chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. refers to feeling dizzy and is placed on the stretcher in a supine position, after verifying vital signs Pulse 63, B/P 90/60 16 Respirations, Dextro 126. Doctor is notified at 5:51 and recommends monitoring her for 30 minutes.
This is a spontaneous report obtained from a contactable nurse through a sales representative. A male patient of an unspecified age and ethnicity received, on an unspecified date, the first dose of TRUMENBA (Lot. M37316, Expiration date: 30Apr2017) single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced fatigue, muscle and joint paint, and chills. He took TYLENOL. The patient developed also discomfort but was getting better at time of this report. Clinical outcome of the other events was unknown. Patient did not have shortness of breath, dizziness or rapid heart rate. Follow-up (11AUG2016): Follow-up attempts are completed. No further information is expected.
Chest pain, throat tightening, bilateral, sharp pain lungs with wheezing breath sounds, severe inflammation at injection site, GI pain and pattern alteration, cessation of menstruation during menses following administration of vaccine.
This is a spontaneous report from a contactable consumer or other non hcp.  A 76-years-old female patient received bnt162b2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 as 1 st dose single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient is a 76-year-old female patient who received her 1st dose of the COVID Vaccine a week ago today, 20May2021. She mentioned that she experienced basically every side effect on the fact sheet except nausea. She had fever, chills, injection site swelling. injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and a general feeling of unwellness. She mentioned that this lasted for 5 days and all came in gradually and not all at once. She is better now as of calling. She was asking if this is to be expected with the 2nd dose as well. The patient enquired whether using a heating pad would affect the effectiveness of the vaccine. The outcome of the events fever, chills, injection site swelling, injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and general feeling of unwellness were recovered. Information on the lot/batch number has been requested.
Information has been received from a physician and registered nurse concerning a 13 year old female patient who on 19-JAN-2007 was vaccinated IM in the right deltoid with a dose of Zostavax (lot#652947/1411F) instead of Gardasil. Concomitant vaccination on 19-JAN-2007 included influenza virus vaccine (unspecified). No adverse experiences were related to this event. On 20-JAN-2007 the patient returned and was vaccinated in the left deltoid with a dose of Gardasil (yeast) (lot#654510/0962F). The nurse reported that the vaccines were stored in separate bins which were clearly labeled and the wrong vaccine was selected by a new nurse. There was no product quality compliant involved. Additional information has been requested.
knees got so stiff/both her knees have stayed stiff; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Feb2021 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Spine Issues", start date: 2003 (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing), notes: for 30 years; "Knee replacement" (unspecified if ongoing), notes: she had both knees replaced about 5 years ago; "car accident", start date: 2003 (unspecified if ongoing). Concomitant medication(s) included: CBD OIL (ongoing). The following information was reported: JOINT STIFFNESS (non-serious) with onset 10Feb2021, outcome "not recovered", described as "knees got so stiff/both her knees have stayed stiff".  Additional information: Patient said she had been medicating with CBD oil and medical marijuana for the past 3 years. Patient wasn't sure of the lot number and stated it was either E19262, EI9262, or EL9262. Events did not result to physician office and emergency room visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no additional vaccines were administered on same date of the Pfizer Suspect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
redness on the skin near the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (redness on the skin near the injection site) in a 24-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027B221A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced VACCINATION SITE ERYTHEMA (redness on the skin near the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness on the skin near the injection site) had not resolved.            Concomitant product use was not provided by the reporter.  On 05-Apr-2021, the patient received first dose of intramuscular Moderna COVID-19 vaccine (lot number 026B21A).  On 03-May-2021, received second dose of intramuscular Moderna COVID-19 vaccine (lot number 030B21A).  On 19-Nov-2021, received third dose of intramuscular Moderna COVID-19 vaccine (lot number 013F21A).  The redness has not changed in any way since patient first noticed it.  Patient has not taken any medications or treatments.
At 1:35pm  patient was sitting in post-ob accompanied by her son. She complained of tingling sensation over entire body mainly in hands. assessed patient no distress or SOB, took vitals Bp 115/66 Hr 58 Resp 16.  Patient was observed for an extra 15 mins and stated that the tingling sensation subsided. Patient stated that if it returned she would contact MD advised patient to go to ER.  Patient left facility via ambulating with her son at 1:59pm.
Anaphylaxis reaction to 3rd dose of Pfizer personal epi-pen used 911 called EMS responded.
heart burn; This is a spontaneous report from a contactable nurse (patient). A 29-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was unknown), via intramuscular in arm right on 18Dec2020 at 10:30 AM (at the age of 29-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient with known allergies were reported as none. The patient's concomitant medications included metformin, levothyroxine sodium, loratadine (CLARITIN [LORATADINE]), all were taken for an unspecified indication. It was reported that, the patient was not pregnant at time of vaccination. No covid prior vaccination and covid tested post vaccination was reported as yes. On an unspecified date, at 2 weeks post first vaccine, the patient experienced heart burn for about a week, not a huge deal. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the event included was the patient went to her PCP where additional labs were drawn CBC, CMP, covid antibodies and covid test. On 09Feb2021, the patient underwent lab tests and procedures which included CBC, CMP, covid antibodies, covid test, all were resulted as unknown result and nasal swab, resulted as negative. The outcome of the event was recovering.  Follow-up attempts completed. No further information expected.
running nose; sneezing; allergy reaction; terrible diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (terrible diarrhea), RHINORRHOEA (running nose), SNEEZING (sneezing) and HYPERSENSITIVITY (allergy reaction) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced DIARRHOEA (terrible diarrhea). On an unknown date, the patient experienced RHINORRHOEA (running nose), SNEEZING (sneezing) and HYPERSENSITIVITY (allergy reaction). At the time of the report, DIARRHOEA (terrible diarrhea) had not resolved and RHINORRHOEA (running nose), SNEEZING (sneezing) and HYPERSENSITIVITY (allergy reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
h/a 11/8/99, 11/9/99  watching TV-jerking movements of whole body mostly in arms;pt was found drooling & unresponsive;
This spontaneous report was received from a consumer refers to a 12 year old female patient who is her daughter. No medical history or drug reactions were reported. On an unknown date in October 2013, the patient was vaccinated with a dose of recalled GARDASIL (lot # J007354, expiry: 20-FEB-2016). No concomitant medications were reported. On an unknown date in October 2013, within one hour of vaccination the patient developed swelling and itching at injection site. Patient took ALLEGRA. No laboratory tests were performed. No medical attention was sought. The symptoms had resolved and the patent recovered from swelling and itching at injection site on an unspecified date. Causality was not reported. Additional information has been requested.
During a refill call for Stelara, the patient's mother reported that the patient was hospitalized due to a reaction to a flu shot. He experienced a rapid heart rate, sweating, and nausea. The flu shot information was not provided. Note that the following product information reflects the last dispense by pharmacy (delivered 28 Oct 2021) and was not provided by the primary reporter.
approx 2hr p/vax pt devel hives around inj site which then spread to the entire arm & then to other areas of body;pt tx w/DPH (w/limited improvements), then w/methylprednisolone dosepak;intermittent hives still occurring;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-DEC-2015 at 07:27, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 7.9 and 4.6 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
On 3/2/21 I administered the Moderna Covid 19 vaccine to patient about 9:20am.  On her PCQF she indicated that she had allergies to milk, shrimp, wheat, almonds and sesame.  She informed me she had no issues with medications or vaccines.  About 936am she came to me saying her throat felt itchy.  I gave her 25mg of diphenhydramine.  A few minutes later she told me she felt her tongue swelling and I gave her another 25mg of diphenhydramine.  At that point she told me her tongue felt very itchy and swollen and I called 911.  EMS arrived 14 minutes later and checked her out.  Her vitals were okay and she declined going to the hospital.  Patient sat for another 30 minutes or so and symptoms seemed to improve.  Patient has an EpiPen at home and patient bought a bottle of diphenhydramine to bring home with her.  I advised patient if any symptoms arise after the diphenhydramine wears off to take another dose.  If things seem to be worse she may need to use her EpiPen or call EMS.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There was no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Doctor ordered Pfizer booster #1 vaccine,  it appeared that he had not received his Pfizer booster #1 vaccine , so  the doctor ordered the Pfizer booster #1 vaccine as that's what his previous 2 doses were per mom. After the vaccine was administered the Medical Assistant found on the COVID-19 vaccine card patient had indeed received Pfizer booster #1 on 1/14/22.  Patient received an extra Pfizer booster vaccine, which patient was not due for. Patient started having arm soreness, fever, and headaches for 2 days and resolved. Mother was notified of error. Patient doing well.
Information has been received from a nurse concerning a female who on 13-OCT-2008 was vaccinated with PNEUMOVAX vaccine (lot # 660717/0224X). On 13-OCT-2008, after receiving PNEUMOVAX vaccine, the patient experienced swelling and redness at the injection site. It was not known if this was the patient's first dose of PNEUMOVAX vaccine. The patient had completed two courses of unspecified antibiotics and was recovering at the time of this report. The patient visited the office for medical attention. This is one of several reports from the same source. Additional information has been requested.
got the shot, a week later had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: This case was reported by the patient's friend via interactive digital media. The patient received dose of Shingles vaccine and a week later patient had severe case of shingles. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note: "Patient is a 90 YO female with h/o paroxysmal atrial fibillation, HTN, CKD stage 3, CAD, and subdural hematoma presenting with fatigue, cough, and wheezing along with rapid heart rate in the 200s at home. She tested positive for COVID at home the day prior and Paxlovid was prescribed, however she did not start taking it yet. In the ED results showed: Lactate 2.9. repeat 1.5, BNP 2500, WBC 9.6, Afebrile, Cr 1.3, CXR significant for LLL pneumonia with mild effusion and Abd/pelvis CT significant for hepatic cirrhosis; Given 1 L IV fluids in ED. She was given rocephin and doxycycline pending viral panel. The viral panel showed parainfluenza # infection, therefore antibiotics were discontinued. She was placed on amiodarone drip and cardiology consulted. Overnight she converted to NSR with a heart rate in the 60s-70s. Dr. increased metoprolol to 50 and started her on a short course of PO amiodarone and stopping the drip. Of note the patient's respiratory status remained stable throughout with coughs and some subjective dyspnea without the need for oxygen. Crea stayed at 1.3, which may be her new baseline given that it was 1.2 in December.The case was discussed with Dr. who felt that she would be safe to discharge home from a cardiac standpoint on a short course of amiodarone 200 daily until her follow up with him in 2-3 weeks. Upon my examination the patient had improved significantly and her respiratory status was stable as well. Per PT recommendations patient could return home with home therapy. "
Pt recvd 3 doses of Recomb last dose 24AUG90 & @ time of report FEB91 pt was five mo pregnant; during last trimester of pregnancy pt exp back problems, UTI, & kidney infect; Pt tx ATB; during labor umbilical cord wrapped arounds child neck;
The initial spontaneous report was received from a medical assistant to an unspecified number of patients of unknown ages and genders. There were no concomitant medications, concurrent conditions or medical history reported. The reporter stated that since 06-MAY-2015, the patients were inadvertently vaccinated with unspecified number of doses of improperly stored ROTATEQ, oral solution (lot # K020181 with expiration date 24-JUN-2016 and lot # K013861 with expiration date 18-MAY-2016; dose and strength were not provided). Product quality complaint (PQC) was not involved. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
lt arm reddened, hard, swollen, warm 3"x2"-from shoulder distally;
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium
woke up with hives on arms, thighs, behind knees, stomach.   took cool shower, which helped.  hives went away after about 30 hours
I experienced within the next day horrible migraine headaches. My headaches have not resolved. M y headaches are constant and I do take OTC Tylenol and ibuprofen which only temporarily relieves my pain.
On 06.7.22,  i started getting pains in my stomach really bad. I started spitting up. I went to the hospital, they gave me some shots with needles with some iv. Hospital. I went home, i started spitting up. and from my stomach to my back. My hand is real swole, it's like an infection in my hand and stomach. I went to Hospital.
Pain in the chest after getting it heart beating fast; Pain in the chest after getting it heart beating fast; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6208, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 13Mar2021 at 12:00 (at the age of 21 years old) as first dose, single for COVID-19 immunisation. The facility where the vaccine was administered was reported to be "other". The patient's  medical history and concomitant medications were not reported. The patient experienced pain in the chest after getting it heart beating fast on an unspecified date. Outcome of all events was unknown.  No follow-up attempts are possible.  No further information is expected.
This case was reported by a healthcare professional (nurse) and described the occurrence of not responding to therapy in a 49-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline), HAVRIX and ENGERIX B. Concurrent medical conditions included allergy to MOTRIN, allergy to PYRIDIUM, aspirin allergy, human immunodeficiency virus and lactose intolerance. Historic vaccination included pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given in 2004. Concurrent vaccination included pandemic vaccine H1N1 (non-gsk); Novartis; unknown; unknown given on 7 January 2010; pneumococcal vaccines (non-gsk); Merck; unknown; unknown given on 7 January 2010. Concurrent medications included HALCION, COLACE, KLONOPIN; with TWINRIX series NEURONTIN, SOMA, ESTRACE cream, FLEXERIL; with ENGERIX B series INVEGA, DESYREL, Benztropine mesylate, ZOLOFT and Morphine. On 7 January 2010, 4 March 2010 and 18 November 2010 the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (unknown route). On 21 June 2011 the subject received a dose of HAVRIX as the 4th dose in the series (unknown) and experienced wrong vaccine administered. The nurse reported that the subject was administered ENGERIX B, but the lot number provided for the vaccine administered was for a HAVRIX vaccination. On 27 July 2011 and 29 December 2011 the subject received a dose of ENGERIX B (unknown) as the 5th and 6th doses in the series (1st and 2nd ENGERIX B vaccine, but the nurse thought it was the 2nd and 3rd). On 26 January 2011, 69 days after vaccination with TWINRIX, 11 months after vaccination with TWINRIX, 13 months after vaccination with TWINRIX, the subject experienced not responding to therapy. Blood work was drawn on 26 January 2011 after 3 doses of TWINRIX and the subject showed seroconversion for Hepatitis A, but "non-immune" for Hepatitis B. On 21 February 2012, 54 days after vaccination with ENGERIX B, 7 months after vaccination with ENGERIX B, the subject experienced decreased therapeutic response. The nurse thought that the subject had received 3 doses of ENGERIX B, but the first dose of what the nurse reported as ENGERIX B was HAVRIX based on the lot number. According to the nurse, the blood drawn on 21 February 2012, showed "borderline antibody protection". On 06 April 2012, updated lot number information was received from a safety review. The lot number was reported as AHAVB944BB for HAVRIX with expiration of 17 March 2013 from the reporter; however, based on safety lot number review, the reported lot has an expiration of 29 March 2013.
Fever (100.8 degrees), body aches (in back), chest tightness - treated with Tylenol and sleep - symptoms started around 10 pm and were resolved by morning
As per caregiver patient claims she has pain in her shoulder and feels like it is SIRVA (Shoulder Injury Related To Vaccination) shortly after vaccination. Patient called within one hours on same day of vaccine to let pharmacist know that patient is having SIRVA because of the vaccination.
Pt began having myalgias, fever, chills, H/A, all within 48 -72 hours after vaccination, then began having chest pain 3-5 days later.
FEVER COVID-19    -  Primary    Relevant Medications   predniSONE (DELTASONE) 20 mg tablet   BMI 22.0-22.9, adult       Fever, unspecified fever cause       Relevant Orders   POCT COVID-19 Antigen (Completed)   Hypoxia       Relevant Orders   POCT COVID-19 Antigen (Completed)   Bradycardia       Relevant Orders   POCT COVID-19 Antigen (Completed)    A&P: Rapid COVID swab taken today and positive. Pt's prednisone was extended. Her duonebs was refilled as well. Given pt's high risk status, she is eligible for monoclonal antibody infusion so this was set up for her. Pt and husband think her status actually started to change on Sunday so this was documented at onset of symptoms. The fever this morning was her first episode. At the office visit today, pt is afebrile and her O2 sat is good. Hence ok to proceed with outpatient management. She is fully vaccinated for COVID. Conservative measures also advised. Return or call back in if with new or worsening symptoms especially if with difficulty breathing    Registered Nurse Specialty:  Oncology Progress Notes    Signed Encounter Date:  8/6/2021     Signed        Hide copied text  Hover for details Patient here for Regeneron infusion. Patient tolerated infusion well and was monitored for 1 hour post. Upon discharge, patient was provided a pulse ox, thermometer, after visit summary and follow up instructions. No adverse events noted during this visit.    Electronically signed by RN at 8/6/2021  9:50 AM