chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Respiratory disorder, Respiratory failure, Spinal disorder, Spondylolisthesis, Thecal sac compression
Clinical narrative: Ascending paralysis starting within days of vaccine officially diagnosed as Guillain Barre Syndrome by 8/12/23. Patient had prolong hospital stay from 8/12/23 - 9/14/23 then transferred to acute rehab facility from 9/14/23 - 10/30/23.
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Vertebral foraminal stenosis
Clinical narrative: Ascending paralysis starting within days of vaccine officially diagnosed as Guillain Barre Syndrome by 8/12/23. Patient had prolong hospital stay from 8/12/23 - 9/14/23 then transferred to acute rehab facility from 9/14/23 - 10/30/23.
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Intensive care, Laboratory test, Lumbar puncture
Clinical narrative: Ascending paralysis starting within days of vaccine officially diagnosed as Guillain Barre Syndrome by 8/12/23. Patient had prolong hospital stay from 8/12/23 - 9/14/23 then transferred to acute rehab facility from 9/14/23 - 10/30/23.
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Magnetic resonance imaging spinal abnormal, Muscular weakness, Plasmapheresis, Respiratory distress, Spondylolisthesis
Clinical narrative: Ascending paralysis starting within days of vaccine officially diagnosed as Guillain Barre Syndrome by 8/12/23. Patient had prolong hospital stay from 8/12/23 - 9/14/23 then transferred to acute rehab facility from 9/14/23 - 10/30/23.
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Spondylolysis, Thecal sac compression, Vertebral foraminal stenosis
Clinical narrative: Ascending paralysis starting within days of vaccine officially diagnosed as Guillain Barre Syndrome by 8/12/23. Patient had prolong hospital stay from 8/12/23 - 9/14/23 then transferred to acute rehab facility from 9/14/23 - 10/30/23.
Age: 67.0
Sex: M
Vaccine: PNC15, UNK, PNC15
Symptoms: Ascending flaccid paralysis, Guillain-Barre syndrome, Imaging procedure, Laboratory test
Clinical narrative: Ascending paralysis starting within days of vaccine officially diagnosed as Guillain Barre Syndrome by 8/12/23. Patient had prolong hospital stay from 8/12/23 - 9/14/23 then transferred to acute rehab facility from 9/14/23 - 10/30/23.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Pelvic pain
Clinical narrative: i was forced to get the covid vaccine at work. Not only was i forced once, but TWICE! to get this vaccine. a week after getting the vaccine i started experiencing extreme chronic pelvic pain and heavy bleeding. since then i have gone to doctors and have undergone several medical testings to determine the cause of my pain and there has been no answers other than an auto immune response to this covid vaccine. i was lied too about what was in the vaccine as well, i could have not given consent because i was not informed about the MAJOR, MAJOR change that the vaccines were manufactered and the fact that i got a different product and it has caused me life long pain and a miscarriage.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Autoimmune disorder, Condition aggravated, Haemorrhage, Immunisation reaction
Clinical narrative: i was forced to get the covid vaccine at work. Not only was i forced once, but TWICE! to get this vaccine. a week after getting the vaccine i started experiencing extreme chronic pelvic pain and heavy bleeding. since then i have gone to doctors and have undergone several medical testings to determine the cause of my pain and there has been no answers other than an auto immune response to this covid vaccine. i was lied too about what was in the vaccine as well, i could have not given consent because i was not informed about the MAJOR, MAJOR change that the vaccines were manufactered and the fact that i got a different product and it has caused me life long pain and a miscarriage.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pelvic pain
Clinical narrative: i was forced to get the covid vaccine at work. Not only was i forced once, but TWICE! to get this vaccine. a week after getting the vaccine i started experiencing extreme chronic pelvic pain and heavy bleeding. since then i have gone to doctors and have undergone several medical testings to determine the cause of my pain and there has been no answers other than an auto immune response to this covid vaccine. i was lied too about what was in the vaccine as well, i could have not given consent because i was not informed about the MAJOR, MAJOR change that the vaccines were manufactered and the fact that i got a different product and it has caused me life long pain and a miscarriage.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Customer called to report an AE for PNEUMOVAX 23. The caller said an expired dose was administered. Confirmed no other AE occurred and no temperature excursion prior to administration; No other AE. No PQC.; This spontaneous report was received from Pharmacist and refers to a patient of unkonwn age and gender. Information regarding te patiens's medical history, patient's concurrent conditions and concomitant therapies were not reported.  On 26-OCT-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, lot #W019533, expiration date: 30-SEP-2023, administered for prophylaxis (strength, and route of administration were not provided). (experied product administered)  No additional adverse was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Pharmacist called to report a patient received inadvertently expired PNEUMOVAX 23; This spontaneous report was received from pharmacist, referring to a patient of unknown age and gender.  The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 03-NOV-2023, the patient was vaccinated with an inadvertently expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (expired product administered), lot #W007035, expiration date: 20-OCT-2023, administered for prophylaxis (strength, dose, and route of administration were not provided). It was confirmed no temperature extrusion (T/E) had occurred. No Side effects were reported. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; Expired PNEUMOVAX 23 (pfs) was administered to a patient. Product expired 9/30/2023 and was administered today 11/21/2023; This spontaneous report was received from a medical assistant and refers to an unspecified gender and age patient (limited pertinent information and demographic data).   The patient's medical history was not reported, concurrent conditions, and concomitant therapies were not reported.  On 21-NOV-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe injection, 0.5 milliliter, lot #: W019533, expiration date: 30-SEP-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). Additionally, it was reported that the product had not experienced temperature excursion through the date of administration. No additional adverse events (AE) reported (No adverse event).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Somnolence
Clinical narrative: Severe drowsiness followed by continuous diarrhea; Severe drowsiness followed by continuous diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Severe drowsiness followed by continuous diarrhea) and DIARRHOEA (Severe drowsiness followed by continuous diarrhea) in an 81-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 18-Oct-2023, the patient experienced SOMNOLENCE (Severe drowsiness followed by continuous diarrhea) and DIARRHOEA (Severe drowsiness followed by continuous diarrhea). At the time of the report, SOMNOLENCE (Severe drowsiness followed by continuous diarrhea) and DIARRHOEA (Severe drowsiness followed by continuous diarrhea) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  It was unknown if the patient experienced any additional symptoms or events.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: medication error/an inappropriate use due to the administration of an expired product with no reported adverse event; Initial information received on 20-Nov-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 1-year-old female patient and the reporter reported medication error/an inappropriate use due to the administration of an expired product HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 03-Nov-2023, the patient received a 0.5 ml dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (strength: unknown) (lot: UJ973AA, expiry date: 07-Oct-2023) via intramuscular route in the thigh nos for Immunization and medication error/an inappropriate use due to the administration of an expired product with no reported adverse event (expired product administered) (latency: same day).    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 and Regulatory Authority 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: 11.0
Sex: M
Vaccine: MEN
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: administered menquadfi diluted with sterile water to a patient with no reported adverse event; Initial information received on 17-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who was administered meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] diluted with sterile water to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Nov-2023, the patient received a dose of 0.5 ml once of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot: U7903AB; strength: standard; expiry date: unknown) via intramuscular route in unknown administration site for Immunization.  On 17-Nov-2023 the patient developed was administered menquadfi diluted with sterile water to a patient with no reported adverse event (product preparation error) (latency: same day).  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.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Pharmacist calling to report the administration of an expired dose of PNEUMOVAX 23 SYRINGE to a patient on 11/01/2023.  Caller confirmed no previous temperature excursions for this product and stored in the recommended range.  HBP states there are no; This spontaneous report was received from a Pharmacist, referring to a patient of unknown age and gender.  The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 01-NOV-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #W021636, expiration date: 01-OCT-2023, administered as prophylaxis (strength, dose, and route of administration were not provided) (expired product administered). It was confirmed no previous temperature excursions for this product and this product had been stored in the recommended range. It was stated that there were no symptoms or further details to report. No other adverse event (AE) was reported (no adverse event).
Sex: M
Vaccine: COVID19
Symptoms: Lymphoma, Recurrent cancer
Clinical narrative: friend who went through chemo from May to September from lymphoma; now, his cancer is back; friend who went through chemo from May to September from lymphoma; now, his cancer is back; This spontaneous case was reported by a consumer and describes the occurrence of RECURRENT CANCER (friend who went through chemo from May to September from lymphoma; now, his cancer is back) and LYMPHOMA (friend who went through chemo from May to September from lymphoma; now, his cancer is back) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Lymphoma (went through chemo from May to September from lymphoma).    On an unknown date, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced RECURRENT CANCER (friend who went through chemo from May to September from lymphoma; now, his cancer is back) (seriousness criterion medically significant) and LYMPHOMA (friend who went through chemo from May to September from lymphoma; now, his cancer is back) (seriousness criterion medically significant). At the time of the report, RECURRENT CANCER (friend who went through chemo from May to September from lymphoma; now, his cancer is back) and LYMPHOMA (friend who went through chemo from May to September from lymphoma; now, his cancer is back) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant mediation was reported. Patient went through chemo from May to September from lymphoma.  His doctor told him to get shot-7. Now his cancer is back because he got shot-7. No treatment information was reported.   Company Comment: This is a spontaneous case concerning an adult male patient of unknown age, with medical history of Lymphoma who experienced a serious (due to medically significant) unexpected, event of Lymphoma and recurrent cancer (a friend who went through chemo from May to September from lymphoma; now his cancer is back). The event occurred on an unknown date after the seventh dose of SPIKEVAX 2023-2024 vaccine. Clinical course, supportive diagnostic procedures and treatment were not provided. The outcome of the event was not reported. The mentioned medical history remains as a confounder. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-748863 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2023: Live follow-up received: medical history updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748863:Different patient
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Renal infarct
Clinical narrative: renal infarct; This spontaneous case was reported by a consumer and describes the occurrence of RENAL INFARCT (renal infarct) in a 36-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3832B) for COVID-19 prophylaxis.    Co-suspect product included non-company product ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 09-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On an unknown date, the patient started ASPIRIN [ACETYLSALICYLIC ACID] (unknown route) at an unspecified dose. On 15-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced RENAL INFARCT (renal infarct) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 7 days due to RENAL INFARCT. At the time of the report, RENAL INFARCT (renal infarct) had not resolved.            Reported that patient had renal infarct and cannot rule out cardiac involvement.  Reported that over 50 tests were performed and stayed in hospital for 1 week.  Treatment medications were not reported.  Company Comment: This is a spontaneous case concerning a 36-year-old, male patient with no reported medical history, who experienced the serious (due to medically significant and hospitalization) unexpected, event of Renal infarct. The event occurred approximately 36 days after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. Clinical course, supportive diagnostic procedures, treatment, circumstances leading to the event, medical history and concomitant medications were not provided. The outcome of the event was reported as not recovered. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024), vaccine is not affected by this report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Defaecation disorder, Headache
Clinical narrative: have a mild headache, stomachache, and defecation after receiving the Moderna Vaccine.; mild headache, stomachache, and defecation after receiving the Moderna Vaccine.; have a mild headache, stomachache, and defecation after receiving the Moderna Vaccine.; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (have a mild headache, stomachache, and defecation after receiving the Moderna Vaccine.), DEFAECATION DISORDER (mild headache, stomachache, and defecation after receiving the Moderna Vaccine.) and HEADACHE (have a mild headache, stomachache, and defecation after receiving the Moderna Vaccine.) in a 47-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057459) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer Vaccines (7 previous Pfizer Vaccines). Past adverse reactions to the above products included No adverse event with Pfizer Vaccines. Concurrent medical conditions included Allergy NOS (Allergies (not specified)), Cholesterol and Diabetes. Concomitant products included EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.    On 24-Nov-2023, the patient received eighth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Nov-2023, the patient experienced ABDOMINAL PAIN UPPER (have a mild headache, stomachache, and defecation after receiving the Moderna Vaccine.), DEFAECATION DISORDER (mild headache, stomachache, and defecation after receiving the Moderna Vaccine.) and HEADACHE (have a mild headache, stomachache, and defecation after receiving the Moderna Vaccine.). At the time of the report, ABDOMINAL PAIN UPPER (have a mild headache, stomachache, and defecation after receiving the Moderna Vaccine.), DEFAECATION DISORDER (mild headache, stomachache, and defecation after receiving the Moderna Vaccine.) and HEADACHE (have a mild headache, stomachache, and defecation after receiving the Moderna Vaccine.) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient was experiencing a mild headache, stomachache, and defecation one day after receiving the vaccine and this was the first time it had happened to her since receiving 7 Pfizer vaccines and the latest was the booster dose of Moderna Vaccine. No treatment medication reported.   Reporter did not allow further contact
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: he is not feeling so good; He also experienced severe muscle stiffness and soreness.; He had a fever for a couple of days; soreness; muscle stiffness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (muscle stiffness), MALAISE (he is not feeling so good), TENDERNESS (soreness), MYALGIA (He also experienced severe muscle stiffness and soreness.) and PYREXIA (He had a fever for a couple of days) in a 63-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19. Previously administered products included for COVID-19 vaccination: Pfizer (2 doses) in 2020 and Pfizer (1 dose) in 2021; for Product used for unknown indication: Flu shot on 16-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu shot, Pfizer and Pfizer. Concurrent medical conditions included Muscle disorder (experienced a rare systemic muscle disease that prompts to anaphylaxis and allergies.), Allergy to antibiotic, Allergy to NSAIDs, Drug allergy (aspirins and related drug), Drug allergy (caused severe nerve pain once.) and Drug allergy (experienced anaphylaxis to most of the medications.).    In October 2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 24-Nov-2023, the patient experienced MUSCULOSKELETAL STIFFNESS (muscle stiffness), TENDERNESS (soreness) and PYREXIA (He had a fever for a couple of days). On an unknown date, the patient experienced MALAISE (he is not feeling so good) and MYALGIA (He also experienced severe muscle stiffness and soreness.). At the time of the report, MUSCULOSKELETAL STIFFNESS (muscle stiffness), TENDERNESS (soreness) and PYREXIA (He had a fever for a couple of days) was resolving and MALAISE (he is not feeling so good) and MYALGIA (He also experienced severe muscle stiffness and soreness.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Body temperature: 100°F, 99°F and 99.5°F.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  He had a fever for a couple of days. Patient received Spikevax about 3 weeks ago.   He believed that he received the vaccine on the week of 23Oct2023. Then on Friday night he started having fever. He said that in the past he had Covid, and the symptoms he experienced are similar to the ones from Covid. Patient doesn´t have a fever anymore. That has improved.  He did not vomit but had a very low fever and over the weekend it climbed over 100°F. Then 99°F, 99.5°F He didn´t see a doctor yet because this happened over the weekend. He thought it was a normal thing, but he was getting progressibly worse with the covid-type symptoms.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: he is not feeling so good; He also experienced severe muscle stiffness and soreness.; He had a fever for a couple of days; soreness; muscle stiffness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (muscle stiffness), MALAISE (he is not feeling so good), TENDERNESS (soreness), MYALGIA (He also experienced severe muscle stiffness and soreness.) and PYREXIA (He had a fever for a couple of days) in a 63-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19. Previously administered products included for COVID-19 vaccination: Pfizer (2 doses) in 2020 and Pfizer (1 dose) in 2021; for Product used for unknown indication: Flu shot on 16-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu shot, Pfizer and Pfizer. Concurrent medical conditions included Muscle disorder (experienced a rare systemic muscle disease that prompts to anaphylaxis and allergies.), Allergy to antibiotic, Allergy to NSAIDs, Drug allergy (aspirins and related drug), Drug allergy (caused severe nerve pain once.) and Drug allergy (experienced anaphylaxis to most of the medications.).    In October 2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 24-Nov-2023, the patient experienced MUSCULOSKELETAL STIFFNESS (muscle stiffness), TENDERNESS (soreness) and PYREXIA (He had a fever for a couple of days). On an unknown date, the patient experienced MALAISE (he is not feeling so good) and MYALGIA (He also experienced severe muscle stiffness and soreness.). At the time of the report, MUSCULOSKELETAL STIFFNESS (muscle stiffness), TENDERNESS (soreness) and PYREXIA (He had a fever for a couple of days) was resolving and MALAISE (he is not feeling so good) and MYALGIA (He also experienced severe muscle stiffness and soreness.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Body temperature: 100°F, 99°F and 99.5°F.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  He had a fever for a couple of days. Patient received Spikevax about 3 weeks ago.   He believed that he received the vaccine on the week of 23Oct2023. Then on Friday night he started having fever. He said that in the past he had Covid, and the symptoms he experienced are similar to the ones from Covid. Patient doesn´t have a fever anymore. That has improved.  He did not vomit but had a very low fever and over the weekend it climbed over 100°F. Then 99°F, 99.5°F He didn´t see a doctor yet because this happened over the weekend. He thought it was a normal thing, but he was getting progressibly worse with the covid-type symptoms.
Sex: U
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received the vaccine and after it was administered, they realized that the vaccine was 18 days expired with no reported adverse event; Initial information received on 20-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves patient (unknown age and gender) who received the typhoid VI polysaccharide vaccine [Typhim VI] and after it was administered, they realized that the vaccine was 18 days expired 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 unknown dose of suspect typhoid VI polysaccharide vaccine, Solution for injection (Expiration Date :02-Nov-2023) (strength, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination and after it was administered, they realized that the vaccine was 18 days expired with no reported adverse event (expired product administered) (latency: same day).  Information on the batch number was requested.  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 and Regulatory Authority 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: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: adacel was administered to a 9 year old less than the approved age in the product labeling with no reported adverse event; Initial information received on 21-Nov-2023 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 9 years old female patient who administered with Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] which was less than the approved age in the product labeling, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Nov-2022, the 9 years old patient received (0.5 ml, once) dose 1 of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, suspension for injection (strength: unknown) (lot: U7534AA, Expiry date: 2-Aug-2024) which is old less than the approved age in the product labeling with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) via intramuscular route in unknown administration site for immunization.  No lab data reported.  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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: I had a miscarriage two days post COVID vaccine administration at 8 weeks pregnant. It may or may not be related to the vaccine.
Sex: U
Vaccine: RSV
Symptoms: Product closure issue
Clinical narrative: Patient to clinic for schedule appointment to receive RSV vaccine. After mixing the medication per the instructions and the needle was secured on the vial, when writer went to pull the needle cap off of the needle, the vial broke at the base of where the needed secured on to the vial. No one was injured.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Headache, Loss of consciousness, Loss of personal independence in daily activities, Malaise, Pyrexia
Clinical narrative: 11 yr. old Patient appeared to have convulsions and passed out after the shot was administered. Patient was monitored for 5 minutes, B/P, R/P, oximeter. Didn't receive any paperwork or advice for followup. Less than 8 hours later patient has headache, fever of 101 . Sent home from school. Sick for 2 days. Notified provider. No return phone call.,
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Seizure
Clinical narrative: 11 yr. old Patient appeared to have convulsions and passed out after the shot was administered. Patient was monitored for 5 minutes, B/P, R/P, oximeter. Didn't receive any paperwork or advice for followup. Less than 8 hours later patient has headache, fever of 101 . Sent home from school. Sick for 2 days. Notified provider. No return phone call.,
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Injection site pain, Nasopharyngitis, Productive cough, Respiratory tract congestion
Clinical narrative: I received RSV vaccine Arevy on 11/16/2023 and developed soreness at injection site, cold symptoms, congestion and fatigue. Still coughing phlegm after 10 days. Injection site soreness lasted 3 days. Cold symptoms progressed from head to chest over several days. Fatigue developed after two days and is resolving. Negative COVID test.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: SARS-CoV-2 test negative
Clinical narrative: I received RSV vaccine Arevy on 11/16/2023 and developed soreness at injection site, cold symptoms, congestion and fatigue. Still coughing phlegm after 10 days. Injection site soreness lasted 3 days. Cold symptoms progressed from head to chest over several days. Fatigue developed after two days and is resolving. Negative COVID test.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Unintentional administration of COVID vaccine to a 3 year old of 3 times the intended amount. Vial contained 3 doses but entire vial was drawn up. It was the second day for this clinic to administer Covid-19 vaccines. A different vial of Pfizer's Covid vaccine (yellow label and yellow cap) is used for children from 6 months to 5 years of age. Poison control was contacted and advised no intervention, just monitoring. Patient is doing well with no untoward effects.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: Macular rash on chest, torso, thighs, back which are not itchy or painful. No other symptoms.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Headache, Pyrexia, Tremor
Clinical narrative: Fever with shaking, joint pain and severe headache.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood sodium decreased, Inappropriate antidiuretic hormone secretion, Urine analysis
Clinical narrative: Recieved this second shot of Shingrix, had routine blood work on 1/17/23 and recieved phone call from doctors office with critically low Na. After lots of lab work next week dx with SIADH
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injected limb mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: Vaccine was administered in shoulder joint rather that intramuscularly. That evening, patient began experiencing severe pain in the shoulder joint when moving, and was restricted to movement in one direction. Symptoms have not resolved.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bronchitis, COVID-19, Cough, Death, Dehydration
Clinical narrative: Pt diagnosed with COVID-19 on 10/30/2023 at a PCP encounter for cough. Prescribed prednisone for acute bronchitis.  Pt admitted through ER on 11/5/23 for shortness of breath. Diagnosed with hypoxia, and pneumonia or right lung. Discharged home 11/8/2023 at 9:30 pm, went home on 11/9/23, on Zithromax, Cepacol, Tessalon, Omnicef, Prednisone. Pt readmitted on 11/10/2023 through ER at 6:40 PM with bi-lateral pneumonia and worsening infiltrates, dehydration. Pt became septic and deceased 11/20/2023 at 18:48.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Hypoxia, Lung infiltration, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Pt diagnosed with COVID-19 on 10/30/2023 at a PCP encounter for cough. Prescribed prednisone for acute bronchitis.  Pt admitted through ER on 11/5/23 for shortness of breath. Diagnosed with hypoxia, and pneumonia or right lung. Discharged home 11/8/2023 at 9:30 pm, went home on 11/9/23, on Zithromax, Cepacol, Tessalon, Omnicef, Prednisone. Pt readmitted on 11/10/2023 through ER at 6:40 PM with bi-lateral pneumonia and worsening infiltrates, dehydration. Pt became septic and deceased 11/20/2023 at 18:48.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sepsis
Clinical narrative: Pt diagnosed with COVID-19 on 10/30/2023 at a PCP encounter for cough. Prescribed prednisone for acute bronchitis.  Pt admitted through ER on 11/5/23 for shortness of breath. Diagnosed with hypoxia, and pneumonia or right lung. Discharged home 11/8/2023 at 9:30 pm, went home on 11/9/23, on Zithromax, Cepacol, Tessalon, Omnicef, Prednisone. Pt readmitted on 11/10/2023 through ER at 6:40 PM with bi-lateral pneumonia and worsening infiltrates, dehydration. Pt became septic and deceased 11/20/2023 at 18:48.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: SEVERE SHORTNESS OF BREATH STARTING APPROX 12-24 HOURS POST INJECTION AND LASTING SEVERAL DAYS
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased
Clinical narrative: 10/19/23 Received Flu vac. at right upper arm.  10/20 23 pain at site of injection.  10/25/23 pain at right shoulder and limitted range of motion, no relief with Ibuprofen and hot packs application.  11/27/23 referrd to Occ. Helath for eva;uation and treatment.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, FLU4, RSV
Symptoms: Underdose
Clinical narrative: No ADR - patient was given pediatric dose of Pfizer COVID19 vaccine rather than adult dose of vaccine ordered - correct vaccine was given within 7 hours of incorrect dose being given
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Discomfort, Joint range of motion decreased, Loss of personal independence in daily activities, Magnetic resonance imaging
Clinical narrative: Within several hours of injection, pain in shoulder (not soreness at injection site) and loss of range of motion began. By the following morning, range of motion was severely limited, making things like fastening seatbelt and pulling hair back impossible. Physician follow up yielded a Rx for Diclofenac to help with pain and swelling. After 2 weeks was referred to orthopedics specialist at my behest, and they confirmed Shoulder Injury Related to Vaccine Administration (SIRVA). Need to follow up with them if pain persists past the 8 week mark (currently in week 4 of pain, discomfort, and medicating)
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Shoulder injury related to vaccine administration, Swelling, X-ray
Clinical narrative: Within several hours of injection, pain in shoulder (not soreness at injection site) and loss of range of motion began. By the following morning, range of motion was severely limited, making things like fastening seatbelt and pulling hair back impossible. Physician follow up yielded a Rx for Diclofenac to help with pain and swelling. After 2 weeks was referred to orthopedics specialist at my behest, and they confirmed Shoulder Injury Related to Vaccine Administration (SIRVA). Need to follow up with them if pain persists past the 8 week mark (currently in week 4 of pain, discomfort, and medicating)
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Acute respiratory failure, Angiogram pulmonary normal, Antinuclear antibody negative, Blood potassium increased
Clinical narrative: Patient is a 62 y.o. male patient of MD with history of ESRD, morbid obesity, DM type II, atrial fibrillation, hypothyroidism transferred to Medical Center for trauma evaluation.     Acute respiratory failure with hypoxia Tachypnea, dyspnea, hypoxia presentation Placed on 2 L nasal cannula in ED. Currently on 2L NC, wean as tolerated CTA of chest without acute gross abnormalities. Likely multifactorial (hypoventilation syndrome, untreated OSA). Pulmonary consulted.  Breathing treatments as needed   Covid-19 Virus Infection Tested positive on arrival; no obvious infiltrates on imaging Continue dexamethasone for 10-day course as was on nasal cannula and hypoxic initially   Acute pancreatitis Periumbilical abdominal pain as well as nausea. No other red flags. Possibly trauma related CT scan of abdomen with mild free fluid in the right upper quadrant in the left pararenal space. Lipase elevated to 1,279 > currently trending down to 281 Evaluated by trauma team in ED. No concern for surgical issues. Holding IV fluids in setting of ESRD. Pain and nausea control as needed. RUQ US evaluation limited due to body habitus; no evidence of acute cholecystitis; Increased echogenicity and heterogeneous echotexture of the liver suggestive of hepatocellular disease and/or steatosis. LFTs stable, INR 1.1; TG 235, ANA negative GI consulted, continue supportive care Currently advanced to solids, tolerating diet Fall Right proximal humerus Fracture Patient sustained a fall off his motorized scooter Diagnosed with right humerus fracture, Currently on sling. Transferred to medical center to be evaluated by trauma team. No other acute traumatic issues and scans; trauma team signed off.  Orthopedics consulted for recommendations - non operative mgmt Patient follow-up in clinic or at medical center as an outpatient PT/OT consulted - recommended for SNF, however patient refusing SNF, preferring to go home with home health care. Counseled on risks of not following this recommendation with regard to re-admission, falls, clinical decline, and potential risk of life-threatening measures such as death. Patient voiced understanding Pain control as needed.   Hyperkalemia - resolved Potassium of 6.3 on presentation. In setting of ESRD. K currently stable Nephrology consulted   ESRD On hemodialysis 3 times a week. Nephrology consulted for inpatient hemodialysis Monitor renal function closely   Paroxysmal atrial fibrillation Rate controlled on admission. Restart home regimen (propafenone, and eliquis). Continue to monitor on telemetry   DM type II A1c 7.8 home dose of long-acting insulin (30 units twice daily). lantus to 30 units bid, continue SSI BG currently slightly above goal, continue to monitor and titrate   Hypothyroidism TSH level 4.52, FT4 0.8 resume dose levothyroxine   Thrombocytopenia, POA - resolved Platelets 114 on arrival, currently 157 OSA Per patient, not using CPAP anymore.   Morbid obesity Body mass index is 46.54 kg/m².
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone normal, COVID-19, Computerised tomogram abdomen abnormal, Dyspnoea, Fall
Clinical narrative: Patient is a 62 y.o. male patient of MD with history of ESRD, morbid obesity, DM type II, atrial fibrillation, hypothyroidism transferred to Medical Center for trauma evaluation.     Acute respiratory failure with hypoxia Tachypnea, dyspnea, hypoxia presentation Placed on 2 L nasal cannula in ED. Currently on 2L NC, wean as tolerated CTA of chest without acute gross abnormalities. Likely multifactorial (hypoventilation syndrome, untreated OSA). Pulmonary consulted.  Breathing treatments as needed   Covid-19 Virus Infection Tested positive on arrival; no obvious infiltrates on imaging Continue dexamethasone for 10-day course as was on nasal cannula and hypoxic initially   Acute pancreatitis Periumbilical abdominal pain as well as nausea. No other red flags. Possibly trauma related CT scan of abdomen with mild free fluid in the right upper quadrant in the left pararenal space. Lipase elevated to 1,279 > currently trending down to 281 Evaluated by trauma team in ED. No concern for surgical issues. Holding IV fluids in setting of ESRD. Pain and nausea control as needed. RUQ US evaluation limited due to body habitus; no evidence of acute cholecystitis; Increased echogenicity and heterogeneous echotexture of the liver suggestive of hepatocellular disease and/or steatosis. LFTs stable, INR 1.1; TG 235, ANA negative GI consulted, continue supportive care Currently advanced to solids, tolerating diet Fall Right proximal humerus Fracture Patient sustained a fall off his motorized scooter Diagnosed with right humerus fracture, Currently on sling. Transferred to medical center to be evaluated by trauma team. No other acute traumatic issues and scans; trauma team signed off.  Orthopedics consulted for recommendations - non operative mgmt Patient follow-up in clinic or at medical center as an outpatient PT/OT consulted - recommended for SNF, however patient refusing SNF, preferring to go home with home health care. Counseled on risks of not following this recommendation with regard to re-admission, falls, clinical decline, and potential risk of life-threatening measures such as death. Patient voiced understanding Pain control as needed.   Hyperkalemia - resolved Potassium of 6.3 on presentation. In setting of ESRD. K currently stable Nephrology consulted   ESRD On hemodialysis 3 times a week. Nephrology consulted for inpatient hemodialysis Monitor renal function closely   Paroxysmal atrial fibrillation Rate controlled on admission. Restart home regimen (propafenone, and eliquis). Continue to monitor on telemetry   DM type II A1c 7.8 home dose of long-acting insulin (30 units twice daily). lantus to 30 units bid, continue SSI BG currently slightly above goal, continue to monitor and titrate   Hypothyroidism TSH level 4.52, FT4 0.8 resume dose levothyroxine   Thrombocytopenia, POA - resolved Platelets 114 on arrival, currently 157 OSA Per patient, not using CPAP anymore.   Morbid obesity Body mass index is 46.54 kg/m².
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Humerus fracture, Hyperkalaemia, Hypoventilation, Hypoxia
Clinical narrative: Patient is a 62 y.o. male patient of MD with history of ESRD, morbid obesity, DM type II, atrial fibrillation, hypothyroidism transferred to Medical Center for trauma evaluation.     Acute respiratory failure with hypoxia Tachypnea, dyspnea, hypoxia presentation Placed on 2 L nasal cannula in ED. Currently on 2L NC, wean as tolerated CTA of chest without acute gross abnormalities. Likely multifactorial (hypoventilation syndrome, untreated OSA). Pulmonary consulted.  Breathing treatments as needed   Covid-19 Virus Infection Tested positive on arrival; no obvious infiltrates on imaging Continue dexamethasone for 10-day course as was on nasal cannula and hypoxic initially   Acute pancreatitis Periumbilical abdominal pain as well as nausea. No other red flags. Possibly trauma related CT scan of abdomen with mild free fluid in the right upper quadrant in the left pararenal space. Lipase elevated to 1,279 > currently trending down to 281 Evaluated by trauma team in ED. No concern for surgical issues. Holding IV fluids in setting of ESRD. Pain and nausea control as needed. RUQ US evaluation limited due to body habitus; no evidence of acute cholecystitis; Increased echogenicity and heterogeneous echotexture of the liver suggestive of hepatocellular disease and/or steatosis. LFTs stable, INR 1.1; TG 235, ANA negative GI consulted, continue supportive care Currently advanced to solids, tolerating diet Fall Right proximal humerus Fracture Patient sustained a fall off his motorized scooter Diagnosed with right humerus fracture, Currently on sling. Transferred to medical center to be evaluated by trauma team. No other acute traumatic issues and scans; trauma team signed off.  Orthopedics consulted for recommendations - non operative mgmt Patient follow-up in clinic or at medical center as an outpatient PT/OT consulted - recommended for SNF, however patient refusing SNF, preferring to go home with home health care. Counseled on risks of not following this recommendation with regard to re-admission, falls, clinical decline, and potential risk of life-threatening measures such as death. Patient voiced understanding Pain control as needed.   Hyperkalemia - resolved Potassium of 6.3 on presentation. In setting of ESRD. K currently stable Nephrology consulted   ESRD On hemodialysis 3 times a week. Nephrology consulted for inpatient hemodialysis Monitor renal function closely   Paroxysmal atrial fibrillation Rate controlled on admission. Restart home regimen (propafenone, and eliquis). Continue to monitor on telemetry   DM type II A1c 7.8 home dose of long-acting insulin (30 units twice daily). lantus to 30 units bid, continue SSI BG currently slightly above goal, continue to monitor and titrate   Hypothyroidism TSH level 4.52, FT4 0.8 resume dose levothyroxine   Thrombocytopenia, POA - resolved Platelets 114 on arrival, currently 157 OSA Per patient, not using CPAP anymore.   Morbid obesity Body mass index is 46.54 kg/m².