chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of chest pain in a 69-year-old male patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. The patient's past medical history included heart disorder and panic disorder. On 3rd July 2018 10:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, 17 hrs after receiving SHINGRIX, the patient experienced chest pain and nausea. On an unknown date, the outcome of the chest pain and nausea were recovered/resolved. The reporter considered the chest pain to be unlikely related to SHINGRIX. The reporter considered the nausea to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right deltoid. On 4th July 2018, at 3 am, the patient woke up complaining of chest pain and nausea. The patient went to the emergency room, troponins was negative, electrocardiogram (EKG) showed no ST segment elevation myocardial infarction and no interventions. The patient was declining his 2nd dose of SHINGRIX. The healthcare professional stated adverse event reported to VAERs.
Over 24 hours after immunization, left deltoid developed expanding erythema at injection site, increased warmth, increasing pain and low grade temperature elevation. Seen the following day, diagnosed with cellulitis and started on antibiotic.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Jul 31, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced a burning sensation, onset 2021, with outcome of unknown. Patient stated, "I got the shot. When I eat a spicy food, it burns inside." No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Moderna vaccine given at external site: 1/13/21, 2/9/21  CHIEF COMPLAINT Weakness, shortness of breath   HISTORY OF PRESENT ILLNESS Patient is a 88 y.o. female with medical comorbidities including atrial fibrillation/atrial flutter rate controlled with a pacemaker, CAD s/p PCI with bare metal stent to LAD, hyperlipidemia, hypertension, CVA, CKD stage 2, stage IV ovarian cancer (diagnosed 12/2019) with retroperitoneal metastasis on chemotherapy with niraparib rosylate, h/o thyroid cancer status post left lobe lobectomy, and h/o ductal carcinoma of the left breast s/p excision who presents to the emergency department and with shortness of breath.    Patient had been in her normal state of health up until 2 weeks ago, when she began to feel run down with headaches, fatigue, new cough, nausea, shortness of breath on exertion, weakness, and increased urinary frequency.  She lives in a nursing facility, where a resident in the memory unit recently tested positive for COVID-19. Due to her symptoms, the patient has been tested multiple times in the past 2 weeks and tested negative until today. She reported that she was unable to get in or out of bed by herself and required 2 people to help her, which her nursing facility does not have the resources for. Due to her worsening weakness, she was transported to the ED for further evaluation.    On arrival to the ED, the patient was hemodynamically stable and saturating well on room air. Labs were significant for Na 131, D-dimer 315, WBC 5.8, baseline troponin 31 with 2H 11. Initial EKG initially showed atrial flutter without RVR and repeat EKG then showed atrial fibrillation without RVR. Chest x-ray showed subsegmental atelectasis in the lung bases. She was given a 1 L bolus, tylenol, and reglan with some improvement in her symptoms. She was then admitted to the Cardiology 2 service for further management.    On arrival to the floor, the patient was hemodynamically stable. She reported that she had progressively worsening weakness over the past 2 weeks as well shortness of breath on exertion. She also reported a several year history of intermittent chest pain that she was told was chest wall pain. This usually resolves after she massages the area for a few minutes. She denied any current chest pain, palpitations, dizziness, headache, abdominal pain, lower extremity edema.   Regarding her cardiac history, she was hospitalized 03/21 for atrial fibrillation with RVR and underwent implantation of Micra VR and AV node ablation. Last TTE was 5/20/20 and showed EF 67% with grade 2/4 diastolic dysfunction and RVSP 39 mmHg, and moderate mitral and tricuspid valve regurgitation. She also has a history of coronary artery disease with PCI and bare metal stent placement to LAD in 2010.
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 with lot # M024261 and expiration date of 30-JUL-2018, lot # M034780 with an expiration date on 15-APR-2019 and lot # M037770 with expiration date on 01-JUN-2019 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccines were exposed to temperature of 12 Centigrade degrees (°C) range for a time frame of 24 hours. The temperature excursion was recorded by a data logger and the previous excursions were reported as 9 °C to 25 °C for 9 hours for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter.  Additional information has been requested. Sender's Comments: US-009507513-1704USA014373: US-009507513-1704USA014374: US-009507513-1704USA007701.
Swelling, redness, warmth to touch starting near vaccine site. Treatment: antibiotic steroids
Injection placed immediately below right shoulder joint. Within 2 hours right arm pain uncharacteristic of usual postvaccination symptoms. Gradual loss of use of right arm due to weakness, stiffness and pain. Numbness in medial forearm and 4th and 5th fingers of right hand along with sensation of pulling and abduction of those same fingers. Right sided neck and occipital pain and stiffness developed over the course of the next few weeks along with decreased and interrupted sleep due to right sided shoulder pain. MRI of right shoulder performed on 02/12/2019 Impression: adhesive capsulitis, bone marrow edema of the posterior lateral humeral head, edema in the overlying teres minor tendon and deep fibers of the deltoid muscle and resultant partial tears of the supraspinatus and infraspinatus tendons.  Steroid injections into R shoulder and elbow joints. Ongoing physical therapy treatments to right shoulder and neck  and possibly further steroid injections.
Rash to face, arms and some on abdomen, none noted around injection sites.  Also reported diarrhea. Mother gave benadryl  after noted some rash, swelling to face early am on the morning after vaccination with 12 month vaccines, MMR, Varicella, Hib and Hep A . No reported respiratory distress, wheezing or nausea or vomiting. Instructed by provider to administer benadryl every 6 hours for the next 48 hours, and rtc or call 911 if noted wheezing, hives, worsening diarrhea.  Today 5/12/22 Mom states child still has rash to face, no respiratory symptoms reported.
Swelling and pain in left arm pit; Swelling and pain in left arm pit; Serious arm pain first 24 hours; Extreme fatigue; Sweating/chills; Sweating/chills; Received 3rd dose of BNT162B2 Pfizer vaccine; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 29Nov2021 at 15:45 (Lot number: 330308D) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing) and "Hypercholesterolemia" (unspecified if ongoing). Concomitant medications included: BIRTH CONTROL; CITALOPRAM; ZYRTEC and PRAVASTATIN. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot Number: EW0162, Anatomical Location: Left arm, Administration time: 12:00, Route of administration: unspecified), administration date: 16Apr2021, and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot Number: ER8730, Anatomical Location: Left arm, Administration time: 16:00, Route of administration: unspecified), administration date: 28Mar2021, both when the patient was 49 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 at 15:45, outcome "unknown", described as "received 3rd dose of BNT162B2 Pfizer vaccine"; SWELLING (non-serious), AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious), HYPERHIDROSIS (non-serious) and CHILLS (non-serious), all with onset 30Nov2021, outcome "not recovered", and all described as "swelling and pain in left arm pit, serious arm pain first 24 hours, extreme fatigue, sweating and chills". Therapeutic measures were not taken as a result of swelling, axillary pain, pain in extremity, fatigue, hyperhidrosis and chills.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
p/vax pt had chickenpox vesicles on back; chest; legs; feels tired; some itching; vesicles; appear in clusters;
On Dec. 1 About 12 days after having the shot I could hardly move my legs. We were on a cruise and when I went to get up from sitting my legs had no feeling in them, I could not seem to get from one place to another. It was very frightening. This went on for the duration of the cruise, and when I got home I went to see my Ortho. on 12/16/2009 at 2:30 because I thought it may have something to do with my back. He documented my symptoms in my file and noted that the vaccine could be the problem. My symptoms had a similarity to Guillain Barre' syndrome. My nerves in my legs were affected. He told me that I should start seeing improvements in approximately 1 Month. It is now 2/22/2010 and I do feel much better. The vaccine definely had a huge effect on me.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA324603, 2018SA324602, 2018SA324605, 2018SA324604, 2018SA324606, 2018SA324607, 2018SA324608, 2018SA324596 and 2018SA324607 (same reporter). This case involves Elderly male patient (age not reported) was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UJ045AA and expiry date: 30-Jun-2019) via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the refrigerator temperature dropped overnight to 29.1 degrees Fahrenheit and was out of range for 11 hours. It was unknown if any adverse event occurred or not following the vaccination. 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. Documents held by sender: none.
Sore arm and shoulder area, post vax, pt started feeling pain several hours afterwards, then had swollen axillary lymph nodes. Pt had a few muscle cramps, too. Pt was much better in a week.
9/12/19 Fever of 102deg and stopped walking an standing 9/13/19 Fever of 100.7 with regular Tylenol, still not standing or walking and noticeable reduced movement of the legs , crying with passive movement of her legs. Took her in to PCP where she had absent reflexes and was sent home with instruction to use motrin. 9/14/19 Fever 100.6 with regular Tylenol, very fussy and now not crawling in addition to standing or walking. Went to ER where imaging ruled out any hip dysfunction or LE fractures. Absent reflexes. Performed an enema due to stool being seen on abdominal x-ray. Was sent home with instruction to return in 24 hours if not resolved. 9/15/19 Now unable to roll over, sit up independently and control her head. Went back to ER due to progression of weakness and she was admitted to the hospital. Absent reflexes. Lumbar puncture was negative. Presentation consistent with guillain barre syndrome and Physicians got approval to use IVIG treatment. 1st dose administered of IVIG.  9/16/19 No change in muscle tone or movement. No more fever. Spinal/brain MRI with and without contrast completed and was normal. Treated with 2nd dose of IVIG and started antibiotic for UTI as well.  9/17/19 Improvement in her movement with head control and kicking her legs. Beginning to be able to roll to her side. Continues use of antibiotic for UTI. 9/18/19 More improvement in movement, now able to roll and briefly bear weight on her legs with support. Good head control and pushing up from prone into crawl position. Discharged from hospital to home. 9/19/19 More improvement in movement, now able to crawl and pull to stand.
Headache, Sedation, Myalgia, Arthralgia, Fever, Chills, Pain/Itching/Rash @ injection site Narrative:
Had minor flare of psoriasis after 1st dose which resolved spontaneously by the time of the second dose. After the second dose had significant flare of psoriasis with larger plaques, multiple new lesions as well as mild persistent arthralgias that are new.
On 4/22/21 she developed moderately pruritic rash with petechial hemorrhage covering the forearm of the vaccinated arm. The erruption lasted 2 weeks, then gradually faded.
I am only wanting to add to the data. My adverse events were not unexpected. After first dose, the only reaction was sore arm. After second dose, I had chills, sweats, headache, weakness and fatigue for about 48 hours.
Olfactory hallucinations; Blood pressure spikes; Did not receive second dose; Agitated; Rapid heart beat; Tingly lips; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, OLFACTORY (Olfactory hallucinations) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced AGITATION (Agitated), PALPITATIONS (Rapid heart beat) and PARAESTHESIA ORAL (Tingly lips). On an unknown date, the patient experienced HALLUCINATION, OLFACTORY (Olfactory hallucinations) (seriousness criterion medically significant), BLOOD PRESSURE FLUCTUATION (Blood pressure spikes) and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose). On 02-Mar-2021, AGITATION (Agitated), PALPITATIONS (Rapid heart beat) and PARAESTHESIA ORAL (Tingly lips) had resolved. At the time of the report, HALLUCINATION, OLFACTORY (Olfactory hallucinations) and BLOOD PRESSURE FLUCTUATION (Blood pressure spikes) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  The patient called in to report that she did not receive the 2nd dose. She reported that she was still experiencing side effects from the 1st dose of the vaccine.   Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-May-2021 will be submitted with initial report. Follow-up information included new adverse events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Trouble breathing; Dehydrated; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (Trouble breathing) and DEHYDRATION (Dehydrated) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced DYSPNOEA (Trouble breathing) (seriousness criterion hospitalization) and DEHYDRATION (Dehydrated) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (Trouble breathing) and DEHYDRATION (Dehydrated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.  Patient reported that On 14-sep-2021, the patient went for walk and experienced trouble breathing.  Treatment information was not provided.  Company Comment: This case concerns a 35-year-old, male patient with no previous relevant medical history, who experienced the unexpected events of dyspnoea and dehydration. The events occurred 1 day after the second dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 35-year-old, male patient with no previous relevant medical history, who experienced the unexpected events of dyspnoea and dehydration. The events occurred 1 day after the second dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pt recvd 2nd in series of DT vax on 18MAY92; pt recvd 1st vax 13APR92; arm became red, swollen, tense, warm; pt was febrile that noc; Seen @ clinic on 19MAY92 dx cellulitis secondary to vax; tx meds;
pt recv vax 25APR94 & 27APR94 devel a rash on chest area; @ time of the report, pt had not recovered; No further details were provided;
patient reported redness, heat, pain and swelling for 4 days in upper arms with the left arm feeling worse. she reported reaction to family doctor. reaction started on 11/1/2023 and lasted for 4 days. she has now recovered.
Information has been received from  registered nurse concerning a 11 year old female who on 11-OCT-2006 at 15:30, was vaccinated with the first dose of Gardasil (yeast) (lot number 654540/0800F) intramuscularly in the left deltoid.  Concomitant vaccinations included hepatitis A vaccine (inactive) (MSD) (lot number 652809/1008F) intramuscularly in the right deltoid, meningococcal ACYW conj vaccine (MENACTRA) (lot number U2002AC) intramusculary in the right deltoid and (ADACEL) (lot number C2455AA) intramuscularly in the left deltoid.  On 11-OCT-206 the patient stated that her arm tingled and felt numb at the injection site (arm not specified). Tingling and numbness lasted one hour. After that the patient stated the arm was just sore at the injection site. On 27-DEC-2006 was vaccinated with the second dose of Gardasil vaccine (yeast). On 27-DEC-2006 the patient again experienced arm tingled at injection site, but it "just lasted a few minutes".  Additional information is not expected.
Fever, arthralgia, cervical & retroauricular adenopathy, conjunctivitis, pharyngitis, rash-macular, erythematous rash beginning on face spreading to trunk & extremities;
Started with fever night shots were given (2/16) Hard swollen lump that was very hot was noticed 5 days after getting shotshib/heb/mmr/chicken pox & flu.  Dr did say it was either the MMR or the Flu shot that is the cause.  Dr said was more than likely an infection caused by the shot and she is now on an antibotic for 10 days.  Hopefully it clears up.  very painful.
I was 6 weeks along and I was suppose to deliver in January 2022. I missed carried May 17, 2021. It can take upto 4 weeks with the miscarried.
Narrative: Patient developed chest pain following first dose of Pfizer covid vaccine. Patient was sent to outside emergency department for follow up. No additional information available. Patient later notes indicate no poor outcomes.
0.5 mL of IPV was drawn up and injected into the pt. instead of PCV 13.
Arm soreness several days out from vaccination date. No site reaction visible. Arm is still painful upon raising up.
pt was sleeping 3-4 hrs p/vax given;noted to be gagging & then apneic;was stimulated & taken to clinic
w/in 12 hrs p/vax, pt exp a fever of 104; tx w/APAP; pt recovered;
Itching, redness and minor swelling at injection site (2 inches in diameter) 8 days after receiving injection.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT) lot# M039200 expiration date 03-MAY-2019. The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 07-FEB-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD injection, lot # N022972, expiration date 19-FEB-2019, for prophylaxis (frequency, route and anatomical location were not provided). The administered dose of vaccine experienced a temperature excursion in the range between 6°F to 14°F during 6 hours as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA007255: US-009507513-1803USA007256: US-009507513-1803USA007257: US-009507513-1803USA007258: US-009507513-1803USA007259.
Throat tightening. 11/23/09 Hosp. recs received for dates 11/11/09. DX: Allergic reaction to H1N1 vaccine. Chief c/o throat swelling. Assessment: WNL, sinus tachycardia, cardiac murmur(+).
My adverse reaction. besides fatigue, was on the 5th day after the left arm Booster injection.  I experienced swelling , aches and inflammation under my left arm.  I could not wear a bra.   I took over-the-counter Aleve and/or Tylenol and used a heating pad for those weeks.  I reached out to my doctor on/around October 5th to report my symptoms and discuss whether she thought it could be from 1.  The Booster and 2.  could it be a lymph node issue.    By October 8th, it started to resolve and feel better.  I am reporting this because I believe the Booster dose was a trigger to my lymphatic system.   This reaction was frightening and uncomfortable for11 days after the initial injection.  I think you should be aware of this.  Had I known, I would NOT have received the Booster vaccine.