chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Severe pain on one side of my body/ pain; Rash; sharp pain between my breasts; itching; face and especially one eye was affected; face and especially one eye was affected; This non-serious case was reported by a consumer and described the occurrence of hemialgia in a 89-month-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included bell's palsy (believed that many years ago had Bell's Palsey). Concurrent medical conditions included immunodeficiency (sensitive, probably had low immune too). Additional patient notes included no side effects from the first shot. Concomitant products included amlodipine, losartan, acetylsalicylic acid (Aspirin) and atorvastatin calcium (Atorvastin).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced hemialgia (Verbatim: Severe pain on one side of my body/ pain), rash (Verbatim: Rash), chest pain (Verbatim: sharp pain between my breasts), pruritus (Verbatim: itching), facial discomfort (Verbatim: face and especially one eye was affected) and eye discomfort (Verbatim: face and especially one eye was affected). The outcome of the hemialgia and chest pain were not resolved and the outcome of the rash, pruritus, facial discomfort and eye discomfort were not reported.   It was unknown if the reporter considered the hemialgia, rash, chest pain, pruritus, facial discomfort and eye discomfort to be related to Shingles vaccine.     It was unknown if the company considered the hemialgia, rash, chest pain, pruritus, facial discomfort and eye discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-JAN-2024 The reporter was a patient. Patient received the Shingles vaccine in 2024. Patient reported that after receiving the Shingles vaccine she experienced pain on her left side and it became severe. Patient had no side effects from the first shot. Patient reported that she had all the symptoms except blisters. Patient had pain and rash after the Shingles vaccine. Patient reported that last several months from reporting day she was experiencing sharp pain between her breasts and some itching but nothing else visible. Patient was told by her physician that it was nothing and she believed that. Many years ago, patient had bell's palsy, diagnosed by physicians. Patient was exposed to children playing. Patient face and especially one eye was affected, that lasted a long time. Patient was sensitive and probably had low immune too, patient did consider herself very healthy. The pain around her left side was on going, she was no longer fatigued, but there was that sharp pain between her breasts. Patient were no treated the symptoms. The reporter consented to follow-up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Appendicitis, Spinal disorder, Thrombosis
Clinical narrative: BLOOD CLOTS; APPENDICITIS; SPINE ON FLUID; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) on 29-JAN-2024 was received on 29-JAN-2024 and concerned multiple patients. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect vaccine included: tozinameran ( form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis.  No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots, spine on fluid, and appendicitis (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the blood clots, spine on fluid and appendicitis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Thrombosis, Appendicitis. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy appeared two weeks after the injection and recur roughly 3 times per week since then; hives appeared two weeks after the injection and recur roughly 3 times per week since then; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchy appeared two weeks after the injection and recur roughly 3 times per week since then) and URTICARIA (hives appeared two weeks after the injection and recur roughly 3 times per week since then) in a 43-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058581) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. In November 2023, the patient experienced PRURITUS (Itchy appeared two weeks after the injection and recur roughly 3 times per week since then) and URTICARIA (hives appeared two weeks after the injection and recur roughly 3 times per week since then). At the time of the report, PRURITUS (Itchy appeared two weeks after the injection and recur roughly 3 times per week since then) and URTICARIA (hives appeared two weeks after the injection and recur roughly 3 times per week since then) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medication was reported.  Patient experienced Itchy hives appeared two weeks after the injection and recur roughly 3 times per week since then. It was unknown if the patient experienced any additional symptoms/events.   No treatment information was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This is the first time the Moderna vaccine was administered to me. All prior doses were Pfizer Covid Vaccine,  These symptoms were not experienced with prior Pfizer doses.  Following the injections,  I had chills and slight fever for a period during the 24 hours post injection. In addition, at the vaccine administration site, I had  severe redness and swelling with heat which was followed by a large bruise with redness that remained for several days.  But the more concerning event is that about 12 hours after dose administration, I awoke with pain and swelling  on the left foot near and beneath my middle toe.  By morning, I had severe bruising and  tenderness on toes and both top and bottom of foot.  I continue to have pain on the bottom of the foot while walking but bruising has subsided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tenderness, Vaccination site bruising, Vaccination site erythema, Vaccination site swelling
Clinical narrative: This is the first time the Moderna vaccine was administered to me. All prior doses were Pfizer Covid Vaccine,  These symptoms were not experienced with prior Pfizer doses.  Following the injections,  I had chills and slight fever for a period during the 24 hours post injection. In addition, at the vaccine administration site, I had  severe redness and swelling with heat which was followed by a large bruise with redness that remained for several days.  But the more concerning event is that about 12 hours after dose administration, I awoke with pain and swelling  on the left foot near and beneath my middle toe.  By morning, I had severe bruising and  tenderness on toes and both top and bottom of foot.  I continue to have pain on the bottom of the foot while walking but bruising has subsided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: This is the first time the Moderna vaccine was administered to me. All prior doses were Pfizer Covid Vaccine,  These symptoms were not experienced with prior Pfizer doses.  Following the injections,  I had chills and slight fever for a period during the 24 hours post injection. In addition, at the vaccine administration site, I had  severe redness and swelling with heat which was followed by a large bruise with redness that remained for several days.  But the more concerning event is that about 12 hours after dose administration, I awoke with pain and swelling  on the left foot near and beneath my middle toe.  By morning, I had severe bruising and  tenderness on toes and both top and bottom of foot.  I continue to have pain on the bottom of the foot while walking but bruising has subsided.
Age: 1.0
Sex: F
Vaccine: MMR, PNC20, VARCEL
Symptoms: Immunisation reaction, Injection site urticaria, Urticaria, Viral infection
Clinical narrative: Mom took patient to the ER the night of 2/1 as patient started with a large hive on her left thigh (covering most of the front and back of her left thigh). No respiratory symptoms, no fevers. Per mom, by the time they got to the ER, the hive was gone, so they did not proceed with ER visit. The next day, 2/2, mom states pt started with a large hive on her right elbow, then multiple hives on her body and mom took pt back to ER for evaluation. Per the ER physician note, it states: "Patient had notable urticaria over her bilateral lower extremities and buttocks in various stages of  resolution. She had stable vital signs and no signs or symptoms concerning for anaphylaxis. She had recently been administered her 12 month vaccinations. Her presentation was most consistent with viral versus vaccine induced urticaria. Father was counseled on her condition and given instructions for supportive care with cetirizine/diphenhydramine. They were instructed to follow-up with her pediatrician should her urticaria persist beyond 1 to 2 weeks. They were given return precautions and patient was ultimately deemed medically stable for discharge home."
Age: 61.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: ADAMTS13 activity increased, Acute kidney injury, Anti-platelet factor 4 antibody negative, Blood culture positive, Blood glucose increased
Clinical narrative: 61 y/o female with a PMH of lupus, poorly controlled DM type II, and HTN referred for consultation on future immunization recommendations following de-Neuvo Immune Thrombotic Thrombocytopenia (iTTP) diagnosis in temporal association to the administration of Influenza  and 5th dose of Spikevax/Moderna 2023-2024 COVID-19 vaccine (lot number 3030701). The preceding COVID-19 immunizations were all Moderna brand (3/24/21, 4/21/21, 12/1/21, and 11/9/22).  She denies having any prior adverse events following immunizations. NKDA. She reported having mild cold symptoms on the day of vaccine receipt (no fever). She woke the following morning (approximately 16 hours after vaccine receipt) with nausea, orange/dark brown colored emesis, red/orange diarrhea, mild chest pain and SOB. No known fever. The initial workup in the ED that morning (09 November, approximately 1030) revealed thrombocytopenia (plt count 15,000>12,000), AKI, hyponatremia, hyperglycemia (BS>500), elevated troponin as well as schistocytes on peripheral smear. She was admitted to the ICU with presumptive TTP, meeting 7/7 on the PLASMIC score for TTP. She was treated with therapeutic plasma exchange (11/9-11/14), daily caplacizumab (11 mg SQ), and methylprednisone 1 mg/kg PO daily. Peripheral blood cultures obtained on admission were positive for Staphylococcus capitis (initially assumed contaminant). Repeat blood cultures via CVP line were also positive, and she completed 5 days of IV vancomycin (11/12-11/16). Post vancomycin blood cultures were negative. Immune mediated TTP was subsequently confirmed by labs obtained prior to treatment showing reduced ADAMTS13 activity (2.8%) with an elevated ADAMTS13 antibody titer (18 u/mL). The anti-platelet Factor 4 antibody ELISA/SRA essay was negative (positive PF4 antibodies are associated with Vaccine-induced Immune Thrombotic thrombocytopenia (VITT)/COVID-19 adeno-virus vector vaccines). Hepatitis A/B/C and HIV testing were negative. Respiratory panel PCR (to include SARS-CoV-2, RSV and Influenza A/B) was negative. Renal ultrasound, head CT and CXR were normal. She received Rituximab 375 mg/m2 infusion therapy weekly x 4 (11/15-12/6).  She responded well to treatment and was discharged on 27 November 2023 to continue daily outpatient Caplacizumab infusions; however, she was readmitted on 28 November due to logistical challenges. This admission was complicated by a mild COVID infection, testing positive on 07 December 2023 (husband tested positive 02 December). She was treated with Paxlovid and was ultimately discharged home on 14 December. She continues with close specialty follow up. Today, aside from some lingering fatigue she is feeling well overall.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Blood smear test abnormal, COVID-19, Chest X-ray normal, Chest pain, Computerised tomogram head normal
Clinical narrative: 61 y/o female with a PMH of lupus, poorly controlled DM type II, and HTN referred for consultation on future immunization recommendations following de-Neuvo Immune Thrombotic Thrombocytopenia (iTTP) diagnosis in temporal association to the administration of Influenza  and 5th dose of Spikevax/Moderna 2023-2024 COVID-19 vaccine (lot number 3030701). The preceding COVID-19 immunizations were all Moderna brand (3/24/21, 4/21/21, 12/1/21, and 11/9/22).  She denies having any prior adverse events following immunizations. NKDA. She reported having mild cold symptoms on the day of vaccine receipt (no fever). She woke the following morning (approximately 16 hours after vaccine receipt) with nausea, orange/dark brown colored emesis, red/orange diarrhea, mild chest pain and SOB. No known fever. The initial workup in the ED that morning (09 November, approximately 1030) revealed thrombocytopenia (plt count 15,000>12,000), AKI, hyponatremia, hyperglycemia (BS>500), elevated troponin as well as schistocytes on peripheral smear. She was admitted to the ICU with presumptive TTP, meeting 7/7 on the PLASMIC score for TTP. She was treated with therapeutic plasma exchange (11/9-11/14), daily caplacizumab (11 mg SQ), and methylprednisone 1 mg/kg PO daily. Peripheral blood cultures obtained on admission were positive for Staphylococcus capitis (initially assumed contaminant). Repeat blood cultures via CVP line were also positive, and she completed 5 days of IV vancomycin (11/12-11/16). Post vancomycin blood cultures were negative. Immune mediated TTP was subsequently confirmed by labs obtained prior to treatment showing reduced ADAMTS13 activity (2.8%) with an elevated ADAMTS13 antibody titer (18 u/mL). The anti-platelet Factor 4 antibody ELISA/SRA essay was negative (positive PF4 antibodies are associated with Vaccine-induced Immune Thrombotic thrombocytopenia (VITT)/COVID-19 adeno-virus vector vaccines). Hepatitis A/B/C and HIV testing were negative. Respiratory panel PCR (to include SARS-CoV-2, RSV and Influenza A/B) was negative. Renal ultrasound, head CT and CXR were normal. She received Rituximab 375 mg/m2 infusion therapy weekly x 4 (11/15-12/6).  She responded well to treatment and was discharged on 27 November 2023 to continue daily outpatient Caplacizumab infusions; however, she was readmitted on 28 November due to logistical challenges. This admission was complicated by a mild COVID infection, testing positive on 07 December 2023 (husband tested positive 02 December). She was treated with Paxlovid and was ultimately discharged home on 14 December. She continues with close specialty follow up. Today, aside from some lingering fatigue she is feeling well overall.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Diarrhoea, Dyspnoea, Faeces discoloured, Fatigue, HIV test negative
Clinical narrative: 61 y/o female with a PMH of lupus, poorly controlled DM type II, and HTN referred for consultation on future immunization recommendations following de-Neuvo Immune Thrombotic Thrombocytopenia (iTTP) diagnosis in temporal association to the administration of Influenza  and 5th dose of Spikevax/Moderna 2023-2024 COVID-19 vaccine (lot number 3030701). The preceding COVID-19 immunizations were all Moderna brand (3/24/21, 4/21/21, 12/1/21, and 11/9/22).  She denies having any prior adverse events following immunizations. NKDA. She reported having mild cold symptoms on the day of vaccine receipt (no fever). She woke the following morning (approximately 16 hours after vaccine receipt) with nausea, orange/dark brown colored emesis, red/orange diarrhea, mild chest pain and SOB. No known fever. The initial workup in the ED that morning (09 November, approximately 1030) revealed thrombocytopenia (plt count 15,000>12,000), AKI, hyponatremia, hyperglycemia (BS>500), elevated troponin as well as schistocytes on peripheral smear. She was admitted to the ICU with presumptive TTP, meeting 7/7 on the PLASMIC score for TTP. She was treated with therapeutic plasma exchange (11/9-11/14), daily caplacizumab (11 mg SQ), and methylprednisone 1 mg/kg PO daily. Peripheral blood cultures obtained on admission were positive for Staphylococcus capitis (initially assumed contaminant). Repeat blood cultures via CVP line were also positive, and she completed 5 days of IV vancomycin (11/12-11/16). Post vancomycin blood cultures were negative. Immune mediated TTP was subsequently confirmed by labs obtained prior to treatment showing reduced ADAMTS13 activity (2.8%) with an elevated ADAMTS13 antibody titer (18 u/mL). The anti-platelet Factor 4 antibody ELISA/SRA essay was negative (positive PF4 antibodies are associated with Vaccine-induced Immune Thrombotic thrombocytopenia (VITT)/COVID-19 adeno-virus vector vaccines). Hepatitis A/B/C and HIV testing were negative. Respiratory panel PCR (to include SARS-CoV-2, RSV and Influenza A/B) was negative. Renal ultrasound, head CT and CXR were normal. She received Rituximab 375 mg/m2 infusion therapy weekly x 4 (11/15-12/6).  She responded well to treatment and was discharged on 27 November 2023 to continue daily outpatient Caplacizumab infusions; however, she was readmitted on 28 November due to logistical challenges. This admission was complicated by a mild COVID infection, testing positive on 07 December 2023 (husband tested positive 02 December). She was treated with Paxlovid and was ultimately discharged home on 14 December. She continues with close specialty follow up. Today, aside from some lingering fatigue she is feeling well overall.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Hepatitis A virus test, Hepatitis B test negative, Hepatitis C virus test, Hyperglycaemia, Hyponatraemia
Clinical narrative: 61 y/o female with a PMH of lupus, poorly controlled DM type II, and HTN referred for consultation on future immunization recommendations following de-Neuvo Immune Thrombotic Thrombocytopenia (iTTP) diagnosis in temporal association to the administration of Influenza  and 5th dose of Spikevax/Moderna 2023-2024 COVID-19 vaccine (lot number 3030701). The preceding COVID-19 immunizations were all Moderna brand (3/24/21, 4/21/21, 12/1/21, and 11/9/22).  She denies having any prior adverse events following immunizations. NKDA. She reported having mild cold symptoms on the day of vaccine receipt (no fever). She woke the following morning (approximately 16 hours after vaccine receipt) with nausea, orange/dark brown colored emesis, red/orange diarrhea, mild chest pain and SOB. No known fever. The initial workup in the ED that morning (09 November, approximately 1030) revealed thrombocytopenia (plt count 15,000>12,000), AKI, hyponatremia, hyperglycemia (BS>500), elevated troponin as well as schistocytes on peripheral smear. She was admitted to the ICU with presumptive TTP, meeting 7/7 on the PLASMIC score for TTP. She was treated with therapeutic plasma exchange (11/9-11/14), daily caplacizumab (11 mg SQ), and methylprednisone 1 mg/kg PO daily. Peripheral blood cultures obtained on admission were positive for Staphylococcus capitis (initially assumed contaminant). Repeat blood cultures via CVP line were also positive, and she completed 5 days of IV vancomycin (11/12-11/16). Post vancomycin blood cultures were negative. Immune mediated TTP was subsequently confirmed by labs obtained prior to treatment showing reduced ADAMTS13 activity (2.8%) with an elevated ADAMTS13 antibody titer (18 u/mL). The anti-platelet Factor 4 antibody ELISA/SRA essay was negative (positive PF4 antibodies are associated with Vaccine-induced Immune Thrombotic thrombocytopenia (VITT)/COVID-19 adeno-virus vector vaccines). Hepatitis A/B/C and HIV testing were negative. Respiratory panel PCR (to include SARS-CoV-2, RSV and Influenza A/B) was negative. Renal ultrasound, head CT and CXR were normal. She received Rituximab 375 mg/m2 infusion therapy weekly x 4 (11/15-12/6).  She responded well to treatment and was discharged on 27 November 2023 to continue daily outpatient Caplacizumab infusions; however, she was readmitted on 28 November due to logistical challenges. This admission was complicated by a mild COVID infection, testing positive on 07 December 2023 (husband tested positive 02 December). She was treated with Paxlovid and was ultimately discharged home on 14 December. She continues with close specialty follow up. Today, aside from some lingering fatigue she is feeling well overall.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Influenza A virus test negative, Influenza B virus test, Intensive care, Nasopharyngitis, Nausea
Clinical narrative: 61 y/o female with a PMH of lupus, poorly controlled DM type II, and HTN referred for consultation on future immunization recommendations following de-Neuvo Immune Thrombotic Thrombocytopenia (iTTP) diagnosis in temporal association to the administration of Influenza  and 5th dose of Spikevax/Moderna 2023-2024 COVID-19 vaccine (lot number 3030701). The preceding COVID-19 immunizations were all Moderna brand (3/24/21, 4/21/21, 12/1/21, and 11/9/22).  She denies having any prior adverse events following immunizations. NKDA. She reported having mild cold symptoms on the day of vaccine receipt (no fever). She woke the following morning (approximately 16 hours after vaccine receipt) with nausea, orange/dark brown colored emesis, red/orange diarrhea, mild chest pain and SOB. No known fever. The initial workup in the ED that morning (09 November, approximately 1030) revealed thrombocytopenia (plt count 15,000>12,000), AKI, hyponatremia, hyperglycemia (BS>500), elevated troponin as well as schistocytes on peripheral smear. She was admitted to the ICU with presumptive TTP, meeting 7/7 on the PLASMIC score for TTP. She was treated with therapeutic plasma exchange (11/9-11/14), daily caplacizumab (11 mg SQ), and methylprednisone 1 mg/kg PO daily. Peripheral blood cultures obtained on admission were positive for Staphylococcus capitis (initially assumed contaminant). Repeat blood cultures via CVP line were also positive, and she completed 5 days of IV vancomycin (11/12-11/16). Post vancomycin blood cultures were negative. Immune mediated TTP was subsequently confirmed by labs obtained prior to treatment showing reduced ADAMTS13 activity (2.8%) with an elevated ADAMTS13 antibody titer (18 u/mL). The anti-platelet Factor 4 antibody ELISA/SRA essay was negative (positive PF4 antibodies are associated with Vaccine-induced Immune Thrombotic thrombocytopenia (VITT)/COVID-19 adeno-virus vector vaccines). Hepatitis A/B/C and HIV testing were negative. Respiratory panel PCR (to include SARS-CoV-2, RSV and Influenza A/B) was negative. Renal ultrasound, head CT and CXR were normal. She received Rituximab 375 mg/m2 infusion therapy weekly x 4 (11/15-12/6).  She responded well to treatment and was discharged on 27 November 2023 to continue daily outpatient Caplacizumab infusions; however, she was readmitted on 28 November due to logistical challenges. This admission was complicated by a mild COVID infection, testing positive on 07 December 2023 (husband tested positive 02 December). She was treated with Paxlovid and was ultimately discharged home on 14 December. She continues with close specialty follow up. Today, aside from some lingering fatigue she is feeling well overall.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Plasmapheresis, Platelet count decreased, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: 61 y/o female with a PMH of lupus, poorly controlled DM type II, and HTN referred for consultation on future immunization recommendations following de-Neuvo Immune Thrombotic Thrombocytopenia (iTTP) diagnosis in temporal association to the administration of Influenza  and 5th dose of Spikevax/Moderna 2023-2024 COVID-19 vaccine (lot number 3030701). The preceding COVID-19 immunizations were all Moderna brand (3/24/21, 4/21/21, 12/1/21, and 11/9/22).  She denies having any prior adverse events following immunizations. NKDA. She reported having mild cold symptoms on the day of vaccine receipt (no fever). She woke the following morning (approximately 16 hours after vaccine receipt) with nausea, orange/dark brown colored emesis, red/orange diarrhea, mild chest pain and SOB. No known fever. The initial workup in the ED that morning (09 November, approximately 1030) revealed thrombocytopenia (plt count 15,000>12,000), AKI, hyponatremia, hyperglycemia (BS>500), elevated troponin as well as schistocytes on peripheral smear. She was admitted to the ICU with presumptive TTP, meeting 7/7 on the PLASMIC score for TTP. She was treated with therapeutic plasma exchange (11/9-11/14), daily caplacizumab (11 mg SQ), and methylprednisone 1 mg/kg PO daily. Peripheral blood cultures obtained on admission were positive for Staphylococcus capitis (initially assumed contaminant). Repeat blood cultures via CVP line were also positive, and she completed 5 days of IV vancomycin (11/12-11/16). Post vancomycin blood cultures were negative. Immune mediated TTP was subsequently confirmed by labs obtained prior to treatment showing reduced ADAMTS13 activity (2.8%) with an elevated ADAMTS13 antibody titer (18 u/mL). The anti-platelet Factor 4 antibody ELISA/SRA essay was negative (positive PF4 antibodies are associated with Vaccine-induced Immune Thrombotic thrombocytopenia (VITT)/COVID-19 adeno-virus vector vaccines). Hepatitis A/B/C and HIV testing were negative. Respiratory panel PCR (to include SARS-CoV-2, RSV and Influenza A/B) was negative. Renal ultrasound, head CT and CXR were normal. She received Rituximab 375 mg/m2 infusion therapy weekly x 4 (11/15-12/6).  She responded well to treatment and was discharged on 27 November 2023 to continue daily outpatient Caplacizumab infusions; however, she was readmitted on 28 November due to logistical challenges. This admission was complicated by a mild COVID infection, testing positive on 07 December 2023 (husband tested positive 02 December). She was treated with Paxlovid and was ultimately discharged home on 14 December. She continues with close specialty follow up. Today, aside from some lingering fatigue she is feeling well overall.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Staphylococcal infection, Thrombosis with thrombocytopenia syndrome, Troponin increased, Ultrasound kidney normal, Vomiting
Clinical narrative: 61 y/o female with a PMH of lupus, poorly controlled DM type II, and HTN referred for consultation on future immunization recommendations following de-Neuvo Immune Thrombotic Thrombocytopenia (iTTP) diagnosis in temporal association to the administration of Influenza  and 5th dose of Spikevax/Moderna 2023-2024 COVID-19 vaccine (lot number 3030701). The preceding COVID-19 immunizations were all Moderna brand (3/24/21, 4/21/21, 12/1/21, and 11/9/22).  She denies having any prior adverse events following immunizations. NKDA. She reported having mild cold symptoms on the day of vaccine receipt (no fever). She woke the following morning (approximately 16 hours after vaccine receipt) with nausea, orange/dark brown colored emesis, red/orange diarrhea, mild chest pain and SOB. No known fever. The initial workup in the ED that morning (09 November, approximately 1030) revealed thrombocytopenia (plt count 15,000>12,000), AKI, hyponatremia, hyperglycemia (BS>500), elevated troponin as well as schistocytes on peripheral smear. She was admitted to the ICU with presumptive TTP, meeting 7/7 on the PLASMIC score for TTP. She was treated with therapeutic plasma exchange (11/9-11/14), daily caplacizumab (11 mg SQ), and methylprednisone 1 mg/kg PO daily. Peripheral blood cultures obtained on admission were positive for Staphylococcus capitis (initially assumed contaminant). Repeat blood cultures via CVP line were also positive, and she completed 5 days of IV vancomycin (11/12-11/16). Post vancomycin blood cultures were negative. Immune mediated TTP was subsequently confirmed by labs obtained prior to treatment showing reduced ADAMTS13 activity (2.8%) with an elevated ADAMTS13 antibody titer (18 u/mL). The anti-platelet Factor 4 antibody ELISA/SRA essay was negative (positive PF4 antibodies are associated with Vaccine-induced Immune Thrombotic thrombocytopenia (VITT)/COVID-19 adeno-virus vector vaccines). Hepatitis A/B/C and HIV testing were negative. Respiratory panel PCR (to include SARS-CoV-2, RSV and Influenza A/B) was negative. Renal ultrasound, head CT and CXR were normal. She received Rituximab 375 mg/m2 infusion therapy weekly x 4 (11/15-12/6).  She responded well to treatment and was discharged on 27 November 2023 to continue daily outpatient Caplacizumab infusions; however, she was readmitted on 28 November due to logistical challenges. This admission was complicated by a mild COVID infection, testing positive on 07 December 2023 (husband tested positive 02 December). She was treated with Paxlovid and was ultimately discharged home on 14 December. She continues with close specialty follow up. Today, aside from some lingering fatigue she is feeling well overall.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness around injection site with pain and itching, warm to touch.  Patient going to local urgent care.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Incorrect vaccine combination was given for patient's age.  Kinrix (DTaP/IPV) combination vaccine was given to 4 month old INSTEAD of Pediarix (DTaP/HepB/IPV) combination vaccine.  Kinrix is not approved for use in children under 4 years old.   This error was noted to physician at the time of incident (according to documentation in following well child visit on 9/8/23) and physician consulted with Immunology at that time to verify if any harm was to come to patient.  Immunology advised that no harm will come to patient from this error and (per physician documentation) no adverse reactions were ever reported by mother.
Age: 31.0
Sex: M
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Arthralgia
Clinical narrative: Patient complained of stiffness and pain in the right and left shoulder areas. Recommended over-the counter remedies , ibuprofen, acetaminophen. If persists then he can seek professional attention.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Body temperature increased, Chills, Feeling abnormal, Thirst
Clinical narrative: She got her vaccine, was fine and after 12 hours she started feeling unbelievable chills that she had never felt in her life.  She could not get warm, could not get enough to drink, and when she woke u in the middle of the night she was completely parched.  At 3:00 AM her temp was 100.6, but she is normally around 97 or 98.  She just feels strange.  She is not having any trouble breathing, no rash or anything like that, just the chills and the parched feeling she is having.  She called her doctors office and he is not in the office today, and the service said that somebody would call her.  Someone did call her, one of the nurses in the office called and she was told to call the pharmacy where she had the shot and tell them about this.  If she felt that she needed to see somebody to go to an UC as they do not have a doctor in today.   The chills have resolved, but she does not know if she still has a fever or not.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Tongue blistering
Clinical narrative: Severe joint pain, blisters over tongue
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: There were two unused vials of the Shingrix vaccine powder vaccine but the diluent is gone.  Meaning, it appears someone administered diluent only and did not mix and give the vaccine.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Blood pressure decreased, Dizziness, Nausea
Clinical narrative: Patient had received Flu vaccine and gardasil 9 vaccine, and later experienced dizziness, nausea, and Bp as low as 98/59 per RN progress note.  "This RN responded to mother yelling for nurse, RN went into room with mother holding child and trying to put him onto the bed. Mother states child did not hit his head but she grabbed him after child stated he was dizzy and felt like he was going to throw up. 0951- BP: 110/66, HR: 52 Dr.  in room and aware of situation 0955- HR:61, O2: 96 Child eating food and drinking some water 0957- HR: 67, O2: 99 1000- BP: 98/59, HR: 60 RN left mother and child in the room for child to continue to eat and advised RN would be back in a few minutes to check on child. 1008- BP: 104/64, HR: 64, O2: 98 At this time child stated he felt fine and was no longer dizzy or nauseous. Mother stated she felt comfortable taking child home/ to school. Advised mother child's vital were WDL and child is fine to resume normal activities today. Mother verbalizes understanding and has no further questions or concerns. "
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Diarrhoea, Gastritis, Headache, Injection site pain
Clinical narrative: Sore arm at injection site, overall achyness, nausea, diarrhea, stomach pain.  These symptoms prevailed for about 3 days.  Afterwards,  intermittent stomach pain, nausea, loose stool, and headache have been ongoing to date (2/9/24). Saw doctor who prescribed a US and Pantoprazole.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Pain
Clinical narrative: Sore arm at injection site, overall achyness, nausea, diarrhea, stomach pain.  These symptoms prevailed for about 3 days.  Afterwards,  intermittent stomach pain, nausea, loose stool, and headache have been ongoing to date (2/9/24). Saw doctor who prescribed a US and Pantoprazole.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Cough, Headache, SARS-CoV-2 test
Clinical narrative: Dry cough, headache
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Euphoric mood, Presyncope, Syncope
Clinical narrative: Patient fainted during blood draw approximately 15 minutes after administration. Fainted again approximately 10 minutes later. Patient continued to fee "out of it" and lightheaded and close to passing out for at least one hour after initial LOC. Taken to ED to be monitored. They diagnosed as a vasovagal response to the venipuncture.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: no adverse reactions noted
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Influenza like illness, Myalgia, Nausea
Clinical narrative: Flu like symptoms. Nausea, headache, congestion, sore muscles and joints. Fever of 101°.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Flu like symptoms. Nausea, headache, congestion, sore muscles and joints. Fever of 101°.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: After investigating it appears 1 of the 5 patients received dilutant only.  As there were 2 vials of the Shingrix Powder without dilutant to mix them. We are contacting all 5 patients to readminister.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: no adverse reactions
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Product preparation issue
Clinical narrative: during the recent quality control check we discovered that          dose of shingles vaccine could have been diluent only and we were to call the patients in question she stated she felt really bad that evening and next day was sure she received the correct vaccine and declined to have this repeated
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 2.0
Sex: F
Vaccine: JEV1, MMR, TYP
Symptoms: COVID-19, Febrile convulsion, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Child received vaccinations on 1.31.2024 at 10:13 am.  Child developed fever and had a febrile seizure on 2.5.2024 at 10:34 pm.  The family called EMS and child was taken by squad to the Hospital Emergency Department where she was treated.  During the ED visit, child tested positive for COVID.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Right arm red from shoulder to elbow on front and outerside of arm, warm to the touch
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Men B was given to this 11 year old patient without any record or documentation that there is any high risk problem that the patient has that would support the patient receiving before the age of 16
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix (DTaP+IPV) were ordered and administered to a patient over the age of 7
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vaccination site cellulitis
Clinical narrative: Patient developed cellulites on both vaccine sites
Age: 0.42
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no symptoms
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test negative, Blood test, Diabetic ketoacidosis, Intensive care, Malaise
Clinical narrative: Approximately 10 to 14 days after second Pfizer covid vaccination started to feel unwell. 19 days after vaccination was admitted to ICU for acute diabetic ketoacidosis and am now type 1 insulin dependent diabetic. I have no familial history of type 1 diabetes, and when tested by my endocrinologist had no auto antibodies. I had no symptoms of diabetes prior to my vaccination and no health problems.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Approximately 10 to 14 days after second Pfizer covid vaccination started to feel unwell. 19 days after vaccination was admitted to ICU for acute diabetic ketoacidosis and am now type 1 insulin dependent diabetic. I have no familial history of type 1 diabetes, and when tested by my endocrinologist had no auto antibodies. I had no symptoms of diabetes prior to my vaccination and no health problems.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC15
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Bilateral leg swelling. Large local site reaction
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis
Clinical narrative: Random areas of dermatitis mostly on back but occasionally on extremities. Back has condition to some degree almost 100% of the time.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Moderna vaccine for ages 6 months to 11 years of age given to adult patient.  Entire vial of 0.50 ml given in one dose.  Pt. had 3 doses of Pfizer in 2021.  Patient, Nurse Manager, and Immunization Coordinator informed of error.  Awaiting guidance as to whether dose needs to be repeated or other direction.  Moved vaccine in freezer and more labeling applied to vaccines.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Syncope resulting in hitting head while falling
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: No adverse effects
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Product preparation issue, Pyrexia
Clinical narrative: During recent quality control check patients may have only received the diluent advised to call patients in question offer them a repeat shingles patient stated she had really bad reaction fever 102, chills all night long doesn't want to repeat is very sure she received the correct dosing
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Cough, General symptom, SARS-CoV-2 test
Clinical narrative: Cough, upper respiratory infection symptoms
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Patient experienced redness in area with significant bruising.  Symptoms lasted for 12 days
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: No adverse effects
Age: 6.0
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pediarix  was ordered, but Vaxelis was inadvertently given; no adverse effects or issues; error discussed with parent
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, FLU4, PNC15, RV1, UNK, UNK
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Client was administered 2 doses of Beyfortus 50mg doses, as client was at a weight range for 100mg, but we only had 50mg individual dose in stock. No adverse reactions or symptoms reported by administering nurse, or parent.
Age: 11.0
Sex: M
Vaccine: FLU4, HEP, HPV9, TDAP, VARCEL
Symptoms: Wrong patient received product
Clinical narrative: Administered vaccines intended for a different patient.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Product expiration was 1/28/24 which was missed when administering vaccine. Patient was administered expired vaccine. Patient stated no adverse events. Vaccine was administered 2/8/24 and error discovered 2/9/24.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicectomy, Appendicitis, COVID-19, Computerised tomogram head abnormal, Craniocerebral injury
Clinical narrative: Admit date: 1/17/2024  Discharge date: 1/26/2024  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician:  DO  Reason for Admission: Acute appendicitis  Brief Summary of Hospital Stay: This is a 67 year old woman with MS who was originally admitted to Facility on 1/17/24 with appendicitis and COVID.  She underwent laparoscopic appendectomy on 1/17 with Dr. for non-perforated appendicitis.  Her postoperative course was complicated by a ground level fall during her admission, resulting in the following injuries below.  She was subsequently transferred to facility  for neurosurgery consultation.  Injuries included: 1. Traumatic brain injury, post-concussion syndrome 2. Nondisplaced fracture of the left occipital bone 3. Acute subarachnoid hemorrhage, stable on repeat CT, no neurological deficit  4. Acute subdural hematoma, stable on repeat CT, no neurological deficit   She was evaluated by the neurosurgical team.  Her repeat head CTs remained stable. Please see their progress notes for full details. She remained stable from a surgical standpoint, and will be discharged to facility today for ongoing recovery.  Discharged to Rehab Facility.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Laparoscopic surgery, Post concussion syndrome, Skull fractured base, Subarachnoid haemorrhage
Clinical narrative: Admit date: 1/17/2024  Discharge date: 1/26/2024  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician:  DO  Reason for Admission: Acute appendicitis  Brief Summary of Hospital Stay: This is a 67 year old woman with MS who was originally admitted to Facility on 1/17/24 with appendicitis and COVID.  She underwent laparoscopic appendectomy on 1/17 with Dr. for non-perforated appendicitis.  Her postoperative course was complicated by a ground level fall during her admission, resulting in the following injuries below.  She was subsequently transferred to facility  for neurosurgery consultation.  Injuries included: 1. Traumatic brain injury, post-concussion syndrome 2. Nondisplaced fracture of the left occipital bone 3. Acute subarachnoid hemorrhage, stable on repeat CT, no neurological deficit  4. Acute subdural hematoma, stable on repeat CT, no neurological deficit   She was evaluated by the neurosurgical team.  Her repeat head CTs remained stable. Please see their progress notes for full details. She remained stable from a surgical standpoint, and will be discharged to facility today for ongoing recovery.  Discharged to Rehab Facility.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiogram pulmonary abnormal, Blood potassium decreased, COVID-19, Cough, Dyspnoea
Clinical narrative: Admit date: 1/26/2024  Discharge date: 01/28/2024  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD Reason for Admission: hypoxia, dyspnea 2/2 COVID and multifocal pneumonia  Brief Summary of Hospital Stay: 59 YO female with h/o chronic pain, chronic obstructive pulmonary disease, bipolar 2 disorder, borderline personality disorder, depression with anxiety, GERD, OSA, and glaucoma who presents with dry rattly cough and shortness of breath for over 2 weeks. In the ED she was febrile, mildly tachycardic, and mildly tachypneic.  Upon arrival, SpO2 was 83% on room air which improved with oxygen via 4 L nasal cannula. Initial labs were notable for leukocytosis (16.2), elevated D-dimer (1010), potassium 3.4, and CT pulmonary CTA showed no PE but multifocal bilateral pneumonia. She received one bolus of NS and was started on Rocephin  and  Doxycycline there, which was continued by hospitalist team, who admitted for acute hypoxic respiratory insufficiency related to multifocal pneumonia and COVID. She also received antitussives, DuoNEb inhalations and was started on Remdesivir once admitted. The patient's clinical condition improved rapidly and she was discharged without the need of oxygen on the second day of admission. She was evaluated by PT who recommended disposition to be home with home therapy or with assist. Discharged to Home.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fibrin D dimer increased, Hypoxia, Leukocytosis, Pneumonia, Pyrexia
Clinical narrative: Admit date: 1/26/2024  Discharge date: 01/28/2024  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD Reason for Admission: hypoxia, dyspnea 2/2 COVID and multifocal pneumonia  Brief Summary of Hospital Stay: 59 YO female with h/o chronic pain, chronic obstructive pulmonary disease, bipolar 2 disorder, borderline personality disorder, depression with anxiety, GERD, OSA, and glaucoma who presents with dry rattly cough and shortness of breath for over 2 weeks. In the ED she was febrile, mildly tachycardic, and mildly tachypneic.  Upon arrival, SpO2 was 83% on room air which improved with oxygen via 4 L nasal cannula. Initial labs were notable for leukocytosis (16.2), elevated D-dimer (1010), potassium 3.4, and CT pulmonary CTA showed no PE but multifocal bilateral pneumonia. She received one bolus of NS and was started on Rocephin  and  Doxycycline there, which was continued by hospitalist team, who admitted for acute hypoxic respiratory insufficiency related to multifocal pneumonia and COVID. She also received antitussives, DuoNEb inhalations and was started on Remdesivir once admitted. The patient's clinical condition improved rapidly and she was discharged without the need of oxygen on the second day of admission. She was evaluated by PT who recommended disposition to be home with home therapy or with assist. Discharged to Home.