chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose given to pediatric patient; Adult dose given to pediatric patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 9-year-old female patient who received HAV (Havrix 1440) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 16-APR-2023, the patient received the 1st dose of Havrix 1440. On 16-APR-2023, an unknown time after receiving Havrix 1440, the patient experienced overdose (Verbatim: Adult dose given to pediatric patient) and adult product administered to child (Verbatim: Adult dose given to pediatric patient). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-FEB-2024 The pharmacist contacted GlaxoSmithKline via phone and inquired about Havrix and wanted to know what information was available about the administration of an adult dose to a 9-year-old patient.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The Havrix 1440 adult dose given to the pediatric patient, which led to an overdose and adult product administered to child.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Tinnitus, ringing of the ears since I received the covid 19 vaccines. Ringing of ears is present 24 hours a day which is bothersome.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Pregnancy test, Pregnancy test urine negative
Clinical narrative: I skipped 2 consecutive menstrual periods after the 2nd dose; with all the discoveries coming out re: reproduction issues, I am finally officially reporting this as I was informed by my doctor that there was nothing being done about reporting at the time.
Age: 0.83
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: administered wrong medications
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: Muscle Aches, Soreness and Fatigue
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: wrong vaccination given
Age: 0.33
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Renal failure, Sarcoidosis
Clinical narrative: Kidney failure; sarcoidosis; AAA IN HEART 4 CM; This solicited report received from a consumer via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported (dose number in series 1), administered in APR-2021 for covid-19 prophylaxis. Batch number was not reported. The company is unable to request for batch number. No concomitant medications were reported.  On an unspecified date in 2021 (6 weeks later), the patient was admitted with kidney failure (dose number in series 1). Six months later, the patient was diagnosed with sarcoidosis (dose number in series 1). Treatment medications (dates unspecified) included: prednisone. The patient was also diagnosed with AAA in heart 4 cm (dose number in series 1). It was reported that the patient was perfectly healthy before the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the kidney failure, sarcoidosis and AAA in heart 4 cm was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and kidney failure was related , and with sarcoidosis, and AAA in heart 4 cm was not related.  This report was serious (Hospitalization Caused / Prolonged, Other medically important condition).; Sender's Comments: V0-Renal Failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered related. Sarcoidosis. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: CLINICAL VACCINATION FAILURE; RECURRING COVID; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: bilateral breast cancer, and allergy. The patient previously treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series-1) (suspension for injection, intramuscular, batch number: 202A21A) dose was not reported, administered on 27-JUL-2021 for covid-19 prophylaxis. Concomitant medications included nirmatrelvir/ritonavir for covid-19, alprazolam, calcium pantothenate/folic acid/vitamins nos, colecalciferol, melatonin, and meloxicam. On 30-JAN-2024, the patient experienced recurring covid. On an unspecified date, the patient experienced clinical Vaccination failure (Dose number in series-1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from recurring covid, and the outcome of clinical Vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0-Vaccination failure . The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: ended up in ER after receiving vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of IMMUNISATION REACTION (ended up in ER after receiving vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (ended up in ER after receiving vaccine). At the time of the report, IMMUNISATION REACTION (ended up in ER after receiving vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.  This case was identified during the regulatory authority inspection 2023 as part of the no patient identifier clean-up finding. All corrections and updates to the case have been made and the case is locked.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Case unlocked on 14-Feb-2024 as a part of regulatory authority inspection 2023 to perform significant correction. Case updated as valid and classification of no patient identifier was removed.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives; Rash; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of URTICARIA (Hives) and RASH (Rash) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Bronchoscopy on 17-Mar-2021. Previously administered products included for Drug use for unknown indication: sensorcaine and tramadol. Past adverse reactions to the above products included Palpitations with sensorcaine; and Rash with tramadol. Family history included Rectal cancer (mother (CA rectum)). Concurrent medical conditions included Metastatic breast cancer (MBC), Hypertension (HTN), PSVT, Hyperlipidemia and Latex allergy (Latex caused rash). Concomitant products included PALBOCICLIB (IBRANCE) for Breast cancer stage IV, ATORVASTATIN for Hyperlipidemia, IRBESARTAN for Hypertension, FULVESTRANT (FASLODEX) for Metastatic breast cancer, METOPROLOL for PSVT.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives) and RASH (Rash). At the time of the report, URTICARIA (Hives) and RASH (Rash) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Patient received Moderna booster dose. Then patient experienced fatigue, constipation, topical yeast infection on hip, groin, thighs and back, eczema flare, WBCs high and missed 2 doses.  Patient had undergone CMP, CBC and CA tests (result: not reported).  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative
Clinical narrative: has a history of ulcerative colitis which might have contributed to her problems with the Moderna vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COLITIS ULCERATIVE (has a history of ulcerative colitis which might have contributed to her problems with the Moderna vaccine) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Ulcerative colitis.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COLITIS ULCERATIVE (has a history of ulcerative colitis which might have contributed to her problems with the Moderna vaccine) (seriousness criterion medically significant). At the time of the report, COLITIS ULCERATIVE (has a history of ulcerative colitis which might have contributed to her problems with the Moderna vaccine) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.  Company comment: This spontaneous case concerns a female patient of an unknown age, with medical history of ulcerative colitis, who experienced the serious (medically significant) and unexpected event of COLITIS ULCERATIVE, after an unspecified dose of SPIKEVAX NOS (SPIKEVAX NOS) vaccine. The vaccination date and events onset date was not reported; hence, latency could not be properly assessed. No treatment medications provided by the reporter. No further clinical information was available for medical review. Patient's medical history of ulcerative colitis remains as a confounder for the event.  The benefit-risk relationship of SPIKEVAX NOS (SPIKEVAX NOS) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-759966, US-MODERNATX, INC.-MOD-2024-760117 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-759966:relative US-MODERNATX, INC.-MOD-2024-760117:same  reporter (the patient who has 1st dose of Moderna )
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: cousin who also had issues with Moderna does not to my knowledge have any history of major gastrointestinal issues; This spontaneous case was reported by a non-health professional and describes the occurrence of IMMUNISATION REACTION (cousin who also had issues with Moderna does not to my knowledge have any history of major gastrointestinal issues) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (cousin who also had issues with Moderna does not to my knowledge have any history of major gastrointestinal issues). At the time of the report, IMMUNISATION REACTION (cousin who also had issues with Moderna does not to my knowledge have any history of major gastrointestinal issues) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Reporter's first cousin who had issues with Moderna does not to reporter's knowledge had any history of major gastrointestinal issues.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-759966, US-MODERNATX, INC.-MOD-2024-760116 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-759966:first cousin US-MODERNATX, INC.-MOD-2024-760116:same  reporter (the patient who has 1st dose of Moderna )
Age: 2.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Abdominal pain, Accidental overdose, Wrong product administered
Clinical narrative: abdominal pain; Mistakenly administered adult dose to pediatric patient; Mistakenly administered adult dose to pediatric patient; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN (abdominal pain), WRONG PRODUCT ADMINISTERED (Mistakenly administered adult dose to pediatric patient) and ACCIDENTAL OVERDOSE (Mistakenly administered adult dose to pediatric patient) in a 24-month-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057658) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 10-Nov-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 10-Nov-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Mistakenly administered adult dose to pediatric patient) and ACCIDENTAL OVERDOSE (Mistakenly administered adult dose to pediatric patient). On 21-Nov-2023, the patient experienced ABDOMINAL PAIN (abdominal pain). At the time of the report, ABDOMINAL PAIN (abdominal pain), WRONG PRODUCT ADMINISTERED (Mistakenly administered adult dose to pediatric patient) and ACCIDENTAL OVERDOSE (Mistakenly administered adult dose to pediatric patient) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   There was no information about previous COVID-19 vaccination doses. The concomitant medication was not reported by reporter.  The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. He was brought to the emergency room for abdominal pain on 21 NOV 2023. No laboratory tests reported. The treatment medication was not reported by reporter.  This case was reported for 3rd patient out of 6 pediatric patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-760337 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-760337:Master case
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Caller took Pfizer Covid vaccines and Moderna Covid vaccines depending on availability; tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 69-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Feb2024, outcome "unknown" and all described as "tested positive for Covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Caller took Pfizer Covid vaccines and Moderna Covid vaccines depending on availability". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Feb2024) Positive, notes: tested positive for Covid on Sunday. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site swelling, Rash erythematous
Clinical narrative: Red target like rash appeared shortly after immunization 2 days ago 2/15. Since then it has grown  to 4.5 inches in diameter. Slight leg swelling.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Vaccination site discolouration, Vaccination site nodule, Vaccination site pain
Clinical narrative: approximately one month after the vaccination, patient entered pharmacy and said her vaccination site was sore, swollen, and had a black spot in the middle of the site. Patient stated there were no other symptoms and that she felt fine but was concerned with the swollen area. Upon observing the site, there seemed to be a knot on her arm with a dark spot in the middle, similar to a spider bite. Patient is concerned with what caused the knot and spot. I referred her to her physician or the ER, both of which she declined to go. I recommended triple antibiotic cream for the site as a precaution. The interaction took place on the 2-15-24 at 5 p.m.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Since initial injection have had soreness, tenderness and restriction in range for my left arm.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient came and asked for flu shot but had already received this season's dose. Was not caught until after vaccine was administered.  After discussing  with patient he was aware he had one a couple of months ago but wanted to "play it safe" and get another one.
Age: 61.0
Sex: M
Vaccine: FLUC4, RSV
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Patient states 2 days after shots he had pain (8 on pain scale) from knee to ankles. Stated it was like sharp stings/pain. States his joints still hurt.
Age: 31.0
Sex: F
Vaccine: COVID19, DTAP, FLU4, HEPA
Symptoms: Extra dose administered
Clinical narrative: Patient had a sheet of 15 different vaccines she was to receive for immigration purposes. Four of them were circled. MA misunderstood patient and thought the four that were circled were the ones she wanted to get. The four that were circled were the four vaccines she received 12 days ago. CDC and manufacturers of each vaccine were called to assess risks/harms to look out for. Increase pain or swelling at the injection sites were the only things told to look out for. Patient left the office before we could assess for this. Patient did remain in the office approx 35-45 after administration. Patient was called two times and left messages to call the office back.
Age: 65.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pain in extremity
Clinical narrative: Per patient, he has been having really bad sore arm from vaccine administration.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: Shoulder pain and stiffness started a few days after vaccine. Tried many remedies, but nothing has worked yet. Over 4 months later, patient is still experiencing bursitis symptoms.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Electroencephalogram, Partial seizures
Clinical narrative: Baby started having what doctors described to look like focal seizures.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood electrolytes normal, Computerised tomogram head normal, Electrocardiogram normal, Electroencephalogram normal, Full blood count
Clinical narrative: 12/31/2023: Facial, eyelid swelling, epiphora, fever, sweats, malaise. 02/13/2024 Transient Global Amnesia
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Laboratory test normal, Lacrimation increased, Malaise, Pyrexia
Clinical narrative: 12/31/2023: Facial, eyelid swelling, epiphora, fever, sweats, malaise. 02/13/2024 Transient Global Amnesia
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Swelling face, Swelling of eyelid, Transient global amnesia
Clinical narrative: 12/31/2023: Facial, eyelid swelling, epiphora, fever, sweats, malaise. 02/13/2024 Transient Global Amnesia
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death, Myocarditis
Clinical narrative: Myocarditis and Death
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Acidosis, Anaemia macrocytic, Asthenia, Blood fibrinogen normal, Blood lactic acid increased
Clinical narrative: Admit date: 2/3/2024  Discharge date: 2/9/24  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician: PA Reason for Admission: Patient is a 83 YO female who presented to the hospital with difficulty breathing and lethargy. Has relevant past medical history of diabetes mellitus type II, hyperlipidemia, hypothyroidism, IBS, MDD/GAD, hypertension, Chronic obstructive pulmonary disease, CKD4, HFpEF.  Patient had been seen in facility previously. On 1/28 patient seen with decreased appetite and generalized weakness, found to have COVID. She was sent home with advice to use oxygen continually until COVID symptoms resolved. Given scripts for pepcid 20mg BID. Later presented on 1/31 with intractable nausea, vomiting. During that visit she denied any blood loss and felt she would be safe to go home with zofran, phenergan for nausea control.  On presentation to ED patient was unstable with mild hypothermia, borderline tachycardia, soft blood pressures. Blood work revealed macrocytic anemia of HgB 4.7, leukocytosis of 16.3. Lactic acid was elevated to 9.1. Fibrinogen was wnl, D-dimer elevated 2k. ABG indicated an acidosis 7.18 with pCO2 31mmHg, pO2 82mmHg. In ED patient received 1g TXA, 1L IVF, protonix infusion and was initiated on blood products.  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive ProcPrincipal Problem:   Acute blood loss anemia (ABLA) - from large bleeding duodenal ulcer. Status post endoscopic attempts to control bleeding with epinephrine, cautery and clip. IR took patient and empiric GDA embolization was performed 2/4/24. No further bleeding noted - and stools are becoming more normal. Hb stable. Continue PPI BID. Diet advanced to soft and tolerated well. No abdo pain.  Discharged to Home.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood loss anaemia, COVID-19, Decreased appetite, Duodenal ulcer haemorrhage, Dyspnoea
Clinical narrative: Admit date: 2/3/2024  Discharge date: 2/9/24  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician: PA Reason for Admission: Patient is a 83 YO female who presented to the hospital with difficulty breathing and lethargy. Has relevant past medical history of diabetes mellitus type II, hyperlipidemia, hypothyroidism, IBS, MDD/GAD, hypertension, Chronic obstructive pulmonary disease, CKD4, HFpEF.  Patient had been seen in facility previously. On 1/28 patient seen with decreased appetite and generalized weakness, found to have COVID. She was sent home with advice to use oxygen continually until COVID symptoms resolved. Given scripts for pepcid 20mg BID. Later presented on 1/31 with intractable nausea, vomiting. During that visit she denied any blood loss and felt she would be safe to go home with zofran, phenergan for nausea control.  On presentation to ED patient was unstable with mild hypothermia, borderline tachycardia, soft blood pressures. Blood work revealed macrocytic anemia of HgB 4.7, leukocytosis of 16.3. Lactic acid was elevated to 9.1. Fibrinogen was wnl, D-dimer elevated 2k. ABG indicated an acidosis 7.18 with pCO2 31mmHg, pO2 82mmHg. In ED patient received 1g TXA, 1L IVF, protonix infusion and was initiated on blood products.  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive ProcPrincipal Problem:   Acute blood loss anemia (ABLA) - from large bleeding duodenal ulcer. Status post endoscopic attempts to control bleeding with epinephrine, cautery and clip. IR took patient and empiric GDA embolization was performed 2/4/24. No further bleeding noted - and stools are becoming more normal. Hb stable. Continue PPI BID. Diet advanced to soft and tolerated well. No abdo pain.  Discharged to Home.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Haemoglobin decreased, Haemostasis, Hypothermia, Lethargy
Clinical narrative: Admit date: 2/3/2024  Discharge date: 2/9/24  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician: PA Reason for Admission: Patient is a 83 YO female who presented to the hospital with difficulty breathing and lethargy. Has relevant past medical history of diabetes mellitus type II, hyperlipidemia, hypothyroidism, IBS, MDD/GAD, hypertension, Chronic obstructive pulmonary disease, CKD4, HFpEF.  Patient had been seen in facility previously. On 1/28 patient seen with decreased appetite and generalized weakness, found to have COVID. She was sent home with advice to use oxygen continually until COVID symptoms resolved. Given scripts for pepcid 20mg BID. Later presented on 1/31 with intractable nausea, vomiting. During that visit she denied any blood loss and felt she would be safe to go home with zofran, phenergan for nausea control.  On presentation to ED patient was unstable with mild hypothermia, borderline tachycardia, soft blood pressures. Blood work revealed macrocytic anemia of HgB 4.7, leukocytosis of 16.3. Lactic acid was elevated to 9.1. Fibrinogen was wnl, D-dimer elevated 2k. ABG indicated an acidosis 7.18 with pCO2 31mmHg, pO2 82mmHg. In ED patient received 1g TXA, 1L IVF, protonix infusion and was initiated on blood products.  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive ProcPrincipal Problem:   Acute blood loss anemia (ABLA) - from large bleeding duodenal ulcer. Status post endoscopic attempts to control bleeding with epinephrine, cautery and clip. IR took patient and empiric GDA embolization was performed 2/4/24. No further bleeding noted - and stools are becoming more normal. Hb stable. Continue PPI BID. Diet advanced to soft and tolerated well. No abdo pain.  Discharged to Home.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Leukocytosis, Nausea, PCO2 decreased, PO2 normal, Tachycardia
Clinical narrative: Admit date: 2/3/2024  Discharge date: 2/9/24  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician: PA Reason for Admission: Patient is a 83 YO female who presented to the hospital with difficulty breathing and lethargy. Has relevant past medical history of diabetes mellitus type II, hyperlipidemia, hypothyroidism, IBS, MDD/GAD, hypertension, Chronic obstructive pulmonary disease, CKD4, HFpEF.  Patient had been seen in facility previously. On 1/28 patient seen with decreased appetite and generalized weakness, found to have COVID. She was sent home with advice to use oxygen continually until COVID symptoms resolved. Given scripts for pepcid 20mg BID. Later presented on 1/31 with intractable nausea, vomiting. During that visit she denied any blood loss and felt she would be safe to go home with zofran, phenergan for nausea control.  On presentation to ED patient was unstable with mild hypothermia, borderline tachycardia, soft blood pressures. Blood work revealed macrocytic anemia of HgB 4.7, leukocytosis of 16.3. Lactic acid was elevated to 9.1. Fibrinogen was wnl, D-dimer elevated 2k. ABG indicated an acidosis 7.18 with pCO2 31mmHg, pO2 82mmHg. In ED patient received 1g TXA, 1L IVF, protonix infusion and was initiated on blood products.  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive ProcPrincipal Problem:   Acute blood loss anemia (ABLA) - from large bleeding duodenal ulcer. Status post endoscopic attempts to control bleeding with epinephrine, cautery and clip. IR took patient and empiric GDA embolization was performed 2/4/24. No further bleeding noted - and stools are becoming more normal. Hb stable. Continue PPI BID. Diet advanced to soft and tolerated well. No abdo pain.  Discharged to Home.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Admit date: 2/3/2024  Discharge date: 2/9/24  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician: PA Reason for Admission: Patient is a 83 YO female who presented to the hospital with difficulty breathing and lethargy. Has relevant past medical history of diabetes mellitus type II, hyperlipidemia, hypothyroidism, IBS, MDD/GAD, hypertension, Chronic obstructive pulmonary disease, CKD4, HFpEF.  Patient had been seen in facility previously. On 1/28 patient seen with decreased appetite and generalized weakness, found to have COVID. She was sent home with advice to use oxygen continually until COVID symptoms resolved. Given scripts for pepcid 20mg BID. Later presented on 1/31 with intractable nausea, vomiting. During that visit she denied any blood loss and felt she would be safe to go home with zofran, phenergan for nausea control.  On presentation to ED patient was unstable with mild hypothermia, borderline tachycardia, soft blood pressures. Blood work revealed macrocytic anemia of HgB 4.7, leukocytosis of 16.3. Lactic acid was elevated to 9.1. Fibrinogen was wnl, D-dimer elevated 2k. ABG indicated an acidosis 7.18 with pCO2 31mmHg, pO2 82mmHg. In ED patient received 1g TXA, 1L IVF, protonix infusion and was initiated on blood products.  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive ProcPrincipal Problem:   Acute blood loss anemia (ABLA) - from large bleeding duodenal ulcer. Status post endoscopic attempts to control bleeding with epinephrine, cautery and clip. IR took patient and empiric GDA embolization was performed 2/4/24. No further bleeding noted - and stools are becoming more normal. Hb stable. Continue PPI BID. Diet advanced to soft and tolerated well. No abdo pain.  Discharged to Home.
Sex: M
Vaccine: RSV, HEP
Symptoms: Death, Product use issue
Clinical narrative: Mother is reporting on behalf of her son who was born prematurely at 34 weeks and was in the NICU and got released 22 days after delivery. He went to the primary care provider who advised that the baby should receive Beyfortus due to his prematurity and that it was RSV season. The mother asked if the injection was new, and was told was not new. Mother was hesitate but the doctor persuaded her to let the baby get the injection. Not even 48 hours after the baby became unresponsive and they went to the hospital and he passed. The baby also received the Hep B vaccine right at birth and was given Beyfortus all within 30 days of each other. The cause of death was fluid build up in the lungs. The mother has all of the baby's health records and is willing to provide the records and would like them reviewed. She questions whether her baby should have even received Beyfortus when not even 28 days old yet and whether he should have also received the Hep B vaccine so soon after being born. She believes he was too young for both and should have gotten both within 30 days of each other.
Sex: M
Vaccine: RSV, HEP
Symptoms: Death, Pulmonary oedema, Unresponsive to stimuli
Clinical narrative: Mother is reporting on behalf of her son who was born prematurely at 34 weeks and was in the NICU and got released 22 days after delivery. He went to the primary care provider who advised that the baby should receive Beyfortus due to his prematurity and that it was RSV season. The mother asked if the injection was new, and was told was not new. Mother was hesitate but the doctor persuaded her to let the baby get the injection. Not even 48 hours after the baby became unresponsive and they went to the hospital and he passed. The baby also received the Hep B vaccine right at birth and was given Beyfortus all within 30 days of each other. The cause of death was fluid build up in the lungs. The mother has all of the baby's health records and is willing to provide the records and would like them reviewed. She questions whether her baby should have even received Beyfortus when not even 28 days old yet and whether he should have also received the Hep B vaccine so soon after being born. She believes he was too young for both and should have gotten both within 30 days of each other.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Caller is a nurse who reports expired GARDASIL 9 was administered to a patient. Product expired 11/9/2023 and was administered 1/31/2024.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 31-JAN-2024, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter (mL) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number 1780876, expiration date was reported and validated as 09-NOV-2023) as prophylaxis (expired product administered). No additional adverse event (AE) reported.
Age: 45.0
Sex: F
Vaccine: HPV4
Symptoms: Brain fog, Chronic fatigue syndrome, Movement disorder, Pain, Premature menopause
Clinical narrative: Chronic fatigue syndrome; Premature Ovarian Failure (POF); Brain fog; Among other severe symptoms; Movement disabilities; Chronic pain syndrome; This initial spontaneous report was received from a lawyer and the consumer regarding a case in litigation and refers to a currently 47-year-old female patient (pt). The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies.   On 01-APR-2022, she was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, lot number, expiration date, route of administration, and anatomical location were not provided) administered as prophylaxis by a physician.   The pt claimed, that on an unknown date, she was injured by the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)vaccine injection which caused her to develop chronic fatigue syndrome, brain fog, movement disabilities, chronic pain syndrome, premature ovarian failure (POF), among other severe symptoms. The outcome of all the events was unknown.  The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and all the aforementioned events was reported as related.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; TE where products have been administered to patients; This spontaneous report was received from a certified medical assistant concerning a 12-months-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 05-FEB-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliter, lot #X022923, expiration date: 12-MAR-2025, administered for prophylaxis (strength, frequency, route of administration and anatomical location were not provided).   The vaccine underwent a temperature excursion (TE) of 5.8F for 0 hours 15 minutes and 0 seconds. There was no previous excursions.  No additional adverse events.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; HCP called to report TE where products have been administered to patients.; This spontaneous report was received from a certified medical assistant referring to a 4 years old patient of unknown gender. Information about the patient's current condition, historical condition and concomitant medications was not provided.    On 05-FEB-2024, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (0.5 milliliter, lot # x022923, expiration date: 12-MAR-2025; dose number, strength and route was unknown) for prophylaxis.         The storage temperature of the vaccine was reported as 5.8 degrees Fahrenheit (°F) for a time frame of 15 minutes. There was no previous temperature excursions. No additional adverse event (AE) or product quality complaint (PQC) was involved.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report TE where products have been administered to patients.; This spontaneous report was received from a healthcare professional (HCP) referring to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On an unknown date in February 2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) injection (0.5 ml, lot#: x022923, expiration date: 12-MAR-2025; strength and route of administration were not reported) by a health professional for prophylaxis. The administered vaccine experienced temperature excursion (TE) on 05-FEB-2024 at 5.8 F for 15 minutes without any other previous excursion (product storage error). No additional adverse events (AE) were reported (no adverse event).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2023 as dose 6 (booster), single (Lot number: GL2042) at the age of 75 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single), as dose 4 (booster), single) and as dose 5 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 30Jan2024 until 03Feb2024.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2023 at 14:00 as dose 6 (booster), single (Lot number: GJ3277) at the age of 52 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 22Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 04Nov2021 as dose 3 (booster), single (Lot number: FE3592), in left arm, on 13Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm and on 22Oct2022 as dose 5 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "genetic periodontitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was prescribed with PAXLOVID as COVID-19 treatment from 31Jan2024 and finished on 05Feb2024.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400038609 Same patient, different product and event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid on 30Jan2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 1, single (Lot number: HG9629) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course information: Patient took Paxlovid as treatment for Covid-19 from 31Jan2024 to 04Feb2024.  No follow-up attempts are possible.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Nurse.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Lot number: H64629) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received other vaccination and did not receive any other medication in 2 weeks. Paxlovid was given as treatment for COVID 19 from 31Jan2024 to 05Feb2024; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "known allergies: Penicillen" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid, from 30Jan2024 to 04Feb2024.  No follow-up attempts are possible.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from an Other HCP.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin"; Ibuprofen, reaction(s): "Known allergies: ibuprofen"; Naproxen, reaction(s): "Known allergies: naproxen"; Bactrim ds, reaction(s): "Known allergies: Bactrim ds". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient took Paxlovid as treatment for Covid-19 from 02Feb2024 to 06Feb2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2, BNT162B2 OMI BA.4-5 cannot be fully excluded.