chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error
Clinical narrative: patient received expired dose of PENTACEL vaccine, with no reported adverse event; Initial information received on 14-Jun-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age male patient who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 07-Jun-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ319AAA and expiry date: 04-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that Office manager states that a patient received PENTACEL 3 days after it had been expired, is it still viable. Does the patient need to get another shot. Caller states that a pentacel was given in the left arm intramuscularly on 07-jun-2021 that expired 04-jun-2021. Caller states that she does not feel comfortable giving any other information and declined to provide additional information.   At the time of report, no adverse event was reported.  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: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received second dose of IMOVAX RABIES on day 02 instead of 03/ NO AE; Initial information received on 14-Jun-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who received second dose RABIES (HDC) VACCINE [IMOVAX RABIES] (batch number and expiry date not reported) instead third day (inappropriate schedule of product administration) on 09-Jun-2021 for post exposure immunization.  The patient's past medical history included animal bite.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to drug dose administration interval too short.  Patient had never been vaccinated for rabies. Patient asking what is the recommended schedule. She was referred to the Hospital Outpatient Department for scheduling the remaining doses of vaccine. She was told she would need 4 total doses on days 0, 3, 7, and 14. The facility for the remainder of the vaccines is not open on weekends, so they scheduled her second vaccine dose on day 2 instead of day 3. She is concerned that her doses will be adequate for protection. She says that it seems schedule deviations are common for this facility since it is never open on weekends. The caller was reluctant to provide details.  At the time of reporting, no adverse event was reported.  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 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.  There will be no information available on the batch number for this case.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was administered an expired Pentacel/no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Medical Information (Reference number- 00642478 and 00645476) and transmitted to Sanofi on 15-Jun-2021.  This case involves a 2 months old male patient who was administered 0.5 ml first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ326AAA, expiry date: 13-Jun-2021) via unknown route in the right thigh for prophylactic vaccination on 15-Jun-2021 (Expired product administered)  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day)  At the time of report, no adverse event was reported.  The caller was calling back to report they had administered an expired Pentacel and asked what should be done regarding the expired dose that was given.   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: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient was inadvertently immunized with an expired dose of Tenivac with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from a physician and other health care professional via Medical Information (Reference number- 00643928) and transmitted to Sanofi on 16-Jun-2021.   This case involves a 52-year old female patient who was inadvertently immunized with an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, suspension for injection [TENIVAC] (expired product administered) On 16-Jun-2021 [lot number: C5578AA and expiration date: 28-Jan-2021] at 0.5 ml dose via intramuscular route in unknown administration site for prophylactic vaccination.  It was unknown if the patient had any medical history, concomitant disease or risk factor, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  It was unknown if there were lab data/results available.  Disclaimer: 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 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: 21.0
Sex: U
Vaccine: DTAPIPVHIB, TDAP
Symptoms: Medication error, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A patient received inadvertently Pentacel instead of Adacel, no AE; A 21 year old patient received inadvertently Pentacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from physician via Medical Information (Reference number- 00645545) and transmitted to Sanofi on 17-Jun-2021.  This case involves a 21-year-old patient (gender not reported) who received inadvertently 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot number and expiry date not reported) via an intramuscular route in an unknown administration site for prophylactic vaccination on 17-Jun-2021 instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and expiry date not reported) (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  The reporter inquired if there were any concerns for the patient. The physician was reluctant to provide information on the adverse event (AE).  The details of laboratory data were not reported.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (latency same day).  At the time of reporting, no adverse events were reported.  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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Meningococcal was administered to a patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a Nurse via Medical Information (Reference number- 00646121) and transmitted to Sanofi on 17-Jun-2021.  This case involves a patient (demographics unknown) who was administered MENINGOCOCCAL VACCINE, produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination on an unknown date (Expired product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  The nurse reported that an expired Meningococcal was administered to a patient and asked what were the adverse events (AEs) that they should look out for. Nurse did not provide the name of the vaccine and before she could provide anymore information, she stated that another staff member was reporting the event to another Sanofi agent. No other information was provided.  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.  There will be no information available on the batch number for this case.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was inadvertently administered a Daptacel dose today (18 Jun 2021) that was expired (with no reported adverse event); Initial information was received on 18-Jun-2021 regarding an unsolicited valid non-serious case from other health professional (Inquiry number: 00647472).  It was reported that a two-year-old female patient was inadvertently administered a 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] dose that was expired (batch number: C5624AA, expiry date: 10-Jun-2021] on 18-Jun-2021 via intramuscular route at left leg for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  This was the first dose in the series.  At the time of report, no adverse event reported.  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 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: 64.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received an expired dose of Menactra, with no reported adverse event; 64 years old patient received a Menactra Vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00647494) and transmitted to Sanofi on 18-Jun-2021.  This case involves a 64-year-old male patient who received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Expired product administered,Product administered to patient of inappropriate age].  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP).  On 15-Jun-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6594AA and expiry: 21-May2021] via an intramuscular route in the left deltoid for prophylactic vaccination.   It was a case of actual medication error due to expired product administered and product administered to patient of inappropriate age [Latency: on the same day].  No laboratory test was reported.  At the time of report no adverse event was reported.  It was not reported if the patient received any corrective treatment for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 36.0
Sex: F
Vaccine: UNK
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Myalgia, Pyrexia
Clinical narrative: fever, muscle ache, change of menstrual cycle and heavier menstrual bleeding. My menstrual cycle started unexpectedly and immediately following the vaccination on both 1st and 2nd dose.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Sudden unexpected death the day after the vaccine
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein normal, Chest discomfort, Electrocardiogram normal, Fibrin D dimer normal, Full blood count normal
Clinical narrative: Left sided Chest Pressure Radiating to Back.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Pain, Troponin normal
Clinical narrative: Left sided Chest Pressure Radiating to Back.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear, nose and throat examination, Loss of personal independence in daily activities, Musculoskeletal discomfort, Tinnitus
Clinical narrative: Loud ringing in left ear feel left side of neck. Treatment: Nothing Cannot do daily function.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: After high fevers, continued and increasing body pain and extreme fatigue
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Bilevel positive airway pressure, Blood culture negative, Computerised tomogram thorax abnormal, Cough
Clinical narrative: Pt  is a 58 yr old female with past medical hx of copd on oxygen, pulmonary cachexia, previous strokes secondary to trauma as a result of severe spousal abuse resulting in seizure disorder who received her J and J vaccine on 6/5/21 and was admitted to the hospital on June 18th c/o 3-5 days of fatigue, increasing shortness or breath and cough, poor appetite, and was diagnosed with R middle and R low lobe pneumonia, sepsis and acute hypoxic, hypercarbic respiratory failure to the ICU where she remains admitted in critical condition as of June 24th. Prior to this she was in her usual state of health and had not been hospitalized in 19 years. She has persistent lymphopenia on her cbc and differential. She is requiring high flow oxygen and bipap support. She is being treated with antibioitics, a naso gastric feeding tube and physical therapy.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspnoea, Echocardiogram normal, Enteral nutrition, Fatigue
Clinical narrative: Pt  is a 58 yr old female with past medical hx of copd on oxygen, pulmonary cachexia, previous strokes secondary to trauma as a result of severe spousal abuse resulting in seizure disorder who received her J and J vaccine on 6/5/21 and was admitted to the hospital on June 18th c/o 3-5 days of fatigue, increasing shortness or breath and cough, poor appetite, and was diagnosed with R middle and R low lobe pneumonia, sepsis and acute hypoxic, hypercarbic respiratory failure to the ICU where she remains admitted in critical condition as of June 24th. Prior to this she was in her usual state of health and had not been hospitalized in 19 years. She has persistent lymphopenia on her cbc and differential. She is requiring high flow oxygen and bipap support. She is being treated with antibioitics, a naso gastric feeding tube and physical therapy.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count abnormal, Hypercapnia, Influenza virus test negative, Intensive care, Legionella test
Clinical narrative: Pt  is a 58 yr old female with past medical hx of copd on oxygen, pulmonary cachexia, previous strokes secondary to trauma as a result of severe spousal abuse resulting in seizure disorder who received her J and J vaccine on 6/5/21 and was admitted to the hospital on June 18th c/o 3-5 days of fatigue, increasing shortness or breath and cough, poor appetite, and was diagnosed with R middle and R low lobe pneumonia, sepsis and acute hypoxic, hypercarbic respiratory failure to the ICU where she remains admitted in critical condition as of June 24th. Prior to this she was in her usual state of health and had not been hospitalized in 19 years. She has persistent lymphopenia on her cbc and differential. She is requiring high flow oxygen and bipap support. She is being treated with antibioitics, a naso gastric feeding tube and physical therapy.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphopenia, Metabolic function test, Pneumonia, SARS-CoV-2 test negative, Sepsis
Clinical narrative: Pt  is a 58 yr old female with past medical hx of copd on oxygen, pulmonary cachexia, previous strokes secondary to trauma as a result of severe spousal abuse resulting in seizure disorder who received her J and J vaccine on 6/5/21 and was admitted to the hospital on June 18th c/o 3-5 days of fatigue, increasing shortness or breath and cough, poor appetite, and was diagnosed with R middle and R low lobe pneumonia, sepsis and acute hypoxic, hypercarbic respiratory failure to the ICU where she remains admitted in critical condition as of June 24th. Prior to this she was in her usual state of health and had not been hospitalized in 19 years. She has persistent lymphopenia on her cbc and differential. She is requiring high flow oxygen and bipap support. She is being treated with antibioitics, a naso gastric feeding tube and physical therapy.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Staphylococcus test negative, White blood cell count normal
Clinical narrative: Pt  is a 58 yr old female with past medical hx of copd on oxygen, pulmonary cachexia, previous strokes secondary to trauma as a result of severe spousal abuse resulting in seizure disorder who received her J and J vaccine on 6/5/21 and was admitted to the hospital on June 18th c/o 3-5 days of fatigue, increasing shortness or breath and cough, poor appetite, and was diagnosed with R middle and R low lobe pneumonia, sepsis and acute hypoxic, hypercarbic respiratory failure to the ICU where she remains admitted in critical condition as of June 24th. Prior to this she was in her usual state of health and had not been hospitalized in 19 years. She has persistent lymphopenia on her cbc and differential. She is requiring high flow oxygen and bipap support. She is being treated with antibioitics, a naso gastric feeding tube and physical therapy.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Discomfort, Fatigue, Herpes zoster, Malaise
Clinical narrative: On June 1, 2021, I received my first dose of Moderna COVID-19 shot [LOT # 042B21-2A].  Within 24 hours, I experienced malaise and tiredness and slept for an unusually amount of time.  No other issues were noted at the time.  The following three days, I was working on building a stone patio in the backyard, an area known to have poison oak.  During this time, I noted a small rash on my abdominal area and a developing pain on my left abdominal side.  At the time I thought it was due to lawn work and otherwise ignored the discomfort and did not believe it was an adverse event from the vaccination.     SEE CONTINUATION PAGE......
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: On June 1, 2021, I received my first dose of Moderna COVID-19 shot [LOT # 042B21-2A].  Within 24 hours, I experienced malaise and tiredness and slept for an unusually amount of time.  No other issues were noted at the time.  The following three days, I was working on building a stone patio in the backyard, an area known to have poison oak.  During this time, I noted a small rash on my abdominal area and a developing pain on my left abdominal side.  At the time I thought it was due to lawn work and otherwise ignored the discomfort and did not believe it was an adverse event from the vaccination.     SEE CONTINUATION PAGE......
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Bacteraemia, Blood culture positive, Cholecystectomy, Clostridium test negative
Clinical narrative: Pt received her Moderna covid vaccines in jan and Feb 2021. She was hospitalized from 5/26/21-5/31/21 with a complicated urinary tract infection with bacteremia and pyelonephritis due to a pansensitive e coli which progressed to bacteremia and pyelonephritis despite being treated with 10 days of keflex and 3 days of macrobid as an out pt. She also had severe sepsis and a NSTEMI as a result of the illness. It is unclear why she progressed despite appropriate treatment and it was suggested an immune deficiency work up be done if she has recurrence in the future.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Condition aggravated, Culture urine positive, Escherichia infection, Hydronephrosis
Clinical narrative: Pt received her Moderna covid vaccines in jan and Feb 2021. She was hospitalized from 5/26/21-5/31/21 with a complicated urinary tract infection with bacteremia and pyelonephritis due to a pansensitive e coli which progressed to bacteremia and pyelonephritis despite being treated with 10 days of keflex and 3 days of macrobid as an out pt. She also had severe sepsis and a NSTEMI as a result of the illness. It is unclear why she progressed despite appropriate treatment and it was suggested an immune deficiency work up be done if she has recurrence in the future.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hysterectomy, Lymphopenia, Perinephritis, Pyelonephritis, SARS-CoV-2 test negative
Clinical narrative: Pt received her Moderna covid vaccines in jan and Feb 2021. She was hospitalized from 5/26/21-5/31/21 with a complicated urinary tract infection with bacteremia and pyelonephritis due to a pansensitive e coli which progressed to bacteremia and pyelonephritis despite being treated with 10 days of keflex and 3 days of macrobid as an out pt. She also had severe sepsis and a NSTEMI as a result of the illness. It is unclear why she progressed despite appropriate treatment and it was suggested an immune deficiency work up be done if she has recurrence in the future.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Sepsis, Splenomegaly, Urinary tract infection
Clinical narrative: Pt received her Moderna covid vaccines in jan and Feb 2021. She was hospitalized from 5/26/21-5/31/21 with a complicated urinary tract infection with bacteremia and pyelonephritis due to a pansensitive e coli which progressed to bacteremia and pyelonephritis despite being treated with 10 days of keflex and 3 days of macrobid as an out pt. She also had severe sepsis and a NSTEMI as a result of the illness. It is unclear why she progressed despite appropriate treatment and it was suggested an immune deficiency work up be done if she has recurrence in the future.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Electrocardiogram, Laboratory test, Pain
Clinical narrative: back pain radiating to chest.  Elevated BP.  Started on aspirin, colchicine and amlodipine.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Feeling hot, Headache, Injection site pain, Myalgia, Pain
Clinical narrative: My head started pounding, my injection spot is really sore, I?m also starting to feel achy? (body aches). Muscles all over my body are throbbing, I?m also starting to feel really hot/ warm.. possibly fever.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Decreased appetite, Fatigue, Feeling hot
Clinical narrative: Woke up at 4 am with a headache and being really warm. Took them and it was 101.5 then I took Tylenol and temp came back to normal around 9 am. Was sluggish weak tired for a few days a little nauseous with no appetite for two days.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Sluggishness
Clinical narrative: Woke up at 4 am with a headache and being really warm. Took them and it was 101.5 then I took Tylenol and temp came back to normal around 9 am. Was sluggish weak tired for a few days a little nauseous with no appetite for two days.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Endotracheal intubation, Mechanical ventilation, Mobility decreased
Clinical narrative: Within 24 hours, my mom's arms swelled up from shoulder to fingertips and she had never had swelling in her arms prior. She also was hanging her head as if she had fallen asleep, but actually was unable to lift her head. 4 days following the vaccine she started having breathing issues and was intubated, we had the ventilator removed  (she was actually a DNR and was not supposed to be intubated).  On January 19, 2021 she died. She went into this facility for rehab regarding an infection she had in her leg.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Posture abnormal
Clinical narrative: Within 24 hours, my mom's arms swelled up from shoulder to fingertips and she had never had swelling in her arms prior. She also was hanging her head as if she had fallen asleep, but actually was unable to lift her head. 4 days following the vaccine she started having breathing issues and was intubated, we had the ventilator removed  (she was actually a DNR and was not supposed to be intubated).  On January 19, 2021 she died. She went into this facility for rehab regarding an infection she had in her leg.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Joint swelling, Pruritus, Swelling, Swelling face
Clinical narrative: I had an adverse reaction (swelling) about 4 hours after getting the first Vaccine shot.  I explained this to the pharmacist when I went back for my second dose, and he gave me 2 Benedryl pils before giving me the second dose of the vaccine. This time I had immediate swelling, and felt it in my face and lips, slightly itchy. Then I felt the Benedryl kick in, and about 2 hours later I felt better. Still had serious joint swelling, especially in my knees (sane as with first dose). But I took photos of my face this time and you can clearly see my face was puffy and swollen immediately after getting the vaccine.  With the first dose, the facial swelling started much later, 4-6 hours later.  I took another photo about 2 hours later and the swelling was gone. Clearly I am allergic to something in this vaccine, and the Benedryl definitely worked but I wouldn?t choose to get another shot since the reaction was so immediate.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram abdomen abnormal, Computerised tomogram pelvis abnormal, Differential white blood cell count normal, Distal intestinal obstruction syndrome
Clinical narrative: Patient received Moderna Covid Vaccine on February 5 and March 5 2021.  Pt with past hx of appendectomy 70 years ago and presented with new/sudden significant mid mesenteric inflammation and suggestion of mesenteric volvulus  resulting in a small bowel obstruction on 6/16 when he presented to the hospital with severe abdominal pain, nausea and vomiting.       -       - CT abdomen and pelvis Consistent with distal small bowel obstruction. There was associated significant mid mesenteric inflammation and suggestion of mesenteric volvulus.  He responded to non surgical management consisting of an NGT, NPO status and iv fluids. He was discharged on 6/18/21
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count normal, Gastrointestinal inflammation, Gastrointestinal tube insertion, Metabolic function test normal, Nausea
Clinical narrative: Patient received Moderna Covid Vaccine on February 5 and March 5 2021.  Pt with past hx of appendectomy 70 years ago and presented with new/sudden significant mid mesenteric inflammation and suggestion of mesenteric volvulus  resulting in a small bowel obstruction on 6/16 when he presented to the hospital with severe abdominal pain, nausea and vomiting.       -       - CT abdomen and pelvis Consistent with distal small bowel obstruction. There was associated significant mid mesenteric inflammation and suggestion of mesenteric volvulus.  He responded to non surgical management consisting of an NGT, NPO status and iv fluids. He was discharged on 6/18/21
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Small intestinal obstruction, Volvulus, Vomiting
Clinical narrative: Patient received Moderna Covid Vaccine on February 5 and March 5 2021.  Pt with past hx of appendectomy 70 years ago and presented with new/sudden significant mid mesenteric inflammation and suggestion of mesenteric volvulus  resulting in a small bowel obstruction on 6/16 when he presented to the hospital with severe abdominal pain, nausea and vomiting.       -       - CT abdomen and pelvis Consistent with distal small bowel obstruction. There was associated significant mid mesenteric inflammation and suggestion of mesenteric volvulus.  He responded to non surgical management consisting of an NGT, NPO status and iv fluids. He was discharged on 6/18/21
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Pericardial effusion, Pericarditis
Clinical narrative: Patient started having intermittent worsening chest pain and shortness of breath starting 5 days after 1st shot.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin normal, Ultrasound scan
Clinical narrative: Patient started having intermittent worsening chest pain and shortness of breath starting 5 days after 1st shot.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: Brief fluttering of heart many times throughout the day, no other symptoms, ongoing but with less frequency
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, SARS-CoV-2 test positive
Clinical narrative: dizziness
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Aerococcus urinae infection, Blood culture negative, Chest X-ray abnormal, Computerised tomogram abdomen abnormal
Clinical narrative: Pr received her Moderna covid 19 vaccines on 2/26 and 3/26/21 and per the daughter she went downhill since with progressive fatigue and not acting herself and failure to thrive with poor appetits. she was hospitalized from 6/9-6/19/21 with recurrent urinary tract infection despite appropriate treatment as an out pt, severe sepsis, diffuse pneumonia, acute metabolic encephalopathy, severe, persistent hypokalemia due to poor po intake and a pancreatic mass- possibly malignant with negative ca 19-9 incidentally found on imaging. She was sent home on comfort/hospice care on 6/19/21 as family opted for no further aggressive treatment for the pancreatic mass. she was treated with antibiotics for the sepsis, pneumonia and urinary tract infection during her hospital course.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Culture urine positive, Failure to thrive, Fatigue, Hypokalaemia, Hypophagia
Clinical narrative: Pr received her Moderna covid 19 vaccines on 2/26 and 3/26/21 and per the daughter she went downhill since with progressive fatigue and not acting herself and failure to thrive with poor appetits. she was hospitalized from 6/9-6/19/21 with recurrent urinary tract infection despite appropriate treatment as an out pt, severe sepsis, diffuse pneumonia, acute metabolic encephalopathy, severe, persistent hypokalemia due to poor po intake and a pancreatic mass- possibly malignant with negative ca 19-9 incidentally found on imaging. She was sent home on comfort/hospice care on 6/19/21 as family opted for no further aggressive treatment for the pancreatic mass. she was treated with antibiotics for the sepsis, pneumonia and urinary tract infection during her hospital course.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Interstitial lung disease, Lung opacity, Magnetic resonance imaging abdominal abnormal, Metabolic encephalopathy, Pancreatic atrophy
Clinical narrative: Pr received her Moderna covid 19 vaccines on 2/26 and 3/26/21 and per the daughter she went downhill since with progressive fatigue and not acting herself and failure to thrive with poor appetits. she was hospitalized from 6/9-6/19/21 with recurrent urinary tract infection despite appropriate treatment as an out pt, severe sepsis, diffuse pneumonia, acute metabolic encephalopathy, severe, persistent hypokalemia due to poor po intake and a pancreatic mass- possibly malignant with negative ca 19-9 incidentally found on imaging. She was sent home on comfort/hospice care on 6/19/21 as family opted for no further aggressive treatment for the pancreatic mass. she was treated with antibiotics for the sepsis, pneumonia and urinary tract infection during her hospital course.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pancreatic cyst, Pancreatic duct dilatation, Pancreatic mass, Pancreatitis, Pleural effusion
Clinical narrative: Pr received her Moderna covid 19 vaccines on 2/26 and 3/26/21 and per the daughter she went downhill since with progressive fatigue and not acting herself and failure to thrive with poor appetits. she was hospitalized from 6/9-6/19/21 with recurrent urinary tract infection despite appropriate treatment as an out pt, severe sepsis, diffuse pneumonia, acute metabolic encephalopathy, severe, persistent hypokalemia due to poor po intake and a pancreatic mass- possibly malignant with negative ca 19-9 incidentally found on imaging. She was sent home on comfort/hospice care on 6/19/21 as family opted for no further aggressive treatment for the pancreatic mass. she was treated with antibiotics for the sepsis, pneumonia and urinary tract infection during her hospital course.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pseudocyst, SARS-CoV-2 test negative, Sepsis, Urinary tract infection
Clinical narrative: Pr received her Moderna covid 19 vaccines on 2/26 and 3/26/21 and per the daughter she went downhill since with progressive fatigue and not acting herself and failure to thrive with poor appetits. she was hospitalized from 6/9-6/19/21 with recurrent urinary tract infection despite appropriate treatment as an out pt, severe sepsis, diffuse pneumonia, acute metabolic encephalopathy, severe, persistent hypokalemia due to poor po intake and a pancreatic mass- possibly malignant with negative ca 19-9 incidentally found on imaging. She was sent home on comfort/hospice care on 6/19/21 as family opted for no further aggressive treatment for the pancreatic mass. she was treated with antibiotics for the sepsis, pneumonia and urinary tract infection during her hospital course.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Dysgeusia, Parosmia
Clinical narrative: My smell and taste has been strange ever since. I can almost always smell a metallic or sickly sweet smell. Its like everything I smell or taste has to pass through a sort of blanket of metal or formaldehyde. I can really only smell really strong things like white vinegar. But not subtle things like candles or when food is cooking. My taste is nearly gone, and I really only get texture, things that are really spicy or really sour. It started within a day or so from when I got my first shot and has been the same since.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Dyspnoea, Palpitations
Clinical narrative: A few days after 2nd vaccine: heart pounding, shortness of breath, arrhythmia.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Infection, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Error: Infection / Cellulitis (diagnosed by MD), Additional Details: hot to touch arm, swollen, red, no fever
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Peripheral swelling, Skin warm
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Error: Infection / Cellulitis (diagnosed by MD), Additional Details: hot to touch arm, swollen, red, no fever
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: onset of polymyalgia rheumatica symptoms
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Feeling hot, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Evening of 7th day after shot red circle at injection site.  Morning of 8th day felt like bruise near collar bone on left side and injection site swelling and redness and itching.  Afternoon of 8th day "rash" started at collar bone with heat and itching going toward neck.  Dr. prescribed antibiotics and took Benadryl.  Went for scheduled 2nd dose and was denied until seeing allergist.  Went to Dr and was ok'd to receive 2nd dose.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Evening of 7th day after shot red circle at injection site.  Morning of 8th day felt like bruise near collar bone on left side and injection site swelling and redness and itching.  Afternoon of 8th day "rash" started at collar bone with heat and itching going toward neck.  Dr. prescribed antibiotics and took Benadryl.  Went for scheduled 2nd dose and was denied until seeing allergist.  Went to Dr and was ok'd to receive 2nd dose.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Discomfort, Herpes zoster, Pain, Rash
Clinical narrative: 1)Shingles developed on right side lower body 10 days after 2nd dose covid vaccine.  First symptom was discomfort & mild pain.  A week letter a rash emerged so I went to Dr & was diagnosed. It?s been 4 weeks & still recovering.   2) A second effect I?m beginning to notice is that my RA which has been under control for several years now through anti-inflammatory diet, is starting to act up.  Pain in fingers - primarily pinky fingers  with swelling at joints. Both hands. First time experiencing any symptoms on right hand.  And I have never had the characteristic bumps at the joints until now. I haven?t yet mentioned this symptom to my dr. It I was overshadowed by the extreme pain from shingles.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: 1)Shingles developed on right side lower body 10 days after 2nd dose covid vaccine.  First symptom was discomfort & mild pain.  A week letter a rash emerged so I went to Dr & was diagnosed. It?s been 4 weeks & still recovering.   2) A second effect I?m beginning to notice is that my RA which has been under control for several years now through anti-inflammatory diet, is starting to act up.  Pain in fingers - primarily pinky fingers  with swelling at joints. Both hands. First time experiencing any symptoms on right hand.  And I have never had the characteristic bumps at the joints until now. I haven?t yet mentioned this symptom to my dr. It I was overshadowed by the extreme pain from shingles.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Aortic valve incompetence, Blood culture negative, Chest pain, Computerised tomogram head normal
Clinical narrative: Pt had her J and J vaccine on 5/18/21. now hospitalized from home on 6/15 with a few days of chest pain and admitted with sepsis, UTI, dense rll pneumonia and new svt/tachycardia/NSTEMI, syncope, rhabdomyolysis. her hospital course was very protracted due to recurrent tachycarida/svt and she was eventually discharged to rehab on 6/23/21.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Culture urine positive, Ejection fraction normal, Escherichia infection, Hyperdynamic left ventricle
Clinical narrative: Pt had her J and J vaccine on 5/18/21. now hospitalized from home on 6/15 with a few days of chest pain and admitted with sepsis, UTI, dense rll pneumonia and new svt/tachycardia/NSTEMI, syncope, rhabdomyolysis. her hospital course was very protracted due to recurrent tachycarida/svt and she was eventually discharged to rehab on 6/23/21.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lung consolidation, Pneumonia, Renal cyst, Rhabdomyolysis, SARS-CoV-2 test negative
Clinical narrative: Pt had her J and J vaccine on 5/18/21. now hospitalized from home on 6/15 with a few days of chest pain and admitted with sepsis, UTI, dense rll pneumonia and new svt/tachycardia/NSTEMI, syncope, rhabdomyolysis. her hospital course was very protracted due to recurrent tachycarida/svt and she was eventually discharged to rehab on 6/23/21.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Sepsis, Sputum culture positive, Staphylococcal infection, Supraventricular tachycardia, Syncope
Clinical narrative: Pt had her J and J vaccine on 5/18/21. now hospitalized from home on 6/15 with a few days of chest pain and admitted with sepsis, UTI, dense rll pneumonia and new svt/tachycardia/NSTEMI, syncope, rhabdomyolysis. her hospital course was very protracted due to recurrent tachycarida/svt and she was eventually discharged to rehab on 6/23/21.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tricuspid valve incompetence, Ultrasound Doppler, Urinary tract infection
Clinical narrative: Pt had her J and J vaccine on 5/18/21. now hospitalized from home on 6/15 with a few days of chest pain and admitted with sepsis, UTI, dense rll pneumonia and new svt/tachycardia/NSTEMI, syncope, rhabdomyolysis. her hospital course was very protracted due to recurrent tachycarida/svt and she was eventually discharged to rehab on 6/23/21.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Hypoacusis, Malaise, Nausea
Clinical narrative: Pt received Pfizer dose 1, in waiting area pt reported feeling unwell. Pt was diaphoretic, pale, reported feeling light headed, dizziness, nausea, and saw stars. Pt reported feeling as if he "couldn't see or hear", tingling in extremities.  Pt denied any SOB/difficulty breathing, pt reported no PMH or medication/substance use. Pt did not faint or vomit. Measured BP with SBP in 80s with nadir at 60/57 at 10 minutes post injection. Pt given water and monitored closely. EMS contacted, when EMS arrived and assessed pt, at which point SBP returned to normal and pt went home with mother.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Paraesthesia, Visual impairment
Clinical narrative: Pt received Pfizer dose 1, in waiting area pt reported feeling unwell. Pt was diaphoretic, pale, reported feeling light headed, dizziness, nausea, and saw stars. Pt reported feeling as if he "couldn't see or hear", tingling in extremities.  Pt denied any SOB/difficulty breathing, pt reported no PMH or medication/substance use. Pt did not faint or vomit. Measured BP with SBP in 80s with nadir at 60/57 at 10 minutes post injection. Pt given water and monitored closely. EMS contacted, when EMS arrived and assessed pt, at which point SBP returned to normal and pt went home with mother.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Rash, Rash erythematous, Rash pruritic
Clinical narrative: I felt fine after the first dose, but the next day I noticed some slightly raised white bumps on the back of my neck. I didn't make the connection until just now that it could possibly be a related side effect from the COVID vaccine. The rash is still there and is seems to be spreading, is more red and itchy.  I've only been putting lotion on it. I went to my primary care Nurse Practitioner and she didn't think it was shingles but more of a contact dermatitis and prescribed a steroid cream. I don't know if this is a true side effect of the COVID shot or not but thought I'd report it. It's been 5 months since my first shot and the rash has grown in size by 3-4 times. After getting the second shot I was a little more tired and had chills, but no fever.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery dissection, Myocardial infarction
Clinical narrative: SCAD Heart Attack
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Burning sensation, Diarrhoea, Dysgeusia
Clinical narrative: about 6 hours after first shot started having bad abdominal pains, burning sensations in hands feet and face. Eyes started burning, horrible tastes in mouth. Joint pains  hands feet hips  ,diarrhea. What felt like allodynia in face really bad for close to a week. Pains in rib cage feels like costochondritis. Headaches im sure i am forgetting a few   many of these are still a problem
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Facial pain, Headache, Musculoskeletal chest pain
Clinical narrative: about 6 hours after first shot started having bad abdominal pains, burning sensations in hands feet and face. Eyes started burning, horrible tastes in mouth. Joint pains  hands feet hips  ,diarrhea. What felt like allodynia in face really bad for close to a week. Pains in rib cage feels like costochondritis. Headaches im sure i am forgetting a few   many of these are still a problem