chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a patient's mother refers to a 32 year old female patient. The patient's concurrent conditions included sulfa drugs reaction or allergy. The patient had none pertinent medical history. On an unspecified date in summer months in 1995, when the patient was 11 years old, she was vaccinated with VARIVAX injection, (dose, route, lot number and expiration date were not reported). There were no concomitant medications. Approximately on 12-AUG-2016 (reported as "about week ago"), the patient had her titre checked and it was found that her level for immunity for varicella was low with the result of 0.3 (units not provided). The physician wanted the patient to have higher immunity level, at least 0.8 (units not provided). No other lab diagnostics studies were performed. No treatment was given for the event. The patient sought an unspecified medical attention. The outcome of the event was reported as not recovered. The relatedness between the event and the VARIVAX was not reported. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a 66 year old female patient with no drug reactions or allergies. Patient's medical history was none. On 20-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # H019999, expiry date was 02-FEB-2014) 0.65 milliliter (ml), subcutaneously. Concomitant therapies included LIPITOR, losartan potassium and VESICARE. On 23-MAY-2013, the patient experienced localized reaction at the injection site that was red, raised, swollen, warm to the touch and was itchy and was seen at the physicians office. Laboratory tests performed was none. The patient sought medical attention (was seen at the physician's office). The events were treated with ice and over the counter cortisone. The outcome of localized reaction at the injection site that was red, raised, swollen, warm to the touch and was itchy was unknown. Additional information is not expected.
Admitted on 2/1 with c/o fever, respiratory distress and diarrhea in spetic shock with 2/2 staph aureus bacteremia and COVID pneumonia. Intubated requiring ventilatory support. Acute renal failure on bumex drip with good urinary output but rising BUN.  On 2/5 fever increased to 106F. CT chest, head and abdomen and pelvis with MRI of brain showed not obvious source. On 2/8 LP done and vas-cath placed for hemodialysis. Sudden  vasopressor requirement worsening. Wife elceted to transition to comfort care. Terminally extubated and meds stopped.
left eye was twitching,; her right leg was itching; had a fever, that is still going down,; This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (left eye was twitching,), PRURITUS (her right leg was itching) and PYREXIA (had a fever, that is still going down,) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced BLEPHAROSPASM (left eye was twitching,), PRURITUS (her right leg was itching) and PYREXIA (had a fever, that is still going down,). On 31-Oct-2021, BLEPHAROSPASM (left eye was twitching,) and PRURITUS (her right leg was itching) outcome was unknown. At the time of the report, PYREXIA (had a fever, that is still going down,) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided  Patient reported that she had miss a day of work.    This case was linked to MOD-2021-368985 (Patient Link).
A non-serious spontaneous report of was received from a nurse concerning a 52-year old female. Information on FLUMIST use in ages 50 to 64 years of age was requested. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 6 months 22 days old female patient who was vaccinated with a 0.5 ml dose of expired vaccine ADACEL (lot number not reported)(Exp. Date 23-MAR-2019) via unknown route in the left thigh on 27-Mar-2019. The patient's medical history not reported and No concomitant vaccines were given. It was an actual medication error case due to expired vaccine used. No side effects 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 and Module VI of the 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. List of documents held by sender: none.
pulmonary embolism; multiple myeloma; This is a spontaneous report received from contactable reporter(s) (Physician).  A 80 year-old male patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Lot number: EL9269) at the age of 80 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "TIA", start date: 30Nov2021 (unspecified if ongoing); "Late onset Alziemers", start date: 28Dec2021 (unspecified if ongoing); "chronic leukemia", start date: 04Aug2020 (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot number: EL9265), administration date: 23Feb2021, when the patient was 80 years old, for COVID-19 Immunization, reaction(s): "pressure in his head", "Dizzy", "nausea", "Headache", "Vomiting", "waves of vertigo/ dizziness", "not feeling well", "achy", "first week he had a typical virus like the flu", "tired", "chills", "sick", "he couldn't stand"; Zoster, administration date: 01Oct2006, when the patient was 66 years old, for Immunization; Flu, administration date: 25Aug2020, when the patient was 80 years old, for Immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "pulmonary embolism"; PLASMA CELL MYELOMA (medically significant) with onset 05Jan2022, outcome "unknown", described as "multiple myeloma". The patient underwent the following laboratory tests and procedures: blood sodium (136-145): (07Feb2022) 135 MiU/L; haematocrit (39.0-53.0): (07Feb2022) 36.5 %; haemoglobin (14.0-17.5): (07Feb2022) 12.3 g/l; white blood cell count (4.8-10.8): (07Feb2022) 4.0 10*9/uL.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022; No adverse event; Patient administered expired Moderna COVID-19 vaccine (Monovalent); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna COVID-19 vaccine (Monovalent)), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (Unspecified COVID-19 vaccine Dose 1), COVID-19 vaccine (Unspecified COVID-19 vaccine, first booster dose), COVID-19 vaccine (Unspecified COVID-19 vaccine Dose 3) and COVID-19 vaccine (Unspecified COVID-19 vaccine Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine.    On 13-Sep-2022 at 2:34 AM, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Sep-2022 at 2:34 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna COVID-19 vaccine (Monovalent)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna COVID-19 vaccine (Monovalent)), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna COVID-19 vaccine (Monovalent)) and PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022).    No concomitant medications were reported.  Vial size was reported as 5.5 ml. The vaccine was delivered and placed into the freezer on 18-Apr-2022 and the vial did not undergo any temperature excursion.  Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 13-Sep-2022 vial was placed into refrigerator on 12-Sep-2022.  No treatment information was reported.
Icky; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (Icky), PYREXIA (Fever) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced IRRITABILITY (Icky), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, IRRITABILITY (Icky), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            No concomitant or treatment medications were reported.
This spontaneous case was reported by a physician and describes the occurrence of EAR PAIN (Aching behind their right ear), NASOPHARYNGITIS (Extremely cold), HEADACHE (Headache), FATIGUE (very very tired) and MYALGIA (Every inch of their body ached) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LUTEIN [XANTOFYL] for Macular degeneration and Prophylaxis, MULTIVITAMIN [VITAMINS NOS] and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced NASOPHARYNGITIS (Extremely cold), HEADACHE (Headache), FATIGUE (very very tired), MYALGIA (Every inch of their body ached) and PYREXIA (fever of 102.1°F). On 19-Mar-2021, the patient experienced EAR PAIN (Aching behind their right ear). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at a dose of 1 dosage form. On 18-Mar-2021, NASOPHARYNGITIS (Extremely cold), HEADACHE (Headache), FATIGUE (very very tired), MYALGIA (Every inch of their body ached) and PYREXIA (fever of 102.1°F) had resolved. At the time of the report, EAR PAIN (Aching behind their right ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.1 degree fahrenheit (High) Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-220917 (Patient Link).
Pt completed Pfizer COVID-19 vaccine series on 1/26/21 and 2/16/21. Pt was transferred to reporting hospital by medical flight transport for ICU. Pt initially admitted to outside hospital on 8/29/21 with shortness of breath, dyspnea with exertion, productive cough, fevers, fatigue and noted to be hypoxic. Symptoms started on 8/22 after a recent trip. She was intubated on 9/1 due to worsening hypoxia and fatigue. COVID PNA with ARDS. Pt is currently admitted.
11/12/2003 red spots with vesicles, itch over face, trunk and extremities. Dx varicella.
day of vaccination, watery stool, stomach ache, tired, painful to lift arm up and down day after vaccination - Painful to lift arm up and down - light headed, fuzzy head, fatique, nausea two days after vaccination - Painful to lift arm up and down very light headed, fatique and nausea Three days after vaccination - arm sore but better, still light headed but better, fatique, nausea Four days after vaccination - arm better, very little light headedness, some fatique, nausea better
COVID-19 infection; COVID-19 infection; feeling a little tightness in chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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 "unknown" and all described as "COVID-19 infection"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "feeling a little tightness in chest". Reporter stating events as non serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
3 hours after receiving injection, I had severe diarrhea.  Into the night I began vomiting (which lasted all night)  I became feverish, had chills with body shaking, extreme nausea. (temp 102) This persisted to the next day and I went to the ER.  There I was given  multiple liters of IV fluids,  IV Zofran and IV Tylenol.   I felt better after treatment but still had the intense headache and ringing in the ears.  The next day, I'm now gradually beginning to feel better, just weak.  I can eat today, two days after the injection and slowly beginning to feel better.   This reaction was terrible for me.
Chills at night; Tiredness; This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Dec2020 (Lot number and expiration date were not reported), and the second dose on 05Jan2021 (Lot number: EL3246; Expiration date was not reported), both at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included ongoing hypertension and ongoing hypercholesterolaemia; both diagnosed more than 10 years ago. There were no concomitant medications. On 06Jan2021, the patient had chills at night and tiredness. The outcome of the events, chills at night and tiredness, was recovered on 06Jan2021.
pt died of SIDS on 17SEP97;pt recv vax 26AUG97;
BODY ACHES AND PAIN ALL OVER BODY. EYE  IRRITATION,, NO APPETITE
Information has been received from a RN concerning a 14 year old pt who was vaccinated with a dose of hep B virus vaccine. Subsequently, the pt developed an allergic type reaction that included a fever 2 to 3 hrs after vaccination and lasted 24 hrs. The pt also developed dizziness, dry mouth, and a swollen tongue. It was reported on 4/3/03 that "presently" the pt was "fine," however,  the doctor was concerned with the tongue swelling and wanted to see how to possibly prevent a future anaphylactoid reaction. Unspecified medical attention was sought. On 4/15/03, it was reported that the pt was not vaccinated at this allergist's office but at a pediatrician's office. No further info is expected.
Felt nausea a few minutes after the shot. 6 hours later, still some mild nausea.
Patient made an appointment to receive Pfizer vaccine at our store, but apparently he had already received 2 doses of Moderna earlier this year. This was not disclosed to us at time of administration. We discovered this when we billed his vaccine to insurance and insurance bounced back saying that the dose did not match previous manufacturer.
Pain in legs, half of face numb. Could not walk. Spread to my stomach and back and hands numb. Dr said I had Guillain Barre. Started treatment and that stopped it from moving to my lungs. This condition was from getting the flu shot. No illness prior.
After injection left forearm 1 mm blister surrounded by red area around 1 cm in diameter.  Slightly painful.
Received shingles vaccine 11/27/2009, developed a painful irritated rash on left side of forehead-now with new area on left temporal area, rash red, raised, purple.
Child was having no problems. At 1:30 pm, were called to treat child for wheezing.
COVID booster; Sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown; MANUFACTUERER UNKNOWN), for Covid-19 immunization, reaction(s): "no ADRs". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID booster"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional information: Event took place after use of product. Name of product: COVID booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Grapefruit size swollen, red, itchy, very painful lump at injection site. Pain in my entire left arm. Unable to bend my left elbow the next day. Low grade fever for one day. Migraine for 3 1/2 days. Severe body aches for 3 days.
Information has been received from a certified medical assistant referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On 05-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (lot #L012036, expiry date: 07-APR-2017) (dose, strength and route were not reported). There was no concomitant medication reported. At the time of the report, no adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chills x 3 days ago. Cellulitis 6.5 cm surrounding blister. Doxycycline 100mg 2X a day.
chills; body pain; lethargy; This is a spontaneous report from a contactable consumer, the patient.   A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208) via an unspecified route of administration in the arm left on 12Mar2021 at 13:30 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, asthma and allergy to certain poultry. Concomitant medications included losartan (MANUFACTURER UNKNOWN) , ascorbic acid (VITAMIN C) and cyanocobalamin (B12), all from unknown dates and for unknown indications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in  Mar2021, the patient experienced chills, body pain and lethargy. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events which included treatment with motrin. The clinical outcome of the events chills, body pain and lethargy was recovered on unknown date in 2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the arm left on 02Apr2021 at 09:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation.    No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility information was added in vaccine sub-tab.
Pt was vomiting, turned extremely pale. All symptoms resolved within 15 min. Never completely passed out.
On 3/8/2023 that night I was coughing and a lot of phlegm, I may have had a low grade temperature. The coughing was keeping me awake. I called my primary care and was unable to get in. I began taking NYQUIL. On 3/9/23 and 3/10/23 I had two at home COVID tests, both were negative. On 3/12/23 I had a telehealth visit and was prescribed benzonatate and albuterol inhaler. He told me to take a few days and if I wasn't feeling better to go to my doctor or urgent care. I went to urgent care on 3/15/2023. I had chest x-rays which revealed fluid in the lower part of the lungs. I was prescribed amox-clav, prednisone and albuterol inhaler again and was told to take MUCINEX. I was to keep taking MUCINEX to cough the phlegm up. I had a COVID test, Flu A and B test. COVID was negative, and Flu A was negative, Flu B was positive.