chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a male patient of unknown age. In October 2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K009106, expiration date:) intramuscularly. In October 2014 (exact date unspecified) the patient developed an injection site reaction of redness, heat, hardness and pain. The affected area was approximately 8 inches. The patient also had body aches and fever (in October 2014). The physician described patient's symptoms as severe. The patient sought medical attention via office visit. At the time of the report the patient did not recover from the events. The relatedness between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Patient with J+J on 07/17/2022 who admitted to hospital with failure to thrive who died on comfort care services.  Provider d/c note below:  "87-year-old female with a past medical history significant for Alzheimer's dementia, hypertension, recurring DVTs, left parietal meningioma, CKD stage 3, diverticulitis who presented with severe hypernatremia in failure to thrive secondary to refusal for any oral intake.  It was noted on admission that the patient was nonverbal and responsive to noxious stimuli but refusing to eat or drink anything over the past week or longer.  The son had visited the patient at Facility and the patient was not doing well and would likely be a hospice candidate in the coming week.  When the patient got to the hospital sodium was notable for at 4:29 p.m., potassium 3.1, bicarb 21, WBC 20.1, lactate 4.0 CT head was negative excluding history of meningioma, CT abdomen pelvis had pancreatic lesions concerning for IPMN.  Patient was evaluated in hospital by speech and patient is still refusing to eat anything.  With the recent CT findings and patient refusal for oral intake with severe failure to thrive and severe dementia, with conversation with son patient was deemed to be comfort care by the son.    Unfortunately, prior to discharge the patient was COVID(+). Patient remained at hospital as the patient was unable to discharge due to COVID status. The patient continued comfort directed care until expiration on 7/11/22 at 21:20. "
Patient passed out and collapsed a few minutes post administration.   Patient was regained conciousness less than a minute after passing out.  Patient was given a small bottle of water and was driven home.
Excess thirst, frequent urination. By mid-November, noticeable loss of vision in left eye (saw optometrist). Diagnosed with LADA Diabetes on 12/17/2011. Administered Metformin 2000 mg/d, and Glyburide 7.5 mg/d.
On Aug 14th, pt reported that she started to develop erythema, itchiness and warmth around the injection site 3 days after the injection. The redness has spread in the next 3 days, it was about 2" x 4" in size by Aug 14th. Pt is afebrile. No other s/sx of systematic toxicity. Instructed pt to take antihistamine, use cold compress then contact her MD the next day.
pt recv vax 15JAN97 & it was reported that w/in 6 to 9 hr p/vax pt exp local erythema (approx 6 inches in size) & muscle pain @ the site;it was a week a/it subsided, bruising was reportedly present p/vax given;
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered doses while the temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered doses while the temperature excursion assessment was ongoing) in a 48-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered doses while the temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered doses while the temperature excursion assessment was ongoing) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. Reporter stated that because of their facility has not been able to download the digital logger, they have been put on hold by the state at the moment and cannot administer the modern vaccine to the patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, she reiterated that because of her facility was unable to download the digital data logger they will need to treat this issue as a temperature excursion. The data logger that was unable to download were for the month of Dec-2021, Jan-2021 and Feb-2021. It was also reported that patient had been administered doses while the temperature excursion assessment was ongoing. No adverse reactions were reported by any patients. No treatment drug was reported.
Approx 1 hour after receiving flu shot, I started feeling severely achy all over. By that evening I was vomiting, diarrhea, and had a fever of 102.0 deg. This continued for 3 1/2 days.
mom reports on unusual high pitched cry that lasted for 3-4hrs;mom states was unable to quiet child;pt was seen by MD that day;no fever noted;
RN identified pt with full name and DOB. Pt was alert and RN administered the flu vaccine. Pt tolerated it well. RN documented the flu vaccine in nurse office. Pt's family was in room and alerted staff to help as pt had become unresponsive. RN went to room and the doctor was there along with other nurses from the unit. Rn was not a part of the code. Witnessed staff attempt to gain vitals, and was unable to get blood pressure. Pt was breathing and had a pulse. A staff member called 911.  An ambulance came and transport pt to ED.
Noted localized vaccinia left arm with scabbing. Approximately 15 lesions.
tested positive with COVID-19; Tested positive with COVID-19; This is a spontaneous report from a contactable consumer, reporting for himself. This is the 1st of 2 reports.  A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 18Feb2021 at 15:30 (Batch/Lot Number: EN6201) as 2ND DOSE, SINGLE, and dose 1 via an unspecified route of administration, administered in the left arm on 28Jan2021 at 15:30 (Batch/Lot Number: EL9262) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient's medical history was not reported. There were concomitant medications, but they were not specified. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient tested positive with covid-19 on 22Apr2021 with outcome of recovering.  It was reported that his daughter and her daycare provider are the people whom exposed him. The event required Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test nasal swab: positive on 22Apr2021. Treatment was not required for the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021460648 same reporter/drug/AE, different patients.
No Adverse event; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022 at 6:18 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.
Patient was admitted to hospital on 01/10/2022 with feverish, cough and shortness of breath. Patient has several underlying health conditions: type 2 diabetes, hypertension and obesity.  No discharge date was given in chart and unknown to stay of days in hospital.   Tested positive for covid on 01/12/2022
Patient has history of dizziness with vaccines.  She received vaccine and was asked to wait for 30 minutes for observation.  After about 5 minutes patient got nauseous and got up to throw up.  She collapsed on her way to the bathroom.  She remained coherent the whole time.  911 was called immediately and patient was taken the hospital.
Child had fever 20APR & 21APR91-highest recorded fever was 103.4 taken to ER 21APR90 @ 8PM Dx BOM amoxile, auralgin; Drooling thick clear mucus 22APR91 temp 101.6;
7 days after vaccine developed itching at site, when seen 11/11 had at 5 cm indurated tender erythematous area, no fever or generalized symptoms.
Seriousness criteria other medically significant (OMIC). Initial report receive on 9/13/06 from a health care professional. A 39 year old female pt had received a left deltoid injection of Fluzone SV 2006-2007, lot number U2204AA, on 9/12/06. Immediately post vaccination, she felt light headed, dizzy and faint. Later the day at home she experienced visual disturbances (floaters) and a blind spot in the visual field of her right eye. Per the reporter, the eye symptoms and dizziness is persisting. The pt has also received a left deltoid first dose injection of Hepatitis A vaccine, lot number 0144F, on 8/24/06. At the time of this report, the pt has not recovered.
Information has been received from a health professional concerning a 6 year old male with no pertinent medical history, drug reactions or allergies who on 28-AUG-2007 was vaccinated with a "booster shot" of varicella virus vaccine live (Oka/Merck) (Lot # 658413/1025U). There was no concomitant medication. On 28-AUG-2007, the patient experienced severe vomiting, developed a rash and swelling "immediately after he was given varicella virus vaccine live (Oka/Merck)". The patient was treated with Benadryl. There were no lab diagnostic studies performed. Additional information has been requested.
Hives on her arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hives on her arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient experienced the event(s) hives on her arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), hives on her arm was unknown.
2 Min post injections Pt became pale, dizzy, and complained of nausea. No LOC, no vomiting. Alert and oriented x3. Reclined in chair. Cool cloth applied to forehead and neck. Monitored x20 min post reaction. 9:32am BP: 103/66, P:89; 9:44am BP: 107/71, P:89; 9:56am: BP 111/74, P:81 cleared by Dr. to go, color returned and no dizziness.
patient was given IPOL intradermally with no reported adverse event; patient was given IPOL intradermally 0.1 ml with no reported adverse event; Initial information received on 14-Sep-2022 regarding an unsolicited valid non-serious case received via Clinic Supervisor. GMI Inquiry Number: 01278936, 01279155.  This case involves an unknown age female patient who was given IPV (VERO) [IPOL] intradermally 0.1 ml with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Sep-2022, the patient received suspect IPOL at 0.1 ml via intradermal route (unknown: lot number, administration site) for prophylactic vaccination with no reported adverse event (incorrect route of product administration, incorrect dose administered) at latency same day.  It was reported that "Reporter states the patient was given IPOL intradermally 0.1 ml instead of the TB test but didn't say which product name for the TB. Caller wants to know what to know what they should look for with the patient and what to do? Caller doesn't have lot or any information. This situation is reported as a misuse as per local labelling due to incorrect route and dose. Caller states it was given today and the consumer was a female but that is all she knows."  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for both 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 guidelines. 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.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 22-JUL-2013 (lot # H011350, exp.: 21-FEB-2015). This is one of the report from the same source, linked reports. Additional information is not expected.
12jan-90 pt vax hepta B. 13jan90 pt devel urticarial rash on face w/ swelling of eyes. pt ex funny feeling. sx remitted in 12 hrs.  3days later, pt devel rash on arms and legs. pt treated w/ Medrol-Dosepak and recovered.
Patient lost consciousness within minutes of receiving both vaccines. Hep A given first followed by HPV.  Patient felt lightheaded and dizzy. While being lied down on exam table he lost consciousness for less than 30 seconds. Concern for seizure activity (witnesses - father and medical assistant - saw rigid extremities). Head also flexed up and to left while eyes rolled back into head. Patient regained consciousness without apparent post-ictal state. Was diaphoretic and pale. Vitals normal. After one hour unable to sit up without vomiting. Also complained of shooting pain in bilateral hands. Given benadryl and monitored until color return and feeling well enough to leave. Feeling in usual state of health within 24 hours.
Patient was administered Monovalent Pfizer vaccine after the FDA unauthorized the use of this vaccine on 04/18/23.
Mom states with last shots which child received at 10AM on 7/26/04, 3 hours later the child started crying inconsolably with high pitched cry . She states around 4PM, the temperature spiked to 104.9 rectally. Stayed there x 3 hours. Around 8PM mother took child to hospital. They gave child 2 doses of Tylenol which brought temp down to 102. They told mom child had reaction to vaccine. They discharged child from ER at temp at 101. This event was not reported to health clinic until today. We received a verbal order form doctor to give ped DT today.
Headache, Myalgia, fatigue, chills, pain and swelling at injection site  Narrative:
I am unsure if my symptoms are vaccine related, but they were new and did occur the evening of the next day after the vaccine Tdap was taken.  I forgot about the vaccine at the time of the ER visit and did not mention it to the provider at the time.  I had fluttering in my chest, weakness, and light-headedness that lasted off and on, but mostly on for a total of about 50 minutes.  My pulse felt normal at the time at 64. I called the ambulence because symptoms were not abating with calming deep breaths.  I had had a few seconds of light-headedness about 2 hours before with no other symptoms while cooking dinner.  At the time of symptoms in the chest, I was laying down channel surfing on the couch.  I had no pain. In the ambulence and at ER my EKG's were normal.  I did have a low potassium, but not very low.  I had eaten 5 times during the day, as usual with balanced nutrition. The ER doctor has scheduled a halter monitor, thinking that I could have had a session of bigeminal rhythms that just self corrected before the EKG's were done.  I felt symptom free after a while with only oxygen.  The ER doctor thought the potassium might explain the weakness and I took a dose of 40 meq. before discharge.    I have no cardiac history and my only risk factors are high blood pressure, being menopausal, and my age. All other lab values and chest X-ray were normal.  I am rarely ever ill.
Employee came and report/showed me a raised rash that is on her face, neck and chest that developed the evening of her vaccine.  Has been utilized OTC Benadryl.  Able to still work.
Right arm pain, right neck stiffness, right fingertip numbness and tingling, right toe numbness and tingling, chills, sweating, waves of nausea. Started15 minutes after the injection, overall improvement but continued distal numbness and tingling of fingertips and toes on right side at 24 hours.
Information has been received from a licensed practical nurse concerning multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On unknown dates, the patients were administered improperly stored doses of ROTATEQ (lot # M004890, expiration date 10-NOV-2017; lot # L037924, expiration date 22-JUN-2017, dose and dose number were not provided) orally for prophylaxis. Concomitant therapies were not informed. No adverse effects were reported. The doses of ROTATEQ were exposed to a temperature of 24.3 degree Centigrade and were out of range for 5 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Follow up information has been received from the nurse on 17-NOV-2016. On unknown dates, an unspecified number of patients received improperly stored doses of ROTATEQ (lot # M004890, expiration date 10-NOV-2017; lot # L037924, expiration date 22-JUN-2017, dose and dose number were not provided) orally for prophylaxis. No adverse effect was reported. More temperature excursion details were provided: the vaccines had been exposed under temperature -17.7 degree Centigrade for 7 hours 50 minutes ("2nd cycle"). Previous excursion included: on 03-OCT-2016, 11.1 degree Centigrade for 1 hour 40 minutes; on 10-OCT-2016, 9.8 degree Centigrade for 14 hours 17 minutes; on 01-NOV-2016, -10.1 degree Centigrade for 1 hour 36 minutes ("1 cycle"). Data logger was involved. Additional information has been requested. Reporter, adverse event information and narrative were updated. Sender's Comments: US-009507513-1611USA004924: US-009507513-1611USA004925: US-009507513-1611USA004926: US-009507513-1611USA004927: US-009507513-1611USA004928: US-009507513-1611USA004929: US-009507513-1611USA004930: US-009507513-1611USA004931: US-009507513-1611USA013266: MERCK 1611USA004908:Mfr number.
Patient called me 6/1/18 to ask if her allergist could send a prescription for Dose #2 to be given in his office. I asked what her symptoms were and she described them as follows: Muscle soreness, GI upset, a large cold sore on her mouth, mild fever, itching on BOTH arms and SCALP, Hives below the injection site (but not at the injection site).
redness, edema, warmth & pain shooting up shoulder & down arm;erythema from 15-25mm;
5 days vomiting and diarrhea Tinnitus ongoing 4 months following first Pfizer Vaccine
Sore throat only in evening of 29th Jan/Worsening sore throat in evening of 31st jan; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat only in evening of 29th Jan/Worsening sore throat in evening of 31st jan) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to one of the statins , Rhabdomyolysis.). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL and ROSUVASTATIN for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat only in evening of 29th Jan/Worsening sore throat in evening of 31st jan). On 01-Feb-2021, OROPHARYNGEAL PAIN (Sore throat only in evening of 29th Jan/Worsening sore throat in evening of 31st jan) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-054823, MOD-2021-054823 (Patient Link).
A rash of red blotchy patches popped up next day. The rash spread all over her body over the next 15 days. A fever was present for the next 15 days.
Information has been received from a nurse referring to a patient of unknown age and gender. On 13-MAR-2015, the patient was inadvertently administered an expired dose of MMR II inject, lot # H017432, expiry date: 20-SEP-2014, (dose and route were not reported). No adverse effect reported. Additional information has been requested.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to 3 patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.