chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received a 4th Hep B Immunization 1/26/10 instead of an HPV #3. Client received the latter one day later 1-27-10.
I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; When I woke up I could not step on my foot other than on toes; heel and the arch were so painful, I couldn't put any weight on them; Hobbling around my hip had a lot of pain throughout the day; My shoulder felt like somebody had pulled it out; Vaccination site pain; I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; This is a spontaneous report from a contactable consumer (patient).  A 80-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot: EL3248) for COVID-19 immunization on an unknown date in Jan2021 at single dose.  The patient medical history and concomitant medications were not reported. The morning after vaccination (unspecified date in 2021), when patient woke up could not step on foot other than on toes, the heel and the arch were so painful that couldn't put any weight on them and then was hobbling around hip had a lot of pain throughout the day.The patient was tired and wasn't quite him/her self, patient was just feeling like tired and a little bit weak-ish (all in 2021). Always in 2021, the patient's shoulder felt like somebody had pulled it out and patient had vaccination site pain.The next morning patient woke up and was fine, had nothing. So, patient thought was strange and was sure a reaction to the vaccine. The patient stated it was a weird reaction and thought was strange reaction to the vaccine and was wondering getting next shot (scheduled at the beginning of Feb2021) can expect the worst reaction; patient had first time such a strong reaction. The final outcome of the events was reported as unknown.
Presented with worsening dyspnea in setting of Covid-19, found to have acute hypoxic respiratory failure and pneumonia. COVID symptom onset 12/18, tested positive for COVID 12/21, received mAb. Had some improvement, but then developed increasing dyspnea leading to admission 12/31 for hypoxia. He was admitted and treated with dexamethasone and baricitinib. CXR with left lower lobe infiltrate c/f lobar pneumonia. Received course of CTX/Azithro. RRT was called near midnight on 1/8/22 due to progressive hypoxia. He was transitioned to optiflow and transferred to the MICU for further care.  Early in the morning on 1/24/22, patient developed worsening shock with phenylephrine up to 200. An Scv02 was checked which was 38 raising concern for cardiogenic shock, and he was transitioned to levophed. Unfortunately, he had worsening afib with RVR and was cross titrated to phenylephrine and levophed. His Hgb was 6. 1 and he received 1 unit of pRBCs and 1 L of fluid for presumed hemorrhagic shock while awaiting blood. He underwent CT scan to evaluate for a source of bleeding in his abdomen which was negative for bleed. Antimicrobial coverage was broadened to vancomycin, meropenem and fluconazole. After returning from the CT scanner, he had worsening presser requirements up to 80 of levophed, 300 of phenylephrine, and vasopressin 0.04. He was also given calcium chloride and 1 amp of sodium bicarb. He was noted to go into VT for about 1 minute with lack of palpable pulses although pulse still visible on the arterial line. The team met with his wife and daughter at the bedside with his son on speaker phone. The decision was made to transition the goals of his care to comfort and to remove artificial support devices including the vasopressors and the bipap. He passed away peacefully with his family at his side at 1249. Due to COVID-19 infection, the medical examiner was notified and declined the case. The patient's family declined an autopsy.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with HEPTAVAX, ENGERIX B.  The subject's medical history included skin problem.   Concurrent medications included RAPTIVAL.  ON 2 November 2006, the subject received 1st dose of Hepatitis B vaccine (unknown, left deltoid), On 5 December 2006, 3 April 2007, the subject received 2nd dose and 3rd dose of ENGERIX (1ml, unknown, left deltoid) and experienced not responding to therapy and drug dose administration interval too short.  On 19 March 2008, 8 May 2008 and 17 July 2008 the subject received 1st dose 2nd dose, and 3rd dose of ENGERIX B(1 ml, unknown, right deltoid) and experienced not responding to therapy and drug dose administration interval too short.  Relevant test results included negative titers. The healthcare professional reported the subject received two separate series of Hepatitis B vaccines and still has a negative titer.  The first series was a mixture of GSK and Merck product.  The subject told the nurse on 08 May 2007, that he had a negative titer.  The second series of hepatitis B vaccines were all GSK products.  The reporting healthcare professional did not know when the titer was drawn.  At the time of reporting the outcome of the events were unspecified. Follow-up information was received on 15 December 2008.   The subject's skin problem was further described as small blisters on hands and feet.  Additional concomitant medications included ATENOLOL, TRICOR and NEXIUM.  The reporter stated RAPTIVA was preventing the subject from building titers with the Hepatitis B vaccine.  The subject started therapy with RAPTIVA in 2007, 125ml per week and continues.  At the time of the report, the events were unresolved.
Patient developed dyspnea, diarrhea, chills and cough.  Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes
The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310760, 2020SA310759, 2020SA310763, 2020SA310761, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Slightly edematous + erythematous at R upper arm surrounding injection site.  BENADRYL, apply ice.
On 1/15/21, resident fell during the night while getting up without assistance and hit her head.  She did not have any neurological impairment after fall and remained at facility to be monitored.  1/26/21, resident had sudden loss of consciousness with hypotension and tachycardia.  This resolved slowly after resident was put in trendelenberg position.  She has not had similar events in the past.  She was sent to ED without a distinct underlying cause of the event identified, differential included cardiac arrhythmia, ? orthostatic hypotension, vasovagal syncope, stroke She had a similar event occur on 1/27 after she had returned to the facility from the ED.  The family elected not to pursue further evaluation for second event and she was placed on hospice as she had been experiencing some gradual decline before these events occurred.
At the moment during the event at the church on 10/13/2021 patient received, PT of 92 years old. Patient's family member completes the consent indicating that PFIZER was administered and the nurse proceeds. At the office and nurse proceeds to the verification in vaccine page but the page was disabled to check information. When the vaccine page worked, I was able to confirm the patient's information and indeed her first two doses were MODERNA. During the observation period the patient did not present adverse or secondary effects. The immediate action I took to avoid future incidents was to check the information on the vaccination cards before they proceed to the vaccination. The procedure was carried out when receiving patients is to request their identification, medical plan and vaccination card, they proceed to make a copy (this was stapled on the back of the consent) and they are vaccinated.
3/28/21 - Fever, Shortness of Breath - (Transfer to Emergency Room and admitted to hospital)
Pfizer COVID-19 vaccine (5 to 11 years) given to patient, exceeded BUD in the refrigerator. No adverse reaction occurred.
2/13/21 None 2/14/21 Late morning, body aches, chills, fever (101.8) Tylenol,  12 hours.  symptoms gone  morning 2/15 2/15  evening checked injection site, pressure sensitive, warm slightly swollen large red area, cool wet compress, no temp 2/16  same as 2/15, took antihistamine 25mg,  informed primary physician 2/17 better, spot that looks like a permanent injection spot. no temp, waiting for doctor reply
pt recv DTP/HIB combo and a separate dose of HIB on 17UL95;
neutropenia; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had multiple comorbidities. On an unspecified date within 2 weeks of vaccination the patient experienced neutropenia, assessed as medically significant. At the time of the reported the event outcome was unknown.  The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: The event neutropenia is considered not related to BNT162B2 per current available information.  The event is more likely an intercurrent medical condition. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Bitter taste in mouth immediately after shot.  A few hours later bad headache, nausea, injection site pain and redness and swelling , tiredness, muscle and joint pain, slight fever,  feeling unwell.  Lasted 5 days.
On 6/16/15 after receiving vaccination shot, patient started feeling radiating pain down (R) elbow, arm and shoulder, severe bruising and pronounced puncture wound in upper (R) shoulder, redness and swollen. Took patient to ER-where pain medication, ultrasound and X-ray taken. Found fluid in the (R) shoulder joint causing a septic joint-Infectious Disease Dr called in antibiotic treatment started with withdrawal of infected fluid. Admitted ER at 4:00 pm 6/16/2015.
Local redness reported 24 hr after injection.  RPh circled redness, pt monitored and additional 24 hrs then called and said redness about 1 inch greater than circled mark on arm.  Pt referred to MD.
sick; rash; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), RASH (rash) and HEADACHE (headache) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), RASH (rash) and HEADACHE (headache). At the time of the report, ILLNESS (sick), RASH (rash) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant details were provided No treatment details were provided
Approx 24 hours latter the patient developed an itchy macular/papular rash on her face including her eyebrows. Her scalp and neck were spared. Nothing like this has ever happened to her before. She is improving when I saw her on 4/20/21
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to case 2018SA295174. This case involves a 60 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration and overdose (60 year of age female patient received FLUZONE High-Dose). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Severe sudden onset migraine with nausea, vomiting, chills, and involuntary shaking over 3.5 hours
Had a little of fever that lasted less than 24Hours after the 2nd dose; Chills that lasted less than 24Hours after the 2nd dose; 2nd dose was given after 36 days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a little of fever that lasted less than 24Hours after the 2nd dose), CHILLS (Chills that lasted less than 24Hours after the 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was given after 36 days) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced PYREXIA (Had a little of fever that lasted less than 24Hours after the 2nd dose), CHILLS (Chills that lasted less than 24Hours after the 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was given after 36 days). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 14-Jun-2021, PYREXIA (Had a little of fever that lasted less than 24Hours after the 2nd dose) and CHILLS (Chills that lasted less than 24Hours after the 2nd dose) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was given after 36 days) had resolved.            Concomitant medications was not reported.
the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; This spontaneous report was received from a registered nurse referring to a 20-year-old male patient. The patient's pertinent concurrent conditions included crohn's disease, her medical history was not provided. The patient's concomitant medications included mesalamine (LIALDA) (reported as LIADIA) and vedolizumab (ENTYVIO) it was reported that, the patient had a previous drug reaction to morphine.  On 26-JUN-2020, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) by intramuscular route as the patient was immunosuppressed (concentration, vaccination scheme frequency and anatomical location of administration were not reported; lot number T007790 and expiration date 03-DEC-2021).  On 26-JUN-2020 (reported as within an hour of the administration), the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected (erythema, muscular weakness, peripheral swelling, pain in extremity and feeling hot). The patient sought medical attention and was prescribed ice and acetaminophen (TYLENOL) and a routine blood work was performed on the same day and the result was normal. The patient was recovering with the prescribed treatment.  The causality assessment between therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the aforementioned events was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-0095075132007USA001706:
Severe Diarrhea which lasted over 2 weeks, became dehydrated and ended up in Emergency room on 1/24/21, received IV fluids, antibiotic even though testing showed no infection
pt recv vax 19MAY98 & 2 days later on 21MAY98 pt felt unwell;over the period of the next 2 days 23MAY98 pt also devel sore throat, h/a, malaise & fever 100-102;LDH 539, AST 211;
Initial report was received from health care professional on 26 May 2010: This patient (Two years old) was vaccinated with H1N1 (batch number unknown) on 16 May 2010. The patient received first dose of the vaccine on 28 Oct 2009, and second dose on 01 Apr 2010. The reporter was not sure whether the first two doses of vaccine were Novartis product. The patient was under observation of the pediatrician. No adverse event was reported. The outcome of the event was not reported. Follow-up report received from a health care professional on 14 Jun 2010: The reporter stated that no adverse reaction were reported on 07 Jun 2010. No further information was provided.
Questionable minor CVA/TIA.  Ataxia, slurring of words, drooping left lower lip that wasn't there prior to vaccine, and memory deficits x 72 hrs. Drooping left lower lip persists. All over symptoms gone
1) Each night I have had severe chills followed by hot sweats. 2) This morning (2 days after shot) I had a very large and sensitive to touch bump in the armpit on the side where I had my shot.  I beleive it was a lymph node. 3) Also this morning, I had a red rash across my chest and abdomin.  I sometime get this when I'm getting well after being sick.  My doctor called.
Pt reported slight feeling of lightheadedness 15 min after injection given. Pt denies dizziness.  Orange Juice given. Symptoms resolved after finishing juice. Vital signs stable. Pt felt well and was  d/c home from vaccine clinic in stable condition.
2nd dose administered too early (1st dose = 10/15/22; 2nd dose = 11/5/22) to patient without experiencing side-effects or adverse reaction.
Flu symptoms Fever low grade Sweats  Extreme exhaustion   Swelling of armpit near site and pain -swollen tender lymph that occurred with the first two but worsened with this  3rd shot- quite concerning and painful -primary care doc informed and awaiting reply - no prior abnormal breast exams   Red swollen knot at site of injection with 2 in diameter
Around the end of June, about a month after the second vaccination, I noticed a dark, egg-size bruise on the back of my upper right calf. A few days later 2 to 3 dime to quarter size bruises appeared on my arms and legs. This was ongoing for about 6 weeks. The bruises don't occur anymore, but ever since I experience a stiffness and pain in my lower back.
I got ready for bed and got extremely lightheaded and dizzy and I started having chest pains and nausea. The same symptoms I had when I had a heart attack. I took some nitro and went to bed. When I got up the next morning, it came back. My blood pressure shot way up to like 208/105. I went to the ER for testing. I had an EKG, blood work, and a chest X-Ray. None of the tests showed any heart attacks. I was told to follow up with my doctor. The chest pains and nausea went away, but the lightheadedness and dizziness remain. I also now have an issue with my blood pressure being too low, this morning it was 93/43. I have an appointment tomorrow for a CT scan.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Almost exactly 6 hours later, I vomited, had body aches, ran a 102.3 fever, and had uncontrollable shivering. The fever and body aches lasted approximately 24 hours.