen use. He received 2 doses of Pfizer COVID -19 vaccines, last dose was around 21 days before admission. The patient was treated with azathioprine and prednisone 60 mg daily with slow tapering and with continuation of his home dose sulfasalazine.; Sender's Comments: Based on the information provided in the narrative, a causal association between the event Autoimmune hepatitis and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain, Vertigo
Clinical narrative: Sore at site of injection; low grade fever; vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-725716 (Moderna).  A 65-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Low grade fever" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (DOSE 1, SINGLE), administration date: 18Feb2021, when the patient was 63-year-old, for COVID-19 IMMUNIZATION; coviD-19 vaccine (DOSE 2, SINGLE), administration date: 13May2021, when the patient was 63-year-old, for COVID-19 IMMUNIZATION; coviD-19 vaccine (DOSE 3 (BOOSTER), SINGLE), administration date: 07Sep2021, when the patient was 63-year-old, for COVID-19 IMMUNIZATION; coviD-19 vaccine (DOSE 4 (BOOSTER), SINGLE), administration date: 07Apr2022, when the patient was 64-year-old, for COVID-19 IMMUNIZATION.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "Sore at site of injection"; PYREXIA (non-serious), outcome "recovering", described as "low grade fever"; VERTIGO (non-serious), outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: The Safety team have your consent for follow-up. The Moderna authorized to communicate with the vaccine recipient's primary healthcare professional regarding this notification. Received Moderna booster on 15May2023. was sore at site of injection. Had occasional chest pressure lasting 3 day and nausea starting the day after administration and has continued. Flu-ish joint aches lasting for about 3 days. Primary 18Feb2021, 13May2021 3rd shot 07Sep2021, 4th 07Apr2022& 5th Pfizer booster Oct2022 - sore at site of injection, low grade fever, & vertigo.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Granuloma skin, Vaccination site mass
Clinical narrative: granuloma skin bumps; Bump at Permanent injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN6205) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MASS (non-serious) with onset 19Mar2021, outcome "unknown", described as "Bump at Permanent injection site"; GRANULOMA SKIN (medically significant), outcome "not recovered", described as "granuloma skin bumps". The event "granuloma skin bumps" required physician office visit. Therapeutic measures were taken as a result of granuloma skin with Biopsy/Steroids. Therapeutic measures were not taken as a result of vaccination site mass.  Additional information: The bump was 1/4", not serious. Patient did get covid after 3rd dose but symptoms mild + clear test after a week.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148992 same patient, different dose/AE;
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: Feeling sick; Heavy chest; Fever; Feeling bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 53-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: ER8730) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pulmonary fibrosis", start date: 2019 (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: chemo; "Lupus", start date: 2016 (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: Medication; "chronic migraines", start date: 2010 (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: Medication; "Fibromyalgia", start date: 2016 (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: Medication; "Chemo" (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: chemo. The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset Apr2021, outcome "unknown", described as "Feeling bad"; MALAISE (non-serious) with onset 15Apr2021, outcome "unknown", described as "Feeling sick"; PYREXIA (non-serious) with onset Apr2021, outcome "unknown", described as "Fever"; CHEST DISCOMFORT (non-serious) with onset Apr2021, outcome "unknown", described as "Heavy chest". The events "feeling sick", "heavy chest", "fever" and "feeling bad" required physician office visit and emergency room visit.  Additional information: Started feeling bad over the next few days went to doctor after about 10 days not feeling good. Had COVID. Mid Jul till 09Sep2021 died 03:00 PM. No vaccinations were taken within four weeks prior to the first administration date of the suspect vaccine. Was a culture performed? Yes, COVID.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), outcome "unknown", described as "Pneumonia after vaccination". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feel sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 3210-2208807018 (RA).  A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "allergy to onions" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "depression" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "Multiple sclerosis" (unspecified if ongoing); "COVID multifocal pneumonia" (unspecified if ongoing); "weight loss" (unspecified if ongoing); "Seizure" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; XIGDUO; MOUNJARO; DULOXETINE; PROPANOLOL [PROPRANOLOL]; METHYLPHENIDATE; EVUSHELD; AMOXICILLIN; ZITHROMAX Z-PACK; MODERNA COVID-19 VACCINE taken for covid-19 immunisation as dose number unknown, single. Past drug history included: Codeine, reaction(s): "allergy to codeine"; Morphine, reaction(s): "allergy to morphine". Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 31Dec2022, outcome "unknown", described as "feel sick".  Additional information: Patient stated that she had the Bivalent shot on 28Dec2022 and started to feel sick (not further clarified) on 31Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had covid about two weeks ago; had covid about two weeks ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "had covid about two weeks ago". Clinical course: A caller said that her husband had covid about two weeks ago and wanted to know if her husband could get the second bivalent vaccine shot now or if he had to wait. Transferred.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 0.75
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: excursion where the temperature rose to 49.6F for 12 minutes for IPOL with no reported adverse event; the patient received IPOL post excursion with no reported adverse event; Initial information received on 23-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 9 months old female patient and reporter reported excursion where the temperature rose to 49.6 f for 12 minutes for poliomyelitis vaccine (inactivated) IPV (VERO) [IPOL] with no reported adverse event and the patient received ipol post excursion 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 Prophylactic vaccination; HIB vaccine conj (tet tox) (ACTHIB) for Prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Infanrix) for Prophylactic vaccination.  On 04-May-2023, the patient received a dose of 0.5 ml  of suspect poliomyelitis vaccine (inactivated) IPV (VERO) Suspension for injection (lot V1A022M, expiry date- 17-FEB-2024) via intramuscular route in the right deltoid for Prophylactic vaccination (Immunisation).  Caller reported, excursion where the temperature rose to 49.6f for 12 minutes for poliomyelitis vaccine (inactivated) IPV (VERO) with no reported adverse event (product storage error) (unknown latency) and the patient received ipol on 04-May-2023 post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly, there was an excursion where the temperature rose to 49.6F for 12 minutes. IPOL multidose vaccine was opened and deemed not viable by manufacturer. No adverse reactions were noted.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   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 guidelines. 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.; Sender's Comments:  US-SA-2023SA146876: SanofiPVPortal20230524000365: SanofiPVPortal20230524000379:
Age: 0.33
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Opened IPOL was exposed to the temperature of 49.6F for 12 minutes with no reported adverse event; the patient received ipol post excursion with no reported adverse event; Initial information received on 23-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA146876.  This case involves a 4 months old female patient (24 cm and 5.7 kg) and reporter reported that the IPV (VERO) [IPOL] was exposed to an 49.6 Fahrenheit temperature for 12 minutes and the patient received ipol post excursion 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); ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); and HIB VACCINE CONJ (TET TOX) (ACTHIB).  On 05-May-2023, the patient received suspect IPV (VERO) for Suspension for injection (with an unknown dosage, frequency, strength, lot: V1A022M, Expiry date: 17-Feb-2024) via Intramuscular in left arm for prophylactic vaccination (immunization) and the ipol was exposed to an 49.6 Fahrenheit temperature for 12 minutes with no reported adverse event. (product storage error) (unknown latency) and on the same day the patient received ipol post excursion with no reported adverse event (poor quality product administered).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.   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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, Medication error
Clinical narrative: Nurse from a clinic called as they administered an expired MENACTRA vaccine with no reported adverse event; Initial information received on 24-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of unknown age and gender and it was reported nurse from a clinic called as they administered an expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On an unknown date, it was reported nurse from a clinic called as they administered an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] Solution for injection (batch/lot number, expiry date, strength: not reported) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (latency: same day). Information on the batch number was requested  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: YF
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received two doses of YF-VAX (Both from the same lot number) with no reported adverse event; Initial information received on 24-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 years old male patient who received two doses of yellow fever vaccine - [YF-VAX] (both from the same lot number) 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 typhoid vaccine polysacch VI (Typhim VI) for Immunisation.  On 24-May-2023, the patient received two doses of 0.5 mL dose of suspect yellow fever vaccine - (Strength: Normal) (batch number: UJ818AA; expiry date: 18-April-2024) via subcutaneous route in the left thigh and right thigh for immunization (both from the same lot number) with no reported adverse event (extra dose administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient received two doses of yf-vax (both from the same lot number) with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: administered post excursion with no reported adverse event; Initial information received on 24-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 years old female patient who was administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] post excursion 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, the patient received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (batch number, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) post excursion with no reported adverse event (poor quality product administered) (same day latency). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: M
Vaccine: TDAP, TDAP, MNQ
Symptoms: Asthenia, Dizziness, Flushing, Hyperhidrosis, Nothing by mouth order
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Severe, Additional Details: EMS STATED TO NOT GIVE ANTHING BY MOUTH
Age: 16.0
Sex: M
Vaccine: TDAP, TDAP, MNQ
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Severe, Additional Details: EMS STATED TO NOT GIVE ANTHING BY MOUTH
Age: 16.0
Sex: M
Vaccine: TDAP, TDAP, MNQ
Symptoms: Confusional state, Dizziness, Fall, Limb injury, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Severe, Additional Details: EMS STATED TO NOT GIVE ANTHING BY MOUTH
Age: 16.0
Sex: M
Vaccine: TDAP, TDAP, MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Severe, Additional Details: EMS STATED TO NOT GIVE ANTHING BY MOUTH
Age: 16.0
Sex: M
Vaccine: TDAP, TDAP, MNQ
Symptoms: Asthenia, Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Severe, Additional Details: EMS STATED TO NOT GIVE ANTHING BY MOUTH
Age: 16.0
Sex: M
Vaccine: TDAP, TDAP, MNQ
Symptoms: Asthenia, Dizziness, Flushing, Hyperhidrosis, Nothing by mouth order
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Severe, Additional Details: EMS STATED NOT TO GIVE ANY MEDS
Age: 16.0
Sex: M
Vaccine: TDAP, TDAP, MNQ
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Severe, Additional Details: EMS STATED NOT TO GIVE ANY MEDS
Age: 16.0
Sex: M
Vaccine: TDAP, TDAP, MNQ
Symptoms: Confusional state, Dizziness, Fall, Limb injury, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Severe, Additional Details: EMS STATED NOT TO GIVE ANY MEDS
Age: 16.0
Sex: M
Vaccine: TDAP, TDAP, MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Severe, Additional Details: EMS STATED NOT TO GIVE ANY MEDS
Age: 16.0
Sex: M
Vaccine: TDAP, TDAP, MNQ
Symptoms: Asthenia, Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Severe, Additional Details: EMS STATED NOT TO GIVE ANY MEDS
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Left arm pain since injection given on 9/14/22.  Radiates up and down arm.  Advised to take advil and use ice pack.  Also advised to visit doctor again.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Hypoaesthesia, Paraesthesia, Paralysis
Clinical narrative: Patient calls pharmacy on morning of 5/27/23 to report a reaction to Shingrix. Patient came to pharmacy on 5/25/23 for shingles vaccine. Patient reported that the next day, she felt "paralyzed" throughout her whole body. Specifically, she reports tingling and numbness in extremities, and unable to walk. She called on the second day after to report to the pharmacy, and reports it has gotten a little better since the day before. Patient also reports a tick bite 2 weeks ago and is unsure if this is related. She is going for blood work for Lyme disease in a few weeks to rule out.  Patient was instructed to contact her doctor to report the incident and to be advised whether to move forward with second dose or not. Patient also instructed to stay well hydrated, and if the symptoms get worse, to seek medical attention immediately.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash maculo-papular, Rash vesicular
Clinical narrative: FULL DEVELOPMENT OF SHINGLES:  2.5 days after the Left Deltoid IM administration of Shingrix, the patient noticed a small patch of rash on Left Torso, associated with burning pain and then progressing to enlarge  in size and dermatomal spread, characterized as classic  maculopapular, vesicular rash of herpes zoster.  Treatment with Valacyclovir 1,000mg po TID begun immediately on Day 1 of presenting with first evidence of rash Adjunctive therapy with OTC NSAIDS 400 mg QID prn Adjunctive Therapy of Prednisone (tapering dosage) begun on Day 4 due to worsening symptoms
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Peripheral swelling, Rash, Rash papular, Skin lesion
Clinical narrative: MEASURE 4 INCH DIAM LEFT SIDE AND 1 INCH IRREGULAR BORDER TO RIGHT SIDE OF LEGS, MAC=PAPULAR RASH IN ANT CHEST.  1 DAY AFTER SHOTS REDNESS, SWELLING TO EXTREMITIES AND HEAT TO TOUCH.  2ND DAY AFTER VACCINES URTICARIA TO LEFT AND RIGHT LEGS, RASH TO CHEST. NO FEVER
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Skin warm, Urticaria
Clinical narrative: MEASURE 4 INCH DIAM LEFT SIDE AND 1 INCH IRREGULAR BORDER TO RIGHT SIDE OF LEGS, MAC=PAPULAR RASH IN ANT CHEST.  1 DAY AFTER SHOTS REDNESS, SWELLING TO EXTREMITIES AND HEAT TO TOUCH.  2ND DAY AFTER VACCINES URTICARIA TO LEFT AND RIGHT LEGS, RASH TO CHEST. NO FEVER
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Experience rash on skin
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received moderna vaccine day after it expired
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was vaccinated on 5/18/2023 with vaccine that expired on 5/17/2023.  Patient did not report any adverse events as a result of the vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abnormal menstrual clots, Dizziness, Dysmenorrhoea, Fall
Clinical narrative: Several months after the first dose of J&J, mensural cycle went from normal (5- 6 days in length) to anywhere from 18-35 days in length, extreme blood clots, pain, bloating, with only 2-3 days before it would start all over again. I would become light headed from all the blood loss, even passed out and fell down a flight of stairs. Massive cramping all over my body in every muscle group. Abnormal hemorrhaging would last for weeks, then stop for a couple days (2-3days) then start again. I was constantly exhausted, fatigued easily (even though I am in good health and have been a gym rat since the3 8th grade). Hemorrhaging has never stopped. I am now expecting to have a partial hysterectomy to deal with the massive amount of bleeding.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Laboratory test, Loss of consciousness, Muscle spasms, Oligomenorrhoea
Clinical narrative: Several months after the first dose of J&J, mensural cycle went from normal (5- 6 days in length) to anywhere from 18-35 days in length, extreme blood clots, pain, bloating, with only 2-3 days before it would start all over again. I would become light headed from all the blood loss, even passed out and fell down a flight of stairs. Massive cramping all over my body in every muscle group. Abnormal hemorrhaging would last for weeks, then stop for a couple days (2-3days) then start again. I was constantly exhausted, fatigued easily (even though I am in good health and have been a gym rat since the3 8th grade). Hemorrhaging has never stopped. I am now expecting to have a partial hysterectomy to deal with the massive amount of bleeding.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea, Vaginal haemorrhage
Clinical narrative: Several months after the first dose of J&J, mensural cycle went from normal (5- 6 days in length) to anywhere from 18-35 days in length, extreme blood clots, pain, bloating, with only 2-3 days before it would start all over again. I would become light headed from all the blood loss, even passed out and fell down a flight of stairs. Massive cramping all over my body in every muscle group. Abnormal hemorrhaging would last for weeks, then stop for a couple days (2-3days) then start again. I was constantly exhausted, fatigued easily (even though I am in good health and have been a gym rat since the3 8th grade). Hemorrhaging has never stopped. I am now expecting to have a partial hysterectomy to deal with the massive amount of bleeding.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, COVID-19, Feeling abnormal, Impaired work ability, Inflammatory marker increased
Clinical narrative: I have been having pain in my "legs" for almost 18 months. The pain started almost 2 weeks after my second vaccination. I have been miserable. I have seen several PCPs, Neurology, Rheumatology, and Pain Managment, a psychiatrist, 2 different Orthopedic surgeons, and had a trip to the emergency room. I woke up one morning with the pain. Absolutely no injuries or falls prior. I ended up with covid shortly after the pain had started in my leg. During the first week of having covid, I HURT even more than I did before in my legs. I was diagnosed with Avascular Necrosis. I am currently using a walker. I have to have total hip replacement on both sides. My first surgery is on June 5th. I have not worked since April 4th, 2023.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging, Osteonecrosis, Pain in extremity, Walking aid user
Clinical narrative: I have been having pain in my "legs" for almost 18 months. The pain started almost 2 weeks after my second vaccination. I have been miserable. I have seen several PCPs, Neurology, Rheumatology, and Pain Managment, a psychiatrist, 2 different Orthopedic surgeons, and had a trip to the emergency room. I woke up one morning with the pain. Absolutely no injuries or falls prior. I ended up with covid shortly after the pain had started in my leg. During the first week of having covid, I HURT even more than I did before in my legs. I was diagnosed with Avascular Necrosis. I am currently using a walker. I have to have total hip replacement on both sides. My first surgery is on June 5th. I have not worked since April 4th, 2023.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: I have been having pain in my "legs" for almost 18 months. The pain started almost 2 weeks after my second vaccination. I have been miserable. I have seen several PCPs, Neurology, Rheumatology, and Pain Managment, a psychiatrist, 2 different Orthopedic surgeons, and had a trip to the emergency room. I woke up one morning with the pain. Absolutely no injuries or falls prior. I ended up with covid shortly after the pain had started in my leg. During the first week of having covid, I HURT even more than I did before in my legs. I was diagnosed with Avascular Necrosis. I am currently using a walker. I have to have total hip replacement on both sides. My first surgery is on June 5th. I have not worked since April 4th, 2023.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received on 5/19/2023 vaccine that expired on 5/17/2023.  Patient did not report any adverse reaction
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Right arm no longer can be lifted without pain or past shoulder height without difficulty.  Arm strength significantly compromised. Signs appeared shortly after second shot. Arm pain did not leave and lifting became difficult.  I was repeated told it was not the shot even though I told people it was.. No treatment or help was given.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: No actual adverse effect observed. Reporting administration error in timing. First dose in series was given on 4/1/23, second dose was given today 5/27/23, not within the 2-6 month recommended window per CDC's guidelines.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site discolouration, Injection site reaction, Rash erythematous, Urticaria
Clinical narrative: Welt at injection site that turned to a yellow bruise.  Red rash that reached down arm almost to the elbow.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: following injection-fatigue, nausea, shivering/rigors(12hrs post injection), swelling/redness quarter size to site/tenderness (1-2hrs post injection), 48hrs later post injection- still fatigue, nausea, swelling. redness and tenderness to site- 3" diameter now
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: following injection-fatigue, nausea, shivering/rigors(12hrs post injection), swelling/redness quarter size to site/tenderness (1-2hrs post injection), 48hrs later post injection- still fatigue, nausea, swelling. redness and tenderness to site- 3" diameter now
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Patient was vaccinated on 5/19/2023 with vaccine that expired on 5/17/2023.  Patient reported redness, heat, pain, swelling (about a hand sized area) at injection site.  Also reported nausea
Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Cerebrovascular accident, Confusional state, Dysarthria, Magnetic resonance imaging head abnormal
Clinical narrative: Confusion, slurred speech
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Diarrhoea, Malaise, Pain, Pyrexia
Clinical narrative: Patient felt sick the Monday after receiving the vaccine after the patient completed her dialysis treatment. She experienced fever, chills, and achiness. She later developed diarrhea. She is still experiencing symptoms.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: The patient called on 5/27/2023 to report that she had a nodule at the injection site. She stated that the nodule is sore at the injection site.  I advised the patient to visit her PCP to have this nodule looked at, but that it is likely a reaction to inactive ingredients within the vaccine (ie: Aluminum).
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Brain natriuretic peptide normal, Cardiac telemetry, Chest pain, Echocardiogram normal, Ejection fraction normal
Clinical narrative: On 5/25 patient began experiencing chest pain while walking. Chest pain also was positional. It began to worsen and did not resolve with rest so the patient presented to the ED on 5/25. He was found to have a high sensitivity troponin I initially elevated to 85. He was admitted to the local ICU ask his chest pain was worsening and his troponin was rising. In the ICU he was monitored with telemetry and troponin continued to rise to a maximum of 2144, and downtrended to 686 on 5/27 after monitoring. When he initially presented there was immediate concern this was COVID vaccine-associated myocarditis. EKGs were followed and on 5/26 he had some ST changes, but these improved and he had a normal EKG on 5/27. He had an ECHO on 5/26 that was normal and showed EF of 64%. Cardiology was consulted and recommended starting a 10 day course of ibuprofen. He was deemed safe for discharge on 5/27 with cardiology follow up per guidelines. Symptoms had improve.  He has an activity restriction for the next month.
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Electrocardiogram ST segment, Fibrin D dimer, Intensive care, Troponin I increased
Clinical narrative: On 5/25 patient began experiencing chest pain while walking. Chest pain also was positional. It began to worsen and did not resolve with rest so the patient presented to the ED on 5/25. He was found to have a high sensitivity troponin I initially elevated to 85. He was admitted to the local ICU ask his chest pain was worsening and his troponin was rising. In the ICU he was monitored with telemetry and troponin continued to rise to a maximum of 2144, and downtrended to 686 on 5/27 after monitoring. When he initially presented there was immediate concern this was COVID vaccine-associated myocarditis. EKGs were followed and on 5/26 he had some ST changes, but these improved and he had a normal EKG on 5/27. He had an ECHO on 5/26 that was normal and showed EF of 64%. Cardiology was consulted and recommended starting a 10 day course of ibuprofen. He was deemed safe for discharge on 5/27 with cardiology follow up per guidelines. Symptoms had improve.  He has an activity restriction for the next month.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast mass, Breast pain, Condition aggravated, Mammogram abnormal, Therapy non-responder
Clinical narrative: Pain in right breast. Very painful. I went to have a mammogram. They found a mass ( benign). They want to see me back in July to be sure.   Ozempic 1 mg is no longer repressing my appetite.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound scan
Clinical narrative: Pain in right breast. Very painful. I went to have a mammogram. They found a mass ( benign). They want to see me back in July to be sure.   Ozempic 1 mg is no longer repressing my appetite.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Activated partial thromboplastin time, Anti-thyroid antibody, Arteriogram carotid abnormal, Asthenia, Blood thyroid stimulating hormone
Clinical narrative: March 17, 2023 Received first dose of Shingrix vaccine. April 11-14, 2023 acute gastroenteritis, diarrhea and fever of 103 F. April 19, 2023 Fell in driveway at home due to weakness. April 20, 2023 Admitted to Hospital. Working diagnosis of Miller Fisher variant  GBS (AIDP) or possible seronegative neuromuscular junction disorder.  May 23, 2023 Transfer to another Hospital intensive inpatient rehabilitation
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein, CSF glucose increased, CSF protein increased, CSF test abnormal, Cerebral vascular occlusion
Clinical narrative: March 17, 2023 Received first dose of Shingrix vaccine. April 11-14, 2023 acute gastroenteritis, diarrhea and fever of 103 F. April 19, 2023 Fell in driveway at home due to weakness. April 20, 2023 Admitted to Hospital. Working diagnosis of Miller Fisher variant  GBS (AIDP) or possible seronegative neuromuscular junction disorder.  May 23, 2023 Transfer to another Hospital intensive inpatient rehabilitation
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head, Computerised tomogram thorax, Diarrhoea, Electrocardiogram, Fall
Clinical narrative: March 17, 2023 Received first dose of Shingrix vaccine. April 11-14, 2023 acute gastroenteritis, diarrhea and fever of 103 F. April 19, 2023 Fell in driveway at home due to weakness. April 20, 2023 Admitted to Hospital. Working diagnosis of Miller Fisher variant  GBS (AIDP) or possible seronegative neuromuscular junction disorder.  May 23, 2023 Transfer to another Hospital intensive inpatient rehabilitation
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fibrin D dimer, Full blood count, Gastroenteritis, Guillain-Barre syndrome, Herpes simplex test
Clinical narrative: March 17, 2023 Received first dose of Shingrix vaccine. April 11-14, 2023 acute gastroenteritis, diarrhea and fever of 103 F. April 19, 2023 Fell in driveway at home due to weakness. April 20, 2023 Admitted to Hospital. Working diagnosis of Miller Fisher variant  GBS (AIDP) or possible seronegative neuromuscular junction disorder.  May 23, 2023 Transfer to another Hospital intensive inpatient rehabilitation
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: International normalised ratio, Laboratory test, Metabolic function test, Miller Fisher syndrome, Perfusion brain scan
Clinical narrative: March 17, 2023 Received first dose of Shingrix vaccine. April 11-14, 2023 acute gastroenteritis, diarrhea and fever of 103 F. April 19, 2023 Fell in driveway at home due to weakness. April 20, 2023 Admitted to Hospital. Working diagnosis of Miller Fisher variant  GBS (AIDP) or possible seronegative neuromuscular junction disorder.  May 23, 2023 Transfer to another Hospital intensive inpatient rehabilitation
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Prothrombin time, Pyrexia, Red blood cell sedimentation rate, Reflex test, Scan with contrast
Clinical narrative: March 17, 2023 Received first dose of Shingrix vaccine. April 11-14, 2023 acute gastroenteritis, diarrhea and fever of 103 F. April 19, 2023 Fell in driveway at home due to weakness. April 20, 2023 Admitted to Hospital. Working diagnosis of Miller Fisher variant  GBS (AIDP) or possible seronegative neuromuscular junction disorder.  May 23, 2023 Transfer to another Hospital intensive inpatient rehabilitation
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Stroke volume, Troponin, Volume blood
Clinical narrative: March 17, 2023 Received first dose of Shingrix vaccine. April 11-14, 2023 acute gastroenteritis, diarrhea and fever of 103 F. April 19, 2023 Fell in driveway at home due to weakness. April 20, 2023 Admitted to Hospital. Working diagnosis of Miller Fisher variant  GBS (AIDP) or possible seronegative neuromuscular junction disorder.  May 23, 2023 Transfer to another Hospital intensive inpatient rehabilitation
Age: 3.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The doctor ordered Dtap for the patient, but the patient was given Tdap in error. There was no adverse reaction and the patient will continue with the regular immunization schedule.
Age: 1.58
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The doctor ordered Dtap to be given to the patient, but the patient was given Tdap in error. There was no adverse reaction. The patient will continue with the recommended immunization schedule.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: Episodes for months following injection of severe chest pain felt and unable to breath,   dizziness, weakness, and headache with constant ringing in my ears. It's been almost two years and I am still having issues.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Headache, Mobility decreased, Syncope, Tinnitus
Clinical narrative: Episodes for months following injection of severe chest pain felt and unable to breath,   dizziness, weakness, and headache with constant ringing in my ears. It's been almost two years and I am still having issues.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: PT HAD STEROID OINT PRESCRIBED. WAS GOING TO SEE THE DR TODAY. BUT NO CALL BACK. I LEFT A MESSAGE FOR PT TO CALL BACK
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Injection site reaction, Injection site warmth, Rash erythematous, Rash papular
Clinical narrative: Covid-19,  mRNA,  LNP-S,  bivalent,  PF  mcg/0.5 mL Dose (Moderna)  Raised 2 1/2  inch round, raised red rash on injection site.  Rash felt hot and the complete circle was all red.  It's slowly going away now.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: pt received DTaP (infanrix) shot on thursday 5/25 with redness to L thigh injection site. - 5x5cm area of erythema with rash per provider note. lot 7HM5J
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Nausea, Night sweats, Pain
Clinical narrative: Chills, fever, night sweats, body aches, nausea, fatigue .  Tylenol , rest. . Symptoms started about 12 hours after the injection and were moderate and higher through the night. I was significantly fatigued throughout the following day. Some fatigue lingered through the next day and with waves of nausea.  My previous COVID vaccines caused similar side affects.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Chills, fever, night sweats, body aches, nausea, fatigue .  Tylenol , rest. . Symptoms started about 12 hours after the injection and were moderate and higher through the night. I was significantly fatigued throughout the following day. Some fatigue lingered through the next day and with waves of nausea.  My previous COVID vaccines caused similar side affects.
Age: 16.0
Sex: M
Vaccine: TDAP, TDAP, MNQ
Symptoms: Asthenia, Dizziness, Flushing, Hyperhidrosis, Nothing by mouth order
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient did not show any signs of adverse event for the first minute, but when exiting the vaccine room they felt light headed and fell over, landing on their shoulder. The patient's father and I tended to him and he responded after a few seconds with some confusion. Emergency services were called immediately and the Nurse Practitioner from the Clinic came to help as well. EMT's showed up very soon and took the patient to the hospital.