chrisvoncsefalvay/vaers-outcomes huggingface dataset:
While seated reviewing email?.  Developed chest pain in lower sternum which gradually traveled up to left neck area and remained steady,  felt slightly somewhat weak, checked pulse  on watch and wrist.  It was slower than normal?about 57.  I lay down and took my blood pressure.intermittently, .it remained normal but my pulse dropped to 52-58 and remained low for 3 hrs.  Initially took warm water, then 2 Tums, without relief.  I had expired SL Nitroglycerin in fridge?took one. Chest pain subsided after 20 min.  Had fatigue for a few days.
large local reaction versus cellulitis 15x20cm red hot area at the injection site, painful, also reported low grade fever
This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient had a bad reaction and was afraid of receiving the 2nd dose of SHINGRIX. The pharmacist declined to provide additional details as the patient was vaccinated at the different location. No further information was available.
15 minutes after receiving the vaccine the pt stated her heart rate was high and had chest pain. Also, she stated that she felt dizzy with nausea.
Experiencing throat congestion with mild tingling on tongue and chest tightness with a slight dry cough
No additional AE reported.; Nurse reported adult patient was accidently administered a pediatric dose of VAQTA; This spontaneous report was received from a nurse, referring to 19-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 05-MAY-2023, the patient was accidentaly vaccinated with a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection (0.5 mL, lot #1966105 which has been verified to be a not valid lot number, expiration date was reported as 06-FEB-2024, route of administration and anatomical location were not provided) for prophylaxis (Adult use of a child product). No further information provided. No additional adverse event reported (No adverse event). No product quality complaint (PQC) reported.
Same day of vaccine in the night I started to get chills & low grade fever I took Tylenol. Then later on that night I woke up & i was sweating & I had body aches. I also lost a little apatite. This lasted about 36hrs.
Flu-like symptoms developing the same evening that vaccine given (1:00 PM). Fitful sleep, felt bad enough that he was unable to work the next day. No documented fever.
Breakthrough case admission after three vaccines Pfizer 1/27/21 Lot# EL9261;  Pfizer 2/15/21 Lot# EM9810;  Pfizer 9/2/21 Lot# FC3184
10x11cm, raised, in parts, with some induration; upper right arm - warm; Placed on Keflex 500g TID x 7Q
Pt's momther called me on 20FEB92; pt started running a fever p/leaving hlth dept; mom administered APAP, but fever continued to inc to 105 @ which time sz began; pt taken to hosp;
Blurred, Double vision, weakness, dizziness, vomiting, 1 hour......fatigue... slept for24 hours
Started with body aches, fever up to 100.5, redness, swelling, heat, to injection site. Generalized symptoms lasted two days. Injection site pain started improving over 3 days but the redness and swelling persisted and even got larger.
Pinching pain on injection side, including left breast that radiates to left shoulder blade for more than 2 weeks.
Pt received 2nd booster against standing orders. Patient was only 38 years old.   No adverse effect
facial flushing and redness, mild swelling.  No shortness of breath or itching.  Started within 1-2 minutes of receiving vaccine Treatment: Benadryl 50mg IM within 5 mins of reaction onset.  Observed for 30 mins; feeling better; sent home; advised to call 911 if recurrent or new symptoms
Case number PHEH2014US024325, is an initial spontaneous report received from a nurse on 02 Dec 2014 with a follow information received from the nurse on 19 Jan 2015. This report refers to a 14 year old male patient. Medical history and concomitant medication were not reported. His vaccination history included administration of previous FLUVIRIN (batch number: not reported) which was previously tolerated. He was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly in the right deltoid at a dose of 0.5 ml on 05 Nov 2014. Nurse reported that pre-filled syringe (PFS) of FLUVIRINI was stored at 49 degree F for 1 hour and 15 minutes. The reporter confirmed that the patient did not experience any adverse reaction following administration of incorrectly stored vaccine. Follow up information received from the nurse on 19 Jan 2015: Updated vaccination history, site of vaccination and reporter's comment.
Within 10 minutes of receiving the vaccine, I experienced chest tightness/discomfort. These symptoms worsened over the first day (Saturday August 7) and persisted through August 9. I was not able to do any strenuous physical activity. Today is August 20 and the symptoms have lessened significantly but I still have a noticeable discomfort in my chest and am still short of breath to the point where I avoid strenuous activity. The chest discomfort affects my ability to get to sleep at night.
Patient started feeling light headedd and experienced chest pain about 5 min post vaccination. She has history no heart attack and described the pain similar. Took HTG tab and ambulance was called in. Pt felt fine after being checked out.
Within 42 to 78 hours after 1st and 2nd dose, she had constant menstrual bleeding that heavy with large blood clots/She is still bleeding heavily; She had burning in nose.; She could taste chemical in her mouth.; She started with immediate burning and pain at injection site.; She had mild fatigue on same day and following day after 1st dose and 2nd dose.; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Within 42 to 78 hours after 1st and 2nd dose, she had constant menstrual bleeding that heavy with large blood clots/She is still bleeding heavily), NASAL DISCOMFORT (She had burning in nose.), DYSGEUSIA (She could taste chemical in her mouth.), VACCINATION SITE PAIN (She started with immediate burning and pain at injection site.) and FATIGUE (She had mild fatigue on same day and following day after 1st dose and 2nd dose.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1088021A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included VITAMINS NOS and IRON for an unknown indication.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced VACCINATION SITE PAIN (She started with immediate burning and pain at injection site.) and FATIGUE (She had mild fatigue on same day and following day after 1st dose and 2nd dose.). On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Within 42 to 78 hours after 1st and 2nd dose, she had constant menstrual bleeding that heavy with large blood clots/She is still bleeding heavily), NASAL DISCOMFORT (She had burning in nose.) and DYSGEUSIA (She could taste chemical in her mouth.). At the time of the report, HEAVY MENSTRUAL BLEEDING (Within 42 to 78 hours after 1st and 2nd dose, she had constant menstrual bleeding that heavy with large blood clots/She is still bleeding heavily) had not resolved and NASAL DISCOMFORT (She had burning in nose.), DYSGEUSIA (She could taste chemical in her mouth.), VACCINATION SITE PAIN (She started with immediate burning and pain at injection site.) and FATIGUE (She had mild fatigue on same day and following day after 1st dose and 2nd dose.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment provided as birth control.   This case was linked to MOD-2021-313162 (Patient Link).
Not well; Big red circle around injection site/affected area 2.5 inches on arm/could see hole in arm; 2nd dose scheduled 45 days after the first dose; A spontaneous report was received from an 87-year-old female patient concerning herself who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced events of not well, big red circle around injection site/affected area 2.5 inches on arm/could see hole in arm, and the 2nd dose scheduled 45 days after the first dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, 4 days prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Batch number: 029L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. The 2nd dose was scheduled 45 days after the first dose.   On an unknown date, the patient was not well. On an unknown date, the patient experienced big red circle around injection site. The affected area was 2.5 inches on arm. The patient stated could see hole in arm. It lasted for 6 days and went away.   The patient did not take any treatment, went away on own.   Action taken with mRNA-1273 in response to the events was unknown.  The event of 2nd dose scheduled 45 days after the first dose was considered resolved, while the outcome of the events of not well, big red circle around injection site/affected area 2.5 inches on arm/could see hole in arm was unknown.; Reporter'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.
Patient reports losing control of fingers/hands momentarily/temporarily.  There is also a surge of pain down his right should to his hand.  His example is when he was drinking a cup of coffee, his hand temporarily lost control of the cup and the coffee spilled all over him.
Information has been received from a licensed practical nurse concerning a healthy patient over 65 years old who was recently vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647029/0460P). Subsequently, the patient developed a red, swollen hot arm from the shoulder down to the elbow and had a high glucose level. Unspecified medical attention was sought. No product quality complaint was involved. The out come was unknown. It was also reported that 4 other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647029/0460P) and developed AE's WAES0408USA01647). No further information is expected.
Waited 15 minutes as required and left. At 20-25 minutes as I was driving my mouth began to severely itch. Arrived home,  and took Benadryl  which lessened the itch and it was almost gone by 2am on 2/24/2021.
Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, continued weakness, diaphoresis, and mild nausea for greater than 24 hours Narrative: Symptoms persisted for greater than 24 hours, limited activites
No adverse event; HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date.) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     Patient had no known relevant medical history, allergy,concomitant diseases and risk factor.     On 08-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date.).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant information was reported. Suspect product dosage text was reported as unknown. The 2.5ml vial was thawed directly from the freezer each time they needed to administer a dose. The vial did not underwent temperature excursions. No treatment information was provided. This case is reported for patient 8 out of 9 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729345 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729345:Same reporter
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: HYPERTONIC BLADDER (non-serious) with onset Dec2021, outcome "unknown", described as "Overactive bladder". The event "overactive bladder" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertonic bladder. Additional information: It was reported that, patient received booster for COVID 17Dec and within a week she had an overactive bladder. she didn't realize what the problem was at the time. she thought she had vaginal infection. she made an appointment to see my gynecologist in Feb and he did tests for both urinary and vaginal disease. Everything was negative. In Apr I started on Ditropan XL. she believe it was due to the COVID booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash started 9 days after MMR (Varivax). No fever. Viral vs 2 degree-MMR?
After Prevnar #1 and #2 - irritability, kicking, sleepless and hive-like to sunburn rash over entire body lasting 72 hours
1425-vaccine administered.  Client and husband were requested to stay on site for observation for 30 minutes due to history of anaphylaxis and car was moved close to staff tent.  1445-check in by vaccinator, client denied any problems.  1455-vaccinator went to check on client prior to discharge to home.  Vaccinator noted flushing of the right side of the client's face.  Call for help placed.  1457-BP 140/80, HR regular, lungs clear to auscultation bilaterally.  Right-sided facial edema and erythema noted, along with right neck and shoulder hives.  Client denied itching of the throat, difficulty breathing, or any other problems.  Oropharynx was visualized, skin was pink and intact, with no hives or edema noted.  Close and constant observation provided.  1502-client reported feeling like her throat was itchy and it was more difficult to get air in.  Is scratching here and there to the right face and shoulder.  Close and constant observation provided, emergency medication prepared.   Epinephrine auto-injector given to right lateral thigh due to continued report of itchy throat and difficulty breathing.  EMS was called.  1507-BP 150/90, HR regular.  Client reports she is throat itching has improved, it is easier to breathe.  1508-facial flushing and hives are clearing and facial edema is less.  1515-EMS on site, they took over care, then client was transported to the hospital with husband following in the car.
Cold chill attack, shaking uncontrollably, headache, muscle soreness all over body.
Large red area around the injection site.  This gradually faded and then returned 8 days after the injection.  This eventually faded and went away. After the second vaccine injection on February 25, red itchy blotch developed near but not at the injection area.  That is still present
This case was reported by a consumer and described the occurrence of influenza in a female subject of unspecified age who was vaccinated with influenza virus vaccine (Influenza vaccine (unspecified), manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (manufacturer unspecified). At an unspecified time after vaccination with an Influenza vaccine, the subject experienced influenza, vaccination failure and allergic to flu shots. Per the source document: "Patient can't get the flu shot (manufacturer unknown) because they are allergic. When they have received the flu shot they have gotten the flu. No further information was provided." This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified.
04/24/01:  Vaccines given in morning (before 11:00 ) Received DTAP #4 and Hib #4 in left lateral thigh.  Approximately 4 hours after receiving vaccine child developed large red area (also warm and hard) in area of shots.  Child had temperature of 100.5 that night 11:00 pm and was given tylenol.  Child active walking and playful hot affected area is uncomfortable when touched.
Information has been received from a pharmacy technician referring to unspecified patients of unknown age and gender. Information about the patients' concurrent condition, medical history, drug reactions/allergies and concomitant medication was unknown. Since 21-DEC-2016, the patients were each vaccinated with a dose of improperly stored PROQUAD (dose and route were unknown, lot # reported as M036158 with expiration date 12-FEB-2018, lot # M033908 with expiration date 16-JAN-2018, lot # M032496 with expiration date 02-JAN-2018) for prophylaxis. No adverse effect was reported. The vaccines had been exposed under temperature 41 Fahrenheit for 9 hours and 15 minutes and there was no previous excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA012911.
Became much sicker than when they had Covid-19; Respiratory symptoms; Fever of 101°F; Muscle pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ILLNESS (Became much sicker than when they had Covid-19), RESPIRATORY DISORDER (Respiratory symptoms), PYREXIA (Fever of 101°F) and MYALGIA (Muscle pain) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included SARS-CoV-2 acute respiratory disease (Mild symptoms, including a slight fever) on 17-Feb-2021.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced ILLNESS (Became much sicker than when they had Covid-19), RESPIRATORY DISORDER (Respiratory symptoms), PYREXIA (Fever of 101°F) and MYALGIA (Muscle pain). At the time of the report, ILLNESS (Became much sicker than when they had Covid-19), RESPIRATORY DISORDER (Respiratory symptoms), PYREXIA (Fever of 101°F) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. On 27-Jan-2021, Body temperature: 101 f (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  HCP reported that after the first dose the patient became much sicker than when they had Covid-19. HCP states it was like a strong acquire immune response, not an allergic one.
Mom noticed day after vaccine given, had 1/5 dollar sized area of redness on thigh. Over next day increase in size, redness, questionable itchy, at times painful. Area of redness 3"x4", indurated, warmth outlined area of redness. Started on Keflex 250mg TID for 7 days and Atorvax, Hep TID.
first dose in October 2021, not yet received second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on October 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was not recovered/not resolved.       Additional Information: GSK Receipt Date: 27-May-2022 Reporter's Comments: The case was reported by patient. The patient reported received first dose of Shingrix in October of 2021 and not received second dose yet. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
Patient started feeling faint. We call the paramedics and they came but the patient was already feeling better. Patient went home with her mother.
This is a 59 year old male that presented to the emergency department at approximately 1447 on 04/27/2021 with sudden onset of left upper and lower extremity weakness and left-sided numbness of his face. The patient stated he may have had some weakness the previous night (04/26/2021), but mostly noticed it when he woke up around 0900 on 04/27/2021. The patient stated he may have also had some transient speech changes which he felt were improved upon emergency department presentation. The patient stated he took an 81 mg aspirin prior to hospital arrival. The patient was overall hemodynamically stable in the emergency department. Past medical history is only significant for benign prostatic hyperplasia. This patient has no history of previous CVA or TIA, no smoking history, no history of clotting disorders, no recent trauma or other injury. CT head revealed a small right frontal subarachnoid hemorrhage with no midline shift and concern for clot. CTA head and neck perfusion study was significant for ?perfusion abnormality involving the right frontal lobe in the region of known subarachnoid hemorrhage, likely related to dural venous sinus thrombosis involving the posterior aspect of the superior sagittal sinus, left greater than right transverse sinus, and left sigmoid sinus.? This patient is noted to have recently received his Johnson and Johnson vaccine on 03/20/2021. The patient was admitted to the intensive care unit. Neurology and hematology were consulted.